S-4/A: Registration of securities issued in business combination transactions
Published on July 20, 2007
As
filed with the Securities and Exchange Commission on July 20,
2007
Registration
No. 333-143587
___________________________________________________________________________
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
____________________
AMENDMENT No. 1
TO
FORM
S-4
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
___________________
ACCESS
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
|
|
|
|
|
|
Delaware
|
|
3841
|
|
83-0221517
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
|
(Primary
Standard Industrial
Classification
Code Number)
|
|
(I.R.S.
Employer
Identification
Number)
|
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
(Address,
including zip code, and telephone number, including area code, of registrant’s
principal executive offices)
___________________
Mr.
Stephen R. Seiler
President
and Chief Executive Officer
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
(Name,
address, including zip code, and telephone number, including area code, of
agent
for service)
___________________
Copies
to:
|
John
J. Concannon, III, Esq.
|
Terrance
J. Bruggeman
|
Adam
Lenain, Esq.,
|
|
Bingham
McCutchen LLP
|
Executive
Chairman
|
Foley
& Lardner LLP
|
|
150
Federal Street
|
Somanta
Pharmaceuticals, Inc.
|
402
W. Broadway, Suite 2100
|
|
Boston,
MA 02110
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19200
Von Karman Avenue, Suite 400
|
San
Diego, CA 92101
|
|
(617)
951-8000
|
Irvine,
CA 92612
|
(619)
685-4604
|
|
(949)
477-8090
|
||
Approximate
date of commencement of proposed sale to the public: As soon as practicable
after the effectiveness of this registration statement and the satisfaction
or
waiver of all other conditions under the merger agreement described herein.
If
the
securities being registered on this form are being offered in connection with
the formulation of a holding company and there is compliance with General
Instruction G, check the following box. མ
If
this
form is filed to register additional securities for an offering pursuant to
Rule
462(b) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. མ
If
this
form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. མ
CALCULATION
OF REGISTRATION FEE
|
Title
of Each Class
of
securities to be registered
|
Amount
to be registered
|
Proposed
maximum offering price
per unit
|
Proposed
maximum aggregate offering price
|
Amount
of
registration
fee
|
|
Common
Stock, $0.01 par value per share
|
1,500,000
(1)
|
$4.93
(1)
|
$7,530,000
|
$227.03
(2)
|
(1)
Estimated solely for the purpose of calculating the registration fee pursuant
to
Rule 457(c) under the Securities Act of 1933. For the purposes of this
table, we have used the average of the high and low prices as reported on the
OTC Bulletin Board on June 1, 2006.
(2)
The registrant previously paid $227.03 of the registration fee
in connection with the filing of its Form S-4 Registration Statement filed
with
the Securities and Exchange Commission on June 8, 2007.
_________________
The
registrant hereby amends the registration statement on such date or dates as
may
be necessary to delay its effective date until the registrant shall file a
further amendment which specifically states that the registration statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933, as amended, or until the registration statement shall
become effective on such date as the Securities and Exchange Commission, acting
pursuant to said Section 8(a), may determine.
The
information in this proxy statement/prospectus is not complete and may be
changed. Access may not sell these securities until the registration statement
filed with the Securities and Exchange Commission, of which this document is
a
part, is declared effective. This proxy statement/prospectus is not an offer
to
sell and it is not soliciting an offer to buy these securities in any
jurisdiction where the offer, solicitation or sale is not permitted or would
be
unlawful prior to registration or qualification under the securities laws of
any
such jurisdiction. Any representation to the contrary is a criminal
offense.
Subject
to completion July 20, 2007
| Access Pharmaceuticals, Inc. |
Somanta
Pharmaceuticals, Inc.
|
1,500,000
Access
Pharmaceuticals, Inc.
Common
Stock
MERGER
PROPOSED - YOUR VOTE IS VERY IMPORTANT
The
boards of directors of Access Pharmaceuticals, Inc., (“Access”), and Somanta
Pharmaceuticals, Inc., (“Somanta”) have each approved the merger of Somanta with
a wholly owned subsidiary of Access. If
the
proposed merger is completed, the holders of Somanta’s common stock are expected
to receive approximately 0.032343 of a share of Access common stock for each
share of Somanta common stock they own immediately prior to completion of the
merger not
to
exceed in the aggregate 500,000 shares of Access common stock, and the holders
of Somanta’s preferred stock are expected to receive approximately 1690.24045
shares of Access common stock for each share of Somanta preferred stock,
including
accrued and unpaid dividends,
they
own immediately prior to completion of the merger not to exceed in the aggregate
1,000,000 shares of Access common stock.
Based
on
the number of shares of Access
common
stock
and
Somanta common stock
and
preferred stock
outstanding on June 6, 2007
and
without giving effect to any further issuances of shares of stock by Access,
after the merger: (i) holders of Somanta common stock are expected to hold
approximately 4.3% of the combined company assuming conversion of Access’s
existing convertible debt under existing terms of conversion, (ii) holders
of
Somanta preferred stock are expected to hold approximately 8.7% of the combined
company assuming conversion of Access’s existing convertible debt under existing
terms of conversion, and (iii) holders of Somanta common stock and preferred
stock taken together
are
expected to hold approximately 13.0% of
the
combined company assuming conversion of Access’s existing convertible debt under
existing terms of conversion.
Access
stockholders will continue to own their existing shares, which will not be
affected by the merger. Access may issue additional shares of its equity
securities prior to the closing of the merger and Somanta stockholders would
be
diluted in the case of any such issuances.
Access
common stock trades on the OTC Bulletin Board under the symbol “ACCP.” As of
July 19, 2007, the last trading day before the date of this proxy
statement/prospectus, the last reported sales price of Access common stock
at
the end of regular trading hours, as reported on the OTC Bulletin Board, was
$4.50. Somanta
common stock trades on the OTC Bulletin Board under the symbol “SMPM.” As of
July 19, 2007, the last trading day before the date of this proxy
statement/prospectus, the last reported sales price of Somanta common stock
at
the end of regular trading hours, as reported on the OTC Bulletin Board, was
$0.15.
Access
and Somanta cannot complete the merger unless Somanta stockholders approve
and
adopt the merger agreement and the merger contemplated by the merger agreement.
Approval and adoption of the merger agreement and the merger
contemplated by the merger agreement, requires the affirmative vote of (i)
the
holders of a majority of the outstanding shares of Somanta common stock and
Somanta Series A preferred stock, voting together as a single class on an
as-converted basis, and (ii) the holders of a majority of the outstanding
shares of Somanta Series A preferred stock, voting separately as a
class.
Certain
executive officers, directors and affiliates of Somanta have entered into voting
agreements with Access in the form attached as Annex A to this document,
pursuant to which such officers, directors and affiliates agreed, among other
things, to vote their shares of Somanta common stock or preferred stock in
favor
of the merger agreement at the special meeting.
Somanta
and Access currently expect that these officers, directors and affiliates,
who
in the aggregate own approximately 85% of the outstanding common stock of
Somanta (assuming the exercise of certain warrants to purchase common stock
by
certain affiliates) and approximately 60% of the preferred stock of
Somanta's or 70.84% of Somanta's outstanding voting stock (on an as-converted
basis), will vote all of their shares in favor of the merger
agreement.
The
Access stockholders are not required to vote on the merger. The obligations
of
Access and Somanta to complete the merger are also subject to the satisfaction
or waiver of several other conditions to the merger. More information about
Access, Somanta and the merger is contained in this proxy statement/prospectus.
We
encourage you to read carefully this proxy statement/prospectus before voting,
including the section entitled “Risk Factors” beginning on page
18.
The
Somanta board of directors recommends that the Somanta stockholders vote “FOR”
the proposal to approve and adopt the merger agreement and the merger
contemplated by the merger agreement. The Access board of directors approves
the
issuance of shares of Access common stock in the merger.
Access
has received voting agreements from certain Somanta stockholders representing
approximately 85% of Somanta’s outstanding common stock and approximately 60% of
its outstanding preferred stock, or 70.84% of Somanta’s outstanding voting stock
(on an as-converted basis), under which the parties, subject to certain limited
exceptions, have granted an irrevocable proxy to Access to vote their shares
in
favor of the merger.
The
proposals are being presented to the Somanta stockholders at their special
meeting. The date, time and place of the meeting is as follows:
|
Friday,
August 17, 2007 at 9:00 a.m., local time at
|
|
Somanta
Pharmaceuticals, Inc.
19200
Von Karman Avenue, Suite 400
Irvine,
California 92612
(949)
477-8090
|
Your
vote is very important.
Whether
or not you plan to attend Somanta’s special meeting, please take the time to
vote by completing and mailing to us the enclosed proxy card or, if the option
is available to you, by granting your proxy by fax. If your shares are held
in
“street name,” you must instruct your broker in order to vote.
|
Sincerely,
|
|
|
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/s/ Stephen R. Seiler
|
/s/
Terrance J. Bruggeman
|
|
|
Stephen
R. Seiler
|
|
Terrance
J. Bruggeman
|
|
President
and Chief Executive Officer
|
|
Executive
Chairman of the Board of Directors and Secretary
|
|
Access
Pharmaceuticals, Inc.
|
|
Somanta
Pharmaceuticals, Inc.
|
None
of
the Securities and Exchange Commission, any state securities regulator or any
regulatory authority has approved or disapproved of these transactions or the
securities to be issued under this proxy statement/prospectus or determined
if
the disclosure in this proxy statement/prospectus is truthful or complete.
Any
representation to the contrary is a criminal offense.
This
proxy statement/prospectus is dated July 20, 2007, and is being mailed to
stockholders of Somanta on or about July 25, 2007.
ADDITIONAL
INFORMATION
This
proxy statement/prospectus incorporates by reference important business and
financial information about Access and Somanta from documents that are not
included in or delivered with this proxy statement/prospectus. For a more
detailed description of the information incorporated by reference into this
proxy statement/prospectus and how you may obtain it, see “Additional
Information—Where You Can Find More Information” beginning on page 205.
You
can
obtain any of the documents incorporated by reference into this proxy
statement/prospectus from Access or Somanta, as applicable, or from the
Securities and Exchange Commission, which is referred to as the SEC, through
the
SEC’s website at www.sec.gov. Documents incorporated by reference are available
from Access and Somanta without charge, excluding any exhibits to those
documents, unless the exhibit is specifically incorporated by reference as
an
exhibit in this proxy statement/prospectus. Access stockholders and Somanta
stockholders may request a copy of such documents by contacting the applicable
department at:
|
Access
Pharmaceuticals, Inc.
|
Somanta
Pharmaceuticals, Inc.
|
|
2600
Stemmons Freeway, Suite 176
|
19200
Von Karman Avenue, Suite 400
|
|
Dallas,
Texas 75207
|
Irvine,
California 92612
|
|
Attn:
Investor Relations
|
Attn:
Chief Financial Officer
|
In
addition, you may obtain copies of the information relating to Access, without
charge, by sending an e-mail to akc@accesspharma.com or by calling (214)
905-5100.
You
may
obtain copies of the information relating to Somanta, without charge, by sending
an e-mail to t.bruggeman@somanta.com or by calling (949) 477-8090.
We
are
not incorporating the contents of the websites of the SEC, Access, Somanta
or
any other person into this document. We are only providing the information
about
how you can obtain certain documents that are incorporated by reference into
this proxy statement/prospectus at these websites for your convenience.
In
order for you to receive timely delivery of the documents in advance of the
Somanta special meeting, Somanta should receive your request no later than
August 14, 2007.
SOMANTA
PHARMACEUTICALS, INC.
19200
Von Karman Avenue, Suite 400
Irvine,
California 92612
NOTICE
OF SPECIAL MEETING OF STOCKHOLDERS
TO
BE HELD ON August 17, 2007
To
the
Stockholders of Somanta Pharmaceuticals, Inc.:
Somanta
will hold a special meeting of stockholders of Somanta at Somanta’s principal
executive offices located at 19200 Von Karman Ave., Suite 400, Irvine,
California 92612, on Friday, August 17, 2007, at 9:00 a.m. local time, to
consider and vote upon a proposal to approve and adopt the Agreement and Plan
of
Merger, dated as of April 18, 2007, by and among Access Pharmaceuticals, Inc.,
Somanta Acquisition Corporation, a wholly owned subsidiary of Access, and
Somanta Pharmaceuticals, Inc., Somanta Incorporated and Somanta Limited and
the
merger contemplated by the merger agreement, pursuant to which Somanta
Pharmaceuticals, Inc. would merge with Somanta Acquisition Corporation. Each
outstanding share of Somanta common stock is expected to be converted into
the
right to receive approximately 0.032343 of a share of Access common stock,
not
to
exceed in the aggregate 500,000 shares of Access common stock, and each
outstanding share of Somanta preferred stock, including accrued and unpaid
dividends, is expected to be converted into the right to receive approximately
1690.24045 shares
of
Access common stock, not to exceed in the aggregate 1,000,000 shares of Access
common stock, and in each case subject
to adjustment as more fully
described in the attached
proxy
statement/prospectus.
Somanta
stockholders will also be asked to consider and vote upon such other business
as
may properly come before the special meeting, or any adjournment or postponement
of the special meeting.
Approval
and adoption of the merger agreement and the merger contemplated by the merger
agreement, requires the affirmative vote of (i) the holders of a majority of
the
outstanding shares of Somanta common stock and Somanta Series A preferred stock,
voting together as a single class on an as-converted basis, and (ii) the holders
of a majority of the outstanding shares of Somanta Series A preferred stock,
voting separately as a class.
The
Somanta board of directors has approved the merger agreement and the merger
contemplated by the merger agreement, and recommends that you vote “FOR” the
proposal to approve and adopt the merger agreement and the merger contemplated
by the merger agreement, as described in this proxy statement/prospectus. In
addition, Access has received voting agreements from certain Somanta
stockholders representing approximately 85% of Somanta’s outstanding common
stock and approximately 60% of its outstanding preferred stock, or 70.84% of
Somanta’s outstanding voting stock on an as-converted basis, under which the
parties, subject to certain limited exceptions, have granted an irrevocable
proxy to Access to vote their shares in favor of the merger.
Only
Somanta stockholders of record at the close of business on July 18, 2007, the
record date for the special meeting, are entitled to notice of, and to vote
at,
the special meeting and any adjournments or postponements of the special
meeting. A complete list of Somanta stockholders entitled to vote at the Somanta
special meeting will be available for inspection at the executive offices of
Somanta during regular business hours for a period of no less than ten days
before the special meeting. You should be prepared to present photo
identification for admittance to the special meeting (including adjournments
or
postponements). In addition, if you are a record holder, your name is subject
to
verification against the list of record holders on the record date prior to
being admitted to the meeting. If you are not a record holder but hold shares
through a broker or nominee (i.e., in “street name”), you should be prepared to
provide proof of beneficial ownership on the record date, such as your most
recent account statement prior to July 18, 2007, or similar evidence of
ownership. If you do not comply with the procedures outlined above, you may
not
be admitted to the special meeting.
Your
vote
is very important. If you are the record holder of your shares, whether or
not
you plan to attend the special meeting, please complete, date and sign the
enclosed proxy card as soon as possible and return it in the postage-prepaid
envelope provided to submit a proxy. If you hold your shares through a broker
or
nominee (i.e., in “street name”), whether or not you plan to attend the special
meeting, please complete, sign and return the voting instruction form provided
to you by the record holder of your shares. In addition, you should check the
voting instruction form provided to you by the record holder of your shares
to
determine whether you will be able to submit voting instructions by fax.
Submitting a proxy by fax or by mailing the enclosed proxy card will ensure
your
shares are represented at the special meeting, but will not prevent you from
attending and voting in person at the special meeting. However, if you do not
submit a proxy or voting instructions now, or if you do not vote in person
at
the special meeting, the effect will be the same as a vote against the proposal
to approve and adopt the merger agreement and the merger contemplated by the
merger agreement. For more detailed instructions on how to vote your shares,
please refer to the section of this proxy statement/prospectus entitled “The
Somanta Special Meeting” beginning on page 38.
By
Order
of the Board of Directors,
/s/
Terrance J. Bruggeman
TERRANCE
J. BRUGGEMAN
Executive
Chairman of the Board of Directors and Secretary
Somanta
Pharmaceuticals, Inc.
TABLE
OF CONTENTS
| Page | |
| QUESTIONS AND ANSWERS ABOUT THE MERGER | 1 |
| SUMMARY | 5 |
| The Companies | 5 |
| The Merger | 8 |
| Access Board of Directors After the Merger | 8 |
| Ownership of Access After the Merger | 9 |
| Opinion of the Financial Advisor | 9 |
| Share Ownership of Directors and Executive Officers | 9 |
| Interests of Directors and Executive Officers of Somanta in the Merger | 9 |
| Dissenters’ or Appraisal Rights | 10 |
| Conditions to Completion of the Merger | 10 |
| Regulatory Matters | 10 |
| Agreement to Complete the Merger | 11 |
| No Solicitation | 11 |
| Termination of the Merger Agreement | 11 |
| Break-up Fees | 11 |
| Material United States Federal Income Tax Consequences of the Merger | 11 |
| Accounting Treatment | 12 |
| Risk Factors | 12 |
| Summary Selected Historical Financial Data | 12 |
| Selected Unaudited Pro Forma Condensed Combined Financial Data | 15 |
| Comparative Per Share Information | 16 |
| Comparative Per Share Market Price Data | 17 |
| RISK FACTORS | 18 |
| Risks Relating to the Merger | 18 |
| Risks Relating to the Business of Access | 19 |
| Risks Relating to the Business of Somanta | 27 |
| CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS | 37 |
| THE SOMANTA SPECIAL MEETING | 38 |
| Date, Time and Place | 38 |
| Purpose; Other Matters | 38 |
| Recommendation of the Somanta Board of Directors | 38 |
| Record Date; Outstanding Shares; Voting Rights | 38 |
| Admission to the Special Meeting | 38 |
| Quorum and Vote Required | 39 |
| Voting by Somanta Directors and Executive Officers | 39 |
| Voting Agreements | 39 |
| Voting; Proxies, Revocation | 39 |
| Abstentions and Broker Non-Votes | 40 |
| Postponements and Adjournments | 40 |
| Proxy Solicitation | 40 |
| Assistance | 40 |
| THE MERGER | 41 |
| Background of the Merger | 41 |
| The Somanta Special Committee | 43 |
|
Reasons
for the Merger
|
44 |
|
Mutual
Reasons for the Merger
|
44 |
| Access's Reason for the Merger | 44 |
|
Somanta’s
Reasons for the Merger
|
46 |
| Recommendation of the Somanta Board of Directors | 48 |
| No Opinion of-Financial Advisor | 49 |
| Treatment of Somanta Options and Warrants | 49 |
| Material Closing Conditions to Merger | 50 |
| Material United States Federal Income Tax Consequences of the Merger | 50 |
| Accounting Treatment | 53 |
| Regulatory Matters | 53 |
| Dissenters’ or Appraisal Rights | 53 |
| Restrictions on Sales of Shares of Access Common Stock Received in the Merger | 56 |
| Interests of Executive Officers and Directors of Somanta in the Merger | 57 |
| Indemnification: Directors’ and Officers’ Insurance | 57 |
| Employment of Somanta Executive Officers by Access after the Merger | 57 |
| Executive Officer Severance Payments | 57 |
| Legal Proceedings Regarding the Merger | 57 |
| THE MERGER AGREEMENT | 58 |
| The Merger | 58 |
| Closing and Effective Time of the Merger | 58 |
| Treatment of Securities | 58 |
| Fractional Shares | 59 |
| Treatment of Somanta Warrants | 59 |
| Treatment of Somanta Stock Options | 59 |
| Exchange Fund; Exchange of Stock Certificates | 59 |
| Distributions with Respect to Unexchanged Shares | 60 |
| Termination of Exchange Fund; No Liability | 60 |
| Lost, Stolen and Destroyed Certificates | 60 |
| Representations and Warranties | 60 |
| Conduct of Business before Completion of the Merger | 61 |
| Somanta Prohibited from Soliciting Other Offers | 63 |
|
Obligations of Somanta Boards of Directors with Respect to its
Recommendation and
Holding a Meeting of Somanta Stockholders
|
64 |
| Regulatory Matters | 64 |
| Public Announcements | 64 |
| Indemnification and Insurance | 65 |
| Access Board of Directors after the Merger | 65 |
| Reasonable Best Efforts to Complete the Merger | 65 |
| Conditions to Obligations to Complete the Merger | 65 |
| Material Adverse Effect | 66 |
| Termination; Break-Up Fees and Expenses | 67 |
| INFORMATION ABOUT ACCESS | 69 |
| Business | 69 |
| Products | 69 |
| Approved Products | 69 |
| Products in Development Status | 70 |
|
Drug
Development Strategy
|
71
|
|
Process
|
72
|
|
Scientific
Background
|
72
|
|
Core
Drug Delivery Technology Platforms
|
73
|
|
Synthetic
Polymer Targeted Drug Delivery Technology
|
73
|
| Cobalamin-Mediated Oral Delivery Technology | 73 |
|
Cobalamin-Mediated
Targeted Delivery Technology
|
74
|
|
Patents
|
75
|
|
Government
Regulation
|
75
|
|
Competition
|
76
|
|
Other
Key Developments
|
77
|
|
Employees
|
79
|
|
Web
Availability
|
79
|
| DESCRIPTION OF PROPERTY | 79 |
| CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | 79 |
| DIRECTORS AND EXECUTIVE OFFICERS | 80 |
| Code of Business Conduct and Ethics | 82 |
| EXECUTIVE COMPENSATION | 82 |
| Outstanding Equity Awards at December 31, 2006 | 86 |
| Director Compensation | 87 |
| LEGAL PROCEEDINGS | 90 |
| SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT | 90 |
| SECURITIES AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS | 91 |
| The 2000 Special Stock Option Plan | 92 |
| The 2007 Special Stock Option Plan | 92 |
| CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS | 92 |
| MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS | 93 |
| Holders | 94 |
| Options and Warrants | 94 |
| Shares Eligible for Future Shares | 94 |
| Dividends | 94 |
| DESCRIPTION OF SECURITIES | 94 |
| Common Stock | 95 |
| Preferred Stock | 95 |
| SCO Capital Partners LLC - Notes and Warrants | 95 |
| Other Convertible Notes | 96 |
| Transfer Agent and Registrar | 96 |
| Delaware Law and Certain Charter and By-Law Provisions | 96 |
| Elimination of Monetary Liability for Officers and Directors | 97 |
| Indemnification of Officers and Directors | 97 |
| EXPERTS | 97 |
| LEGAL MATTERS | 97 |
| HOW TO GET MORE INFORMATION | 97 |
| MANAGEMENT’S DISCUSSION AND ANALYSIS OR PLAN OF OPERATIONS | 99 |
| Overview | 99 |
| Products | 99 |
| Approved Products | 99 |
| Products in Development Status | 100 |
| Results of Operations | 101 |
| Discontinued Operations | 104 |
| Liquidity and Capital Resources | 104 |
| Critical Accounting Policies and Estimates | 108 |
| Off-Balance Sheet Transactions | 110 |
| QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 110 |
| CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | 110 |
| INDEX TO ACCESS FINANCIAL STATEMENT | 112 |
| REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM | 113 |
| ACCESS AUDITED FINANCIAL STATEMENTS | 115 |
| Consolidated Balance Sheet | 115 |
| Consolidated Statements of Operations and Comprehensive Loss | 116 |
| Consolidated Statements of Shareholders' Equity (Deficit) | 117 |
| Consolidated Statements of Cash Flows | 119 |
| Notes to Consolidated Financial Statements | 121 |
| INDEX TO ACCESS UNAUDITED QUARTERLY FINANCIAL STATMENT | 136 |
|
Condensed Consolidated Balance Sheets
|
137 |
| Condensed Consolidated Statements of Operations | 138 |
| Condensed Consolidated Statements of Cash Flows | 139 |
| Notes to Condensed Consolidated Financial Statements | 140 |
| INFORMATION ABOUT SOMANTA | 143 |
| Overview | 143 |
| Strategy | 144 |
| Cancer and Cancer Therapeutic Market | 145 |
| Regulatory Approval Process | 145 |
| Products in Academic Investigator-Sponsored Clinical Development | 147 |
| Products in Pre-Clinical Development | 150 |
| Intellectual Property | 153 |
| Government Regulation | 154 |
| Raw Materials | 155 |
| Employees | 155 |
| DESCRIPTION OF PROPERTY | 155 |
| LEGAL PROCEEDINGS | 155 |
| MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTER AND SMALL BUSINESS ISSUER PURCHASES OF EQUITY SECURITIES | 155 |
| Dividend Policy | 156 |
| Securities Authorized for Issuance Under Equity Compensation Plan | 156 |
| SECURITY OWNDERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT | |
| AND RELATED STOCKHOLDERS MATTERS FOR SOMANTA PHARMACEUTICALS, INC. | 157 |
| MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 159 |
| Background | 159 |
| Revenues | 159 |
| Critical Accounting Policies and Estimates | 159 |
| Intangible Assets - Patents and Licenses | 159 |
| Stock Based Compensation | 160 |
| Use of Estimates | 160 |
| Fair Value of Financial Instruments | 160 |
| Research and Development | 160 |
| Results of Operations | 160 |
|
Fluctuations in Operating Results
|
160 |
| Change in Functional Currency | 162 |
| Related Party Transactions | 162 |
| Liquidity and Capital Resources | 162 |
| Competition | 163 |
| Historical Expenditures | 164 |
| Expenditures of Completion | 164 |
| Trend Information | 164 |
| Off Balance Sheet Financing Arrangements | 164 |
| INDEX TO SOMANTA FINANCIAL STATEMENT | 165 |
| REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM | 166 |
| SOMANTA AUDITED FINANCIAL STATMENTS | 167 |
| Consolidated Balance Sheet | 167 |
| Consolidated Statements of Operations | 168 |
| Consolidated Statement of Stockholders' Deficit | 169 |
| Consolidated Statements of Cash Flows | 171 |
| Notes to Consolidated Financial Statements | 172 |
| UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS | 192 |
| Pro Forma Condensed Combined Balance Sheet | 193 |
| Notes to Pro Forma Condensed Combined Balance Sheet | 194 |
| Pro Forma Condensed Combined Statement of Operations and Notes | 195 |
| COMPARISON OF STOCKHOLDER RIGHTS AND CORPORATE GOVERNANCE MATTERS | 197 |
| ADDITIONAL INFORMATION | 204 |
| Stockholder Proposals | 204 |
| Experts | 204 |
| Householding of Proxy Materials | 205 |
| Where You Can Find More Information | 205 |
| Annex A Agreement and Plan of Merger | |
| Annex B Section 262 of the Delaware General Corporation Law | |
| Annex C Form of Voting Agreement | |
QUESTIONS
AND ANSWERS ABOUT THE MERGER
The
following are some questions that you, as a stockholder of Somanta, may have
regarding the merger and the other matters being considered at the special
meeting of Somanta stockholders and brief answers to those questions. Access
and
Somanta urge you to read carefully the remainder of this proxy
statement/prospectus because the information in this section does not provide
all the information that might be important to you with respect to the merger
and the other matters being considered at the Somanta special meeting of
stockholders. Additional important information is also contained in the annexes
to and the documents incorporated by reference into this proxy
statement/prospectus.
|
Q:
|
Why
am I receiving this proxy statement/prospectus?
|
|
A.
|
Access
and Somanta have agreed to the merger of Somanta with a wholly owned
Subsidiary of Access under the terms of a merger agreement that is
described in this proxy statement/prospectus. A copy of the merger
agreement is attached to this proxy statement/prospectus as Annex
A.
|
In
order
to complete the merger, Somanta stockholders must approve and adopt the merger
agreement and the merger contemplated by the merger agreement. Somanta will
hold
a special meeting of their stockholders to obtain this approval.
No
approval is required by the Access stockholders.
This
proxy statement/prospectus contains important information about the merger,
the
merger agreement and the special meeting of the stockholders of Somanta, which
you should read carefully.
Your
vote
is very important. We encourage you to vote as soon as possible. The enclosed
voting materials allow you to vote your shares without attending Somanta's
special meeting. For more specific information on how to vote, please see the
questions and answers for the Somanta stockholders below.
|
Q:
|
Why
are Access and Somanta proposing the merger?
|
|
A.
|
Access
and Somanta both believe that the merger will provide substantial
strategic and financial benefits to the stockholders of both companies
because the merger will allow stockholders of both companies the
opportunity to participate in a larger, more diversified company.
They
both also believe that the combination will create a stronger and
more
competitive developer of pharmaceutical products that we believe
to be
well positioned to create more stockholder value than either Access
or
Somanta could on its own. The Access and Somanta boards of directors
also
considered various negative factors including the debt of Access,
the
costs and challenges of integrating the businesses of Access and
Somanta,
and the risk that the potential benefits sought in the merger might
not be
fully realized. To review the reasons for the merger as well as the
negative factors considered by the Access and Somanta boards of directors
in greater detail, see “The Merger—Recommendation of the Somanta Board of
Directors” beginning on page 48, “The Merger—Reasons for the Merger”
beginning on page 44 and “Risk Factors—Risks Relating to the Merger”
beginning on page 18.
|
|
Q:
|
What
will happen in the merger?
|
|
A.
|
In
the merger, Somanta Acquisition Corporation, a wholly owned subsidiary
of
Access, will merge with Somanta, with Somanta surviving as a wholly
owned
subsidiary of Access.
|
Q: What
consideration will Somanta stockholders receive in the merger?
|
A.
|
If
the proposed merger is completed, each outstanding share of Somanta
common
stock is expected to be converted into the right to receive approximately
0.032343 of a share of Access common stock, not
to exceed in the aggregate 500,000 shares of Access common stock,
and each
outstanding share of Somanta preferred stock, including accrued and
unpaid
dividends on such preferred stock, is expected to be converted into
the
right to receive approximately 1690.24045 shares
of Access common stock, not to exceed in the aggregate 1,000,000
shares of
Access common stock, and in each case subject
to adjustment as more fully described in the attached proxy
statement/prospectus. Each Somanta stockholder will receive cash
for any
fractional share of Access common stock that the stockholder would
otherwise be entitled to receive in the merger after aggregating
all
fractional shares to be received by the stockholder.
|
1
|
Q:
|
How
will Access stockholders be affected by the merger and issuance of
Access
common stock in the merger?
|
|
A:
|
After
the merger, Access stockholders will continue to own their existing
shares
of Access common stock. Accordingly, Access stockholders will hold
the
same number of shares of Access common stock that they held immediately
prior to the merger. However, because Access will be issuing new
shares of
Access common stock to Somanta stockholders in the merger, each
outstanding share of Access common stock immediately prior to the
merger
will represent a smaller percentage of the total number of shares
of
Access common stock outstanding after the merger. Based on the number
of
shares of Access and Somanta common stock outstanding on July 19,
2007 we
expect that Access stockholders before the merger to hold approximately
87.0% of the combined company, assuming conversion of Access’s existing
convertible debt under existing terms.
|
|
Q:
|
When
do Access and Somanta expect the merger to be completed?
|
|
A:
|
Access
and Somanta are working to complete the merger as quickly as practicable
and currently expect that the merger would be completed in the third
quarter of 2007 within two business days following the approval and
adoption by the Somanta stockholders of the merger agreement and
the
merger contemplated by the merger
agreement
|
|
Q:
|
What
are the United States federal income tax consequences of the merger?
|
|
A:
|
Somanta
expects the merger to qualify as a “reorganization” within the meaning of
Section 368(a) of the Internal Revenue Code. If the merger qualifies
as a
“reorganization,” Somanta stockholders generally will not recognize a gain
or loss for federal income tax purposes. No gain or loss will be
recognized for federal income tax purposes by Somanta, Access, or
Access
stockholders as a result of the
merger.
|
Tax
matters are complicated, and the tax consequences of the merger to each Somanta
stockholder will depend on the facts of each stockholder’s situation. Somanta
stockholders are urged to read carefully the discussion in the section entitled
“The Merger—Material United States Federal Income Tax Consequences of the
Merger” beginning on page 51 and to consult their tax advisors for a full
understanding of the tax consequences of their participation in the merger.
|
Q:
|
Why
are Access stockholders not voting?
|
|
A:
|
Access
stockholders are not voting on the merger. The Access board of directors
has approved the merger and the stockholders of Access are not required
to
approve this merger under Delaware law because Access is not a constituent
party to the merger. The Access board of directors believes that
the
merger is advisable to and in the best interests of Access and its
stockholders and unanimously recommends the proposal to issue shares
of
Access common stock in the merger.
|
|
Q:
|
What
are Somanta stockholders voting on?
|
|
A:
|
Somanta
stockholders are voting on a proposal to approve and adopt the merger
agreement and the merger contemplated by the merger agreement. The
approval of this proposal by Somanta stockholders is a condition
to the
effectiveness of the merger.
|
|
Q:
|
What
vote of Somanta stockholders is required to approve and adopt the
merger
agreement and the merger contemplated by the merger agreement?
|
A: Approval
and adoption of the merger agreement and the merger contemplated by the merger
agreement, requires the affirmative vote of (i) the holders of a majority of
the
outstanding shares of Somanta common stock and Somanta Series A preferred stock,
voting together as a single class on an as-converted basis, and (ii) the holders
of a majority of the outstanding shares of Somanta Series A preferred stock,
voting separately as a class.
2
|
Q:
|
How
does the Somanta board of directors recommend that Somanta stockholders
vote?
|
|
A:
|
The
Somanta board of directors recommends that Somanta stockholders vote
“FOR”
the proposal to approve and adopt the merger agreement and the merger
contemplated by the merger agreement. The Somanta board of directors
has
determined that the merger agreement and the merger contemplated
by the
merger agreement are advisable, and fair to and in the best interests
of
Somanta and its stockholders. Accordingly, the Somanta board of directors
has approved the merger agreement and the merger contemplated by
the
merger agreement. For a more complete description of the Recommendation
of
the Somanta board of directors, see “The Somanta Special
Meeting—Recommendation of the Somanta Board of Directors” beginning on
page 38.
|
|
Q:
|
When
and where will the special meeting of stockholders be held?
|
|
A:
|
The
Somanta special meeting will take place at the offices of Somanta
Pharmaceuticals, Inc., located at 19200 Von Karman Avenue, Suite
400,
Irvine, California 92612, on Friday, August 17, 2007, at 9:00 a.m.
local
time.
|
|
Q:
|
Who
can attend and vote at the special meeting?
|
|
A:
|
All
Somanta stockholders of record as of the close of business on July
18,
2007, the Somanta record date, are entitled to receive notice of
and to
vote at the Somanta special meeting. If you hold common stock, you
may
cast one vote for each share of Somanta common stock that you owned
on the
record date. If you hold Somanta’s preferred stock, you may cast one vote
for each share of common stock into which your preferred stock is
then
convertible
|
|
Q:
|
What
should I do now in order to vote on the proposals being considered
at
Somanta’s special meeting?
|
|
A:
|
Somanta
stockholders of record as of the Somanta record date may vote by
proxy by
completing, signing, dating and returning the enclosed proxy card
in the
accompanying pre-addressed postage paid envelope or by submitting
a proxy
by fax by following the instructions on the enclosed proxy card.
If you
hold Somanta common stock in “street name,” which means your shares are
held of record by a broker, bank or nominee, you must complete, sign,
date
and return the enclosed voting instruction form to the record holder
of
your shares with instructions on how to vote your shares. Please
refer to
the voting instruction form used by your broker, bank or nominee
to see if
you may submit voting instructions using the fax.
|
Additionally,
you may also vote in person by attending Somanta’s special meeting. If you plan
to attend Somanta’s special meeting and wish to vote in person, you will be
given a ballot at the special meeting. Please note, however, that if your shares
are held in “street name,” and you wish to vote at Somanta’s special meeting,
you must bring a proxy from the record holder of the shares authorizing you
to
vote at the special meeting. Whether or not you plan to attend Somanta’s special
meeting, you should submit your proxy card or voting instruction form as
described in this proxy statement/prospectus.
|
Q:
|
What
will happen if I abstain from voting or fail to vote?
|
|
A:
|
An
abstention occurs when a stockholder attends a meeting, either in
person
or by proxy, but abstains from voting.
|
An
abstention or the failure of a Somanta stockholder to vote or to instruct your
broker to vote if your shares are held in “street name” will have the same
effect as voting against the proposal to approve and adopt the merger agreement
and the merger contemplated by the merger agreement.
|
Q:
|
Can
I change my vote after I have delivered my proxy?
|
|
A:
|
Yes.
If you are a holder of record, you can change your vote at any time
before
your proxy is voted at the special meeting by:
|
•
delivering a signed written notice of revocation to the Secretary of Somanta;
•
signing
and delivering a new, valid proxy bearing a later date;
•
submitting another proxy by fax; or
•
attending the special meeting and voting in person, although your attendance
alone will not revoke your proxy.
If
your
shares are held in “street name” you must contact your broker, bank or other
nominee to change your vote.
3
|
Q:
|
What
should I do if I receive more than one set of voting materials for
Somanta’s special meeting?
|
|
A:
|
You
may receive more than one set of voting materials for Somanta’s special
meeting, including multiple copies of this proxy statement/prospectus
and
multiple proxy cards or voting instruction forms. For example, if
you hold
your shares in more than one brokerage account, you will receive
a
separate voting instruction form for each brokerage account in which
you
hold shares. If you are a holder of record and your shares are registered
in more than one name, you will receive more than one proxy card.
Please
complete, sign, date and return each proxy card and voting instruction
form that you receive.
|
|
Q:
|
Am
I entitled to appraisal rights?
|
|
A:
|
Under
Delaware law, holders of Somanta’s capital stock have the right to dissent
from the merger and obtain payment in cash for the fair value of
their
shares of common stock or preferred stock, as the case may be, as
determined by the Delaware Chancery Court, rather than the merger
consideration. The fair value determined by the court could be more
than,
less than or equal to the value of the merger consideration. To exercise
appraisal rights, Somanta stockholders must strictly follow the procedures
prescribed by Delaware law. These procedures are summarized under
the
section entitled “The Merger-Dissenters’ or Appraisal Rights” beginning on
page 53. In addition, the text of the applicable provisions of Delaware
General Corporation Law, or the DGCL, is included as Annex B to this
proxy statement/prospectus. Any Somanta stockholder wishing to exercise
appraisal rights is urged to consult with legal counsel before attempting
to exercise those rights.
|
Holders
of Access common stock are not entitled to appraisal rights in connection with
the issuance of Access common stock in the merger.
|
Q:
|
Who
can help answer my questions?
|
|
A:
|
If
you have any questions about the merger or how to submit your proxy,
or if
you need additional copies of this proxy statement/prospectus or
the
enclosed proxy card or voting instructions, you should contact:
|
Somanta
Pharmaceuticals, Inc.
19200
Von
Karman Avenue, Suite 400
Irvine,
California 92612
Phone:
(949) 477-8090
Email:
t.bruggeman@somanta.com
4
SUMMARY
The
following is a summary that highlights information contained in this proxy
statement/prospectus. This summary may not contain all of the information that
may be important to you. For a more complete description of the merger agreement
and the merger contemplated by the merger agreement, we encourage you to read
carefully this entire proxy statement/prospectus, including the attached
annexes. In addition, we encourage you to read the information incorporated
by
reference into this proxy statement/prospectus, which includes important
business and financial information about Access and Somanta that has been filed
with the SEC. You may obtain the information incorporated by reference into
this
proxy statement/prospectus without charge by following the instructions in
the
section entitled “Additional Information—Where You Can Find More Information”
beginning on page 232.
The
Companies
Access
Access
Pharmaceuticals, Inc.
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
Access’
Business
Access
Pharmaceuticals, Inc. (“Access”) is a Delaware corporation. Access is an
emerging biopharmaceutical company developing products for use in the treatment
of cancer, the supportive care of cancer, and other disease states. Access’
product for the management of oral mucositis, MuGard™, has received marketing
clearance by the FDA as a device. Access’ lead clinical development program for
the drug candidate ProLindac™ (formerly known as AP5346) is in Phase II clinical
testing. Access also has advanced drug delivery technologies including
Cobalamin™ mediated oral drug delivery and targeted delivery.
Together
with Access’ subsidiaries, Access has proprietary patents or rights to one
technology approved for marketing and three drug delivery technology
platforms:
•
MuGard™ (mucoadhesive liquid technology),
•
synthetic polymer targeted delivery,
•
Cobalamin-mediated oral delivery,
•
Cobalamin-mediated targeted delivery.
Products
Access
used its drug delivery technologies to develop the following products and
product candidates:
Access
Drug Portfolio
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage
|
|||||
|
|
|||||||||
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
|||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (1)
|
Access
- U London
|
Synthetic
polymer
|
Cancer
|
Phase
II
|
|||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-Clinical
|
|||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-Clinical
|
|||||
|
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-Clinical
|
|||||
(1)
Licensed from the School of Pharmacy, The University of London. Subject to
a 1%
royalty and milestone payments on sales.
5
Somanta
Somanta
Pharmaceuticals, Inc.
19200
Von
Karman Avenue, Suite 400
Irvine,
California 92612
(949)
477-8090
Somanta’s
Business
Somanta
is a biopharmaceutical company engaged in the development of drugs primarily
for
the treatment of cancer. Somanta in-licenses substances designed for anti-cancer
therapy in order to advance them along the regulatory and clinical pathway
toward commercial approval. Somanta’s licenses are generally worldwide in scope
and territory, with the exception of Somanta’s license for Sodium Phenylbutyrate
which is worldwide, excluding U.S. and Canada. Somanta uses its expertise to
manage and perform what Somanta believes are the most critical aspects of the
drug development process which includes the design and conduct of clinical
trials, the development and execution of strategies for the protection and
maintenance of intellectual property rights and the interaction with drug
regulatory authorities internationally. Somanta concentrates on drug development
and engages in a very limited way in drug discovery, avoiding the significant
investment of time and financial resources that is generally required before
a
compound is identified and brought into clinical trials. Somanta intends to
out-source clinical trials, pre-clinical testing and the manufacture of clinical
materials to experienced and qualified third parties.
Somanta
was originally incorporated in New Jersey in 1991 under the name PRS I, Inc.
Somanta subsequently changed its name to Service Lube, Inc., then to Fianza
Commercial Corp. and then to Hibshman Optical Corp. Neither PRS I, Inc., nor
Service Lube, Inc., nor Fianza Commercial Corp., nor Hibshman Optical Corp.,
ever engaged in any active business.
On
January 31, 2006, Somanta reincorporated in the State of Delaware under the
name
Somanta Pharmaceuticals, Inc. and acquired Somanta Incorporated through the
merger of a wholly-owned subsidiary with and into Somanta Incorporated. Somanta
Incorporated was formerly known as Bridge Oncology Products, Inc., which was
formed on February 10, 2005. On August 22, 2005, Bridge Oncology Products,
Inc.,
entered into a Share Exchange Agreement with Somanta Limited, a company
organized under the laws of England pursuant to which Somanta Limited became
a
wholly-owned subsidiary of Bridge Oncology Products, Inc., and Bridge Oncology
Products, Inc., changed its name to Somanta Incorporated. Somanta Limited was
formed on April 19, 2001.
Prior
to
the date of the share exchange between Bridge Oncology Products, Inc., and
Somanta Limited, each of Bridge Oncology Products, Inc., and Somanta Limited
were engaged in a limited amount of business. Bridge Oncology Products, Inc.,
was formed in February 2005, and in February 2005, it entered into the Sodium
Phenylbutyrate Co-development and Sub-license Agreement with Virium
Pharmaceuticals, Inc., to develop Sodium Phenylbutyrate outside of the U.S.
and
Canada for the treatment of cancer, autoimmune diseases and other clinical
indications. It engaged in no other business during that period of
time.
Although
Somanta Limited was formed in April of 2001, its primary business prior to
the
date of the share exchange with Bridge Oncology Products, Inc., was to secure
intellectual property rights to the various chemical entities that Somanta
now
desires to develop as product candidates. To that end, in November 2001, Somanta
Limited entered into an Exclusive License Agreement with De Montfort University
related to Somanta’ drug development candidate, Alchemix. In January 2002,
Somanta Limited entered into an Exclusive Patent and Know-how License and Option
Agreement with Immunodex, Inc. covering its drug product candidates know as
Phoenix and Angiolix. In October 2003, Somanta Limited entered into an agreement
with the Cancer Research Institute of Contra Costa for the support of an
academic human clinical trial for Phoenix. In March 2004, Somanta Limited
entered into an Exclusive Patent and Know-how Assignment and License Agreement
with the School of Pharmacy, University of London related to Somanta’s drug
development candidate known as Prodrax. In March 2004, Somanta Limited entered
into a Research and Development Agreement with The School of Pharmacy,
University of London for the purpose of further developing Prodrax. In addition
to securing the various intellectual property rights related to the agreements
described above, in August of 2004, Somanta Limited also entered into a Research
Collaboration and License Agreement with Advanced Cardiovascular Devices, LLC,
pursuant to which Somanta Limited licensed Advanced Cardiovascular Devices,
LLC,
rights to Somanta’s drug development candidate,
6
Alchemix,
solely for use on drug eluting stents. In 2001 Somanta Limited entered into
a
shareholder and intellectual property rights agreement with Cypomics, Ltd.
pursuant to which Somanta Limited was to fund a research and development program
of Cypomics, Ltd. in exchange for a certain amount of capital stock of Cypomics,
Ltd. However, neither party performed any of its obligations under the agreement
and neither party is liable to the other party for any such failure to perform.
In July 2005, this agreement was formally terminated.
Somanta’s
current product candidate in academic-investigator-sponsored clinical
development includes an anti-cancer agent (a small molecule) targeting four
different tumors and/or stages of cancer. Somanta has three additional product
development candidates (two small molecules and a monoclonal antibody) in
pre-clinical development targeting eleven different tumor types.
The
following table sets forth the eleven types of cancer targeted by each of
Somanta’s current product development candidates:
|
Sodium
Phenylbutyrate
|
• Central
nervous system cancers, particularly glioblastoma
multiforme
|
|
|
|
• Myelodysplastic
syndrome
|
|
|
|
• Acute
leukemia
|
|
|
|
• Colon
|
|
|
Alchemix
|
• Central
nervous system cancers
|
|
|
|
• Colon
|
|
|
|
• Non-small
cell lung
|
|
|
|
• Ovarian
|
|
|
|
• Renal
|
|
|
Prodrax
|
• Lung
|
|
|
|
• Breast
|
|
|
|
• Ovarian
|
|
|
|
• Colon
|
|
|
|
• Pancreatic
|
|
|
|
• Esophageal
|
|
|
Angiolix
|
• Breast
|
|
|
|
• Colorectal
|
Products
Somanta
has the following product candidates:
Somanta
Drug Candidate Portfolio
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage
|
|||||
|
Sodium
Phenylbutyrate
|
National
Institutes of Health
|
Small
molecule
|
Cancer
|
Academic
Investigator Phase I
|
|||||
|
Angiolix
(huMc-3 mAb)
|
Immunodex,
Inc.
|
Humanized
monoclonal antibody
|
Cancer
|
Pre-Clinical
|
|||||
|
Alchemix
(chloroethylaminoanthraquinone)
|
DeMontford
University
|
Small
Molecule
|
Cancer
|
Pre-Clinical
|
|||||
|
Prodrax
(di-N-oxides of chloroethylaminoanthraquinone)
|
School
of Pharmacy, University of London
|
Small
Molecule
|
Cancel
|
Pre-Clinical
|
7
The
Merger (see page 41)
Access
and Somanta have agreed to the acquisition of Somanta by Access under the terms
of the merger agreement that is described in this proxy statement/prospectus.
In
the merger, Somanta Acquisition Corporation, a wholly owned subsidiary of
Access, will merge with Somanta, with Somanta surviving as a wholly owned
subsidiary of Access. We have attached the merger agreement to this proxy
statement/prospectus as Annex A. We encourage you to carefully read the merger
agreement in its entirety because it is the legal document that governs the
merger.
Merger
Consideration
If
the
proposed merger is completed, the holders of Somanta’s common stock are expected
to receive approximately 0.032343 of a share of Access common stock for each
share of Somanta common stock they own immediately prior to completion of the
merger not to exceed in the aggregate 500,000 of Access common stock, and the
holders of Somanta’s preferred stock are expected to receive approximately
1690.24045 shares of Access common stock for each share of Somanta preferred
stock, including accrued and unpaid dividends, they own immediately prior to
completion of the merger not to exceed in the aggregate 1,000,000 shares of
Access common stock. In accordance with the Certificate of Designation of
Somanta’s Series A preferred stock, holders of a majority of the Series A
preferred stock of Somanta have acknowledged and agreed that if the stockholders
of Somanta approve the Merger Agreement and the transactions contemplated
thereby, then each share of preferred stock will be exchanged for common stock
of Access and the rights, preferences and privileges associated with such Series
A preferred stock will cease to exist as of the closing of the Merger. For
a
full description of a comparison of the rights of the Access common stock to
the
rights of the Somanta common stock and Series A preferred stock, see “Comparison
of Stockholder Rights and Corporate Governance Matters” beginning on page 197.
The merger is expected to qualify as a “reorganization” under the Internal
Revenue Code. See “Risk Factors—Risks Relating to the Merger” beginning on page
18.
For
a
full description of the merger consideration and the possible adjustment to
the
merger consideration, see “The Merger Agreement—Treatment of Securities”
beginning on page 58.
Fractional
Shares
Access
will not issue fractional shares of Access common stock in the merger. As a
result, each Somanta stockholder will receive cash for any fractional share
of
Access common stock the stockholder would otherwise be entitled to receive
in
the merger after aggregating all fractional shares to be received by the
stockholder.
For
a
full description of the treatment of fractional shares, see “The Merger
Agreement—Fractional Shares” beginning on page 59.
Treatment
of Somanta Stock Options
Each
outstanding option to purchase Somanta common stock will either convert upon
exercise to common stock of Somanta before the merger or cease to exist after
the merger.
Treatment
of Somanta Warrants
Each
outstanding warrant to purchase a share of Somanta common stock, excluding
outstanding warrants covering 1,166,534 shares of Somanta common stock which
are
held by SCO Capital Partners LLC or SCO Financial Group LLC and which will
be
exercised prior to the closing of the merger, will convert into a warrant to
purchase 0.032343 shares of Access common stock at an adjusted exercise price
utilizing the same exchange ratio.
Access
Board of Directors after the Merger
Upon
completion of the merger, the Access board of directors will be remain the
same.
The directors of Access prior to the completion of the merger will continue
to
serve as the directors of Access after the merger.
8
Ownership
of Access after the Merger
Based
on
the number of shares of Access
common
stock
and
Somanta common stock
and
preferred stock
outstanding on July 19, 2007
and
without giving effect to any further issuances of shares of stock by Access:
(i)
holders of Somanta common stock are expected to hold approximately 4.3% of
the
fully diluted shares of Access common stock immediately after the merger, (ii)
holders of Somanta preferred stock are expected to hold approximately 8.7%
of
the fully diluted shares of Access common stock immediately after the merger,
and (iii) holders of Somanta common stock and preferred stock taken
together
are
expected to hold approximately 13.0% of the fully diluted shares of Access
common stock immediately after the merger.
Access
stockholders will continue to own their existing shares, which will not be
affected by the merger. Access may issue additional shares of its equity
securities prior to the closing of the merger and Somanta stockholders would
be
diluted in the case of any such issuances.
Opinion
of Financial Advisor
Somanta
The
special committee of
the
Somanta board of directors
did
not
engage a financial advisor to assist in the sale of Somanta or to render a
financial opinion as to the fairness, from a financial point of view,
of
the
consideration to be paid
to
the Somanta stockholders in the merger. The special committee determined that
the factors which weighed in favor of the merger, as discussed below, were
substantial in relation to the factors which weighed against the merger. The
special committee also considered the cost of obtaining a fairness opinion
as
prohibitively expensive in light of Somanta’s financial condition.
Share
Ownership of Directors and Executive Officers
At
the
close of business on the Somanta record date, directors and executive officers
of Somanta and their affiliates beneficially owned and were entitled to vote
approximately 17,937,213 shares of Somanta common stock (on an as-converted
basis and after the exercise of certain warrants held by them), collectively
representing approximately 70.84% of the shares of Somanta common stock (on
an
as-converted basis) outstanding on that date. SCO Capital Partners LLC, and
its
affiliates, are represented on Somanta’s Board of Directors and collectively
control 44.52% of Somanta’s common stock and 55.6% of Somanta’s outstanding
preferred stock or 48.82% of Somanta’s outstanding voting stock (on an
as-converted basis). Lake End Capital, LLC are represented on Somanta’s board of
directors and controls 5.09% of Somanta’s common stock and 4.23% of Somanta’s
outstanding preferred stock. Walbrook Trustees (Jersey Ltd REK33), of which
Agamemnon A Epenetos, Somanta’s President and Chief Executive Officer, is a
beneficiary, is the beneficial owner of 25.03% of Somanta’s common stock or
15.28% of Somanta’s outstanding voting stock (on an as-converted basis). Access
has received voting agreements from certain Somanta stockholders representing
approximately 85% of Somanta’s outstanding common stock and approximately 60% of
its outstanding preferred stock or 70.84% of Somanta’s outstanding voting stock
(on an as-converted basis) under which the parties, subject to certain limited
exceptions, have granted an irrevocable proxy to Access to vote their shares
in
favor of the merger. A copy of the form of the Voting Agreement is attached
as
Annex C.
Interests
of Directors and Executive Officers of Somanta in the Merger (see page 57)
In
considering the recommendation of the Somanta board of directors with respect
to
the merger agreement and the merger contemplated by the merger agreement, you
should be aware that members of the Somanta board of directors and Somanta
executive officers have interests in the merger contemplated by the merger
agreement that may be different than, or in addition to, the interests of
Somanta stockholders, generally. These interests include:
| • |
the
continued indemnification of, and provision of directors’ and officers’
insurance coverage to, current directors and officers of Somanta
following
the merger;
|
•
the
employment of certain executive officers of Somanta by Access upon completion
of
the merger;
| • |
the
potential receipt of severance payments, payable to the following
executive officers in the following respective amounts if he were
to be
terminated without cause or were to resign pursuant to an involuntary
termination at any time following the completion of the merger:
|
9
| Name |
Total
Severance
Payments
|
|||
| Agamemnon A. Epenetos, MD, PhD | $ | 275,000 | ||
| Terrance J. Bruggeman | 248,000 | |||
| • |
that
Jeffrey Davis is a director of both Somanta and Access and that Mr.
Davis
is also an affiliate of SCO Capital an entity that is a secured lender
to
Access and that beneficially owns 44.52% of Somanta’s common stock and
74.1% of Access’ common stock.
Mr. Davis and Mark Alvino, who is also an affiliate of SCO, are each
also
directors of Access and Mr. Davis is the Chairman of the Board of
Access.
|
Each
of
the Somanta and Access boards of directors were aware of these interests and
considered them, among other matters, in making their
recommendations.
Dissenters’
or Appraisal Rights (see page 53)
Holders
of shares of Somanta common stock or preferred stock who do not vote in favor
of
approval and adoption of the merger agreement and approval of the merger and
who
properly demand appraisal of their shares will be entitled to appraisal rights
in connection with the merger under Section 262 of the DGCL. Under the DGCL,
holders of shares of Access common stock are not entitled to appraisal rights
in
connection with the merger.
Merely
voting against the merger will not preserve the right of Somanta stockholders
to
appraisal under the DGCL. Also, because a submitted proxy not marked “against”
or “abstain” will be voted “FOR” the proposal to approve and adopt the merger
agreement and the merger contemplated by the merger agreement, the submission
of
a proxy not marked “against” or “abstain” will result in the waiver of appraisal
rights. Somanta stockholders who hold shares in the name of a broker or other
nominee must instruct their nominee to take the steps necessary to enable them
to demand appraisal of their shares.
Annex
B
to this proxy statement/prospectus contains the full text of Section 262 of
the
DGCL, which relates to the rights of appraisal. We encourage you to read these
provisions carefully and in their entirety.
A
number
of conditions must be satisfied before the merger will be completed. These
include among others:
|
|
•
|
|
the
approval and adoption of the merger agreement and the merger contemplated
by the merger agreement by Somanta stockholders;
|
|
|
•
|
|
the
absence of any legal restraints or prohibitions preventing the completion
of the merger;
|
|
|
•
|
|
that
Access has received a favorable fairness opinion of TSG Partners
to the
effect that the payment by it of the merger consideration is fair
to
Access’ stockholders from a financial point of
view;
|
|
|
•
|
|
the
representations and warranties of each party contained in the merger
agreement being true and correct, except to the extent that breaches
of
these representations and warranties would not result in a material
adverse effect on the representing party;
|
|
|
•
|
|
the
performance or compliance in all material respects of each party
with all
agreements and covenants contained in the merger agreement at the
completion of the merger;
|
|
|
•
|
|
the
absence of events or developments since the date of the merger agreement
that would reasonably be expected to have a material adverse effect
with
respect to either party; and
|
|
|
•
|
|
that
as of the completion of the merger all of Somanta’s liabilities, including
accounts payables and amounts owed to officers and employees, shall
not
exceed $1,000,000 in the aggregate.
|
|
|
•
|
|
the
applicable maturity date of all of Access's outstanding debt (whether
principal or interest) owed to each of SCO Partners LLC (and its
affiliates) and Oracle Partners LP (and its affiliates) shall
have been extended to a date on or after April 27, 2008, or such
debt
shall have been converted into Access common stock. The notes are
currently due July 26, 2007 and July 27, 2007, respectively. Access
currently does not have adequate funds to repay the loans. As of
the date
of this Proxy Statement/Prospectus the notes have not been converted
into
Parent Common Stock and the principal and interest on such notes
have not
been repaid or extended to a date on or after April 27, 2008. If
such
notes have not converted into Parent Common Stock, been repaid
or extended
to a date on or after April 27, 2008, Somanta may, in its sole
discretion,
choose to waive the condition of the performance of this
obligation.
|
Each
of
Access, Somanta Acquisition Corporation and Somanta may waive the conditions
to
the performance of its respective obligations under the merger agreement and
complete the merger even though one or more of these conditions has not been
met.
Regulatory
Matters (see page 53)
The
merger is not subject to antitrust laws or any federal or state regulatory
requirements.
10
Each
of
Access and Somanta has agreed to cooperate fully with the other party and use
its reasonable best efforts to take, or cause to be taken, all actions
necessary, proper or advisable under applicable law and regulations to complete
the merger as promptly as practicable, but in no event later than August 31,
2007.
No
Solicitation
The
merger agreement contains detailed provisions that prohibit Somanta and its
subsidiaries, and their officers, directors agents, representatives and advisors
from taking any action to solicit or engage in discussions or negotiations
with
any person or group with respect to an acquisition proposal as defined in the
merger agreement, including an acquisition that would result in the person
or
group acquiring more than a 33.33% interest in the party’s total outstanding
securities, a sale of more than 33.33% of the party’s assets or a merger or
other business combination. The merger agreement does not, however, prohibit
either party or its board of directors from considering and recommending to
the
party’s stockholders an unsolicited acquisition proposal from a third party if
specified conditions are met.
Under
circumstances specified in the merger agreement, either Access or Somanta may
terminate the merger agreement. Subject to the limitations set forth in the
merger agreement, the circumstances generally include if:
|
|
•
|
|
the
other party consents to termination;
|
|
|
•
|
|
the
merger is not completed by August 31, 2007, unless extended by mutual
agreement;
|
|
|
•
|
|
either
party if any governmental authority shall have issued an order, decree,
or
ruling or taken any other action permanently enjoining restraining,
or
otherwise prohibiting the merger and such order, decree, ruling,
or other
action shall have become final and nonappealable;
|
|
|
•
|
|
the
required approval of the stockholders of Somanta has not been obtained
at
its special meeting;
|
|
|
•
|
|
the
other party breaches its representations, warranties or covenants
in the
merger agreement such that its conditions to completion of the merger
regarding representations, warranties or covenants would not be satisfied;
or
|
|
|
•
|
|
the
other party has not complied with the provisions of the merger agreement
relating to non-solicitation and board
recommendations.
|
On
April
26, 2007, after the Board’s approval of the merger agreement, Somanta entered
into a Note Purchase Agreement, a Security Agreement, a Patent Collateral
Assignment and Security Agreement and a Trademark Collateral Security and
Pledge
Agreement (collectively, the “Loan Documents”) with Access. Under the terms of
the Loan Documents, Access initially loaned Somanta $33,461.89. Access, in
its
sole discretion, may from time to time advance additional loan amounts to
Somanta. All amounts loaned to Somanta by Access are secured by substantially
all of the assets of Somanta pursuant to the terms of the Loan Documents.
The
Note bears interest at 10% and is repayable at the earlier of: (i) August
31,
2007, or (ii) the date of the termination of the Agreement and Plan of Merger
dated as of August 18, 2007 between Somanta and Access. As of July 20, 2007
Somanta had borrowed $485,745.55 from Access.
If
the
merger is not completed under certain circumstances specified in the merger
agreement, Somanta may be required to pay Access expenses in the amount of
up to
$750,000 and a break-up fee of $750,000. If the merger is not completed under
certain circumstances specified in the merger agreement, Access may be required
to pay Somanta expenses in the amount of up to $100,000.
Somanta
expects the merger to qualify as a “reorganization” within the meaning of
Section 368(a) of the Internal Revenue Code. If the merger qualifies as a
“reorganization,” Somanta stockholders generally will not recognize a gain or
loss for federal income tax purposes. No gain or loss will be recognized for
federal income tax purposes by Somanta, Access, or Access stockholders as a
result of the merger.
Tax
matters are complicated, and the tax consequences of the merger to each Somanta
stockholder will depend on the facts of each stockholder’s situation. Somanta
stockholders are urged to read carefully the discussion in the section entitled
“The Merger—Material United States Federal Income Tax Consequences of the
Merger” and to consult their tax advisors for a full understanding of the tax
consequences of their participation in the merger.
11
Access
will account for the merger as a business combination under United States
generally accepted accounting principles.
Risk
Factors
In
evaluating the merger agreement and the merger, in the case of Somanta
stockholders, or the issuance of shares of Access common stock in the merger,
you should carefully read this proxy statement/prospectus and especially
consider the factors discussed in the section entitled “Risk Factors” beginning
on page 18.
Access
and Somanta are providing the following information to aid you in your analysis
of the financial aspects of the merger.
Access
The
selected consolidated financial data below as of and for each of the years
in
the five-year period ended December 31, 2006 has been derived from Access’
consolidated financial statements. The information is only a summary and should
be read in conjunction with Access consolidated financial statements,
accompanying notes and management’s discussion and analysis of results of
operations and financial condition, all of which can be found in publicly
available documents, including those incorporated by reference into this proxy
statement/prospectus. See “Additional Information—Where You Can Find More
Information” beginning on page 205.
|
For
the Years Ended December 31,
|
||||||||||||||||
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2002
|
||||
|
|
(In
thousands, except per share data)
|
|||||||||||||||
|
Consolidated
Statement of
Operations
and Comprehensive
Loss
Data:
|
||||||||||||||||
|
Total
revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
89
|
||||||
|
Operating
loss
|
(5,175
|
)
|
(9,622
|
)
|
(6,003
|
)
|
(5,426
|
)
|
(5,925
|
)
|
||||||
|
Interest
and miscellaneous income
|
294
|
100
|
226
|
279
|
594
|
|||||||||||
|
Interest
and other expense
|
(7,436
|
)
|
(2,100
|
)
|
(1,385
|
)
|
(1,281
|
)
|
(1,278
|
)
|
||||||
|
Unrealized
loss
|
(1,107
|
)
|
-
|
-
|
-
|
-
|
||||||||||
|
Income
tax benefit
|
173
|
4,067
|
-
|
-
|
-
|
|||||||||||
|
Loss
from continuing operations
|
(13,251
|
)
|
(7,555
|
)
|
(7,162
|
)
|
(6,428
|
)
|
(6,520
|
)
|
||||||
|
Discontinued
operations net of taxes ($173 in 2006 and $4,067 in 2005)
|
377
|
5,855
|
(3,076
|
)
|
(507
|
)
|
(2,864
|
)
|
||||||||
|
Net
loss
|
(12,874
|
)
|
(1,700
|
)
|
(10,238
|
)
|
(6,935
|
)
|
(9,384
|
)
|
||||||
|
Common
Stock Data: (2)
|
||||||||||||||||
|
Net
loss per basic and diluted
common
share
|
$
|
(3.65
|
)
|
$
|
(0.53
|
)
|
$
|
(3.38
|
)
|
$
|
(2.61
|
)
|
$
|
(3.58
|
)
|
|
|
Weighted
average basic and
diluted
common shares
outstanding
|
3,532
|
3,237
|
3,032
|
2,653
|
2,621
|
|||||||||||
12
|
As
of December 31,
|
||||||||||||||||
|
2006
|
2005
|
2004
|
2003
|
2002
|
||||||||||||
|
(In
thousands)
|
||||||||||||||||
|
Consolidated
Balance Sheet Data:
|
||||||||||||||||
|
Cash,
cash equivalents and
short
term investments
|
$
|
4,389
|
$
|
474
|
$
|
2,261
|
$
|
2,587
|
$
|
9,776
|
||||||
|
Restricted
cash
|
-
|
103
|
1,284
|
649
|
468
|
|||||||||||
|
Total
assets
|
6,426
|
7,213
|
11,090
|
11,811
|
19,487
|
|||||||||||
|
Deferred
revenue
|
173
|
173
|
1,199
|
1,184
|
1,199
|
|||||||||||
|
Convertible
notes, net of discount
|
8,833
|
7,636
|
13,530
|
13,530
|
13,530
|
|||||||||||
|
Total
liabilities
|
16,313
|
11,450
|
17,751
|
17,636
|
18,998
|
|||||||||||
|
Total
stockholders' equity (deficit)
|
(9,887
|
)
|
(4,237
|
)
|
(6,661
|
)
|
(5,825
|
)
|
489
|
|||||||
| (1) |
This
data has been adjusted for discontinued operations and sales of assets.
The discontinued operations relate to the sale of Access’ oral care and
dermatology business to Uluru, Inc. and the closing and sale of the
Access’ Australian laboratory described more fully in “Management’s
Discussion and Analysis or Plan of Operations” appearing elsewhere in this
Prospectus.
|
| (2) |
All
shares and per share information reflect a one for five reverse stock
split effected June 5, 2006.
|
13
Somanta
Somanta
has derived the following historical information from Somanta audited
consolidated financial statements from inception through the fiscal year ended
April 30, 2006 contained in Somanta’s annual reports on Form 10-KSB. The
information is only a summary and should be read in conjunction with Somanta’s
consolidated financial statements and accompanying notes, as well as
management’s discussion and analysis of results of operations and financial
condition, all of which can be found in publicly available documents, including
those incorporated by reference into this proxy statement/prospectus. See
“Additional Information—Where You Can Find More Information” beginning on page
205.
|
For
the Years Ended April 30,
|
||||||||||
|
2007
|
2006
|
2005
|
||||||||
|
(In
thousands, except per share
data)
|
||||||||||
|
Consolidated
Statement of Operations and Comprehensive
Loss Data
|
||||||||||
|
Total
revenues
|
$
|
1
|
$
|
1
|
$ | - | ||||
|
Operating
loss
|
(4,550
|
)
|
(4,108
|
)
|
(1,129
|
)
|
||||
|
Interest
and miscellaneous income
|
28
|
17
|
-
|
|||||||
|
Interest
and other expense
|
(2,969
|
)
|
(908
|
) |
-
|
|||||
|
Income
tax
|
4
|
2
|
-
|
|||||||
|
Net
loss
|
(7,496
|
)
|
(5,002
|
)
|
(1,129
|
)
|
||||
|
Deemed
dividends on convertible preferred stock
|
-
|
|
(1,522
|
) |
-
|
|||||
|
Net
loss applicable to common shareholders
|
(7,496
|
)
|
(6,524
|
)
|
(1,129
|
)
|
||||
|
Comprehensive
loss-foreign currency translation
adjustment
|
-
|
-
|
(6
|
) | ||||||
|
Comprehensive
loss
|
(7,496
|
)
|
(6,524
|
)
|
(1,135
|
)
|
||||
|
Common
Stock Data:
|
||||||||||
|
Net
loss per basic and diluted
common
share
|
$
|
(0.56
|
)
|
$
|
(0.47
|
)
|
$
|
(0.20
|
)
|
|
|
Weighted
average basic and
diluted
common shares
outstanding
|
14,278,247
|
14,274,365
|
5,576,845
|
|||||||
|
As
of April 30,
|
|||||||
|
2007
|
2006
|
||||||
|
(In
thousands)
|
|||||||
|
Consolidated Balance
Sheet Data
|
|||||||
|
Cash,
cash equivalents and short
term investments
|
$
|
5
|
$
|
1,588
|
|||
|
Restricted
cash
|
2
|
152
|
|||||
|
Total
assets
|
67
|
1,859
|
|||||
|
Current
liabilities
|
8,245
|
3,443
|
|||||
|
Total
liabilities
|
8,245
|
3,443
|
|||||
|
Total
stockholders' equity (deficit)
|
(8,178
|
)
|
(1,585
|
)
|
|||
14
Selected
Unaudited Pro Forma Condensed Combined Financial Data
The
following unaudited pro forma condensed combined financial statements are based
upon the historical condensed consolidated financial statements and notes
thereto (as applicable) of Access and Somanta, which are included elsewhere
in
this proxy statement/prospectus. The financial data gives pro forma effect
to
the merger as if the merger had been completed on March 31, 2007 for the
unaudited pro forma condensed combined balance sheet and January 1, 2006 for
the
unaudited pro forma condensed combined statement of operations.
Somanta
preferred and common stockholders are expected to receive 1,500,000 shares
of
Access common stock for Somanta capital stock they own immediately prior to
the completion of the merger.
The
pro
forma adjustments are based upon available information and certain assumptions
that Access believes are reasonable under the circumstances. A final
determination of fair values relating to the merger, which cannot be made prior
to the completion of the merger, may differ materially from the preliminary
estimates and will include management’s final valuation of the fair value of
assets acquired and liabilities assumed. This final valuation will be based
on
the actual net tangible assets of Somanta that exist as of the date of the
completion of the merger. The final valuation may change the allocations of
the
purchase price, which could affect the fair value assigned to the assets and
liabilities and could result in a change to the unaudited pro forma condensed
combined financial statements data. These adjustments are more fully described
in the notes to the unaudited pro forma condensed combined financial statements
under the heading “Unaudited Pro Forma Condensed Combined Financial Statements.”
beginning on page 192.
The
selected unaudited pro forma condensed combined financial data (i) have been
derived from and should be read in conjunction with the unaudited pro forma
condensed combined financial statements and accompanying notes included in
this
proxy statement/prospectus as described under “Unaudited Pro Forma Condensed
Combined Financial Statements” beginning on page 192, and (ii) should be read in
conjunction with the consolidated financial statements of Access and Somanta
and
other information filed by Access and Somanta with the SEC and incorporated
by
reference into this proxy statement/prospectus. See “Additional
Information—Where You Can Find More Information” beginning on page 205.
|
Unaudited
Pro Forma Condensed Combined
Consolidated
Statement
of
Operations Data:
|
For
the Twelve
Months
Ended
December
31, 2006
|
For
the Three
Months
Ended
March
31, 2007
|
|||||
|
(in
thousands)
|
(in
thousands)
|
||||||
|
Total
revenues
|
$ |
1
|
$
|
-
|
|||
| Total expenses |
9,929
|
2,291 | |||||
|
Loss
from operations
|
(9,928
|
) |
(2,291
|
)
|
|||
|
Interest
and miscellaneous income
|
337
|
37
|
|||||
|
Interest
and other expenses
|
(7,436
|
)
|
(2,535
|
)
|
|||
|
Change
in fair value of warrant liabilities
|
(3,350
|
)
|
(2,775
|
)
|
|||
|
Net
loss before discontinued
operations
and before tax benefit
|
(20,416
|
)
|
(7,565
|
)
|
|||
|
Income
tax benefit
|
171
|
-
|
|||||
|
Loss
from continuing operations
|
(20,245
|
) |
(7,565
|
)
|
|||
|
Discontinued
operations, net of
taxes
of $173,000
|
377
|
-
|
|||||
|
Net
loss
|
$ |
(19,868
|
) |
$
|
(7,565
|
)
|
|
15
|
Unaudited
Pro Forma Condensed Combined
Consolidated
Balance Sheet:
|
As
of March 31, 2007
|
||||
|
(in
thousands)
|
|||||
|
Cash
and cash equivalents
|
$
|
364
|
|||
|
Short
term investments, at cost
|
2,724
|
||||
|
Total
current assets
|
3,844
|
||||
| Property and equipment, net | 224 | ||||
|
Patents
net
|
836
|
||||
|
Total
assets
|
4,943
|
||||
|
Accounts
payables and accrued expenses
|
4,103
|
||||
|
Current
portion of long-term debt net of discount
|
10,794
|
||||
|
Long-term
debt
|
5,500
|
||||
|
Total
liabilities
|
22,476
|
||||
|
Additional
paid-in capital
|
75,576
|
||||
|
Notes
receivable from stockholders
|
(1,045
|
)
|
|||
|
Accumulated
deficit
|
(92,110
|
)
|
|||
|
Total
stockholders’ deficit
|
(17,533
|
)
|
|||
Comparative
Per Share Information
The
following tables set forth historical per share information of Access and
Somanta and unaudited pro forma condensed combined per share information after
giving effect to the merger under the purchase method of accounting, based
on an
average price per share of Access common stock of $5.00. The unaudited pro
forma
combined financial data are not necessarily indicative of the financial position
had the merger occurred on December 31, 2006, or operating results that would
have been achieved had the merger been in effect as of January 1, 2006 and
should not be construed as representative of future financial position or
operating results. The unaudited pro forma condensed combined per share
information is derived from, and should be read in conjunction with, the
unaudited pro forma condensed combined financial statements and accompanying
notes included in this proxy statement/prospectus as described under “Unaudited
Pro Forma Condensed Combined Financial Statements” beginning on page 219. The
historical per share information is derived from the audited financial
statements as of and for the years ended December 31, 2006 and 2005 for Access.
The historical per share information is derived from the audited financial
statements as of and for the years ended April 30, 2006 and 2005 and the
unaudited financial statements for the periods ended January 31, 2007 and 2006
for Somanta.
|
|
|
Historical
Access
|
Historical
Somanta
|
Pro
Forma
Combined
|
Pro
Forma
Equivalent
of
One
Somanta
Share
(1)
|
||||||||
|
Net
earnings (loss) per share—basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months ended March 31, 2007 (2)
|
|
$
|
(1.17
|
)
|
|
$
|
(0.25)
|
|
$
|
(1.50)
|
|
$
|
(0.05)
|
|
Year
ended December 31, 2006 (3)
|
|
|
(3.65
|
)
|
|
|
(0.53)
|
|
|
(3.95)
|
|
|
(0.13)
|
|
Book
value per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31, 2007 (2)
|
|
$
|
(3.88
|
)
|
|
$
|
(0.49)
|
|
$
|
(3.48)
|
|
$
|
(0.11)
|
|
December
31, 2006 (3)
|
|
|
(2.80
|
)
|
|
|
(0.11)
|
|
|
(4.69)
|
|
|
(0.15)
|
|
Cash
dividends declared per share
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Outstanding
shares (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31, 2007 (2)
|
|
|
3.5
|
|
|
|
14.3
|
|
|
5.0
|
|
|
|
|
December
31, 2006 (3)
|
|
|
3.5
|
|
|
|
14.3
|
|
|
5.0
|
|
|
|
|
(1)
|
The Pro Forma Equivalent of one
Somanta
Share amounts were calculated by applying the exchange ratio
of .032343 to the pro forma combined net earnings and book value per
share. The actual exchange ratio in the merger is subject to change.
|
|
(2)
|
Three months ended January 31,
2007 for
Somanta
|
|
(3)
|
Twelve months ended January 31,
2007 for
Somanta
|
16
This
information is only a summary and should be read in conjunction with the
financial statements and accompanying notes of Access and Somanta contained
in
the annual reports and other information that has been filed with the SEC and
incorporated by reference into this proxy statement/prospectus and with the
unaudited pro forma condensed combined financial statements referred to above.
See “Additional Information—Where You Can Find More Information” beginning on
page 205.
Comparative
Per Share Market Price Data
Access
common stock trades on the OTC Bulletin Board under the symbol “ACCP.” Somanta
common stock trades on the OTC Bulletin Board under the symbol “SMPM.” The
following table sets forth the closing prices for Access common stock and
Somanta common stock as reported on the OTC Bulletin Board on February 21,
2007,
the last trading day before Access and Somanta announced the merger,
and July 19, 2007 the last trading day before the date of this proxy
statement/ prospectus.
|
|
|
Access
Common Stock
|
|
Somanta
Common Stock
|
|
Pro Forma Equivalent Value
of
Somanta Common Stock
|
|||
|
February
21, 2007
|
|
$8.25
|
|
$1.10
|
|
$0.27
|
|||
|
July 19,
2007
|
|
$4.50
|
|
$0.15
|
|
$0.17
|
|||
The
above
tables show only historical comparisons. These comparisons may not provide
meaningful information to Somanta stockholders in determining whether to approve
and adopt the merger agreement and approve the merger contemplated by the merger
agreement. See “Additional Information—Where You Can Find More Information”
beginning on page 205.
17
RISK
FACTORS
In
addition to the other information included in this proxy statement/prospectus,
including the matters addressed in “Cautionary Statement Concerning
Forward-Looking Statements,” you should carefully consider the following risks
before deciding whether to vote for approval and adoption of the merger
agreement and the merger contemplated by the merger agreement, in the case
of
Somanta stockholders.
Although
Access and Somanta expect that the merger will result in benefits to the
combined company, the combined company may not realize those benefits because
of
integration and other challenges.
Access’
ability to realize the anticipated benefits of the merger will depend, in part,
on the ability of Access to integrate the business of Somanta with the business
of Access. The combination of two independent companies is a complex, costly
and
time-consuming process. This process may disrupt the business of either or
both
of the companies, and may not result in the full benefits expected by Access
and
Somanta. The difficulties of combining the operations of the companies include,
among others:
|
|
•
|
|
unanticipated
issues in integrating information, communications and other systems;
|
|
|
•
|
|
retaining
key employees;
|
|
|
•
|
|
consolidating
corporate and administrative infrastructures;
|
|
|
•
|
|
the
diversion of management’s attention from ongoing business concerns; and
|
|
|
•
|
|
coordinating
geographically separate organizations.
|
We
cannot
assure you that the combination of Somanta with Access will result in the
realization of the full benefits anticipated from the merger. For a full
description of the benefits anticipated from the merger, see “The Merger—Reasons
for the Merger” beginning on page 44.
If
the proposed merger is not completed, Access and Somanta will have incurred
substantial costs that may adversely affect Access’ and Somanta’s financial
results and operations and the market price of Access and Somanta common stock.
Access
and Somanta have incurred and will incur substantial costs in connection with
the proposed merger. These costs are primarily associated with the fees of
attorneys, accountants and Access’ financial advisors. In addition, Access and
Somanta have each diverted significant management resources in an effort to
complete the merger and are each subject to restrictions contained in the merger
agreement on the conduct of its business. If the merger is not completed, Access
and Somanta will have incurred significant costs, including the diversion of
management resources, for which each will have received little or no benefit.
Also, if the merger is not completed under certain circumstances specified
in
the merger agreement, Somanta may be required to pay Access’ expenses in the
amount of up to $750,000 and Access may be required to pay Somanta’s expenses in
the amount of up to $100,000. Somanta could also be required to pay a break-up
fee of $750,000. See “The Merger Agreement—Termination; Break-Up Fees and
Expenses” beginning on page 67.
In
addition, if the merger is not completed, Access and Somanta may experience
negative reactions from the financial markets and Access’ and Somanta’s
collaborative partners, customers and employees. Each of these factors may
adversely affect the trading price of Access and/or Somanta common stock and
Access’ and/or Somanta’s financial results and operations.
18
Certain
directors and executive officers of Somanta have interests in the merger that
may be different from, or in addition to, the interests of Somanta stockholders.
When
considering the Somanta board of directors’ recommendation that Somanta
stockholders vote in favor of the proposal to approve and adopt the merger
agreement and the merger contemplated by the merger agreement, Somanta
stockholders should be aware that some directors and executive officers of
Somanta have interests in the merger that may be different from, or in addition
to, the interests of Somanta stockholders. These interests include the continued
indemnification and insurance coverage of officers and directors of Somanta
following the merger, the employment of certain executive officers of Somanta
by
Access upon completion of the merger, and the potential for severance payments
to Somanta’s executive officers under change of control agreements, and the fact
that Mr. Davis is a director of both Somanta and Access and is also an affiliate
of SCO Capital, an entity that owns 48.82% of Somanta’s common stock (on an
as-converted basis) and 74.1% of Access’ common stock and is the holder of $6.0
million of Access secured convertible debt. As a result of these interests,
these directors and officers could be more likely to vote to approve and adopt
the merger agreement and the merger contemplated by the merger agreement than
if
they did not hold these interests, and may have reasons for doing so that are
not the same as the interests of other Somanta stockholders. For a full
description of the interests of directors and executive officers of Somanta
in
the merger, see “The Merger—Interests of Executive Officers and Directors of
Somanta in the Merger” beginning on page 57.
Although
Access and Somanta expect that the merger will result in benefits to the
combined company, the combined company may not realize those benefits because
of
integration and other challenges.
Access’
ability to realize the anticipated benefits of the merger will depend, in part,
on the ability of Access to integrate the business of Somanta with the business
of Access. The combination of two independent companies is a complex, costly
and
time-consuming process. This process may disrupt the business of either or
both
of the companies, and may not result in the full benefits expected by Access
and
Somanta. The difficulties of combining the operations of the companies include,
among others:
|
|
•
|
|
unanticipated
issues in integrating information, communications and other systems;
|
|
|
•
|
|
retaining
key employees;
|
|
|
•
|
|
consolidating
corporate and administrative infrastructures;
|
|
|
•
|
|
the
diversion of management’s attention from ongoing business concerns; and
|
|
|
•
|
|
coordinating
geographically separate organizations.
|
We
cannot
assure you that the combination of Somanta with Access will result in the
realization of the full benefits anticipated from the merger.
Without
obtaining adequate capital funding, Access may not be able to continue as a
going concern.
The
report of Access’ independent registered public accounting firm for the fiscal
year ended December 31, 2006 contained a fourth explanatory paragraph to reflect
its significant doubt about Access’ ability to continue as a going concern as a
result of Access’ history of losses and Access’ liquidity position. If Access is
unable to obtain adequate capital funding in the future, Access may not be
able
to continue as a going concern, which would have an adverse effect on Access’
business and operations, and investors’ investment in Access may
decline.
Access
has experienced a history of losses, Access expects to incur future losses
and
Access may be unable to obtain necessary additional capital to fund operations
in the future.
Access
recorded minimal revenue to date and Access has incurred a cumulative operating
loss of approximately $81.8 million through March 31, 2007. Net losses for
the
years ended 2006, 2005 and 2004 were $12,874,000, $1,700,000 and $10,238,000,
respectively. Access’ losses have resulted principally from costs incurred in
research and development activities related to Access’ efforts to develop
clinical drug candidates and from the associated administrative costs. Access
expects to incur additional operating losses over the next several years. Access
also expects cumulative losses to increase if Access expands research and
development efforts and preclinical and clinical trials. Access’ net cash burn
rate for the three months ended March 31, 2007 was approximately $435,000 per
month. Access projects its net cash burn rate for the next six months to be
approximately $450,000 per month. Capital expenditures are forecasted to be
minor for the next six months.
19
Access
requires substantial capital for its development programs and operating
expenses, to pursue regulatory clearances and to prosecute and defend its
intellectual property rights. Access believes that its existing capital
resources, interest income, product sales, royalties and revenue from possible
licensing agreements and collaborative agreements will be sufficient to fund
its
currently expected operating expenses and capital requirements for six months
(other than debt and interest obligations including the approximately
$6
million of Senior Convertible notes due July 26, 2007 plus accrued interest;
and
approximately $4.0
million of convertible notes which are required to be repaid July 27, 2007
plus
accrued interest; and capitalized interest of $880,000 due September 13, 2007).
Access will need to raise substantial additional capital to support its ongoing
operations and debt obligations.
If
Access
does raise additional funds by issuing equity securities, further dilution
to
existing stockholders would result and future investors may be granted rights
superior to those of existing stockholders. If adequate funds are not available
to Access through additional equity offerings, Access may be required to delay,
reduce the scope of or eliminate one or more of its research and development
programs or to obtain funds by entering into arrangements with collaborative
partners or others that require Access to issue additional equity securities
or
to relinquish rights to certain technologies or drug candidates that Access
would not otherwise issue or relinquish in order to continue independent
operations.
Access
does not have operating revenue and it may never attain
profitability.
To
date,
Access has funded its operations primarily through private sales of common
stock
and convertible notes. Contract research payments and licensing fees from
corporate alliances and mergers have also provided funding for its operations.
Its
ability to achieve significant revenue or profitability depends upon its ability
to successfully complete the development of drug candidates, to develop and
obtain patent protection and regulatory approvals for Access’ drug candidates
and to manufacture and commercialize the resulting drugs. Access sold its only
revenue producing assets to Uluru, Inc. in October 2005. Access is not expecting
any revenues in the short-term from its other assets. Furthermore, Access may
not be able to ever successfully identify, develop, commercialize, patent,
manufacture, obtain required regulatory approvals and market any additional
products. Moreover, even if Access does identify, develop, commercialize,
patent, manufacture, and obtain required regulatory approvals to market
additional products, Access may not generate revenues or royalties from
commercial sales of these products for a significant number of years, if at
all.
Therefore, its proposed operations are subject to all the risks inherent in
the
establishment of a new business enterprise. In the next few years, its revenues
may be limited to minimal product sales and royalties, any amounts that Access
receives under strategic partnerships and research or drug development
collaborations that Access may establish and, as a result, Access may be unable
to achieve or maintain profitability in the future or to achieve significant
revenues in order to fund its operations.
Access
may not be able to pay its debt and other obligations and its assets may be
seized as a result.
Access
may not generate the cash flow required to pay its liabilities as they become
due. Its outstanding debt includes approximately $6.0 million of Senior
Convertible notes due July 26, 2007, and approximately $4.0 million of its
Convertible Subordinated Notes due July 27, 2007 and $5.5 million are due in
September 2010. Access has also capitalized interest of $880,000 due
September 13, 2007 or earlier if Access raises over $5.0 million in new
equity.
If
its
cash flow is inadequate to meet these obligations, Access will default on the
notes. Any default on the notes could allow its note holders to foreclose upon
its assets, and force it into bankruptcy. Access
may be unable to repay, repurchase or restructure the convertible subordinated
notes due in July 2007 and September 2010 and could be forced into bankruptcy.
In
the
event of a default, the holders of its secured convertible notes have the right
to foreclose on substantially all of its assets, which could force it to curtail
or cease its business operations.
The
holders of Access’s convertible notes may require it to repurchase or prepay all
of the outstanding convertible notes under certain circumstances. Access may
not
have sufficient cash reserves to repurchase the convertible notes at such time,
which would cause an event of default under the convertible notes and may force
it to declare bankruptcy.
Access
may not successfully commercialize its drug candidates.
Access’
drug candidates are subject to the risks of failure inherent in the development
of pharmaceutical products based on new technologies and its failure to develop
safe, commercially viable drugs would severely limit its ability to become
profitable or to achieve significant revenues. Access may be unable to
successfully commercialize Access’ drug candidates because:
| · |
some
or all of its drug candidates may be found to be unsafe or ineffective
or
otherwise fail to meet applicable regulatory standards or receive
necessary regulatory clearances;
|
| · |
its
drug candidates, if safe and effective, may be too difficult to develop
into commercially viable drugs;
|
| · |
it
may be difficult to manufacture or market its drug candidates on
a large
scale;
|
| · |
proprietary
rights of third parties may preclude it from marketing its drug
candidates; and
|
| · |
third
parties may market superior or equivalent
drugs.
|
20
The
success of Access’ research and development activities, upon which Access
primarily focuses, is uncertain.
Access’
primary focus is on its research and development activities and the
commercialization of compounds covered by proprietary biopharmaceutical patents
and patent applications. Research and development activities, by their nature,
preclude definitive statements as to the time required and costs involved in
reaching certain objectives. Actual research and development costs, therefore,
could exceed budgeted amounts and estimated time frames may require extension.
Cost overruns, unanticipated regulatory delays or demands, unexpected adverse
side effects or insufficient therapeutic efficacy will prevent or substantially
slow Access’ research and development effort and Access’ business could
ultimately suffer. Access anticipates that it will remain principally engaged
in
research and development activities for an indeterminate, but substantial,
period of time.
Access
may be unable to successfully develop, market, or commercialize its products
or
its product candidates without establishing new relationships and maintaining
current relationships.
Access’
strategy for the research, development and commercialization of its potential
pharmaceutical products may require it to enter into various arrangements with
corporate and academic collaborators, licensors, licensees and others, in
addition to its existing relationships with other parties. Specifically, Access
may seek to joint venture, sublicense or enter other marketing arrangements
with
parties that have an established marketing capability or Access may choose
to
pursue the commercialization of such products on its own. Access may, however,
be unable to establish such additional collaborative arrangements, license
agreements, or marketing agreements as Access may deem necessary to develop,
commercialize and market Access’ potential pharmaceutical products on acceptable
terms. Furthermore, if Access maintains and establishes arrangements or
relationships with third parties, its business may depend upon the successful
performance by these third parties of their responsibilities under those
arrangements and relationships.
Access’
ability to successfully commercialize, and market Access’ product candidates
could be limited if a number of these existing relationships were
terminated.
Furthermore,
its strategy with respect to its polymer platinate program is to enter into
a
licensing agreement with a pharmaceutical company pursuant to which the further
costs of developing a product would be shared with its licensing partner.
Although Access has had discussions with potential licensing partners with
respect to its polymer platinate program, to date Access has not entered into
any licensing arrangement. Access may be unable to execute its licensing
strategy for polymer platinate.
Access
may be unable to successfully manufacture its products and its product
candidates in clinical quantities or for commercial purposes without the
assistance of contract manufacturers, which may be difficult for it to obtain
and maintain.
Access
has limited experience in the manufacture of pharmaceutical products in clinical
quantities or for commercial purposes and Access may not be able to manufacture
any new pharmaceutical products that Access may develop. As a result, Access
has
established, and in the future intends to establish arrangements with contract
manufacturers to supply sufficient quantities of products to conduct clinical
trials and for the manufacture, packaging, labeling and distribution of finished
pharmaceutical products if any of its potential products are approved for
commercialization. If Access is unable to contract for a sufficient supply
of
its potential pharmaceutical products on acceptable terms, its preclinical
and
human clinical testing schedule may be delayed, resulting in the delay of its
clinical programs and submission of product candidates for regulatory approval,
which could cause its business to suffer. Its business could suffer if there
are
delays or difficulties in establishing relationships with manufacturers to
produce, package, label and distribute its finished pharmaceutical or other
medical products, if any, market introduction and subsequent sales of such
products. Moreover, contract manufacturers that Access may use must adhere
to
current Good Manufacturing Practices, as required by the FDA. In this regard,
the FDA will not issue a pre-market approval or product and establishment
licenses, where applicable, to a manufacturing facility for the products until
the manufacturing facility passes a pre-approval plant inspection. If Access
is
unable to obtain or retain third party manufacturing on commercially acceptable
terms, Access may not be able to commercialize its products as planned. Its
potential dependence upon third parties for the manufacture of its products
may
adversely affect its ability to generate profits or acceptable profit margins
and its ability to develop and deliver such products on a timely and competitive
basis.
21
ProLindac™
is manufactured by third parties for Access’ Phase II clinical trials.
Manufacturing is ongoing for the current clinical trials. Certain manufacturing
steps are conducted by the Company to enable significant cost savings to be
realized.
Access
is subject to extensive governmental regulation which increases its cost of
doing business and may affect its ability to commercialize any new products
that
Access may develop.
The
FDA
and comparable agencies in foreign countries impose substantial requirements
upon the introduction of pharmaceutical products through lengthy and detailed
laboratory, preclinical and clinical testing procedures and other costly and
time-consuming procedures to establish its safety and efficacy. All of its
drugs
and drug candidates require receipt and maintenance of governmental approvals
for commercialization. Preclinical and clinical trials and manufacturing of
its
drug candidates will be subject to the rigorous testing and approval processes
of the FDA and corresponding foreign regulatory authorities. Satisfaction of
these requirements typically takes a significant number of years and can vary
substantially based upon the type, complexity and novelty of the product. The
status of Access’ principal products is as follows:
| l |
A
mucoadhesive liquid technology product, MuGard™, has received marketing
approval by the FDA.
|
| l |
ProLindac™
is currently in a Phase II trial in Europe and a Phase II trial in
the
US.
|
| l |
ProLindac™
has been approved for an additional Phase I trial in the US by the
FDA.
|
| l |
Cobalamin™
mediated delivery technology is currently in the pre-clinical
phase.
|
| l |
Access
also has other products in the preclinical
phase.
|
Due
to
the time consuming and uncertain nature of the drug candidate development
process and the governmental approval process described above, Access cannot
assure you when Access, independently or with its collaborative partners, might
submit a NDA, for FDA or other regulatory review.
Government
regulation also affects the manufacturing and marketing of pharmaceutical
products. Government regulations may delay marketing of Access’ potential drugs
for a considerable or indefinite period of time, impose costly procedural
requirements upon its activities and furnish a competitive advantage to larger
companies or companies more experienced in regulatory affairs. Delays in
obtaining governmental regulatory approval could adversely affect Access’
marketing as well as its ability to generate significant revenues from
commercial sales. Access’ drug candidates may not receive FDA or other
regulatory approvals on a timely basis or at all. Moreover, if regulatory
approval of a drug candidate is granted, such approval may impose limitations
on
the indicated use for which such drug may be marketed. Even if Access obtains
initial regulatory approvals for its drug candidates, Access’ drugs and its
manufacturing facilities would be subject to continual review and periodic
inspection, and later discovery of previously unknown problems with a drug,
manufacturer or facility may result in restrictions on the marketing or
manufacture of such drug, including withdrawal of the drug from the market.
The
FDA and other regulatory authorities stringently apply regulatory standards
and
failure to comply with regulatory standards can, among other things, result
in
fines, denial or withdrawal of regulatory approvals, product recalls or
seizures, operating restrictions and criminal prosecution.
The
uncertainty associated with preclinical and clinical testing may affect Access’
ability to successfully commercialize new products.
Before
Access can obtain regulatory approvals for the commercial sale of any of its
potential drugs, the drug candidates will be subject to extensive preclinical
and clinical trials to demonstrate their safety and efficacy in humans.
Preclinical or clinical trials of any of its future drug candidates may not
demonstrate the safety and efficacy of such drug candidates at all or to the
extent necessary to obtain regulatory approvals. In this regard, for example,
adverse side effects can occur during the clinical testing of a new drug on
humans which may delay ultimate FDA approval or even lead it to terminate its
efforts to develop the drug for commercial use. Companies in the biotechnology
industry have suffered significant setbacks in advanced clinical trials, even
after demonstrating promising results in earlier trials. In particular, polymer
platinate has taken longer to progress through clinical trials than originally
planned. This extra time has not been related to concerns of the formulations
but rather due to the lengthy regulatory process. The failure to adequately
demonstrate the safety and efficacy of a drug candidate under development could
delay or prevent regulatory approval of the drug candidate. A delay or failure
to receive regulatory approval for any of Access’ drug candidates could prevent
Access from successfully commercializing such candidates and Access could incur
substantial additional expenses in its attempts to further develop such
candidates and obtain future regulatory approval.
22
Access
may incur substantial product liability expenses due to the use or misuse of
its
products for which Access may be unable to obtain insurance
coverage.
Access’
business exposes it to potential liability risks that are inherent in the
testing, manufacturing and marketing of pharmaceutical products. These risks
will expand with respect to its drug candidates, if any, that receive regulatory
approval for commercial sale and Access may face substantial liability for
damages in the event of adverse side effects or product defects identified
with
any of its products that are used in clinical tests or marketed to the public.
Access generally procures product liability insurance for drug candidates that
are undergoing human clinical trials. Product liability insurance for the
biotechnology industry is generally expensive, if available at all, and as
a
result, Access may be unable to obtain insurance coverage at acceptable costs
or
in a sufficient amount in the future, if at all. Access may be unable to satisfy
any claims for which Access may be held liable as a result of the use or misuse
of products which Access has developed, manufactured or sold and any such
product liability claim could adversely affect its business, operating results
or financial condition.
Access
may incur significant liabilities if it fails to comply with stringent
environmental regulations or if Access did not comply with these regulations
in
the past.
Access’
research and development processes involve the controlled use of hazardous
materials. Access is subject to a variety of federal, state and local
governmental laws and regulations related to the use, manufacture, storage,
handling and disposal of such material and certain waste products. Although
Access believes that its activities and its safety procedures for storing,
using, handling and disposing of such materials comply with the standards
prescribed by such laws and regulations, the risk of accidental contamination
or
injury from these materials cannot be completely eliminated. In the event of
such accident, Access could be held liable for any damages that result and
any
such liability could exceed its resources.
Intense
competition may limit Access’ ability to successfully develop and market
commercial products.
The
biotechnology and pharmaceutical industries are intensely competitive and
subject to rapid and significant technological change. Access’ competitors in
the United States and elsewhere are numerous and include, among others, major
multinational pharmaceutical and chemical companies, specialized biotechnology
firms and universities and other research institutions.
The
following products may compete with polymer platinate:
•
Cisplatin, marketed by Bristol-Myers Squibb, the originator of the drug, and
several generic manufacturers;
•
Carboplatin, marketed by Bristol-Myers Squibb in the US; and
•
Oxaliplatin, marketed exclusively by Sanofi-Aventis.
The
following companies are working on therapies and formulations that may be
competitive with Access’ polymer platinate:
• Antigenics
and Regulon are developing liposomal platinum formulations;
•
Spectrum Pharmaceuticals and GPC Biotech are developing oral platinum
formulations;
•
Poniard Pharmaceuticals is developing both iv and oral platinum
formulations;
•
Nanocarrier and Debio are developing micellar nanoparticle platinum
formulations; and
• American
Pharmaceutical Partners, Cell Therapeutics, Daiichi, and Enzon are developing
alternate drugs in combination
with polymers and other drug delivery systems.
Companies
working on therapies and formulations that may be competitive with Access’
vitamin mediated drug delivery system are Bristol-Myers Squibb, Centocor
(acquired by Johnson & Johnson), Endocyte, GlaxoSmithKline, Imclone and Xoma
which are developing targeted monoclonal antibody therapy.
Amgen,
Carrington Laboratories, CuraGen Corporation, Cytogen Corporation, Endo
Pharmaceuticals, MGI Pharma, Nuvelo, Inc. and OSI Pharmaceuticals are developing
products to treat mucositis that may compete with Access’ mucoadhesive liquid
technology.
BioDelivery
Sciences International, Biovail Corporation, Cellgate, CIMA Labs, Inc., Cytogen
Corporation, Depomed Inc., Emisphere Technologies, Inc., Eurand, Flamel
Technologies, Nobex and Xenoport are developing products which compete with
Access’ oral drug delivery system.
23
Many
of
these competitors have and employ greater financial and other resources,
including larger research and development, marketing and manufacturing
organizations. As a result, Access’ competitors may successfully develop
technologies and drugs that are more effective or less costly than any that
Access is developing or which would render Access’ technology and future
products obsolete and noncompetitive.
In
addition, some of Access competitors have greater experience than Access does
in
conducting preclinical and clinical trials and obtaining FDA and other
regulatory approvals. Accordingly, Access’ competitors may succeed in obtaining
FDA or other regulatory approvals for drug candidates more rapidly than Access
does. Companies that complete clinical trials, obtain required regulatory agency
approvals and commence commercial sale of their drugs before their competitors
may achieve a significant competitive advantage. Drugs resulting from Access’
research and development efforts or from its joint efforts with collaborative
partners therefore may not be commercially competitive with its competitors'
existing products or products under development.
Access’
ability to successfully develop and commercialize its drug candidates will
substantially depend upon the availability of reimbursement funds for the costs
of the resulting drugs and related treatments.
The
successful commercialization of, and the interest of potential collaborative
partners to invest in the development of its drug candidates, may depend
substantially upon reimbursement of the costs of the resulting drugs and related
treatments at acceptable levels from government authorities, private health
insurers and other organizations, including health maintenance organizations,
or
HMOs. Limited reimbursement for the cost of any drugs that Access develops
may
reduce the demand for, or price of such drugs, which would hamper its ability
to
obtain collaborative partners to commercialize its drugs, or to obtain a
sufficient financial return on its own manufacture and commercialization of
any
future drugs.
The
market may not accept any pharmaceutical products that Access successfully
develops.
The
drugs
that Access is attempting to develop may compete with a number of
well-established drugs manufactured and marketed by major pharmaceutical
companies. The degree of market acceptance of any drugs developed by it will
depend on a number of factors, including the establishment and demonstration
of
the clinical efficacy and safety of its drug candidates, the potential advantage
of its drug candidates over existing therapies and the reimbursement policies
of
government and third-party payers. Physicians, patients or the medical community
in general may not accept or use any drugs that Access may develop independently
or with its collaborative partners and if they do not, its business could
suffer.
Trends
toward managed health care and downward price pressures on medical products
and
services may limit its ability to profitably sell any drugs that Access may
develop.
Lower
prices for pharmaceutical products may result from:
| · |
third-party
payers' increasing challenges to the prices charged for medical products
and services;
|
| · |
the
trend toward managed health care in the United States and the concurrent
growth of HMOs and similar organizations that can control or significantly
influence the purchase of healthcare services and products;
and
|
| · |
legislative
proposals to reform healthcare or reduce government insurance
programs.
|
The
cost
containment measures that healthcare providers are instituting, including
practice protocols and guidelines and clinical pathways, and the effect of
any
healthcare reform, could limit Access’ ability to profitably sell any drugs that
Access may successfully develop. Moreover, any future legislation or regulation,
if any, relating to the healthcare industry or third-party coverage and
reimbursement, may cause its business to suffer.
24
Access
may not be successful in protecting its intellectual property and proprietary
rights.
Access’
success depends, in part, on its ability to obtain U.S. and foreign patent
protection for its drug candidates and processes, preserve its trade secrets
and
operate its business without infringing the proprietary rights of third parties.
Legal standards relating to the validity of patents covering pharmaceutical
and
biotechnological inventions and the scope of claims made under such patents
are
still developing and there is no consistent policy regarding the breadth of
claims allowed in biotechnology patents. The patent position of a biotechnology
firm is highly uncertain and involves complex legal and factual questions.
Access cannot assure you that any existing or future patents issued to, or
licensed by, it will not subsequently be challenged, infringed upon, invalidated
or circumvented by others. As a result, although Access, together with its
subsidiaries, are either the owner or licensee to 13 U.S. patents and to 9
U.S.
patent applications now pending, and 4 European patents and 12 European patent
applications, Access cannot assure you that any additional patents will issue
from any of the patent applications owned by, or licensed to, it. Furthermore,
any rights that Access may have under issued patents may not provide it with
significant protection against competitive products or otherwise be commercially
viable.
Access’
patents for the following technologies expire in the years and during the date
ranges indicated below:
| · |
Mucoadhesive
technology in 2021,
|
| · |
ProLindac™
in 2021,
|
| · |
Cobalamin
mediated technology between 2007 and
2019
|
In
addition to issued patents, Access has a number of pending patent applications.
If issued, the patents underlying theses applications could extend the patent
life of its technologies beyond the dates listed above.
Patents
may have been granted to third parties or may be granted covering products
or
processes that are necessary or useful to the development of Access’ drug
candidates. If Access’ drug candidates or processes are found to infringe upon
the patents or otherwise impermissibly utilize the intellectual property of
others, Access’ development, manufacture and sale of such drug candidates could
be severely restricted or prohibited. In such event, Access may be required
to
obtain licenses from third parties to utilize the patents or proprietary rights
of others. Access cannot assure you that it will be able to obtain such licenses
on acceptable terms, if at all. If Access becomes involved in litigation
regarding its intellectual property rights or the intellectual property rights
of others, the potential cost of such litigation, regardless of the strength
of
its legal position, and the potential damages that Access could be required
to
pay could be substantial.
Access’
business could suffer if Access loses the services of, or fail to attract,
key
personnel.
Access
is
highly dependent upon the efforts of its senior management and scientific team,
including its President and Chief Executive Officer, Stephen R. Seiler. The
loss
of the services of one or more of these individuals could delay or prevent
the
achievement of its research, development, marketing, or product
commercialization objectives. While Access has employment agreements with
Stephen R. Seiler, David P. Nowotnik, PhD its Senior Vice President Research
and
Development, and Stephen B. Thompson, its Vice President and Chief Financial
Officer, their employment may be terminated by them or Access at any time.
Mr.
Seiler’s, Dr. Nowotnik's and Mr. Thompson’s agreements expire within one year
and are extendable each year on the anniversary date. Access does not have
employment contracts with its other key personnel. Access does not maintain
any
"key-man" insurance policies on any of its key employees and Access does not
intend to obtain such insurance. In addition, due to the specialized scientific
nature of its business, Access is highly dependent upon its ability to attract
and retain qualified scientific and technical personnel. In view of the stage
of
its development and its research and development programs, Access has restricted
its hiring to research scientists and a small administrative staff and Access
has made only limited investments in manufacturing, production, sales or
regulatory compliance resources. There is intense competition among major
pharmaceutical and chemical companies, specialized biotechnology firms and
universities and other research institutions for qualified personnel in the
areas of Access’ activities, however, and Access may be unsuccessful in
attracting and retaining these personnel.
An
investment in Access’ common stock may be less attractive because it is not
traded on a recognized public market.
Access’
common stock has traded on the OTC Bulletin Board, or OTCBB since June 5, 2006.
From February 1, 2006 until June 5, 2006 Access traded on the “Pink Sheets”
after its common stock was de-listed from trading on AMEX. The OTCBB and Pink
Sheets are viewed by most investors as a less desirable, and less liquid,
marketplace. As a result, an investor may find it more difficult to purchase,
dispose of or obtain accurate quotations as to the value of its common
stock.
25
Access’
common stock is subject to Rules 15g-1 through 15g-9 under the Exchange Act,
which imposes certain sales practice requirements on broker-dealers who sell
its
common stock to persons other than established customers and "accredited
investors" (as defined in Rule 501(c) of the Securities Act). For transactions
covered by this rule, a broker-dealer must make a special suitability
determination for the purchaser and have received the purchaser's written
consent to the transaction prior to the sale. This rule adversely affects the
ability of broker-dealers to sell Access’ common stock and purchasers of its
common stock to sell their shares of Access’ common stock.
Additionally,
Access’ common stock is subject to SEC regulations applicable to "penny stock."
Penny stock includes any non-NASDAQ equity security that has a market price
of
less than $5.00 per share, subject to certain exceptions. The regulations
require that prior to any non-exempt buy/sell transaction in a penny stock,
a
disclosure schedule proscribed by the SEC relating to the penny stock market
must be delivered by a broker-dealer to the purchaser of such penny stock.
This
disclosure must include the amount of commissions payable to both the
broker-dealer and the registered representative and current price quotations
for
Access’ common stock. The regulations also require that monthly statements be
sent to holders of penny stock that disclose recent price information for the
penny stock and information of the limited market for penny stocks. These
requirements adversely affect the market liquidity of Access’common
stock.
Ownership
of Access’ shares is concentrated in the hands of a few investors which could
limit the ability of Access’ other stockholders to influence the direction of
the company.
As
calculated by the SEC rules of beneficial ownership, SCO Capital Partners LLC
and affiliates, Larry N. Feinberg (Oracle Partners LP, Oracle Institutional
Partners LP and Oracle Investment Management Inc.), and Jeffrey B. Davis each
beneficially owned approximately 74.1%, 26.4%, and 14.9%, respectively, of
Access’ common stock as of July 19, 2007. Accordingly,
they collectively may have the ability to significantly influence or determine
the election of all of Access’ directors or the outcome of most corporate
actions requiring stockholder approval. They may exercise this ability in a
manner that advances their best interests and not necessarily those of Access’
other stockholders.
Provisions
of Access’ charter documents could discourage an acquisition of its company that
would benefit its stockholders and
may
have the effect of entrenching, and making it difficult to remove,
management.
Provisions
of Access’ Certificate of Incorporation, By-laws and Stockholders Rights Plan
may make it more difficult for a third party to acquire control of the Company,
even if a change in control would benefit Access stockholders. In particular,
shares of Access preferred stock may be issued in the future without further
stockholder approval and upon such terms and conditions, and having such rights,
privileges and preferences, as Access’ Board of Directors may determine,
including, for example, rights to convert into Access common stock. The rights
of the holders of Access common stock will be subject to, and may be adversely
affected by, the rights of the holders of any of Access’ preferred stock that
may be issued in the future. The issuance of Access preferred stock, while
providing desirable flexibility in connection with possible acquisitions and
other corporate purposes, could have the effect of making it more difficult
for
a third party to acquire control of Access. This could limit the price that
certain investors might be willing to pay in the future for shares of Access
common stock and discourage these investors from acquiring a majority of Access
common stock. Further, the existence of these corporate governance provisions
could have the effect of entrenching management and making it more difficult
to
change Access’ management.
Substantial
sales of Access common stock could lower its stock price.
The
market price for Access common stock could drop as a result of sales of a large
number of its presently outstanding shares or shares
that Access may issue or be obligated to issue in the future.
All of
the 3,541,394 shares of Access common stock that are outstanding as of
July 19, 2007, are unrestricted and freely tradable or tradable pursuant to
a resale registration statement or under Rule 144 of the Securities Act or
are
covered by a registration rights agreement.
26
Failure
to achieve and maintain effective internal controls could have a material
adverse effect on Access’ business.
Effective
internal controls are necessary for Access to provide reliable financial
reports. If Access cannot provide reliable financial reports, Access’ operating
results could be harmed. All internal control systems, no matter how well
designed, have inherent limitations. Therefore, even those systems determined
to
be effective can provide only reasonable assurance with respect to financial
statement preparation and presentation.
While
Access continues to evaluate and improve its internal controls, Access cannot
be
certain that these measures will ensure that Access implements and maintains
adequate controls over its financial processes and reporting in the future.
Any
failure to implement required new or improved controls, or difficulties
encountered in their implementation, could harm its operating results or cause
Access to fail to meet its reporting obligations.
Risks Relating to the Business of Somanta
Somanta's independent
auditor’s report contains a going concern qualification which means there is
substantial doubt about Somanta's ability to continue as a going
concern.
The
report of Somanta's independent registered public accounting firm for the
fiscal year ended April 30, 2007, contains an explanatory paragraph which
states
that Somanta has suffered recurring losses from operations and has a
working capital deficit that raises substantial doubt about its ability to
continue as a going concern. Somanta incurred a net loss of $7,495,637 for
the year ended April 30, 2007 and a net loss of $15,796,145 from the date
of
inception, April 19, 2001 through April 30, 2007.
At
April
30, 2007, Somanta had an accumulated deficit of $15,796,145, a loss from
operations of $10,434,908 and cash flows used in operations of
$6,535,983. Somanta expects its operating losses to increase for at
least the next several years as it pursues the clinical development
of its lead product candidates and expand its discovery and
development pipeline.
Somanta
has not generated any significant revenues from product sales to date,
and does not expect to generate revenues from product sales for at least
the next several years, if at all. Somanta expects its revenues for
the next several years to consist of payments under certain of its current
agreements and any additional collaborations, including upfront payments
upon
execution of new agreements, research funding and related fees throughout
the
research term of the agreements and milestone payments contingent upon
achievement of agreed-upon objectives. To date, Somanta has received
$10,000 in payments under such agreements.
Somanta consumed
substantial amounts of capital since its inception. Somanta does not
expect to have sufficient cash to fund operations after April 30,
2007
On
April
18, 2007, Somanta Incorporated, a wholly-owned subsidiary of and Somanta
Limited, a wholly-owned subsidiary of Somanta Incorporated, and Access
Pharmaceuticals, Inc. (“Access”) and Somanta Acquisition Corporation (“Merger
Sub”), a wholly-owned subsidiary of Access and a Delaware corporation, entered
into an Agreement and Plan of Merger (the “Merger Agreement”). Pursuant to the
terms and subject to the conditions set forth in the Merger Agreement,
Merger
Sub will merge with and into Somanta, with Somanta continuing as the surviving
corporation and becoming a wholly-owned subsidiary of Access (the “Merger”). The
Board of Directors of Somanta has approved the Merger and the Merger
Agreement.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the “Effective Time”) will be converted into
500,000 shares of Access common stock. No fractional shares of Access common
stock will be issued as a result of the Merger. In addition, all of Somanta’s
preferred stock that is outstanding at the Effective Time of the Merger
will be
converted into 1,000,000 shares of Access’ common stock. No shares of Access
preferred stock will be issued as a result of the Merger.
On
April
26, 2007, Somanta entered into a Note Purchase Agreement, a Security Agreement,
a Patent Collateral Assignment and Security Agreement and a Trademark Collateral
Security and Pledge Agreement (collectively, the “Loan Documents”) with Access.
Under the terms of the Loan Documents, Access initially loaned the Company
$33,462. Access, in its sole discretion, may from time to time advance
additional loan amounts to the Company. All amounts loaned to Somanta by
Access are secured by substantially all of the assets of Somanta pursuant
to the terms of the Loan Documents. The Note bears interest at 10% and
is
repayable at the earlier of: (i) August 31, 2007, or (ii) the date of the
termination of the Agreement and Plan of Merger dated as of April 18, 2007
between Somanta and Access.
If
the
merger fails to close, Somanta expects that it will no longer be able to
operate its business and will not have the resources to repay the loan
in which
case Access may foreclose on its assets in order to repay the
loan.
27
Somanta is
an early stage development company with a history of losses, and as
a
result, Somanta is unable to predict whether it will ever become
profitable.
Somanta
Limited was founded in 2001, and Somanta has since been primarily engaged
in
organizational activities, including the development of a strategic
plan, and
entering into various licensing agreements for the rights to certain
product
candidates. Through April 30, 2007, Somanta has accumulated deficit of
$15,796,145. None of its licensed products candidates have received
regulatory approval for sale in any jurisdiction in which Somanta
has the right to market and sell such product candidates.
Accordingly, Somanta has not generated any revenue from the
commercialization of any licensed product. Somanta expects expenditures and
the accumulated deficit to increase as Somanta proceeds with its
commercialization program. To obtain revenues from the sale of its
products, or in the form of license fees or other payments from
collaboration partners, Somanta must succeed, either alone or with others,
in developing, obtaining regulatory approval for, and manufacturing
and
marketing products with significant market potential. Somanta may never
succeed in these activities and may never generate revenues that are
significant
enough to achieve profitability.
In
the near term, Somanta will likely require additional funding for the
development and commercialization of its existing product
candidates.
Somanta will
require substantial additional funding for the development and commercialization
of its existing product candidates. The amount of additional funding
required depends on the status of each product or opportunity at any
given
time. Somanta does not expect to have sufficient cash to fund its
operations after April 30, 2007.
Somanta must
incur substantial expenses and expend substantial resources developing
products
that it may never be able to sell.
Before
obtaining regulatory approval for the commercial sale of a product, Somanta
must demonstrate through pre-clinical testing and clinical trials that
a product
candidate is safe and effective for use in humans. Conducting clinical
trials is
a lengthy, time-consuming and extremely expensive process. Completion
of
clinical trials for any product may take several years or more. The length
of
time generally varies substantially according to the type, complexity,
novelty
and intended use of the product candidate. Somanta's commencement and rate
of completion of clinical trials may be delayed by many factors,
including:
|
•
|
Inability
of vendors to manufacture sufficient quantities of materials
for use in
clinical trials;
|
|
|
•
|
Slower
than expected rate of patient recruitment or variability in
the number and
type of patients in a study;
|
|
|
•
|
Inability
to adequately follow patients after treatment;
|
|
|
•
|
Unforeseen
safety issues or side effects;
|
|
|
•
|
Lack
of efficacy during the clinical trial; or
|
|
|
•
|
Government
or regulatory delays.
|
As
a
result, Somanta will incur substantial expense for, and devote a
significant amount of time to pre-clinical and clinical
trials. Historically, the results from pre-clinical testing and early
clinical trials have often not been predictive of results obtained in
later
clinical trials. A number of new products have shown promising results
in
clinical trials, but subsequently failed to establish sufficient safety
and
efficacy data to obtain necessary regulatory approvals. Data obtained
from
pre-clinical and clinical activities are susceptible to varying interpretations,
which may delay, limit or prevent regulatory approvals. Regulatory delays
or
rejections may also be encountered as a result of other factors, including
changes in regulatory policy during the period of product development. In
addition, regulatory authorities may require additional clinical trials,
which
could result in increased additional costs and significant additional
development delays. If the results of Somanta's clinical trials are
significantly delayed or are ultimately not positive, Somanta may never be
able to seek marketing approval to sell its product candidates or generate
revenue from product sales.
Somanta
relies on third parties to coordinate its research and clinical trials and
perform data collection and analysis, which may result in costs and delays
that
prevent Somanta from successfully commercializing its product
candidates.
Although Somanta
uses contracted consultants to design and manage its pre-clinical studies
and clinical trials, Somanta currently does not have the resources to
coordinate
clinical trials for its product candidates. Somanta historically
relies on contract research organizations, medical institutions, academic
institutions, clinical investigators and contract laboratories to perform
data
collection and analysis and other aspects of its clinical trials. Somanta
also relies on third parties to assist with its pre-clinical studies,
including studies regarding biological activity, safety, absorption,
metabolism
and excretion of product candidates.
Somanta's pre-clinical
development activities or clinical trials may be delayed, suspended or
terminated if:
|
•
|
these
third parties do not successfully carry out their contractual
duties or
regulatory obligations or meet expected deadlines;
|
|
|
•
|
these
third parties need to be replaced; or
|
|
|
•
|
the
quality or accuracy of the data obtained by third parties is
compromised
due to their failure to adhere to Somanta's clinical protocols or
regulatory requirements or for other
reasons.
|
28
Failure
to perform by these third parties may increase Somanta's development costs,
delay its ability to obtain regulatory approval and prevent the
commercialization of its product candidates.
Somanta has
no experience in commercial manufacturing of its licensed products and may
encounter problems or delays in having its products manufactured, which
could result in delayed development, regulatory approval and marketing
of its products.
Somanta has
not commercially launched any of its product candidates and has no
commercial manufacturing experience. To be successful, its product
candidates must be manufactured in commercial quantities in compliance with
regulatory requirements and at an acceptable cost. Somanta does not have
and does not intend to acquire facilities for the production of its
licensed product candidates. Somanta intends to negotiate contract
manufacturing agreements with third parties to provide the products for its
development and commercialization activities, but Somanta does
not know if it will be able to enter into such agreements on
commercially reasonable terms, if at all. Somanta is in the process of
negotiating such third party manufacture, formulation and supply agreements
with
several entities. All facilities and manufacturing techniques used in the
manufacture of products for clinical use or for sale in the U.S. must be
operated in conformity with current good manufacturing practices guidelines
established by the U.S. Food and Drug Administration, or the FDA. Somanta
does not know whether the FDA will determine that any such third party
facilities comply with such current good manufacturing practices. Somanta's
inability to enter into an agreement with any such third party, the inability
of
such a third party to manufacture its products in commercial quantities, or
a delay in manufacturing due to a failure to comply with current good
manufacturing practices by such a third party, would delay the marketing
of its products and negatively impact its revenue and
profitability.
Somanta depends
on licenses from third parties and the maintenance of its licenses are
necessary for its success.
Somanta does
not conduct its own initial research with respect to the identification of
new
product candidates. Instead, Somanta relies upon research and development
work conducted by others as a primary source for new product candidates.
As
such, Somanta has obtained its rights to its product
candidates through license agreements with various third party licensors
as
follows:
|
•
|
Exclusive
Patent and Know-how Sub-license Agreement between Somanta and
Immunodex, Inc. dated August 18, 2005, as amended;
|
|
|
•
|
Patent
and Know-how Assignment and License Agreement between Somanta and De
Montfort University dated March 20, 2003;
|
|
|
•
|
Patent
and Know-how Assignment and License Option Agreement between Somanta
and The School of Pharmacy, University of London dated March 16,
2004, as amended on September 21, 2005; and
|
|
|
•
|
The
Phenylbutyrate Co-Development and Sublicense Agreement
between Somanta and Virium Pharmaceuticals, Inc. dated
February 16, 2005, as amended.
|
Somanta
is dependent upon these licenses for its rights to develop and
commercialize its product candidates. While Somanta believes it
is in compliance with its obligations under the licenses, certain licenses
may be terminated or converted to non-exclusive licenses by the licensor
if Somanta breaches the terms of the license. Somanta cannot guarantee
you that the licenses will not be terminated or converted in the
future.
While Somanta
expects that it will be able to continue to identify licensable product
candidates or research suitable for licensing and commercialization by it,
there
can be no assurance that this will occur. For example, Somanta is in
discussions with the National Institutes of Health to obtain licenses to
certain
patents held by them that will be necessary for the manufacture of its
product candidate Angiolix. Unless Somanta obtains licenses on terms that
are acceptable to it, Somanta may not be able to manufacture and obtain
product registrations on Angiolix. On December 5, 2006, NIH provided
Somanta with proposed terms for a non-exclusive license. Somanta is in
discussion with NIH on those proposed terms and conditions. On May 15, 2007,
NIH
terminated Somanta’s non-exclusive license application since it had not
accepted the terms and had not executed the proposed license
agreement.
Somanta depends
on collaborations with third parties to develop and commercialize its products
and to provide the majority of its revenues.
A
key
aspect of Somanta's strategy is to selectively enter into collaborations
with third parties and to license certain technology to such third
parties. Somanta intends to rely on its collaborators for financial
resources and for development, commercialization and regulatory
expertise. Somanta has entered into its first license agreement with
Advanced Cardiovascular Devices, LLC, for the use of its product
candidate known as Alchemix for the treatment of vascular diseases
worldwide. Somanta is entitled to milestone payments and a royalty on
net sales if product approvals are obtained by Advanced Cardiovascular Devices,
LLC. Somanta has not yet entered into a collaboration agreement with
respect to any of its other product candidates.
29
In
addition, its existing and future collaborators may fail to develop or
effectively commercialize its product candidates or technologies because
they:
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do
not have sufficient resources or decide not to devote the necessary
resources due to internal constraints such as limited cash or human
resources;
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decide
to pursue a competitive potential product developed outside of
the
collaboration; or
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cannot
obtain the necessary regulatory
approvals.
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If its
collaboration partners fail to develop or effectively commercialize its
product candidates, its results of operations will suffer.
If
conflicts arise with Somanta's collaborators, they may act in their
self-interests, which may be adverse to Somanta's
interests.
Conflicts
may arise in Somanta's collaborations due to one or more of the
following:
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disputes
with respect to payments that Somanta believes are due under a
collaboration agreement;
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disagreements
with respect to ownership of intellectual property
rights;
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unwillingness
on the part of a collaborator to keep Somanta informed regarding the
progress of its development and commercialization activities, or
to permit
public disclosure of these activities;
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delay
of a collaborator’s development or commercialization efforts with respect
to Somanta product candidates; or
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termination
or non-renewal of the
collaboration.
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Conflicts
arising with Somanta's collaborators could harm its reputation, result
in a loss of revenues, reduce its cash position and cause a decline in its
stock price.
Somanta may
not be able to obtain necessary funding from product sales, license fees
or
royalties, and as a result, Somanta may require additional funding through
public or private financing, which may not be available on acceptable terms,
if
at all.
Somanta assesses its
additional funding needs on a project-by-project basis from
time-to-time. Its business strategy is to license rights to promising
product candidates, further develop those product candidates by progressing
the
product candidates toward regulatory approval by conducting clinical trials,
and
finally to license rights to manufacture and/or market the resulting products
to
other pharmaceutical firms in exchange for royalties and license fees. Due
to
these licensing arrangements and its dependence on others for the
manufacture, development and sale of its licensed products, Somanta
does not have consistent monthly or quarterly expenditures and cannot determine
the amount and timing of required additional funding. To the extent
that Somanta is unable to fund its development efforts from
product sales, license fees and royalties, it may be necessary to reconsider
the
continuation of certain existing projects and to curtail entering into any
new
projects. In addition, Somanta will likely have to seek additional funding
through public or private financing; however, Somanta does not know if
such funding will be available, or that if available, if it will be available
on
favorable terms. If Somanta is unable to obtain such additional
funding, it may not be able to develop its product candidates which
will materially and adversely affect its business.
If Somanta
fails to keep up with rapid technological change and evolving
therapies, its product candidates could become less competitive or
obsolete.
The
pharmaceutical industry is characterized by rapid and significant technological
change. Somanta expects that pharmaceutical technology will continue to
develop rapidly, and its future success will depend on its ability to
develop and maintain a competitive position. Technology development by others
may result in product candidates developed by it becoming obsolete before
they are marketed or before Somanta has recovered a significant
portion of the development and commercialization expenses incurred with respect
to these product candidates. Alternative therapies or new medical treatments
could alter existing treatment regimes, and thereby reduce the need for one
or
more of the product candidates developed by Somanta, which would adversely
affect its revenue and cash flow.
30
Somanta is subject
to extensive competition. If Somanta is unsuccessful in establishing
and maintaining a competitive advantage, its business will
suffer.
The
biopharmaceutical industry is intensely competitive. Many companies, including
other biopharmaceutical companies and biotechnology companies, are actively
engaged in activities similar to Somanta's, including research and development
of products for the treatment of cancer. More specifically, competitors
for the
development of new therapeutic products to treat cancer also focus on the
same
approach to delivering cancer therapeutics as Somanta does. A 2006 survey
by the
Pharmaceutical Research and Manufacturers of America listed nearly 400
new
treatments for cancer that are currently being tested by
researchers.
To Somanta's
knowledge, other companies that are involved in the development of monoclonal
antibody cancer therapeutics directly related to its efforts include
Abgenix/Amgen, Genmab, ImClone/Bristol-Myers Squibb, ImmunoGen, Schering
AG,
Biogen Idec, Roche, Antisoma, Genentech and Merck.
Somanta expects
to encounter significant competition for the pharmaceutical product
candidates they are developing and plan to develop in the future. Many
of its competitors have substantially greater financial and other
resources, larger research and development capabilities and more extensive
marketing and manufacturing organizations than Somanta does. In addition,
some such companies have considerable experience in pre-clinical testing,
clinical trials and other regulatory approval procedures. There are also
academic institutions, governmental agencies and other research organizations
which are conducting research in areas in which Somanta is working and
they may also market commercial products, either on their own or through
collaborative efforts. If any of these competitors were to complete clinical
trials, obtain required regulatory approvals and commence commercial sales
of
their product candidates before Somanta does, they would achieve a
significant competitive advantage.
Somanta conducts its
business internationally and is subject to the laws and regulations of
several countries which may affect its ability to access regulatory
agencies and may affect the enforceability and value of its
licenses.
Somanta intends
to conduct clinical trials in the U.S. and the European Union. In
addition, Somanta intends to license the rights to develop and
commercialize its product candidates to third parties who may be located
anywhere in the world. Somanta does not know whether any sovereign
government will establish laws or regulations that might be deleterious
to its
interests. Governments have, from time to time, established foreign exchange
controls which could have a material adverse effect on Somanta and its
financial condition, since such controls may limit its ability to flow
funds into a country to meet its obligations under certain licensing
agreements and to flow funds out of a country which Somanta may be entitled
to, in the form of royalty and milestone pavements, under other licensing
agreements. In addition, the value of Somanta's licenses will be dependent
upon no punitive or prohibitive legislation being enacted with respect
to
biological materials.
Somanta's business
strategy involves obtaining orphan drug designation for certain of its
product
candidates. Somanta may not be successful in receiving orphan drug status
for certain of its product candidates or, if that status is obtained, fully
enjoying the benefits of orphan drug status.
Under
the
Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended
to
treat a rare disease or condition. A disease or condition that affects
a
population of fewer than 200,000 people in the U.S. generally constitutes
a rare
disease or condition. Orphan drug designation must be requested before
submitting a new drug application. After the FDA grants orphan drug designation,
the generic identity of the therapeutic agent and its potential orphan
use are
publicized by the FDA. Under current law, orphan drug status is conferred
upon
the first company to receive FDA approval to market the designated drug
for the
designated indication. Orphan drug status grants marketing exclusivity
in the
U.S. for a period of seven years following the approval of the new drug
application, subject to limitations. Orphan drug designation does not provide
an
advantage in, or shorten the duration of, the FDA regulatory approval process.
Although obtaining FDA approval to market a product with orphan drug status
can
be advantageous, the scope of protection or level of marketing exclusivity
that
is currently afforded by orphan drug status and marketing may not remain
in
effect in the future. Possible amendments of the Orphan Drug Act by the
U.S.
Congress have been the subject of frequent discussion. Although no significant
changes to the Orphan Drug Act have been made for a number of years, members
of
Congress have proposed legislation that would limit the application of
the
Orphan Drug Act. The precise scope of protection afforded by orphan drug
designation and marketing approval may be subject to change in the
future.
The
price Somanta charges for its products and the level of third-party
reimbursement may decrease, resulting in a decrease in its
revenues.
Somanta's ability
to commercialize product candidates successfully depends in part on the
price Somanta may be able to charge for resulting products and on the
extent to which reimbursement for the cost of such products and related
treatment will be available from government health administration authorities,
private health insurers and other third-party payors. Somanta believes that
government officials and private health insurers are increasingly challenging
the price of medical products and services. Significant uncertainty exists
as
to the pricing flexibility which distributors will have with respect to
newly
approved health care products as well as the reimbursement status for such
approved products. Third-party payors may attempt to control costs further
by
selecting exclusive providers of their pharmaceutical products. The lack
of
reimbursement would diminish the market for its product candidates and
would have a material adverse effect on Somanta's
business.
31
Somanta may
face exposure from product liability claims, and product liability insurance
may
not be sufficient to cover the costs of its liability claims related
to its products.
At
such
time as Somanta has a product approved for commercial sale, Somanta
will face exposure to product liability claims if the use of any such products
or those Somanta licenses from third parties is alleged to have resulted in
an adverse effect to the user of such product. Product liability claims may
also
be brought by clinical trial participants with respect to its product
candidates. If such a claim is brought against Somanta, the cost of defending
such a claim may adversely affect its business. In addition, regulatory
approval for the commercial sale of products does not mitigate product liability
risk. Any precautions Somanta takes may not be sufficient to avoid
significant product liability exposure. Somanta obtained product
liability and clinical trial insurance at levels which management deems
reasonable. However, Somanta's insurance coverage may not be adequate and
may not cover all claims that may be brought against it. The pharmaceutical
industry has experienced increasing difficulty in maintaining product liability
insurance coverage at reasonable levels, and substantial increases in insurance
premium costs may render coverage economically impractical. To the extent
that
product liability insurance, if available, does not cover potential
claims, Somanta will be required to self-insure the risks associated with
those claims. The successful assertion of any uninsured product liability
or
other claim against Somanta could limit its ability to sell the applicable
product or develop the applicable product candidate or result in monetary
damages, any of which would have a material adverse effect on its business.
In addition, future product labeling may include disclosure of additional
adverse events, precautions and contra indications, which may adversely impact
product sales.
If Somanta
loses key management, its business may suffer.
Somanta is
highly dependent on its Chief Executive Officer and its Executive
Chairman to develop its products. Dr. Epenetos and Mr. Bruggeman have
entered into employment agreements with Somanta for an initial term of one
year, which term automatically extends for an additional one year period
until
either party gives the other written notice of termination at least 90 days
prior to the end of the current term. To the best of Somanta's knowledge,
neither of the officers is near retirement age and neither, to Somanta's
knowledge, plans to leave the Company. If either of the executives was no
longer
employed by the Company, the development of its products could be delayed
and otherwise would be adversely impacted. Dr. Epenetos is currently a
practicing medical oncologist in the National Health Service in the United
Kingdom. His practice is limited to one half day per week and this does not
now,
and Somanta has no reason to believe that it will in the future, interfere
with his responsibilities as Somanta's Chief Executive
Officer.
RISKS
RELATED TO SOMANTA'S INTELLECTUAL PROPERTY
Somanta's ability
to compete may decline if Somanta does not adequately protect its
proprietary rights.
Somanta believes
that its success will depend largely on its ability to obtain and
maintain patent protection for its own inventions, to license the use of
patents owned by third parties when necessary, to protect trade secrets and
to
conduct its business without infringing the proprietary rights of
others. Somanta has obtained, or licensed the rights to, patents covering
three of its four current product candidates.
The
patents licensed to Somanta expire at various times as follows
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in
2015 for Angiolix related patents;
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between
2011 and 2016 for the Phenylbutyrate related patents;
and
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in
2015 for the Alchemix related
patents.
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As
patents expire, the products and processes described and claimed in those
patents become generally available for use by the public, which will
reduce Somanta's ability to realize revenues from making products derived
from those patents due to increased competition and potential limitations
and
will result in Somanta's results of operations and cash flows relating to
the future products being less favorable than they would be while the patent
is
valid. It is also possible that because of the extensive time required for
development, testing and regulatory review of product candidates, before
any of
Somanta's product candidates or the products developed by Somanta's
possible future collaborators can be commercialized, any related patent may
expire or remain in force for only a short period of time following
commercialization, thereby reducing any advantages of the
patent.
32
In
addition, Somanta has filed a patent application on its fourth product
candidate, Prodrax, a small molecule for use in the treatment of lung,
breast,
ovarian, colon, pancreatic, and esophageal cancers, and when appropriate,
will
file other patent applications with respect to its products and processes
in the U.S. and in foreign countries. Somanta does not know, however,
whether:
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any
of its current or future patent applications will result in the
issuance of patents;
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any
of its issued patents will provide significant proprietary protection
or commercial advantage; or
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any
of its issued patents will not be circumvented by
others.
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The
patent positions of pharmaceutical medical products and biotechnology firms
can
be uncertain and involve complex legal and factual questions. It is possible
that a third party may successfully challenge any of Somanta's patents or
any of the patents licensed to them. If that were to happen, Somanta would
lose the right to prevent others from using the applicable
technology.
Confidentiality
agreements with employees and others may not adequately prevent disclosure
of Somanta's trade secrets and other proprietary information and may not
adequately protect its intellectual property, which could limit its
ability to compete.
Because
Somanta operates in a highly technical field, Somanta relies in part on
trade secret protection in order to protect its proprietary technology and
processes; however, trade secrets are difficult to protect. Somanta enters
into confidentiality and intellectual property assignment agreements with
its
corporate partners, employees, consultants, outside scientific collaborators,
sponsored researchers and other advisors. These agreements generally require
that the other party keep confidential and not disclose to third parties
all
confidential information developed by the party or made known to the party
by Somanta during the course of the party’s relationship Somanta.
These agreements also generally provide that inventions conceived by the
party
in the course of rendering services to Somanta will be its exclusive
property. However, these agreements may not be honored and may not effectively
assign intellectual property rights to Somanta. Enforcing a claim that
a party
illegally obtained and is using Somanta's trade secrets is difficult,
expensive and time consuming, and the outcome is unpredictable. In addition,
courts outside the U.S. may be less willing to protect trade secrets. The
failure to obtain or maintain trade secret protection could adversely
affect Somanta's competitive position.
A
dispute concerning the infringement or misappropriation of Somanta's
proprietary rights or the proprietary rights of others could be time-consuming
and costly, and an unfavorable outcome could harm Somanta's
business.
There
is
significant litigation in Somanta's industry regarding patent and other
intellectual property rights. If Somanta's product development activities
are found to infringe any such intellectual property rights of
others, Somanta may have to pay significant damages. Somanta may need
to resort to litigation to enforce a patent issued to it, protect its trade
secrets, or determine the scope and validity of third-party proprietary
rights.
From time to time, Somanta may hire scientific personnel formerly employed
by other companies involved in one or more areas similar to the activities
conducted by it. Either Somanta or these individuals may be subject to
allegations of trade secret misappropriation or other similar claims as
a result
of their prior affiliations. If Somanta becomes involved in litigation, it
could consume a substantial portion of its managerial and financial
resources, regardless of whether Somanta wins or loses. Somanta may
not be able to afford the costs of litigation. Any legal action
against Somanta or its collaborators could lead to:
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payment
of damages, potentially treble damages, if Somanta is found to
have
willfully infringed a party’s patent rights;
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injunctive
or other equitable relief that may effectively block Somanta's
ability to further develop, commercialize and sell products;
or
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Somanta or its
collaborators having to enter into license arrangements that
may not be
available on commercially acceptable terms, if at
all.
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As
a
result, significant litigation with respect to Somanta's proprietary rights
could prevent it from commercializing current or future product
candidates.
33
RISKS
RELATED TO SOMANTA'S INDUSTRY
Somanta's
product candidates must go through a lengthy regulatory approval process
before
Somanta can market or sell them, which could delay or prevent its ability
to sell that product commercially.
Somanta
has a variety of product candidates under development. All new product
candidates must be the subject of an FDA-approved new drug application
before
they can be marketed in the U.S. The FDA has the authority to determine
what
testing procedures are appropriate for a particular product candidate and,
in
some instances, has not published or otherwise identified guidelines as
to the
appropriate procedures. The required product candidate testing and approval
process can take a number of years and require the expenditure of substantial
resources. Testing of any product under development may not result in a
commercially viable product. Further, Somanta may decide to modify a
product candidate in testing, which could materially extend the test period
and
increase
the development cost of the product candidate in question. Even after the
time
and expenses associated with the approval process, regulatory approval
by the
FDA may not be obtained for any product Somanta develops. In addition,
delays or
rejection may be encountered based upon changes in FDA policy during the
period
of product development and FDA review. Any delay or failure in obtaining
required approval could have a material adverse effect on Somanta's ability
to generate revenues from the particular product candidate. Even if regulatory
approval is obtained, it may impose significant restrictions on the indicated
uses, conditions for use, labeling, advertising, promotion and/or marketing
of
such products, and requirements for post-approval studies, including additional
research and development and clinical trials.
Furthermore,
even if the required FDA approval has been obtained with respect to a product
in
the U.S., foreign regulatory approval of a product must be obtained prior
to Somanta's marketing the product internationally. Foreign approval
procedures vary from country to country and the time required for approval
may
delay or prevent marketing. In certain instances, Somanta or our
collaborative partners may seek approval to market and sell its products
outside the U.S. before submitting an application for approval to the FDA.
Although there is now a centralized European Union approval mechanism for
new
pharmaceutical products in place, each European Union country may nonetheless
impose its own procedures and requirements, many of which are time consuming
and
expensive, and some European Union countries require price approval as
part of
the regulatory process. Thus, there can be substantial delays in obtaining
regulatory approval from both the FDA and foreign regulatory authorities
after
the relevant application is filed.
Somanta's
industry is subject to extensive government regulation in general, which
makes
it more expensive to operate Somanta's business.
Virtually
all aspects of Somanta's business are regulated by federal and state
statutes and governmental agencies in the U.S. and other countries. Failure
to
comply with applicable statutes and government regulations could have a
material
adverse effect on Somanta's ability to develop and sell product candidates
which would have a negative impact on its cash flow. The development,
testing, manufacturing, processing, quality, safety, efficacy, packaging,
labeling, record-keeping, distribution, storage and advertising of
pharmaceutical products, and disposal of waste products arising from these
activities, are subject to regulation by one or more federal agencies.
These
activities are also regulated by similar state and local agencies and equivalent
foreign authorities. In Somanta's agreements with vendors providing any
portion of these types of services, Somanta seeks assurance that its
vendors comply and will continue to maintain compliance with all applicable
rules and regulations; however, Somanta cannot be certain that its
most significant vendors will continue to comply with these rules and
regulations.
In
addition, the regulatory requirements applicable to any aspect of its business
may be modified in the future. Somanta cannot determine what effect changes
in regulations or statutes or legal interpretations may have on its
business in the future. Such changes could require modifications to
manufacturing methods, expanded or different labeling, the recall, replacement
or discontinuation of certain products, additional record keeping and expanded
documentation of the properties of certain products or added scientific
substantiation. Any changes or new legislation could have a material adverse
effect on Somanta's ability to develop and sell products and, therefore, to
generate revenue and cash flow.
The
use of Somanta's products may be limited or eliminated by professional
guidelines which would decrease the sales of these products and
therefore, its revenues and cash flow.
In
addition to government agencies, private health/science foundations and
organizations involved in various diseases may also publish guidelines
or
recommendations to healthcare and patient communities. These private
organizations may make recommendations that affect the use of therapies,
drugs
or procedures, including products developed by us. These recommendations
may
relate to matters such as usage, dosage, route of administration and use
of
concomitant therapies. Recommendation or guidelines that are followed by
patients and healthcare providers and that result in, among other things,
decreased use or elimination of products developed by Somanta could have a
material adverse effect on Somanta's revenue and cash flow.
34
RISKS
RELATED TO AN INVESTMENT IN SOMANTA'S SECURITIES
Somanta
issued shares of its Series A Convertible Preferred Stock which carries
with it a liquidation preference over its common
stock.
Somanta
issued 591.6318 shares of its Series A Convertible Preferred Stock which
includes a liquidation preference over its common stock. If Somanta
is liquidated in a bankruptcy or otherwise wound down, the holders
of its Series A Convertible Preferred Stock would receive the first $5.9
million in value of Somanta's assets and if the value of its assets is
not enough to satisfy the foregoing amount, a holder of Somanta common
stock will not receive any proceeds from such liquidation or winding
down.
The
market price of Somanta's common stock could be volatile and your investment
could suffer a decline in value.
On
September 12, 2006 Somanta's common stock began to trade on the OTC
Bulletin Board under the symbol SMPM The market price for Somanta's
common stock, as with many emerging biopharmaceutical companies, is likely
to be
volatile and could be susceptible to wide price fluctuations due to a
number of
internal and external factors, many of which are beyond Somanta's control,
including:
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quarterly
variations in operating results and overall financial
condition;
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efficacy
of its products or the products of its
competitors;
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economic
and political developments affecting the economy as a
whole;
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short-selling
programs;
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the
stock market’s perception of the biopharmaceutical industry as a
whole;
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changes
in earnings estimates by analysts;
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additions
or departures of key personnel; and
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sales
of substantial numbers of shares of common stock or securities
convertible
into or exercisable for Somanta's common
stock.
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In
addition, the price of Somanta's common stock is likely to be highly
volatile since it may take many years before any of its licensed products
will
receive final regulatory approval to be marketed in the U.S. or
elsewhere.
Somanta has
a small public float which results in a thin trading market for its
shares.
The
public float of Somanta's common stock is small in comparison to its
total shares outstanding on a fully diluted basis, resulting in a very
thin
public market for the trading of its shares, and Somanta expects
limited trading volume for the foreseeable future. Limited trading volume
entails a high degree of volatility in Somanta's stock price. This limited
liquidity and volatile stock price will likely continue for the foreseeable
future.
The
application of the “penny stock” rules could adversely affect the market price
of Somanta's common stock and increase your transaction costs to sell those
shares.
As
long
as the trading price of Somanta's common stock is below $5.00 per share,
the open-market trading of Somanta's common stock will be subject to
the “penny
stock” rules. The penny stock rules impose additional sales practice
requirements on broker-dealers who sell securities to persons other than
established customers and accredited investors (generally those with
assets in
excess of $1 million or annual income exceeding $200,000 or $300,000
together
with their spouses). For transactions covered by these rules, the broker-dealer
must make a special suitability determination for the purchase of securities
and
have received the purchaser’s written consent to the transaction before the
purchase. Additionally, for any transaction involving a penny stock,
unless
exempt, the broker-dealer must deliver, before the transaction, a disclosure
schedule prescribed by the Securities and Exchange Commission relating
to the
penny stock market. The broker-dealer also must disclose the commissions
payable
to both the broker-dealer and the registered representative and current
quotations for the securities. Finally, monthly statements must be sent
disclosing recent price information on the limited market in penny
stocks. These additional burdens imposed on broker-dealers may restrict the
ability or decrease the willingness of broker-dealers to sell Somanta
common stock, and may result in decreased liquidity of Somanta common stock
and increased transaction costs for sales and purchases of Somanta common
stock as compared to other securities.
35
Your
ability to influence corporate decisions may be limited because Somanta's
major stockholders own a large percentage of its common
stock.
Somanta's significant
stockholders own a substantial portion of its outstanding stock. As a result
of
their stock ownership, if these stockholders were to choose to act together,
they may be able to effectively control all matters submitted to its
stockholders for approval, including the election of directors, approval
of any
merger or other business combination involving it, its acquisition or
disposition of assets, future issuances of common stock or other securities
by
it, its incurrence of debt or obtaining other sources of financing, and the
payment of dividends on its common stock. This concentration of voting
power could delay or prevent an acquisition of Somanta on terms that
other stockholders may desire. In addition, as the interests of Somanta's
majority and minority stockholders may not always be the same, this large
concentration of voting power may lead to stockholder votes that may be
inconsistent with your interests or what you perceive to be the best interest
of
our Somanta as a whole.
Somanta's
charter documents and Delaware law may deter potential acquirers
of Somanta's business and may thus depress its
stock.
Somanta's certificate
of incorporation and bylaws contain provisions that could delay or prevent
a
change of control of its company that its stockholders might consider
favorable. In addition, Somanta is governed by the provisions of
Section 203 of the Delaware General Corporation Law, which may discourage,
delay
or prevent certain business combinations with stockholders owning 15% or
more
of its outstanding voting stock. These and other provisions in its
charter documents may make it more difficult for stockholders or potential
acquirers to initiate actions that are opposed by the then-current board
of
directors, including delaying or impeding a merger, tender offer, or proxy
contest or other change of control transaction involving Somanta. Any delay
or prevention of a change of control transaction could cause stockholders
to
lose a substantial premium over the then current market price of their
shares.
Somanta's certificate
of incorporation authorizes the issuance of up to 100,000,000 shares of
common
stock and 20,000,000 shares of “blank check” preferred stock with such
designations, rights and preferences as may be determined from time to
time by
our board of directors.
Pursuant
to its certificate of incorporation, Somanta may issue shares of
common and preferred stock in the future that will dilute its existing
stockholders without prior notice or approval of Somanta's
exisitng stockholders. Additionally, Somanta's board of directors does
not intend to solicit further approval from its stockholders prior to
designating the rights, preferences or privileges of any such preferred
stock,
including, without limitation, rights as to dividends, conversion, voting,
liquidation preference or redemption, which in each case may be superior
to the
rights of its common stock. The rights of the holders of common stock will
be subject to, and may be adversely affected by, the rights of the holders
of
any preferred stock that may be issued in the future. The issuance of preferred
stock, while providing desirable flexibility in connection with possible
acquisitions and other corporate purposes, could also have the effect of
discouraging, delaying or preventing a change of control, and preventing
holders
of common stock from realizing a premium on their shares.
Somanta does
not plan on declaring or paying dividends on its common stock; however, our
Series A Convertible Preferred Stock has an accruing 8% per annum
dividend.
Somanta has
never declared or paid a dividend on its common stock, nor
does Somanta have any plans to do so in the future. Dividends on
its Series A Convertible Preferred Stock accrue at a rate of 8% per annum
and are payable by Somanta in cash or shares of its common
stock.
36
CAUTIONARY
STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS
This
proxy statement/prospectus and the other documents incorporated by reference
into this proxy statement/prospectus contain or may contain “forward-looking
statements” intended to qualify for the safe harbor from liability established
by the Private Securities Litigation Reform Act of 1995. These statements can
be
identified by the fact that they do not relate strictly to historical or current
facts. Access and Somanta have based these forward-looking statements on its
current expectations about future events. Further, statements that include
words
such as “may,” “will,” “project,” “might,” “expect,” “believe,” “anticipate,”
“intend,” “could,” “would,” “estimate,” “continue” or “pursue,” or the negative
of these words or other words or expressions of similar meaning, may identify
forward-looking statements. These forward-looking statements are found at
various places throughout this proxy statement/prospectus and the other
documents incorporated by reference. These forward-looking statements,
including, without limitation, those relating to future actions, new projects,
strategies, future performance, the outcome of contingencies such as legal
proceedings and future financial results, in each case relating to Access or
Somanta, respectively, wherever they occur in this proxy statement/prospectus
or
the other documents incorporated by reference herein, are necessarily estimates
reflecting the best judgment of the respective management of Access and Somanta
and involve a number of risks and uncertainties that could cause actual results
to differ materially from those suggested by the forward-looking statements.
These forward-looking statements should, therefore, be considered in light
of
various important factors, including those set forth in this proxy
statement/prospectus and incorporated by reference into this proxy
statement/prospectus. In addition to the risk factors identified elsewhere,
important factors that could cause actual results to differ materially from
estimates or projections contained in the forward-looking statements include,
without limitation:
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•
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the
effects of local and national economic, credit and capital market
conditions on the economy in general, and on the pharmaceutical industry
in particular, and the effects of foreign exchange rates and interest
rates;
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•
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the
ability to obtain the approvals of Somanta’s stockholders, to obtain or
meet the closing conditions in the merger agreement, including applicable
regulatory and tax requirements, and to otherwise complete the merger
in a
timely manner;
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•
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the
ability to timely and cost-effectively integrate the operations of
Access
and Somanta;
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•
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the
ability to realize the synergies and other perceived advantages resulting
from the merger;
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•
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access
to available and feasible financing on a timely basis;
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•
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the
ability to retain key personnel both before and after the merger;
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•
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the
ability of each company to successfully execute its business strategies;
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•
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the
extent and timing of market acceptance of new products or product
indications;
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•
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the
ability of each company to procure, maintain, enforce and defend
its
patents and proprietary rights;
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•
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changes
in laws, including increased tax rates, regulations or accounting
standards, third party relations and approvals, and decisions of
courts,
regulators and governmental bodies;
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•
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litigation
outcomes and judicial actions, including costs and existing or additional
litigation associated with the merger, and legislative action, referenda
and taxation;
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•
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acts
of war or terrorist incidents; and
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•
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the
effects of competition, including locations of competitors and operating
and market competition.
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You
are
cautioned not to place undue reliance on these forward-looking statements,
which
speak only as of the date of this proxy statement/prospectus or, in the case
of
documents incorporated by reference, as of the date of those documents. Neither
Access nor Somanta undertakes any obligation to publicly update or release
any
revisions to these forward-looking statements to reflect events or circumstances
after the date of this proxy statement/prospectus or to reflect the occurrence
of unanticipated events, except as required by law.
37
THE
SOMANTA SPECIAL MEETING
The
special meeting of Somanta stockholders will be held on Friday, August 17,
2007,
at 9:00 a.m. local time at Somanta’s principal executive offices located at
19200 Von Karman Ave., Suite 400, Irvine, California 92612.
At
the
Somanta special meeting, the Somanta stockholders will be asked to consider
and
vote upon a proposal to approve and adopt the merger agreement and approve
the
merger contemplated by the merger agreement. Somanta stockholders will also
be
asked to consider and vote upon such other business as may properly come before
the special meeting, or any adjournment or postponement of the special meeting.
Somanta is not aware of any business to be acted upon at the Somanta special
meeting other than the proposals set forth in this proxy statement/prospectus.
If, however, other matters incident to the conduct of the special meeting are
properly brought before the Somanta special meeting, or any adjournment or
postponement of the special meeting, the persons named as proxies will vote
in
accordance with their best judgment with respect to those matters. If you vote
“AGAINST” the proposal, the proxies are not authorized to vote for any
adjournments, postponements, continuations or reschedulings of the meeting,
including for the purpose of soliciting additional proxies, unless you so
indicate by marking the appropriate box on the proxy card.
After
careful consideration, the Somanta board of directors, having determined that
the merger is advisable, fair to and in the best interests of Somanta and its
stockholders, approved the merger agreement and the merger contemplated by
the
merger agreement. Accordingly, the Somanta board of directors recommends that
Somanta’s stockholders vote “FOR” the proposal to approve and adopt the merger
agreement and the merger contemplated by the merger agreement. Access has
received voting agreements from certain Somanta stockholders representing
approximately 85% of Somanta’s outstanding common stock and approximately 60% of
its outstanding preferred stock, or 70.84% of Somanta’s outstanding voting stock
(on an as-converted basis), under which the parties, subject to certain limited
exceptions, have granted an irrevocable proxy to Access to vote their shares
in
favor of the merger. A form of the Voting Agreement is attached as Annex
C.
Holders
of record of Somanta common stock and
preferred stock at
the
close of business on the Somanta record date, July 18, 2007, are entitled to
notice of, and to vote at, the Somanta special meeting. As of the Somanta record
date, there were 15,459,137 shares of Somanta common stock outstanding and
entitled to vote at the special meeting, held by approximately 714 holders
of
record
and
591.6318 shares of Series A Convertible Preferred Stock outstanding and entitled
to vote at the special meeting, held by 8 holders of record.
Each
holder of Somanta common stock on the Somanta record date is entitled to one
vote for each share of Somanta common stock owned as of the Somanta record
date
on the proposal to approve and adopt the merger agreement and the merger
contemplated by the merger agreement. Each
holder of Somanta Series A Convertible Preferred Stock on the Somanta record
date is entitled to 16,667 votes for each share of Somanta Series A Convertible
Preferred Stock (representing the number of shares of common stock into which
one (1) share of Series A Convertible Preferred Stock was then convertible)
owned as of the Somanta record date on the proposal to approve and adopt the
merger agreement and the merger contemplated by the merger
agreement.
A
list of
Somanta stockholders will be available for review at the Somanta special meeting
and at the executive offices of Somanta during regular business hours for a
period of ten days before the Somanta special meeting.
Only
Somanta stockholders, including joint holders, as of the close of business
on
the Somanta record date and other persons holding valid proxies for the special
meeting will be entitled to attend the special meeting. All stockholders and
their proxies should be prepared to present photo identification. In addition,
record holders’ names are subject to verification against the list of record
holders on the record date prior to being admitted to the special meeting.
Somanta stockholders who are not record holders but hold shares through a broker
or nominee (i.e., in
“street name”) should be prepared to provide proof of beneficial ownership on
the record date, such as a recent account statement prior to the Somanta record
date, or similar evidence of ownership. Persons who do not provide photo
identification or comply with the other procedures outlined above upon request
may not be admitted to the special meeting. If you plan to attend the Somanta
special meeting and wish to vote in person, you will be given a ballot at the
special meeting.
38
A
quorum
of stockholders is necessary to hold a valid meeting of Somanta stockholders.
A
majority of the shares of Somanta common stock
and
preferred stock, taken together as a single class,
issued
and outstanding and entitled to vote on the record date must be present in
person or by proxy at the Somanta special meeting for a quorum to be
established.
Approval
and adoption of the merger agreement and the merger contemplated by the merger
agreement, requires the affirmative vote of (i) the holders of a majority of
the
outstanding shares of Somanta common stock and Somanta Series A preferred stock,
voting together as a single class on an as-converted basis, and (ii) the holders
of a majority of the outstanding shares of Somanta Series A preferred stock,
voting separately as a class.
As
of the
Somanta record date for the Somanta special meeting, the directors and executive
officers of Somanta and their affiliates beneficially owned and were entitled
to
vote approximately 17,937,213 shares of Somanta common stock (on an as-converted
basis), after the exercise by SCO Capital Partners LLC and SCO Financial Group
LLC of warrants to purchase 1,166,534 shares of common stock of Somanta, which
represents approximately 70.84% of the shares of Somanta common stock
outstanding (on an as-converted basis) on that date. In addition, the directors
and executive officers of Somanta and their affiliates beneficially owned and
were entitled to vote approximately 353.6318 shares of Somanta preferred stock,
which represents approximately 55.6% of the shares of Somanta preferred stock
outstanding on that date. Approval of the transaction will require an
affirmative vote of (i) 12,685,252 number of shares or 50.1% of the shares
of Somanta common stock and
preferred stock (on an as-converted basis) voting together as a single class,
and (ii) 296.408 number of shares or 50.1% of the shares of Somanta preferred
stock, voting separately as a class, in each case outstanding
on the Somanta record date.
Voting
Agreements
Access
received voting agreements from certain Somanta stockholders representing
approximately 85% of Somanta’s outstanding common stock and approximately 60% of
its outstanding preferred stock or 70.84% of Somanta’s outstanding voting stock
on an as-converted basis under which the parties, subject to certain limited
exceptions, have granted an irrevocable proxy to Access to vote their shares
in
favor of the merger. A form of the Voting Agreement is attached as Annex
C.
General
Somanta
stockholders of record may vote their shares by attending the Somanta special
meeting and voting their shares in person, by completing, signing and dating
their proxy cards and mailing them in the enclosed pre-addressed envelopes,
or if
available, by faxing a completed proxy card in accordance with the instructions
set forth in this document.
Somanta
stockholders holding shares of Somanta common stock in “street name,” which
means that their shares are held of record by a broker or nominee, may vote
by
mail by completing, signing and dating the voting instruction forms for the
Somanta special meeting provided by their brokers or nominees and returning
their voting instruction forms to the record holders of their shares. Even
if
you plan to attend the meeting, Somanta recommends that you submit a proxy
prior
to the meeting. You can always change your vote as described below.
Voting
by Proxy
All
properly signed proxies that are received prior to the Somanta special meeting
and that are not revoked will be voted at the special meeting according to
the
instructions indicated on the proxies. If Somanta stockholders of record do
not
include instructions on how to vote their properly signed proxy cards for the
Somanta special meeting, their shares will be voted “FOR” the proposal to
approve and adopt the merger agreement and the merger contemplated by the merger
agreement.
You
may
receive more than one proxy card depending on how you hold your shares.
Generally, you need to sign and return all of your proxy cards to vote all
of
your shares. For example, if you hold shares through someone else, such as
a
stockbroker, you may get proxy material from that person.
39
Changing
Your Vote
Somanta
stockholders may change their votes at any time prior to the vote at the Somanta
special meeting. Somanta stockholders of record may change their votes by
granting new proxies bearing a later date (which automatically revoke the
earlier proxies) or by attending the Somanta special meeting and voting in
person. Attendance at the Somanta special meeting in and of itself, will not
cause previously granted proxies to be revoked, unless Somanta stockholders
so
request. Somanta stockholders may also revoke their proxies by notifying the
Secretary of Somanta in writing. Written notices of revocation and other
communications with respect to revocation of Somanta proxies should be addressed
to:
Somanta
Pharmaceuticals, Inc.
19200
Von
Karman Avenue, Suite 400
Irvine,
California 92612
Attn:
Secretary
Somanta
stockholders who hold their Somanta shares in street name may change their
votes
by submitting new voting instructions to the record holders of their shares
or
by attending the Somanta special meeting and voting in person, provided that
they have obtained a signed legal proxy from the record holders of their shares
giving them the right to vote their shares at the Somanta special meeting.
Somanta stockholders who hold their shares in street name should contact the
record holders of their shares for information about obtaining legal proxies
for
the Somanta special meeting.
Abstentions
and “broker non-votes” will be counted for the purpose of determining whether a
quorum is present at the Somanta special meeting. Brokers who hold shares of
Somanta common stock in “street name” for a beneficial owner of those shares
typically have the authority to vote in their discretion on “routine” proposals
when they have not received instructions from beneficial owners. However,
brokers are not allowed to exercise their voting discretion with respect to
the
approval of matters which the National Association of Security Dealers
determines to be “non-routine,” such as the proposal to approve and adopt the
merger agreement and the merger contemplated by the merger agreement, without
specific instructions from the beneficial owner. These non-voted shares are
referred to as “broker non-votes.” If a broker holds a Somanta stockholder’s
common stock in “street name,” that broker will vote shares held in “street
name” only to the extent the Somanta stockholder provides instructions on how to
vote by filling out the voting instruction form sent by the broker with this
proxy statement/prospectus. Shares held by a broker or nominee that are not
voted because the customer has not provided instructions to the broker or
nominee will have the same effect as a vote “against” the proposal.
For
the
purpose of determining whether the proposal to approve and adopt the merger
agreement and to approve the merger contemplated by the merger agreement has
received the requisite number of affirmative votes, abstentions will be counted
and have the same effect as a vote “against” the proposal. Failing to vote will
also have the same effect as a vote “against” the proposal.
Postponements
and adjournments may be made for the purpose of, among other things, soliciting
additional proxies. Pursuant to the Somanta bylaws, Somanta stockholders present
in person or represented by proxy at the Somanta special meeting have the power
to adjourn the meeting without notice other than announcement at the meeting.
Somanta
is soliciting proxies for the Somanta special meeting from Somanta stockholders.
Somanta will bear the entire cost of soliciting proxies from Somanta
stockholders, a cost estimated to be approximately $75,000, except that Somanta
and Access have each agreed to share equally all expenses incurred in connection
with the filing with the SEC of the registration statement of which this proxy
statement/prospectus forms a part, and the printing and mailing of this proxy
statement/prospectus and related proxy materials. In addition to the
solicitation of proxies by mail, Somanta will request that brokers, banks and
other nominees send proxies and proxy materials to the beneficial owners of
Somanta common stock held by them and secure their voting instructions, if
necessary. Somanta will reimburse those record holders for their reasonable
expenses. Somanta also may use its regular employees, who will not be specially
compensated, to solicit proxies from Somanta stockholders, either personally
or
by telephone, Internet, facsimile or special delivery letter.
Please
do
not send in any Somanta stock certificates with your proxy cards or voting
instruction forms. American Stock Transfer & Trust Company, the exchange
agent for the merger, will send transmittal forms with instructions for the
surrender of certificated representing shares of Somanta common stock to former
Somanta stockholders shortly after the merger is completed. If you hold your
shares of Somanta common stock in book entry, instructions for the exchange
of
your shares for the merger consideration will be included in the transmittal
forms sent to you by the exchange agent.
If
you
need assistance in completing your proxy card or have questions regarding the
Somanta special meeting, please contact Somanta Investor Relations at (919)
477-8090 or write to Somanta Pharmaceuticals, Inc., 19200 Von Karman Ave.,
Suite
400, Irvine, California 92612, Attn: Chief Financial Officer.
40
THE
MERGER
The
following is a description of the material aspects of the merger, including
the
merger agreement. While Access and Somanta believe that the following
description covers the material terms of the merger, the description may not
contain all of the information that is important to you. Access and Somanta
encourage you to read carefully this entire proxy statement/prospectus,
including the merger agreement attached to this proxy statement/prospectus
as
Annex A, for a more complete understanding of the merger.
Background
of the Merger
In
January and February 2006, members of management began to identify and meet
with
investment banking firms to discuss their interest in serving as a placement
agent for Somanta in connection with raising additional financing needed for
research and development purposes and for general working capital subsequent
to
its becoming a public reporting company.
In
addition, in April and May 2006, Somanta held meetings with certain
pharmaceutical and biopharmaceutical companies for the purpose of exploring
the
possibility of licensing one or more drug candidates to such pharmaceutical
or
biopharmaceutical companies. Somanta ultimately identified one pharmaceutical
company that expressed interest in licensing the rights to Somanta’s huBrE-3 mAb
product candidate, and that entity began its due diligence process with respect
to that drug candidate.
In
June
2006, Somanta engaged Merriman Curhan Ford (“Merriman”) to serve as its
exclusive financial advisor for the purpose of assisting Somanta in raising
equity or debt financing necessary to continue the development of Somanta’s
other drug candidates. From June to December 2006, members of Somanta’s
management team made presentations at a number of investor conferences in
connection with fundraising efforts and met with certain potential investors
who
expressed an interest in Somanta. In addition, during this time period Somanta
held discussions with several United Kingdom-based investment banks about the
prospect of a dual listing of Somanta’s common stock on the AIM market and a
potential fundraising effort in Europe.
In
June
2006, the pharmaceutical company with whom Somanta was discussing a potential
license and development agreement related to the huBrE-3 mAb product candidate
terminated those discussions and elected not to license the product candidate
from Somanta.
In
September 2006, Dr. Epenetos identified a United Kingdom-based company, on
whose
board of directors he served and was a principal owner, that had an interest
in
discussing a potential strategic transaction or merger given the similarities
in
each company’s drug
candidate pipeline. The board of directors of Somanta authorized Somanta’s
management team to begin to explore such a potential transaction.
In
October 2006, Somanta’s placement agent informed Somanta that investor interest
was limited due to a combination of factors, including factors that were
adversely affecting public reporting companies that had a public float with
a
value of less than $75,000,000, as was the case with Somanta. In addition,
in
early November of 2006, after preliminary discussions, the United Kingdom-based
company identified by Dr. Epenetos discontinued any discussion related to a
possible strategic transaction or merger.
On
January 9, 2007, Somanta’s Chief Executive Officer, Agamemnon Epenetos, and
Executive Chairman, Terrance J. Bruggeman met with Access’ President and Chief
Executive Officer, Stephen Seiler, and Rosemary Mazanet MD, Vice Chairman of
Access, at the J P Morgan Chase Healthcare Conference in San Francisco. The
meeting was arranged by members of SCO Financial Group. The meeting was also
attended by Mark Alvino, a Managing Director of SCO Financial Group and a member
of the Board of Directors of Access. The purpose of the meeting was to discuss
a
possible relationship between the two companies.
On
February 6, 2007, Dr. Epenetos met with Mr. Seiler and Dr. Mazanet at the SCO
Financial Group offices in New York City. Also in attendance were Mr. Alvino,
Steve Rouhandeh Chief Executive Officer of SCO Capital Group and Jeffrey Davis,
President of SCO Financial Group, and Chairman of the Board of Access
and a director of Somanta. The purpose of the meeting was to continue the
exploratory conversations with respect to a proposed strategic transaction
or a
potential merger transaction between the two companies.
41
On
February 13, 2007, at a regularly scheduled meeting of the Somanta board of
directors, Dr. Epenetos gave a presentation related to his discussions with
Access as well as Access’ business and drug candidate pipeline and he stated his
belief
that
such a relationship or combination could help broaden Somanta’s drug
candidate pipeline and strengthen its research and development
capabilities
more
quickly and effectively than other realistic alternatives available to
Somanta.
On
February 15, 2007, after informal discussions among management and the Access
Board of Directors, Access submitted a non-binding letter of intent to Somanta
which was provided to the Somanta Board of Directors and to Somanta’s outside
counsel the same day. Informal discussions were held among members of management
and members of the Somanta board, including Mr. Davis with respect to the
proposal and alternatives available to Somanta.
On
February 16, 2007, Dr. Epenetos signed the non-binding letter of intent, which
was conditioned on, among other things, the satisfactory completion of each
company’s due diligence investigation of the other and the negotiation and
execution of a definitive merger agreement. On February 21, 2007, the companies
issued a joint press release announcing the non-binding letter of intent, and
on
February
22,
2007, each of Dr. Epenetos and Mr. Seiler participated in an Access-sponsored
investor conference call with investors of Access for the purpose of answering
questions related to the proposed transaction.
From
February 23, 2007 through April 17, 2007, each party engaged in a due diligence
investigation of the other party, including, without limitation, a review of
the
relevant intellectual property and other assets, as well as a complete financial
and legal review.
On
March
9, 2007, Access through its outside counsel, Bingham McCutchen LLP, provided
to
Somanta a first draft of a proposed merger agreement.
On
March
15, 2007, at a special meeting of Somanta’s board of directors, the board of
directors determined, due to the various conflicts of interest resulting from
the proposed transaction, that it
would be
in the best interests of Somanta’s
stockholders and other relevant corporate constituencies that the Board appoint
a special committee of disinterested directors to (i) evaluate the merits of
the
transaction, (ii) to oversee the negotiation of the merger agreement, and (iii)
ultimately to recommend to the full Somanta board whether or not to approve
the
final fully negotiated merger agreement. It was determined at this meeting
that
each of John Gibson and Kathleen Van Sleen was sufficiently independent and
disinterested with respect to the proposed transaction to function as such
special committee. In addition, the special committee was authorized to engage
an independent financial advisor for the purpose of obtaining an opinion as
to
the fairness of the transaction from a financial point of view to the
stockholders of Somanta. Please see the discussion below under the heading
“The
Somanta Special Committee” for a more complete description of the Somanta
special committee.
From
March 15 through April 17, 2007, the parties negotiated the final terms of
the
merger agreement. The Somanta special committee formally met on March 15, 2007,
March 28, 2007, March 29, 2007, April 3, 2007 and April 12, 2007 for the purpose
of discussing the terms of the proposed merger agreement and directing
management with respect to the same as well as to discuss the engagement of
a
financial advisor who would render an opinion as to the fairness of the
transaction from a financial point of view. In addition, the special committee
received and responded to reports from management with respect to the merger
agreement negotiations on each of March 9, 2007, March 16, 2007, March 30,
2007,
April 6, 2007 and April 11, 2007.
During
this period of time, Ms. Van Sleen interviewed three different potential
financial advisors; however, the special committee ultimately concluded that
one
of the financial advisors was not sufficiently independent to render the
requisite opinion and that Somanta did not have the resources available to
it to
pay to either of the other two or any other qualified
independent financial advisor the significant up front cash payment needed
to
engage such a financial advisor for this purpose.
At
a
meeting of the special committee held on April 12, 2007, Mr. Bruggeman reported
as to the resolution of each of the open business, legal and financial issues
related to the terms of the merger agreement. Mr. Bruggeman also provided the
special committee with an analysis of the value of the consideration to be
received by stockholders of Somanta as of that date as well as the treatment
of
other relevant corporate constituencies in the merger, including option holders,
warrant holders, employees and creditors. Mr. Bruggeman also reported to the
special committee with respect to each of the alternative transactions pursued
in the prior fifteen months, Somanta’s financial condition and the likely
liquidation value
of the
company. The special committee then determined that based on the foregoing
reports and analyses and its own independent analysis of Somanta’s financial
condition and alternatives, the transaction and the terms of the merger
agreement as presented to the special committee at this meeting were fair,
advisable and in the best interests of the company, its stockholders and each
of
the other relevant corporate constituencies and that it would recommend to
the
full board to approve the merger agreement and the transactions contemplated
thereby.
42
At
a
special meeting of the board of directors held on April 13, 2007, at which
all
the members of the Somanta board of directors were in attendance with the
exception of Jeffrey Davis. Also in attendance was Mr. Rouhandeh and Mr. Alvino,
representatives of SCO Capital Group and SCO Financial Group as well as a
representative of Foley & Lardner LLP, outside counsel to Somanta. At this
meeting, (i) Mr. Bruggeman provided a report and analysis related to the terms
of the proposed transaction, including, without limitation, the value of the
consideration to be received in the transaction by the stockholders of Somanta
as of that date and the conditions to closing the transaction, (ii) the
representative of Foley & Lardner reviewed the terms of the merger agreement
and the relevant legal approvals necessary to consummate the merger, (iii)
Mr.
Rouhandeh and Mr. Alvino were asked to provide a report regarding the status
of
Access’ proposed fundraising effort and financial condition, and (iv) the
special committee gave its formal recommendation to the full board of directors
to approve the merger agreement. After deliberating, the Board determined that
the merger agreement and the transactions contemplated thereby, including the
merger, were fair to, advisable and in the best interests of the stockholders
of
Somanta and each other relevant corporate constituency and voted to approve
the
terms of the merger agreement and the merger.
On
April
26, 2007, after the Board’s approval of the merger agreement, Somanta entered
into a Note Purchase Agreement, a Security Agreement, a Patent Collateral
Assignment and Security Agreement and a Trademark Collateral Security and Pledge
Agreement (collectively, the “Loan Documents”) with Access. Under the terms of
the Loan Documents, Access initially loaned Somanta $33,461.89. Access, in
its
sole discretion, may from time to time advance additional loan amounts to
Somanta. All amounts loaned to Somanta by Access are secured by substantially
all of the assets of Somanta pursuant to the terms of the Loan Documents. The
Note bears interest at 10% and is repayable at the earlier of: (i) August 31,
2007, or (ii) the date of the termination of the Agreement and Plan of Merger
dated as of August 18, 2007 between Somanta and Access. As of July 20, 2007
Somanta had borrowed $485,745.55 from Access.
The
Somanta Special Committee
Due
to
various conflicts of interests brought to the attention of the board of
directors at a meeting of the board of directors held on March 15, 2007, the
board of directors established an independent special committee to evaluate
and
negotiate the terms of the merger agreement and related transactions. In
determining which members of the board were sufficiently independent and
disinterested with respect to the transaction, the Board noted that (i) each
of
Mr. Bruggeman and Dr. Epenetos were entitled to a significant amount of deferred
salary that would likely be paid at the closing of the transaction as well
as
potential employment agreements with the surviving entity or severance payments,
(ii) Jeffrey Davis is a member of the board of directors of each of Somanta
and
Access, (iii) Jeffrey Davis is also affiliated with both SCO Capital Partners
LLC and Lake End Capital LLC, entities that beneficially own 49.62% of Somanta’s
common stock and 55.6% of Somanta’s preferred stock and 74.1% of Access common
stock and $6.0 million of Access’ secured convertible debt, and (iv) each of Dr.
Gibson and Ms. Van Sleen hold unexercised options to purchase Somanta common
stock. After deliberating, it was determined that each of Dr. Gibson and Ms.
Van
Sleen were sufficiently independent and disinterested to function as Somanta’s
special committee.
The
board
then delegated to the special committee the power and authority to:
| · |
examine
and evaluate the merits of the transaction with
Access;
|
| · |
negotiate
the terms of the proposed merger
agreement;
|
| · |
engage
and consult with such advisors, including, without limitation, any
financial or legal advisor as the special committee deemed necessary;
and
|
| · |
recommend
to the full board whether the proposed terms of any fully negotiated
merger agreement and the transactions contemplated thereby, are fair,
advisable and in the best interests of Somanta, its stockholders
and each
of the other relevant corporate constituencies and whether such merger
agreement, and the transactions contemplated thereby, should be approved
by the full board and submitted to the stockholders for
approval.
|
43
The
following discussion of the parties’ reasons for the merger contains a number of
forward-looking statements that reflect the current views of Access and/or
Somanta with respect to future events that may have an effect on their future
financial performance. Forward-looking statements are subject to risks and
uncertainties. Actual results and outcomes may differ materially from the
results and outcomes discussed in the forward-looking statements. Cautionary
statements that identify important factors that could cause or contribute to
differences in results and outcomes include those discussed in
“Summary-Forward-Looking Information” and “Risk Factors.”
Mutual
Reasons for the Merger
Access
and Somanta believe that the combined company represents a biopharmaceutical
company with the following potential advantages:
|
|
•
|
|
Deeper
Pipeline. The diverse product pipeline for the combined company is
composed of one approved product, two drug candidates which are or
shortly
will be in Phase II development and five drug candidates in pre-clinical
development.
|
|
•
|
Diverse
Pipeline. Each of the product candidates is a different drug with
its own
mechanism of action. Consequently, the diversity of drugs in the
pipeline
of the combined company may provide investors with significant risk
diversification.
|
||
|
•
|
Multiple
Indications. Many of the products in the pipeline could be used for
one or
more types of cancer and these types differ from drug candidate to
drug
candidate proving additional opportunities for approval and not limiting
the approvability of the drug candidates to any single clinical
setting.
|
||
|
•
|
Retained
Product Rights. All of the rights to each of the drug candidates,
with the
exception of Sodium Phenylbutyrate, in the portfolio of the combined
company would be wholly-owned. These retained rights offer the flexibility
to structure partnerships, when in the best interests of stockholders,
to
accelerate development or commercialization within the United States
or
abroad.
|
||
|
•
|
Financial
Resources. The financial resources of the combined company would
allow it
to immediately focus on execution with respect to the product
portfolio.
|
||
|
•
|
Experienced
Management Team. It is expected that the combined company will be
led by a
combination of experienced senior management from both Access and
Somanta,
which will provide management continuity to support the integration
of the
two companies.
|
Access’s
Reasons for the Merger
Access’s
Reasons. The Access board of directors approved the merger based on a number
of
factors, including, among other factors, the following:
|
|
•
|
|
Broader
Pipeline. Access currently has one approved product, one product
candidate
in clinical trials and two in pre-clinical studies. The addition
of the
one Somanta product currently in a clinical program and three additional
drug candidates in pre-clinical development significantly broadens
the
product pipeline.
|
|
•
|
Risk
Diversification. The addition of the Somanta product candidates to
the
portfolio for a total of seven of product candidates, each with a
different mechanism of action, potentially affords significant risk
diversification for Access stockholders.
|
||
|
•
|
Attractive
Market. The Somanta product candidates are attractive because alone
and/or
in combination with existing cancer treatments which is a market
that is
attractive to Access.
|
||
44
In
addition to considering the strategic factors outlined above, the Access board
of directors considered the following factors in reaching its conclusion to
approve the merger, all of which it viewed as generally supporting its decision
to approve the business combination with Somanta:
|
|
•
|
|
The
results of the due diligence review of Somanta’s businesses and operations
by Access’s management, legal advisors and financial
advisors;
|
|
|
•
|
The
terms and conditions of the merger agreement, including the following
related factors:
|
|||
|
•
|
the
determination that the relative percentage ownership of the Access
stockholders and Somanta stockholders ratio that is fixed captures
the
respective ownership interests of the Access and Somanta stockholders
in
the combined company based on valuations of Access and Somanta at
the time
of the board’s approval of the merger agreement and avoids fluctuations
caused by near-term market volatility;
|
|||
|
•
|
the
no-solicitation provisions governing Somanta’s ability to engage in
negotiations with, provide any confidential information or data to,
and
otherwise have discussions with, any person relating to an alternative
acquisition proposal;
|
|||
|
•
|
the
limited ability of the parties to terminate the merger agreement;
and
|
|||
|
•
|
the
possible effects of the provisions regarding termination
fees;
|
|||
|
•
|
The
likelihood that the merger will be consummated on a timely basis;
and
|
|||
|
•
|
The
likelihood of retaining key Somanta employees to help manage the
combined
company.
|
|||
In
the
course of its deliberations, Access’s board of directors also considered a
variety of risks and other countervailing factors related to entering into
the
merger agreement, including, among other risks and countervailing factors:
|
|
•
|
|
the
risks, challenges and costs inherent in combining the operations
and the
substantial expenses to be incurred in connection with the merger,
including the possibility that delays or difficulties in completing
the
integration could adversely affect the combined company’s operating
results and preclude the achievement of some benefits anticipated
from the
merger;
|
|
•
|
the
possible volatility, at least in the short term, of the trading price
of
Access’s common stock resulting from the merger
announcement;
|
||
|
•
|
the
possible loss of key management, scientific or other personnel of
either
of the combining companies as a result of the management and other
changes
that will be implemented in integrating the businesses;
|
||
|
•
|
the
risk of diverting management’s attention from other strategic priorities
to implement merger integration efforts;
|
||
|
•
|
the
risk that the merger might not be consummated in a timely manner
or at all
and the potential adverse effect of the public announcement of the
merger
on Access’s reputation;
|
||
|
•
|
the
risk to Access’s business, operations and financial results in the event
that the merger is not consummated;
|
||
|
•
|
various
other applicable risks associated with the combined company and the
merger, including those described in the section of this proxy
statement/prospectus entitled “Risk Factors;” end
|
||
|
•
|
the
financial impact of funding a larger pipeline of drug candidates
and the
larger staff required to do so.
|
The
foregoing information and factors considered by Access’s board of directors are
not intended to be exhaustive but are believed to include all of the material
factors considered by Access’s board of directors. In view of the wide variety
of factors considered in connection with its evaluation of the merger and the
complexity of these matters, the Access board of directors did not find it
useful, and did not attempt, to quantify, rank or otherwise assign relative
weights to these factors. In considering the factors described above, individual
members of the Access board of directors may have given different weight to
different factors. The Access board of directors conducted an overall analysis
of the factors described above, including thorough discussions with, and
questioning of, Access’ management and Access’ legal and financial advisors, and
considered the factors overall to be favorable to, and to support, its
determination.
45
Somanta’s
Reasons for the Merger
The
Somanta board of directors approved the merger based on a number of factors,
including, among other factors, the following:
|
|
•
|
|
Lack
of Alternative Strategic Relationships. Somanta’s board of directors’ view
as to the limited potential for other third parties to enter into
strategic relationships with Somanta or to finance or acquire Somanta,
particularly based on the thorough and formal process Somanta conducted
with Merriman Curhan & Ford as well as the business development effort
by management with respect to identifying potential partner for huBrE-3
mAb product candidate and the results of such process.
|
|
•
|
Historical
and Current Information. Historical and current information concerning
Somanta’s business, including its financial performance and condition,
operations, management and competitive position, current industry
and
economic conditions, and Somanta’s prospects if it was to remain an
independent company, including its immediate need to obtain additional
financing and the likely terms on which it would be able to obtain
that
financing, if at all.
|
||
|
•
|
Merger
Conditions. The provisions of the merger agreement, including the
fact
that the value of the consideration to be paid to the common stockholders
of Somanta and the preferred stockholders of Somanta exceeded the
aggregate amounts each such class of stockholders had invested in
Somanta
as of the date the merger agreement was approved.
|
||
|
•
|
Management
Team. The availability of an experienced management team that includes
a
team capable of developing a commercialization plan the Somanta product
candidates.
|
||
|
•
|
Access
to Capital. Access’ ability as a public company to raise additional
capital.
|
||
|
•
|
Liquidity.
Access’ status as a public company, which would provide Somanta
stockholders with the possibility of
liquidity.
|
In
addition to considering the strategic factors outlined above, the Somanta’s
board of directors considered the following factors in reaching its conclusion
to approve the merger and to recommend that the Somanta stockholders adopt
the
merger agreement, all of which it viewed as generally supporting its decision
to
approve the business combination with Access:
|
|
•
|
|
Access’
attractiveness as a strategic partner, including
Access’:
|
|
|
•
|
Potential
ability to raise further capital, particularly in light of Somanta’s cash
needs and limited cash resources;
|
|||
|
•
|
high
quality and complementary management team; and
|
|||
|
•
|
public
company infrastructure and stock liquidity, particularly in light
of
Somanta’s relatively illiquid trading market in its common
stock.
|
|||
|
•
|
the
opportunity for Somanta stockholders to participate in the long-term
value
of Somanta’s development programs through the ownership of Access common
stock;
|
|||
|
•
|
the
terms and conditions of the merger agreement, including the following
related factors:
|
|||
|
•
|
the
expectation that the merger will be treated as a tax-free reorganization
for U.S. federal income tax purposes, with the result that the
Somanta stockholders will generally not recognize taxable gain or
loss for
U.S. federal income tax purposes;
|
|||
|
•
|
the
determination that the relative percentage ownership of Access
stockholders and Somanta stockholders ratio that is fixed, and subject
to
adjustment is appropriate to reflect the strategic purpose of the
merger
and consistent with market practice for a merger of this type and
captures
the respective ownership interests of the Access and Somanta stockholders
in the combined company based on Somanta’s perceived valuations of Access
and Somanta at the time of the board’s approval of the merger
agreement;
|
|||
46
|
•
|
the
fact that shares of Access common stock issued to Somanta stockholders
will be registered on Form S-4 and will be freely tradable for
Somanta stockholders who are not affiliates of Somanta;
|
|||
|
•
|
the
requirement that the merger agreement be submitted to a vote of the
stockholders of Somanta;
|
|||
|
•
|
Somanta’s
rights under the merger agreement to consider certain unsolicited
acquisition proposals and to change its recommendation to Somanta
stockholders to adopt the merger agreement under certain circumstances
should Somanta receive a superior proposal; and
|
|||
|
|
|
|||
|
•
|
the
likelihood that the merger will be consummated on a timely basis;
and
|
|||
|
•
|
the
major risks and uncertainties of alternatives to the merger, such
as
Somanta remaining an independent company.
|
|||
In
the
course of its deliberations, Somanta’s board of directors also considered a
variety of risks and other countervailing factors related to entering into
the
merger agreement, including, among other risks and countervailing factors:
|
•
|
Risks
of Combination. The challenges and costs of combining the operations
and
the substantial expenses to be incurred in connection with the merger,
including the risks that delays or difficulties in completing the
integration and the inability to retain key employees could adversely
affect the combined company’s operating results and preclude the
achievement of some benefits anticipated from the
merger.
|
||
|
•
|
Stock
Price. The price volatility of Access’ common stock, which may reduce the
value of the Access common stock that the Somanta stockholders will
receive upon the consummation of the merger.
|
||
|
•
|
Value.
The inability of Somanta’s stockholders to realize the long-term value of
the successful execution of Somanta’s current strategy as an independent
company.
|
||
|
•
|
Reputation.
The possibility that the merger might not be completed and the potential
adverse effect of the public announcement of the merger on Somanta’s
reputation and ability to obtain financing in the
future.
|
In
addition to the risks and countervailing factors outlined above, Somanta’s board
of directors also considered other risks and countervailing factors, including
the following:
|
•
|
the
possible loss of key management, technical or other personnel of
either of
the combining companies as a result of the management and other changes
that will be implemented in integrating the businesses;
|
||
|
•
|
the
$750,000 termination fee payable to Access upon the occurrence of
certain
events, and the potential effect of such termination fee in deterring
other potential acquirers from proposing an alternative transaction
that
may be more advantageous to Somanta stockholders;
|
||
|
•
|
the
risk of diverting management’s attention from other strategic priorities
to implement merger integration efforts;
|
||
|
•
|
the
risk that the merger might not be consummated in a timely manner
or at
all;
|
||
|
•
|
the
risk that the anticipated benefits of integration and interoperability
and
cost savings will not be realized; and
|
||
|
•
|
various
other applicable risks associated with the combined company and the
merger, including those described in the section of this proxy
statement/prospectus entitled “Risk
Factors.”
|
47
The
foregoing information and factors considered by Somanta’s board of directors are
not intended to be exhaustive but are believed to include all of the material
factors considered by Somanta’s board of directors. In view of the wide variety
of factors considered in connection with its evaluation of the merger and the
complexity of these matters, the Somanta board of directors did not find it
useful, and did not attempt, to quantify, rank or otherwise assign relative
weights to these factors. In considering the factors described above, individual
members of the Somanta board of directors may have given different weight to
different factors. The Somanta board of directors conducted an overall analysis
of the factors described above, including thorough discussions with, and
questioning of, Somanta’s management and Somanta’s legal advisors, and
considered the factors overall to be favorable to, and to support, its
determination.
Recommendation
of the Somanta Board of Directors
At
a
special meeting of the Somanta board of directors held on April 13, 2007, the
Somanta board of directors:
|
|
•
|
|
After
receipt of the recommendation of the Somanta special committee,
determined
that the merger is advisable, and is fair to and in the best interests
of
Somanta and its stockholders
and each of the other relevant corporate constituencies;
|
|
|
•
|
|
approved
the merger agreement;
|
|
|
•
|
|
directed
that approval and adoption of the merger agreement and approval of
the
merger be submitted for consideration by Somanta stockholders at
a Somanta
special meeting; and
|
|
|
•
|
|
resolved
to recommend that the Somanta stockholders vote “FOR” the proposal to
approve and adopt the merger agreement and the merger contemplated
by the
merger agreement.
|
In
reaching its decision to approve the merger agreement, the Somanta board of
directors (i)
relied on the recommendation of the Somanta special committee, and (ii)
consulted
with management, and
Somanta’s
legal
advisors in connection with the merger. Particularly persuasive among the
factors considered by the Somanta board of directors in its deliberations were
the reasons for the merger described in the section entitled “Reasons for the
Merger” beginning on page 45 of this proxy
statement/prospectus. The Somanta board of directors also considered each of
the
following factors in its deliberations:
|
|
•
|
|
that
the fixed exchange ratio for the stock portion of the merger consideration
provides certainty as to the number of shares of Access common stock
to be
issued to Somanta stockholders and the percentage of shares of Access
common stock that current Somanta stockholders will own as a group
after
the merger;
|
|
|
•
|
|
that
Somanta stockholders will receive the merger consideration in stock,
which
provides them with an opportunity to participate in the potential
growth
of the combined company following the merger as stockholders of Access;
|
|
•
|
that
the value of the consideration to be received by each stockholder
of
Somanta on the date the board approved the merger agreement exceeded
the
amount that each such stockholder had invested in
Somanta;
|
|
•
|
that
the liquidation value of Somanta was likely less than the value of
the
consideration to be paid to the stockholders of Somanta in the
merger;
|
|
|
•
|
|
that
the merger is structured such that Somanta stockholders will not
be
immediately taxed on the stock component of the merger
consideration;
|
|
|
•
|
|
the
conditions
to consummation of the merger, in particular the likelihood of obtaining
stockholder approvals, and the likelihood that the merger will be
completed;
|
|
|
•
|
|
current
financial market conditions and historical market prices, volatility
and
trading information with respect to Somanta common stock;
and
|
|
|
•
|
|
the
prospects
for Somanta’s growth and profitability as a stand-alone
company,
and the risks
of such growth and profitability.
|
48
In
addition, the Somanta board of directors also identified and considered a
variety of potentially negative factors in its deliberations concerning the
merger, including, but not limited to:
|
|
•
|
|
the
effect of the public announcement of the merger, and the possibility
that
the merger might not be completed, Somanta’s stock price and Somanta’s
ability to attract and retain key management and other personnel;
|
|
|
•
|
|
the
risk that the potential benefits sought in the merger might not be
fully
realized;
|
|
|
•
|
|
the
challenges of integrating the management teams, strategies, cultures
and
organizations of the companies;
|
|
|
•
|
|
the
limitations on the right of Somanta to pursue alternative transactions
that could conflict with the merger, including the possible effect
of the
expense and break-up fee provisions in the merger agreement;
|
|
|
•
|
|
the
possibility that the value of the Access common stock to be issued
in the
merger could decline; and;
|
|
|
•
|
|
other
applicable risks described in the section entitled “Risk Factors”
beginning on page 18.
|
The
Somanta board of directors concluded, however, that these negative factors
could
be managed or mitigated by Somanta or by Access or were unlikely to have a
material impact on the merger or Access after the merger, and that, overall,
the
potentially negative factors associated with the merger were far outweighed
by
the potential benefits of the merger.
The
above
discussion of material factors considered by the Somanta board of directors
is
not intended to be exhaustive, but does set forth the principal factors
considered by the Somanta board of directors. The Somanta board of directors
collectively reached the conclusion to approve the merger agreement (with
Mr.
Davis recusing himself from such discussions and vote) and
the
merger in light of the various factors described above and other factors that
each board member felt were appropriate. In view of the wide variety of factors
considered by the Somanta board of directors in connection with its evaluation
of the merger and the complexity of these matters, the Somanta board did not
consider it practical, and did not attempt, to quantify, rank or otherwise
assign relative weights to the specific factors it considered in reaching its
decision. Rather, the Somanta board of directors made its recommendations based
on the totality of the information presented to and the investigation conducted
by it, and the judgments of individual members of the board of directors may
have been influenced to a greater or lesser degree by different factors.
On
the
basis of the foregoing, the Somanta board of directors (with Mr. Davis
abstaining) recommends that Somanta stockholders vote “FOR” the approval and
adoption of the merger agreement and the merger contemplated by the merger
agreement.
No
Opinion of Financial Advisor
The
special committee of
the
Somanta board of directors did
not
engage a financial advisor to assist in the sale of Somanta or to render a
financial opinion as to the fairness, from a financial point of view,
of
the
consideration to be paid
to
the Somanta stockholders in the merger. The special committee determined that
the factors which weighed in favor of the merger, as discussed above, were
substantial in relation to the factors which weighed against the merger. The
special committee also considered the cost of obtaining a fairness opinion
as
prohibitively expensive in light of Somanta’s financial condition.
Treatment
of Somanta Options and Warrants
Pursuant
to the terms of the Merger Agreement, Somanta has warrants outstanding to
purchase 5,936,304 shares of Somanta common stock that are not expected to
be
exercised prior to the closing of the merger and are expected to be converted
into warrants to purchase approximately 192,000 shares of Access’ common stock
based on the ratio of common stock of Access to be issued in the merger in
exchange for common stock of Somanta. Warrants to purchase 1,166,534 shares
of
Somanta common stock which are held by SCO Capital Partners LLC and SCO
Financial Group LLC are expected to be exercised prior to the closing of the
merger.
Pursuant
to the terms of the Merger Agreement, Access will not assume, or provide a
substitute option, for any of Somanta’s outstanding stock options. As a result,
pursuant to the terms of Section 11.3(d) of the Equity Incentive Plan, the
Somanta’s Board of Directors has resolved to: (i) allow the immediate and
accelerated vesting of all of the options granted, and (ii) allowed for the
exercise of the outstanding options, in whole or in part, until the close of
business on Thursday, May 31, 2007. A failure to validly exercise the options
in
accordance prior to the close of business on May 31, 2007 will mean that after
such time, the unexercised option will have expired and will no longer be
exercisable in whole or in part. Somanta does not expect any of the options
to
be exercised since the options are substantially out of the money.
49
Material
Closing Conditions to Merger
A
number
of conditions must be satisfied before the merger will be completed. These
include among others:
|
|
•
|
|
the
approval and adoption of the merger agreement and the merger contemplated
by the merger agreement by Somanta stockholders;
|
|
|
•
|
|
the
absence of any legal restraints or prohibitions preventing the completion
of the merger;
|
|
|
•
|
|
that
Access will have received a favorable fairness opinion of TSG Partners
to
the effect that the payment by it of the merger consideration is
fair to
Access’ stockholders from a financial point of
view;
|
|
|
•
|
|
the
representations and warranties of each party contained in the merger
agreement being true and correct, except to the extent that breaches
of
these representations and warranties would not result in a material
adverse effect on the representing party;
|
|
|
•
|
|
the
performance or compliance in all material respects of each party
with all
agreements and covenants contained in the merger agreement at the
completion of the merger;
|
|
|
•
|
|
the
absence of events or developments since the date of the merger agreement
that would reasonably be expected to have a material adverse effect
with
respect to either party; and
|
|
|
•
|
|
that
as of the completion of the merger all of Somanta’s liabilities, including
accounts payables and amounts owed to officers and employees, shall
not
exceed $1,000,000 in the aggregate.
|
Each
of
Access, Somanta Acquisition Corporation and Somanta may waive the conditions
to
the performance of its respective obligations under the merger agreement and
complete the merger even though one or more of these conditions has not been
met.
Material
United States Federal Income Tax Consequences of the Merger
The
following discussion summarizes the material U.S. federal income tax
considerations of the merger that are expected to apply generally to Somanta
stockholders upon an exchange of their Somanta common stock or preferred stock
for Access common stock in the merger. This summary is based upon current
provisions of the Internal Revenue Code of 1986, as amended, or the Code,
existing Treasury Regulations under the Code and current administrative rulings
and court decisions, all of which are subject to change and to differing
interpretations, possibly with retroactive effect. Any change or different
interpretation could alter the tax consequences to Access, Somanta or the
stockholders of Somanta as described in this summary. This summary is not
binding on the Internal Revenue Service, or the IRS, and there can be no
assurance that the IRS (or a court, in the event of an IRS challenge) will
agree
with the conclusions stated herein.
This
summary applies only to a Somanta stockholder that is a “U.S. person,” defined
to include:
|
|
•
|
|
a
citizen or resident of the United
States;
|
|
|
•
|
|
a
corporation created or organized in or under the laws of the United
States
or any political subdivision thereof (including the District of
Columbia);
|
|
|
•
|
|
an
estate the income of which is subject to U.S. federal income taxation
regardless of its source;
|
|
|
•
|
|
a
trust if either a court within the United States is able to exercise
primary supervision over the administration of such trust and one
or more
U.S. persons have the authority to control all substantial decisions
of
such trust, or the trust has a valid election in effect to be treated
as a
U.S. person for U.S. federal income tax purposes;
and
|
|
|
•
|
|
any
other person or entity that is treated for U.S. federal income tax
purposes as if it were one of the
foregoing.
|
50
Any
Somanta stockholder that is neither a “U.S. person” as defined above nor an
entity that is treated as a partnership or disregarded entity for U.S. federal
income tax purposes is, for purposes of this discussion, a “non-U.S.
person.”
No
attempt has been made to comment on all U.S. federal income tax consequences
of
the merger that may be relevant to particular holders of Somanta common stock or
preferred stock that are subject to special treatment under U.S. federal income
tax laws, including, without limitation:
|
|
•
|
|
dealers,
brokers, and traders in securities;
|
|
|
•
|
|
non-U.S.
persons;
|
|
|
•
|
|
tax-exempt
entities;
|
|
|
•
|
|
financial
institutions, regulated investment companies, real estate investment
trusts, or insurance companies;
|
|
|
•
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entities
that are treated as partnerships for federal income tax purposes,
S
corporations, and other pass-through
entities;
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holders
who are subject to the alternative minimum tax provisions of the
Code;
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holders
who acquired their shares in connection with stock option or stock
purchase plans or in other compensatory
transactions;
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•
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holders
who hold shares that constitute qualified small business stock within
the
meaning of Section 1202 of the
Code;
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holders
with a functional currency other than the U.S.
dollar;
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holders
who hold their shares as part of an integrated investment such as
a hedge
or as part of a hedging, straddle or other risk reduction strategy;
or
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holders
who do not hold their shares as capital assets within the meaning
of
Section 1221 of the Code (generally, property held for investment
will be
a capital asset).
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If
an
entity treated as a partnership for U.S. federal income tax purposes holds
Somanta common stock or preferred stock, the tax treatment of a person holding
interests in that entity generally will depend upon the status of that person
and the activities of that entity. Such entities and persons holding interests
in such entities should consult a tax advisor regarding the tax consequences
of
the merger.
The
following discussion does not address:
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the
tax consequences of the merger under U.S. federal non-income tax
laws or
under state, local, or foreign tax
laws;
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the
tax consequences of transactions effectuated before, after or at
the same
time as the merger, whether or not they are in connection with the
merger,
including, without limitation, transactions in which Somanta shares
are
acquired or Access shares are disposed
of;
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the
tax consequences to holders of options issued by Somanta that are
exercised or terminated prior to the
merger;
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the
tax consequences to holders of warrants issued by Somanta that are
exercised or assumed in connection with the
merger;
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the
tax consequences of the receipt of Access shares other than in exchange
for Somanta shares;
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the
tax consequences of the ownership or disposition of Access shares
acquired
in the merger; or
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the
tax implications of a failure of the merger to qualify as a reorganization
within the meaning of Section 368 of the
Code.
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51
No
tax opinion will be sought or obtained in connection with the merger. In
addition, no ruling from the IRS has been or will be requested in connection
with the merger. Accordingly, holders of Somanta common stock and holders of
Somanta preferred stock are advised and expected to consult their own tax
advisers regarding the federal income tax consequences of the merger in light
of
their personal circumstances and the consequences of the merger under federal
non-income tax laws and state, local and foreign tax laws.
Subject
to the foregoing, Access and Somanta expect that the merger will be treated
for
U.S. federal income tax purposes as a reorganization within the meaning of
Section 368 of the Code. Accordingly, Access and Somanta expect that the
following material U.S. federal income tax consequences will result:
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Access,
Somanta Acquisition Corporation and Somanta will each be a party
to the
reorganization;
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Access,
Somanta Acquisition Corporation, Somanta and the Access stockholders
will
not recognize any gain or loss solely as a result of the
merger;
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stockholders
of Somanta will not recognize any gain or loss upon the receipt of
solely
Access common stock for their Somanta common stock or preferred stock,
other than with respect to cash received in lieu of fractional shares
of
Access common stock;
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the
aggregate tax basis of the shares of Access common stock received
by a
Somanta stockholder in the merger (including any fractional share
deemed
received, as described below) will be equal to the aggregate tax
basis of
the shares of Somanta common stock or preferred stock surrendered
in
exchange therefor;
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the
holding period of the shares of Access common stock received by a
Somanta
stockholder in the merger will include the holding period of the
shares of
Somanta common stock or preferred stock surrendered in exchange therefor;
and
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cash
payments received by Somanta stockholders in lieu of fractional shares
of
Access common stock will be treated as if such fractional shares
of Access
common stock were issued in the merger and then sold. A stockholder
of
Somanta who receives a cash payment in lieu of a fractional share
will
recognize gain or loss equal to the difference, if any, between such
stockholder’s basis in the fractional share and the amount of cash
received. Such gain or loss will be a capital gain or loss and any
such
capital gain or loss will be long-term capital gain or loss if the
Somanta
common stock or preferred stock is held by such stockholder as a
capital
asset at the effective time of the merger and such stockholder’s holding
period for his, her or its Somanta common stock or preferred stock
is more
than one year.
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Somanta
stockholders that owned at least five percent (by vote of value) of the total
outstanding stock of Somanta are required to attach a statement to their tax
returns for the year in which the merger is consummated that contains the
information listed in Treasury Regulations Section 1.368-3T(b). Such statement
must include the stockholder’s tax basis in the stockholder’s Somanta common
stock and preferred stock and the fair market value of such stock.
For
purposes of the foregoing discussion, stockholders who acquired different blocks
of Somanta common stock or preferred stock at different times for different
prices must calculate their gains and losses and holding periods separately
for
each identifiable block of such stock exchanged, converted, cancelled, or
received in the merger.
The
foregoing discussion does not apply to Somanta stockholders who properly perfect
appraisal rights. Generally, a Somanta stockholder who perfects appraisal rights
with respect to such stockholder’s shares of Somanta common stock or preferred
stock will recognize capital gain or loss equal to the difference between such
stockholder’s tax basis in those shares and the amount of cash received in
exchange for those shares. In addition, a portion of any proceeds received
following the effective time of the merger may be characterized as interest,
taxable as ordinary income, thus reducing the amount of such capital gain or
increasing the amount of such capital loss (as the case may be). Given the
uncertain treatment under federal income tax law, a Somanta stockholder who
intends to perfect appraisal rights should consult his, her or its tax
advisor.
52
Certain
noncorporate Somanta stockholders may be subject to backup withholding, at
a
rate of 28% for 2007, on cash received pursuant to the merger. Backup
withholding will not apply, however, to a Somanta stockholder who (1) furnishes
a correct taxpayer identification number and certifies that the Somanta
stockholder is not subject to backup withholding on IRS Form W-9 or a
substantially similar form, (2) provides a certification of foreign status
on an
appropriate IRS Form W-8 or successor form, or (3) is otherwise exempt from
backup withholding. If a Somanta stockholder does not provide a correct taxpayer
identification number on IRS Form W-9 or a substantially similar form, the
Somanta stockholder may be subject to penalties imposed by the IRS. Amounts
withheld, if any, are generally not an additional tax and may be refunded or
credited against the Somanta stockholder’s U.S. federal income tax liability,
provided that the Somanta stockholder timely furnishes the required information
to the IRS.
The
preceding discussion is intended only as a summary of certain U.S. federal
income tax consequences of the merger and does not purport to be a complete
analysis or discussion of all of the merger’s potential tax effects. Somanta
stockholders are urged to consult their own tax advisors as to the specific
tax
consequences to them of the merger, including tax return reporting requirements,
and the applicability and effect of federal, state, local and other applicable
tax laws.
In
accordance with accounting principles generally accepted in the United States,
Access will account for the merger as a business combination. Upon the
completion of the merger, Access will record the market value of its common
stock issued (based on an average of the closing prices of Access common stock
for a range of trading days from two days before and after February 21, 2007,
the announcement date) in the merger, the fair value of Somanta’s debt at the
time of the merger, the fair value of Access warrants issued in exchange for
warrants to purchase shares of Somanta common stock outstanding at the effective
time of the merger and the amount of direct transaction costs associated with
the merger, as the purchase price of acquiring Somanta. Access will allocate
the
purchase price to the tangible and identifiable intangible assets acquired
and
liabilities assumed based on their respective fair values at the effective
time
of the merger. Any excess of the purchase price over the fair value of net
assets acquired will be accounted for as goodwill.
In
accordance with the Statement of Financial Accounting Standards No. 142,
“Goodwill and Other Intangible Assets,” goodwill resulting from the business
combination will not be amortized but instead will be tested for impairment
at
least annually (more frequently if certain indicators are present). In the
event
that Access management determines that the value of goodwill has become
impaired, the combined company will incur an accounting charge for the amount
of
impairment during the fiscal quarter in which the determination is made.
There
are
no antitrust laws that would apply to the proposed transaction.
Dissenters’
or Appraisal Rights
Holders
of shares of Somanta common and preferred stock who do not vote in favor of
approval and adoption of the merger agreement and approval of the merger and
who
properly demand appraisal of their shares will be entitled to appraisal rights
in connection with the merger under Section 262 of the DGCL. Under the DGCL,
holders of shares of Access common stock are not entitled to appraisal rights
in
connection with the merger.
The
following discussion is not a complete statement of the law pertaining to
appraisal rights under the DGCL and is qualified in its entirety by the full
text of Section 262 which is attached to this proxy statement/prospectus as
Annex C. The following summary does not constitute any legal or other advice
nor
does it constitute a recommendation that stockholders exercise their appraisal
rights under Section 262. All references in Section 262 and in this summary
to a
“stockholder” are to the record holder of the shares of Somanta common and
preferred stock as to which appraisal rights are asserted. A person having
a
beneficial interest in shares of Somanta common and preferred stock held of
record in the name of another person, such as a broker, fiduciary, depositary
or
other nominee, must act promptly to cause the record holder to follow the steps
summarized below properly and in a timely manner to perfect appraisal rights.
Under
Section 262, persons who hold shares of Somanta common and preferred stock
who
do not vote in favor of approval and adoption of the merger agreement and
approval of the merger and who otherwise follow the procedures set forth in
Section 262 will be entitled to have their shares appraised by the Delaware
Court of Chancery and to receive payment in cash of the “fair value” of the
shares, exclusive of any element of value arising from the accomplishment or
expectation of the merger, together with a fair rate of interest, if any, as
determined by the court.
53
Notice
of Appraisal Rights.
Under
Section 262, where a merger is to be submitted for approval at a meeting of
a
corporation’s stockholders, as in the case of approval and adoption of the
merger agreement and approval of the merger by Somanta’s stockholders, the
corporation, not less than 20 days prior to the meeting, must notify each of
its
stockholders entitled to appraisal rights that appraisal rights are available
and include in the notice a copy of Section 262. This proxy statement/prospectus
shall constitute the notice, and the full text of Section 262 is attached to
this proxy statement/prospectus as Annex B. Any holder of Somanta common and
preferred stock who wishes to exercise appraisal rights, or who wishes to
preserve such holder’s right to do so, should review the following discussion
and Annex B carefully because failure to timely and properly comply with the
procedures specified will result in the loss of appraisal rights. Moreover,
because of the complexity of the procedures for exercising the right to seek
appraisal of shares of common stock, Somanta believes that if a Somanta
stockholder considers exercising such rights, such stockholder should seek
the
advice of legal counsel.
Filing
Written Demand.
Any
Somanta stockholder wishing to exercise appraisal rights must deliver to
Somanta, before the vote on approval and adoption of the merger agreement and
approval of the merger at the Somanta special meeting, a written demand for
the
appraisal of the stockholder’s shares, and that stockholder must not vote in
favor of approval and adoption of the merger agreement and approval of the
merger. A holder of shares of Somanta common stock wishing to exercise appraisal
rights must hold of record the shares on the date the written demand for
appraisal is made and must continue to hold the shares of record through
completion of the merger, since appraisal rights will be lost if the shares
are
transferred prior to completion of the merger. The holder must not vote in
favor
of approval and adoption of the merger agreement and approval of the merger.
A
proxy which is signed and submitted but does not contain voting instructions
will, unless revoked, be voted in favor of approval and adoption of the merger
agreement and approval of the merger, and it will constitute a waiver of the
stockholder’s right of appraisal and will nullify any previously delivered
written demand for appraisal. Therefore, a stockholder who votes by proxy and
who wishes to exercise appraisal rights must vote against approval and adoption
of the merger agreement and approval of the merger or abstain from voting on
the
merger agreement and the merger. Neither voting against approval and adoption
of
the merger agreement and approval of the merger (in person or by proxy), nor
abstaining from voting or failing to vote on the proposal to approve and adopt
the merger agreement and approval of the merger will in and of itself constitute
a written demand for appraisal satisfying the requirements of Section 262.
The
written demand for appraisal must be in addition to and separate from any proxy
or vote. The demand must reasonably inform Somanta of the identity of the holder
as well as the intention of the holder to demand an appraisal of the “fair
value” of the shares held by the holder. A stockholder’s failure to make the
written demand prior to the taking of the vote on approval and adoption of
the
merger agreement and approval of the merger at the Somanta special meeting
will
constitute a waiver of appraisal rights.
Only
a
holder of record of shares of Somanta common stock is entitled to assert
appraisal rights for the shares registered in that holder’s name. A demand for
appraisal in respect of shares of Somanta common stock should be executed by
or
on behalf of the holder of record, fully and correctly, as the holder’s name
appears on the holder’s stock certificates, should specify the holder’s name and
mailing address and the number of shares registered in the holder’s name and
must state that the person intends thereby to demand appraisal of the holder’s
shares in connection with the merger. If the shares are owned of record in
a
fiduciary capacity, such as by a trustee, guardian or custodian, execution
of
the demand should be made in that capacity, and if the shares are owned of
record by more than one person, as in a joint tenancy and tenancy in common,
the
demand should be executed by or on behalf of all joint owners. An authorized
agent, including an agent for two or more joint owners, may execute a single
demand for appraisal on behalf of a holder of record; however, the agent must
identify the record owner or owners and expressly disclose that, in executing
the demand, the agent is acting as agent for the record owner or owners. If
the
shares are held in “street name” by a broker, bank or nominee, the broker, bank
or nominee may exercise appraisal rights with respect to the shares held for
one
or more beneficial owners while not exercising the rights with respect to the
shares held for other beneficial owners; in such case, however, the written
demand should set forth the number of shares as to which appraisal is sought,
and where no number of shares is expressly mentioned, the demand will be
presumed to cover all shares of Somanta common stock held in the name of the
record owner. Stockholders who hold their shares in brokerage accounts or other
nominee forms and who wish to exercise appraisal rights are urged to consult
with their brokers to determine the appropriate procedures for the making of
a
demand for appraisal by such a nominee.
All
written demands for appraisal pursuant to Section 262 should be sent or
delivered to Somanta Pharmaceuticals, Inc., 19200 Von Karman Avenue, Suite
400,
Irvine, California 92612 Attention: Secretary. The method of delivery of the
written demand for appraisal to the address above is the option and risk of
the
stockholder.
54
Withdrawal
of Demand. Any
holder of Somanta common and preferred stock may withdraw his, her or its demand
for appraisal and accept the consideration offered pursuant to the merger
agreement by delivering to the surviving corporation a written withdrawal of
the
demand for appraisal. However, any such attempt to withdraw the demand made
more
than 60 days after the effective date of the merger will require written
approval of the surviving corporation. No appraisal proceeding in the Delaware
Court of Chancery will be dismissed without the approval of the Delaware Court
of Chancery, and such approval may be conditioned upon such terms as the Court
deems just. If the surviving corporation does not approve a request to withdraw
a demand for appraisal when that approval is required, or if the Delaware Court
of Chancery does not approve the dismissal of an appraisal proceeding, the
Somanta stockholder will be entitled to receive only the appraised value
determined in any such appraisal proceeding, which value could be less than,
equal to or more than the consideration being offered pursuant to the merger
agreement.
Notice
by the Surviving Corporation.
Within
ten days after completion of the merger, the surviving corporation must notify
each holder of Somanta common and preferred stock who has made a written demand
for appraisal pursuant to Section 262, and who has not voted in favor of
approval and adoption of the merger agreement and approval of the merger, that
the merger has become effective.
Filing
a Petition for Appraisal.
Within
120 days after completion of the merger, but not thereafter, the surviving
corporation or any holder of Somanta common stock who has complied with Section
262 and is entitled to appraisal rights may file a petition in the Delaware
Court of Chancery demanding a determination of the fair value of the shares
held
by all dissenting holders. The surviving corporation is under no obligation
to
and has no present intention to file such a petition and holders should not
assume that the surviving corporation will file a petition. Accordingly, it
is
the obligation of the holders of Somanta common stock to initiate all necessary
action to perfect their appraisal rights in respect of shares of Somanta common
stock within the time prescribed in Section 262. Within 120 days after
completion of the merger, any holder of Somanta common stock who has complied
with the requirements for exercise of appraisal rights will be entitled, upon
written request, to receive from the surviving corporation a statement setting
forth the aggregate number of shares not voted in favor of approval and adoption
of the merger agreement and approval of the merger and with respect to which
demands for appraisal have been received and the aggregate number of holders
of
such shares. The statement must be mailed within ten days after a written
request therefore has been received by the surviving corporation or within
ten
days after the expiration of the period for delivery of demands for appraisal,
whichever is later.
Under
the
merger agreement, Somanta has agreed to provide Access notice of any demands
for
appraisal received by it. Access will have the right to participate in and
direct all negotiations and proceedings with respect to demands for appraisal
under Section 262 of the DGCL. Somanta will not voluntarily make any payments
with respect to, or settle or offer to settle, any demand for appraisal without
the prior written consent of Access. If a petition for an appraisal is timely
filed by a holder of shares of Somanta common stock and a copy thereof is served
upon the surviving corporation, the surviving corporation will then be obligated
within 20 days to file with the Delaware Register in Chancery a duly verified
list containing the names and addresses of all stockholders who have demanded
an
appraisal of their shares and with whom agreements as to the value of their
shares have not been reached. After notice to the stockholders as required
by
the court, the Delaware Court of Chancery is empowered to conduct a hearing
on
the petition to determine those stockholders who have complied with
Section 262 and who have become entitled to appraisal rights thereunder.
The Delaware Court of Chancery may require the stockholders who demanded payment
for their shares to submit their stock certificates to the Register in Chancery
for notation thereon of the pendency of the appraisal proceeding; and if any
stockholder fails to comply with the direction, the Court of Chancery may
dismiss the proceedings as to the stockholder.
Determination
of Fair Value.
After
determining the holders of Somanta common and preferred stock entitled to
appraisal, the Delaware Court of Chancery will appraise the “fair value” of
their shares, exclusive of any element of value arising from the accomplishment
or expectation of the merger, together with a fair rate of interest, if any,
to
be paid upon the amount determined to be the fair value. In determining fair
value and, if applicable, a fair rate of interest, the Court of Chancery of
Delaware will take into account all relevant factors. In Weinberger
v. UOP,
Inc.,
the
Supreme Court of Delaware discussed the factors that could be considered in
determining fair value in an appraisal proceeding, stating that “proof of value
by any techniques or methods that are generally considered acceptable in the
financial community and otherwise admissible in court” should be considered, and
that “fair price obviously requires consideration of all relevant factors
involving the value of a company.” The Delaware Supreme Court stated that, in
making this determination of fair value, the court must consider market value,
asset value, dividends, earnings prospects, the nature of the enterprise and
any
other facts that could be ascertained as of the date of the merger that throw
any light on future prospects of the merged corporation. Section 262 provides
that fair value is to be “exclusive of any element of value arising from the
accomplishment or expectation of the merger.” In Cede
& Co. v. Technicolor, Inc.,
the
Delaware Supreme Court stated that this exclusion is a “narrow exclusion [that]
does not encompass known elements of value,” but which rather applies only to
the speculative elements of value arising from such accomplishment or
expectation. In Weinberger,
the
Supreme Court of Delaware also stated that “elements of future value, including
the nature of the enterprise, which are known or susceptible of proof as of
the
date of the merger and not the product of speculation, may be considered.”
55
Stockholders
considering seeking appraisal should be aware that the fair value of their
shares as so determined could be more than, the same as or less than the merger
consideration they would receive pursuant to the merger if they did not seek
appraisal of their shares. Although Somanta believes that the merger
consideration is fair, no representation is made as to the outcome of the
appraisal of fair value as determined by the Delaware Court of Chancery, and
stockholders should recognize that such an appraisal could result in a
determination of a value higher or lower than, or the same as, the merger
consideration. Neither Somanta nor Access anticipate offering more than the
applicable merger consideration to any Somanta stockholder exercising appraisal
rights, and reserve the right to assert, in any appraisal proceeding, that
for
purposes of Section 262, the “fair value” of a share of Somanta common stock is
less than the applicable merger consideration, and that the methods which are
generally considered acceptable in the financial community and otherwise
admissible in court should be considered in the appraisal proceedings. In
addition, Delaware courts have decided that the statutory appraisal remedy,
depending on factual circumstances, may or may not be a dissenter’s exclusive
remedy. The Delaware Court of Chancery will also determine the amount of
interest, if any, to be paid upon the amounts to be received by persons whose
shares of Somanta common stock have been appraised. If a petition for appraisal
is not timely filed, then the right to an appraisal will cease. The costs of
the
action may be determined by the Court and taxed upon the parties as the Court
deems equitable under the circumstances. The Court may also order that all
or a
portion of the expenses incurred by a stockholder in connection with an
appraisal, including, without limitation, reasonable attorneys’ fees and the
fees and expenses of experts utilized in the appraisal proceeding, be charged
pro rata against the value of all the shares entitled to be appraised.
If
any
stockholder who demands appraisal of shares of Somanta common stock under
Section 262 fails to perfect, or successfully withdraws or loses, his or her
right to appraisal, the stockholder’s shares of Somanta common stock will be
deemed to have been converted upon completion of the merger into the right
to
receive the merger consideration under the merger agreement. A stockholder
will
fail to perfect, or effectively lose or withdraw, the holder’s right to
appraisal if no petition for appraisal is filed within 120 days after completion
of the merger or if the stockholder delivers to the surviving corporation a
written withdrawal of the holder’s demand for appraisal and an acceptance of the
merger, in accordance with Section 262.
From
and
after completion of the merger, no dissenting stockholder shall have any rights
of a Somanta stockholder with respect to that holder’s shares for any purpose,
except to receive payment of fair value and to receive payment of dividends
or
other distributions on the holder’s shares of Somanta common stock, if any,
payable to Somanta stockholders of record as of a time prior to completion
of
the merger; provided, however, that if a dissenting stockholder delivers to
the
surviving company a written withdrawal of the demand for an appraisal within
60
days after completion of the merger or subsequently with the written approval
of
the surviving company, or, if no petition for appraisal is filed within 120
days
after completion of the merger, then the right of that dissenting stockholder
to
an appraisal will cease and the dissenting stockholder will be entitled to
receive only the merger consideration. Once a petition for appraisal is filed
with the Delaware court, the appraisal proceeding may not be dismissed as to
any
Somanta stockholder without the approval of the court.
Failure
to comply strictly with all of the procedures set forth in Section 262 of the
DGCL will result in the loss of a stockholder’s statutory appraisal rights.
Consequently, any stockholder wishing to exercise appraisal rights is urged
to
consult legal counsel before attempting to exercise those rights.
Closing
Condition. Under
the
terms of the merger agreement, Access and Somanta Acquisition Corp. shall not
be
obligated to complete the merger if, during any applicable period during which
stockholders of Somanta have the right to exercise appraisal, dissenters’ or
other similar rights under Section 262 of Delaware General Corporate Law or
other applicable law, stockholders of Somanta holding in aggregate more than
five percent (5%) of the outstanding shares of Somanta Common Stock or
Somanta Preferred Stock shall not have exercised appraisal, dissenters’ or
similar rights under Section 262 of Delaware General Corporate Law or other
applicable law with respect to such shares by virtue of the Merger.
The
shares of Access common stock to be issued in connection with the merger will
be
registered under the Securities Act of 1933, as amended, which is referred
to as
the Securities Act of 1933, and will be freely transferable, except for shares
of Access common stock issued to any person who is deemed to be an “affiliate”
of Somanta prior to the merger. Persons who may be deemed to be “affiliates” of
Somanta prior to the merger include individuals or entities that control, are
controlled by, or are under common control of Somanta prior to the merger,
and
may include officers and directors, as well as principal stockholders of Somanta
prior to the merger.
56
Persons
who may be deemed to be affiliates of Somanta prior to the merger may not sell
any of the shares of Access common stock received by them in connection with
the
merger except pursuant to:
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an
effective registration statement under the Securities Act of 1933
covering
the resale of those shares;
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an
exemption under paragraph (d) of Rule 145 under the Securities Act
of
1933; or
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•
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any
other applicable exemption under the Securities Act of 1933.
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In
considering the recommendation of the Somanta board of directors that Somanta
stockholders vote in favor of approval and adoption of the merger agreement
and
the merger contemplated by the merger agreement, Somanta stockholders should
be
aware that some Somanta executive officers, directors and affiliates may have
interests in the merger that may be different from, or in addition to, their
interests as stockholders of Somanta.
These
interests relate to or arise from, among other things:
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the
continued indemnification of, and provision of directors’ and officers’
insurance coverage to, current directors and officers of Somanta
following
the merger;
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the
employment of certain executive officers of Somanta by Access upon
completion of the merger;
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•
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the
potential receipt of severance payments by executive officers; and
the
ownership of substantial equity interests in both Somanta and
Access:
•
SCO
Capital Partners
LLC, and its affiliates, are represented on the Somanta Board of
Directors
and collectively control 44.52% of Somanta’s common stock and 55.6% of the
Somanta’s outstanding preferred stock or 48.82% of Somanta’s outstanding
voting securities on an as-converted basis. SCO Capital Partners
is
represented on the Access’ Board of Directors and collectively controls
convertible notes and warrants which if converted and exercised would
represent 74.1% of Access’s common stock.;
• Lake
End Capital
LLC, and its affiliates, are represented on the Somanta board of
directors
and collectively control 5.09% of Somanta’s common stock and 4.23% of
Somanta’s outstanding preferred stock, or 4.76% of Somanta’s outstanding
voting securities on an as-converted basis; and
•
Walbrook
Trustees
(Jersey Ltd REK33), of which Agamemnon A Epenetos, Somanta’s President and
Chief Executive Officer, is a beneficiary, is the beneficial owner
of
25.03% of Somanta’s common stock.
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Indemnification;
Directors’ and Officers’ Insurance
Access
agreed that, for a period of six years following completion of the merger,
the
indemnification obligations set forth in Somanta’s certificate of incorporation
and bylaws and any Somanta indemnification agreements will survive.
In
addition, for a period of six years from the completion of the merger, Access
will cause Somanta’s existing policy of directors’ and officers’ liability
insurance to be maintained, subject to certain limitations.
Employment
of Somanta Executive Officers by Access after the Merger
Prior
to
executing the merger agreement, Access and Somanta reached an informal
understanding that Agamemnon Epenetos would continue as an executive officer
of
the combined company following the merger, although no discussions occurred
at
that time regarding the terms and conditions of Dr. Epenetos’ employment.
Currently, however, Access anticipates that Dr. Epenetos will serve as an
executive officer of the combined company, and that Dr. Epenetos will execute
an
Access standard form employment agreement and at his current annual salary
of
$275,000.
Somanta
has from time to time entered into change of control severance agreements with
each of its executive officers, Agamemnon A. Epenetos and Terrance J. Bruggeman.
Each of the executive officers is subject to an agreement with substantially
similar terms and conditions that provide each executive officer with certain
severance payments if he is terminated without “cause,” as defined in the
applicable agreement, or terminates due to an “involuntary termination,” as
defined in the applicable agreement, at any time following a change of control,
which includes the completion of the merger. These benefits include payment
of a
lump sum amount equal to:
| Name |
Total
Severance
Payments
|
|||
| Agamemnon A. Epenetos, MD, PhD | $ |
275,000
|
||
| Terrance J. Bruggeman | 248,000 | |||
Legal
Proceedings Regarding the Merger
There
are
no legal proceedings regarding the merger.
57
THE
MERGER AGREEMENT
The
following summary describes the material provisions of the merger agreement.
The
provisions of the merger agreement are complicated and not easily summarized.
This summary may not contain all of the information about the merger agreement
that is important to you. The merger agreement is attached to this proxy
statement/prospectus as Annex A and is incorporated by reference into this
proxy
statement/prospectus, and we encourage you to read it carefully in its entirety
for a more complete understanding of the merger agreement.
The
merger agreement provides for the merger of Somanta Acquisition Corporation,
a
newly formed, wholly owned subsidiary of Access, with Somanta. Somanta will
survive the merger as a wholly owned subsidiary of Access.
We
will
complete the merger when all of the conditions to completion of the merger
contained in the merger agreement, which are described in the section entitled
“Conditions to Obligations to Complete the Merger” beginning on page 65, are
satisfied or waived, including the issuance of shares of Access common stock
in
the merger and approval and adoption of the merger agreement and approval of
the
merger contemplated by the merger agreement by the Somanta stockholders. The
merger will become effective upon the filing of a certificate of merger with
the
Secretary of State of the State of Delaware.
We
are
working to complete the merger as quickly as possible. Because completion of
the
merger is subject to certain conditions that are beyond our control, we cannot
predict the exact timing, although absent any unanticipated delay, we expect
to
close the merger during the third quarter of 2007 and within two business
days of obtaining the required Somanta stockholder approvals.
If
the
proposed merger is completed, the holders of Somanta’s common stock are expected
to receive approximately 0.032343 of a share of Access common stock for each
share of Somanta common stock they own immediately prior to completion of the
merger, not
to
exceed in the aggregate 500,000 shares of Access common stock, and the holders
of Somanta’s preferred stock, including their accrued and unpaid dividends are,
expected to receive approximately 1690.24045 shares of Access common stock
for
each share of Somanta preferred stock they own immediately prior to completion
of the merger, not to exceed in the aggregate 1,000,000 shares of Access common
stock.
The
number of shares of Access common stock to be received by holders of Somanta's
common stock and/or preferred stock will be adjusted if the number of
outstanding Somanta common stock and/or preferred stock changes prior to the
effective time of the merger because the aggregate number of shares of Access
common stock to be issued in the merger will not change. In
addition, a total of approximately 192,000 shares of Access common stock will
be
reserved for issuance upon the exercise of the outstanding 5,936,304 warrants
to
purchase Somanta common stock assumed by Access in connection with the merger.
Warrants to purchase 1,166,534 shares of common stock of Somanta which are
held
by SCO Capital Partners LLC and SCO Financial Group LLC are expected to be
exercised prior to the closing of the merger and are more fully described below
under “Treatment of Somanta Warrants” beginning on page 59.
The
exchange ratios in the merger will be adjusted to reflect the effect of any
stock split, reverse stock split, reclassification, stock dividend,
reorganization, recapitalization, consolidation, exchange or other like change
with respect to Access common stock or Somanta common stock occurring or having
a record date after the date of the merger agreement and prior to the effective
time of the merger.
After
the
merger, Access stockholders will continue to own their existing shares of Access
common stock. Accordingly, Access stockholders will hold the same number of
shares of Access common stock that they held immediately prior to the merger.
However, because Access will be issuing new shares of Access common stock to
Somanta stockholders in the merger, each outstanding share of Access common
stock immediately prior to the merger will represent a smaller percentage of
the
total number of shares of Access common stock outstanding after the merger.
Based on the number of shares of Access and Somanta common stock and preferred
stock outstanding on the Somanta record date, we expect that Access stockholders
before the merger will hold approximately 87% of the fully diluted shares of
Access common stock immediately after the merger.
In
accordance with the Certificate of Designation of Somanta’s Series A preferred
stock, holders of a majority of the Series A preferred stock of Somanta have
acknowledged and agreed that, if the stockholders of Somanta approve the Merger
Agreement and the transactions contemplated thereby, then each share of Somanta
Series A preferred stock will be exchanged for common stock of Access and the
rights, preferences and privileges associated with such Series A preferred
stock
will cease to exist as of the closing of the Merger. For a full description
of a
comparison of the rights of the Access common stock to the rights of the Somanta
common stock and Somanta Series A preferred stock, see “Comparison of
Stockholder Rights and Corporate Governance Matters” beginning on page
197.
58
Access
will not issue any fractional shares of common stock in connection with the
merger. Instead, each holder of Somanta common stock or preferred stock who
would otherwise be entitled to receive a fraction of a share of Access common
stock will receive cash, without interest, in an amount equal to the fraction
multiplied by the average closing price of Access common stock (determined
after
aggregating all of the Somanta common stock or preferred stock held by each
such
holder and multiplying such shares by the stock exchange ratio), as reported
on
the OTC Bulletin Board, for the ten (10) trading days immediately preceding
the
closing date of the merger.
When
the
merger is completed, Access will assume each outstanding warrant to purchase
shares of Somanta common stock and convert them into warrants to purchase shares
of Access common stock. As of the Somanta record date, warrants for
approximately 5,936,304 shares of Somanta common stock were outstanding in
the
aggregate which shall become warrants to purchase approximately 192,000 shares
of common stock of Access with exercise prices ranging from $18.55 to $23.19.
Treatment
of Somanta Options
Access
will not assume, or provide a substitute option, for any of Somanta’s
outstanding stock options. As a result, pursuant to the terms of Section 11.3(d)
of the Equity Incentive Plan, Somanta’s Board of Directors resolved to: (i)
allow the accelerated vesting of all of the options granted, and (ii) allow
for
the exercise of the outstanding options, in whole or in part, until the close
of
business on Thursday, May 31, 2007. A failure to validly exercise the
options prior to the close of business on May 31, 2007 meant that,
after such time, any unexercised options have expired and are no
longer exercisable in whole or in part.
Upon
completion of the merger, Access will establish an exchange fund with American
Stock Transfer & Trust Company, the exchange agent for the merger, to hold
the stock and cash to be issued in lieu of fractional shares of Access common
stock to be paid to Somanta stockholders (other than holders demanding appraisal
of their shares of Somanta common stock) in connection with the merger. The
exchange fund will consist of stock certificates representing shares of Access
common stock, and cash to be issued in lieu of fractional shares of Access
common stock, after the completion of the merger. Access may withhold any
tax amounts as required by law.
As
soon
as reasonably practicable following completion of the merger, American Stock
Transfer & Trust Company will mail to each record holder of Somanta common
stock and preferred stock a letter of transmittal and instructions for
surrendering the record holder’s stock certificates in exchange for the
certificate representing the shares of Access common stock issuable to each
such
holder pursuant to the merger. Only those holders of Somanta common stock or
preferred stock who properly surrender their Somanta stock certificates in
accordance with the exchange agent’s instructions will receive (1) a certificate
representing the shares of Access common stock issuable to each such holder
pursuant to the merger and (2) cash in lieu of any fractional share of Access
common stock issuable to any such holders. The surrendered certificates
representing Somanta common stock or preferred stock will be canceled. After
the
effective time of the merger, each certificate representing shares of Somanta
common stock or preferred stock that has not been surrendered will represent
only the right to receive shares of Access common stock issuable pursuant to
the
merger and cash in lieu of any fractional share of Access common stock to which
the holder of any such certificate is entitled. Somanta stockholders who hold
their shares in book entry will receive instructions for the exchange of their
shares for the merger consideration included in the transmittal forms sent
to
them by the exchange agent. Following the completion of the merger, Somanta
will
not register any transfers of Somanta common stock on its stock transfer books.
Holders
of Somanta common stock or preferred stock should not send in their Somanta
stock certificates until they receive a letter of transmittal from American
Stock Transfer & Trust Company with instructions for the surrender of
Somanta stock certificates.
59
Unexchanged
holders of Somanta common stock and preferred stock are not entitled to receive
any dividends or other distributions on Access common stock for which the
record date is after the merger is completed. After the merger is
completed, holders of Somanta common stock or preferred stock will be entitled
to dividends and other distributions declared or made after completion of the
merger with respect to the number of whole shares of Access common stock which
they are entitled to receive upon exchange of their Somanta common stock or
preferred stock. These holders will not be entitled to receive these dividends
or distributions, however, until they surrender their Somanta common stock
or
preferred stock to the exchange agent in accordance with the exchange agent
instructions.
At
any
time following the first six (6) months of the completion of the merger, Access
will be entitled to the return of all cash and shares of Access common stock
held in the exchange fund. Thereafter, Somanta stockholders may look only to
Access for any merger consideration and any cash payment relating to any
dividends or distributions to which they may be entitled upon surrender of
their
certificates representing shares of Somanta common stock or preferred stock.
Neither
Access, Somanta Acquisition Corporation nor Somanta will be liable to any holder
of Somanta common stock or preferred stock or Access common stock, as the case
may be, for any shares (or any related dividends or distributions) delivered
to
a public official under any applicable abandoned property, escheat or similar
law following the passage of time specified therein.
Access
will issue only (1) Access common stock and (2) cash in lieu of a fractional
share that may be applicable in a name other than the name in which a
surrendered Somanta stock certificate is registered if the person requesting
the
exchange presents to the exchange agent all documents required to show and
effect the unrecorded transfer of ownership and to show that the requesting
person paid any applicable stock transfer taxes. If a Somanta stock certificate
is lost, stolen or destroyed, the holder of the certificate may need to deliver
an affidavit and an indemnity bond prior to receiving any merger consideration.
Representations
and Warranties
The
merger agreement contains general representations and warranties made by each
of
Access and Somanta Acquisition Corporation on the one hand, and Somanta, Somanta
Incorporated, its wholly owned Delaware subsidiary and Somanta Limited, Somanta
Incorporated’s wholly owned United Kingdom subsidiary on the other, regarding
aspects of their respective businesses, financial condition and structure,
as
well as other facts pertinent to the merger. These representations and
warranties are subject to materiality, knowledge and other similar
qualifications in many respects, expire at the effective time of the merger
and
relate to the following subject matters:
|
|
•
|
|
corporate
organization, qualifications to do business, corporate standing and
corporate power;
|
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•
|
|
absence
of any breach of each party’s certificate of incorporation and bylaws and
the certificates of incorporation, bylaws and similar organizational
documents of its subsidiaries;
|
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•
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|
capitalization;
|
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•
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|
corporate
authorization, including board approval, to enter into and carry
out the
obligations contained in the merger agreement;
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•
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enforceability
of the merger agreement;
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•
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the
vote of Somanta stockholders required to complete the merger;
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•
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|
governmental
and regulatory approvals required in connection with the merger;
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•
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absence
of any conflict or violation of the corporate charter and bylaws
and the
charter, bylaws and similar organizational documents of subsidiaries,
any
applicable legal requirements, or any agreements with third parties,
as a
result of entering into and carrying out the obligations contained
in the
merger agreement;
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60
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•
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|
absence
of any rights of first refusal or acquisition or pre-emptive rights
with
respect to capital stock or other assets or properties arising or
resulting from entering into and carrying out the obligations contained
in
the merger agreement;
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•
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|
compliance
with applicable laws, and possession and compliance with all permits
required for the operation of business;
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•
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SEC
filings and the financial statements contained in those filings;
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•
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controls
and procedures for required disclosures of financial and non-financial
information to the SEC;
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•
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absence
of certain changes or events between the date of the last audited
balance
sheet and April 30, 2006;
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•
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absence
of undisclosed liabilities;
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•
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litigation;
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•
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material
contracts and the absence of breaches of material contracts;
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•
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employee
benefit plans and labor relations;
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•
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real
property matters;
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•
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taxes;
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•
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environmental
matters;
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•
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intellectual
property;
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•
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brokers
used in connection with the merger;
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•
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applicability
of Delaware anti-takeover statutes to the merger;
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•
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insurance;
and
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•
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opinion
of financial advisor, in the case of Access.
|
Conduct
of Business before Completion of the Merger
Under
the
merger agreement, each Somanta and its subsidiaries have agreed that, until
the
earlier of the completion of the merger or termination of the merger agreement,
or unless Access consents in writing, it will carry on its business in the
ordinary course consistent with past practices and in material compliance with
applicable law, and will use commercially reasonable efforts to:
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•
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preserve
intact its present business organization;
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•
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keep
available the services of its current officers, employees and consultants;
and
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•
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preserve
its relationships with customers, suppliers, distributors and others
with
which it has significant business relations.
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61
Under
the
merger agreement, Somanta has agreed that, until the earlier of the completion
of the merger or termination of the merger agreement, or unless Access consents
in writing, it will not (and will not permit its subsidiaries to):
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•
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declare,
set aside or pay any dividends;
|
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•
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authorize
for issuance, issue, deliver, sell pledge or otherwise encumber any
shares
of its capital stock, or any other securities or equity equivalents,
other
than the issuance of Somanta common stock on the exercise of Somanta
stock
options, the exercise of the Somanta warrants or the conversion of
Somanta
preferred stock;
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•
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amend
the Certificate of Incorporation, By-Laws or other comparable charter
or
organizational documents;
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•
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|
acquire
or agree to acquire or merging or consolidating with any business
or any
corporation, partnership joint venture, association or other business
organization;
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•
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|
sell,
lease, license, mortgage or otherwise encumber or subject to any
lien or
otherwise dispose of any assets or properties other than in the ordinary
course of business;
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•
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|
incur
or guarantee any indebtedness or make any loans, advances or capital
contributions to, or investments in, any other person or
entity;
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•
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acquire
or agree to acquire any assets other than inventory in the ordinary
course
of business;
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•
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|
pay,
discharge or satisfy any claims, liabilities or obligations other
than
those arising in the ordinary course of
business;
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•
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waive,
release, grant or transfer any rights of material value other than
as set
for in the Company Disclosure Schedules to the merger
agreement;
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•
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adopt
a plan of complete or partial liquidation or dissolution, merger,
consolidation, restructuring, recapitalization or
reorganization;
|
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•
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|
enter
into or amend any collective bargaining
agreement;
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•
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change
any material accounting principle;
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•
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settle
or compromise any litigation
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•
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engage
in any transaction or enter into any agreement with any of Somanta’s
affiliates;
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•
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transfer
any rights to its intellectual
property;
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•
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enter
into or amend any agreement to which any other party is granted exclusive
rights to any product or
technology;
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•
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make
any material tax election or settle or compromise any material tax
liability;
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•
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adopt
or amend any bonus, profit sharing, compensation, stock option, employment
or other employment benefit plan or
agreement;
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•
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grant
any new or modify any severance or termination
arrangement;
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•
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|
effectuate
a “plant closing” or “mass layoff,” as those terms are defined in
WARN;
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•
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intentionally
take or cause to be taken any action not otherwise consistent with
the
transactions contemplated by this merger, which could reasonably
be
expected to prevent the merger from qualifying as a “reorganization”
within the meaning of Section 368(a) of the Code; and
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•
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take
any actions that could reasonably be expected to result in any of
its
representations and warranties set for in the Merger Agreement being
or
becoming untrue in any material
respect.
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62
Somanta
Prohibited from Soliciting Other Offers
Under
the
terms of the merger agreement, subject to certain exceptions described below,
Somanta agreed that it will not, directly or indirectly:
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•
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solicit,
initiate or take any action knowingly to facilitate the submission
of
inquiries, proposals or offers from any person (other than Access
or
Somanta Acquisition Corporation) relating to an acquisition proposal;
or
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•
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enter
into or participate in any discussions or negotiations regarding
any
acquisition proposal, or furnish to any other person any information
with
respect to its business, properties or assets or any acquisition
proposal,
or otherwise cooperate in any way with, or knowingly assist or
participate
in, facilitate or encourage, any effort or attempt by any other
person
(other than Access or Somanta Acquisition Corporation) to do or
seek any
acquisition proposal.
|
In
addition, Somanta agreed that it will not authorize or permit any of its
subsidiaries, directors, officers, employees, agents or representatives
(including any retained investment banker, attorney or accountant), to do any
of
the foregoing.
For
purposes of the restrictions described above, an acquisition proposal is any
inquiry, proposal or offer, filing of any regulatory application or disclosure
of any intention relating to any of the following:
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•
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the
direct or indirect acquisition by any person or group of equity securities
representing 33.3% or more of the consolidated assets or any class
of
equity securities of Somanta and/or its subsidiaries;
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•
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a
tender offer or exchange offer that would result in any person owning
33.3% or more of any class of equity securities of Somanta or any
of its
subsidiaries;
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•
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|
any
merger, consolidation, business combination or similar transaction
involving Somanta or any of its subsidiaries whose assets, individually
or
in the aggregate, constitute more than 33.3% of Somanta's consolidated
assets, other than transactions specifically permitted under the
merger
agreement; or
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•
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any
transaction, the consummation of which would or could reasonably
be
expected to impede, interfere with, prevent or materially delay
the
merger.
|
Under
the
merger agreement, Somanta also agreed, and agreed to cause their subsidiaries,
affiliates, directors, officers, employees, agents and representatives
(including any retained investment banker, attorney or accountant), to:
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•
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cease
all existing activities or negotiations with respect to any acquisition
proposal; and
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•
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not
release any third party from, or waive any provisions of, any existing
confidentiality or standstill agreement with respect to any acquisition
proposal.
|
Notwithstanding
the prohibitions described above, Somanta may (either directly or indirectly
through advisors, agents or other intermediaries):
|
·
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furnish
information, pursuant to an appropriate confidentiality letter
(a copy of
which is required to be provided to Access), concerning Somanta
and its
businesses, properties or assets to a third party who has made
a bona fide
transaction proposal;
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·
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engage
in discussions or negotiations with a third party who has made
a bona fide
transaction proposal;
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·
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following
receipt of a bona fide transaction proposal, make disclosure to
its
stockholders;
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|
·
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following
receipt of a bona fide transaction proposal, fail to make or withdraw
or
modify the recommendation of its board of directors;
and/or
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·
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take
any action required to be taken by Somanta pursuant to a non-appealable,
final order by any court of competent
jurisdiction.
|
The
actions referred to above may be taken only to the extent that the board
of
directors of Somanta shall have concluded in good faith on the basis of advice
from outside counsel that such action is required in order to satisfy its
fiduciary duties to the stockholders of Somanta under applicable law and
not
until after prompt advance notice to Access with respect to such
action. The Somanta board of directors is required to continue to
advise Access after taking such action, including disclosing the terms and
conditions of the acquisition proposal and the identity of the person making
it.
63
The
board
of directors of Somanta, at a meeting duly called and held, has by unanimous
vote of those directors present approved the merger agreement and the merger
and
resolved to recommend that the holders of shares of Somanta's capital stock
approve the merger agreement and the merger.
In
the
merger agreement, Somanta has agreed to call, give notice of, convene and
hold a
meeting of its stockholders for the purpose of approving the merger agreement
and the transactions contemplated by the merger agreement to the extent
required
by Delaware law as soon as practicable after this registration statement
is
declared effective through the use of its reasonable best
efforts. Somanta’s board of directors has agreed to recommend to its
stockholders approval of the merger. Under the terms of the merger
agreement, the board of directors of Somanta may fail to make or withdraw
or
modify its recommendation, but only to the extent the board of directors
of
Somanta conclude in good faith on the basis of advice from outside counsel
that
such action is required in order to satisfy its fiduciary duties to the
stockholders of Somanta under applicable law.
The
merger is not subject to antitrust laws.
Neither
Access nor Somanta will issue any press release or make any public statement
with respect to the merger agreement or the merger without the prior written
consent of the other party, which consent shall not be unreasonably withheld.
However, Access and Somanta may, without the prior consent of the other, issue
a
press release or make a public statement relating to the merger agreement or
the
merger if, after consulting with outside counsel, it determines that the press
release or public statement is required by applicable law or the rules and
regulations of the OTC Bulletin Board, and it has consulted with the other
party
prior to the issue of such press release or public statement.
64
Under
the
terms of the merger agreement, Access agreed, for six years from completion
of
the merger, to honor all obligations of Somanta contained in any
indemnification agreement in effect prior to completion of the merger between
Somanta or its subsidiaries and any of its current or former directors or
officers. Access and its subsidiaries will cause the certificate of
incorporation and bylaws of the surviving corporation in the merger to contain
provisions with respect to indemnification and exculpation that are at least
as
favorable as the indemnification and exculpation provisions contained in the
certificate of incorporation or bylaws or similar organizational documents
of
Somanta and its subsidiaries in effect prior to completion of the merger, and
Access and its subsidiaries will not amend, repeal or otherwise modify the
documents in any respect, except as required by law.
For
six
years from completion of the merger, Access also agreed to purchase and maintain
a tail policy of Somanta’s directors’ and officers’ liability insurance covering
claims arising from facts or events that occurred prior to the completion of
the
merger, including acts or omissions occurring in connection with the merger
agreement and completion of the merger to the extent such acts or omissions
are
covered by the existing insurance policy, and covering each director and officer
of Somanta who was covered at the effective time of the merger on terms with
respect to coverage and amounts no less favorable than those in effect prior
to
the signing of the merger agreement.
Access
Board of Directors after the Merger
Upon
completion of the merger, the directors of Access prior to the completion of
the
merger will continue to serve as the directors of Access.
Under
the
terms of the merger agreement, each of Access and Somanta has agreed to
cooperate fully with the other and use its reasonable best efforts to take
all
actions, and to do all things necessary, proper or advisable to complete the
merger in the most expeditious manner possible, including:
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obtaining
all consents, approvals, waivers, licenses, permits or authorizations
as
are required to be obtained in connection with the merger;
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•
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defending
any lawsuit or proceeding seeking to challenge the merger agreement
or the
merger contemplated by the merger agreement;
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•
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accepting
and delivering any additional instruments necessary to consummate
the
merger;
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•
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in
the case of Somanta, delivering proper notice to its stockholders
in
accordance with Delaware Law of such stockholders’ appraisal rights;
and
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•
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satisfying
the conditions to closing set forth in the merger
agreement.
|
Conditions
to Obligations to Complete the Merger
The
respective obligations of Access and Somanta Acquisition Corporation, on
the one
hand, and Somanta, on the other, to complete the merger and the other
transactions contemplated by the merger agreement are subject to the
satisfaction or waiver of each of the following conditions:
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·
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the
vote of a majority of the outstanding shares of Somanta common
stock
(including, for these purposes, all shares of Somanta common stock
issuable upon conversion of Somanta preferred stock) and a majority
of the outstanding shares of Somanta preferred stock , voting as
a
separate class, for the approval thereof shall have been
obtained;
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|
·
|
the
waiting period (and any extension thereof), if any, applicable
to the
merger under the HSR Act shall have been terminated or shall have
expired;
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·
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no
temporary restraining order, preliminary or permanent injunction
or other
order issued by any court of competent jurisdiction or other legal
restraint or prohibition preventing the consummation of the merger
shall
be in effect; provided, however, that the parties to the merger
agreement
shall use their best efforts to have any such injunction, order,
restraint
or prohibition vacated;
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·
|
this
registration statement shall have become effective under the Securities
Act and shall not be the subject of any stop order or proceedings
seeking
a stop order, and any material "blue sky" and other state securities
laws
applicable to the registration and qualification of Access common
stock
issuable or required to be reserved for issuance pursuant to the
merger
agreement shall have been complied
with;
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·
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other
than the filing of the certificate of merger, all authorizations,
consents, orders or approvals of, or declarations or filings
with, or
expirations of waiting periods imposed by, any governmental
entity in
connection with the merger and the consummation of the other
transactions
contemplated by the merger agreement, the failure of which
to file, obtain
or occur is reasonably likely to have a material adverse effect
with
respect to Access or Somanta, shall have been filed, been obtained
or
occurred on terms and conditions which would not reasonably
be likely to
have a material adverse effect with respect to Access or
Somanta;
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·
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No
stop order suspending the use of the proxy statement relating
to Somanta
stockholder approval shall have been issued and no proceeding
for that
purpose shall have been initiated or threatened in writing
by the SEC or
its staff; and
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·
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Access
and Somanta shall have executed and delivered a mutually agreeable
flow of
funds memorandum setting forth certain payments to be made
by Access
concurrently with the closing.
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65
The
obligations of Access and Somanta Acquisition Corporation to effect the merger
and the other transactions contemplated by the merger agreement are subject
to
the satisfaction or waiver of the following additional conditions:
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·
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the
representations and warranties of Somanta set forth in the merger
agreement shall be true and correct in each case as of the date
of the
merger agreement and (except to the extent such representations
and
warranties speak as of an earlier date) as of the merger closing date
as though made on and as of the merger closing date, except where
the
failure of such representations and warranties to be so true
and correct
(without giving effect to any limitation as to "materiality"
or "material
adverse effect" set forth therein) would not individually or in the
aggregate have a material adverse effect. Access shall have received
a
certificate dated as of the merger closing date signed on behalf
of
Somanta by the chief executive officer and the chief financial
officer of
Somanta to such effect;
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·
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Somanta
shall have performed in all material respects all obligations
required to
be performed by it under the merger agreement at or prior to
the merger
closing date. Access shall have received a certificate signed
on behalf of
Somanta by the chief executive officer and the chief financial
officer of
Somanta to such effect;
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·
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Access
and Somanta Acquisition Corporation shall have received evidence,
in form
and substance reasonably satisfactory to Access, that such licenses,
permits, consents, approvals, authorizations, qualifications,
and orders
of governmental authorities and other third parties as are necessary
(in
Access' sole discretion) in connection with the transactions
contemplated hereby have been obtained, except where the failure
to obtain
such licenses, permits, consents, approvals, authorizations,
qualifications, and orders would not, individually or in the
aggregate
with all other failures, have a material adverse effect with
respect to
Somanta;
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·
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there
shall not be pending by any governmental entity or any other
person or
solely with respect to any governmental entity, threatened
by any suit,
action, or proceeding, (i) challenging or seeking to restrain or
prohibit the consummation of the merger or any of the other
transactions
contemplated by the merger agreement or seeking to obtain
from any party
hereto or any of their affiliates any damages that are material
in
relation to Somanta and its subsidiaries taken as a whole;
(ii) seeking to prohibit or limit the ownership or operation by
Somanta or any of its subsidiaries of any material portion
of the business
or assets of Somanta and its subsidiaries taken as a whole
or to dispose
of or hold separate any material portion of the business
or assets of
Somanta and its subsidiaries taken as a whole, as a result
of the merger
or any of the other transactions contemplated by the merger
agreement;
(iii) seeking to impose limitations on the ability of Access to
acquire or hold, or exercise full rights of ownership of,
any shares of
the common stock of the surviving corporation, including,
without
limitation, the right to vote such common stock on all matters
properly
presented to the stockholders of the surviving corporation;
or seeking to
prohibit Access or any of its subsidiaries from effectively
controlling in
any material respect the business or operations of Somanta
and its
subsidiaries taken as a
whole;
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·
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Somanta
shall have (i) entered into a termination agreement with each holder
of a Somanta option pursuant to which all outstanding Somanta
options held
by each such holder shall be terminated and each such holder
shall no
rights thereunder to purchase shares of Somanta common stock
or
(ii) accelerated the expiration date of all Somanta options to a date
no later than April 30, 2007 and required each such holder to
exercise all
such Somanta options held by such holder (including, if Somanta
so elects
in accordance thereunder, to accelerate the vesting of such Somanta
options) by such date;
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·
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counsel
to Somanta, shall have delivered to Access a written legal opinion
addressed to Access, dated on and as of the merger closing date,
and in
form reasonably satisfactory to
Access;
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·
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the
directors and officers of Somanta, in office immediately prior
to the
effective time of the merger shall have resigned as directors
and officers
of the surviving corporation effective as of the effective time
of the
merger;
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·
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Somanta
and each other party thereto shall have terminated certain agreements
set
forth on a schedule attached to the merger agreement. SCO
Partners LLC and its affiliates shall have executed and delivered
to
Somanta a waiver, in form satisfactory to Access, of any rights
to
(i) require Somanta to register for resale under the Securities Act
any securities of Somanta held by such persons, (ii) liquidated or
other damages in respect of any failure by Somanta to timely
satisfy any
such obligation or (iii) any fees resulting from the merger or any
financing, under any agreement with Access or Somanta. Each
holder of a Somanta warrant to be assumed by Access shall have
executed
and delivered to Access a waiver, in form satisfactory to Access,
of any
rights to require Access to register for resale under the Securities
Act
any such Somanta warrants held by such person or Access common
stock
issuable upon exercise of such Somanta warrants. The employment
agreement between Somanta and Agamemnon A. Epenetos, dated
January 31, 2006 shall have been amended and restated to be in the
form of the standard Access executive employment agreement and
acceptable
to Access;
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·
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any
applicable period during which stockholders of Somanta have the
right to
exercise appraisal, dissenters' or other similar rights under
Section 262
of Delaware Law or other applicable law shall have expired and
stockholders of Somanta holding in the aggregate more than five
percent
(5%) of the outstanding shares of Somanta common stock or Somanta
preferred stock shall not have exercised appraisal, dissenters'
or similar
rights under Section 262 of Delaware General Corporation Law
or other
applicable law with respect to such shares by virtue of the
merger;
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·
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since
the date of the merger agreement, there shall not have occurred
any
material adverse effect with respect to
Somanta;
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·
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Somanta
shall have delivered a properly executed statement, dated as
of the merger
closing date, in a form reasonably acceptable to Access, conforming
to the
requirements of Treasury Regulations Section
1.1445-2(c)(3);
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·
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Access shall
have received evidence, satisfactory to it, that as of the merger
closing
date the amount of Somanta's then outstanding accounts payable
and other
liabilities (including, without limitation, all amounts owed
(i) to
employees, officers and consultants of Somanta (and its
subsidiaries) and (ii) to any person in respect of any failure
by Somanta to timely satisfy any obligation to register for resale
under
the Securities Act any securities of Somanta held by such person)
does not
exceed $1,000,000 in the aggregate;
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·
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Somanta
shall have required certain holders of Somanta warrants to exercise
each
such Somanta warrant held by such holder prior to the merger
closing date,
or such holder and Somanta shall have executed and delivered
a termination
agreement terminating each such Somanta warrant and all of such
holder's
rights thereunder, including any right to purchase shares of
Somanta
common stock;
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·
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Access
shall have received the opinion of TSG Partners to the effect
that the
payment by it of the merger consideration is fair to Access's
stockholders
from a financial point of view;
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·
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Somanta
shall have obtained letter certifications from each licensor
of Somanta or
any of its subsidiaries (including, without limitation, Virium
Pharmaceuticals, Inc. and Immunodex, Inc.), in form satisfactory
to
Access, that any agreement between such person and Somanta (or
Somanta's
subsidiary, if applicable) is in full force and effect, that
such
agreement constitutes a legal, valid and binding obligation of,
and is
legally enforceable against, it and Somanta (or Somanta's subsidiary,
if
applicable), that there exists no uncured breach or default by
either it
or Somanta (or Somanta's subsidiary, if applicable) under any
such
agreement and that any consents required under such agreement
have been
obtained, are valid and are currently in effect;
and
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·
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all
conditions to the approval by NIH of the Phenylbutyrate Co-development
and
Sublicense Agreement between Somanta and Virium Pharmaceuticals,
Inc.
shall have been met. Virium Pharmaceuticals, Inc. shall have
executed and delivered to Somanta each of the two amendments
previously
negotiated and executed by Somanta, copies of which have been
provided to
Access. Somanta and Virium Pharmaceuticals, Inc. shall have
negotiated, and each shall have executed and delivered to the
other party,
the letter of intent previously executed by Somanta in the form
previously
provided to Access with such changes as may be approved by Access
in its
sole discretion.
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The
obligations of Somanta, Somanta Incorporated and Somanta Limited to effect
the
merger and the other transactions contemplated by the merger agreement
are
subject to the satisfaction or waiver of the following additional
conditions:
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·
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the
representations and warranties of Access and Somanta Acquisition
Corporation set forth in the merger agreement shall be true and
correct,
in each case as of the date of the merger agreement and (except
to the
extent such representations and warranties speak as of an earlier
date) as
of the merger closing date as though made on and as of the merger
closing
date, except where the failure of such representations and warranties
to
be so true and correct (without giving effect to any limitation
as to
"materiality" or "material adverse effect" set forth therein) would
not individually or in the aggregate have a material adverse
effect with
respect to Access. Somanta shall have received a certificate
signed on behalf of Access and Somanta Acquisition Corporation
by an
authorized officer of Access and Somanta Acquisition Corporation
to such
effect;
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·
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Access
and Somanta Acquisition Corporation shall have performed in all
material
respects all obligations required to be performed by each of
them under
the merger agreement at or prior to the merger closing
date. Somanta shall have received a certificate signed on
behalf of Access and Somanta Acquisition Corporation by an authorized
officer of Access and Somanta Acquisition Corporation to such
effect;
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·
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counsel
to Access and Somanta Acquisition Corporation shall have delivered
to
Somanta a written legal opinion addressed to Somanta, dated on
and as of
the merger closing date, and in form reasonably satisfactory
to
Somanta;
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·
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there
shall not be pending by any governmental entity or any other
person or
solely with respect to any governmental entity, threatened by
any suit,
action, or proceeding, (i) challenging or seeking to restrain or
prohibit the consummation of the merger or any of the other transactions
contemplated by the merger agreement or seeking to obtain from
any party
hereto or any of their affiliates any damages that are material
in
relation to Access and its subsidiaries taken as a whole;
(ii) seeking to prohibit or limit the ownership or operation by
Access or any of its subsidiaries of any material portion of
the business
or assets of Access and its subsidiaries taken as a whole or
to dispose of
or hold separate any material portion of the business or assets
of Access
and its subsidiaries taken as a whole, as a result of the merger
or any of
the other transactions contemplated by the merger agreement;
(iii) seeking to impose limitations on the ability of Access to
acquire or hold, or exercise full rights of ownership of, any
shares of
the common stock of the surviving corporation, including, without
limitation, the right to vote such common stock on all matters
properly
presented to the stockholders of the surviving corporation; or
seeking to
prohibit Access or any of its subsidiaries from effectively controlling
in
any material respect the business or operations of Somanta and
its
subsidiaries taken as a whole; and
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·
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the
applicable maturity date of all of Access's outstanding debt
(whether
principal or interest) owed to each of SCO Partners LLC (and its
affiliates) and Oracle Partners LP (and its affiliates) shall
have been extended to a date on or after April 27, 2008, or such
debt
shall have been converted into Access common stock. The notes
are
currently due July 26, 2007 and July 27, 2007, respectively.
As of the
date of this Proxy Statement/Prospectus the notes have not been
converted
into Parent Common Stock and the principal and interest on such
notes have
not been repaid or extended to a date on or after April 27, 2008.
Access
currently does not have adequate funds to repay the loans. If
such notes
have not converted into Parent Common Stock, been repaid or extended
to a
date on or after April 27, 2008, Somanta may, in its sole discretion,
choose to waive the condition of the performance of this
obligation.
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Material
Adverse Effect
Under
the
terms of the merger agreement, a material adverse effect means, when used
in
connection with Somanta or Access, any change, effect, event or occurrence
that
either individually or in the aggregate with all other such changes, effects,
events and occurrences is materially adverse to the business, properties,
financial condition or results of operations of Somanta or Access, as the
case
may be, and its subsidiaries taken as a whole. However, the meaning
of material adverse effect excludes, in certain instances, any material adverse
change in Somanta's or Access’ results of operations for any fiscal period prior
to the date of consummation of the merger that is directly attributable to
a
disruption in the conduct of Somanta's business arising from the transactions
contemplated by the merger agreement or its public
announcement. Material adverse effect also does not include the
impact of (i) any change in laws and regulations or interpretations thereof
by courts or governmental authorities generally applicable to Somanta and
Access, (ii) any change in generally accepted accounting principles as
applied in the United States or regulatory accounting principles generally
applicable to Somanta and Access, (iii) any change arising or resulting
from general industry, economic or capital market conditions or conditions
in
markets relevant to Somanta or Access, as applicable, that affects Access
or
Somanta, as applicable (or the markets in which Access or Somanta, as
applicable, compete) in a manner not disproportionate to the manner in
which such conditions affect comparable companies in the industries or markets
in which Somanta or Access, as applicable, compete, (iv) any act or
omission of Somanta (or any of its subsidiaries) taken with the prior written
consent of Access or (v) the expenses reasonably incurred by Somanta in
entering into the merger agreement and consummating the transactions
contemplated by the merger agreement and the expenses associated with the
termination of any Somanta plan contemplated in the merger
agreement.
66
Termination
The
merger agreement may be terminated in accordance with its terms at any time
prior to completion of the merger, whether before or after the approval and
adoption of the merger agreement and approval of the merger by Somanta
stockholders:
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•
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by
mutual written consent of Access and Somanta;
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•
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by
Access or Somanta, if the merger is not completed by August 31, 2007,
provided that neither Access nor Somanta may terminate the merger
agreement on this basis if that party has breached its obligations
under
the merger agreement if such breach resulted in the failure of the
merger
to occur on or before that date;
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•
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by
Access or Somanta, if a governmental entity has issued a nonappealable
final order or taken any other action having the effect of permanently
prohibiting the merger;
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•
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by
Access or Somanta, if the merger agreement and the merger fails to
receive
the requisite affirmative vote for adoption and approval at the Somanta
stockholders’ meeting, provided that Somanta may not terminate the merger
agreement on this basis if Somanta has breached, in any material
respect,
the provisions of the merger agreement relating to non-solicitation,
board
recommendations and filing this proxy statement/prospectus, or if
the
terminating party has not complied with its obligations relating
to
payment of fees and expenses described below;
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•
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by
Access, if Somanta or its board of directors
has:
|
|
o
|
withdrawn,
modified, or amended in any respect adverse to Access its approval
or
recommendation of the merger agreement or any of the transactions
contemplated therein;
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o
|
failed
as promptly as reasonably practicable after the effectiveness of
this
registration statement to mail the Stockholder Statement to its
stockholders or failed to include in such statement such
recommendation;
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o
|
recommended
any transaction proposal from a person other than Access or any
of its
affiliates;
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o
|
resolved
to do any of the foregoing; or
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o
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in
response to the commencement of any tender offer or exchange offer
for
more than 10% of the outstanding shares of Somanta’s common stock or
preferred stock, not recommended rejection of the tender offer
or exchange
offer at the time of filing of the requisite Schedule 14d-9 with
the
SEC;
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•
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|
by
Somanta, if its board of directors concludes in good faith,
based on
advice from outside counsel, that in order to satisfy its fiduciary
duties
to the stockholders of Somanta under Delaware law, Somanta’s board of
directors must not make or must withdraw or modify its recommendation
of
the merger, and Somanta’s board of directors does not make or withdraws or
modifies such recommendation;
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•
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by
Access, upon a breach of any representation, warranty, covenant or
agreement on the part of Somanta set forth in the merger agreement,
or if
any representation or warranty of Somanta shall have become untrue,
in
either case such that certain closing conditions would not be satisfied
at
the time of such breach or as of the time such representation or
warranty
shall have become untrue; however, Somanta may cure any such breach
or
failure to be true within ten (10) business days of the time such
representation or warranty shall have become untrue or such breach
and
Access may not terminate the merger agreement during this time while
Somanta attempts to cure the breach or failure to be true;
or
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•
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|
by
Somanta, upon a breach of any representation, warranty, covenant
or
agreement on the part of Access set forth in the merger agreement,
or if
any representation or warranty of Access shall have become untrue,
in
either case such that certain closing conditions would not be satisfied
at
the time of such breach or as of the time such representation or
warranty
shall have become untrue; however, Access may cure any such breach
or
failure to be true within ten (10) business days of the time such
representation or warranty shall have become untrue or such breach
and
Somanta may not terminate the merger agreement during this time while
Access attempts to cure the breach or failure to be
true.
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Break-Up
Fees and Expenses
Under
the
terms of the merger agreement, Access must pay up to $100,000 as reimbursement
for Somanta’s expenses actually incurred if:
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• |
either
Access or Somanta terminates the merger agreement because the merger
has
not been completed on or before August 31, 2007, but only if such
failure
to complete the merger occurs because: (i) the representations and
warranties of Access become untrue prior to or as of the closing
date of
the merger; or (ii) Access fails to perform its obligations as required
under the merger agreement; or
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• |
Somanta
terminates the merger agreement because of Access’ breach of any
representation, warranty, covenant or agreement made in the merger
agreement, or because Access’ representations and warranties become
untrue, and such breach or inaccuracy in Access’ representations and
warranties is not cured within ten (10) business days of the time
such
representations or warranties of Access become untrue or such breach
by
Access occurs.
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67
Under
the
terms of the merger agreement, Somanta must pay up to $750,000 as reimbursement
for Access’ expenses if:
|
• |
either
Access or Somanta terminates the merger agreement because the merger
has
not been completed on or before August 31, 2007, because of the failure
of
any of the conditions to Access' obligation to consummate the merger
set
forth in the merger agreement, with certain exceptions, including,
without limitation: (i) Somanta fails to perform the obligations
that it
is required to perform under the terms of the merger agreement; (ii)
a
material adverse effect occurs with respect to Somanta; or (iii)
Somanta
breaches of a representation, warranty, covenant or agreement made
in the
merger agreement, or Somanta’s representations and warranties have become
untrue, and such breach or inaccuracy in Somanta’s representations and
warranties would have a material adverse effect and has not been
cured
within ten (10) business days of the time such representations or
warranties of Somanta become untrue or such breach by Somanta has
occurred.
|
Under
the
terms of the merger agreement, Somanta must pay Access a termination fee of
$750,000 if:
|
• |
Access
terminates the merger agreement because of Somanta’s failure to obtain the
requisite vote by Somanta stockholders at the Somanta stockholders’
meeting approving the merger agreement and the
merger;
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•
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Access
terminates the merger agreement because: (i) Somanta’s Board of Directors
withdraws, modifies or amends its approval or recommendation for
stockholder approval of the merger in a manner adverse to Access;
(ii)
Somanta fails to mail the stockholder statement to Somanta stockholders
as
promptly as reasonably practicable after this registration statement
became effective; (iii) Somanta’s Board of Directors recommends an
acquisition proposal from an entity other than Access; (iv) Somanta’s
Board resolves to do any of the actions defined in clauses (i)-(iii);
and
(v) Somanta’s Board of Directors fails to recommend rejection of a tender
offer or exchange offer for more than ten percent (10%) of the outstanding
shares of Somanta’s common stock or preferred stock at the time of filing
of the requisite Schedule 14d-9 with the
SEC;
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•
|
Somanta
terminates the merger agreement because Somanta’s Board concludes in good
faith, based on advice from its legal counsel, that in order to
satisfy
its fiduciary duties to Somanta stockholders under Delaware law
it must
not make, or must withdraw or modify, its recommendation that the
Somanta
stockholders approve the merger, and makes such a withdrawal or
modification of its recommendation for approval of the merger;
or
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• |
Access
terminates the merger agreement because of Somanta’s breach of any
representation, warranty, covenant or agreement made in the merger
agreement, or because Somanta’s representations and warranties have become
untrue, and such breach or inaccuracy in Somanta’s representations and
warranties has not been cured within ten (10) business days of the
time
such representations or warranties of Somanta become untrue or such
breach
by Somanta occurs.
|
Under
the terms of the Loan Documents, Somanta must repay to Access
all amounts borrowed on the earlier of (i) August 31, 2007 or (ii) the date
of
the termination of the Merger Agreement.
Expenses Generally
Except
as
provided above, all fees and expenses incurred in connection with the merger
will be paid by the party incurring the fees or expenses, whether or not the
merger is completed, other than expenses incurred in connection with filing,
printing and mailing this proxy statement/prospectus, the registration
statement, or any similar filing requirement of any governmental entity
applicable to the merger, which will be shared equally by Access and
Somanta.
68
INFORMATION
ABOUT ACCESS
Business
Access
Pharmaceuticals, Inc. (“Access”) is a Delaware corporation. Access is an
emerging biopharmaceutical company developing products for use in the treatment
of cancer, the supportive care of cancer, and other disease states. Access’
product for the management of oral mucositis, MuGard™, received marketing
clearance by the FDA as a device. Its lead clinical development program for
the
drug candidate ProLindac™ (formerly known as AP5346) is in Phase II clinical
testing. Access also has advanced drug delivery technologies including
Cobalamin™-mediated oral drug delivery and targeted delivery.
Together
with its subsidiaries, Access has proprietary patents or rights to one
technology approved for marketing and three drug delivery technology
platforms:
•
MuGard™ (mucoadhesive liquid technology),
•
synthetic polymer targeted delivery,
•
Cobalamin-mediated oral delivery,
•
Cobalamin-mediated targeted delivery.
Products
Access
has used its drug delivery technologies to develop the following products and
product candidates:
ACCESS
DRUG PORTFOLIO
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Compound
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Originator
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Technology
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Indication
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Clinical
Stage
(1)
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MuGard™
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Access
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Mucoadhesive
liquid
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Mucositis
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Marketing
clearance received
|
||||
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ProLindacTM
(Polymer
Platinate,
AP5346) (2)
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Access
- U London
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Synthetic
polymer
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Cancer
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Phase
II
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Oral
Insulin
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Access
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Cobalamin
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Diabetes
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Pre-Clinical
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||||
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Oral
Delivery System
|
Access
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Cobalamin
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Various
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Pre-Clinical
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||||
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Cobalamin-Targeted
Therapeutics
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Access
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Cobalamin
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Anti-tumor
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Pre-Clinical
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(1)
For more information, see “Government Regulation” for description of clinical
stages.
(2)
Licensed from the School of Pharmacy, The University of London. Subject to
a 1%
royalty and milestone payments on sales.
Approved
Products
MuGard™
- Mucoadhesive Liquid Technology (MLT)
Mucositis
is a debilitating condition involving extensive inflammation of mouth tissue
that affects annually an estimated 400,000 cancer patients in the United States
undergoing chemotherapy and radiation treatment. Any treatment that would
accelerate healing and/or diminish the rate of appearance of mucositis would
have a significant beneficial impact on the quality of life of these patients
and may allow for more aggressive chemotherapy. Access believes the potential
addressable market for a mucositis product could be over $1 billion
world-wide.
69
Access’
MuGard™ is a viscous polymer solution which provides a coating for the oral
cavity. MuGard™ is dispensed in a ready to use form. A multi-site, randomized
clinical study was performed in the United States testing MuGard™ and MuGard™
containing an anti-inflammatory drug to determine the effect of these products
on the prevention and treatment of mucositis. The data from this trial indicated
that the patients using MuGard™ displayed a lower incidence of mucositis than is
typically seen in the studied population with no additional benefit from the
drug.
The
data
were retrospectively compared with two historical patient databases to evaluate
the potential advantages MuGard™ may represent in the prevention, treatment and
management of mucositis. The patient evaluation was conducted using the oral
mucositis assessment scale, which qualifies the disease severity on a scale
of
0-5. Key highlights of the comparison with the historical patient databases
are
as follows:
•
the average severity of the disease was reduced by approximately
40%;
•
the maximum intensity of the mucositis was approximately 35% lower;
and
•
the median peak intensity was approximately 50% lower.
These
data confirmed that fact that MuGard™ could represent an important advancement
in the management and prevention of mucositis. On September 20, 2006, Access
announced that it had submitted a Premarket Notification 510(k) application
to
the United States Food and Drug Administration (FDA) announcing Access’ intent
to market MuGard™. On December 13, 2006, Access announced that it had received
marketing clearance for MuGard™ from FDA for the indication of the management of
oral wounds including mucositis, aphthous ulcers and traumatic
ulcers.
Access
is
currently seeking marketing partners to market MuGard™ in the United States and
in other territories worldwide.
Products
in Development Status
ProLindac™
(Polymer Platinate, AP5346) DACH Platinum
Chemotherapy,
surgery and radiation are the major components in the clinical management of
cancer patients. Chemotherapy serves as the primary therapy for some solid
tumors and metastases and is increasingly used as an adjunct to radiation and
surgery to improve their effectiveness. For chemotherapeutic agents to be
effective in treating cancer patients, however, the agent must reach the target
cells in effective quantities with minimal toxicity in normal
tissues.
The
current optimal strategy for chemotherapy involves exposing patients to the
most
intensive cytotoxic regimens they can tolerate and clinicians attempt to design
a combination of chemotherapeutic drugs, a dosing schedule and a method of
administration to increase the probability that cancerous cells will be
destroyed while minimizing the harm to healthy cells. Notwithstanding
clinicians’ efforts, most current chemotherapeutic drugs have significant
shortcomings that limit the efficacy of chemotherapy. For example, certain
cancers are inherently unresponsive to chemotherapeutic agents. Alternatively,
other cancers may initially respond, but subgroups of cancer cells acquire
resistance to the drug during the course of therapy and the resistant cells
may
survive and cause a relapse. Serious toxicity, including bone marrow
suppression, renal toxicity, neuropathy, or irreversible cardiotoxicity, are
some of the limitations of current anti-cancer drugs that can prevent their
administration in curative doses.
Oxaliplatin,
a formulation of DACH platinum, is a chemotherapeutic which was initially
approved in France and in Europe in 1999 for the treatment of colorectal cancer.
It is now also being marketed in the United States and is generating worldwide
sales in excess of $2 billion annually. Carboplatin and Cisplatin, two other
approved platinum chemotherapy drugs, are not indicated for the treatment of
metastatic colorectal cancer. Oxaliplatin, in combination with 5-flurouracil
and
folinic acid (known as the FOLFOX regime) is indicated for the first-line
treatment of metastatic colorectal cancer in Europe and the U.S. The colorectal
cancer market is a significant opportunity as there are over 940,000 reported
new cases annually worldwide, increasing at a rate of approximately three
percent per year, and 500,000 deaths.
Currently,
platinum compounds are one of the largest selling categories of chemotherapeutic
agents, with annual sales in excess of $3.0 billion. As is the case with all
chemotherapeutic drugs, the use of such compounds is associated with serious
systemic side effects. The drug development goal therefore is to enhance
delivery of the active drug to the tumor and minimize the amount of active
drug
affecting normal organs in the body.
70
Utilizing
a biocompatible water-soluble polymer HPMA as a drug carrier, Access’ drug
candidate ProLindac™, links DACH platinum to a polymer in a manner which permits
the selective release of active drug to the tumor by several mechanisms,
including taking advantage of the differential pH in tumor tissue compared
to
healthy tissue. The polymer also capitalizes on the biological differences
in
the permeability of blood vessels at tumor sites versus normal tissue. In this
way, tumor selective delivery and platinum release is achieved. The ability
of
ProLindac™ to inhibit tumor growth has been evaluated in more than ten
preclinical models. Compared with the marketed product oxaliplatin, ProLindac™
showed either marked superiority or superiority in most of these models.
Preclinical studies of the delivery of platinum to tumors in an animal model
have shown that, compared with oxaliplatin at equitoxic doses, ProLindac™
delivers in excess of 16 times more platinum to the tumor. An analysis of tumor
DNA, which is the main target for anti-cancer platinum agents, has shown that
ProLindac™ delivers
approximately 14 times more platinum to tumor DNA than oxaliplatin. Results
from
preclinical efficacy studies conducted in the B16 and other tumor models have
also shown that ProLindac™ is superior to oxaliplatin in inhibiting the growth
of tumors. An extensive preclinical package has been developed supporting the
development of ProLindac™.
In
2005
Access completed a Phase I multi-center clinical study conducted in Europe,
which enrolled 26 patients. The study was reported at the AACR-NCI-EORTC
conference in Philadelphia in November 2005. The European trial was
designed to identify the maximum tolerated dose, dose limiting toxicities,
the
pharmacokinetics of the platinum in plasma and the possible anti-tumor activity
of ProLindacTM.
The
open-label, non-randomized, dose-escalation Phase I study was performed at
two
European centers. ProLindacTM
was
administered as an intravenous infusion over one hour, once a week on days
1, 8
and 15 of each 28-day cycle to patients with solid progressive tumors. Access
obtained results in 26 patients with a broad cross-section of tumor types,
with
doses ranging from 80-1,280 mg Pt/m2.
Of
the 26
patients, 10 were not evaluable for tumor response, principally due to
withdrawal from the study prior to completing the required cycle. Of the 16
evaluable patients, 2 demonstrated a partial response, 1 experienced a partial
response based on a biomarker and 4 experienced stable disease. One of the
patients who attained a partial response had a melanoma with lung metastasis;
a
CT scan revealed a tumor decrease of greater than 50%. The other patient who
responded had ovarian cancer; she had a reduction in lymph node metastasis
and
remission of a liver metastasis. The patient who experienced a partial response
based on a biomarker was an ovarian cancer patient for whom CA-125 levels
returned to normal. Also of note, a patient with cisplatin resistant cervical
cancer showed a short lasting significant reduction in lung metastasis after
3
doses. However, due to toxicity, the patient could not be retreated to determine
whether the partial response could be maintained.
Access
has commenced a European Phase II ProLindac™ trial in ovarian cancer patients
who have relapsed after first line platinum therapy. The primary aim of the
study is to the determine the response rate of ProLindacTM
monotherapy in this patient population. The response rates for other platinum
compounds in this indication are well known, and will be used for comparison.
Access
has provided ProLindacTM
to the
Moores Cancer Center at the University of California, San Diego to conduct
a
Phase II clinical study in patients with head and neck cancer under a
physician-sponsored IND. The primary aim of the study is to demonstrate the
ability of the tumor-targeting polymer system to deliver more platinum to tumors
than can be attained with oxaliplatin, the approved DACH platinum compound.
Access
has submitted an IND application to the US Food and Drug Administration, and
has
received clearance from the agency to proceed with a Phase I clinical study
of
ProLindac in combination with fluorouracil and leucovorin. The study is designed
to evaluate the safety of the ProLindac in combination with two standard drugs
used to treat colorectal cancer and to establish a safe dose for Phase II
clinical studies of this combination in colorectal cancer. Access is currently
evaluating whether clinical development of ProLindac in this indication might
proceed more rapidly by utilizing an alternative clinical strategy and/or
conducting studies in the US and/or elsewhere in the world.
Research
Projects, Products and Products in Development
Drug
Development Strategy
A
part of
Access’ integrated drug development strategy is to form alliances with centers
of excellence in order to obtain alternative lead compounds while minimizing
the
overall cost of research. Access does not spend significant resources on
fundamental biological research but rather focuses on its chemistry expertise
and clinical development. For example, certain of Access’ polymer platinate
technology has resulted in part from a research collaboration with The School
of
Pharmacy, University of London.
71
Access’
strategy is to focus on its polymer therapeutic program for the treatment of
cancer while continuing to develop technologies such as MuGard™ and
Cobalamin-mediated oral drug delivery which could provide it with a revenue
stream in the short term through commercialization or outlicensing to fund
its
longer-term polymer development program. To reduce financial risk and equity
financing requirements, Access is directing its resources to the preclinical
and
early clinical phases of development. Where the size of the necessary clinical
studies and cost associated with the later clinical development phases are
significant, Access plans to co-develop with or to outlicense to marketing
partners its therapeutic product candidates. By forming strategic alliances
with
pharmaceutical and/or biotech companies, Access believes that its technology
can
be more rapidly developed and successfully introduced into the
marketplace.
Access
will continue to evaluate the most cost-effective methods to advance its
programs. Access will contract certain research and development, manufacturing
and manufacturing scaleup, certain preclinical testing and product production
to
research organizations, contract manufacturers and strategic partners. As
appropriate to achieve cost savings and accelerate its development programs,
Access will expand its internal core capabilities and infrastructure in the
areas of chemistry, formulation, analytical methods development, clinical
development, biology and project management to maximize product opportunities
in
a timely manner.
Process
Access
began the product development effort by screening and formulating potential
product candidates, selecting an optimal active component, developing a
formulation, and developing the processes and analytical methods. Pilot
stability, toxicity and efficacy testing are conducted prior to advancing the
product candidate into formal preclinical development. Specialized skills
are required to produce these product candidates utilizing its technology.
Access has a limited core internal development capability with significant
experience in developing these formulations, but also depend upon the skills
and
expertise of its contractors.
Once
the
product candidate has been successfully screened in pilot testing, Access’
scientists, together with external consultants, assist in designing and
performing the necessary preclinical efficacy, pharmacokinetic and toxicology
studies required for IND submission. External investigators and scaleup
manufacturing facilities are selected in conjunction with its consultants.
The
initial Phase I and Phase II studies are conducted by institutions and
investigators supervised and monitored by Access’ employees and contract
research organizations. Access does not plan to have an extensive clinical
development organization as Access plans to have the advance phases of this
process conducted by a development partner. Should Access conduct Phase III
clinical studies Access expects to engage a contract research organization
to
perform this work.
Access
contracts with third party contract research organizations to complete its
large
clinical trials and for data management of all of its clinical trials.
Generally, Access manages the smaller Phase I and II trials ourselves.
Currently, Access has one Phase II trial in process and two Phase II trials
planned for this year subject to preliminary findings in other trials and
Access’ ability to fund such trials.
With
all
of Access’ product development candidates, Access cannot assure you that the
results of the in vitro or animal studies are or will be indicative of the
results that will be obtained if and when these product candidates are tested
in
humans. Access cannot assure you that any of these projects will be successfully
completed or that regulatory approval of any product will be
obtained.
Access
expended approximately $2,053,000, $2,783,000 and $2,335,000 on research and
development during the years 2006, 2005 and 2004, respectively.
Scientific
Background
The
ultimate criteria for effective drug delivery is to control and optimize the
localized release of the drug at the target site and rapidly clear the
non-targeted fraction. Conventional drug delivery systems such as controlled
release, sustained release, transdermal systems and others are designed for
delivering active product into the systemic circulation over time with the
objective of improving patient compliance. These systems do not address the
biologically relevant issues such as site targeting, localized release and
clearance of drug. The major factors that impact the achievement of this
ultimate drug delivery goal are the physical characteristics of the drug and
the
biological characteristics of the disease target sites. The physical
characteristics of the drug affect solubility in biological systems, its
biodistribution throughout the body, and its interactions with the intended
pharmacological target sites and undesired areas of toxicity. The biological
characteristics of the diseased area impact the ability of the drug to
selectively interact with the intended target site to allow the drug to express
the desired pharmacological activity.
72
Access
believes its drug delivery technologies are differentiated from conventional
drug delivery systems in that they seek to apply a disease-specific approach
to
improve the drug delivery process with formulations to significantly enhance
the
therapeutic efficacy and reduce toxicity of a broad spectrum of
products.
Core
Drug Delivery Technology Platforms
Access’
current drug delivery technology platforms for use in cancer chemotherapy
are:
•
Synthetic Polymer Targeted Drug Delivery Technology;
•
Cobalamin-Mediated Oral Delivery Technology; and
•
Cobalamin-Mediated Targeted Delivery Technology.
Each
of these platforms is discussed below:
Synthetic
Polymer Targeted Drug Delivery Technology
In
collaboration with The School of Pharmacy, University of London, Access
developed a synthetic polymer technology, which utilizes
hydroxypropylmethacrylamide with platinum, designed to exploit enhanced
permeability and retention, or EPR, at tumor sites to selectively accumulate
drug and control drug release. This technology is employed in Access’ lead
clinical program, ProLindac™. Many solid tumors possess vasculature that is
hyperpermeable, or leaky, to macromolecules. In addition to this enhanced
permeability, tumors usually lack effective lymphatic and/or capillary drainage.
Consequently, tumors selectively accumulate circulating macromolecules,
including, for example, up to 10% of an intravenous dose in mice. This effect
has been termed EPR, and is thought to constitute the mechanism of action of
styrene-maleic/anhydride-neocarzinostatin, or SMANCS, which is in regular
clinical use in Japan for the treatment of hepatoma. These polymers take
advantage of endothelial permeability as the drug carrying polymers are trapped
in tumors and then taken up by tumor cells. Linkages between the polymer and
drug can be designed to be cleaved extracellularly or intracellularly. Utilizing
the principles of prodrugs, the drug is essentially inert while attached to
the
polymer, but is released inside the tumor mass while polymer/drug not delivered
to tumors is renally cleared from the body. For example, ProLindac is attached
to a pH-sensitive linker which releases the platinum cytotoxic agent much faster
in the low pH environments found typically outside of tumor cells and within
specific compartments inside of tumor cells. Data generated in animal studies
have shown that the polymer/drug complexes are far less toxic than free drug
alone and that greater efficacy can be achieved. Thus, these polymer complexes
have demonstrated significant improvement in the therapeutic index of
anti-cancer drugs, including, for example, platinum.
Cobalamin-Mediated
Oral Delivery Technology
Oral
delivery is the preferred method of administration of drugs where either
long-term or daily use (or both) is required. However many therapeutics,
including peptide and protein drugs, are poorly absorbed when given orally.
With
more and more peptide and protein based biopharmaceuticals entering the market,
there is an increasing need to develop an effective oral delivery system for
them, as well as for long-standing injected drugs such as insulin.
The
difficulty in administering proteins orally is their susceptibility to
degradation by digestive enzymes, their inability to cross the intestinal wall
and their rapid excretion by the body. Over the years, many different
methodologies for making protein drugs available orally have been attempted.
Most of the oral protein delivery technologies involve protecting the protein
degradation in the intestine. More recently, strategies have been developed
that
involve attaching the protein or peptide to a molecule that transports the
protein across the gut wall. However, the field of oral drug delivery of
proteins and peptides has yet to achieve successful commercialization of a
product (although positive results have been achieved in early clinical trials
for some products under development).
Many
pharmaceutically active compounds such as proteins, peptides and cytotoxic
agents cannot be administered orally due to their instability in the
gastrointestinal tract or their inability to be absorbed and transferred to
the
bloodstream. A technology that would allow many of these actives to be taken
orally would greatly enhance their acceptance and value. Several technologies
for the protection of sensitive actives in the gastro-intestinal tract and/or
enhancement of gastro-intestinal absorption have been explored and many have
failed.
73
Access’
proprietary technology for oral drug delivery utilizes the body’s natural
vitamin B12 (VB12) transport system in the gut. The absorption of VB12 in the
intestine occurs by way of a receptor-mediated endocytosis. Initially, VB12
binds to intrinsic factor (IF) in the small intestine, and the VB12-IF complex
then binds to the IF receptor on the surface of the intestine. Receptor-mediated
endocytosis then allows the transport of VB12 across the gut wall. After binding
to another VB12-binding protein, transcobalamin II (TcII), VB12 is transferred
to the bloodstream.
Access’
scientists discovered that Cobalamin (analogs of VB12) will still be transported
by this process even when drugs, macromolecules, or nanoparticles are coupled
to
the Cobalamin. Thus Cobalamin serves as a carrier to transfer these
materials from the intestinal lumen to the bloodstream. For drugs and
macromolecules that are stable in the gastro-intestinal tract, the drug or
macromolecule can be coupled directly (or via a linker) to Cobalamin. If the
capacity of the Cobalamin transport system is inadequate to provide an effective
blood concentration of the active, transport can be amplified by attaching
many
molecules of the drug to a polymer, to that Cobalamin is also attached. A
further option, especially for drugs and macromolecules that are unstable in
the
intestine, is to formulate the drug in a nanoparticle which is then coated
with
Cobalamin. Once in the bloodstream, the active is released by diffusion and/or
erosion of the nanoparticle. Utilization of nanoparticles also serves to
‘amplify’ delivery by transporting many molecules at one time due to the
inherently large nanoparticle volume compared with the size of the
drug.
Access’
proprietary position in this technology involves the conjugation of Cobalamin
and/or folic acid and/or biotin (or their analogs) to a polymer to which is
also
attached the drug to be delivered, or attached to a nanoparticle in which the
drug is incorporated. Since many molecules of the drug are attached to a single
polymer strand, or are incorporated in a single nanoparticle, disease targeting
is amplified compared to simpler conjugates involving one molecule of the
vitamin with one drug molecule. However, in situations when such a simple
conjugate might be preferred, its patents also encompass these Cobalamin-drug
conjugates.
Cobalamin-Mediated
Targeted Delivery Technology
Most
drugs are effective only when they reach a certain minimum concentration in
the
region of disease, yet are well distributed throughout the body contributing
to
undesirable side effects. It is therefore advantageous to alter the natural
biodistribution of a drug to have it more localized where it is needed. Access’
Cobalamin-mediated targeted delivery technology utilizes the fact that in many
diseases where there is rapid growth and/or cell division, the demand for
certain vitamins increases. By coupling the drug to a vitamin analog, the analog
serves as a carrier to increase the amount of drug at the disease site relative
to its normal distribution.
One
application of this technology is in tumor targeting. The use of cytotoxic
drugs
is one of the most common methods for treating a variety of malignancies
including solid and non-solid tumors. The drawbacks of chemotherapeutic
treatments, which include tumor resistance, cancer relapse and toxicity from
severe damage to healthy tissues, has fuelled a scientific quest for novel
treatments that are specifically targeted to malignant cells thus reducing
damage to collateral tissues.
The
design of targeted therapies involves exploitation of the difference between
the
structure and function of normal cells compared with malignant cells.
Differences include the increased levels of surface molecules on cancer cells,
which makes them more sensitive to treatment regimes that target surface
molecules and differences in blood supply within and around tumor cells compared
with normal cells.
Two
basic
types of targeting approaches are utilized, passive tumor targeting and active
tumor targeting.
| • |
passive
tumor targeting involves transporting anti-cancer agents through
the
bloodstream to tumor cells using a “carrier” molecule. Many different
carrier molecules, which can take a variety of forms (micelles,
nanoparticles, liposomes and polymers), are being investigated as
each
provides advantages such as specificity and protection of the anti-cancer
drug from degradation due to their structure, size (molecular weights)
and
particular interactions with tumor cells. Access’ polymer platinate
program is a passive tumor targeting
technology.
|
| • |
active
tumor targeting involves attaching an additional fragment to the
anticancer drug and the carrier molecule to create a new “targeted” agent
that will actively seek a complementary surface molecule to which
it binds
(preferentially located on the exterior of the tumor cells). The
theory is
that the targeting of the anti-cancer agent through active means
to the
affected cells should allow more of the anti-cancer drug to enter
the
tumor cell, thus amplifying the response to the treatment and reducing
the
toxic effect on bystander, normal
tissue.
|
74
Examples
of active targeting fragments include antibodies, growth factors and vitamins.
Access’ scientists have specifically focused on using Cobalamin compounds
(analogs of vitamin B12), but Access has also used and has certain intellectual
property protection for the use of folate and biotin which may more effectively
target anti-cancer drugs to solid tumors.
It
has
been known for some time that vitamin B12 and folic acid are essential for
tumor
growth and as a result, receptors for these vitamins are up-regulated in certain
tumors. Vitamin B12 receptor over-expression occurs in breast, lung, leukemic
cells, lymphoma cells, bone, thyroid, colon, prostate and brain cancers and
some
other tumor lines, while folate receptor over-expression occurs in breast,
lung,
ovarian, endometrial, renal, colon, brain and cancers of myeloid hemotopoietic
cells and methotrexate-sensitive tumors.
Patents
Access
believes that the value of technology both to it and to its potential corporate
partners is established and enhanced by its broad intellectual property
positions. Consequently, Access has already been issued and seeks to obtain
additional U.S. and foreign patent protection for products under development
and
for new discoveries. Patent applications are filed with the U.S. Patent and
Trademark Office and, when appropriate, with the Paris Convention's Patent
Cooperation Treaty (PCT) Countries (most major countries in Western Europe
and
the Far East) for its inventions and prospective products.
One
U.S.
patent has issued and one U.S. patent application and two European patent
applications are under review for its mucoadhesive liquid technology. Access’
patent applications cover a
range of
products utilizing its mucoadhesive liquid technology for the management of
the
various phases of mucositis.
Three
U.S. patents and two European patents have issued and one U.S. patent and two
European patent applications are pending for polymer platinum compounds. The
two
patents and patent applications are the result in part of Access’ collaboration
with The School of Pharmacy, University of London, from which the technology
has
been licensed and include a synthetic polymer, hydroxypropylmethacrylamide
incorporating platinates, that can be used to exploit enhanced permeability
and
retention in tumors and control drug release. The patents and patent
applications include a pharmaceutical composition for use in tumor treatment
comprising a polymer-platinum compound through linkages that are designed to
be
cleaved under selected conditions to yield a platinum which is selectively
released at a tumor site. The patents and patent applications also include
methods for improving the pharmaceutical properties of platinum compounds.
Access
has three
patented Cobalamin-mediated targeted therapeutic technologies:
| - |
folate
conjugates of polymer therapeutics, to enhance tumor delivery by
targeting
folate receptors, which are upregulated in certain tumor types with
two
U.S. and two European patent
applications;
|
| - |
the
use of vitamin B12 to target the transcobalamin II receptor which
is
upregulated in numerous diseases including cancer, rheumatoid arthritis,
certain neurological and autoimmune disorders with two U.S. patents
and
three U.S. and four European patent applications;
and
|
| - |
oral
delivery of a wide variety of molecules which cannot otherwise be
orally
administered, utilizing the active transport mechanism which transports
vitamin B12 into the systemic circulation with six U.S. patents and
two
European patents and one U.S. and one European patent
application.
|
Access’
patents for the following technologies expire in the years and during the date
ranges indicated below:
| · |
Mucoadhesive
technology in 2021,
|
| · |
ProLindac™
in 2021,
|
| · |
Cobalamin
mediated technology between 2007 and
2019
|
In
addition to issued patents, Access has a number of pending patent applications.
If issued, the patents underlying theses applications could extend the patent
life of its technologies beyond the dates listed above.
Access
has a strategy of maintaining an ongoing line of patent continuation
applications for each major category of patentable carrier and delivery
technology. By this approach, Access is extending the intellectual property
protection of its basic targeting technology and initial agents to cover
additional specific carriers and agents, some of which are anticipated to carry
the priority dates of the original applications.
Government
Regulation
Access
is
subject to extensive regulation by the federal government, principally by the
FDA, and, to a lesser extent, by other federal and state agencies as well as
comparable agencies in foreign countries where registration of products will
be
pursued. Although a number of Access’ formulations incorporate extensively
tested drug substances, because the resulting formulations make claims of
enhanced efficacy and/or improved side effect profiles, they are expected to
be
classified as new drugs by the FDA.
75
The
Federal Food, Drug and Cosmetic Act and other federal, state and foreign
statutes and regulations govern the testing, manufacturing, safety, labeling,
storage, shipping and record keeping of Access’ products. The FDA has the
authority to approve or not approve new drug applications and inspect research,
clinical and manufacturing records and facilities.
Among
the
requirements for drug approval and testing is that the prospective
manufacturer's facilities and methods conform to the FDA's Code of Good
Manufacturing Practices regulations, which establish the minimum requirements
for methods to be used in, and the facilities or controls to be used during,
the
production process. Such facilities are subject to ongoing FDA inspection to
insure compliance.
The
steps
required before a pharmaceutical product may be produced and marketed in the
U.S. include preclinical tests, the filing of an IND with the FDA, which must
become effective pursuant to FDA regulations before human clinical trials may
commence, numerous phases of clinical testing and the FDA approval of a New
Drug
Application (“NDA”) prior to commercial sale.
Preclinical
tests are conducted in the laboratory, usually involving animals, to evaluate
the safety and efficacy of the potential product. The results of preclinical
tests are submitted as part of the IND application and are fully reviewed by
the
FDA prior to granting the sponsor permission to commence clinical trials in
humans. All trials are conducted under International Conference on
Harmonization, or ICH, good clinical practice guidelines. All investigator
sites
and sponsor facilities are subject to FDA inspection to insure compliance.
Clinical trials typically involve a three-phase process. Phase I, the initial
clinical evaluations, consists of administering the drug and testing for safety
and tolerated dosages and in some indications such as cancer and HIV, as
preliminary evidence of efficacy in humans. Phase II involves a study to
evaluate the effectiveness of the drug for a particular indication and to
determine optimal dosage and dose interval and to identify possible adverse
side
effects and risks in a larger patient group. When a product is found safe,
an
initial efficacy is established in Phase II, it is then evaluated in Phase
III
clinical trials. Phase III trials consist of expanded multi-location testing
for
efficacy and safety to evaluate the overall benefit to risk index of the
investigational drug in relationship to the disease treated. The results of
preclinical and human clinical testing are submitted to the FDA in the form
of
an NDA for approval to commence commercial sales.
The
process of forming the requisite testing, data collection, analysis and
compilation of an IND and an NDA is labor intensive and costly and may take
a
protracted time period. In some cases, tests may have to be redone or new tests
instituted to comply with FDA requests. Review by the FDA may also take
considerable time and there is no guarantee that an NDA will be approved.
Therefore, Access cannot estimate with any certainty the length of the approval
cycle.
Access
is
also governed by other federal, state and local laws of general applicability,
such as laws regulating working conditions, employment practices, as well as
environmental protection.
Competition
The
pharmaceutical and biotechnology industry is characterized by intense
competition, rapid product development and technological change. Competition
is
intense among manufacturers of prescription pharmaceuticals and other product
areas where Access may develop and market products in the future. Most of
Access’ potential competitors are large, well established pharmaceutical,
chemical or healthcare companies with considerably greater financial, marketing,
sales and technical resources than are available to Access. Additionally, many
of Access’ potential competitors have research and development capabilities that
may allow such competitors to develop new or improved products that may compete
with Access’ product lines. Access’ potential products could be rendered
obsolete or made uneconomical by the development of new products to treat the
conditions to be addressed by its developments, technological advances affecting
the cost of production, or marketing or pricing actions by one or more of
Access’ potential competitors. Access’ business, financial condition and results
of operation could be materially adversely affected by any one or more of such
developments. Access cannot assure you that Access will be able to compete
successfully against current or future competitors or that competition will
not
have a material adverse effect on Access’ business, financial condition and
results of operations. Academic institutions, governmental agencies and other
public and private research organizations are also conducting research
activities and seeking patent protection and may commercialize products on
their
own or with the assistance of major health care companies in areas where Access
is developing product candidates. Access is aware of certain development
projects for products to treat or prevent certain diseases targeted by it,
the
existence of these potential products or other products or treatments of which
Access is not aware, or products or treatments that may be developed in the
future, may adversely affect the marketability of products developed by
Access.
76
Access’
principal competitors in the polymer area are Cell Therapeutics, Daiichi, Enzon,
Polytherics Ltd, and Inhale which are developing alternate drugs in combination
with polymers. Access believes it is the only company conducting clinical
studies in the polymer drug delivery of platinum compounds. Access believes
that
the principal current competitors to its polymer targeting technology fall
into
two categories: monoclonal antibodies and liposomes. Access believes that its
technology potentially represents a significant advance over these older
technologies because its technology provides a system with a favorable
pharmacokinetic profile.
A
number
of companies are developing or may in the future engage in the development
of
products competitive with the Access polymer delivery system. Several companies
are working on targeted monoclonal antibody therapy including Bristol-Myers
Squibb, Centocor (acquired by Johnson & Johnson), GlaxoSmithKline, Imclone
and Xoma. Currently, liposomal formulations being developed by Gilead Sciences
and Alza Corporation (acquired by Johnson & Johnson), are the major
competing intravenous drug delivery formulations that deliver similar drug
substances.
In
the
area of advanced drug delivery, which is the focus of Access’ early stage
research and development activities, a number of companies are developing or
evaluating enhanced drug delivery systems. Access expects that technological
developments will occur at a rapid rate and that competition is likely to
intensify as various alternative delivery system technologies achieve similar
if
not identical advantages.
Even
if
Access’ products are fully developed and receive required regulatory approval,
of which there can be no assurance, Access believes that its products can only
compete successfully if marketed by a company having expertise and a strong
presence in the therapeutic area. Consequently, Access does not currently plan
to establish an internal marketing organization. By forming strategic alliances
with major and regional pharmaceutical companies, management believes that
its
development risks should be minimized and that the technology potentially could
be more rapidly developed and successfully introduced into the
marketplace.
Other
Key Developments
On
June
11, 2007, Access Pharmaceuticals, Inc. (“Access”) and SCO Capital Partners LLC
and affiliates (“SCO”) agreed to extend the maturity date of an aggregate of
$6,000,000 of 7.5% convertible notes to July 26, 2007 from June 11, 2007. On
June 11, 2007, Access and Oracle Partners LP and affiliates agreed to extend
the
maturity date of an aggregate of $4,015,000 of 7.7% convertible notes to July
27, 2007 from June 12, 2007.
On
April
19, 2007 Access announced it had entered into an agreement to acquire Somanta
Pharmaceuticals, Inc. Pursuant to the terms of merger agreement, upon
consummation of the acquisition, Somanta’s preferred and common stockholders
would receive an aggregate of 1.5 million shares of Access’ common shares which
would represent approximately 13% of the combined company assuming the
conversion of Access’ existing convertible debt under existing terms of
conversion. The closing of the transaction is subject to numerous conditions
including receipt of necessary approvals including approval of the Somanta
stockholders. There can be no assurance that the transaction will be consummated
or if consummated, that it will be on the terms described herein.
Access
has upcoming maturity dates on its convertible notes. The $6
million of Senior Convertible notes are due July 26, 2007 plus accrued interest;
and the approximately $4.0
million of convertible notes which are due July 27, 2007 including interest;
and
capitalized interest of $880,000. Access is currently negotiating with the
debt
holders to convert their debt to equity or to extend the terms of their due
dates.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
On
December 8, 2006 Access amended its 2005 Asset Sale Agreement with Uluru, Inc.
Access received from Uluru an upfront payment of $4.9 million, received an
additional $350,000 on April 9, 2007 and in the future could receive potential
milestones of up to $4.8 million based on Uluru sales. The amendment agreement
included the anniversary payment due October 12, 2006, the early payment of
the
two year anniversary payment, and a payment in satisfaction of certain future
milestones. Access also transferred to Uluru certain patent applications that
Access had previously licensed to Uluru under the 2005 License Agreement. Under
a new agreement, Access has acquired a license from Uluru to utilize the
nanoparticle aggregate technology contained in the transferred patent
applications for subcutaneous, intramuscular, intra-peritoneal and intra-tumoral
drug delivery. Additionally, one future milestone was increased by
$125,000.
77
On
December 6, 2006, Access entered into a note and warrant purchase agreement
pursuant to which Access sold and issued an aggregate of $500,000 of 7.5%
convertible notes due July 26, 2007 and warrants to purchase 386,364 shares
of
common stock of Access. Net proceeds to Access were $450,000. The notes and
warrants were sold in a private placement to a group of accredited investors
led
by SCO Capital Partners LLC (“SCO”) and affiliates. Each noteholder received a
warrant to purchase a number of shares of common stock of Access equal to 75%
of
the total number shares of Access common stock into which such holder’s note is
convertible. Each warrant has an exercise price of $1.32 per share and is
exercisable at any time prior to December 6, 2012.
On
October 24, 2006, Access entered into a note and warrant purchase agreement
pursuant to which Access sold and issued an aggregate of $500,000 of 7.5%
convertible notes due July 26, 2007 and warrants to purchase 386,364 shares
of
common stock of Access. Net proceeds to Access were $450,000. The notes and
warrants were sold in a private placement to a group of accredited investors
led
by SCO and affiliates. Each noteholder received a warrant to purchase a number
of shares of common stock of Access equal to 75% of the total number shares
of
Access common stock into which such holder’s note is convertible. Each
warrant has an exercise price of $1.32 per share and is exercisable at any
time
prior to October 24, 2012.
On
February 16, 2006, Access entered into a note and warrant purchase agreement
pursuant to which Access sold and issued an aggregate of $5,000,000 of 7.5%
convertible notes due July 26, 2007 and warrants to purchase an aggregate of
3,863,634 shares of common stock of Access. Net proceeds to Access were $4.5
million. The notes and warrants were sold in a private placement to a group
of
accredited investors led by SCO and affiliates. Each noteholder received a
warrant to purchase a number of shares of common stock of Access equal to 75%
of
the total number shares of Access common stock into which such holder’s note is
convertible. Each warrant has an exercise price of $1.32 per share and is
exercisable at any time prior to February 16, 2012.
All
the
secured notes mature on July 26, 2007, are convertible into Access common stock
at a fixed conversion rate of $1.10 per share, bear interest of 7.5% per annum
and are secured by substantially all of the assets of Access. Each note may
be
converted at the option of the noteholder or Access under certain circumstances
as set forth in the notes.
In
the event SCO and its affiliates were to convert all of their notes and exercise
all of their warrants, they would own approximately 74.1% of the voting
securities of Access. Access may be required to pay in cash, up to 2% per month,
as defined, as liquidated damages for failure to file a registration statement
timely as required by an investor rights agreement.
In
connection with the sale and issuance of notes and warrants, Access entered
into
an investors rights agreement whereby it granted SCO the right to designate
two
individuals to serve on the Board of Directors of Access while the notes are
outstanding, and also granted registration rights with respect to the shares
of
common stock of Access underlying the notes and warrants. SCO designated Jeffrey
B. Davis and Mark J. Alvino to the Board of Directors, and on March 13, 2006
Messrs, Davis and Alvino were appointed to the Board of Directors.
On
October 12, 2005, Access sold its oral/topical care business unit to Uluru,
Inc,
a private Delaware corporation, for up to $18.8 million to focus on Access’
technologies in oncology and oral drug delivery. The products and technologies
sold to Uluru included amlexanox 5% paste (marketed under the trade names
Aphthasol® and Aptheal®), OraDiscTM,
Zindaclin® and Residerm® and all of Access’ assets related to these products. In
addition, Access sold to Uluru its nanoparticle hydrogel aggregate technology
which could be used for applications such as local drug delivery and tissue
filler in dental and soft tissue applications. Access received a license from
Uluru for certain applications of the technology. The CEO of Uluru is Kerry
P.
Gray, the former CEO of Access. In conjunction with the sale transaction, Access
received a fairness opinion from a nationally recognized investment banking
firm.
At
the
closing of the agreement Access received $8.7 million. In addition, due to
the
Amended Asset Sale Agreement in December 2006, Access received $4.9 million
and
received an additional $350,000 on April 9, 2007 for the first and second
anniversary payments and settlement of certain milestones. Access recorded
$550,000 less $173,000 tax expense as income from the discontinued operations
in
2006.
Access
was incorporated in Wyoming in 1974 as Chemex Corporation, and in 1983 Access
changed its name to Chemex Pharmaceuticals, Inc. Access changed its state of
incorporation from Wyoming to Delaware on June 30, 1989. In 1996 Access merged
with Access Pharmaceuticals, Inc., a private Texas corporation, and changed
its
name to Access Pharmaceuticals, Inc. Access’ principal executive office is
located at 2600 Stemmons Freeway, Suite 176, Dallas, Texas 75207; Access’
telephone number is (214) 905-5100.
78
Employees
As
of
July 19, 2007, Access had nine full time employees, four of whom have advanced
scientific degrees. Access has never experienced employment-related work
stoppages and considers that it maintains good relations with its personnel.
In
addition, to complement its internal expertise, Access has contracts with
scientific consultants, contract research organizations and university research
laboratories that specialize in various aspects of drug development including
clinical development, regulatory affairs, toxicology, process scale-up and
preclinical testing.
Web
Availability
Access
makes available free of charge through its web site, www.accesspharma.com,
its
annual reports on Form 10-K and other reports required under the Securities
and
Exchange Act of 1934, as amended, as soon as reasonably practicable after such
reports are filed with, or furnished to, the Securities and Exchange Commission
(the “SEC”). These documents are also available through the SEC’s website at
www.sec.gov certain of its corporate governance policies, including the charters
for the Board of Directors’ audit, compensation and nominating and corporate
governance committees and its code of ethics, corporate governance guidelines
and whistleblower policy. Access will provide to any person without charge,
upon
request, a copy of any of the foregoing materials. Any such request must be
made
in writing to Access Pharmaceuticals, Inc., 2600 Stemmons Freeway, Suite 176,
Dallas, TX 75207 attn: Investor Relations.
Access
maintains one facility of approximately 9,000 square feet for administrative
offices and laboratories in Dallas, Texas. Access has a lease agreement for
the
facility, which terminates in December 2007. Adjacent space may be available
for
expansion which Access believes would accommodate growth for the foreseeable
future.
Access
believes that its existing properties are suitable for the conduct of its
business and adequate to meet its present needs.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON
ACCOUNTING AND FINANCIAL DISCLOSURE
Grant
Thornton LLP ("Grant Thornton") was previously the principal accounts for the
Access. On September 15, 2006, Grant Thornton resigned as its independent
registered public accounting firm.
In
connection with the audits of fiscal years ended December 31, 2005 and 2004
and
the subsequent interim period through September 15, 2006, (i) there have been
no
disagreements with Grant Thornton on any matter of accounting principles or
practices, financial statement disclosure or auditing scope or procedure, which
disagreement(s), if not resolved to Grant Thornton's satisfaction, would have
caused Grant Thornton to make reference to the subject matter of the
disagreement(s) in connection with its reports for such year, and (ii) there
were no "reportable events" as such term is defined in Item 304(a)(1)(v) of
Regulation S-K. However, as reported in Access’ Form 10-K for the year ended
December 31, 2005, Grant Thornton has communicated to Access’ audit committee
the existence of material weaknesses in its system of internal control over
financial reporting related to the inadequacy of staffing and a lack of
segregation of duties.
Grant
Thornton's reports did not contain an adverse opinion or disclaimer of opinion,
but the 2005 report was modified to include an explanatory paragraph related
to
uncertainties about Access’ ability to continue as a going concern.
Effective
September 20, 2006, the Audit Committee of the Board of Directors of Access
approved the engagement of Whitley Penn LLP (“Whitley Penn”) as its independent
registered public accounting firm to audit the Access’ financial statements for
the year ended December 31, 2006. On October 2, 2006, Whitley Penn formally
advised Access that it was accepting the position as Access’ independent
registered public accounting firm for the year ending December 31,
2006.
During
the years ended December 31, 2005 and 2004, and the interim period through
October 2, 2006, Whitley Penn was not engaged as an independent registered
public accounting firm to audit either the financial statements of Access or
any
of its subsidiaries, nor has Access or anyone acting on its behalf consulted
with Whitley Penn regarding: (i) the application of accounting principles to
a
specified transaction, either completed or proposed, or the type of audit
opinion that might be rendered on Access’ financial statements; or (ii) any
matter that was the subject of a disagreement or reportable event as set forth
in Item 304(a)(2)(ii) of Regulation S-K.
79
The
Directors of Access shall remain the Directors of Access after consummation
of
the merger as contemplated in the merger agreement.
The
following table sets forth the Directors, Executive Officers, and Key Employees
of Access along with their respective ages and positions and is as
follows:
| Name | Age | Title |
| Jeffrey B. Davis | 44 | Chairman of the Board |
| Stephen R. Seiler | 51 | President, Chief Executive Officer, Director |
| Rosemary Mazanet, M.D., Ph.D. | 51 | Vice Chairman |
| Esteban Cvitkovic , M.D. | 57 | Vice Chairman - Europe |
| Mark J. Ahn, Ph.D. | 44 | Director |
| Mark J. Alvino | 39 | Director |
| Stephen B. Howell, M.D. | 62 | Director |
| David P. Luci | 40 | Director |
| John J. Meakem, Jr. | 70 | Director |
| David P. Nowotnik, Ph.D. | 58 | Senior Vice President Research & Development |
| Phillip S. Wise | 48 | Vice President, Business Development & Strategy |
| Stephen B. Thompson | 53 | Vice President, Chief Financial Officer, Treasurer, Secretary |
No
director, officer, affiliate or promoter of Access has, within the past five
years, filed any bankruptcy petition, been convicted in or been the subject
of
any pending criminal proceedings, or is any such person the subject or any
order, judgment or decree involving the violation of any state or federal
securities laws.
The
following is a brief account of the business experience during the past five
years of each director and executive officer of Access, including principal
occupations and employment during that period and the name and principal
business of any corporation or other organization in which such occupation
and
employment were carried on.
Mr.
Jeffrey B. Davis became
a director in March 2006 as a designee of SCO Capital Partners LLC. Mr. Davis
is
Chairman of the Board and a member of the Compensation Committee of the Board.
Mr. Davis currently serves as President of SCO Financial Group LLC. Prior to
joining SCO Securities LLC, Mr. Davis served as Senior Vice President and Chief
Financial Officer of HemaSure, Inc., a publicly traded development stage
healthcare technology company. Prior to that, Mr. Davis was Vice President,
Corporate Finance, at Deutsche Morgan Grenfell, both in the U.S. and Europe.
Mr.
Davis also served in senior marketing and product management positions at
AT&T Bell Laboratories, where he was also a member of the technical staff.
Prior to that, Mr. Davis was involved in marketing and product management at
Philips Medical Systems North America. Mr. Davis is currently on the board
of
MacroChem Corporation, Uluru, Inc. and Virium Pharmaceuticals, Inc., a private
biotechnology company. Mr. Davis served previously on the board of Bioenvision,
Inc. Mr. Davis holds a B.S. in biomedical engineering from Boston University
and
an M.B.A. degree from the Wharton School, University of Pennsylvania.
Mr.
Stephen R. Seiler has
been
Access’ President and Chief Executive Officer and a Director since January 2007.
Until recently, Mr. Seiler had been Acting Chief Executive Officer of Effective
Pharmaceuticals, Inc. and advising other companies in the healthcare field.
From
2001 until 2004 he was Chief Executive Officer of Hybridon, Inc. (now Idera
Pharmaceuticals, Inc.). Mr. Seiler was Executive Vice President, Planning,
Investment & Development at Elan Corporation plc from 1995 until 2001. He
also worked as an investment banker at Paribas Capital Markets in both London
and New York from 1991 to 1995 where he was founder and head of Paribas’
pharmaceutical investment banking group.
Rosemary
Mazanet, M.D. serves
as
Chief Executive Officer of Breakthrough Therapeutics, LLC, a privately held
development stage biotechnology company. From May 2005 to January 2007 she
served as Access’ Acting Chief Executive Officer. From June 1998 to February
2004, Dr. Mazanet served as Chief Scientific Officer and a General Partner
of
Oracle Partners, L.P., a healthcare investment firm. Dr. Mazanet also serves
as
an independent director at GTx, Inc (Nasdaq: GTXI), Aksys, Ltd. and is a trustee
at the University of Pennsylvania, School of Medicine. Prior to joining Oracle,
Dr. Mazanet was the Director of Clinical Research at Amgen, Inc. She has over
20
years experience in the pharmaceutical industry, and was trained as a Medical
Oncologist/Hematologist in the Harvard Medical System, and holds an M.D. and
Ph.D. from University of Pennsylvania.
80
Dr.
Esteban Cvitkovic
became a
director in February 2007. Recently, the oncology-focused CRO, Cvitkovic &
Associés Consultants (CAC), founded by Dr. Cvitkovic 11 years ago and which he
developed from a small oncology consultancy to a full-service CRO, was sold
to
AAIPharma to become AAIOncology. Dr. Cvitkovic is currently a Senior Medical
Consultant to AAIOncology. In addition, he maintains a part-time academic
practice including teaching at the hospitals Beaujon and St Louis in Paris.
Dr.
Cvitkovic is Scientific President of the FNAB, a foundation devoted to the
furthering of personalised cancer treatments. Together with a small number
of
collaborators he has recently co-founded Oncoethix, a biotech company focused
on
licensing and co-development of anti-cancer molecules. Dr. Cvitkovic has
authored more than 200 peer-reviewed articles and 600 abstracts focused on
therapeutic oncology development. His international career includes staff and
academic appointments at Memorial Sloan Kettering Cancer Center (New York),
Columbia Presbyterian (New York), Instituto Mario Negri (Milan), Institut
Gustave Roussy (Villejuif), Hôpital Paul Brousse (Villejuif) and Hôpital St.
Louis (Paris).
Dr.
Mark J. Ahn
became a
director in September 2006. Dr. Ahn is President
and Chief Executive Officer and a member of the board of directors of Hana
Biosciences, Inc. since November 2003. Prior to joining Hana, from December
2001
to November 2003, he served as Vice President, Hematology and corporate officer
at Genentech, Inc. where he was responsible for commercial and clinical
development of the Hematology franchise. From February 1991 to February 1997
and
from February 1997 to December 2001, Dr. Ahn was employed by Amgen and
Bristol-Myers Squibb Company, respectively, holding a series of positions of
increasing responsibility in strategy, general management, sales &
marketing, business development, and finance. He has also served as an officer
in the U.S. Army. Dr. Ahn is a Henry Crown Fellow at the Aspen Institute,
founder of the Center for Non-Profit Leadership, a director of TransMolecular,
Inc., a privately held biotechnology company focused on neuroncology, and a
member of the Board of Trustees for the MEDUNSA (Medical University of South
Africa) Trust. Dr. Ahn received a B.A. in History and an M.B.A. in Finance
from
Chaminade University. He was a graduate fellow in Economics at Essex University,
and has a Ph.D. in Business Administration from the University of South
Australia.
Mr.
Mark J. Alvino became
a
director in March 2006 as a designee of SCO Capital Partners LLC. Mr.
Alvino currently works as Managing Director for Griffen Securities. From 2002
to
2007 he was Managing Director for SCO Financial Group LLC. He is currently
on
the board of directors of MacroChem Corporation. He previously worked at
Feinstein Kean Healthcare, an Ogilvy Public Relations Worldwide Company. There
he was Senior Vice President, responsible for managing both investor and
corporate communications programs for many private and public companies and
acted as senior counsel throughout the agency's network of offices. Prior to
working at FKH, Mr. Alvino served as Vice President of Investor Relations and
managed the New York Office of Allen & Caron, Inc., an investor relations
agency. His base of clients included medical devices, biotechnology, and
e-healthcare companies. Mr. Alvino also spent several years working with Wall
Street brokerages including Ladenburg, Thallman & Co. and Martin Simpson
& Co.
Stephen
B. Howell, M.D.
has
served as one of Access’ directors since 1996. Dr. Howell is a member of the
Compensation Committee of the Board. Dr. Howell is a Professor of Medicine
at
the University of California, San Diego, and director of the Cancer Pharmacology
Program of the UCSD Cancer Center. Dr. Howell is a recipient of the Milken
Foundation prize for his contributions to the field of cancer chemotherapy.
He
has served on the National Research Council of the American Cancer Society
and
is on the editorial boards of multiple medical journals. Dr. Howell founded
DepoTech, Inc. and served as a member of its board of directors from 1989 to
1999. Dr. Howell served on the board of directors of Matrix Pharmaceuticals
from
2000 to 2002. Dr. Howell received his A.B. at the University of Chicago and
his
M.D. from Harvard Medical School.
Mr.
David P. Luci
has
served as one of Access’ directors since January 2007. Mr. Luci is Executive
Vice President of Bioenvision, Inc. He has also served as Bioenvision’s chief
financial officer, general counsel and corporate secretary since July 2004,
after serving as director of finance, general counsel and corporate secretary
since July 2002. From September 1994 to July 2002, Mr. Luci served as a
corporate associate at Paul, Hastings, Janofsky & Walker LLP (New York
office). Prior to that, Mr. Luci served as a senior auditor at Ernst & Young
LLP (New York office). Mr. Luci is a certified public accountant. He holds
a
Bachelor of Science in Business Administration with a concentration in
accounting from Bucknell University and a J.D. (cum laude) from Albany Law
School of Union University.
Mr.
John J. Meakem, Jr. has
been
one of Access’ directors since 2001. Mr. Meakem is also a member of the
Nominating and Corporate Governance Committee of the Board and a member of
the
Audit and Finance Committee of the Board. Mr. Meakem is a private investor
with
portfolio holdings in innovative companies with a particular focus on
healthcare. Most recently Mr. Meakem served as Chairman of the Board, President
and Chief Executive Officer of Advanced Polymer Systems, Inc. from 1991 to
2000.
Prior to 1991, he was Corporate Executive Vice President of Combe, Inc. and
President of Combe North America. Prior to 1970, Mr. Meakem was with Vick
Chemical Company, a division of Richardson Merrell Drug Corporation, for ten
years as Vice President of Marketing, New Products &
Acquisitions.
David
P. Nowotnik, Ph.D.
has
been Senior Vice President Research and Development since January 2003 and
was
Vice President Research and Development from 1998. From 1994 until 1998, Dr.
Nowotnik had been with Guilford Pharmaceuticals, Inc. in the position of Senior
Director, Product Development and was responsible for a team of scientists
developing polymeric controlled-release drug delivery systems. From 1988 to
1994
he was with Bristol-Myers Squibb researching and developing technetium
radiopharmaceuticals and MRI contrast agents. From 1977 to 1988 he was with
Amersham International leading the project which resulted in the discovery
and
development of Ceretec.
81
Mr.
Phillip S. Wise
has been
Access’ Vice President Business Development since June 2006. Mr. Wise was Vice
President of Commercial and Business Development for Enhance Pharmaceuticals,
Inc. and Ardent Pharmaceuticals, Inc. from 2000 until 2006. Prior to that time
he was with Glaxo Wellcome, from 1990 to 2000 in various
capacities.
Mr.
Stephen B. Thompson
has been
Vice President since 2000 and Access’ Chief Financial Officer since 1996. From
1990 to 1996, he was Controller and Administration Manager of Access
Pharmaceuticals, Inc., a private Texas corporation. Previously, from 1989 to
1990, Mr. Thompson was Controller of Robert E. Woolley, Inc., a hotel real
estate company where he was responsible for accounting, finances and investor
relations. From 1985 to 1989, he was Controller of OKC Limited Partnership,
an
oil and gas company, where he was responsible for accounting, finances and
SEC
reporting. Between 1975 and 1985 he held various accounting and finance
positions with Santa Fe International Corporation.
Code
of Business Conduct and Ethics
In
October 2004, Access adopted a written Code of Business Conduct and Ethics
for
Employees, Executive Officers and Directors, applicable to all employees,
management, and directors, designed to deter wrongdoing and promote honest
and
ethical conduct, full, fair and accurate disclosure, compliance with laws,
prompt internal reporting and accountability to adherence to the Code of
Business Conduct and Ethics.
The
following executive compensation disclosure reflects compensation awarded to,
earned by or paid to Access’ Chief Executive Officer and each of Access’ other
executive officers listed below whose total compensation exceeded $100,000
for
the fiscal year ended December 31, 2006. Access refers to Access’ Chief
Executive Officer and these other executive officers as Access’ "named executive
officers" elsewhere in this prospectus.
Summary
Compensation Table
|
Name
and Principal Position (7)
|
Year
|
Salary
($) (1)
|
Bonus
($)
|
Stock
Awards($) (2)
|
Option
Award($) (3)
|
All
Other Compensation (4)
|
Total
($)
|
|||||||||||||||
|
Rosemary
Mazanet(5)(8)
Acting
CEO
|
2006
2005
|
$
|
357,385
217,500
|
$
|
100,000
30,000
|
$
|
-
-
|
$
|
81,464
168,468
|
$
|
2,594
1,297
|
$
|
541,443
248,797
|
|||||||||
|
Kerry
P. Gray(6)
Former
President and CEO
|
2005
|
$
|
133,332
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
3,505
|
$
|
136,837
|
|||||||||
|
David
P. Nowotnik, Ph.D.
Senior
Vice President Research
and
Development
|
2006
2005
|
$
|
253,620
250,710
|
$
|
20,000
25,408
|
$
|
-
24,154
|
$
|
40,732
67,619
|
$
|
7,152
7,094
|
$
|
321,504
374,985
|
|||||||||
|
Phillip
S. Wise(7)
Vice
President, Business
Development
|
2006
|
$
|
116,667
|
$
|
25,000
|
$
|
-
|
$
|
40,732
|
$
|
358
|
$
|
182,757
|
|||||||||
|
Stephen
B. Thompson
Vice
President, Chief Financial Officer
|
2006
2005
|
$
|
154,080
152,310
|
$
|
20,000
15,435
|
$
|
-
14,704
|
$
|
40,732
42,262
|
$
|
4,508
4,455
|
$
|
219,320
229,166
|
|||||||||
____________________
82
|
(1)
|
Includes
amounts deferred under Access’ 401(k)
Plan.
|
|
(2)
|
There
were no stock awards granted in 2006 and no restricted stock outstanding
at December 31, 2006.
|
|
(3)
|
The
value listed in the above table represents the fair value of the
options
granted in prior years that were recognized in 2006 under FAS 123R.
Fair
value is calculated as of the grant date using a Black-Sholes
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by Access’ stock
price as well as assumptions regarding a number of complex and subjective
variables. Access’ assumptions in determining fair value are described in
note 10 to Access’ audited financial statements for the year ended
December 31, 2006, included in Access’ Annual Report on Form
10-KSB.
|
|
(4)
|
Amounts
reported for fiscal years 2006 and 2005 consist of: (i) amounts Access
contributed to its 401(k) Plan with respect to each named individual,
(ii)
amounts Access paid for group term life insurance for each named
individual, and (iii) for Mr. Gray, premiums paid by Access each
year for
life insurance for Mr. Gray.
|
|
(5)
|
Amounts
listed in 2006 and 2005 for Dr. Mazanet indicate compensation paid
to her
in connection with her services as Access’ Acting CEO commencing on May
11, 2005.
|
|
(6)
|
Amounts
listed in 2005 for Mr. Gray indicate compensation paid to him in
connection with his services as Access’ President and CEO through May 10,
2005. In addition to such amounts listed in the table above, Mr.
Gray also
received a total of $333,333 and $488,335 per the terms of his Separation
Agreement in 2006 and 2005,
respectively.
|
|
(7)
|
Phillip
S. Wise became Access’ Vice President Business Development June 1,
2006.
|
|
(8)
|
Stephen
R. Seiler became Access’ President and Chief Executive Officer effective
January 1, 2007 and is not included in this table.
|
Employment
Agreements
President
and Chief Executive Officer
Access
is
a party to an employment arrangement with Stephen R. Seiler, who was named
by
the Board as Access’ President and Chief Executive Officer and director,
effective as of January 4, 2007 (the "Effective Date"). Mr. Seiler is paid
an
annual salary of $350,000 and was granted stock options to purchase 500,000
shares of Common Stock with an exercise price equal to the closing price of
Common Stock on the day preceding the Effective Date. Mr. Seiler's options
vest
25% on January 4, 2008 and monthly thereafter over a 36 month period. The stock
options are granted under Access’ 2005 Equity Incentive Plan and the 2007
Special Stock Option Plan. Mr. Seiler is entitled to similar employee benefits
as Access’ other executive officers. Under certain circumstances relating to a
change of control of Access, Mr. Seiler may be entitled to receive a payment
equal to his annual salary, acceleration of options and extension of health
care
benefits.
Access
is
a party to an employment arrangement with Rosemary Mazanet, Access’ former
Acting Chief Executive Officer. Dr. Mazanet reported directly to, and was
subject to the direction of, the Board. Dr. Mazanet salary was set at $25,000
monthly. Dr. Mazanet was granted a non-qualified stock option of 6,000 shares
of
Common Stock, vesting over a six month period. In November 2005, Dr. Mazanet
was
also granted 50,000 options under Access’ 2005 Equity Incentive Plan. 14,000
options vested on grant, the rest vest upon attainment of preset milestones.
Dr.
Mazanet also received similar employee benefits as Access’ other executive
officers, D&O insurance coverage and received a signing bonus of $30,000.
The Board granted Dr. Mazanet an additional 200,000 options in 2006.
Additionally, Dr. Mazanet was awarded a bonus of $100,000 in April
2007.
Senior
Vice President
Access
is
a party to an employment agreement with David P. Nowotnik, Ph.D., Access’ Senior
Vice President, Research and Development, which renews automatically for
successive one-year periods, with the current term extending until November
16,
2007. Under this agreement, Dr. Nowotnik is currently entitled to receive an
annual base salary of $253,620, subject to adjustment by the Board. Dr. Nowotnik
is eligible to participate in all of Access’ employee benefit programs available
to executives. Dr. Nowotnik is also eligible to receive:
| · |
a
bonus payable in cash and Common Stock related to the attainment
of
reasonable performance goals specified by the
Board;
|
| · |
stock
options at the discretion of the
Board;
|
| · |
long-term
disability insurance to provide compensation equal to at least $60,000
annually; and
|
| · |
term
life insurance coverage of $254,000.
|
Dr.
Nowotnik is entitled to certain severance benefits in the event that Access
terminates his employment without cause or if Dr. Nowotnik terminates his
employment following a change of control. In the event that Access terminates
the employment agreement for any reason, other than for cause, Dr. Nowotnik
will
receive his salary for six months. Access will also continue benefits for such
period. In the event that Dr. Nowotnik's employment is terminated within six
months following a change in control or by Dr. Nowotnik upon the occurrence
of
certain events following a change in control, Dr. Nowotnik will receive twelve
months salary and his stock options will become immediately exercisable. Access
will also continue payment of benefits for such period.
83
Vice
President - Chief Financial Officer
Access
is
party to an employment agreement with Stephen B. Thompson, Access’ Vice
President and Chief Financial Officer, which renews automatically for successive
one-year periods. Mr. Thompson is entitled to an annual base salary of $154,080,
subject to adjustment by the Board. The employment agreement also grants Mr.
Thompson similar employee benefits as Access’ other executive officers. Mr.
Thompson is also eligible to receive:
| · |
a
bonus payable in cash and Common Stock related to the attainment
of
reasonable performance goals specified by the
Board;
|
| · |
stock
options at the discretion of the
Board;
|
| · |
long-term
disability insurance to provide compensation equal to at least $90,000
annually; and
|
| · |
term
life insurance coverage of
$155,000.
|
Mr.
Thompson is entitled to certain severance benefits in the event that Access
terminates his employment without cause or if Mr. Thompson terminates his
employment following a change of control. In the event that Access terminates
the employment agreement for any reason, other than cause, Mr. Thompson will
receive salary for six months. Access will also continue benefits for such
period. In the event that Mr. Thompson's employment is terminated within six
months following a change of control or by Mr. Thompson upon the occurrence
of
certain events following a change in control, Mr. Thompson will receive twelve
months salary and his stock options will become immediately exercisable. Access
will also continue payment of benefits for such period.
2006
Equity Incentive Plan
Access’
board of directors adopted and Access’ stockholders approved Access’ 2005 Equity
Incentive Plan in May 2005. As of December 31, 2006, options to purchase 802,672
shares of common stock were outstanding at a weighted average exercise price
of
$1.04 per share and 197,328 shares remained available for future grant.
Purpose.
The
purpose of the Plan is to attract and retain the best available personnel for
positions of substantial responsibility and to provide additional incentive
to
employees and directors of and advisers and consultants to the Company. The
purpose of the proposed amendment is to provide the Company with additional
capacity to award stock options to existing personnel and to attract qualified
new employees, directors, advisers and consultants through grants of stock
options.
Administration.
The
Plan
is administered by the Compensation Committee. During 2006, the Compensation
Committee was composed of four directors, Jeffrey B. Davis, Herbert H. McDade,
Jr., J. Michael Flinn and Max Link. The Compensation Committee presently is
composed of Jeffrey B. Davis, David P. Luci and Stephen B. Howell, MD. Subject
to the provisions of the Plan, the Compensation Committee has discretion to
determine when awards are made, which employees are granted awards, the number
of shares subject to each award and all other relevant terms of the awards.
The
Compensation Committee also has broad discretion to construe and interpret
the
Plan and adopt rules and regulations thereunder. The Compensation Committee
approved the 2007 Special Stock Option Plan and the grant of 450,000 options
to
Access’ new President and Chief Executive Officer in January 2007.
Eligibility.
Awards
may be granted to persons who are employees of Access whether or not officers
or
members of the Board and directors of or advisers or consultants to Access
or of
any of Access’ subsidiaries. No election by any such person is required to
participate in the Plan.
Shares
Subject to the Plan. The
shares issued or to be issued under the Plan are shares of Common Stock, which
may be newly issued shares or shares held in the treasury or acquired in the
open market. Previously, no more than 1,000,000 shares could be issued under
the
Plan. The foregoing limit is subject to adjustment for stock dividends, stock
splits or other changes in the Company’s capitalization.
Stock
Options. The
Compensation Committee in its discretion may issue stock options which qualify
as incentive stock options under the Internal Revenue Code or non-qualified
stock options. The Compensation Committee will determine the time or times
when
each stock option becomes exercisable, the period within which it remains
exercisable and the price per share at which it is exercisable, provided that
no
incentive stock option shall be exercised more than 10 years after it is granted
and no other options shall be exercised more than 10 years and one day after
it
is granted, and further provided that the exercise price of any incentive stock
option shall not be less than the fair market value of the Common Stock on
the
date of grant. The closing price of the Common Stock on the OTC Bulletin Board
on March 30, 2007 was $6.45 per share.
84
Payment
for shares purchased upon exercise of an option must be made in full in cash
or
check, by payment through a broker in accordance with Regulation T of the
Federal Reserve Board or by such other mode of payment as the Committee may
approve, including payment in whole or in part in shares of the Common Stock,
when the option is exercised. No option is transferable except by will or the
laws of descent and distribution or pursuant to a qualified domestic relations
order, as defined by the Code or in Title I of the Employee Retirement Income
Security Act of 1974, as amended.
Notwithstanding
any other provision of the Plan, each non-employee director is also entitled
to
receive options to purchase 2,500 shares of Common Stock on the date of each
annual meeting of stockholders and options to purchase 25,000 shares of Common
Stock when he or she is first appointed as a director.
Tax
Considerations.
The
following is a brief and general discussion of the federal income tax rules
applicable to awards under the Plan. With respect to an incentive stock option,
an employee will generally not be taxed at the time of grant or exercise,
although exercise of an incentive option will give rise to an item of tax
preference that may result in an alternative minimum tax. If the employee holds
the shares acquired upon exercise of an incentive stock option until at least
one year after issuance and two years after the option grant, he or she will
have long-term capital gain (or loss) based on the difference between the amount
realized on the sale or disposition and his or her option price. If these
holding periods are not satisfied, then upon disposition of the shares the
employee will recognize ordinary income equal, in general, to the excess of
the
fair market value of the shares at time of exercise over the option price,
plus
capital gain in respect of any additional appreciation. With respect to a
non-qualified option, an employee will not be taxed at the time of grant; upon
exercise, he or she will generally realize compensation income to the extent
the
then fair market value of the stock exceeds the option price. Access will
generally have a tax deduction to the extent that, and at the time that, an
employee realizes compensation income with respect to an award.
Any
tax
deductions Access may be entitled to in connection with awards under the Plan
may be limited by the $1 million limitation under Section 162(m) of the Code
on
compensation paid to any of Access’ chief executive officer or other named
officers. This limitation is further discussed in the Compensation Committee
Discussion on Executive Compensation.
For
purposes of this summary, Access has assumed that no award will be considered
“deferred
compensation”
as that
term is defined for purposes of the federal tax rules governing nonqualified
deferred compensation arrangements, Section 409A of the Code, or, if any award
were considered to any extent to constitute deferred compensation, its terms
would comply with the requirements of that legislation (in general, by limiting
any flexibility in the time of payment). For example, the award of a
non-qualified stock option with an exercise price which is less than the market
value of the stock covered by the option would constitute deferred compensation.
If an award includes deferred compensation, and its terms do not comply with
the
requirements of these tax rules, then any deferred compensation component of
the
award will be taxable when it is earned and vested (even if not then payable)
and the recipient will be subject to a 20% additional tax.
In
all
cases, recipients of awards should consult their tax advisors regarding the
tax
treatment of any awards received by them.
401(k)
Plan
Access
maintains a defined contribution employee retirement plan, or 401(k) plan,
for
Access’ employees. Access’ executive officers are also eligible to participate
in the 401(k) plan on the same basis as Access’ other employees. The plan is
intended to qualify as a tax-qualified plan under Section 401(k) of the Internal
Revenue Code. The plan provides that each participant may contribute up to
the
statutory limit, which is $15,500 for calendar year 2007. Participants who
are
50 years or older can also make "catch-up" contributions, which in calendar
year
2007 may be up to an additional $5,000 above the statutory limit. Under the
plan, each participant is fully vested in his or her deferred salary
contributions, including any matching contributions by us, when contributed.
Participant contributions are held and invested by the participants in the
plan's investment options. The plan also permits Access to make discretionary
contributions and matching contributions, subject to established limits and
a
vesting schedule. In 2006, Access matched 100% of participant contributions
up
to the first two percent of eligible compensation. Access matches participant
contributions at the first four percent of eligible compensation in 2007.
85
Outstanding
Equity Awards at December 31, 2006
The
following table sets forth certain information regarding outstanding equity
awards held by Access’ named executive officers at December 31,
2006.
|
Option
Awards (1)
|
||||||
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of Securities Underlying Unexercised Options (#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned
Options
(#)
|
Option
Exercise
Price
($)
|
Option
Exercise Date
|
|
|
Rosemary
Mazanet(2)
|
50,000
39,796
6,000
|
150,000
10,204
|
-
|
0.63
5.45
12.50
|
08/17/06
11/02/05
05/11/05
|
|
|
Kerry
P. Gray(3)
|
20,000
28,000
32,000
32,000
20,000
100,000
32,000
32,000
|
-
|
-
|
29.25
11.50
18.65
34.38
27.50
12.50
10.00
15.00
|
01/23/04
05/19/03
03/22/02
11/20/00
10/12/00
03/01/00
07/20/99
06/18/98
|
|
|
David
P. Nowotnik, Ph.D.
|
25,000
3,167
3,646
6,854
10,000
10,000
10,000
10,000
|
75,000
4,833
1,354
146
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/06
05/23/05
01/23/04
01/30/03
03/22/02
03/01/00
07/20/99
11/16/98
|
|
|
Phillip
S. Wise
|
25,000
|
75,000
|
-
|
0.63
|
08/17/06
|
|
|
Stephen
B. Thompson
|
25,000
1,979
2,187
3,917
6,000
9,000
4,000
4,000
|
75,000
3,021
813
83
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/06
05/23/05
01/23/04
01/30/03
03/22/02
03/01/00
07/20/99
06/18/98
|
|
____________________
|
(1)
|
On
December 31, 2006, the closing price of Access’ Common Stock as quoted on
the OTC Bulletin Board was $2.80.
|
|
(2)
|
Options
listed for Dr. Mazanet include options paid to her in connection
with her
services as Access’ Acting CEO commencing on May 11,
2005.
|
|
(3)
|
Options
listed for Mr. Gray include options paid to him in connection with
his
services as Access’ President and CEO through May 10,
2005.
|
Board
Committees
The
Board
established an Audit and Finance Committee, a Compensation Committee and a
Nominating and Corporate Governance Committee. Each of the committees of the
Board acts pursuant to a separate written charter adopted by the Board. On
February 8, 2007, the Board also established an Executive Committee consisting
of Mr. Davis, Mr. Seiler and Dr. Ahn.
86
The
Audit
and Finance Committee is currently comprised of David P. Luci (chairman) and
John J. Meakem, Jr. During 2006, the Audit and Finance Committee was composed
of
four directors, Max
Link,
Ph.D., Stuart M. Duty, John J. Meakem, Jr., and Jeffrey B. Davis.
All of
the current members of the Audit and Finance Committee are independent under
applicable SEC and AMEX rules and regulations. During 2006 Dr. Link, Mr. Duty
and Mr. Meakem were independent under applicable SEC and AMEX rules and
regulations. The Board has determined that Mr. Luci, the chairman of the Audit
and Finance Committee, is an “audit committee financial expert,” under
applicable SEC rules and regulations. The Audit and Finance Committee’s
responsibilities and duties are among
other things to engage the independent auditors, review the audit fees,
supervise matters relating to audit functions and review and set internal
policies and procedure regarding audits, accounting and other financial
controls.
The
Compensation Committee is currently comprised of Jeffrey B. Davis (chairman),
Mr. David P. Luci and Dr. Stephen B. Howell. Mr.
Luci
is
independent under
applicable AMEX rules and regulations
and is a
non-employee director under applicable SEC rules and “outside” under Internal
Revenue Code Section 162(m). Mr. Davis and Mr. Howell are not independent
applicable AMEX rules and regulations. During
2006, the Compensation Committee was composed of Herbert H. McDade, Jr., Jeffrey
B. Davis, J. Michael Flinn and Stephen B. Howell, MD.
The
Nominating and Corporate Governance Committee is currently comprised of John
J.
Meakem, Jr. (chairman), Mark Ahn, PhD and Mark J. Alvino. During 2006 Stuart
M.
Duty was also a member of the committee. Mr. Meakem and Mr. Ahn
are independent
under
applicable AMEX rules and regulations. Mr.
Alvino is not independent under applicable AMEX rules and regulations.
The
Nominating and Corporate Governance Committee is responsible for, among other
things, considering potential Board members, making recommendations to the
full
Board as to nominees for election to the Board, assessing the effectiveness
of
the Board and implementing Access’ corporate governance guidelines.
Compensation
of Directors
Each
director who is not also an Access employee receives a quarterly fee of $3,000
and $1,000 per quarter per committee (aggregate for all committees) in which
he/she is a member. The Chairman of the Board is paid an additional $1,000
per
quarter and the Chairman of each of the Audit and Finance and Compensation
Committee is paid an additional $500 per quarter. Mr. Flinn was paid $183,000
in
2006 for serving as Chairman of the Board for 2005 and 2006. Each director
will
have $2,000 deducted from his or her fee if the director misses more than one
Board meeting, and $1,000 deducted per committee meeting not attended. In
addition, Access reimbursed each director, whether an employee or not, the
expenses of attending Board and committee meetings. Each non-employee director
is also entitled to receive options to purchase 2,500 shares of Common Stock
on
the date of each annual meeting of stockholders and options to purchase 25,000
shares of Common Stock when he/she is first appointed as a director.
Director
Compensation Table - 2006
The
table
below represents the compensation paid to Access’ outside directors during the
year ended December 31, 2006:
|
Name
|
Fees
earned or Paid in Cash ($)
|
Option
Awards ($)(1)
|
All
Other Compensation ($)
|
Total
($)
|
|
Mark
J. Ahn, PhD (2)
|
4,000
|
7,592
|
-
|
11,592
|
|
Mark
J. Alvino (3)
|
13,000
|
5,581
|
-
|
18,581
|
|
Esteban
Cvitkovic, MD (8)
|
-
|
-
|
-
|
-
|
|
Jeffrey
B. Davis (3)
|
16,650
|
5,581
|
-
|
22,231
|
|
Stuart
M. Duty (4)
|
16,000
|
8,379
|
-
|
24,379
|
|
J.
Michael Flinn (5)
|
17,525
|
15,411
|
183,333
|
216,269
|
|
Stephen
B. Howell, MD (6)
|
12,000
|
6,137
|
-
|
18,137
|
|
David
P. Luci (8)
|
-
|
-
|
-
|
-
|
|
Rosemary
Mazanet, MD, PhD (9)
|
-
|
-
|
-
|
-
|
|
Max
Link, PhD (7)
|
12,000
|
556
|
-
|
12,557
|
|
Herbert
H. McDade, Jr. (6)
|
17,200
|
6,137
|
-
|
23,338
|
|
John
J. Meakem, Jr. (4)
|
16,000
|
8,379
|
-
|
24,380
|
|
|
(1)
|
|
The
value listed in the above table represents the fair value of the
options
recognized as expense under FAS 123R during 2006, including unvested
options granted before 2006 and those granted in2006. Fair value
is
calculated as of the grant date using a Black-Sholes (“Black-Sholes”)
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by Access’ stock
price as well as assumptions regarding a number of complex and subjective
variables. Access’ assumptions in determining fair value are described in
note 10 to Access’ audited financial statements for the year ended
December 31, 2006, included in Access’ Annual Report on Form
10-KSB.
|
|
(2)
|
Represents
expense recognized in 2006 in respect of 25,000 options to purchase
share
based on a grant date fair value of $7,592.
|
||
|
(3)
|
Represents
expense recognized in 2006 in respect of 25,000 options to purchase
shares
based on grant date fair value of
$5,581.
|
87
|
(4)
|
Represents
expense recognized in 2006 in respect of 25,000 options to purchase
shares
based on a grant date fair value of $5,581; 1,200 options to purchase
shares based on a grant date fair value of $556; and 4,836 options
to
purchase shares based on a grant date fair value of
$2,242.
|
||
|
(5)
|
Represents
expense recognized in 2006 in respect of 25,000 options to purchase
shares
based on a grant date fair value of $5,581; 1,200 options to purchase
shares based on a grant date fair value of $556; and 20,000 options
to
purchase shares based on a grant date fair value of
$9,274.
|
||
|
(6)
|
Represents
expense recognized in 2006 in respect of 25,000 options to purchase
shares
based on a grant date fair value of $5,581 and 1,200 options to purchase
shares based on a grant date fair value of $556.
|
||
|
(7)
|
Represents
expense recognized in 2006 in respect of 1,200 options to purchase
shares
based on grant date fair value of $556.
|
||
|
(8)
|
Dr.
Cvitkovic and Mr. Luci became directors in 2007.
|
||
|
(9)
|
Dr.
Mazanet was an inside director during 2006 and was not paid directors
fees. She became an outside director in January
2007.
|
The
following table summarizes the aggregate number of option awards held by each
director at December 31, 2006. There were no outstanding stock awards held
by
any director at December 31, 2006:
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of Securities Underlying Unexercised Options (#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options (#)
|
Option
Exercise Price ($)
|
Option
Expiration Date
|
|
Mark
J. Ahn, PhD
|
-
|
25,000
|
-
|
0.85
|
09/01/16
|
|
Mark
J. Alvino
|
-
|
25,000
|
-
|
0.63
|
08/17/16
|
|
Jeffrey
B. Davis
|
-
|
25,000
|
-
|
0.63
|
08/17/16
|
|
Esteban
Cvitkovic, MD (1)
|
-
|
-
|
-
|
-
|
-
|
|
Stuart
M. Duty
|
2,500
4,836
1,200
|
25,000
|
-
|
0.63
12.40
3.15
3.15
|
08/17/16
5/12/15
2/05/16
2/05/16
|
|
J.
Michael Flinn
|
2,000
2,000
1,000
2,000
2,000
2,500
2,500
2,500
1,200
20,000
|
25,000
|
-
|
0.63
15.00
10.00
17.81
23.05
14.05
11.50
28.50
12.40
3.15
3.15
|
08/17/16
06/18/08
07/20/09
06/26/10
05/21/11
05/20/12
05/19/13
05/19/14
05/12/15
02/05/16
02/05/16
|
|
Stephen
B. Howell, MD (3)
|
417
1,000
2,000
2,000
2,500
2,500
2,500
1,200
|
25,000
|
-
|
0.63
15.00
17.81
23.05
14.05
11.50
28.50
12.40
3.15
|
08/17/16
06/18/08
06/26/10
05/21/11
05/20/12
05/19/13
05/19/14
05/12/15
02/05/16
|
|
David
P. Luci (1)
|
-
|
-
|
-
|
-
|
-
|
|
Rosemary
Mazanet, MD, PhD (2)
|
-
|
||||
|
Max
Link, PhD
|
1,200
|
|
-
|
0.63
|
08/17/16
|
|
Herbert
H. McDade, Jr.
|
2,500
1,000
2,000
2,000
2,500
2,500
1,200
|
25,000
|
-
|
0.63
15.00
17.81
23.05
14.05
28.50
12.40
3.15
|
08/17/16
06/18/08
06/26/10
05/21/11
05/20/12
05/19/14
05/12/15
02/05/16
|
88
|
John
J. Meakem, Jr.
|
4,000
2,000
2,500
2,500
2,500
4,836
1,200
|
25,000
|
-
|
0.63
20.25
14.05
11.50
28.50
12.40
3.15
3.15
|
08/17/16
02/16/11
05/20/12
05/19/13
05/19/14
05/12/15
02/05/16
02/05/16
|
____________________
|
(1)
|
Dr.
Cvitkovic and Mr. Luci became directors in 2007.
|
|
(2)
|
Since
Dr. Mazanet became an outside director in January 2007, her options
are
reported in the executive compensation tables.
|
|
(3)
|
Dr.
Howell also has a warrant to purchase 3,000 shares of Access Common
Stock
at an exercise price of $15.00 per share, and a warrant to purchase
2,000
shares of Access Common Stock at an exercise price of $24.80 per
share.
|
89
Access
is
not currently subject to any material pending legal proceedings.
Based
solely upon information made available to Access, the following table sets
forth
certain information with respect to the beneficial ownership of Access’ Common
Stock as of July 19, 2007 by (i) each person who is known by Access to
beneficially own more than five percent of Access’ Common Stock; (ii) each of
Access’ directors; (iii) each of Access’ named executive officers; and (iv) all
Access’ executive officers and directors as a group. Beneficial ownership as
reported in the following table has been determined in accordance with Rule
13d-3 under the Securities Exchange Act of 1934, as amended. The address of
each
holder listed below, except as otherwise indicated, is c/o Access
Pharmaceuticals, Inc., 2600 Stemmons Freeway, Suite 176, Dallas, Texas 75207.
|
Common
Stock Beneficially Owned
|
||||
|
Name
of Beneficial Owner
|
Number
of Shares(1)
|
%
of Class
|
||
|
Jeffery
B. Davis (2)
|
30,820
|
|
*
|
|
|
Rosemary
Mazanet (3)
|
147,256
|
|
4.0%
|
|
|
Mark
Ahn (4)
|
25,000
|
|
*
|
|
|
Mark
J. Alvino (5)
|
80,525
|
|
2.2%
|
|
|
Stephen
B. Howell, M.D. (6)
|
53,839
|
|
1.5%
|
|
|
John
J. Meakem, Jr.
(7)
|
53,536
|
|
1.5%
|
|
|
David
P. Nowotnik, Ph.D. (8)
|
122,682
|
|
3.4%
|
|
|
Phillip
S. Wise (9)
|
50,000
|
|
1.4%
|
|
|
Stephen
B. Thompson (10)
|
91,521
|
|
2.5%
|
|
|
Larry
N. Feinberg (11)
|
1,142,964
|
|
26.4%
|
|
|
Kerry
P. Gray (12)
|
355,136
|
|
9.3%
|
|
|
SCO
Capital Partners LLC (13)
|
4,682,040
|
|
57.0%
|
|
|
All
Directors and Executive Officers as a group
(consisting
of 10 persons) (14)
|
655,180
|
|
14.8%
|
|
*
- Less
than 1%
| (1) |
Includes
Access’ outstanding shares of Common Stock held plus all shares of Common
Stock issuable upon exercise of options, warrants and other rights
exercisable within 60 days of July 19, 2007.
|
| (2) |
Mr.
Davis is President of SCO Securities LLC. His address is c/o SCO
Capital
Partners LLC, 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. SCO Securities LLC and affiliates (SCO
Capital
Partners LLC, Beach Capital LLC, Lake End Capital LLC, Howard Fischer,
Mr.
Davis and Mark J. Alvino) are known to beneficially own warrants
to
purchase an aggregate of 4,682,040 of Access’ Common Stock and 5,454,544
shares of Common Stock issuable to them upon conversion of notes.
Mr.
Davis disclaims beneficial ownership of all such shares except to
the
extent of his pecuniary interest therein. Does not include any such
shares
other than 5,280 shares underlying warrants held directly by Mr.
Davis.
Includes presently exercisable options for the purchase of 25,000
shares
of Access’ Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
| (3) |
Includes
presently exercisable options for the purchase of 141,256 shares
of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and 6,000
shares of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
| (4) |
Includes
presently exercisable options for the purchase of 25,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
90
|
|
| (5) |
Includes
55,525 shares of Common Stock underlying warrants held by Mr. Alvino.
Mr.
Alvino is Managing Director of SCO Securities LLC. His address is
c/o SCO
Capital Partners LLC, 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. SCO Securities LLC and affiliates (SCO
Capital
Partners LLC, Beach Capital LLC, Lake End Capital LLC, Howard Fischer,
Jeffrey B. Davis and Mr. Alvino) are known to beneficially own warrants
to
purchase an aggregate of 4,682,040 of Access’ Common Stock and 5,454,544
shares of Common Stock issuable to them upon conversion of notes.
Mr.
Alvino disclaims beneficial ownership of all such shares except to
the
extent of his pecuniary interest therein. Does not include any such
shares
other than 55,525 shares underlying warrants held directly by Mr.
Alvino.
Includes presently exercisable options for the purchase of 25,000
shares
of Access’ Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
| (6) |
Includes
presently exercisable options for the purchase of 26,200 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan, 12,917 shares
of
Access’ Common Stock pursuant to the 1995 Stock Option Plan, a warrant to
purchase 3,000 shares of Access’ Common Stock at an exercise price of
$15.00 per share, and a warrant to purchase 2,000 shares of Access’ Common
Stock at an exercise price of $24.80 per
share.
|
| (7) |
Includes
presently exercisable options for the purchase of 31,036 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and 13,500
shares
of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
| (8) |
Includes
presently exercisable options for the purchase of 50,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and 55,167
shares
of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
| (9) |
Includes
presently exercisable options for the purchase of 50,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
| (10) |
Includes
presently exercisable options for the purchase of 50,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and 32,000
shares
of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
| (11) |
Larry
N. Feinberg is a partner in Oracle Partners, L.P. His address is
c/o
Oracle Partners, L.P., 200 Greenwich Avenue, 3rd
Floor, Greenwich, CT 06830. Oracle Partners, L.P. and affiliates
(Oracle
Institutional Partners, L.P., Oracle Investment Management, Inc.,
Sam
Oracle Fund, Inc. and Mr. Feinberg) are known to beneficially own
an
aggregate of 339,964 shares of Access’ Common Stock and convertible notes
which may convert into an aggregate of 803,000 shares of Access’ Common
Stock.
|
| (12) |
Mr.
Gray's address is 4939 Stony Ford Dr., Dallas, Texas 75287. Includes
presently exercisable options for the purchase of 296,000 shares
of
Access’ Common Stock pursuant to the 1995 Stock Option Plan and the 2000
Special Stock Option Plan.
|
| (13) |
SCO
Capital Partners LLC's address is 1285 Avenue of the Americas,
35th
Floor, New York, NY 10019. SCO Capital Partners LLC and affiliates
(Beach
Capital LLC, Lake End Capital LLC, Howard Fisher, Jeffrey B. Davis
and
Mark J. Alvino) are known to beneficially own warrants to purchase
an
aggregate of 4,682,040 shares of Access’ Common Stock and 5,454,544 shares
of Common Stock issuable to them upon conversion of notes. Each of
Mr.
Davis and Mr. Alvino, Access’ directors and executives with SCO Capital
Partners LLC, disclaims beneficial ownership of such shares except
to the
extent of his pecuniary interest
therein.
|
| (14) |
Does
not include shares held by SCO Securities LLC and affiliates (other
than
shares underlying warrants held directly by Messrs. Davis and
Alvino).
|
SECURITIES
AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS
Access
adopted its 2005 Equity Incentive Plan in May 2005, as amended, authorizing
1,675,000 shares under the plan. Access issued 977,672 options or rights under
this plan as of July 19, 2007. The balance of the options outstanding as
of July 19, 2007 is 697,328. Access adopted its 2001 Restricted Stock Plan
in May 2001, authorizing 80,000 shares of its authorized but unissued common
stock were reserved for issuance to certain employees, directors, consultants
and advisors. Access issued 27,182 shares and 52,818 shares available for
grant.
91
The
following table sets forth information as of December 31, 2006 about shares
of
Common Stock outstanding and available for issuance under Access’ equity
compensation plans existing as of such date.
|
Plan
Category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
|
Weighted-average
exercise price of outstanding options, warrants
and rights
|
Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in
column (a))
|
|||
|
(a)
|
(b)
|
(c)
|
||||
|
Equity
compensation plans approved by security holders
|
||||||
|
2005
Equity Incentive Plan
1995
Stock Awards Plan
2001
Restricted Stock Plan
|
802,672
360,917
-
|
$
1.04
$18.03
-
|
197,328
-
52,818
|
|||
|
Equity
compensation plans not approved by security holders
|
||||||
|
2000
Special Stock Option
Plan
|
100,000
|
$12.50
|
-
|
|||
|
Total
|
1,263,589
|
$
6.80
|
250,146
|
|||
The
2000 Special Stock Option Plan
The
2000
Special Stock Option Plan (the "Special Plan") was adopted by the Board in
October 2000. The Special Plan is a non-stockholder approved plan (as permitted
under NASD rules and regulations applicable at the time of adoption by the
Board). The Special Plan is intended to be a broadly based plan within the
meaning of NASD rules and regulations applicable at the time of adoption by
the
Board. The Special Plan is not intended to be an incentive stock option plan
within the meaning of Section 422 of the Internal Revenue Code of 1986, as
amended (the “Code”). The Special Plan allows for the issuance of up to 100,000
options to acquire Access’ stock all of which have been issued. The purpose of
the Special Plan is to encourage ownership of Common Stock by employees,
consultants, advisors and directors of Access and its affiliates and to provide
additional incentive for them to promote the success of Access’ business. The
Special Plan provides for the grant of non-qualified stock options to employees
(including officers, directors, advisors and consultants). The Special Plan
will
expire in October 2010, unless earlier terminated by the Board. The options
that were granted expired June 30, 2007.
The
2007 Special Stock Option Plan
The
2007
Special Stock Option Plan (the "Plan") was adopted by the Board in January
2007.
The Plan is not intended to be an incentive stock option plan within the meaning
of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”).
The Plan allows for the issuance of up to 450,000 options to acquire Access’
stock all of which have been issued. The purpose of the Plan is to encourage
ownership of Common Stock by employees, consultants, advisors and directors
of
Access and its affiliates and to provide additional incentive for them to
promote the success of Access’ business. The Plan provides for the grant of
non-qualified stock options to employees (including officers, directors,
advisors and consultants). The Plan will expire in January 2017, unless earlier
terminated by the Board. All of the options have been granted in the Plan in
January 2007.
In
the
event SCO Capital Partners LLC (“SCO”) and its affiliates were to convert all of
their notes and exercise all of their warrants, they would own approximately
74.1% of the voting securities of Access. During 2006 SCO and affiliates were
paid $415,000 in fees relating to the issuance of convertible notes and were
paid $131,000 in investor relations fees.
92
Dr.
Howell, one of Access’ directors, also serves as a scientific consultant to
Access pursuant to a consulting agreement that provides for a minimum of two
days consulting during 2007 at a rate of $5,880 per month plus expenses. Dr.
Howell received warrants to purchase 2,000 shares Access’ Common Stock at $24.80
per share that can be exercised until January 1, 2009; and warrants to purchase
3,000 shares of Access’ Common Stock at $15.00 per share that can be exercised
until January 1, 2008. During 2006, Dr. Howell was paid $69,000 in consulting
fees; during 2005, Dr. Howell was paid $79,000 in consulting fees; and during
2004 Dr. Howell was paid $58,000 in consulting fees. Dr. Howell’s agreement with
Access expires March 1, 2008.
On
January 20, 2006, the Board approved the payment of a fee of $140,000 to J.
Michael Flinn, Access’ former Chairman of the Board, for services as Chairman of
the Board for fiscal 2005. The $140,000 fee was paid on the completion of a
financing. The Board also approved the grant of options to purchase 20,000
shares of Common Stock at an exercise price of $3.15 per share to J. Michael
Flinn for services as Chairman of the Board. In May 2006, the Board also
approved the payment of a fee of $43,333 to Mr. Flinn for services as Chairman
of the Board for 2006. The Board also approved the grant of options to purchase
4,836 shares of Common Stock at an exercise price of $3.15 per share to Messrs.
Duty and Meakem, members of the then existing Merger and Acquisitions Committee
of the Board, for services in connection therewith. The Board also approved
the
grant of options to purchase 1,200 shares of Common Stock at an exercise price
of $3.15 per share to each member of the Board, for services as members of
the
Board.
In
August
2006, the Board approved the grant of options to purchase 25,000 shares of
Common Stock at an exercise price of $0.63 per share to each member of the
Board.
On
October 12, 2000, the Board authorized a restricted stock purchase program.
Under the program, Access’ executive officers were given the opportunity to
purchase shares of Common Stock in an individually designated amount per
participant determined by Access’ Compensation Committee. A total of 36,000
shares were purchased by such officers at $27.50 per share, the fair market
value of the Common Stock on October 12, 2000, for an aggregate consideration
of
$990,000. The purchase price was paid through the participant’s delivery of a
50%-recourse promissory note payable to Access. Each note bears interest at
5.87% compounded semi-annually and has a maximum term of ten years. The notes
are secured by a pledge to Access of the purchased shares. Access recorded
the
notes receivable of $990,000 from participants in this program as a reduction
of
equity in the Consolidated Balance Sheet. As of December 31, 2006, principal
and
interest on the notes was: Mr. Gray - $809,000; Dr. Nowotnik - $404,000; and
Mr.
Thompson - $243,000. In accordance with the Sarbanes-Oxley Act of 2002, Access
no longer makes loans to its executive officers.
Access’
common stock has traded on the OTC Bulletin Board, or OTCBB, under the trading
symbol ACCP since June 5, 2006. From February 1, 2006 until June 5, 2006 Access
traded on the “Pink Sheets” under the trading symbol AKCA. From March 30, 2000
until January 31, 2006 Access traded on the American Stock Exchange, or AMEX,
under the trading symbol AKC.
The
following table sets forth, for the periods indicated, the high and low closing
prices as reported by OTCBB, the Pink Sheets and AMEX for Access’ common stock
for fiscal years 2006 and 2005, and for the first quarter of fiscal year 2007.
The OTCBB and Pink Sheet quotations reflect inter-dealer prices, without retail
mark-up, mark-down or commission and may not represent actual
transactions.
All
per
share information reflect a one for five reverse stock split effected June
5,
2006.
|
Common
Stock
|
||
|
High
|
Low
|
|
|
Period Ended
|
||
|
First
quarter March 31, 2007
|
$10.66
|
$2.50
|
| Second quarter June 30, 2007 |
6.75
|
4.30
|
| To July 19, 2007 |
5.16
|
4.35
|
|
Fiscal
Year Ended December 31, 2006
|
||
|
First
quarter
|
$2.65
|
$0.80
|
|
Second
quarter
|
1.50
|
0.10
|
|
Third
quarter
|
1.30
|
0.45
|
|
Fourth
quarter
|
3.00
|
1.05
|
|
Fiscal
Year Ended December 31, 2005
|
||
|
First
quarter
|
$18.30
|
$11.00
|
|
Second
quarter
|
15.05
|
8.80
|
|
Third
quarter
|
9.95
|
2.80
|
|
Fourth
quarter
|
8.65
|
2.60
|
93
Holders
The
number of record holders of Access common stock at July 19, 2007 was
approximately 3,000. On July 19, 2007, the closing price for the common
stock as quoted on the OTCBB was $4.50. There were 3,541,394 shares of common
stock outstanding at July 19, 2007.
Options
and Warrants
There
are
4,826,517 outstanding warrants and 1,888,704 outstanding options to purchase
Access’ common equity as of July 19, 2007.
Shares
Eligible for Future Sales
Access
issued 3,541,394 shares of its common stock as of July 19, 2007. Of these
shares, all shares are unrestricted and held by non-affiliates, and are freely
tradable without restriction under the Securities Act. These shares will be
eligible for sale in the public market, subject to certain volume limitations
and the expiration of applicable holding periods under Rule 144 under the
Securities Act. In general, under Rule 144 as currently in effect, a person
(or
persons whose shares are aggregated) who has beneficially owned restricted
shares for at least one year (including the holding period of any prior owner
or
affiliate) would be entitled to sell within any three-month period a number
of
shares that does not exceed the greater of one percent (1%) of the number of
shares of common stock then outstanding or (2) the average weekly trading volume
of the common stock during the four calendar weeks preceding the filing of
a
Form 144 with respect to such sale. Sales under Rule 144 are also subject to
certain manner of sale provisions and notice requirements and to the
availability of current public information about us. Under Rule 144(k), a person
who is not deemed to have been an affiliate of Access at any time during the
three months preceding a sale, and who has beneficially owned the shares
proposed to be sold for at least two years (including the holding period of
any
prior owner except an affiliate), is entitled to sell such shares without
complying with the manner of sale, public information, volume limitation or
notice provisions of Rule 144.
Dividends
Access
never declared or paid any cash dividends on its preferred stock or common
stock
and Access does not anticipate paying any cash dividends in the foreseeable
future. The payment of dividends, if any, in the future is within the discretion
of Access’ Board of Directors and will depend on its earnings, capital
requirements and financial condition and other relevant facts. Access currently
intends to retain all future earnings, if any, to finance the development and
growth of its business.
Access’
certificate of incorporation authorizes the issuance of 100,000,000 shares
of
its common stock, $.01 par value per share, and 2,000,000 shares of preferred
stock, $.01 par value per share, which may be issued in one or more series.
As
of July 19, 2007 there were 3,541,394 shares of Access’ common stock
outstanding and held of record by approximately 3,000 stockholders, and there
were no shares of its preferred stock outstanding.
94
Common
Stock
Holders
of Access’ common stock are entitled to one vote for each share held on all
matters submitted to a vote of stockholders and have the right to vote
cumulatively for the election of directors. This means that in the voting at
Access’ annual meeting, each stockholder or his proxy, may multiply the number
of his shares by the number of directors to be elected then cast the resulting
total number of votes for a single nominee, or distribute such votes on the
ballot among the nominees as desired. Holders of Access’ common stock are
entitled to receive ratably such dividends, if any, as may be declared by
Access’ Board of Directors out of funds legally available therefore, subject to
any preferential dividend rights for Access’ outstanding preferred stock. Upon
Access’ liquidation, dissolution or winding up, the holders of Access’ common
stock are entitled to receive ratably Access’ net assets available after the
payment of all debts and other liabilities and subject to the prior rights
of
any of Access’ outstanding preferred stock. Holders of Access’ common stock have
no preemptive, subscription, redemption or conversion rights. The outstanding
shares of Access’ common stock are, and the shares offered by the selling
stockholders in this offering will be, fully paid and nonassessable. The rights,
preferences and privileges of holders of Access’ common stock are subject to,
and may be adversely affected by, the rights of the holders of shares of any
series of Access’ preferred stock which Access may designate and issue in the
future.
Preferred
Stock
Access’
Board of Directors is authorized, subject to certain limitations prescribed
by
law, without further stockholder approval, to issue from time to time up to
an
aggregate of 2,000,000 shares of preferred stock in one or more series and
to
fix or alter the designations, preferences, rights and any qualifications,
limitations or restrictions of the shares of each such series thereof, including
the dividend rights, dividend rates, conversion rights, voting rights and terms
of redemption of shares constituting any series or designations of such series.
The issuance of preferred stock may have the effect of delaying, deferring
or
preventing a change of control. The fact that Access’ board of directors has the
right to issue preferred stock without stockholder approval could be used to
institute a “poison pill” that would work to dilute the stock ownership of a
potential hostile acquirer, effectively preventing acquisitions that have not
been approved by Access’ board of directors. Access has no present plans to
issue any shares of preferred stock.
SCO
Capital Partners LLC - Notes and Warrants
On
December 6, 2006, Access entered into a secured note and warrant purchase
agreement pursuant to which Access sold and issued an aggregate of $500,000
of
7.5% convertible notes now due July 26, 2007 and warrants to purchase 386,364
shares of common stock of Access. Net proceeds to Access were $450,000. The
notes and warrants were sold in a private placement to a group of accredited
investors led by SCO and affiliates. Each noteholder received a warrant to
purchase a number of shares of common stock of Access equal to 75% of the total
number shares of Access common stock into which such holder's note is
convertible. Each warrant has an exercise price of $1.32 per share and is
exercisable at any time prior to December 6, 2012.
On
October 24, 2006, Access entered into a secure note and warrant purchase
agreement pursuant to which Access sold and issued an aggregate of $500,000
of
7.5% convertible notes now due July 26, 2007 and warrants to purchase 386,364
shares of common stock of Access. Net proceeds to Access were $450,000. The
notes and warrants were sold in a private placement to a group of accredited
investors led by SCO and affiliates. Each noteholder received a warrant to
purchase a number of shares of common stock of Access equal to 75% of the total
number shares of Access common stock into which such holder's note is
convertible. Each warrant has an exercise price of $1.32 per share and is
exercisable at any time prior to October 24, 2012.
On
February 16, 2006, Access entered into a secured note and warrant purchase
agreement pursuant to which Access sold and issued an aggregate of $5,000,000
of
7.5% convertible notes now due July 26, 2007 and warrants to purchase an
aggregate of 3,863,634 shares of common stock of Access. Net proceeds to Access
were $4.5 million after offering costs of approximately $500,000, which are
being amortized to interest expense over the term of the debt. The notes and
warrants were sold in a private placement to a group of accredited investors
led
by SCO and its affiliates. Each noteholder received a warrant to purchase a
number of shares of common stock of Access equal to 75% of the total number
shares of Access common stock into which such holder's note is convertible.
Each
warrant has an exercise price of $1.32 per share and is exercisable at any
time
prior to February 16, 2012.
95
All
the
secured notes mature on July 26, 2007, are convertible into Access common stock
at a fixed conversion rate of $1.10 per share, bear interest of 7.5% per annum
and are secured by the assets of Access. Each note may be converted at the
option of the noteholder or Access under certain circumstances as set forth
in
the notes.
In
the
event SCO and its affiliates were to convert all of their notes and exercise
all
of their warrants, it would own approximately 74.1% of the voting securities
of
Access. Access may be required to pay in cash, up to 2% per month, as defined,
as liquidated damages for failure to file and keep effective a registration
statement timely as required by investor rights agreements.
In
connection with the sale and issuance of notes and warrants, Access entered
into
an investors rights agreement whereby it granted SCO the right to designate
two
individuals to serve on the Board of Directors of Access while the notes are
outstanding, and also granted registration rights with respect to the shares
of
common stock of Access underlying the notes and warrants. SCO designated Jeffrey
B. Davis and Mark J. Alvino to the Board of Directors, and on March 13, 2006
Messrs, Davis and Alvino were appointed to the Board of Directors.
Other
Convertible Notes
One
holder of $4 million worth of 7.7% convertible notes (Oracle Partners LP and
related funds) has amended their notes to a new maturity date, initially to
April 28 (and subsequently to July 27, 2007), with the conversion price being
reduced from $27.50 per share to $5.00 per share. In addition, Access may cause
a mandatory conversion of the notes into common stock if the common stock trades
at a price of at least 1.5 times the conversion price for a minimum number
of
trading days. There is also a provision to allow for a minimum price for
conversion in the event of a change of control of Access. This modification
resulted in Access recording additional debt discount of $2.1 million, which
will be accreted to interest expense to the revised maturity date. At March
31,
2007, there is $100,000 of debt discount remaining.
Another
noteholder, holding $5.5 million worth of 7.7% convertible notes has amended
their note to a new maturity date, September 13, 2010 and elected to have the
2005 and 2006 interest of $880,000 to be paid on September 13, 2007 or earlier
if Access receives $5.0 million of new funds. The delayed interest will earn
interest at a rate of 10.0%.
Since
Access’ inception, Access has devoted its resources primarily to fund its
research and development programs. Access has been unprofitable since inception
and to date has received limited revenues from the sale of products. Access
cannot assure you that Access will be able to generate sufficient product
revenues to attain profitability on a sustained basis or at all. Access expects
to incur losses for the next several years as Access continues to invest in
product research and development, preclinical studies, clinical trials and
regulatory compliance. As of March 31, 2007, Access’ accumulated deficit was
$81,799,000.
Transfer
Agent and Registrar
The
transfer agent and registrar of Access’ common stock is American Stock Transfer
& Trust Company, New York, New York.
Delaware
Law and Certain Charter and By-Law Provisions
Certain
anti-takeover provisions.
Access
is
subject to the provisions of Section 203 of the General Corporation Law of
Delaware. Section 203 prohibits certain publicly held Delaware corporations
from
engaging in a “business combination” with an “interested stockholder,” for a
period of three years after the date of the transaction in which the person
became an “interested stockholder”, unless the business combination is approved
in a prescribed manner. A “business combination” includes mergers, asset sales
and other transactions resulting in a financial benefit to the interested
stockholder. Subject to certain exceptions, an “interested stockholder” is a
person or entity who, together with affiliates and associates, owns (or within
the preceding three years, did own) 15% or more of Access’ voting stock. The
statute contains provisions enabling Access to avoid the statute’s restrictions
if the stockholders holding a majority of the Access’ voting stock approve its
Certificate of Incorporation which provides that Access’ directors shall be
divided into three classes, with the terms of each class to expire on different
years.
In
addition, Access’ Certificate of Incorporation, in order to combat “greenmail,”
provides in general that any direct or indirect purchase by Access of any of
Access’ voting stock or rights to acquire voting stock known to be beneficially
owned by any person or group which holds more than five percent of a class
of
Access’ voting stock and which has owned the securities being purchased for less
than two years must be approved by the affirmative vote of at least two-thirds
of the votes entitled to be cast by the holders of voting stock, subject to
certain exceptions. The prohibition of “greenmail” may tend to discourage or
foreclose certain acquisitions of Access’ securities which might temporarily
increase the price of Access’ securities. Discouraging the acquisition of a
large block of Access’ securities by an outside party may also have a potential
negative effect on takeovers. Parties seeking control of Access through large
acquisitions of its securities will not be able to resort to “greenmail” should
their bid fail, thus making such a bid less attractive to persons seeking to
initiate a takeover effort.
96
Elimination
of Monetary Liability for Officers and Directors
Access’
Certificate of Incorporation incorporates certain provisions permitted under
the
General Corporation Law of Delaware relating to the liability of directors.
The
provisions eliminate a director’s liability for monetary damages for a breach of
fiduciary duty, including gross negligence, except in circumstances involving
certain wrongful acts, such as the breach of director’s duty of loyalty or acts
or omissions, which involve intentional misconduct or a knowing violation of
law. These provisions do not eliminate a director’s duty of care. Moreover,
these provisions do not apply to claims against a Director for violations of
certain laws, including certain federal securities laws. Access’ Certificate of
Incorporation also contains provisions to indemnify the directors, officers,
employees or other agents to the fullest extent permitted by the General
Corporation Law of Delaware. Access believes that these provisions will assist
Access in attracting and retaining qualified individual to serve as
directors.
Indemnification
of Officers and Directors
Access’
Certificate of Incorporation also contains provisions to indemnify the
directors, officers, employees or other agents to the fullest extent permitted
by the General Corporation Law of Delaware. These provisions may have the
practical effect in certain cases of eliminating the ability of stockholders
to
collect monetary damages from directors. Access believes that these provisions
will assist Access in attracting or retaining qualified individuals to serve
as
Access’ directors.
The
consolidated financial statements incorporated in this proxy
statement/prospectus by reference to the Access Annual Report on Form 10-KSB
for
the year ended December 31, 2006 have been so incorporated in reliance on
the
report of Whitley Penn LLP, an independent registered public accounting firm,
given on the authority of said firm as experts in auditing and accounting.
The
consolidated financial statements as of December 31, 2005 and for each of
the
two years in the period ended December 31, 2005 included in this registration
statement have been audited by Grant Thornton LLP, independent registered
public
accountants, as indicated in their report with respect thereto, and are included
herein in reliance upon the authority of said firm as experts in accounting
and
auditing.
None
of
the independent public registered accounting firms named above have any interest
in the merger.
Bingham
McCutchen LLP has passed upon the validity of the shares of common stock offered
hereby.
Access
filed with the Securities and Exchange Commission in Washington, DC, a
registration statement on Form S-4 under the Securities Act of 1933 with respect
to the shares Access is offering. Prior to the effective date of the
registration statement, Access was subject to the information requirements
of
the Securities Exchange Act of 1934 (the "Exchange Act"). This prospectus does
not contain all of the information set forth in the registration statement,
as
permitted by the rules and regulations of the SEC. Reference is hereby made
to
the registration statement and exhibits thereto for further information with
respect to Access and the shares to which this prospectus relates. Copies of
the
registration statement and other information filed by with the SEC can be
inspected and copied at the public reference facilities maintained by the SEC
in
Washington, DC at 450 Fifth Street, NW, Washington, DC 20549. In addition,
the
SEC maintains a World Wide Web site that contains reports, proxy statements
and
other information regarding registrants such as Access which filed
electronically with the SEC at the following Internet address:
(http:www.sec.gov).
97
Access
files periodic reports, proxy statements and other information with the
Securities and Exchange Commission in accordance with requirements of the
Exchange Act. These periodic reports, proxy statements and other information
are
available for inspection and copying at the regional offices, public reference
facilities and Internet site of the Securities and Exchange Commission referred
to above. In addition, you may request a copy of any of Access’ periodic reports
filed with the Securities and Exchange Commission at no cost, by writing or
telephoning us at the following address:
Investors
Relations
Access
Pharmaceuticals, Inc.
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
Information
contained on Access’ website is not a prospectus and does not constitute a part
of this Prospectus.
You
should rely only on the information contained in or incorporated by reference
or
provided in this Prospectus. Access has not authorized anyone else to provide
you with different information. Access is not making an offer of these
securities in any state where the offer is not permitted. You should not assume
the information in this Prospectus is accurate as of any date other than the
date on the front of this Prospectus.
98
The
following discussion should be read in conjunction with Access’ consolidated
financial statements and related notes included in this Form S-4.
Overview
Access
Pharmaceuticals, Inc. (“Access”) is a Delaware corporation. Access is an
emerging biopharmaceutical company developing products for use in the treatment
of cancer, the supportive care of cancer, and other disease states. Access’
product for the management of oral mucositis, MuGard™, received marketing
clearance by the FDA as a device. Its lead clinical development program for
the
drug candidate ProLindac™ (formerly known as AP5346) is in Phase II clinical
testing. Access also has advanced drug delivery technologies including
Cobalamin™-mediated oral drug delivery and targeted delivery.
Together
with its subsidiaries, Access has proprietary patents or rights to one
technology approved for marketing and three drug delivery technology
platforms:
•
MuGard™ (mucoadhesive liquid technology),
•
synthetic polymer targeted delivery,
•
Cobalamin-mediated oral delivery,
•
Cobalamin-mediated targeted delivery.
Products
Access
has used its drug delivery technologies to develop the following products and
product candidates:
ACCESS
DRUG PORTFOLIO
|
Compound
|
|
Originator
|
|
Technology
|
|
Indication
|
|
Clinical
Stage
(1)
|
|
|
|
|
|
|
|
|
|
|
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
|
Access
- U London
|
|
Synthetic
polymer
|
|
Cancer
|
|
Phase
II
|
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-Clinical
|
||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-Clinical
|
||||
|
Cobalamin-Targeted
Therapeutics
|
|
Access
|
|
Cobalamin
|
|
Anti-tumor
|
|
Pre-Clinical
|
|
|
|
|
|
|
|
|
|
(1)
For more information, see “Government Regulation” for description of clinical
stages.
(2)
Licensed from the School of Pharmacy, The University of London. Subject to
a 1%
royalty and milestone payments on sales.
Approved
Products
MuGard™
- Mucoadhesive Liquid Technology (MLT)
Mucositis
is a debilitating condition involving extensive inflammation of mouth tissue
that affects annually an estimated 400,000 cancer patients in the United States
undergoing chemotherapy and radiation treatment. Any treatment that would
accelerate healing and/or diminish the rate of appearance of mucositis would
have a significant beneficial impact on the quality of life of these patients
and may allow for more aggressive chemotherapy. Access believes the potential
addressable market for a mucositis product could be over $1 billion
world-wide.
99
Access’
MuGard™ is a viscous polymer solution which provides a coating for the oral
cavity. MuGard™ is dispensed in a ready to use form. A multi-site, randomized
clinical study was performed in the United States testing MuGard™ and MuGard™
containing an anti-inflammatory drug to determine the effect of these products
on the prevention and treatment of mucositis. The data from this trial indicated
that the patients using MuGard™ displayed a lower incidence of mucositis than is
typically seen in the studied population with no additional benefit from the
drug.
The
data
were retrospectively compared with two historical patient databases to evaluate
the potential advantages MuGard™ may represent in the prevention, treatment and
management of mucositis. The patient evaluation was conducted using the oral
mucositis assessment scale, which qualifies the disease severity on a scale
of
0-5. Key highlights of the comparison with the historical patient databases
are
as follows:
•
the average severity of the disease was reduced by approximately
40%;
•
the maximum intensity of the mucositis was approximately 35% lower;
and
•
the median peak intensity was approximately 50% lower.
These
data confirmed that fact that MuGard™ could represent an important advancement
in the management and prevention of mucositis. On September 20, 2006, Access
announced that it had submitted a Premarket Notification 510(k) application
to
the United States Food and Drug Administration (FDA) announcing Access’ intent
to market MuGard™. On December 13, 2006, Access announced that it had received
marketing clearance for MuGard™ from FDA for the indication of the management of
oral wounds including mucositis, aphthous ulcers and traumatic
ulcers.
Access
is
currently seeking marketing partners to market MuGard™ in the United States and
in other territories worldwide.
Products
in Development Status
ProLindac™
(Polymer Platinate, AP5346) DACH Platinum
Chemotherapy,
surgery and radiation are the major components in the clinical management of
cancer patients. Chemotherapy serves as the primary therapy for some solid
tumors and metastases and is increasingly used as an adjunct to radiation and
surgery to improve their effectiveness. For chemotherapeutic agents to be
effective in treating cancer patients, however, the agent must reach the target
cells in effective quantities with minimal toxicity in normal
tissues.
The
current optimal strategy for chemotherapy involves exposing patients to the
most
intensive cytotoxic regimens they can tolerate and clinicians attempt to design
a combination of chemotherapeutic drugs, a dosing schedule and a method of
administration to increase the probability that cancerous cells will be
destroyed while minimizing the harm to healthy cells. Notwithstanding
clinicians’ efforts, most current chemotherapeutic drugs have significant
shortcomings that limit the efficacy of chemotherapy. For example, certain
cancers are inherently unresponsive to chemotherapeutic agents. Alternatively,
other cancers may initially respond, but subgroups of cancer cells acquire
resistance to the drug during the course of therapy and the resistant cells
may
survive and cause a relapse. Serious toxicity, including bone marrow
suppression, renal toxicity, neuropathy, or irreversible cardiotoxicity, are
some of the limitations of current anti-cancer drugs that can prevent their
administration in curative doses.
Oxaliplatin,
a formulation of DACH platinum, is a chemotherapeutic which was initially
approved in France and in Europe in 1999 for the treatment of colorectal cancer.
It is now also being marketed in the United States and is generating worldwide
sales in excess of $2 billion annually. Carboplatin and Cisplatin, two other
approved platinum chemotherapy drugs, are not indicated for the treatment of
metastatic colorectal cancer. Oxaliplatin, in combination with 5-flurouracil
and
folinic acid (known as the FOLFOX regime) is indicated for the first-line
treatment of metastatic colorectal cancer in Europe and the U.S. The colorectal
cancer market is a significant opportunity as there are over 940,000 reported
new cases annually worldwide, increasing at a rate of approximately three
percent per year, and 500,000 deaths.
Currently,
platinum compounds are one of the largest selling categories of chemotherapeutic
agents, with annual sales in excess of $3.0 billion. As is the case with all
chemotherapeutic drugs, the use of such compounds is associated with serious
systemic side effects. The drug development goal therefore is to enhance
delivery of the active drug to the tumor and minimize the amount of active
drug
affecting normal organs in the body.
100
Utilizing
a biocompatible water-soluble polymer HPMA as a drug carrier, Access’ drug
candidate ProLindac™, links DACH platinum to a polymer in a manner which permits
the selective release of active drug to the tumor by several mechanisms,
including taking advantage of the differential pH in tumor tissue compared
to
healthy tissue. The polymer also capitalizes on the biological differences
in
the permeability of blood vessels at tumor sites versus normal tissue. In this
way, tumor selective delivery and platinum release is achieved. The ability
of
ProLindac™ to inhibit tumor growth has been evaluated in more than ten
preclinical models. Compared with the marketed product oxaliplatin, ProLindac™
showed either marked superiority or superiority in most of these models.
Preclinical studies of the delivery of platinum to tumors in an animal model
have shown that, compared with oxaliplatin at equitoxic doses, ProLindac™
delivers in excess of 16 times more platinum to the tumor. An analysis of tumor
DNA, which is the main target for anti-cancer platinum agents, has shown that
ProLindac™ delivers
approximately 14 times more platinum to tumor DNA than oxaliplatin. Results
from
preclinical efficacy studies conducted in the B16 and other tumor models have
also shown that ProLindac™ is superior to oxaliplatin in inhibiting the growth
of tumors. An extensive preclinical package has been developed supporting the
development of ProLindac™.
In
2005
Access completed a Phase I multi-center clinical study conducted in Europe,
which enrolled 26 patients. The study was reported at the AACR-NCI-EORTC
conference in Philadelphia in November 2005. The European trial was
designed to identify the maximum tolerated dose, dose limiting toxicities,
the
pharmacokinetics of the platinum in plasma and the possible anti-tumor activity
of ProLindacTM.
The
open-label, non-randomized, dose-escalation Phase I study was performed at
two
European centers. ProLindacTM
was
administered as an intravenous infusion over one hour, once a week on days
1, 8
and 15 of each 28-day cycle to patients with solid progressive tumors. Access
obtained results in 26 patients with a broad cross-section of tumor types,
with
doses ranging from 80-1,280 mg Pt/m2.
Of
the 26
patients, 10 were not evaluable for tumor response, principally due to
withdrawal from the study prior to completing the required cycle. Of the 16
evaluable patients, 2 demonstrated a partial response, 1 experienced a partial
response based on a biomarker and 4 experienced stable disease. One of the
patients who attained a partial response had a melanoma with lung metastasis;
a
CT scan revealed a tumor decrease of greater than 50%. The other patient who
responded had ovarian cancer; she had a reduction in lymph node metastasis
and
remission of a liver metastasis. The patient who experienced a partial response
based on a biomarker was an ovarian cancer patient for whom CA-125 levels
returned to normal. Also of note, a patient with cisplatin resistant cervical
cancer showed a short lasting significant reduction in lung metastasis after
3
doses. However, due to toxicity, the patient could not be retreated to determine
whether the partial response could be maintained.
Access
has commenced a European Phase II ProLindac™ trial in ovarian cancer patients
who have relapsed after first line platinum therapy. The primary aim of the
study is to the determine the response rate of ProLindacTM
monotherapy in this patient population. The response rates for other platinum
compounds in this indication are well known, and will be used for comparison.
Access
has provided ProLindacTM
to the
Moores Cancer Center at the University of California, San Diego to conduct
a
Phase II clinical study in patients with head and neck cancer under a
physician-sponsored IND. The primary aim of the study is to demonstrate the
ability of the tumor-targeting polymer system to deliver more platinum to tumors
than can be attained with oxaliplatin, the approved DACH platinum compound.
Access
has submitted an IND application to the US Food and Drug Administration, and
has
received clearance from the agency to proceed with a Phase I clinical study
of
ProLindac in combination with fluorouracil and leucovorin. The study is designed
to evaluate the safety of the ProLindac in combination with two standard drugs
used to treat colorectal cancer and to establish a safe dose for Phase II
clinical studies of this combination in colorectal cancer. Access is currently
evaluating whether clinical development of ProLindac in this indication might
proceed more rapidly by utilizing an alternative clinical strategy and/or
conducting studies in the US and/or elsewhere in the world.
Results
of Operations
First
Quarter 2007 Compared to First Quarter 2006
Total
research spending for the first quarter of 2007 was $413,000, as compared to
$756,000 for the same period in 2006, a decrease of $343,000. The decrease
in
expenses was primarily due to the following:
| · |
lower
costs for product manufacturing for ProLindac™ ($247,000). Product
manufacturing was completed early in 2006 which Access believes is
adequate to supply drug product for all of Access’ current ovarian cancer
trial;
|
| · |
lower
costs of clinical trials for ProLindac™ ($137,000). Access incurred
start-up costs for the clinical trial in early 2006;
and
|
| · |
Other
net decreases ($8,000).
|
101
The
decrease in research spending is partially offset by higher salary and related
cost due to the hiring of additional scientific staff ($49,000).
Total
general and administrative expenses were $1,139,000 for the first quarter of
2007, an increase of $473,000 as compared to the same period in 2006. The
increase in spending was due primarily to the following:
| · |
higher
salary related expenses due to stock option expenses
($203,000);
|
| · |
higher
investor relations expenses ($133,000) due to Access’ increased investor
relations efforts;
|
| · |
increased
salary and related expenses due to the hiring of a business development
officer ($47,000);
|
| · |
higher
franchise taxes ($34,000);
|
| · |
higher
patent costs ($28,000); and
|
| · |
by
other net increases ($28,000).
|
Depreciation
and amortization was $75,000 for the first quarter of 2007 as compared to
$77,000 for the same period in 2006 reflecting a decrease of $2,000. The
decrease in depreciation and amortization was due to assets becoming fully
depreciated.
Total
operating expenses in the first quarter of 2007 were $1,627,000 as compared
to
total operating expenses of $1,499,000 for the same period in 2006 an increase
of $128,000.
Interest
and miscellaneous income was $35,000 for the first quarter of 2007 as compared
to $92,000 for the same period in 2006, a decrease of $57,000. The decrease
in
interest income was due to accretion of the receivable due from Uluru that
was
recorded in 2006.
Interest
and other expense was $2,535,000 for the first quarter of 2007 as compared
to
$1,299,000 the same period in 2006, an increase of $1,236,000. The increase
in
interest and other expense was due to amortization of the discount on the Oracle
convertible notes and the amortization of the SCO notes.
In
2006
there was an unrealized loss on fair value of warrants of $2,150,000 due to
the
warrants issued to SCO and affiliates. Access changed its accounting for the
warrants in the fourth quarter of 2006 and there are no unrealized losses or
gains in 2007.
Net
loss
in the first quarter of 2007 was $4,127,000, or a $1.17 basic and diluted loss
per common share, compared with a loss of $4,856,000, or a $1.38 basic and
diluted loss per common share for the same period in 2006.
Comparison
of Years Ended December 31, 2006 and 2005
Access’
total research spending for continuing operations for the year ended December
31, 2006 was $2,053,000, as compared to $2,783,000 in 2005, a decrease of
$730,000. The decrease in expenses was the result of Phase II clinical trial
start-up costs, including manufacturing costs for ProLindac™ in 2005 whereas
2006 costs were primarily clinical trial costs.
Access
total general and administrative expenses were $2,813,000 for 2006, a decrease
of $1,825,000 over 2005 expenses of $4,638,000, due to lower:
|
·
|
Salary
expenses due to the separation agreement in 2005 with its former CEO
($909,000);
|
|
·
|
Professional
fees for investment strategies and fairness opinions in 2005
($397,000);
|
|
·
|
Legal
fees ($313,000);
|
|
·
|
Patent
and license fees ($194,000);
|
|
·
|
Rent
($113,000);
|
|
·
|
Compensation
paid to Chairman in 2005 ($140,000)
and
|
|
·
|
Other
net decreases ($41,000).
|
102
The
decrease in general and administrative expenses is offset partially by
higher:
|
·
|
Salary
related costs due to the expensing of stock options ($180,000);
and
|
|
·
|
Investor/public
relations fees ($102,000).
|
Depreciation
and amortization was $309,000 in 2006 as compared to $333,000 in 2005, a
decrease of $24,000 due to the lower depreciation expense.
In
2005
Access wrote off its goodwill of $1,868,000 following an impairment
analysis.
Access’
loss from operations in 2006 was $5,175,000 as compared to a loss of $9,622,000
in 2005.
Interest
and miscellaneous income was $294,000 for 2006 as compared to $100,000 for
2005,
an increase of $194,000, relating to interest recognized on the Uluru receivable
and higher cash balances in 2006 as compared with 2005.
Interest
and other expense was $7,436,000 for 2006 as compared to $2,100,000 for the
same
period in 2005, an increase of $5,336,000. The increase was due to amortization
of the discount of the Secured Convertible Notes and to amortization of the
discount on the extension of a convertible note.
Access
had $550,000 less $173,000 tax expense in 2006 in milestone revenues from
its oral care assets that Access sold to Uluru, Inc. due to the amended 2005
Asset Sale Agreement. Access had no milestone revenues in 2005.
The
Secured Convertible Notes include warrants and a conversion feature. Until
September 30, 2006 Access accounted for the warrants and conversion feature
as
liabilities and recorded at fair value. From the date of issuance to September
30, 2006, the fair value of these instruments increased resulting in a net
unrealized loss of $1.1 million. On October 1, 2006, Access adopted the
provisions of Financial Accounting Standards Board Staff Position EITF No.
00-19-2, “Accounting
for Registration Payment Arrangements” (EITF
00-19-2), which requires that contingent obligations to make future payments
under a registration payment arrangement be recognized and measured separately
in accordance with SFAS No. 5, “Accounting
for Contingencies.”
Under
previous guidance, the fair value of the warrant was recorded as a current
liability in Access’ balance sheet, due to a potential cash payment feature in
the warrant. The current liability was marked-to-market at each quarter end,
using the Black-Scholes option-pricing model, with the change being recorded
to
general and administrative expenses. Under the new guidance in EITF 00-19-2,
as
Access believes the likelihood of such a cash payment to not be probable, Access
has not recognized a liability for such obligations. Accordingly, a
cumulative-effect adjustment of $1.4 million was made as of October 1, 2006
to accumulated deficit, representing the difference between the initial value
of
this warrant and its fair value as of this date and recorded to equity.
Net
loss
for 2006 was $12,874,000, or $3.65 basic and diluted loss per common share
compared with a loss of $1,700,000, or a $0.53 basic and diluted loss per common
share, for 2005.
Comparison
of Years Ended December 31, 2005 and 2004
Access’
total research spending for continuing operations for the year ended December
31, 2005 was $2,783,000, as compared to $2,335,000 in 2004, an increase of
$448,000. The increase in expenses was the result of Phase II start-up costs
including manufacturing and clinical costs for ProLindac™ clinical trials
($674,000) and other net costs ($20,000) offset by lower salary costs due to
cutbacks in scientific staff ($246,000).
Access’
total general and administrative expenses were $4,638,000 for 2005, an increase
of $1,439,000 over 2004 expenses of $3,199,000, due to:
|
·
|
Expenses
due to the separation agreement with Access’ former CEO
($909,000);
|
|
·
|
Professional
fees for investment banking and financing decisions
($397,000);
|
|
·
|
Higher
legal fees due to changes in Access’ convertible debt and legal fees
associated with merger candidates ($161,000);
and
|
|
·
|
Royalty
license fee ($150,000).
|
103
The
increases in general and administrative expenses is offset by:
|
·
|
Lower
investor relations costs ($90,000);
|
|
·
|
Lower
patent expenses ($61,000); and
|
|
·
|
Lower
net other increases ($27,000).
|
Depreciation
and amortization was $333,000 in 2005 as compared to $469,000 in 2004, a
decrease of $136,000 due to the impairment of a license which is no longer
effective ($109,000) plus lower depreciation.
In
addition Access wrote off its goodwill in 2005 of $1,868,000 following an
impairment analysis.
Access’
loss from operations in 2005 was $9,622,000 as compared to a loss of $6,003,000
in 2004.
Interest
and miscellaneous income was $100,000 for 2005 as compared to $226,000 for
2004,
a decrease of $126,000, relating to interest income due to lower cash balances
in 2005 as compared with 2004.
Interest
and miscellaneous expense was $2,100,000 for 2005 as compared to $1,385,000
for
the same period in 2004, an increase of $715,000. The increase was due to
repayment of the secured convertible notes and contractually accelerated
interest and penalty and due to amortization of the discount on the extension
on
of the convertible note.
Net
loss
for 2005 was $1,700,000, or a $0.53 basic and diluted loss per common share
compared with a loss of $10,238,000, or a $3.38 basic and diluted loss per
common share, for 2004.
Discontinued
Operations
In
October 2005 Access sold its oral/topical care business to Uluru, Inc. for
a
gain of $12,891,000 less $4,067,000 tax expense and Access closed down its
Australian operations. The loss from its discontinued operations of its
oral/topical care business and its Australian operation was
$2,969,000.
Liquidity
and Capital Resources
Access
funded its operations primarily through private sales of common stock and
convertible notes and its principal source of liquidity is cash and cash
equivalents. Contract research payments, licensing fees and milestone payments
from corporate alliances and mergers have also provided funding for operations.
As
of
March 31, 2007 Access’ cash and cash equivalents and short-term investments were
$3,083,000 and its net cash burn rate for the three months ending March 31,
2007
was approximately $435,000 per month. Access’ working capital deficit was
$9,302,000. Access’ working capital at March 31, 2006 represented a decrease of
$3,520,000 as compared to its working capital deficit as of December 31, 2006
of
$5,782,000. Access’ working capital is negative reflecting approximately $10.9
million of debt that becomes due prior to March 31, 2008 and $899,000 of accrued
interest payments accrued at March 31, 2007.
As
of
March 31, 2007, Access did not have enough capital to achieve its long-term
goals.
104
Access
does not have sufficient funds to repay its convertible notes at their maturity.
Access may not be able to restructure the convertible notes or obtain additional
financing to repay them on terms acceptable to Access, if at all. If Access
raises additional funds by selling equity securities, the relative equity
ownership of Access’ existing investors would be diluted and the new investors
could obtain terms more favorable than previous investors. A failure to
restructure its convertible notes or obtain additional funding to repay the
convertible notes and support its working capital and operating requirements,
could cause Access to be in default of its convertible notes and prevent Access
from making expenditures that are needed to allow Access to maintain its
operations. A failure to restructure its existing convertible notes or obtain
necessary additional capital in the future could jeopardize its
operations.
Access
has generally incurred negative cash flows from operations since inception,
and
has expended, and expects to continue to expend in the future, substantial
funds
to complete its planned product development efforts. Since
inception, its expenses have significantly exceeded revenues, resulting in
an
accumulated deficit as of March 31, 2007 of $81,799,000. Access
expects that its capital resources will be adequate to fund its current level
of
operations for just over six months, excluding any obligation to repay the
convertible notes and the debt service on the convertible notes, which at this
time Access does not have the ability to pay. Access
cannot assure you that
it
will ever be able to generate significant product revenue or achieve or sustain
profitability. Access currently does not have the cash resources to repay its
debt obligations due in June and September 2007. Access plans to satisfy its
obligations under the notes either through conversion of the notes into equity
or through the sale of equity.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
SCO
Capital Partners LLC - Notes and Warrants
On
December 6, 2006, Access entered into a secured note and warrant purchase
agreement pursuant to which Access sold and issued an aggregate of $500,000
of
7.5% convertible notes now due July 26, 2007 and warrants to purchase 386,364
shares of common stock of Access. Net proceeds to Access were $450,000. The
notes and warrants were sold in a private placement to a group of accredited
investors led by SCO and affiliates. Each noteholder received a warrant to
purchase a number of shares of common stock of Access equal to 75% of the total
number shares of Access common stock into which such holder's note is
convertible. Each warrant has an exercise price of $1.32 per share and is
exercisable at any time prior to December 6, 2012.
On
October 24, 2006, Access entered into a secure note and warrant purchase
agreement pursuant to which Access sold and issued an aggregate of $500,000
of
7.5% convertible notes now due July 26, 2007 and warrants to purchase 386,364
shares of common stock of Access. Net proceeds to Access were $450,000. The
notes and warrants were sold in a private placement to a group of accredited
investors led by SCO and affiliates. Each noteholder received a warrant to
purchase a number of shares of common stock of Access equal to 75% of the total
number shares of Access common stock into which such holder's note is
convertible. Each warrant has an exercise price of $1.32 per share and is
exercisable at any time prior to October 24, 2012.
On
February 16, 2006, Access entered into a secured note and warrant purchase
agreement pursuant to which Access sold and issued an aggregate of $5,000,000
of
7.5% convertible notes now due July 26, 2007 and warrants to purchase an
aggregate of 3,863,634 shares of common stock of Access. Net proceeds to Access
were $4.5 million after offering costs of approximately $500,000, which are
being amortized to interest expense over the term of the debt. The notes and
warrants were sold in a private placement to a group of accredited investors
led
by SCO and its affiliates. Each noteholder received a warrant to purchase a
number of shares of common stock of Access equal to 75% of the total number
shares of Access common stock into which such holder's note is convertible.
Each
warrant has an exercise price of $1.32 per share and is exercisable at any
time
prior to February 16, 2012.
All
the
secured notes mature on July 26, 2007, are convertible into Access common stock
at a fixed conversion rate of $1.10 per share, bear interest of 7.5% per annum
and are secured by the assets of Access. Each note may be converted at the
option of the noteholder or Access under certain circumstances as set forth
in
the notes.
In
the
event SCO and its affiliates were to convert all of their notes and exercise
all
of their warrants, it would own approximately 74.1% of the voting securities
of
Access. Access may be required to pay in cash, up to 2% per month, as defined,
as liquidated damages for failure to file and keep effective a registration
statement timely as required by investor rights agreements.
105
In
connection with the sale and issuance of notes and warrants, Access entered
into
an investors rights agreement whereby it granted SCO the right to designate
two
individuals to serve on the Board of Directors of Access while the notes are
outstanding, and also granted registration rights with respect to the shares
of
common stock of Access underlying the notes and warrants. SCO designated Jeffrey
B. Davis and Mark J. Alvino to the Board of Directors, and on March 13, 2006
Messrs. Davis and Alvino were appointed to the Board of Directors.
Uluru,
Inc. - Sale of Oral/Topical Care Assets
On
December 8, 2006 Access amended its 2005 Asset Sale Agreement with Uluru, Inc.
Access received from Uluru an upfront payment of $4.9 million at the time of
the
amendment, received an additional $350,000 on April 9, 2007 and in the future
could receive potential milestones of up to $4.8 million based on Uluru sales.
The amendment agreement included the anniversary payment due October 12, 2006,
the early payment of the two year anniversary payment, and a payment in
satisfaction of certain future milestones. Access also transferred to Uluru
certain patent applications that Access had previously licensed to Uluru under
the 2005 License Agreement. Under a new agreement, Access has acquired a license
from Uluru to utilize the nanoparticle aggregate technology contained in the
transferred patent applications for subcutaneous, intramuscular,
intra-peritoneal and intra-tumoral drug delivery. Additionally, one future
milestone was increased by $125,000.
Other
Convertible Notes
One
holder of $4 million worth of 7.7% convertible notes (Oracle Partners LP and
related funds) has amended their notes to a new maturity date, initially to
April 28 (and subsequently to July 27, 2007), with the conversion price being
reduced from $27.50 per share to $5.00 per share. In addition, Access may cause
a mandatory conversion of the notes into common stock if the common stock trades
at a price of at least 1.5 times the conversion price for a minimum number
of
trading days. There is also a provision to allow for a minimum price for
conversion in the event of a change of control of Access. This modification
resulted in Access recording additional debt discount of $2.1 million, which
will be accreted to interest expense to the revised maturity date. At March
31,
2007, there is $100,000 of debt discount remaining.
Another
noteholder, holding $5.5 million worth of 7.7% convertible notes has amended
their note to a new maturity date, September 13, 2010 and elected to have the
2005 and 2006 interest of $880,000 to be paid on September 13, 2007 or earlier
if Access receives $5.0 million of new funds. The delayed interest will earn
interest at a rate of 10.0%.
Since
Access’ inception, Access has devoted its resources primarily to fund its
research and development programs. Access has been unprofitable since inception
and to date has received limited revenues from the sale of products. Access
cannot assure you that Access will be able to generate sufficient product
revenues to attain profitability on a sustained basis or at all. Access expects
to incur losses for the next several years as Access continues to invest in
product research and development, preclinical studies, clinical trials and
regulatory compliance. As of March 31, 2007, Access’ accumulated deficit was
$81,799,000.
Cornell
Capital Partners Standby Equity Distribution Agreement and Securities Purchase
Agreement
On
March
30, 2005 Access executed a Standby Equity Distribution Agreement (SEDA) with
Cornell Capital Partners. Under the SEDA, Access could issue and sell to Cornell
Capital Partners common stock for a total purchase price of up to $15,000,000.
The purchase price for the shares is equal to their market price, which was
defined in the SEDA as 98% of the lowest volume weighted average price of the
common stock during a specified period of trading days following the date notice
is given by Access that it desires to access the SEDA. Further, Access agreed
to
pay Cornell Capital Partners 3.5% of the proceeds that Access receives under
the
Equity Line of Credit. The amount of each draw down was subject to a maximum
amount of $1,000,000. The terms of the SEDA did not allow Access to make draw
downs if the draw down would cause Cornell Capital to own in excess of 9.9%
of
Access’ outstanding shares of common stock. Upon closing of the transaction,
Cornell Capital Partners received a one-time commitment fee of 146,500 shares
of
Access’ common stock. On the same date, Access entered into a Placement Agent
Agreement with Newbridge Securities Corporation, a registered broker-dealer.
Pursuant to the Placement Agent Agreement, upon closing of the transaction
Access paid a one-time placement agent fee of 3,500 shares of common stock.
The
shares issued were valued at $500,000 and recorded as Debt issuance costs and
such costs are amortized as the SEDA is accessed. As of December 31, 2006 Access
accessed $600,000 of the SEDA and $20,000 of the debt issuance costs were
charged to additional paid-in capital and $384,000 of the issuance costs have
been charged to interest expense. The SEDA expired March 30, 2007.
106
In
addition, on March 30, 2005, Access executed a Securities Purchase Agreement
with Cornell Capital Partners and Highgate House Funds. Under the Securities
Purchase Agreement, Cornell Capital Partners and Highgate House Funds purchased
an aggregate of $2,633,000 principal amount of Secured Convertible Debentures
from Access (net proceeds to Access of $2,360,000). The Secured Convertible
Debentures accrue interest at a rate of 7% per year and were to mature 12 months
from the issuance date with scheduled monthly repayment commencing on November
1, 2005 to the extent that the Secured Convertible Debenture had not been
converted to common stock. The Secured Convertible Debenture was convertible
into Access’ common stock at the holder's option any time up to maturity at a
conversion price equal to $20.00. The Secured Convertible Debentures were
secured by all of the assets of Access. Access had the right to redeem the
Secured Convertible Debentures upon 3 business days notice for 110% of the
amount redeemed. Pursuant to the Securities Purchase Agreement, Access issued
to
the holders an aggregate of 50,000 shares of common stock of Access. The Secured
Convertible Notes were paid in full on October 12, 2005 in conjunction with
the
sale of its oral care assets.
Access
has generally incurred negative cash flows from operations since inception,
and
has expended, and expect to continue to expend in the future, substantial funds
to complete its planned product development efforts. Since inception, Access’
expenses have significantly exceeded revenues, resulting in an accumulated
deficit as of December 31, 2006 of $77,672,000. Access expects that its capital
resources as of March 31, 2007, together with receivables will be adequate
to
fund its current level of operations for seven months, excluding any obligation
to repay the convertible notes and the debt service on the convertible notes,
which at this time Access does not have the ability to pay. Access
cannot assure you that
Access will ever be able to generate significant product revenue or achieve
or
sustain profitability. Access currently does not have the cash resources to
repay its debt obligations due in March, April and September 2007. Either
through conversion of its debt to equity or its financing plan through the
sales
of equity are expected to provide the resources to repay such notes.
Access
plans to expend substantial funds to conduct research and development programs,
preclinical studies and clinical trials of potential products, including
research and development with respect to its acquired and developed technology.
Access’ future capital requirements and adequacy of available funds will depend
on many factors, including:
|
·
|
the
successful development and commercialization of ProLindac™, MuGard™ and
Access' other product candidates;
|
|
·
|
the
ability to convert, repay or restructure Access’ outstanding convertible
notes and debentures;
|
|
·
|
the
ability to merge with Somanta Pharmaceuticals, Inc. and integrate
their
assets and programs with Access’;
|
|
·
|
the
ability to establish and maintain collaborative arrangements with
corporate partners for the research, development and commercialization
of
products;
|
|
·
|
continued
scientific progress in Access’ research and development
programs;
|
|
·
|
the
magnitude, scope and results of preclinical testing and clinical
trials;
|
|
·
|
the
costs involved in filing, prosecuting and enforcing patent
claims;
|
|
·
|
the
costs involved in conducting clinical
trials;
|
|
·
|
competing
technological developments;
|
|
·
|
the
cost of manufacturing and scale-up;
|
|
·
|
the
ability to establish and maintain effective commercialization arrangements
and activities; and
|
|
·
|
successful
regulatory filings.
|
Access
has devoted substantially all of its efforts and resources to research and
development conducted on its own behalf. The following table summarizes research
and development spending by project category (in thousands), which spending
includes, but is not limited to, payroll and personnel expense, lab supplies,
preclinical expense, development cost, clinical trial expense, outside
manufacturing expense and consulting expense:
107
|
(in
thousands)
|
|
Twelve
month ended
|
|
Inception
to
|
|
|||||
|
|
|
December
31
|
|
Date
(1)
|
|
|||||
|
Project
|
|
2006
|
|
2005
|
|
|
|
|||
|
Polymer
Platinate
(ProLindac™)
|
|
$
|
2,043
|
|
$
|
2,653
|
|
$
|
19,654
|
|
|
Mucoadhesive
Liquid
Technology
(MLT)
|
|
|
10
|
|
|
-
|
|
|
1,490
|
|
|
Others
(2)
|
|
|
-
|
|
|
130
|
|
|
5,044
|
|
|
Total
|
|
$
|
2,053
|
|
$
|
2,783
|
|
$
|
26,188
|
|
|
(1)
|
Cumulative
spending from inception of Access or project through December 31,
2006.
|
|
(2)
|
The
following projects are among the ones included in this line item:
Vitamin
Mediated Targeted Delivery, carbohydrate targeting, amlexanox cream
and
gel and other related projects.
|
Due
to
uncertainties and certain of the risk factors described above, including those
relating to Access’ ability to successfully commercialize its drug candidates,
its ability to obtain necessary additional capital to fund operations in the
future, its ability to successfully manufacture its products and its product
candidates in clinical quantities or for commercial purposes, government
regulation to which Access is subject, the uncertainty associated with
preclinical and clinical testing, intense competition that Access faces, market
acceptance of its products and protection of its intellectual property, it
is
not possible to reliably predict future spending or time to completion by
project or product category or the period in which material net cash inflows
from significant projects are expected to commence. If Access is unable to
timely complete a particular project, its research and development efforts
could
be delayed or reduced, Access’ business could suffer depending on the
significance of the project and Access might need to raise additional capital
to
fund operations, as discussed in the risk factors above, including without
limitation those relating to the uncertainty of the success of Access’ research
and development activities and its ability to obtain necessary additional
capital to fund operations in the future. As discussed in such risk factors,
delays in Access’ research and development efforts and any inability to raise
additional funds could cause Access to eliminate one or more of its research
and
development programs.
Access
plans to continue its policy of investing any available funds in certificates
of
deposit, money market funds, government securities and investment-grade
interest-bearing securities. Access does not invest in derivative financial
instruments.
Critical
Accounting Policies and Estimates
The
preparation of Access’ consolidated financial statements in conformity with
accounting principles generally accepted in the United State of America requires
Access to make estimates and assumptions that affect the reported amounts of
assets and liabilities, disclosure of contingent assets and liabilities at
the
date of the financial statements and the reported amount of revenues and
expenses during the reported period. In applying its accounting principles,
Access must often make individual estimates and assumptions regarding expected
outcomes or uncertainties. As you might expect, the actual results or outcomes
are often different than the estimated or assumed amounts. These differences
are
usually minor and are included in Access’ consolidated financial statements as
soon as they are known. Access’ estimates, judgments and assumptions are
continually evaluated based on available information and experience. Because
of
the use of estimates inherent in the financial reporting process, actual results
could differ from those estimates.
Asset
Impairment
On
January 1, 2002, Access adopted SFAS 142, “Goodwill
and Other Intangible Assets.” Upon
adoption, Access performed a transitional impairment test on its recorded
intangible assets that consisted primarily of acquisition related goodwill
and
license intangibles. Access also performed an annual impairment test in the
fourth quarter of 2005. The analysis compared Access’ market capitalization with
net asset value resulting in an impairment charge in 2005 of $1,868,000.
Access’
intangible assets at December 31, 2006 consist primarily of patents
acquired in acquisitions and licenses which were recorded at fair value on
the
acquisition date. Access performs an impairment test on at least an annual
basis
or when indications of impairment exist. At December 31, 2006, Management
believes no impairment of Access’ intangible assets exists.
108
Based
on
an assessment of Access’ accounting policies and underlying judgments and
uncertainties affecting the application of those policies, Access believe that
its consolidated financial statements provide a meaningful and fair perspective
of Access. Access does not suggest that other general factors, such as those
discussed elsewhere in this report, could not adversely impact its consolidated
financial position, results of operations or cash flows. The impairment test
involves judgment on the part of management as to the value of goodwill,
licenses and intangibles.
Stock
Based Compensation Expense
On
January 1, 2006, Access adopted SFAS No. 123 (revised 2004),
“Share-Based
Payment,”
(“SFAS
123(R)”), which requires the measurement and recognition of all share-based
payment awards made to employees and directors including stock options based
on
estimated fair values. SFAS 123(R) supersedes Access’ previous accounting under
Accounting Principles Board (“APB”) Opinion No. 25, “Accounting
for Stock Issued to Employees”
(“APB
25”), for periods beginning in fiscal year 2006. In March 2005, the Securities
and Exchange.
Commission
issued Staff Accounting Bulletin No. 107 (“SAB 107”) relating to SFAS
123(R). Access applied the provisions of SAB 107 in its adoption of SFAS 123(R).
Access
adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006,
the first day of Access’ 2006 fiscal year. Access’ consolidated financial
statements for the year ended December 31, 2006, reflect the impact of SFAS
123(R). In accordance with the modified prospective transition method, Access’
consolidated financial statements for prior periods have not been restated
to
include the impact of SFAS 123(R). Stock-based compensation expense recognized
under SFAS 123(R) for the year ended December 31, 2006 was approximately
$248,000. Stock-based compensation expense which would have been recognized
under the fair value based method would have been approximately $750,000 during
the year ended December 31, 2005.
SFAS
123(R) requires companies to estimate the fair value of share-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service period in the company’s Statement of
Operations. Prior to the adoption of SFAS 123(R), Access accounted for
stock-based awards to employees and directors using the intrinsic value method
in accordance with APB No. 25 as allowed under SFAS No. 123,
“Accounting
for Stock-Based Compensation”
(“SFAS
123”). Under the intrinsic value method, no stock-based compensation expense for
stock option grants was recognized because the exercise price of Access’ stock
options granted to employees and directors equaled the fair market value of
the
underlying stock at the date of grant. In 2005, Access did recognize stock
compensation expense for restricted stock awards based on the fair value of
the
underlying stock on date of grant and this expense was amortized over the
requisite service period. There were no restricted stock awards granted in
2006
and therefore no stock compensation expense is recognized in 2006 for these
awards.
Stock-based
compensation expense recognized in Access’ Statement of Operations for the first
year ended December 31, 2006 includes compensation expense for share-based
payment awards granted prior to, but not yet vested as of December 31,
2005, based on the grant date fair value estimated in accordance with the pro
forma provisions of SFAS 123 and compensation expense for the share-based
payment awards granted subsequent to December 31, 2005, based on the grant
date
fair value estimated in accordance with the provisions of SFAS 123(R).
Stock-based compensation expense recognized in the Company’s Statement of
Operations for the year ended December 31, 2006 is based on awards ultimately
expected to vest and has been reduced for estimated forfeitures, which currently
is nil. SFAS 123(R) requires forfeitures to be estimated at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates. In Access’ pro forma information required under SFAS 123
for periods prior to fiscal year 2006, forfeitures have been accounted for
as
they occurred.
Access
uses the Black-Scholes option-pricing model (“Black-Scholes”) as its method of
valuation under SFAS 123(R) in fiscal year 2006 and a single option award
approach. This fair value is then amortized on a straight-line basis over the
requisite service periods of the awards, which is generally the vesting period.
Black-Scholes was also previously used for Access’ pro forma information
required under SFAS 123 for periods prior to fiscal year 2006. The fair value
of
share-based payment awards on the date of grant as determined by the
Black-Scholes model is affected by Access’ stock price as well as other
assumptions. These assumptions include, but are not limited to the expected
stock price volatility over the term of the awards, and actual and projected
employee stock option exercise behaviors.
109
Recent
Accounting Pronouncements
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157, “Fair
Value Measurements”
(SFAS 157). SFAS 157 defines fair value, establishes a framework for
measuring fair value in accordance with generally accepted accounting
principles, and expands disclosures about fair value measurements. SFAS 157
is effective for fiscal years beginning after November 15, 2007. Access is
evaluating the potential impact of the implementation of SFAS 157 on its
financial position and results of operations.
In
June
2006, the FASB issued FASB Interpretation No. 48, “Accounting
for Income Tax Uncertainties”
(FIN 48). FIN 48 defines the threshold for recognizing the benefits of
tax return positions in the financial statements as “more-likely-than-not” to be
sustained by the taxing authority. The recently issued literature also provides
guidance on the derecognition, measurement and classification of income tax
uncertainties, along with any related interest and penalties. FIN 48 also
includes guidance concerning accounting for income tax uncertainties in interim
periods and increases the level of disclosures associated with any recorded
income tax uncertainties. FIN 48 is effective for Access as of
January 1, 2007. Any differences between the amounts recognized in the
balance sheets prior to the adoption of FIN 48 and the amounts reported
after adoption will be accounted for as a cumulative-effect adjustment recorded
to the beginning balance of retained earnings. Access is evaluating the
potential impact of the implementation of FIN 48 on its financial position
and results of operations.
Off-Balance
Sheet Transactions
None
Contractual
Obligations
Access’
contractual obligations as of December 31, 2006 are set forth
below.
|
|
|
Payment
Due by Period
|
|
||||||||||
|
|
Total
|
|
Less
Than 1
Year
|
|
1-4
Years
|
|
|||||||
|
Long-Term
Debt
Obligations
|
$
|
16,395,000
|
|
$
|
10,895,000
|
|
$
|
5,500,000
|
|
||||
|
Interest
|
|
|
2,422,000
|
|
|
1,151,000
|
|
|
1,271,000
|
|
|||
|
Lease
Obligations
|
|
|
135,000
|
|
|
92,000
|
|
|
43,000
|
|
|||
|
Total
|
|
$
|
18,952,000
|
|
$
|
12,138,000
|
|
$
|
6,814,000
|
|
|||
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Access
invests any excess cash in certificates of deposit, corporate securities with
high quality ratings, and U.S. government securities. These investments are
not
held for trading or other speculative purposes. These financial investment
securities all mature in 2007 and their estimated fair value approximates cost.
Changes in interest rates affect the investment income Access earns on its
investments and, therefore, impact Access’ cash flows and results of operations.
A hypothetical 50 basis point decrease in interest rates would result in a
decrease in annual interest income and a corresponding increase in net loss
of
approximately $2,000. The estimated effect assumes no changes in Access’
short-term investments from December 31, 2006. Access does not believe that
Access is exposed to any market risks, as defined. Access is not exposed to
risks for changes in commodity prices, or any other market risks.
FINANCIAL
DISCLOSURE
Grant
Thornton LLP ("Grant Thornton") was previously the principal accounts for
Access. On September 15, 2006, Grant Thornton resigned as Access’ independent
registered public accounting firm.
110
In
connection with the audits of fiscal years ended December 31, 2005 and 2004
and
the subsequent interim period through September 15, 2006, (i) there have been
no
disagreements with Grant Thornton on any matter of accounting principles or
practices, financial statement disclosure or auditing scope or procedure, which
disagreement(s), if not resolved to Grant Thornton's satisfaction, would have
caused Grant Thornton to make reference to the subject matter of the
disagreement(s) in connection with its reports for such year, and (ii) there
were no "reportable events" as such term is defined in Item 304(a)(1)(v) of
Regulation S-K. However, as reported in Access’ Form 10-K for the year ended
December 31, 2005, Grant Thornton has communicated to Access’ audit committee
the existence of material weaknesses in Access’ system of internal control over
financial reporting related to the inadequacy of staffing and a lack of
segregation of duties.
Grant
Thornton's reports did not contain an adverse opinion or disclaimer of opinion,
but the 2005 report was modified to include an explanatory paragraph related
to
uncertainties about Access’ ability to continue as a going concern.
Effective
September 20, 2006, the Audit Committee of the Board of Directors of Access
Pharmaceuticals, Inc. (the “Company”) approved the engagement of Whitley Penn
LLP (“Whitley Penn”) as its independent registered public accounting firm to
audit Access’ financial statements for the year ended December 31, 2006. On
October 2, 2006, Whitley Penn formally advised Access that it was accepting
the
position as Access’ independent registered public accounting firm for the year
ending December 31, 2006.
During
the years ended December 31, 2005 and 2004, and the interim period through
October 2, 2006, Whitley Penn has not been engaged as an independent registered
public accounting firm to audit either the financial statements of Access or
any
of its subsidiaries, nor has Access or anyone acting on its behalf consulted
with Whitley Penn regarding: (i) the application of accounting principles to
a
specified transaction, either completed or proposed, or the type of audit
opinion that might be rendered on Access’ financial statements; or (ii) any
matter that was the subject of a disagreement or reportable event as set forth
in Item 304(a)(2)(ii) of Regulation S-K.
111
INDEX
TO ACCESS FINANCIAL STATEMENTS
ACCESS
PHARMACEUTICALS, INC. AND SUBSIDIARIES
Table
of
Contents
December
31, 2006
|
|
FINANCIAL
INFORMATION
|
Page
|
|
|
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
113
|
|
Report
of Independent Registered Public Accounting Firm
|
114
|
|
|
|
Consolidated
Balance Sheets at December 31, 2006 and 2005
|
115
|
|
|
Consolidated
Statements of Operations and Comprehensive Loss for 2006, 2005 and
2004
|
116
|
|
|
Consolidated
Statements of Stockholders’ Equity (Deficit) for 2006, 2005 and
2004
|
117
|
|
|
Consolidated
Statements of Cash Flows for 2006, 2005 and 2004
|
119
|
|
|
Notes
to Consolidated Financial Statements
|
121
|
|
|
|
|
112
Report
of Independent Registered Public Accounting Firm
To
the
Board of Directors and Stockholders of Access Pharmaceuticals, Inc. and
Subsidiaries
We
have
audited the accompanying consolidated balance sheet of Access Pharmaceuticals,
Inc. and Subsidiaries, as of December 31, 2006, and the related consolidated
statements of operations, changes in stockholders’ deficit, and cash flows for
the year then ended. These financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on these
financial statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. An audit includes consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures
in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the consolidated financial position of Access
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2006, and the
consolidated results of their operations and their cash flows for the year
then
ended in conformity with accounting principles generally accepted in the United
States of America.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 2 to the
consolidated financial statements, the Company has had recurring losses from
operations and a net working capital deficiency and accumulated deficit that
raises substantial doubt about its ability to continue as a going concern.
Management’s plans in regard to these matters are also described in Note 2.
These conditions raise substantial doubt about the Company’s ability to continue
as a going concern. These consolidated financial statements do not include
any
adjustments to reflect the possible future effects on the recoverability and
classification of assets or the amounts and classification of liabilities that
may result from the outcome of this uncertainty.
As
discussed in Note 1 to the consolidated financial statements, the Company
adopted Statement of Financial Accounting Standards No. 123(R),
“Share-Based Payment”, effective January 1, 2006. As discussed in Note 7 to
the consolidated financial statements the Company adopted Financial Accounting
Standards Board Staff Position No. EITF 00-19-2, “Accounting for
Registration Payment Arrangements”, effective October 1, 2006.
/s/
WHITLEY PENN LLP
Dallas,
Texas
March
30,
2007
113
Report
of Independent Registered Public Accounting Firm
Board
of Directors and
Stockholders
of Access
Pharmaceuticals, Inc. and Subsidiaries
We
have
audited the accompanying consolidated balance sheets of Access Pharmaceuticals,
Inc. (the “Company”), as of December 31, 2005, and the related consolidated
statements of operations and comprehensive loss, stockholders' equity (deficit),
and cash flows for each of the two years in the period ended December 31,
2005. These financial statements are the responsibility of the Company's
management. Our responsibility is to express an opinion on these consolidated
financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform an audit of its internal control over
financial reporting. Our audit included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures
in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the consolidated financial position of Access
Pharmaceuticals, Inc., as of December 31, 2005, and the results of their
consolidated operations and their consolidated cash flows for each of the two
years in the period ended December 31, 2005, in conformity with accounting
principles generally accepted in the United States of America.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. The Company has incurred
significant losses in each of the two years in the period ended December 31,
2005 in the amounts of $1.7 million and $10.2 million, respectively; the
Company’s total liabilities exceeded its assets by $4.2 million at December 31,
2005; and its operating cash flows were negative $7.3 million and negative
$9.1
million for the years ended December 31, 2005 and 2004, respectively. These
matters, and others described in Note 2, raise substantial doubt about the
Company’s ability to continue as a going concern. Management’s plans in regard
to these matters are also described in Note 2. The consolidated financial
statements do not include any adjustments that might result from the outcome
of
this uncertainty.
/s/
GRANT
THORNTON LLP
Dallas,
Texas
April
25,
2006
114
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
BALANCE SHEETS
|
ASSETS
|
|
December
31, 2006
|
|
December
31, 2005
|
|
||
|
Current
assets
|
|
|
|
|
|
||
|
Cash
and cash equivalents
|
|
$
|
1,194,000
|
|
$
|
349,000
|
|
|
Short
term investments, at cost
|
|
|
3,195,000
|
|
|
125,000
|
|
|
Receivables
|
|
|
359,000
|
|
|
4,488,000
|
|
|
Prepaid
expenses and other current assets
|
|
|
283,000
|
|
|
197,000
|
|
|
Total
current assets
|
|
|
5,031,000
|
|
|
5,159,000
|
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
212,000
|
|
|
300,000
|
|
|
Debt
issuance costs, net
|
|
|
158,000
|
|
|
-
|
|
|
Patents,
net
|
|
|
878,000
|
|
|
1,046,000
|
|
|
Licenses,
net
|
|
|
25,000
|
|
|
75,000
|
|
|
Restricted
cash and other assets
|
|
|
122,000
|
|
|
633,000
|
|
|
Total
assets
|
|
$
|
6,426,000
|
|
$
|
7,213,000
|
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
$
|
1,226,000
|
|
$
|
2,883,000
|
|
|
Accrued
interest payable
|
|
|
581,000
|
|
|
652,000
|
|
|
Deferred
revenues
|
|
|
173,000
|
|
|
173,000
|
|
|
Current
portion long-term debt, net of discount $2,062,000 in 2006
|
|
|
8,833,000
|
|
|
106,000
|
|
|
Total
current liabilities
|
|
|
10,813,000
|
|
|
3,814,000
|
|
|
Long-term
debt, net of discount $1,879,000 in 2005
|
|
|
5,500,000
|
|
|
7,636,000
|
|
|
Total
liabilities
|
|
|
16,313,000
|
|
|
11,450,000
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
deficit
|
|
|
|
|
|
|
|
|
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
none
issued or outstanding
|
|
|
-
|
|
|
-
|
|
|
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
3,535,108 at December 31, 2006 and authorized
50,000,000
shares; issued 3,528,108 at December 31, 2005
|
|
|
35,000
|
|
|
35,000
|
|
|
Additional
paid-in capital
|
|
|
68,799,000
|
|
|
62,942,000
|
|
|
Notes
receivable from stockholders
|
|
|
(1,045,000
|
)
|
|
(1,045,000
|
)
|
|
Treasury
stock, at cost - 163 shares
|
|
|
(4,000
|
)
|
|
(4,000
|
)
|
|
Accumulated
deficit
|
|
|
(77,672,000
|
)
|
|
(66,165,000
|
)
|
|
Total
stockholders' deficit
|
|
|
(9,887,000
|
)
|
|
(4,237,000
|
)
|
|
Total
liabilities and stockholders' deficit
|
|
$
|
6,426,000
|
|
$
|
7,213,000
|
|
The
accompanying notes are an integral part of these consolidated
statements.
115
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
Year
ended December 31,
|
|
|||||||
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
Expenses
|
|
|
|
|
|
|
|
|||
|
Research
and development
|
|
$
|
2,053,000
|
|
$
|
2,783,000
|
|
$
|
2,335,000
|
|
|
General
and administrative
|
|
|
2,813,000
|
|
|
4,638,000
|
|
|
3,199,000
|
|
|
Depreciation
and amortization
|
|
|
309,000
|
|
|
333,000
|
|
|
469,000
|
|
|
Write
off of goodwill
|
|
|
-
|
|
|
1,868,000
|
|
|
-
|
|
|
Total
expenses
|
|
|
5,175,000
|
|
|
9,622,000
|
|
|
6,003,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(5,175,000
|
)
|
|
(9,622,000
|
)
|
|
(6,003,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and miscellaneous income
|
|
|
294,000
|
|
|
100,000
|
|
|
226,000
|
|
|
Interest
and other expense
|
|
|
(7,436,000
|
)
|
|
(2,100,000
|
)
|
|
(1,385,000
|
)
|
|
Unrealized
loss on fair value of warrants and beneficial
conversion
feature
|
|
|
(1,107,000
|
)
|
|
-
|
|
|
-
|
|
|
|
|
|
(8,249,000
|
)
|
|
(2,000,000
|
)
|
|
(1,159,000
|
|
|
Loss
before discontinued operations and before tax benefit
|
|
|
(13,424,000
|
)
|
|
(11,622,000
|
)
|
|
(7,162,000
|
)
|
|
Income
tax benefit
|
|
|
173,000
|
|
|
4,067,000
|
|
|
-
|
|
|
Loss
from continuing operations
|
|
|
(13,251,000
|
)
|
|
(7,555,000
|
)
|
|
(7,162,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DDiscontinued
operations, net of taxes of $173,000 in 2006 and $4,067,000 in
2005
|
|
|
377,000
|
|
|
5,855,000
|
|
|
(3,076,000
|
)
|
|
Net
loss
|
|
$
|
(12,874,000
|
)
|
$
|
(1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per common share
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from continuing operations allocable to common
stockholders
|
|
$
|
(3.75
|
)
|
$
|
(2.34
|
)
|
$
|
(2.36
|
)
|
|
Discontinued
operations
|
|
|
0.11
|
|
|
1.81
|
|
|
(1.02
|
)
|
|
Net
loss allocable to common stockholders
|
|
$
|
(3.65
|
)
|
$
|
(0.53
|
)
|
$
|
(3.38
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average basic and diluted common shares
outstanding
|
|
|
3,531,934
|
|
|
3,237,488
|
|
|
3,032,451
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(12,874,000
|
)
|
$
|
(
1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
Other
comprehensive loss
Foreign
currency translation adjustment
|
|
|
-
|
|
|
3,000
|
|
|
(17,000
|
)
|
|
Comprehensive
loss
|
|
$
|
(12,874,000
|
)
|
$
|
(1,697,000
|
)
|
$
|
(10,255,000
|
)
|
The
accompanying notes are an integral part of these consolidated
statements.
116
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
Shares
|
|
Amount
|
|
Additional
paid in capital
|
|
Notes
receivable from stockholders
|
|
Unamortized
value
of restricted stock grants
|
|
Treasury
stock
|
|
Accumulated
other
comprehensive
income
(loss)
|
|
Accumulated
deficit
|
|
Balance,
December
31,
2003
|
2,679,000
|
|
$
27,000
|
|
$49,704,000
|
|
(1,045,000)
|
|
$(294,000)
|
|
$(4,000)
|
|
$14,000
|
|
$(54,227,000)
|
|
Common
stock
issued
for
cash,
net
of offering costs
|
359,000
|
|
4,000
|
|
9,012,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Common
stock issued for
cash
exercise of
warrants
and options
|
23,000
|
|
-
|
|
283,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Common
stock issued for cashless
exercise
of warrants
|
42,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Issuance
of restricted
stock
grants
|
2,000
|
|
-
|
|
135,000
|
|
-
|
|
(135,000)
|
|
-
|
|
-
|
|
-
|
|
Other
comprehensive
loss
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(17,000)
|
|
-
|
|
Amortization
of restricted stock grants
|
-
|
|
-
|
|
-
|
|
-
|
|
120,000
|
|
-
|
|
-
|
|
-
|
|
Net
loss
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(10,238,000)
|
|
Balance,
December 31, 2004
|
3,105,000
|
|
31,000
|
|
59,134
000
|
|
(1,045,000)
|
|
(309,000)
|
|
(4,000)
|
|
(3,000)
|
|
(64,465,000)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued, net
of
offering
costs
|
237,000
|
|
2,000
|
|
1,119,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Common
stock issued
for
payment of interest
|
190,000
|
|
2,000
|
|
616,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Other
comprehensive
income
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
3,000
|
|
-
|
|
Discount
on convertible
note
extension
|
-
|
|
-
|
|
2,109,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Amortization
and
forfeiture
of restricted
stock
grants
|
(4,000)
|
|
-
|
|
(36,000)
|
|
-
|
|
309,000
|
|
-
|
|
-
|
|
-
|
|
Net
loss
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(1,700,000)
|
117
|
Balance,
December 31, 2005
|
3,528,000
|
|
35,000
|
|
62,942,000
|
|
(1,045,000)
|
|
-
|
|
(4,000)
|
|
-
|
|
(66,165,000)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for
compensation
|
7,000
|
|
-
|
|
77,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Warrants
issued
|
-
|
|
-
|
|
100,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Stock
option
compensation
expense
|
-
|
|
-
|
|
248,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Issuance
of convertible
debt
with warrants
|
-
|
|
-
|
|
5,432,000
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Cumulative
effect of
change
in accounting
principle
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
1,367,000
|
|
Net
loss
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(12,874,000)
|
|
Balance,
December 31, 2006
|
3,535,000
|
|
$
35,000
|
|
$
68,799,000
|
|
(1,045,000)
|
|
$
-
|
|
$
(4,000)
|
|
$
-
|
|
$(77,672,000)
|
The
accompanying notes are an integral part of these consolidated
statements.
118
Access
Pharmaceuticals, Inc. and Subsidiaries
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|||
|
|
|
Year
ended December 31,
|
|
|||||||
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
Cash
flows from operating activities
|
|
|
|
|
|
|
|
|||
|
Net
loss
|
|
$
|
(12,874,000
|
)
|
$
|
(1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
|
|
|
|
|
|
|
|
|
|
|
in
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
Loss
|
|
|
1,107,000
|
|
|
-
|
|
|
-
|
|
|
Loss
on sale Australia assets
|
|
|
-
|
|
|
208,000
|
|
|
-
|
|
|
Impairment
of investment
|
|
|
-
|
|
|
-
|
|
|
112,000
|
|
|
Write
off of goodwill
|
|
|
-
|
|
|
1,868,000
|
|
|
-
|
|
|
Amortization
of restricted stock grants
|
|
|
-
|
|
|
309,000
|
|
|
120,000
|
|
|
Stock
option expense
|
|
|
248,000
|
|
|
-
|
|
|
-
|
|
|
Stock
issued for compensation
|
|
|
77,000
|
|
|
42,000
|
|
|
-
|
|
|
Stock
issued for interest
|
|
|
-
|
|
|
618,000
|
|
|
-
|
|
|
Depreciation
and amortization
|
|
|
309,000
|
|
|
570,000
|
|
|
773,000
|
|
|
Amortization
of debt costs and discounts
|
|
|
6,749,
000
|
|
|
695,000
|
|
|
183,000
|
|
|
Gain
on sale of assets
|
|
|
(550,000)
|
|
|
(12,891,000
|
)
|
|
-
|
|
|
Change
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Receivables
|
|
|
4,129,000
|
|
|
622,000
|
|
|
358,000
|
|
|
Inventory
|
|
|
-
|
|
|
104,000
|
|
|
60,000
|
|
|
Prepaid
expenses and other current assets
|
|
|
14,000
|
|
|
817,000
|
|
|
(195,000
|
)
|
|
Restricted
cash and other assets
|
|
|
127,000
|
|
|
-
|
|
|
-
|
|
|
Accounts
payable and accrued expenses
|
|
|
(1,657,000
|
)
|
|
490,000
|
|
|
401,000
|
|
|
Accrued
interest payable
|
|
|
363,000
|
|
|
341,000
|
|
|
-
|
|
|
Deferred
revenues
|
|
|
-
|
|
|
606,000
|
|
|
15,000
|
|
|
Net
cash used in operating activities
|
|
|
(1,958,000
|
)
|
|
(7,301,000
|
)
|
|
(8,411,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
Capital
expenditures
|
|
|
(3,000
|
)
|
|
(28,000
|
)
|
|
(221,000
|
)
|
|
Proceeds
from sale of equipment
|
|
|
-
|
|
|
335,000
|
|
|
-
|
|
|
Proceeds
from sale of patents
|
|
|
-
|
|
|
974,000
|
|
|
-
|
|
|
Proceeds
from sale of oral/topical care assets
|
|
|
550,000
|
|
|
7,391,000
|
|
|
-
|
|
|
Restricted
cash and other assets
|
|
|
|
|
|
684,000
|
|
|
(666,000
|
)
|
|
Redemptions
of short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
and
certificates of deposit, net
|
|
|
(3,070,000
|
)
|
|
361,000
|
|
|
1,374,000
|
|
|
Net
cash provided by (used in) investing activities
|
|
|
(2,523,000
|
)
|
|
9,717,000
|
|
|
487,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
Payments
of notes payable
|
|
|
(106,000
|
)
|
|
(407,000
|
)
|
|
(310,000
|
)
|
|
Payment
of secured notes payable and convertible notes
|
|
|
-
|
|
|
(6,648,000
|
)
|
|
-
|
|
|
Proceeds
from secured notes payable
|
|
|
5,432,000
|
|
|
2,633,000
|
|
|
-
|
|
|
Proceeds
from stock issuances, net of costs
|
|
|
-
|
|
|
577,000
|
|
|
9,299,000
|
|
|
Net
cash provided by (used in) financing activities
|
|
|
5,326,000
|
|
|
(3,845,000
|
)
|
|
8,989,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash and cash equivalents
|
|
|
845,000
|
|
|
(1,429,000
|
)
|
|
1,065,000
|
|
|
Effect
of exchange rate changes on cash and cash equivalents
|
|
|
-
|
|
|
3,000
|
|
|
(17,000
|
)
|
|
Cash
and cash equivalents at beginning of year
|
|
|
349,000
|
|
|
1,775,000
|
|
|
727,000
|
|
|
Cash
and cash equivalents at end of year
|
|
$
|
1,194,000
|
|
$
|
349,000
|
|
$
|
1,775,000
|
|
119
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$
|
315,000
|
|
$
|
445,000
|
|
$
|
1,073,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of noncash transactions
|
|
|
|
|
|
|
|
|
|
|
|
Value
of restricted stock grants
|
|
|
-
|
|
|
-
|
|
|
135,000
|
|
|
Assets
acquired under capital leases
|
|
|
-
|
|
|
-
|
|
|
59,000
|
|
|
Common
stock issued for SEDA and
|
|
|
|
|
|
|
|
|
|
|
|
Secured
Convertible Notes
|
|
|
-
|
|
|
502,000
|
|
|
-
|
|
|
Discount
on convertible note extension
|
|
|
-
|
|
|
2,109,000
|
|
|
-
|
|
|
Debt
issuance costs
|
|
|
568,000
|
|
|
|
|
|
|
|
|
Accrued
interest capitalized
|
|
|
433,000
|
|
|
|
|
|
|
|
|
Warrants
issued per professional agreement of consulting
services
|
|
|
100,000
|
|
|
|
|
|
|
|
|
Cumulative
change of accounting principle
|
|
|
1,367,000
|
|
|
|
|
|
|
|
|
Issuance
of convertible debt with warrants
|
|
|
5,432,000
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of these consolidated
statements.
120
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Three
years ended December 31, 2006
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Nature
of Operations
Access
Pharmaceuticals, Inc. is an emerging pharmaceutical company engaged in the
development of novel therapeutics for the treatment of cancer and supportive
care of cancer patients. This development work is based primarily on the
adaptation of existing therapeutic agents using the Company’s proprietary drug
delivery technology. Our efforts have been principally devoted to research
and
development, resulting in significant losses since inception on February 24,
1988.
A
summary
of the significant accounting policies applied in the preparation of the
accompanying consolidated financial statements follows.
Principles
of Consolidation
The
consolidated financial statements include the financial statements of Access
Pharmaceuticals, Inc. and our wholly-owned subsidiaries. All intercompany
balances and transactions have been eliminated in consolidation.
Use
of
Estimates
In
preparing consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America, management is
required to make estimates and assumptions that affect the reported amounts
of
assets and liabilities, the disclosure of contingent assets and liabilities
at
the date of the financial statements, and the reported amounts of revenues
and
expenses during the reporting period. Actual results could differ from those
estimates.
We
tested
intangible assets for impairment based on estimates of fair value. It is at
least reasonably possible that the estimates used by us will be materially
different from actual amounts. These differences could result in the impairment
of all or a portion of our intangible assets, which could have a materially
adverse effect on our results of operations.
Cash
and Cash Equivalents
We
consider all highly liquid instruments purchased with a maturity of three months
or less to be cash equivalents for purposes of the statements of cash flows.
Cash and cash equivalents consist primarily of cash in banks, money market
funds
and short-term corporate securities. We invest any excess cash in government
and
corporate securities. All other investments are reported as short-term
investments.
Short-term
Investments
Short-term
investments consist of certificates of deposit. All short term investments
are
classified as held to maturity. The cost of debt securities is adjusted for
amortization of premiums and accretion of discounts to maturity. Such
amortization is included in interest income. The cost of securities sold is
based on the specific identification method.
Property
and Equipment
Property
and equipment are recorded at cost. Depreciation is provided using the
straight-line method over estimated useful lives ranging from three to seven
years. Expenditures for major renewals and betterments that extend the useful
lives are capitalized. Expenditures for normal maintenance and repairs are
expensed as incurred. The cost of assets sold or abandoned and the related
accumulated depreciation are eliminated from the accounts and any gains or
losses are recognized in the accompanying consolidated statements of operations
of the respective period.
121
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -
Continued
Research
and Development Expenses
Pursuant
to SFAS No. 2, “Accounting
for Research and Development Costs,”
our
research and development costs are expensed as incurred. Research and
development expenses include, but are not limited to, payroll and personnel
expense, lab supplies, preclinical, development cost, clinical trial expense,
outside manufacturing and consulting. The cost of materials and equipment or
facilities that are acquired for research and development activities and that
have alternative future uses are capitalized when acquired.
Fair
Value of Financial Instruments
The
carrying value of cash, cash equivalents, short-term investments and accounts
payable approximates fair value due to the short maturity of these items. It
is
not practical to estimate the fair value of the Company’s long-term debt because
quoted market prices do not exist and there were no available securities with
similar terms to use as a basis to value our debt.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax
assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts
of
existing assets and liabilities and their respective tax bases and operating
loss and tax credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a change in tax
rates is recognized in income in the period that includes the enactment date.
A
valuation allowance is provided for deferred tax assets to the extent their
realization is in doubt.
Loss
Per Share
We
have
presented basic loss per share, computed on the basis of the weighted average
number of common shares outstanding during the year, and diluted loss per share,
computed on the basis of the weighted average number of common shares and all
dilutive potential common shares outstanding during the year. Potential common
shares result from stock options, vesting of restricted stock grants,
convertible notes and warrants. However, for all years presented, all
outstanding stock options, restricted stock grants, convertible notes and
warrants are anti-dilutive due to the losses for the periods. Anti-dilutive
common stock equivalents of 12,548,342; 1,730,135; and 1,114,122 were excluded
from the loss per share computation for 2006, 2005 and 2004,
respectively.
Restricted
Cash
Restricted
cash is cash that is or may be committed for a particular purpose. We had
restricted cash in 2005 as collateral for a note payable of $103,000. The note
was paid in full in 2006 and there is no restricted cash in 2006.
Intangible
Assets
We
expense internal patent and application costs as incurred because, even though
we believe the patents and underlying processes have continuing value, the
amount of future benefits to be derived therefrom are uncertain. Purchased
patents are capitalized and amortized over the life of the patent. We recognize
the purchase cost of licenses and amortize them over their estimated useful
lives.
The
Company operates in a single segment. In 2005, the Company wrote off its
goodwill as determined by comparing the Company’s market capitalization with its
net asset value resulting in an impairment charge of $1,868,000. In 2005, the
Company sold one of its patents for $974,000 and the Company believes the fair
value of the remaining patents based on discounted cash flow analysis exceeds
the carry value.
122
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -
Continued
Intangible
assets consist of the following (in thousands):
|
|
|
December
31, 2006
|
|
December
31, 2005
|
|
December
31, 2004
|
|
||||||||||||
|
|
|
Gross
carrying
value
|
|
Accumulated
amortization
|
|
Gross
carrying
value
|
|
Accumulated
amortization
|
|
Gross
carrying
value
|
|
Accumulated
amortization
|
|
||||||
|
Amortizable
intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents
|
|
$
|
1,680
|
|
$
|
802
|
|
$
|
1,680
|
|
$
|
634
|
|
$
|
3,179
|
|
$
|
864
|
|
|
Licenses
|
|
|
500
|
|
|
475
|
|
|
500
|
|
|
425
|
|
|
500
|
|
|
375
|
|
|
Total
|
|
$
|
2,180
|
|
$
|
1,277
|
|
$
|
2,180
|
|
$
|
1,059
|
|
$
|
3,679
|
|
$
|
1,239
|
|
Amortization
expense related to intangible assets totaled $218,000, $345,000 and $421,000
for
the years ended December 31, 2006, 2005 and 2004, respectively. The aggregate
estimated amortization expense for intangible assets remaining as of December
31, 2006 is as follows (in thousands):
|
2007
|
|
$
|
193
|
|
|
2008
|
|
|
168
|
|
|
2009
|
|
|
168
|
|
|
2010
|
|
|
168
|
|
|
2011
|
|
|
168
|
|
|
Thereafter
|
|
|
38
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
903
|
|
Stock-Based
Compensation
On
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based
Payment,”
(“SFAS
123(R)”), which requires the measurement and recognition of all share-based
payment awards made to employees and directors including stock options based
on
estimated fair values. SFAS 123(R) supersedes the Company’s previous accounting
under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting
for Stock Issued to Employees”
(“APB
25”), for periods beginning in fiscal year 2006. In March 2005, the Securities
and Exchange Commission issued Staff Accounting Bulletin No. 107 (“SAB
107”) relating to SFAS 123(R). We applied the provisions of SAB 107 in its
adoption of SFAS 123(R).
We
adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006,
the first day of the Company’s 2006 fiscal year. Our consolidated financial
statements for the year ended December 31, 2006, reflect the impact of SFAS
123(R). In accordance with the modified prospective transition method, our
consolidated financial statements for prior periods have not been restated
to
include the impact of SFAS 123(R). Stock-based compensation expense recognized
under SFAS 123(R) for the year ended December 31, 2006 was approximately
$248,000. Stock-based compensation expense which would have been recognized
under the fair value based method would have been approximately $750,000 during
the year ended December 31, 2005.
123
NOTE
1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -
Continued
SFAS
123(R) requires companies to estimate the fair value of share-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service period in the company’s Statement of
Operations. Prior to the adoption of SFAS 123(R), we accounted for stock-based
awards to employees and directors using the intrinsic value method in accordance
with APB No. 25 as allowed under SFAS No. 123, “Accounting
for Stock-Based Compensation”
(“SFAS
123”). Under the intrinsic value method, no stock-based compensation expense for
stock option grants was recognized because the exercise price of our stock
options granted to employees and directors equaled the fair market value of
the
underlying stock at the date of grant. In 2005, we did recognize stock
compensation expense for restricted stock awards based on the fair value of
the
underlying stock on date of grant and this expense was amortized over the
requisite service period. There were no restricted stock awards granted in
2006
and therefore no stock compensation expense is recognized in 2006.
Stock-based
compensation expense recognized in our Statement of Operations for the first
year ended December 31, 2006 includes compensation expense for share-based
payment awards granted prior to, but not yet vested as of December 31,
2005, based on the grant date fair value estimated in accordance with the pro
forma provisions of SFAS 123 and compensation expense for the share-based
payment awards granted subsequent to December 31, 2005, based on the grant
date
fair value estimated in accordance with the provisions of SFAS 123(R).
Stock-based compensation expense recognized in the Company’s Statement of
Operations for the year ended December 31, 2006 is based on awards ultimately
expected to vest and has been reduced for estimated forfeitures, which currently
is nil. SFAS 123(R) requires forfeitures to be estimated at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates. In the Company’s pro forma information required under SFAS
123 for periods prior to fiscal year 2006, forfeitures have been accounted
for
as they occurred.
We
use
the Black-Scholes option-pricing model (“Black-Scholes”) as its method of
valuation under SFAS 123(R) in fiscal year 2006 and a single option award
approach. This fair value is then amortized on a straight-line basis over the
requisite service periods of the awards, which is generally the vesting period.
Black-Scholes was also previously used for our pro forma information required
under SFAS 123 for periods prior to fiscal year 2006. The fair value of
share-based payment awards on the date of grant as determined by the
Black-Scholes model is affected by our stock price as well as other assumptions.
These assumptions include, but are not limited to the expected stock price
volatility over the term of the awards, and actual and projected employee stock
option exercise behaviors.
During
2006, 753,872 stock options were granted and 50,000 stock options were granted
during 2005 under the 2005 Equity Incentive Plan. In addition, 49,700 stock
options were granted during 2005 under the 1995 Stock Award Program. Assumptions
for 2006 are:
|
·
|
127%
- the expected volatility assumption was based upon a combination
of
historical stock price volatility measured on a twice a month basis
and is
a reasonable indicator of expected volatility.
|
|
·
|
4.85%
(average) - the risk-free interest rate assumption is based upon
U.S.
Treasury bond interest rates appropriate for the term of the Company’s
employee stock options.
|
|
·
|
None
- the dividend yield assumption is based on our history and expectation
of
dividend payments.
|
|
·
|
1.6
years - the estimated expected term (average of 1.6 years) is based
on
employee exercise behavior.
|
At
December 31, 2006, the balance of unearned stock-based compensation to be
expensed in future periods related to unvested share-based awards, as adjusted
for expected forfeitures, is approximately $360,000. The period over which
the
unearned stock-based compensation is expected to be recognized is approximately
three years. We anticipate that we will grant additional share-based awards
to
employees in the future, which will increase our stock-based compensation
expense by the additional unearned compensation resulting from these grants.
The
fair value of these grants is not included in the amount above, because the
impact of these grants cannot be predicted at this time due to the dependence
on
the number of share-based payments granted. In addition, if factors change
and
different assumptions are used in the application of SFAS 123(R) in future
periods, stock-based compensation expense recorded under SFAS 123(R) may
differ significantly from what has been recorded in the current
period.
124
Our
Employee Stock Option
Plans
have been deemed compensatory in accordance with SFAS 123(R). Stock-based
compensation relating to this plan was computed using the Black-Scholes model
option-pricing formula with interest rates, volatility and dividend assumptions
as of the respective grant dates of the purchase rights provided to employees
under the plan. The weighted-average fair value of options existing under all
plans during 2006 was $5.00.
The
following table summarizes stock-based compensation in accordance with SFAS
123(R) for the year ended December 31, 2006, which was allocated as follows
(in thousands):
|
|
|
Year ended
December 31,
2006
|
|
|
Research
and development
|
|
$
|
68
|
|
General
and administrative
|
|
|
180
|
|
|
|
|
|
|
Stock-based
compensation expense included in operating expenses
|
|
|
248
|
|
|
|
|
|
|
Total
stock-based compensation expense
|
|
|
248
|
|
Tax
benefit
|
|
|
—
|
|
|
|
|
|
|
Stock-based
compensation expense, net of tax
|
|
$
|
248
|
|
|
|
|
|
The
following table reflects net income and diluted earnings per share for the
year
ended December 31, 2006, compared with proforma information for the year
ended December 31, 2005, had compensation cost been determined in
accordance with the fair value-based method prescribed by SFAS 123(R).
|
(in
thousands)
|
|
Year
ended
December
31,
|
|||||
|
|
|
|
2006
|
|
|
2005
|
|
|
Net
loss, as reported under APB 25 for the prior period (1)
|
|
$
|
N/A
|
|
$
|
(1,700
|
)
|
|
Add
back stock based employee compensation expense in
reported
net loss, net of related tax effects
|
|
|
-
|
|
|
-
|
|
|
Subtract
total stock-based compensation expense determined
under
fair value-based method for all awards, net of related tax
effects(2)
|
|
|
(248
|
)
|
|
(750
|
)
|
|
Net
loss including the effect of stock-based compensation expense(3)
|
|
$
|
(12,874
|
)
|
$
|
(2,450
|
)
|
|
Loss
per share:
|
|
|
|
|
|
|
|
|
Basic
and diluted, as reported for the prior period(1)
|
|
$
|
(3.65
|
)
|
$
|
(0.53
|
)
|
|
Basic
and diluted, including the effect of stock-based
compensation
expense(3)
|
|
$
|
(3.65
|
)
|
$
|
(0.76
|
)
|
|
(1)
|
Net
loss and loss per share for periods prior to year 2006 does not include
stock-based compensation expense under SFAS 123 because the Company
did
not adopt the recognition provisions of SFAS 123.
|
|
(2)
|
Stock-based
compensation expense for periods prior to year 2006 was calculated
based
on the pro forma application of SFAS 123.
|
|
(3)
|
Net
loss and loss per share for periods prior to year 2006 represent
pro forma
information based on SFAS 123.
|
125
Stock
compensation expense for options granted to nonemployees has been determined
in
accordance with SFAS 123 and EITF 96-18, “Accounting
for Equity Instruments That Are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services,” as
the
fair value of the consideration received or the fair value of the equity
instruments issued, whichever is more reliably measured.
Recent
Accounting Pronouncement
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157, “Fair
Value Measurements”
(SFAS 157). SFAS 157 defines fair value, establishes a framework for
measuring fair value in accordance with generally accepted accounting
principles, and expands disclosures about fair value measurements. SFAS 157
is effective for fiscal years beginning after November 15, 2007. We are
evaluating the potential impact of the implementation of SFAS 157 on our
financial position and results of operations.
In
June
2006, the FASB issued FASB Interpretation No. 48, “Accounting
for Income Tax Uncertainties”
(FIN 48). FIN 48 defines the threshold for recognizing the benefits of
tax return positions in the financial statements as “more-likely-than-not” to be
sustained by the taxing authority. The recently issued literature also provides
guidance on the derecognition, measurement and classification of income tax
uncertainties, along with any related interest and penalties. FIN 48 also
includes guidance concerning accounting for income tax uncertainties in interim
periods and increases the level of disclosures associated with any recorded
income tax uncertainties. FIN 48 is effective for Access as of
January 1, 2007. Any differences between the amounts recognized in the
balance sheets prior to the adoption of FIN 48 and the amounts reported
after adoption will be accounted for as a cumulative-effect adjustment recorded
to the beginning balance of retained earnings. We are evaluating the potential
impact of the implementation of FIN 48 on our financial position and
results of operations.
NOTE
2 - LIQUIDITY
The
Company incurred significant losses from continuing operations of $13.4 million
for the year ended December 31, 2006 and $7.6 million for the year ended
December 31, 2005. Additionally, at December 31, 2006, we had negative working
capital of $5.8 million. As of December 31, 2006, we did
not have
sufficient funds to repay our convertible notes at their maturity and support
our working capital and operating requirements.
We
do not
have funds to pay our debt obligations which are due in March, April and
September 2007 and will have to raise more funds or attempt to restructure
the
convertible notes.
SCO
Capital Partners LLC Note and Warrant Purchase Agreement
On
December 6, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due March 31, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. The notes and warrants were sold
in a private placement to a group of accredited investors led by SCO Capital
Partners LLC (“SCO”) and affiliates.
On
October 24, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due March 31, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. The notes and warrants were sold
in a private placement to a group of accredited investors led by SCO and
affiliates.
On
February 16, 2006, we entered into a note and warrant purchase agreement
pursuant to which we sold and issued an aggregate of $5,000,000 of 7.5%
convertible notes due March 31, 2007 and warrants to purchase an aggregate
of
3,863,634 shares of common stock of Access. Net proceeds to Access were $4.5
million. The notes and warrants were sold in a private placement to a group
of
accredited investors led by SCO and affiliates.
All
of
the notes mature on March 31, 2007, are convertible into Access common stock
at
a fixed conversion rate of $1.10 per share, bear interest of 7.5% per annum
and
are secured by certain assets of Access. Each note may be converted at the
option of the noteholder or Access under certain circumstances as set forth
in
the notes.
Each
noteholder received a warrant to purchase a number of shares of common stock
of
Access equal to 75% of the total number shares of Access common stock into
which
such holder's note is convertible. Each warrant has an exercise price of $1.32
per share and is exercisable at any time prior to February 16, 2012, October
24,
2012 and December 6, 2012. In the event SCO and its affiliates were to convert
all of their notes and exercise all of their warrants, they would own
approximately 74.1% of the voting securities of Access.
126
In
connection with its sale and issuance of notes and warrants, Access entered
into
an investors rights agreement whereby it granted SCO the right to designate two
individuals to serve on the Board of Directors of Access while the notes are
outstanding, and also granted registration rights with respect to the shares
of
common stock of Access underlying the notes and warrants.
The
Company believes that based on the funds available the Company will have the
ability to pay its projected net cash burn rate of $750,000 per month for seven
months. We will have to raise more funds to cover future months net cash burn
rate and to pay our debt service or attempt to restructure the convertible
notes.
NOTE
3 - RELATED PARTY TRANSACTIONS
Stephen
B. Howell, M.D., a Director, receives payments for consulting services and
reimbursement of direct expenses and has also received warrants for his
consulting services. Dr. Howell’s payments for consulting services, expense
reimbursements and warrants are as follows:
|
Year
|
|
|
Consulting
Fees
|
|
|
Expense
Reimbursement
|
|
|
2006
|
|
$
|
69,000
|
|
$
|
5,000
|
|
|
2005
|
|
|
79,000
|
|
|
5,000
|
|
|
2004
|
|
|
58,000
|
|
|
9,000
|
|
In
the
event SCO Capital Partners LLC (“SCO”) and its affiliates were to convert all of
their notes and exercise all of their warrants, they would own approximately
74.1% of the voting securities of Access. During 2006 SCO and affiliates were
paid $415,000 in fees for the convertible notes that Access issued and were
paid
$131,000 in investor relations fees.
See
Note
9 for a discussion of our Restricted Stock Purchase Program.
NOTE
4 - PROPERTY AND EQUIPMENT
|
Property
and equipment consists of the following:
|
|
December
31,
|
|||||
|
|
|
|
2006
|
|
|
2005
|
|
|
Laboratory
equipment
|
|
$
|
1,090,000
|
|
$
|
1,090,000
|
|
|
Laboratory
and building improvements
|
|
|
167,000
|
|
|
167,000
|
|
|
Furniture
and equipment
|
|
|
134,000
|
|
|
138,000
|
|
|
|
|
|
1,391,000
|
|
|
1,395,000
|
|
|
Less
accumulated depreciation and amortization
|
|
|
1,179,000
|
|
|
1,095,000
|
|
|
Net
property and equipment
|
|
$
|
212,000
|
|
$
|
300,000
|
|
Depreciation
and amortization on property and equipment was $91,000, $225,000, and $244,000
for the years ended December 31, 2006, 2005 and 2004, respectively.
NOTE
5 - 401(k) PLAN
We
have a
tax-qualified employee savings and retirement plan (the “401(k) Plan”) covering
all our employees. Pursuant to the 401(k) Plan, employees may elect to reduce
their current compensation by up to the statutorily prescribed annual limit
($15,000 in 2006; $14,000 in 2005; and $13,000 in 2004) and to have the amount
of such reduction contributed to the 401(k) Plan. We have a 401(k) matching
program whereby we contribute for each dollar a participant contributes a like
amount, with a maximum contribution of 2% of a participant’s earnings. The
401(k) Plan is intended to qualify under Section 401 of the Internal Revenue
Code so that contributions by employees or by us to the 401(k) Plan, and income
earned on 401(k) Plan contributions, are not taxable to employees until
withdrawn from the 401(k) Plan, and so that contributions by us, if any, will
be
deductible by us when made. At the direction of each participant, we invest
the
assets of the 401(k) Plan in any of 23 investment options. Company contributions
under the 401(k) Plan were approximately $11,000 in 2006; $31,000 in 2005;
and
$46,000 in 2004.
127
NOTE
6 - DISCONTINUED OPERATIONS
In
October 2005 we sold our oral/topical care business to Uluru, Inc. for up to
$18.6 million. At the closing of this agreement we received $8.7 million. In
addition, due to the Amended Asset Sale Agreement in December 2006, we received
$4.9 million and an obligation to receive from Uluru $350,000 on April 8, 2007
for the first and second anniversary payments and settlement of certain
milestones. We recorded $550,000 as revenue for the discontinued operations
in
2006. Any contingent liabilities arise in the future relating to our former
business could reduce future receipts. Additional payments of up to $4.8
million, as amended by the Amended Asset Sale Agreement may be made upon the
achievement of certain additional sales milestones.
In
September 2005 we closed our Australian laboratory and office, keeping the
vitamin B12 technology.
In
accordance with Statement of Financial Accounting Standards (“SFAS”) No. 144,
“Accounting for the Impairment or Disposal of Long-Lived Assets” operating
results for assets sold or held for sale are presented as discontinued
operations for current and all prior years presented. In accordance with SFAS
No. 144 the operating results of these assets, along with the gain on sale,
have
been presented in discontinued operations for all periods
presented.
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
Revenues
|
|
$
|
550,000
|
|
$
|
781,000
|
|
$
|
549,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of product sales
|
|
|
|
|
(1,012,000
|
)
|
|
(239,000
|
)
|
|
|
Research
and development
|
|
|
|
|
|
(2,501,000
|
)
|
|
(3,082,000
|
)
|
|
Depreciation
|
|
|
|
|
|
(237,000
|
)
|
|
(304,000
|
)
|
|
Total
expenses
|
|
|
-
|
|
|
(3,750,000
|
)
|
|
(3,625,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/loss
from discontinued operations
|
|
|
550,000
|
|
|
(2,969,000
|
)
|
|
(3,076,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain
on sale of assets
|
|
|
-
|
|
|
12,891,000
|
|
|
-
|
|
|
Tax
expense
|
|
|
(173,000
|
)
|
|
(4,067,000
|
)
|
|
-
|
|
|
Discontinued
operations
|
|
$
|
377,000
|
|
$
|
5,855,000
|
|
$
|
(3,076,000
|
)
|
We
previously had licenses for the oral/topical assets. These licenses were sold
to
Uluru, Inc. in October 2005. In the Asset Sale Agreement between us and Uluru
certain refunds and receipts were incurred before the date of sale and were
assigned to either us or to Uluru. We have $173,000 recorded as a deferred
gain
on the sale until such time as approvals are received.
NOTE
7 - DEBT
On
September 20, 2000, we completed a $13.5 million convertible note offering.
The
offering was placed with three investors. One investor was repaid in 2005,
$4,015,000. Our other convertible notes are due in two parts. The notes bear
interest at 7.7% per annum with $733,000 of interest due annually on September
13th.
$4,015,000
due on April 28, 2007.
This
investor’s notes have a fixed conversion price of $5.00 per share of common
stock and may be converted by the note holder or us under certain circumstances
as defined in the note. Upon a change of control, this investor is not required
to automatically convert the note unless the amount payable to the investor
upon
change of control, issuable upon conversion of the note equals or exceeds $7.50.
If the notes are not converted we will have to repay the notes on the due dates.
The investor’s notes were amended November 3, 2005 extending the term and
adjusting the conversion price from $27.50 to $5.00 per common share. The
amendment and modification resulted in us recording additional debt discount
of
$2.1 million, which will be accreted to interest expense to the revised maturity
date. The interest due at December 31, 2006 was $92,000.
128
$5,500,000
due on September 13, 2010.
This
investor delayed his interest payment which was due in 2005 and 2006 until
September 13, 2007 or earlier if the Company raises more than $5.0 million
in
funds. The capitalized interest was $880,000 and interest on the capitalized
interest was $26,000 at December 31, 2006. The interest due on the convertible
note was $126,000 at December 31, 2006. This note has a fixed conversion price
of $27.50 per share of common stock and may be converted by the note holder
or
us under certain circumstances as defined in the note. If the notes are not
converted we will have to repay the notes on the due dates.
$6,000,000
due on March 31, 2007.
The
notes were sold in February 2006 in a private placement to a group of accredited
investors led by SCO Capital Partners LLC and affiliates. We entered into a
note
and purchase agreement to which we sold and issued an aggregate of $5 million
of
7.5% convertible notes due March 31, 2007 and warrants to purchase 3,863,634
shares of common stock of Access. Net proceeds to Access were $4.5
million.
On
October 24, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due March 31, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. On December 6, 2006, we entered
into a note and warrant purchase agreement pursuant to which we sold and issued
an aggregate of $500,000 of 7.5% convertible notes due March 31, 2007 and
warrants to purchase 386,364 shares of common stock of Access. Net proceeds
to
Access were $450,000. Interest due at December 31, 2006 on all notes with SCO
and affiliates was $336,000.
All
these
notes with SCO and affiliates have a fixed conversion price of $1.10 per share
of common stock and may be converted by the note holder or us under certain
circumstances as defined in the note. If the notes are not converted we will
have to repay the notes on the due dates.
The
Secured Convertible Notes include warrants and a conversion feature. Until
September 30, 2006 we accounted for the warrants and conversion feature as
liabilities and recorded at fair value. From the date of issuance to September
30, 2006, the fair value of these instruments increased resulting in a net
unrealized loss of $1.1 million. On October 1, 2006, we adopted the
provisions of EITF 00-19-2, “Accounting
for Registration Payment Arrangements” (EITF
00-19-2), which requires that contingent obligations to make future payments
under a registration payment arrangement be recognized and measured separately
in accordance with SFAS No. 5, “Accounting
for Contingencies.”
Under
previous guidance, the fair value of the warrant was recorded as a current
liability in our balance sheet, due to a potential cash payment feature in
the
warrant. Access may be required to pay in cash, up to 2% per month, as defined,
as liquidated damages for failure to file a registration statement timely as
required by an investor rights agreement. The current liability was
marked-to-market at each quarter end, using the Black-Scholes option-pricing
model, with the change being recorded to general and administrative expenses.
Under the new guidance in EITF 00-19-2, as we believe the likelihood of such
a
cash payment to not be probable, have not recognized a liability for such
obligations. Accordingly, a cumulative-effect adjustment of $1.4 million was
made as of October 1, 2006 to accumulated deficit, representing the
difference between the initial value of this warrant and its fair value as
of
this date and recorded to equity.
Subsequent
to the adoption of EITF 00-19-2 on October 1, 2006, the Company has accounted
for the $6,000,000 notes under EITF Issue No. 00-27, Application
of Issue No. 98-5 to Certain Instruments.
The
value of the warrants was valued using a Black-Scholes option-pricing model
with
the following assumptions with a weighted average volatility of
120%,
expected
life of 6 years, expected yield of 0% and risk free rate of 5.0%. At December
31, 2006, approximately $1.6M of
debt
discount related to the warrants and embedded conversion feature had not been
amortized to interest expense. This will be amortized over the remaining life
of
the debt through March 31, 2007.
On
September 20, 2001, we completed a $600,000 installment loan with a bank. The
note was paid in full in 2006.
NOTE
8 - COMMITMENTS AND CONTINGENCIES
Future
maturities of the note payable and other obligations are as
follows:
|
Future
Maturities
|
|
Debt
|
|
2007
|
|
10,895,000
|
|
2010
|
|
5,500,000
|
The
debt
of $4,015,000 is discounted and at December 31, 2006 is on the balance sheet
as
$3,559,000.
The
debt
of $6,000,000 is discounted and at December 31, 2006 is on the balance sheet
as
$4,394,000.
129
Operating
Leases
At
December 31, 2006, we have commitments under noncancelable operating leases
for
office and research and development facilities until December 31, 2007 totaling
$75,000. Rent expense for the years ended December 31, 2006, 2005 and 2004
was
$94,000, $168,000 and $166,000, respectively. We also have two other
noncancelable operating leases - one lease for a fire alarm system totaling
$12,000 ending in 2008 (expensing $7,000 in 2007 and $5,000 in 2008) and
one lease for a copier totaling $48,000 ending in 2011 (with $9,600
expensed each year).
Legal
The
Company is not currently subject to any material pending legal
proceedings.
NOTE
9 - STOCKHOLDERS' EQUITY
Restricted
Stock Purchase Program
On
October 12, 2000, the Board of Directors authorized a Restricted Stock Purchase
Program. Under the Program, the Company’s executive officers and corporate
secretary were given the opportunity to purchase shares of common stock in
an
individually designated amount per participant determined by the Compensation
Committee of the Board of Directors. A total of 38,000 shares were purchased
under the Program by four
eligible participants at $27.50 per share, the fair market value of the common
stock on October 12, 2000, for an aggregate consideration of $1,045,000. The
purchase price was paid through the participants’ delivery of a 50%-recourse
promissory note payable to the Company for three executive officer participants
and a full-recourse promissory note payable to the Company for one participant.
Each note bears interest at 5.87% compounded semi-annually and has a maximum
term of ten years. The notes are secured by a pledge of the purchased shares
to
the Company. The Company recorded the notes receivable from participants in
this
Program of $1,045,000 as a reduction of equity in the Consolidated Balance
Sheet. Interest on the notes is neither being collected nor accrued. The stock
granted under the Program is fully vested at December 31, 2006.
Warrants
There
were warrants to purchase a total of 4,826,517 shares of common stock
outstanding at December 31, 2006. All warrants were exercisable at December
31,
2006. The warrants had various prices and terms as follows:
|
Summary
of Warrants
|
|
|
Outstanding
|
|
Exercise
Price
|
|
Expiration
Date
|
|
||||
|
2006
convertible note (a)
|
|
|
|
3,863,634
|
|
$
|
1.32
|
|
|
2/16/12
|
|
|
|
2006
convertible note (a)
|
|
|
|
386,364
|
|
|
1.32
|
|
|
10/24/12
|
|
|
|
2006
convertible note (a)
|
|
|
|
386,364
|
|
|
1.32
|
|
|
12/06/12
|
|
|
|
2006
investor relations advisor (b)
|
|
|
|
50,000
|
|
|
2.70
|
|
|
12/27/11
|
|
|
|
2004
offering (c)
|
|
|
|
89,461
|
|
|
35.50
|
|
|
2/24/09
|
|
|
|
2004
offering (c)
|
|
|
|
31,295
|
|
|
27.00
|
|
|
2/24/09
|
|
|
|
2003
financial advisor (d)
|
|
|
|
14,399
|
|
|
19.50
|
|
|
10/30/08
|
|
|
|
2002
scientific consultant (e)
|
|
|
|
2,000
|
|
|
24.80
|
|
|
2/01/09
|
|
|
|
2001
scientific consultant (f)
|
|
|
|
3,000
|
|
|
15.00
|
|
|
1/1/08
|
|
|
|
Total
|
|
|
|
4,826,517
|
|
|
|
|
|
|
|
|
|
a)
|
In
connection with the convertible note offerings in 2006, warrants
to
purchase a total of 4,636,362 shares of common stock were issued.
All of
the warrants are exercisable immediately and expire six years from
date of
issue.
|
|
b)
|
During
2006, an investor relations advisor received warrants to purchase
50,000
shares of common stock at an exercise price of $2.70 per share at
any time
from December 27, 2006 until December 27, 2011, for investor relations
consulting services to be rendered in 2007. All of the warrants were
exercisable at December 31, 2006. The fair value of the warrants
was $2.00
per share on the date of the grant using the Black-Scholes pricing
model
with the following assumptions: expected dividend yield 0.0%, risk-free
interest rate 4.58%, expected volatility 138% and a term of 2.5 years.
|
|
c)
|
In
connection with offering of common stock in 2004, warrants to purchase
a
total of 120,756 shares of common stock were issued. All of the warrants
are exercisable and expire five years from date of
issuance.
|
130
|
d)
|
During
2003, financial advisors received warrants to purchase 14,399 shares
of
common stock at any time until October 30, 2008, for financial consulting
services rendered in 2003 and 2004. All the warrants are exercisable.
The
fair value of the warrants was $14.10 per share on the date of the
grant
using the Black-Scholes pricing model with the following assumptions:
expected dividend yield 0.0%, risk-free interest rate 2.9%, expected
volatility 92% and a term of 5 years.
|
|
e)
|
During
2002, a director who is also a scientific advisor received warrants
to
purchase 2,000 shares of common stock at an exercise price of $24.55
per
share at any time until February 1, 2009, for scientific consulting
services rendered in 2002. The fair value of the warrants was $18.50
per
share on the date of the grant using the Black-Scholes pricing model
with
the following assumptions: expected dividend yield 0.0%, risk-free
interest rate 3.90%, expected volatility 81% and a term of 7 years.
|
|
f)
|
During
2001, a director who is also a scientific advisor received warrants
to
purchase 3,000 shares of common stock at an exercise price of $15.00
per
share at any time until January 1, 2008, for scientific consulting
services rendered in 2001. The fair value of the warrants was $13.70
per
share on the date of the grant using the Black-Scholes pricing model
with
the following assumptions: expected dividend yield 0.0%, risk-free
interest rate 5.03%, expected volatility 118% and a term of 7 years.
|
2001
Restricted Stock Plan
We
have a
restricted stock plan, the 2001 Restricted Stock Plan, as amended, under which
80,000 shares of our authorized but unissued common stock were reserved for
issuance to certain employees, directors, consultants and advisors. The
restricted stock granted under the plan generally vests, 25% two years after
the
grant date with additional 25% vesting every anniversary date. All stock is
vested after five years. At December 31, 2006 there were 27,182 shares issued
and 52,818 shares available for grant under the 2001 Restricted Stock
Plan.
NOTE
10 - STOCK OPTION PLANS
We
have
various stock-based employee compensation plans described below:
2005
Equity Incentive Plan
We
have a
stock awards plan, (the “2005 Equity Incentive Plan”), under which 1,000,000
shares of our authorized but unissued common stock were reserved for issuance
to
employees of, or consultants to, one or more of the Company and its affiliates,
or to non-employee members of the Board or of any board of directors (or similar
governing authority) of any affiliate of the Company. The 2005 Equity Incentive
Plan replaced the previously approved stock option plan (the 1995 Stock Awards
Plan").
For
the
2005 Equity Incentive Plan, the fair value of options was estimated at the
date
of grant using the Black-Scholes option pricing model with the following
weighted average assumptions used for grants in fiscal 2006: dividend yield
of
0%; volatility of 127%; risk-free interest rate of 4.85%; and expected lives
of
1.6 years. The weighted average fair value of options granted was $0.36 per
share during 2006. The assumptions for grants in fiscal 2005 were: dividend
yield of 0%; volatility of 113%; risk-free interest rate of 4.71%; and expected
lives of four years. The weighted average fair value of options granted was
$8.50 per share during 2005.
Summarized
information for the 2005 Equity Incentive Plan is as follows:
|
|
|
|
Weighted-
|
|
|
|
|
average
|
|
|
|
|
exercise
|
|
|
Options
|
|
price
|
|
Outstanding
options at January 1, 2005
|
-
|
|
$
-
|
|
Granted,
fair value of $8.50 per share
|
50,000
|
|
5.45
|
|
Outstanding
options at December 31, 2005
|
50,000
|
|
5.45
|
|
|
|
|
|
|
Granted,
fair value of $ 0.36 per share
|
753,872
|
|
1.32
|
|
Forfeited
|
(1,200)
|
|
3.15
|
|
Outstanding
options at December 31, 2006
|
802,672
|
|
1.04
|
|
Exercisable
at December 31, 2005
|
14,000
|
|
5.45
|
|
Exercisable
at December 31, 2006
|
204,718
|
|
2.00
|
131
The
intrinsic value of options under this plan related to the outstanding and
exercisable options were $1,554,000 and $281,000, respectively, at December
31,
2006.
Further
information regarding options outstanding under the 2005 Equity Incentive Plan
at December 31, 2006 is summarized below:
|
Number
of
|
Weighted
average
|
Number
of
|
Weighted
average
|
|||
|
|
options
|
Remaining
|
Exercise
|
options
|
Remaining
|
Exercise
|
|
Range
of exercise prices
|
outstanding
|
life
in years
|
price
|
exercisable
|
life
in years
|
price
|
|
|
|
|
|
|
|
|
|
$0.63
- 0.85
|
717,000
|
9.6
|
$0.63
|
129,250
|
9.6
|
$0.63
|
|
$3.15
- 5.45
|
85,672
|
8.9
|
4.49
|
75,468
|
8.9
|
4.36
|
|
|
802,672
|
|
|
204,718
|
|
|
2000
Special Stock Option Plan
On
February 11, 2000 we adopted the 2000 Special Stock Option Plan and Agreement
(the “Plan”). The Plan provides for the award of options to purchase 100,000
shares of the authorized but unissued shares of common stock of the Company.
At
December 31, 2006, there were no additional shares available for grant under
the
Plan.
Under
the
2000 Special Stock Option Plan, 100,000 options were issued in 2000 and are
outstanding at December 31, 2006. All of the options in the 2000 Special Stock
Option Plan were exercisable at December 31, 2006, 2005 and 2004. All of the
options expire on June 30, 2007 and have an exercise price of $12.50 per
share.
1995
Stock Awards Plan
Under
the
1995 Stock Awards Plan, as amended, 500,000 shares of our authorized but
unissued common stock were reserved for issuance to optionees including
officers, employees, and other individuals performing services for us. At
December 31, 2006, there were no additional shares available for grant under
the
1995 Stock Awards Plan. A total of 360,917 options were outstanding under this
plan at December 31, 2006.
Options
granted under all the plans generally vest ratably over a four to five year
period and are generally exercisable over a ten-year period from the date of
grant. Stock options were generally granted with an exercise price equal to
the
market value at the date of grant.
Under
the
1995 Stock Awards Plan, the fair value of options was estimated at the date
of
grant using the Black-Scholes option pricing model with the following weighted
average assumptions used for grants in fiscal 2005 and 2004, respectively:
dividend yield of 0% for both periods; volatility of 104% and 41%; risk-free
interest rates of 4.15% and 3.61%, respectively, and expected lives of four
years for all periods. The weighted average fair values of options granted
were
$6.45 and $10.90 per share during 2005 and 2004, respectively.
132
Summarized
information for the 1995 Stock Awards Plan is as
follows:
|
|
|
Weighted-
|
|
|
|
average
|
|
|
|
exercise
|
|
|
Options
|
price
|
|
|
|
|
|
Outstanding
options at January 1, 2004
|
410,725
|
$
17.25
|
|
Granted,
fair value of $10.90 per share
|
62,840
|
28.75
|
|
Exercised
|
(21,939)
|
11.90
|
|
Forfeited
|
(15,196)
|
21.05
|
|
Outstanding
options at December 31, 2004
|
436,430
|
18.80
|
|
|
|
|
|
Granted,
fair value of $6.45 per share
|
49,700
|
12.05
|
|
Forfeited
|
(55,859)
|
17.30
|
|
Outstanding
options at December 31, 2005
|
430,271
|
18.20
|
|
|
|
|
|
Forfeited
|
(69,354)
|
19.12
|
|
Outstanding
options at December 31, 2006
|
360,917
|
18.03
|
|
|
|
|
|
Exercisable
at December 31, 2004
|
334,232
|
18.20
|
|
Exercisable
at December 31, 2005
|
406,760
|
18.40
|
|
Exercisable
at December 31, 2006
|
349,990
|
18.12
|
There
was
no intrinsic value related to outstanding or exercisable options under
this plan at December 31, 2006.
Further
information regarding options outstanding under the 1995 Stock Awards Plan
at
December 31, 2006 is summarized below:
|
Range
of
|
Number
of
|
Weighted
average
|
Number
of
|
Weighted
average
|
||
|
exercise
|
shares
|
Remaining
|
Exercise
|
shares
|
Remaining
|
Exercise
|
|
prices
|
outstanding
|
life
in years
|
price
|
exercisable
|
life
in years
|
Price
|
|
|
|
|
|
|
|
|
|
$10.00
- 12.50
|
147,640
|
3.6
|
$11.15
|
139,032
|
3.3
|
$11.12
|
|
$14.05
- 18.65
|
112,717
|
1.9
|
16.61
|
112,717
|
1.9
|
16.61
|
|
$20.25
- 34.38
|
100,560
|
2.1
|
29.73
|
98,241
|
2.0
|
29.74
|
|
|
|
|
|
|
|
|
|
|
360,917
|
|
|
349,990
|
|
|
NOTE
11 - INCOME TAXES
Income
tax expense differs from the statutory amounts as follows:
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
|
|
|
|
|
|
|
|
|||
|
Income
taxes at U.S. statutory rate
|
|
$
|
(4,378,000
|
)
|
$
|
(438,000
|
)
|
$
|
(3,442,000
|
)
|
|
Change
in valuation allowance
|
|
|
3,972,000
|
|
|
(2,051,000
|
)
|
|
895,000
|
|
|
Change
in miscellaneous items
|
|
|
(130,000)
|
|
|
397,000
|
|
|
598,000
|
|
|
Benefit
of foreign losses not recognized
|
|
|
58,000
|
|
|
304,000
|
|
|
-
|
|
|
Expenses
not deductible
|
|
|
240,000
|
|
|
738,000
|
|
|
7,000
|
|
|
Expiration
of net operating loss and general
|
|
|
|
|
|
|
|
|
|
|
|
business
credit carryforwards, net of revisions
|
|
|
238,000
|
|
|
1,050,000
|
|
|
1,942,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
tax expense
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
133
Deferred
taxes are provided for the temporary differences between the financial reporting
bases and the tax bases of our assets and liabilities. The temporary differences
that give rise to deferred tax assets were as follows:
|
|
|
December
31,
|
|
|||||||
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
Deferred
tax assets (liabilities)
|
|
|
|
|
|
|
|
|||
|
Net
operating loss carryforwards
|
|
$
22,634,000
|
|
$
20,261,000
|
|
$
20,808,000
|
|
|||
|
General
business credit carryforwards
|
|
|
2,402,000
|
|
|
2,261,000
|
|
|
2,094,000
|
|
|
Deferred
gain on sale of oral/topical care assets
|
|
|
-
|
|
|
(1,490,000
|
)
|
|
-
|
|
|
Property,
equipment and goodwill
|
|
|
46,000
|
|
|
78,000
|
|
|
259,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
deferred tax assets
|
|
|
25,082,000
|
|
|
21,110,000
|
|
|
23,161,000
|
|
|
Valuation
allowance
|
|
|
(25,082,000
|
)
|
|
(21,110,000
|
)
|
|
(23,161,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
deferred taxes
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At
December 31, 2006, we had approximately $66,569,000 of net operating loss
carryforwards and approximately $2,402,000 of general business credit
carryforwards. These carryforwards expire as follows:
|
|
|
Net
operating
loss
carryforwards
|
|
General
business
credit
carryforwards
|
|
||
|
2007
|
|
$
|
994,000
|
|
$
|
26,000
|
|
|
2008
|
|
|
4,004,000
|
|
|
138,000
|
|
|
2009
|
|
|
1,661,000
|
|
|
185,000
|
|
|
2010
|
|
|
2,171,000
|
|
|
140,000
|
|
|
2011
|
|
|
4,488,000
|
|
|
13,000
|
|
|
Thereafter
|
|
|
53,251,000
|
|
|
1,900,000
|
|
|
|
|
$
|
66,569,000
|
|
$
|
2,402,000
|
|
As
a
result of a merger on January 25, 1996, a change in control occurred for federal
income tax purposes which limits the utilization of pre-merger net operating
loss carryforwards of approximately $3,100,000 to approximately $530,000 per
year.
NOTE
12 - QUARTERLY FINANCIAL DATA (UNAUDITED)
Our
results of operations by quarter for the years ended December 31, 2006 and
2005
were as follows (in thousands, except per share amounts):
|
|
|
2006
Quarter Ended
|
|
||||||||||
|
|
|
March
31
|
|
June
30
|
|
September
30
|
|
December
31
|
|
||||
|
Loss
from operations
|
|
$
|
(4,856
|
)
|
$
|
(3,331
|
)
|
$
|
(2,015
|
)
|
$
|
(3,222
|
)
|
|
Discontinued
operations
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
550
|
|
|
Net
loss
|
|
$
|
(4,856
|
)
|
$
|
(3,331
|
)
|
$
|
(2,015
|
)
|
$
|
(2,672
|
)
|
|
Basic
and diluted income/loss per common share
|
|
$
|
(1.38
|
)
|
$
|
(0.94
|
)
|
$
|
(0.57
|
)
|
$
|
(0.76
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
Quarter Ended
|
||||||||||||
|
|
|
|
March
31
|
|
|
June
30
|
|
|
September30
|
|
|
December31
|
|
|
Loss
from operations
|
|
$
|
(1,616
|
)
|
$
|
(2,988
|
)
|
$
|
(1,612
|
)
|
$
|
(1,339
|
)
|
|
Discontinued
operations
|
|
|
(806
|
)
|
|
(798
|
)
|
|
(451
|
)
|
|
7,910
|
|
|
Net
loss/income
|
|
$
|
(2,422
|
)
|
$
|
(3,786
|
)
|
$
|
(2,063
|
)
|
$
|
6,571
|
|
|
Basic
and diluted loss per
common
share
|
|
$
|
(0.78
|
)
|
$
|
(1.21
|
)
|
$
|
(0.65
|
)
|
$
|
2.11
|
|
134
NOTE
13 - SUBSEQUENT EVENTS (UNAUDITED)
On
March
30, 2007, Access Pharmaceuticals, Inc. ("Access") and SCO Capital Partners
LLC and affiliates ("SCO") agreed to extend the maturity date of an aggregate
of
$6,000,000 of 7.5% convertible notes to April 27, 2007 from March 31,
2007.
On
February 21, 2007 we announced we had entered into a non-binding letter of
intent to acquire Somanta Pharmaceuticals, Inc. Pursuant to the terms of the
non-binding letter of intent, upon consummation of the acquisition, Somanta’s
preferred and common stockholders would receive an aggregate of 1.5 million
shares of Access’ common shares which would represent approximately 13% of the
combined company assuming the conversion of Access’ existing convertible debt
under existing terms of conversion. The closing of the transaction is subject
to
numerous conditions including the execution of a definitive Merger Agreement,
receipt of necessary approvals as well as completion of our due diligence
investigation. There can be no assurance that the transaction will be
consummated or if consummated, that it will be on the terms described
herein.
135
INDEX
TO ACCESS UNAUDITED QUARTERLY FINANCIAL STATEMENTS
ACCESS
PHARMACEUTICALS, INC. AND SUBSIDIARIES
Table
of
Contents
March
30,
2007
|
|
FINANCIAL
INFORMATION
|
Page
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets at March 30, 2007 and December
31,
2006
|
137
|
|
|
Condensed
Consolidated Statements of Operations and Comprehensive Loss
for the three
months ended March 30, 2007 and March 30, 2006
|
138
|
|
|
Condensed
Consolidated Statements of Cash Flows for the three months
ended March 30,
2007 and March 30, 2006
|
139
|
|
|
Notes
to Condensed Consolidated Unaudited Quarterly Financial Statements
|
140
|
|
|
|
|
136
Access
Pharmaceuticals, Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
|
|
|
|
March
31, 2007
|
|
|
December
31,2006
|
|
|
ASSETS
|
(unaudited)
|
|
(audited)
|
|
|||
|
Current
assets
Cash
and cash equivalents
Short
term investments, at cost
Receivables
Prepaid
expenses and other current assets
|
$
|
359,000
2,724,000
356,000
357,000
|
$
|
1,194,000
3,195,000
359,000
283,000
|
|||
|
Total
current assets
|
3,796,000
|
5,031,000
|
|||||
|
Property
and equipment, net
|
207,000
|
212,000
|
|||||
|
Debt
issuance costs, net
|
-
|
158,000
|
|||||
|
Patents,
net
|
836,000
|
878,000
|
|||||
|
Licenses,
net
|
12,000
|
25,000
|
|||||
|
Other
assets
|
25,000
|
122,000
|
|||||
|
Total
assets
|
$
|
4,876,000
|
$
|
6,426,000
|
|||
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
|
Current
liabilities
Accounts
payable and accrued expenses
Accrued
interest payable
Deferred
revenues
Current
portion of long-term debt, net of discount $101,000 at
March
31, 2007 and $2,062,000 at December 31, 2006
|
$
|
1,232,000
899,000
173,000
10,794,000
|
$
|
1,226,000
581,000
173,000
8,833,000
|
|||
|
Total
current liabilities
|
13,098,000 | 10,813,000 | |||||
|
Long-term
debt
|
5,500,000
|
5,500,000
|
|||||
|
Total
liabilities
|
18,598,000
|
16,313,000
|
|||||
|
Commitments
and contingencies
|
-
|
-
|
|||||
|
Stockholders'
deficit
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
none
issued or outstanding
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
3,535,358 at March 31, 2007 and 3,535,108 at
December
31, 2006
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost - 163 shares
Accumulated
deficit
|
-
35,000
(69,091,000
(1,045,000
(4,000
(81,799,000
|
)
)
)
|
-
35,000
(68,799,000
(1,045,000
(4,000
(77,672,000
|
)
)
)
)
|
|||
|
Total
stockholders' deficit
|
(13,722,000
|
) |
(9,887,000
|
) | |||
|
Total
liabilities and stockholders' deficit
|
$
|
4,876,000
|
$
|
6,426,000
|
The
accompanying notes are an integral part of these statements.
137
Access
Pharmaceuticals, Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations
(unaudited)
|
Three
Months ended March 31,
|
|||||||
|
2007
|
|
2006
|
|||||
|
Expenses
|
|||||||
|
Research
and development
|
$
|
413,000
|
$
|
756,000
|
|||
|
General
and administrative
|
1,139,000
|
666,000
|
|||||
|
Depreciation
and amortization
|
75,000
|
77,000
|
|||||
|
Total
expenses
|
1,627,000
|
1,499,000
|
|||||
|
Loss
from operations
|
(1,627,000
|
)
|
(1,499,000
|
)
|
|||
|
Interest
and miscellaneous income
|
35,000
|
92,000
|
|||||
|
Interest
and other expense
|
(2,535,000
|
)
|
(1,299,000
|
)
|
|||
|
Unrealized
loss on fair value of warrants
|
-
(2,500,000
|
)
|
(2,150,000
(3,357,000
|
)
)
|
|||
|
Net
loss
|
$
|
(4,127,000
|
)
|
$
|
(4,856,000
|
)
|
|
|
|
|||||||
|
Basic
and diluted loss per common share
Net
loss allocable to common stockholders
|
$
|
(1.17
|
)
|
$
|
(1.38
|
)
|
|
|
Weighted
average basic and diluted
common
shares outstanding
|
3,535,197
|
3,528,831
|
|||||
The
accompanying notes are an integral part of these statements.
138
Access
Pharmaceuticals, Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows
(unaudited)
|
Three
Months ended March 31,
|
|||||||
|
2007
|
|
2006
|
|||||
|
Cash
flows from operating activities:
|
|||||||
|
Net
loss
|
$
|
(4,127,000
|
)
|
$
|
(4,856,000
|
)
|
|
|
Adjustments
to reconcile net loss to cash used
in
operating activities:
|
|||||||
|
Depreciation
and amortization
|
75,000
|
77,000
|
|||||
|
Stock
option expense
|
292,000
|
95,000
|
|||||
|
Stock
expense
|
-
|
23,000
|
|||||
|
Amortization
of debt costs and discounts
|
2,215,000
|
986,000
|
|||||
|
Unrealized
loss on fair value of warrants
|
-
|
2,150,000
|
|||||
|
Change
in operating assets and liabilities:
|
-
|
||||||
|
Receivables
|
3,000
|
-
|
|||||
|
Prepaid
expenses and other current assets
|
(74,000
|
)
|
58,000
|
||||
|
Other
assets
|
1,000
|
35,000
|
|||||
|
Accounts
payable and accrued expenses
|
6,000
|
(150,000
|
)
|
||||
|
Accrued
interest payable
|
318,000
|
235,000
|
|||||
|
Net
cash used in operating activities
|
(1,291,000
|
)
|
(1,347,000
|
)
|
|||
|
Cash
flows from investing activities:
|
|||||||
|
Capital
expenditures
|
(15,000
|
)
|
-
|
||||
|
Redemptions
of short term investments and
certificates
of deposit
|
471,000
|
(34,000
|
)
|
||||
|
Net
cash provided by (used in) investing activities
|
456,000
|
(34,000
|
)
|
||||
|
Cash
flows from financing activities:
|
|||||||
|
Payments
of notes payable
|
-
|
(37,000
|
)
|
||||
|
Proceeds
from secured convertible notes payable
|
-
|
4,532,000
|
|||||
|
Net
cash provided by financing activities
|
-
|
4,495,000
|
|||||
|
Net
(decrease) increase in cash and cash equivalents
|
(835,000
|
)
|
3,114,000
|
||||
|
Cash
and cash equivalents at beginning of period
|
1,194,000
|
349,000
|
|||||
|
Cash
and cash equivalents at end of period
|
$
|
359,000
|
$
|
3,463,000
|
|||
|
Supplemental
cash flow information:
|
|||||||
|
Cash
paid for interest
|
$
|
2,000
|
$
|
2,000
|
|||
|
|
|||||||
The
accompanying notes are an integral part of these statements.
139
Access
Pharmaceuticals, Inc. and Subsidiaries
Notes
to
Condensed Consolidated Financial Statements
Three
Months Ended March 31, 2007 and 2006
(unaudited)
(1) Interim
Financial Statements
The
consolidated balance sheet as of March 31, 2007 and the consolidated statements
of operations and cash flows for the three months ended March 31, 2007
and 2006
were prepared by management without audit. In the opinion of management,
all
adjustments, consisting only of normal recurring adjustments, except as
otherwise disclosed, necessary for the fair presentation of the financial
position, results of operations, and changes in financial position for
such
periods, have been made. All share and per share information reflect a
one for
five reverse stock split effected on June 5, 2006.
Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with accounting principles generally accepted in
the
United States of America have been condensed or omitted. It is suggested
that
these interim financial statements be read in conjunction with the consolidated
financial statements and notes thereto included in our Annual Report on
Form
10-KSB for the year ended December 31, 2006. The results of operations
for the
period ended March 31, 2007 are not necessarily indicative of the operating
results which may be expected for a full year. The consolidated balance
sheet as
of December 31, 2006 contains financial information taken from the audited
financial statements as of that date.
The
report of our independent registered public accounting firm for the fiscal
year
ended December 31, 2006 contained a fourth explanatory paragraph to reflect
its
significant doubt about our ability to continue a going concern as a result
of
our history of losses and our liquidity position, as discussed herein and
in
this Form 10-QSB. If we are unable to obtain adequate capital funding in
the
future, we may not be able to continue as a going concern, which would
have an
adverse effect on our business and operations, and investors’ investment in us
may decline.
(2) Intangible
Assets
Intangible
assets consist of the following (in thousands):
|
March
31, 2007
|
December
31, 2006
|
||||||||||||
|
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
||||||||||
|
Amortizable
intangible assets
Patents
Licenses
Total
|
$
$
|
1,680
500
2,180
|
$
$
|
844
488
1,332
|
$
$
|
1,680
500
2,180
|
$
$
|
802
475
1,277
|
|||||
140
Amortization
expense related to intangible assets totaled $55,000 for each of the three
months ended March 31, 2007 and 2006. The aggregate estimated amortization
expense for intangible assets remaining as of March 31 is as follows (in
thousands):
| 2007 | $ | 138 | ||
| 2008 | 168 | |||
| 2009 | 168 | |||
| 2010 | 168 | |||
| 2011 | 168 | |||
| Thereafter | 38 | |||
| Total | $ | 848 |
(3) Liquidity
The
Company incurred significant losses from continuing operations of $4.1
million
for the quarter ended March 31, 2007, $13.3 million for the year ended
December
31, 2006 and $7.6 million for the year ended December 31, 2005. Additionally,
at
March 31, 2007, our working capital deficit is $9,302,000. As of March
31, 2007,
we did
not have
sufficient funds to repay our convertible notes at their maturity and support
our working capital and operating requirements. Our current funds will
allow us
to support our working capital and operating requirements for six months.
We do
not have funds to pay the obligations which are due in June 2007 or September
2007 and will have to raise more funds and/or attempt to restructure the
convertible notes.
(4)
Stock
Based Compensation
For
the
first quarter, we recognized stock-based compensation expense of $292,000
in
2007 and $95,000 in 2006. For the first quarter, we granted 205,000 stock
options at weighted average grant prices of $3.30, under the terms of our
2005
Equity Incentive Plan and 450,000 stock options at weighted average grant
prices
of $2.90, under the terms of our 2007 Special Stock Option Plan.
Our
weighted average Black-Scholes fair value assumptions are as follows:
|
|
|
3/31/07
|
|
|
3/31/06
|
|
|
|
Expected
life
|
|
4.3
yrs.
|
|
|
2 yrs.
|
|
|
|
Risk
free interest rate
|
|
4.66
|
%
|
|
4.72
|
%
|
|
|
Expected
volatility(a)
|
|
137
|
%
|
|
113
|
%
|
|
|
Expected
dividend yield
|
|
0.0
|
%
|
|
0.0
|
%
|
|
|
(a)
|
Reflects
movements in our stock price over the most recent historical
period
equivalent to the expected life.
|
141
(5)
Income
Taxes
In
2006,
the Financial Accounting Standards Board issued FASB Interpretation No. 48
(FIN 48),
which
clarifies the accounting for uncertainty in tax positions. FIN 48 requires
that
we recognize in our financial statements the impact of a tax position,
if that
position is more likely than not of being sustained on audit, based on
the
technical merits of the position. We adopted the provisions of FIN 48 as
of the
beginning of our 2007 fiscal year. There was no effect as a result of our
adoption of FIN 48.
As
of the
beginning of our 2007 fiscal year, due to our cumulative net losses we
do not
have any reserves for income taxes because no taxes are due.
We
file
income tax returns in the U.S. federal jurisdiction and various state
jurisdictions. A number of years may elapse before an uncertain tax position
is
audited and finally resolved. While it is often difficult to predict the
final
outcome or the timing of resolution of any particular uncertain tax position,
we
believe that our reserves for income taxes reflect the most probable outcome.
We
adjust these reserves, as well as the related interest, in light of changing
facts and circumstances. Settlement of any particular position would usually
require the use of cash. The resolution of a matter would be recognized
as an
adjustment to our provision for income taxes and our effective tax rate
in the
period of resolution.
(7)
Debt
|
March
31,
2007
|
December
31,
2006
|
||||||
|
Convertible
note - Oracle and affiliates
|
$
|
4,015,000
|
$
|
4,015,000
|
|||
|
Convertible
note
|
5,500,000
|
5,500,000
|
|||||
|
Convertible
note
|
880,000
|
880,000
|
|||||
|
10,395,000
|
10,395,000
|
||||||
|
Discount
|
(101,000
|
)
|
(456,000
|
)
|
|||
|
10,294,000
|
9,939,000
|
||||||
|
Convertible
note - SCO and affiliates
|
6,000,000
|
6,000,000
|
|||||
|
Discount
|
-
|
(1,606,000
|
)
|
||||
|
6,000,000
|
4,394,000
|
||||||
|
Total
|
$
|
16,294,000
|
$
|
14,333,000
|
|||
|
Short
term
|
$
|
10,794,000
|
$
|
8,833,000
|
|||
|
Long
term
|
5,500,000
|
5,500,000
|
|||||
|
Total
|
$
|
16,294,000
|
$
|
14,333,000
|
|||
(8)
Subsequent Events
On
April
26, 2007, Access and SCO Capital Partners LLC and affiliates (“SCO”) agreed to
extend the maturity date of an aggregate principal amount of $6,000,000
of 7.5%
convertible notes to June 11, 2007 from April 27, 2007. On April 30, 2007,
Access and SCO and affiliates agreed to amend an Investor Rights Agreement
to
extend the required filing date of a registration statement to the earlier
of
the filing of a future registration statement in connection with a qualified
financing or August 31, 2007.
On
April
24, 2007, Access and Oracle Partners LP and affiliates (“Oracle”) agreed to
extend the maturity date of an aggregate principal amount of $4,015,000
of 7.7%
convertible notes to June 12, 2007 from April 28, 2007.
On
April
19, 2007 we announced we had entered into an agreement to acquire Somanta
Pharmaceuticals, Inc. Pursuant to the terms of the merger agreement, upon
consummation of the acquisition, Somanta’s preferred and common shareholders
would receive an aggregate of 1.5 million shares of Access’ common shares which
would represent approximately 13% of the combined company assuming the
conversion of Access’ existing convertible debt under existing terms of
conversion. The closing of the transaction is subject to numerous conditions
including receipt of necessary approvals including approval of Somanta
shareholders. There can be no assurance that the transaction will be consummated
or if consummated that it will be on the terms described
herein.
142
INFORMATION
ABOUT SOMANTA
DESCRIPTION
OF BUSINESS
Overview
Somanta
is a biopharmaceutical company engaged in the development of drugs primarily
for
the treatment of cancer. Somanta in-licenses substances designed for anti-cancer
therapy in order to advance them along the regulatory and clinical pathway
toward commercial approval. Somanta’s licenses are generally worldwide in scope
and territory, with the exception of its license for Sodium Phenylbutyrate
which
is worldwide, excluding the U.S. and Canada. Somanta uses its expertise to
manage and perform what Somanta believes are the most critical aspects of the
drug development process which includes the design and conduct of clinical
trials, the development and execution of strategies for the protection and
maintenance of intellectual property rights and the interaction with drug
regulatory authorities internationally. Somanta concentrates on drug development
and engages in a very limited way in drug discovery, avoiding the significant
investment of time and financial resources that is generally required before
a
compound is identified and brought into clinical trials. Somanta intends to
out-source clinical trials, pre-clinical testing and the manufacture of clinical
materials to experienced and qualified third parties.
Somanta
was originally incorporated in New Jersey in 1991 under the name PRS I, Inc.
Somanta subsequently changed its name to Service Lube, Inc., then to Fianza
Commercial Corp. and then to Hibshman Optical Corp. Neither PRS I, Inc., nor
Service Lube, Inc., nor Fianza Commercial Corp., nor Hibshman Optical Corp.,
ever engaged in any active business.
On
January 31, 2006, Somanta reincorporated into the State of Delaware under the
name Somanta Pharmaceuticals, Inc. and acquired Somanta Incorporated through
the
merger of a wholly-owned subsidiary with and into Somanta Incorporated. Somanta
Incorporated was formerly known as Bridge Oncology Products, Inc., which was
formed on February 10, 2005. On August 22, 2005, Bridge Oncology Products,
Inc.,
entered into a Share Exchange Agreement with Somanta Limited, a company
organized under the laws of England pursuant to which Somanta Limited became
a
wholly-owned subsidiary of Bridge Oncology Products, Inc., and Bridge Oncology
Products, Inc., changed its name to Somanta Incorporated. Somanta Limited was
formed on April 19, 2001.
Prior
to
the date of the share exchange between Bridge Oncology Products, Inc., and
Somanta Limited, each of Bridge Oncology Products, Inc., and Somanta Limited
were engaged in a limited amount of business. Bridge Oncology Products, Inc.,
was formed in February 2005, and in February 2005, it entered into the Sodium
Phenylbutyrate Co-development and Sub-license Agreement with Virium
Pharmaceuticals, Inc., to develop Sodium Phenylbutyrate outside
of the U.S. and Canada for the treatment of cancer, autoimmune
diseases and other clinical indications. It engaged in no other business during
that period of time.
Although
Somanta Limited was formed in April of 2001, its primary business prior to
the
date of the share exchange with Bridge Oncology Products, Inc., was to secure
intellectual property rights to the various chemical entities that Somanta
now
desires to develop as product candidates. To that end, in November 2001, Somanta
Limited entered into an Exclusive License Agreement with De Montfort University
related to Somanta’s drug development candidate, Alchemix. In January 2002,
Somanta Limited entered into an Exclusive Patent and Know-how License and Option
Agreement with Immunodex, Inc. covering Somanta’s drug product candidates know
as Phoenix and Angiolix. In October 2003, Somanta Limited entered into an
agreement with the Cancer Research Institute of Contra Costa for the support
of
an academic human clinical trial for Phoenix. In March 2004, Somanta Limited
entered into an Exclusive Patent and Know-how Assignment and License Agreement
with the School of Pharmacy, University of London related to Somanta’s drug
development candidate known as Prodrax. In March 2004, Somanta Limited entered
into a Research and Development Agreement with The School of Pharmacy,
University of London for the purpose of further developing Prodrax. In addition
to securing the various intellectual property rights related to the agreements
described above, in August of 2004, Somanta Limited also entered into a Research
Collaboration and License Agreement with Advanced Cardiovascular Devices, LLC,
pursuant to which Somanta Limited licensed Advanced Cardiovascular Devices,
LLC,
rights to Somanta’s drug development candidate, Alchemix, solely for use on drug
eluting stents. In 2001 Somanta Limited entered into a shareholder and
intellectual property rights agreement with Cypomics, Ltd. pursuant to which
Somanta Limited was to fund a research and development program of Cypomics,
Ltd.
in exchange for a certain amount of capital stock of Cypomics, Ltd. However,
neither party performed any of its obligations under the agreement and neither
party is liable to the other party for any such failure to perform. In July
2005, this agreement was formally terminated.
Somanta’s
current product candidates in academic-investigator-sponsored clinical
development includes an anti-cancer agents (a small molecule) targeting four
different tumors and/or stages of cancer. Somanta has three additional product
development candidates (two small molecules and a monoclonal antibody) in
pre-clinical development targeting eleven different tumor types.
143
The
following table sets forth the eleven types of cancer targeted by each of
Somanta’s current product development candidates:
|
Sodium
Phenylbutyrate
|
• Central
nervous system cancers, particularly glioblastoma
multiforme
|
|
|
• Myelodysplastic
syndrome
|
|
|
• Acute
leukemia
|
|
|
• Colon
|
|
Alchemix
|
• Central
nervous system cancers
|
|
|
• Colon
|
|
|
• Non-small
cell lung
|
|
|
• Ovarian
|
|
|
• Renal
|
|
Prodrax
|
• Lung
|
|
|
• Breast
|
|
|
• Ovarian
|
|
|
• Colon
|
|
|
• Pancreatic
|
|
|
• Esophageal
|
|
Angiolix
|
• Breast
|
|
|
• Colorectal
|
Somanta
intends to license the rights to manufacture and market its product candidates
to other pharmaceutical companies in exchange for license fees and royalty
payments and to continue to seek other in-licensing opportunities in pursuit
of
its business strategy. Somanta does not currently intend to manufacture or
market products, although Somanta may if the opportunity is available on terms
that are considered attractive, or Somanta may retain co-development rights
to
specific drugs.
Strategy
Somanta
is principally focused on the development of drug candidates for the treatment
of cancer. Somanta seeks to use its product development capabilities to bridge
discoveries and research from scientific/academic institutions or other
biopharmaceutical companies, on the one hand, with commercial manufacturing
and
marketing of biopharmaceutical products, on the other hand.
The
main
elements of Somanta’s business strategy are described below:
Identification
of Product Candidates.
Somanta
directly performs the scientific evaluation and market assessment of
biopharmaceutical product candidates and research developments in
scientific/academic institutions and other biopharmaceutical companies. As
a
part of this process, Somanta evaluates the related scientific research and
pre-clinical and clinical research, if any, and the intellectual property rights
in such products, with a view to determining the therapeutic and commercial
potential of the product candidate.
In-Licensing.
Upon
identifying a promising product candidate, Somanta seeks to negotiate a license
to the rights to such product from the holder of those rights, the developer
or
researcher. The terms of the licenses vary, but generally Somanta’s goal is to
secure licenses that permit Somanta to engage in further development, clinical
trials, intellectual property protection and further licensing of manufacturing
and marketing rights to any resulting approved drug product. This process of
securing license rights to drug products is commonly known as
“in-licensing.”
Further
Development.
Upon
in-licensing a product candidate, Somanta’s strategy is to apply its skills and
expertise to progress the product candidate toward regulatory approval and
commercial production and sale in major markets. These activities include
implementing intellectual property protection and registration strategies,
performing or having performed, pre-clinical research and testing, the
formulating or reformulating of product candidates, making regulatory
submissions, identifying appropriate third parties to conduct clinical trials,
and undertaking the collection, collation and interpretation of clinical data
and the submission of data to the relevant drug regulatory authorities in
compliance with applicable protocols and standards.
144
Out-licensing.
Somanta
generally plans to further license manufacturing and marketing rights to its
licensed product candidates to other pharmaceuticals companies. This is commonly
known as “out-licensing.” Under Somanta’s business model, licensees would be
expected, to the extent necessary, to participate in the remaining clinical
development required to obtain final regulatory approval for the product
candidate. Somanta expects that out-licensing would result in licensing fees
in
addition to royalties on any sale of the resulting licensed product. Somanta
believes this model is consistent with current biotechnology and pharmaceutical
licensing practices. In addition, although out-licensing is Somanta’s primary
strategy, Somanta may retain co-development or marketing rights to particular
product candidates or territories. To date, Somanta has exclusively out-licensed
one of its product candidates, Alchemix, for application in vascular
diseases.
Somanta
actively searches for new product opportunities using the relationships of
its
management and scientific advisory board, and Somanta continuously monitors
the
academic and biotechnology environment for cancer treatment
developments.
Somanta
recorded research and development expenses of $1,239,146 and $1,264,225 for
the
years ended April 30, 2007 and 2006, respectively.
Cancer
and Cancer Therapeutic Market
According
to the International Agency for Research on Cancer of the World Health
Organization, based on available data as of 2005, there were 10.9 million new
cases of cancer worldwide, 6.7 million deaths, and 24.6 million persons who
have
been diagnosed with cancer in the previous five years. China has 20% of the
world’s total of new cancer cases (2.2 million) and lung cancer is the most
common cancer worldwide with 1.35 million new cases (12.4% of the total) and
1.18 million deaths (17.6% of the total).
In
the
U.S., the American Cancer Society estimates that for 2006 a total of
1.4 million new cases of cancer will occur and 565,000 deaths will occur
from cancer. The most prevalent new cancers, which account for approximately
55%
of all cancers, are:
|
Disease
Site
|
Estimated New
Cases
|
||
|
Prostate....................................................................................................................
|
235,000
|
||
|
Breast.......................................................................................................................
|
215,000
|
||
|
Lung
and
bronchus....................................................................................................
|
186,000
|
||
|
Colorectal.................................................................................................................
|
150,000
|
||
|
Total
for All
Sites:....................................................................................................
|
1,399,000
|
||
Bladder,
ovarian, brain and oral cancers, as well as lymphoma, leukemia and melanoma
account for a majority of the balance of cancer deaths.
Surgery,
radiation and chemotherapy remain the principal effective treatments for cancer.
In addition, although the reason is not clearly understood, current
chemotherapeutic drugs are effective in only subpopulations of individuals
with
the same disease. Revenues in the global oncology market were reported by IMS
Health to be approximately $35 billion in 2006 and are expected to grow to
approximately $65 billion by 2010.
Numerous
new approaches to cancer are in clinical trials. As targets become validated
and
technologies improve, research is beginning to yield therapeutic approaches
that
appear to be more effective than existing ones. Monoclonal antibodies were
first
described in 1978 and are now beginning to yield commercially viable therapeutic
products. At the current time there are ten monoclonal antibodies approved
in
the U.S. for the treatment of cancer including, Avastin ®,
Rituxan
®,
Campath
®,
Herceptin ®,
Erbitux
®,
Myelotarg ®,
Bexxar
®,
Zevalin
®,
Vectibix
® and Lucentis ® and five in late stage cancer trials. A second approach to
cancer treatment, therapeutic cancer vaccines, has been under development for
many years. Finally, advances in chemotherapeutic drugs have increased their
ability to overcome chemo resistance.
Regulatory
Approval Process
Somanta’s
ability to market and sell products that may result from the development of
Somanta’s product candidates is dependent upon Somanta’s ability to obtain
governmental approval of such products in the U.S. and elsewhere. The regulatory
approval process is administered by the FDA in the U.S., by the European
Medicines Evaluation Agency, or EMEA, in the European Union and by similar
agencies in other countries. None of Somanta’s current product candidates have
been approved for sale in the U.S. or any foreign market. The process of
obtaining regulatory clearances or approvals is costly and time-consuming,
and
Somanta cannot predict how long the necessary clearances or approvals will
take
or whether Somanta will be successful in obtaining them.
145
Generally,
all potential pharmaceutical products must successfully complete two major
stages of development (pre-clinical and clinical testing) prior to receiving
marketing approval by the applicable governing regulatory agency. In
pre-clinical testing, potential compounds are tested both in vitro and in animal
studies to gain important safety information prior to administration in humans.
Knowledge is obtained regarding the effects of the compound on bodily functions
as well as its absorption, distribution, metabolism and
elimination.
Clinical
trials are typically conducted in three sequential phases, although the phases
may overlap. In Phase I, which frequently begins with the initial
introduction of the drug into healthy human subjects prior to introduction
into
patients, the compound is tested for safety and dosage tolerance. Phase II
typically involves studies in a larger patient population to identify possible
adverse effects and safety risks, to begin gathering preliminary efficacy data,
and to investigate potential dose sizes and schedules. Phase III trials are
undertaken to further evaluate clinical efficacy and to further test for safety
within an expanded patient population that will represent the intended clinical
indication that is being pursued. Each trial is conducted in accordance with
current good clinical practice standards under protocols that detail the
objectives of the study, the parameters to be used to monitor safety and the
efficacy criteria to be evaluated. Each protocol must be submitted to the FDA
as
part of the Investigational New Drug, or IND, application. Further, an
independent Institutional Review Board, or IRB, or ethics committee at each
clinical center at which the study will be conducted must evaluate and approve
each clinical study. The review board will consider, among other things, ethical
factors, the safety of human subjects and the possible liability of the
institution.
Somanta
cannot be certain that Somanta will successfully complete Phase I, Phase II,
or
Phase III testing of its product candidates within any specific time period,
if
at all. Furthermore, the FDA, the IRB, or Somanta may suspend clinical trials
at
any time on various grounds, including a finding that the subjects or patients
are being exposed to an unacceptable health risk.
Following
completion of these studies, a New Drug Application, or NDA, must be submitted
to and approved by the FDA in order to market the product in the U.S. The FDA
conducts an initial review of each NDA submitted to assess whether it is
acceptable for filing. The FDA may refuse to file the NDA and may request
additional information. In this event, the application must be resubmitted
with
the additional information. The resubmitted application is also subject to
review before the FDA accepts it for filing. Once the FDA accepts the NDA for
filing, the agency begins an in-depth review of the NDA. The FDA has substantial
discretion in the approval process and may disagree with Somanta’s
interpretation of the data submitted in the NDA. The review process may be
significantly extended by the FDA requests for additional information or
clarification regarding information already provided. Also, as part of this
review, the FDA may refer the application to an appropriate advisory committee,
typically a panel of clinicians, for review, evaluation and a recommendation.
The FDA’s response to the NDA will be in the form of an approval letter, or a
non-approvable letter. Any response from the FDA that is not approval of the
NDA
may require Somanta to submit additional information, which may include
additional clinical data. Even if the FDA approves the NDA, the agency may
decide later to withdraw product approval if compliance with regulatory
standards is not maintained or if safety problems occur after the product
reaches the market. The FDA may require post-approval studies, also known as
Phase IV studies, to develop additional information regarding the product.
In
addition, the FDA requires post-approval adverse event reporting, and the agency
has the power to require changes in labeling or to prevent further marketing
of
a product. The agency may also decide later to withdraw product approval if
compliance with regulatory standards is not maintained or if safety problems
occur after the product reaches the market. If and when approval is obtained
to
market a product, the FDA’s regulations (or the applicable foreign agency’s)
will then govern manufacturing and commercialization activities.
Satisfaction
of the above FDA requirements or requirements of state, local and foreign
regulatory agencies typically takes several years, and the actual time required
may vary substantially based upon the type, complexity and novelty of the
pharmaceutical product. Government regulation may delay or prevent marketing
of
potential products for a considerable period of time and impose costly
procedures upon Somanta’s activities. Somanta cannot be certain that the FDA or
any other regulatory agency will grant approval for any of Somanta’s product
candidates on a timely basis, if at all. Success in preclinical or early-stage
clinical trials does not assure success in later-stage clinical trials. Data
obtained from pre-clinical and clinical activities are not always conclusive
and
may be susceptible to varying interpretations that could delay, limit or prevent
regulatory approval. Even if a product receives regulatory approval, the
approval may be significantly limited to specific indications or uses. Further,
even after regulatory approval is obtained, later discovery of previously
unknown problems with a product may result in restrictions on the product or
even complete withdrawal of the product from the market. Delays in obtaining,
or
failures to obtain regulatory approvals would have a material adverse effect
on
Somanta’s business.
In
addition, whether or not FDA approval has been obtained, approval of a
pharmaceutical product by comparable governmental regulatory authorities in
foreign countries must be obtained prior to the commencement of clinical trials
and subsequent sales and marketing efforts in those countries. The approval
procedure varies in complexity from country to country, and the time required
may be longer or shorter than that required for FDA approval. Somanta may incur
significant costs to comply with these laws and regulations now or in the
future.
146
For
example, in order to gain marketing approval in the E.U., Somanta must submit
a
dossier to the relevant authority for review, which is known in the E.U. as
a
Marketing Authorization Application (“MAA”) and is submitted to the European
Medicines Evaluation Agency in Europe. The format is usually specific and laid
out by each authority, although in general it will include information on the
quality of the chemistry, manufacturing and pharmaceutical aspects of the
product as well as the non-clinical and clinical data.
Approval
can take several months to several years, or can be denied. The approval process
can be affected by a number of factors. Additional studies or clinical trials
may be requested during the review and may delay marketing approval and involve
unbudgeted costs. The regulatory authorities may conduct an inspection of
relevant facilities and review manufacturing procedures, operating systems
and
personnel qualifications. In addition to obtaining approval for each product,
in
many cases each drug manufacturing facility must be approved. Further
inspections may occur over the life of the product. An inspection of the
clinical investigation sites by a competent authority may be required as part
of
the regulatory approval procedure. As a condition of marketing approval, the
regulatory agency may require post-marketing surveillance to monitor for adverse
effects, or other additional studies as deemed appropriate. After approval
for
the initial indication, further clinical studies are usually necessary to gain
approval for any additional indications. The terms of any approval, including
labeling content, may be more restrictive than expected and could affect the
marketability of a product.
Failure
to comply with applicable regulatory requirements after obtaining regulatory
approval can, among other things, result in the suspension of regulatory
approval, as well as possible civil and criminal sanctions. Renewals in Europe
may require additional data, which may result in a license being withdrawn.
In
the E.U., regulators have the authority to revoke, suspend or withdraw approvals
of previously approved products, to prevent companies and individuals from
participating in the drug approval process, to request recalls, to seize
violative products and to obtain injunctions to close manufacturing plants
not
operating in conformity with regulatory requirements and to stop shipments
of
violative products.
The
MAA
review and approval process typically takes one to several years for approval,
rejection, or approval subject to completion of additional requirements imposed
on the corporation by the regulatory agencies at the time of review
completion.
Products
in Academic Investigator-Sponsored Clinical Development
Sodium
Phenylbutyrate
Overview. Sodium
Phenylbutyrate, or PB, is a small molecule that was previously approved by
the
FDA for sale as a treatment for a rare genetic disorder in infants known as
hyperuremia. PB has a number of additional mechanisms of action, including
the inhibition of histone deacetylase. Histone deacetylase is a class of
enzymes that remove acetyl groups from the amino acids in DNA. The
inhibition of histone deacetylase allows the body’s cancer suppressing genes to
work as intended. In addition, PB is not toxic to cells. These
characteristics make PB a good candidate to become a chemopotentiator. A
chemopotentiator is a substance that enhances the activity of a chemotherapeutic
agent. As a result, PB is designed to be administered in conjunction with
radiation and chemotherapy.
In-License
for PB. In
February 2005, Somanta entered into a Phenylbutyrate Co-development and
Sublicense Agreement with Virium Pharmaceuticals, Inc., pursuant to which Virium
granted Somanta an exclusive, worldwide sublicense to PB, excluding the U.S.
and
Canada, for the treatment of cancer, autoimmune diseases and other clinical
indications. Somanta paid Virium a license fee of $50,000. Virium has retained
all rights with respect to PB inside the U.S. and Canada. Note that
Somanta’s single largest stockholder, SCO Capital Partners, LLC, is also the
single largest stockholder of Virium Pharmaceuticals, Inc.
Virium
is
also a party to a sublicense agreement with VectraMed, Inc. for the rights
to
develop and commercialize PB worldwide for the treatment of cancer, autoimmune
diseases and other clinical indications. VectraMed obtained its rights to the
product under an Exclusive Patent License Agreement dated May 25, 1995 with
the
U.S. Public Health Service, representing the National Institutes of Health.
VectraMed subsequently assigned all its rights to PB to Virium pursuant to
a
novation agreement dated May 10, 2005.
Pursuant
to Somanta’s agreement with Virium, Somanta is responsible for the conduct of
clinical trials and patent prosecution related to PB outside of the U.S. and
Canada. The Virium agreement also requires Somanta to pay Virium a royalty
on
the sales of PB products until such time as the patents covering such products
expire. These patents expire at various times between 2011 and 2016.
Somanta’s agreement with Virium expires upon the expiration of the last to
expire of these patents in 2016.
147
Somanta’s
agreement with Virium does not fully comply with the sublicensing requirements
set forth in Virium’s agreement with the National Institutes of Health because
it does not expressly incorporate by reference all of the relevant sections
of
Virium’s license with NIH. Somanta is currently seeking to amend its
agreement with Virium to bring it into full compliance with such sublicensing
requirements and to permit Somanta to become a direct licensee of the NIH,
should Virium default on its license with the NIH.
On
October 20, 2006, NIH conditionally consented to the sublicense to Somanta.
However, the NIH conditions include an amendment to the Virium license to
reflect an updated Virium development plan and milestones, the payment of
$216,971 in past due patent expenses and the payment of a $5,000 sublicense
royalty. Based on the information provided by NIH, it appears that about
$200,000 relates to foreign patent expenses for calendar 2005 which would be
Somanta ‘s responsibility under its license agreement with Virium. Of that
amount, approximately $12,000 relates to foreign patent maintenance fees and
$197,000 largely relates to foreign patent legal expenses. Somanta accrued
$248,300 as patent annuity and legal expense for the year ended April 30, 2007.
Virium advised Somanta that they satisfied two of the three conditions to
obtaining final NIH approval for Somanta’s sublicense. Virium is in the process
of negotiating an installment payment plan with respect to the past due patent
expenses.
On
December 6, 2006, Somanta signed a letter of intent (LOI) pertaining to a
license and collaboration agreement with Virium covering all formulations or
drug combinations where Phenylbutyrate is an active ingredient. Pursuant to
the
LOI, in addition to current worldwide rights, excluding North America, involving
the current formulation of Phenylbutyrate, Somanta would obtain a participation
in any revenue or royalties derived from sales in the U.S. and Canada. In
return, Somanta would grant Virium a reciprocal participation in Europe. In
the
rest of the world, Somanta and Virium would share revenues and royalties
equally. The LOI’s terms provide that both companies will, among other things,
share data and jointly undertake the necessary pre-clinical and clinical
studies, seek regulatory approvals and file for patent protection in all
territories. It also provides for the formation of a joint development committee
to oversee all aspects of the development and commercialization of
Phenylbutyrate. Completion of the transaction contemplated by the LOI remains
subject to the negotiation and execution of a definitive agreement.
Clinical
Status To
date, Somanta has not been involved in any capacity in the conduct of any
clinical trial related to PB.
Rationale.
Somanta
believes that PB may be a candidate to become a biological-response modifier
that acts as a dose-dependent inhibitor of cancer cell proliferation, migration,
and invasiveness, possibly by inhibition of urokinase and c-myc pathways, which
means that it inhibits the protease activity that irreversibly induces
programmed cell death. In addition, Somanta believes that PB shows potential
for
the treatment of malignant gliomas, which are cancers of the brain.
Competitive
Position.
Somanta
is aware of numerous products in development for brain cancers. Somanta is
aware
of several products being developed by academic and commercial organizations
targeting glioblastoma. Medicis Pharmaceuticals currently sells Sodium
Phenylbutyrate (Buphenyl ®
) for
the treatment of a urea cycle disorder, hyperuremia.
There
are
thirteen key use patents related to PB which have been issued as
follows:
|
|
•
|
|
A
patent covering a method of inhibiting rapid tumor growth issued
in the
U.S. that expires on March 14, 2014 with foreign counterparts in
Austria, Australia, Canada, Germany, European Union, Spain, Israel,
New
Zealand and South Africa;
|
|
|
•
|
|
A
patent covering a method of treating brain cancer, leukemia, prostate
cancer, breast cancer, skin cancer and non-small cell lung cancer
issued
in the U.S. that expires on June 3, 2014 with foreign counterparts
in
Austria, Australia, Canada, Germany, European Union, Spain, Israel,
Japan,
New Zealand, Portugal and South
Africa;
|
|
|
•
|
|
A
patent covering a method of treating brain cancer, skin cancer, benign
enlarged prostate and a cervical infection issued in the U.S. that
expires
on February 25, 2014 with foreign counterparts in Austria, Australia,
Canada, Germany, European Union, Spain, Israel, Japan, New Zealand,
Portugal and South Africa;
|
|
|
•
|
|
A
patent covering a method of inducing the production of TGF alpha
(which
slows the growth of cancer cells) issued in the U.S. that expires
on
January 13, 2015 with foreign counterparts in Austria, Australia,
Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal
and
South Africa;
|
148
|
|
•
|
|
A
patent covering a pharmaceutical composition for treating or preventing
a
cancerous condition issued in the U.S. that expires on January 20,
2015
with foreign counterparts in Austria, Australia, Canada, Germany,
European
Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
|
•
|
|
A
patent covering a method of inducing the differentiation of a cell
issued
in the U.S. that expires on June 3, 2014 with foreign counterparts
in
Austria, Australia, Canada, Germany, European Union, Spain, Israel,
Japan,
New Zealand, Portugal and South
Africa;
|
|
|
•
|
|
A
patent covering a method of treating brain cancer, non-small cell
lung
cancer, prostate cancer, skin cancer, brain tumors, cancers of the
blood,
lung cancer and breast cancer issued in the U.S. that expires on
August
26, 2014 with foreign counterparts in Austria, Australia, Canada,
Germany,
European Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
|
•
|
|
A
patent covering a method of inhibiting the growth of rapidly growing
nonmalignant or malignant tumor cells issued in the U.S. that expires
on
March 2, 2016 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal
and
South Africa;
|
|
|
•
|
|
A
patent covering a method of sensitizing a subject to radiation therapy
or
chemotherapy and a method of treating brain cancer, leukemia, non-small
cell lung cancer, skin cancer, cancers of the blood, lung cancer,
or renal
cancer issued in the U.S. that expires on December 1, 2015 with foreign
counterparts in Austria, Australia, Canada, Germany, European Union,
Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
|
•
|
|
A
patent covering a method of treating brain cancer, non-small cell
lung
cancer, prostate cancer, skin cancer, cancers of the blood, breast
cancer,
benign prostate enlargement, cervical infection, bladder cancer,
kidney
cancer, colon cancer, or nose cancer issued in the U.S. that expires
on
March 16, 2016 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal
and
South Africa;
|
|
|
•
|
|
A
patent covering a method of inducing the production of hemoglobin
(blood)
and a method of treating a pathology associated with abnormal hemoglobin
(blood) activity issued in the U.S. that expires on January 27, 2015
with
foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
|
•
|
|
A
patent covering a method of preventing prostate cancer, brain cancer,
skin
cancer, cancers of the blood, breast cancer, non-small cell lung
cancer,
or renal cancer issued in the U.S. that expires on August 5, 2014
with
foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South Africa;
and
|
|
|
•
|
|
A
patent covering a method of inhibiting the production of cancer in
a cell
issued in the U.S. that expires on March 14, 2011, June 3, 2013 or
March
7, 2014, depending on the subject matter disclosed in the priority
applications with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal
and
South Africa.
|
Development
Plan. Somanta’s
co-development partner, Virium advised Somanta that it intends to initiate
a
Phase I/II clinical trial using PB to treat glioblastoma in the near future.
Somanta intends to wait for the results of this Phase I/II clinical trial and
the re-formulation of the PB compound to a sustained release version before
initiating Somanta’s own clinical trial related to PB in Europe. At this
time, Somanta does not know when Virium will initiate such clinical trial or
when it will be completed, nor does Somanta know when Virium will have completed
the re-formulation of the PB compound to a sustained release
version.
Somanta
also believes that further studies should be considered to identify a subset
of
patients that have tumors sensitive to PB, either as a single agent or in
combination with radiation therapy or other chemotherapeutic agents, and that
Somanta should focus on this subset of patients in Somanta’s future clinical
trials related to PB.
149
Products
in Pre-Clinical Development
Alchemix
Overview. Alchemix,
or chloroethylaminoanthraquinone, is a small molecule that is toxic to cancer
cells. Alchemix is intended to interrupt all phases of the cancer cell
growth cycle by selectively binding to DNA and inhibiting many DNA processing
enzymes to overcome drug resistant tumors. Somanta believes that Alchemix
is toxic to cancer cells due to its selective inhibition of many DNA processing
enzymes and that it is as well tolerated in animals as a number of classes
of
approved chemotherapeutic drugs such as epirubicin and cisplatin, meaning that
it resulted in no more adverse side effects than such approved
chemotherapeutics.
Agreement
Related to Alchemix. In
November 2001, Somanta entered into a Patent and Know-how Assignment and License
Agreement with De Montfort University pursuant to which De Montfort University
agreed to assign to Somanta the key patent related to Alchemix and to
exclusively license to Somanta certain know-how related to Alchemix for use
in
field of the treatment of cancer. In March 2003, Somanta amended and restated
that agreement to extend the time period in which the assignment and license
to
Somanta would be triggered. In October 2005, De Montfort University formally
assigned the patent that covers Alchemix to Somanta. Pursuant to Somanta’s
agreement with De Montfort
University, Somanta paid De Montfort an initial assignment fee of $42,815 and
issued to De Montfort 219,010 shares of Somanta’s common stock valued at $4,677.
Although Somanta is not obligated to make any royalty payments to De Montfort
based on the sale of any product that is based on Alchemix, Somanta is obligated
to pay De Montfort certain milestone payments based on the achievement of agreed
upon clinical milestones. If Somanta successfully achieve each of these
milestones, Somanta would be obligated to pay De Montfort a total aggregate
amount of milestone payments of GBP 250,000, or approximately $500,000. Somanta
is obligated to use its commercial best efforts to achieve these agreed upon
clinical milestones. In addition, Somanta has the right to terminate its
agreement with the De Montfort on ninety (90) days advance notice, and either
party has the right to terminate the agreement for breach by the other party
upon ninety (90) days (sixty (60) days for payment failures) advance notice
if
such breach is not cured within the notice period. Somanta’s agreement with De
Montfort expires upon the expiration of the last to expire of these patents
in
2015.
Rationale. Somanta
believes that Alchemix selectively inhibits specific DNA processing enzymes
that
are required for cancer cells to divide and grow, which appears to be unique
among anthraquinones, the class of small molecules to which Alchemix belongs.
This leads Somanta to believe that Alchemix may also react with certain other
DNA processing enzymes required for the cell to progress through the cell life
cycle, although the direct evidence only demonstrates its interaction with
certain specific DNA processing enzymes.
Competitive
Position.
Somanta
is not aware of any other organization developing a drug similar to Alchemix.
Several groups are developing agents against p-glycoprotein, which is only
one
of the identified mechanisms of drug resistance within cells, and other groups
are developing agents that have the potential to become chemosensitisers, which
means they will make cancer cells more sensitive to the effects of
chemotherapy.
The
key
patent relating to Alchemix has been issued in the U.S, the European Union
and
in Australia. In general, it covers composition of matter. The U S patent will
expire in 2015.
Development
Plan.
In 2005
and 2006, Somanta prepared a detailed pre-clinical and clinical development
plan
related to Alchemix. Somanta intends to manufacture, undertake pre-clinical
studies and, based on the results of these studies, to initiate a Phase I/II
clinical trial with respect to Alchemix within the next twelve months. To date,
Somanta has contacted a contract manufacturing organization to undertake the
process development for the manufacture of Alchemix and have evaluated a number
of qualified contract manufacturing organizations with respect to the production
of sufficient quantities of Alchemix for Somanta’s pre-clinical studies,
formulation studies and for Somanta’s proposed human clinical trial. In March
2006, Somanta entered into a two year agreement with the University of Bradford
to continue these pre-clinical studies.
Out-License
of Alchemix.
In
August 2004, Somanta entered into a Research Collaboration and License Agreement
with Advanced Cardiovascular Devices, LLC. Under this agreement, Somanta granted
Advanced Cardiovascular Devices an exclusive, worldwide license to Alchemix
solely for use in the treatment of vascular disorders or proliferations using
stents and other medical devices. The term of this agreement expires when the
underlying patent expires in 2015. Pursuant to this agreement, Advanced
Cardiovascular Devices paid Somanta an upfront fee of $10,000. In addition,
Advanced Cardiovascular Devices is obligated to develop a product based on
Alchemix pursuant to an agreed upon timetable. If Advanced Cardiovascular
Devices fails to achieve any of the agreed upon milestones, Somanta would then
have the right to terminate the agreement; provided, however, that Advanced
Cardiovascular Devices could prevent Somanta from so terminating the agreement
with respect to the applicable failure by paying Somanta a fee not to exceed
$500,000 to reinstate its rights under the agreement. In addition, Advanced
Cardiovascular Devices is also obligated to pay Somanta a royalty based on
net
sales, if any, of products based on Alchemix. Either party may terminate this
agreement on thirty (30) days advance notice for breach by the other party
if
the breach is not cured within such thirty (30) day period. In addition, Advance
Cardiovascular Devices may terminate the agreement upon written notice to
Somanta and without any further obligation to Somanta if the licensed technology
does not perform to the reasonable satisfaction of Advanced Cardiovascular
Devices or cannot be commercialized because of safety or efficacy reasons or
because Advanced Cardiovascular Devices is unable to raise the funds necessary
to develop a product based on the licensed technology.
150
Prodrax
Overview. Prodrax
(di-N-oxides of chloroethylaminoanthraquinone) is a small molecule that is
non-toxic in normally oxygenated healthy tissue but that becomes highly toxic
in
low oxygen tumors where it binds to the DNA in tumor cells and becomes
irreversibly converted to its toxic form. It is in this state that tumor
cells are killed by the Prodrax they are carried out through potent DNA
damage.
Prodrax
is both a specific chemical entity and a platform technology to make other
drugs
that are intended to induce cancer cell death more effective.
In-License
for Prodrax.
In
March 2004, Somanta entered into a Patent and Know-how Assignment and License
Option Agreement with The School of Pharmacy, University of London pursuant
to
which The School of Pharmacy granted Somanta an option to acquire the rights
to
the key patent application related to Prodrax and an exclusive worldwide license
to the know-how related to Prodrax to develop and commercialize Prodrax in
the
field of the treatment of cancer. Pursuant to this agreement, Somanta paid
The
School of Pharmacy an initial option fee of $44,575 and issued to The School
of
Pharmacy 131,505 shares of Somanta’s common stock valued at $2,630. In September
2005, The School of Pharmacy formally assigned the rights to the key patent
application to Somanta and licensed to Somanta the relevant know-how in the
field of the treatment of cancer. Somanta is currently pursuing the prosecution
of this patent application. Somanta is obligated to pay The School of Pharmacy
certain milestone payments based on the achievement of agreed upon clinical
milestones with respect to Prodrax. If Somanta successfully achieves each of
these milestones, Somanta would be obligated to pay The School of Pharmacy
a
total aggregate amount of milestone payments of GBP 275,000, or approximately
$550,000. Somanta is obligated to use its commercial best efforts to achieve
these agreed upon clinical milestones. If Somanta fails to: (i) commence Phase
I
clinical trials prior to September 21, 2009, (ii) commence Phase II clinical
trials prior to September 21, 2011, (iii) commence Phase III clinical trials
prior to September 21, 2013, (iv) complete its report with respect to such
Phase
III clinical trials prior to September 21, 2015, (v) receive regulatory approval
by the U.S. FDA, the EMEA in the European Union, or the applicable regulatory
body in Japan, in each case, enabling Somanta to market and sell Prodrax in
the
applicable jurisdiction prior to September 21, 2017, or (vi) make a first
commercial sale of Prodrax prior to September 21, 2018, then, in each case,
The
School of Pharmacy would have the right to terminate Somanta’s know-how license
under the agreement. In addition, Somanta is obligated to pay The School of
Pharmacy a royalty on net sales, if any, of products based on Prodrax. In
addition, Somanta has the right to terminate its agreement with The School
of
Pharmacy on ninety (90) days advance notice, and either party has the right
to
terminate the agreement for breach by the other party upon ninety (90) days
(sixty (60) days for payment failures) advance notice if such breach is not
cured within the notice period. Somanta’s agreement with The School of Pharmacy
expires upon the expiration of the last to expire of the patents, if any, that
issue from the patent application that is the subject of Somanta’s agreement
with The School of Pharmacy.
Rationale.
Prodrax
is inert in normally oxygenated cells and becomes toxic in low oxygen areas,
enabling it to kill tumor cells. Many solid tumors have a low oxygen area that
is resistant to radiation and conventional chemotherapy. These cells repopulate
the tumor with additional radiation- and conventional chemotherapy-resistant
cells. These cells are often referred to as quiescent.
Prodrax
becomes irreversibly converted to its toxic form in low oxygen tumor cells
where
it remains localized. When the surrounding oxygenated cells are killed by
radiotherapy or chemotherapy, these Prodrax-containing quiescent cells move
closer to the oxygen source and attempt to resume more active
replication. It is in this state that they are killed by Prodrax, through
potent DNA damage.
When
given in conjunction with radiotherapy or chemotherapy Somanta expects Prodrax
to result in significant improvement of tumor clearance and to reduce the
likelihood of tumor repopulation, improving disease free survival. It is
estimated that over 50% of all solid tumors exhibit clinically significant
hypoxia, or low oxygenation, and that over two million people in the U.S. and
Europe suffer from solid tumor cancers. If successful, Prodrax could improve
the
prognosis for a significant number of cancer sufferers in a wide range of tumor
types.
Competitive
Position.
Somanta
is aware that Novocea, Inc., has exclusively licensed from KuDOS
Pharmaceuticals, a subsidiary of Astra Zeneca, a small molecule prodrug that
is
selectively activated by low oxygen tumors that is similar to Somanta’s Prodrax,
and that Novocea is developing this small molecule prodrug in a similar fashion
to Prodrax.
The
key
composition of matter patent application relating to Prodrax was filed in
December 2003 in the European Union, Taiwan, Australia, Canada, China, India,
Japan, South Africa and the U.S.
151
Development
Plan.
In
2004, Somanta entered into a research and development agreement with The School
of Pharmacy, University of London to further evaluate Prodrax in pre-clinical
studies and funded research there in 2004 and 2005. In 2005, the applicable
investigators left the School of Pharmacy and joined the University of Bradford.
As a result, Somanta terminated its agreement with The School of Pharmacy.
In
March 2006, Somanta entered into a two year agreement with the University of
Bradford to continue these pre-clinical studies.
The
Prodrax technology allows for the modification of various drugs to make them
inert until they are activated by a low oxygen environment. Varieties of
analogues have been developed and are being tested by researchers at the
University of Bradford for the purpose of enabling Somanta to select the lead
compound to take forward into clinical development. Somanta expects to select
a
lead compound in 2007.
Angiolix
Background. Angiolix
(huMc-3 mAB) is a humanized monoclonal antibody targeting a protein known as
Lactadherin. Lactadherin promotes the growth of new blood vessels to support
tumor growth. Angiolix, by blocking Lactadherin, has the potential to induce
programmed cell death, or apoptosis, in blood vessels supporting
tumors.
In-License
for Angiolix.
In
August 2005, Somanta entered into a Patent and Know-how Exclusive Sublicense
Agreement with Immunodex, Inc. pursuant to which Immunodex granted Somanta
the
exclusive worldwide rights to two monoclonal antibodies including Somanta’s
product development candidate, Angiolix, for the development and
commercialization of products in the field of the treatment of cancer. Pursuant
to this agreement, Somanta paid Immunodex an initial license fee of
$300,000.
Previously
on January 25, 2002, Somanta entered into a predecessor Patent Know-how and
License Option Agreement with Immunodex which had essentially the same terms
and
conditions as Somanta’s existing agreement with Immunodex but which was
superseded by its existing agreement with Immunodex. Pursuant to the
2002
agreement, Somanta paid Immunodex an initial license fee of $10,000 and sold
Immunodex 292,012 shares of Somanta’s common stock at a value of $5,638.
Pursuant to the August 2005 agreement Somanta is obligated to pay Immunodex
an
annual license maintenance fee. The license maintenance fee is $250,000 per
year
until such time as one of the product candidates receives regulatory approval
to
be marketed and sold at which time the license maintenance fee is reduced to
$100,000 per year. Somanta’s obligation to pay this annual license maintenance
fee terminates in its entirety at such time as Somanta is selling products
based
on both the monoclonal antibodies. This obligation also terminates if Somanta
terminates the agreement with respect to both product candidates, subject to
Somanta’s obligation to pay the termination fee described below. As noted below,
on November 3,2006 Somanta terminated its license with respect to one of the
monoclonal antibodies (huBrE-3 mAb), and continue to develop on Angiolix.
Assuming
that Somanta begins to sell products based on Angiolix fifteen (15) years after
the date of the August 2005 agreement, or August 2020, which is Somanta’s
anticipated development timetable, Somanta would have to pay to Immunodex an
additional $2,600,000 in maintenance fees during that time period. In addition,
Somanta is obligated to pay Immunodex a royalty based on the net sales, if
any,
of products based on Angiolix. Further, Somanta is obligated to develop Angiolix
on an agreed upon timetable. If Somanta fails to achieve any of the agreed
upon
clinical development and regulatory milestones, Immunodex would then have the
right to terminate the August 2005 agreement, and if such a termination occurs,
Somanta would be obligated to pay Immunodex a termination fee of up to $500,000.
Somanta is also entitled to terminate the agreement with respect to Angiolix
upon ninety (90) days advance notice to Immunodex. If Somanta does so without
cause, Somanta would also be required to pay a termination fee of up to
$500,000. Notwithstanding the foregoing, Somanta does not have to pay a
termination fee with respect to Angiolix if the agreement is terminated due
to:
(i) negative results of toxicity testing for the applicable drug candidate
that
the FDA indicates would preclude further testing of such drug candidate, (ii)
a
third party being granted orphan drug status by the FDA for a drug that would
preclude Somanta from receiving orphan drug status with respect to the
applicable drug candidate, or (iii) Somanta’s inability to achieve commercially
viable yields with respect to the manufacture of the applicable drug
candidate.
If
Somanta sublicenses its rights with respect to Angiolix, Somanta would be
obligated to pay to Immunodex a sublicensing fee not to exceed $1,000,000 for
each such sublicense granted based on payments received from each such
sublicensee.
The
term
of the August 2005 agreement expires on the later to occur of: (i) the
expiration of the last to expire licensed patent, or (ii) fifteen (15) years
after the first commercial sale of a product covered by the licensed patents.
The August 2005 agreement superseded prior agreements with Immunodex dated
January 25, 2002, March 1, 2002 and September 17, 2002, in each case
related to the same subject matter.
In
February 2006, Somanta made a deposit of $150,000 into an escrow account
pursuant to the agreement. This amount was released on November 7, 2006.
152
Effective
November 3, 2006, Somanta entered into a Side Amendment to Patent and
Know-how Exclusive Sublicense Agreement with Immunodex and the Cancer Research
Institute of Contra Costa (“CRICC”) (the “Side Amendment”). Pursuant to the
Side Amendment, Somanta has agreed with Immunodex and CRICC to reduce the amount
of the annual maintenance fee under the License Agreement from $250,000 to
$200,000 and to defer the annual maintenance fee that was due in August, 2006
until the earlier of (i) the closing of a fundraising resulting in gross
proceeds to Somanta of at least $5,000,000, or (ii) January 31, 2007
(the “2006 Annual Maintenance Fee”). If Somanta is unable to timely pay the 2006
Annual Maintenance Fee, the annual maintenance fee due under the License
Agreement would revert to $250,000.
Somanta
retained its rights with respect to huMc-3 mAb and its product candidate
Angiolix; however, Somanta agreed to suspend the development of Angiolix until
such time as Somanta pays the 2006 Annual Maintenance Fee. In addition, each
of
the product development milestones with respect to Angiolix set forth in the
License Agreement has been reset to begin at such time as Somanta makes the
2006
Annual Maintenance Fee payment.
In
addition, Somanta agreed to reimburse Immunodex for certain out of pocket
expenses in the aggregate amount of approximately $21,000, which amount was
payable upon the execution of the Side Amendment.
On
January 18, 2007 Somanta entered into an Amendment to the Side Amendment which
defers the amounts due on January 31, 2007, including the 2006 Annual
Maintenance Fee, until July 31, 2007. In consideration for the deferral, Somanta
will pay $12,000 for each month of the deferral. In addition, Somanta paid
$2,050 of patent annuity payments.
Additional
Licenses Needed to Commercialize Angiolix.
Angiolix is humanized, a process by which genetic material from a mouse cell
is
made tolerable to humans, using a patented technology developed by the National
Institutes of Health. The NIH previously granted to the Cancer Research
Institute of Contra Costa a license to the applicable humanization technology.
Pursuant to the Immunodex agreement, Immunodex and the Cancer Research Institute
of Contra Costa are seeking to obtain for Somanta the NIH’s consent to a
sublicense to Somanta of the Cancer Research Institute of Contra Costa right
to
use the NIH humanization technology.
On
August 8, 2005, Somanta made a direct application to NIH to obtain a
non-exclusive commercial license to such humanization technology, and Somanta
is
currently in discussions with NIH on the terms of such a license. The terms
proposed by NIH would not be acceptable to Somanta since they are materially
more costly than those that are contained in the Cancer Research Institute
of
Contra Costa sublicense. On November 8, 2006, Somanta made application to
the National Institutes of Health for a non-exclusive license to certain patents
held by NIH related to the humanization of Angiolix (huMc-3 mAb). On December
5,
2006 NIH provided Somanta with proposed terms for a non-exclusive license.
Somanta is in discussion with NIH on those proposed terms and conditions. On
May
15, 2007, the NIH terminated Somanta’s non-exclusive license application since
Somanta had not accepted the terms and had not executed the proposed license
agreement.
Rationale. Lactadherin
is expressed in and around blood vessels of tumors and has a critical role
in
providing new blood vessels to support tumor growth. Somanta believes that
Angiolix binds to Lactadherin and induces the death of new blood vessels,
thereby blocking the supply of blood to the tumor and causing the tumor to
die.
A
similar
antibody on the market, Avastin ®
, is
used in the treatment of colorectal and other cancer types.
Development
Plan. Somanta
intends to enter into a research agreement with an academic investigator to
undertake further animal studies on Angiolix within the next six
months.
Competitive
Position. Somanta
is targeting a propriety gene product which is expressed by cancerous
tumors. Somanta is not aware of any other organization developing similar
products targeting this type of protein. The key patent relating to
Angiolix has been issued in the U.S. and Australia. In general, it covers
the composition of matter and various aspects of the binding to applicable
antigens as well as the manufacture of Angiolix. Somanta also has foreign
counterparts to this patent pending in the European Union and Canada. This
patent will expire in 2015.
Intellectual
Property
Somanta’s
success will depend in large part on its ability to obtain and maintain patent
protection for its product candidates, products and technologies, preserve
trade
secrets and operate without infringing the intellectual property rights of
others. Somanta intends to prosecute and defend its intellectual property rights
aggressively. Somanta’s policy is to seek patent protection for the inventions
that Somanta considers important to the development of its business. Currently
Somanta owns one patent that relates to Alchemix together with its foreign
counterpart in the European Union, and Somanta filed a patent application in
the
United States and the European Union related on Prodrax. Somanta’s
intellectual property related to Angiolix consists of an exclusive sub-license
from Immunodex, Inc. to practice the patents that relate to Angiolix in the
field of the treatment of cancer. Somanta has responsibility for the filing,
prosecution and maintenance of patent rights associated with this
license. Somanta’s intellectual property related to PB consists of an
exclusive sub-license from Virium Pharmaceuticals, Inc. to practice the patents
that relate to PB in the field of the treatment of cancer outside of North
America. Virium is responsible for the filing, prosecution and maintenance
of these patents; provided, however, that Somanta has agreed to pay all costs
and expenses associated with the filing, prosecution and maintenance of patents
outside of the U.S. or Canada.
153
Although
Somanta believes its patents, and its patent applications, if they issue as
patents, will provide a competitive advantage, the patent positions of
pharmaceutical and biotechnology companies are highly uncertain and involve
complex legal and factual questions. Somanta may not be able to develop
patentable products or processes, and may not be able to obtain patents from
pending applications. Even if patent claims are allowed, the claims may not
issue, or in the event of issuance, may not be sufficient to protect Somanta’s
technology. In addition, any patents or patent rights Somanta obtains may be
circumvented, challenged or invalidated by Somanta’s competitors.
While
Somanta’s product candidates are in clinical trials, and prior to
commercialization, Somanta believes its current activities in the United States
fall within the scope of the exemptions against patent infringement provided
by
35 U.S.C. Section 271(e) which covers activities related to developing
information for submission to the FDA. As Somanta’s product candidates progress
toward commercialization, the possibility of an infringement claim against
Somanta increases. While Somanta attempts to ensure that its product candidates
and the methods Somanta employs to manufacture them do not infringe other
parties’ patents and proprietary rights, competitors or other parties may assert
that Somanta infringes on their patents or proprietary rights. Competitors
or
third parties may be issued patents that may cover subject matter that Somanta
uses in developing, producing, or administering its products. Additionally,
because patent prosecution can proceed in secret prior to issuance of a patent,
third parties may obtain other patents with claims of unknown scope prior to
the
issuance of patents relating to Somanta’s product candidates which they could
attempt to assert against Somanta. Further, as Somanta develops its products,
Somanta may infringe the current patents of third parties or patents that may
issue in the future.
Although
Somanta believes that its product candidates, production methods and other
activities do not currently infringe the intellectual property rights of these
and other third parties, Somanta cannot be certain that a third party will
not
challenge its position in the future. If a third party alleges that Somanta
is
infringing its intellectual property rights, Somanta may need to obtain a
license from that third party, but there can be no assurance that any such
license will be available on acceptable terms or at all. Any infringement claim
that results in litigation could result in substantial cost to Somanta and
the
diversion of management’s attention away from Somanta’s core business and could
also prevent Somanta from marketing its products. To enforce patents issued
to
Somanta or to determine the scope and validity of other parties’ proprietary
rights, Somanta may also become involved in litigation or in interference
proceedings declared by the United States Patent and Trademark Office, which
could result in substantial costs to Somanta or an adverse decision as to the
priority of its inventions. Somanta may be involved in interference and/or
opposition proceedings in the future. Somanta believes there will continue
to be
significant litigation in the industry regarding patent and other intellectual
property rights.
Somanta
also relies on trade secrets to protect its technology, particularly when
Somanta does not believe that patent protection is appropriate or available.
However, trade secrets are difficult to protect. Somanta attempts to protect
its
trade secrets by requiring each of its employees, consultants and advisors
to
execute a non-disclosure and assignment of invention agreement before beginning
his or her employment, consulting or advisory relationship with Somanta. Somanta
cannot guarantee that these agreements will provide meaningful protection,
that
these agreements will not be breached, that Somanta will have an adequate remedy
for any such breach, or that Somanta’s trade secrets will not otherwise become
known or independently developed by a third party.
Government
Regulation
In
addition to FDA regulatory approval process discussed above, Somanta is subject
to regulation by various governmental agencies including, without limitation,
the Drug Enforcement Administration, the U.S. Department of Agriculture, the
Environmental Protection Agency, the Occupational Safety and Health
Administration, and the California State Department of Health Services, Food
and
Drug Branch. Such regulation by governmental authorities in the U.S. and
other countries may impede or limit Somanta’s ability to develop and market
Somanta’s products.
154
Any
products Somanta manufactures or distributes pursuant to the FDA clearances
or
approvals are subject to pervasive and continuing regulation by the FDA,
including record-keeping requirements, reporting of adverse experiences with
the
drug, submitting other periodic reports, drug sampling and distribution
requirements, notifying the FDA and gaining its approval of certain
manufacturing or labeling changes, complying with the FDA promotion and
advertising requirements. The FDA has actively enforced regulations prohibiting
the marketing of products for unapproved uses. However, in certain
circumstances, and subject to very stringent requirements, the FDA will permit
the dissemination of peer-reviewed scientific reprints related to unapproved
uses. Drug manufacturers and their subcontractors are required to register
their
facilities with the FDA and state agencies and are subject to periodic
unannounced inspections by the FDA and state agencies for compliance with
current good manufacturing practices, which impose procedural and documentation
requirements upon Somanta and its third-party manufacturers. Failure to comply
with these regulations could result, among other things, in warning letters,
suspension of regulatory approval, refusal to approval pending applications
or
supplements to approved applications, recalls, suspension or closure of
production or injunctions, seizures, or civil or criminal sanctions Somanta
cannot be certain that Somanta or its present or future subcontractors will
be
able to comply with those regulations and other FDA regulatory
requirements.
The
FDA’s
policies may change, and additional government regulations may be enacted which
could prevent or delay regulatory approval of its potential products. Moreover,
increased attention to the containment of health care costs in the U.S. and
in
foreign markets could result in new government regulations that could have
a
material adverse effect on Somanta’s business. Somanta cannot predict the
likelihood, nature or extent of adverse governmental regulation that might
arise
from future legislative or administrative action, either in the U.S. or
abroad.
Raw
Materials
Somanta
needs sufficient supplies of raw materials to develop and market its products
successfully. The raw materials in products that are approved by the FDA
cannot be changed without equivalency testing of the new material by Somanta
and
approval by the FDA. Some of the raw materials for Somanta’s products are
expected to be qualified from only one supplier. At times, one or more of these
qualified materials may not be available or may be available only in limited
quantities. If Somanta is unable to obtain the necessary raw materials from
its existing sources, Somanta could incur significant delays in marketing and
selling its products until an alternate vendor can be qualified and approved
for
use. At this time, Somanta has not entered into any agreement with a third
party manufacturer or supplier for the purpose of supplying Somanta with the
raw
materials necessary to conduct its clinical trials or to commercialize any
of
its product candidates; however, Somanta believes that raw materials relevant
to
the manufacture of both its monoclonal antibody product candidates and small
molecule product candidates are available from a variety of
sources.
Employees
As
of
July 19, 2007, Somanta employed three full time employees. Somanta’s three
current employees are located in two separate facilities. Somanta’s
headquarters, where its Executive Chairman operates, is located in Irvine,
California. Somanta currently has an office in a medical office building
in London, England which houses its President and Chief Executive Officer as
well as his assistant.
For
the
foreseeable future, Somanta intends to outsource all of its research,
pre-clinical, manufacturing, clinical and regulatory activities to
well-qualified contract research organizations, contract manufacturing
organizations, clinical research organizations and independent contractors.
These organizations and individuals will perform their activities under detailed
project plans developed by Somanta’s management and in accordance with its
global development strategy.
DESCRIPTION
OF PROPERTY
In
addition, Somanta rents approximately 500 square feet in London, England for
approximately $2,000 per month which lease terminates on May 16,
2008.
LEGAL
PROCEEDINGS
On
February 8, 2007, Somanta’s United Kingdom subsidiary, Somanta Limited, had a
creditor, Cornel Associates Limited, institute a collection action against
it in
the Northampton County Court in the United Kingdom in the amount of GBP 6,201.
Somanta’s subsidiary has disputed a portion of the claim. On February 23, 2007,
the creditor threatened to initiate liquidation proceedings against Somanta’s
United Kingdom subsidiary in the High Court of justice, Chancery Division,
Companies Court in the United Kingdom. No hearing has been scheduled in this
matter.
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Until
October 24, 2005, Somanta’s common stock was quoted on the OTCBB under the
symbol “HBSM.OB.” On October 24, 2005, the OTCBB removed Somanta’s symbol from
its file as an inactive security.
On
September 12, 2006, the OTCBB approved for quotation Somanta’s common stock
under the symbol “SMPM.” As of July 19, 2007, the last reported sales price
of Somanta’s common stock was $0.15.
155
The
following table sets forth, for the periods indicated, the high and low closing
prices as reported by the OTCBB, of Somanta’s common stock for the two most
recent fiscal quarters following the approval on September 12, 2006 for
quotation of Somanta’s common stock on the OTCBB. Prior to September 12, 2006,
Somanta’s common stock was not quoted on the OTCBB or any other trading market.
The OTCBB quotations reflect inter-dealer prices, without retail mark-up,
mark-down or commission and may not represent actual transactions.
|
Common
Stock
|
|||||||
|
High
|
Low
|
||||||
|
Fiscal
Year Ended April 30, 2007
|
|||||||
|
Third
quarter January 31, 2007
|
$
|
1.75
|
$
|
1.05
|
|||
|
Fourth
quarter April 30, 2007
|
1.25
|
0.75
|
|||||
| Period Ended | |||||||
| To July 19, 2007 | $ | 1.25 | $ | 0.13 | |||
As
of
April 30, 2007, there were approximately seven hundred thirteen (713)
stockholders of record of Somanta’s common stock and eight (8) stockholders of
record of Somanta’s Series A Convertible Preferred Stock.
Dividend
Policy
Somanta
has never declared or paid a dividend on its common stock, nor does Somanta
have
any plans to do so in the future. Dividends on Somanta’s Series A Convertible
Preferred Stock accrue at a rate of 8% per annum and are payable by Somanta
in
cash or shares of its common stock. Additionally, Somanta may not declare or
pay
a dividend, other than that set forth for shares of Series A Convertible
Preferred Stock above, without the prior approval of the holders of a majority
of Somanta’s Series A Convertible Preferred Stock.
Securities
Authorized for Issuance Under Equity Compensation Plans
The
following table sets forth information as of April 30, 2007 related to Somanta’s
equity compensation plans in effect as of that date.
|
Plan
Category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
|
Weighted-average
exercise price of outstanding options, warrants and rights
|
Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in column
(a))
|
|
(a)
|
(b)
|
(c)
|
|
|
Equity
Compensation
Plans
approved by security holders
|
3,483,163
|
$.95
|
4,516,837
|
|
Equity
Compensation
Plans
not approved by
security
holders
|
--
|
--
|
--
|
|
Total
|
3,483,163
|
$.95
|
4,516,837
|
Recent
Sales of Unregistered Securities
During
the last three years, we have issued the following unregistered
securities. None of these transactions involved any underwriters,
underwriting discounts or commissions, except as specified below, or any
public
offering.
On
February 27, 2007, Somanta Pharmaceuticals, Inc. issued a warrant to purchase
150,000 shares of common stock to SCO Securities, LLC, its financial advisor
in
consideration for services rendered in connection with the March 1, 2005
engagement agreement. These warrants are immediately exercisable at an exercise
price of $0.01 per share, subject to certain adjustments, and have a term
of six
years.
On
March
13, 2006, Somanta Pharmaceuticals, Inc. issued a warrant to purchase 150,000
shares of common stock to SCO Securities, LLC, its financial advisor in
consideration for services rendered in connection with the March 1, 2005
engagement agreement. These warrants are immediately exercisable at an exercise
price of $0.01 per share, subject to certain adjustments, and have a term
of six
years. On January 31, 2006, in connection with the merger with Somanta
Incorporated, Somanta Pharmaceuticals, Inc., issued an aggregate of 13,697,834
shares of common stock to the 30 prior stockholders of Somanta Incorporated
in
exchange for all of the issued and outstanding capital stock of Somanta
Incorporated.
On
January 31, 2006, Somanta Pharmaceuticals, Inc., issued and sold to eight
investors 464 shares of Series A Convertible Preferred Stock at a price of
$10,000 per share, which are initially convertible into 7,733,334 shares
of our
common stock and warrants to purchase an additional 3,866,666 shares of our
common stock. In connection with the private placement, SCO Capital
Partners LLC also converted the entire amount of principal and interest
outstanding on that certain secured convertible promissory note dated August
23,
2005, as amended, issued by Somanta Incorporated (formerly Bridge Oncology
Products, Inc.) and assumed by us in connection with the merger with Somanta
Incorporated. A total of $1,286,318 outstanding under the note was
converted into 128.6318 shares of Series A Preferred Stock and additional
warrants to purchase 2,143,863 shares of our common stock. All the warrants
are
immediately exercisable at an exercise price of $0.75 per share, subject
to
certain adjustments, and have a term of six years.
On
January 31, 2006, Somanta Pharmaceuticals, Inc., assumed a warrant issued
by
Somanta Incorporated in favor of SCO Capital Partners LLC, dated November
8,
2005, in connection with the debt financing described above, and it thereby
became a warrant to purchase 866,534 shares of Somanta Pharmaceuticals, Inc.,
common stock at an exercise price of $0.01 per share.
On
January 31, 2006, Somanta Pharmaceuticals, Inc., issued a warrant to purchase
987,720 shares of common stock to SCO Securities, LLC, its financial advisor
in
consideration for services rendered in connection with the Private Placement.
These warrants are immediately exercisable at an exercise price of $0.60
per
share, subject to certain adjustments, and have a term of six
years.
On
April
1, 2005, Somanta Pharmaceuticals, Inc. (formerly Hibshman Optical Corp.)
issued
31,378,452 shares of common stock in exchange for 8% convertible notes payable
totaling $62,000 plus $16,446 of accrued interest. The conversion price was
$.0025 per share. The notes were issued on December 7, 1998. Hibshman Optical
Corp. received an aggregate of $50,000 and issued two $25,000 8% convertible
notes payable to Hibshman Optical Corp.’s two current officers, directors and
principal stockholders. The notes were due on December 7, 2001 and were
convertible in whole or in part at any time prior to maturity and upon 30
days
written notice from the holders into common stock of Hibshman Optical Corp.
at a
conversion price of $.0025 per share. These notes were extended on December
7,
2001 for three years until December 7, 2004 at the same rate of interest,
conversion price and terms, and the accrued interest payable of $12,000 at
that
date was added to the principal increasing the balance of the convertible
notes
payable to $62,000. On December 7, 2004, the notes were further extended
to
March 31, 2005.
The
offers, sales and issuances of the securities listed above were deemed to
be
exempt from registration under the Securities Act in reliance on Section
4(2) of
the Securities Act and/or Regulation D and/or Regulation S promulgated
thereunder as transactions by the issuer not involving a public offering.
The
Company made this determination based on the representations of the recipients
of these securities of their intention to acquire the securities for investment
only and not with a view to or for sale in connection with any distribution
thereof, as well as, their respective investment experience and financial
condition. Appropriate legends were affixed to the share certificates issued
in
such transactions. Furthermore, all recipients had adequate access to
information about the registrant.
156
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS FOR SOMANTA PHARMACEUTICALS, INC.
As
of
July 19, 2007, Somanta had 14,292,603 shares of common stock issued and
outstanding. after. The following table sets forth as of July 19, 2007, the
number of shares of common stock owned of record and beneficially by Somanta’s
current executive officers, directors, persons who hold 5% or more of the
outstanding common stock of Somanta and by current officers and directors as
a
group. On April 13, 2007, Somanta’s Board of Directors approved a merger
agreement with Access Pharmaceuticals, Inc., more fully described in Note 15.
Under the terms of the merger agreement, Access will not assume, or provide
a
substitute option, for any of Somanta’s stock options. Rather, all of the
outstanding options to purchase Somanta’s common stock issued pursuant to
Somanta’s 2005 Equity Incentive Plan will be cancelled prior to the closing of
the transaction in accordance with Section 11.3(d) of the Equity Incentive
Plan.
As a result, pursuant to the terms of Section 11.3(d) of the Equity Incentive
Plan, Somanta’s Board of Directors has resolved to: (i) allow the immediate and
accelerated vesting of all of the options granted, and (ii) allowed the exercise
of the option in whole or in part until May 31, 2007. Since the value of the
Access stock to be exchanged for the Somanta stock is less than the exercise
price of the options, the options expired and were not exercised. Therefore,
any
options have been excluded from the following table.
Under
the
rules of the Securities and Exchange Commission, a person (or group of persons)
is deemed to be a “beneficial owner” of a security if he or she, directly or
indirectly, has or shares the power to vote or to direct the voting of such
security, or the power to dispose of or to direct the disposition of such
security. Accordingly, more than one person may be deemed to be a
beneficial owner of the same security. A person is also deemed to be a
beneficial owner of any security, which that person has the right to acquire
within sixty (60) days, such as warrants or options to purchase shares of
Somanta’s common stock.
|
Class
|
Name
and Address of Beneficial Owner
|
Amount
and
Nature
of
Beneficial
Ownership
|
Percentage
of
Class
Beneficially
Owned
|
||
|
Executive
Officers and Directors:
|
|||||
|
Common
|
Agamemnon
A. Epenetos
80
Harley Street, London, England
|
-
(1)
|
*
|
||
|
Common
|
Terrance
J. Bruggeman
19200
Von Karman Ave, Suite 400, Irvine, CA
|
-
|
*
|
||
|
Common
|
Jeffrey
B. Davis
|
1,609,044
(2)
|
10.94%
|
||
|
Preferred
|
33
Tall Oak Drive, Summit, NJ
|
25
|
4.23%
|
||
|
Common
|
John
R. Gibson
19200
Von Karman Ave, Suite 400, Irvine, CA
|
98,554
(3)
|
.69%
|
||
|
Common
|
Kathleen
H. Van Sleen
19200
Von Karman Ave, Suite 400, Irvine, CA
|
-
|
*
|
||
|
Common
|
All
Officers & Directors as a Group
(5
persons)
|
1,707,606
|
11.62%
|
||
|
5%
Stockholders:
|
|||||
|
Common
|
Walbrook
Trustees (Jersey Ltd. REK33)
PO
Box 248, Lord Coutanche House, 66-68 Esplanade St.
Helier,
Jersey JE4 5PS, Channel Islands
|
3,869,152(4)
|
27.07%
|
||
|
Common
|
SCO
Capital Partners LLC
|
15,691,785(5)
|
65.47%
|
||
|
Preferred
|
1285
Avenue of the Americans, 35th Floor, New York, NY
|
328.6318
|
55.55%
|
||
|
Common
|
Alpha
Capital AG
|
1,000,000(6)
|
6.40%
|
||
|
Preferred
|
Pradafant
7 Furestentums 9490, Vaduz, Liechtenstein
|
40
|
6.76%
|
||
|
Common
|
Whalehaven
Capital Fund Limited
|
1,875,000(7)
|
12.46%
|
||
|
Preferred
|
14
Par-La-Ville Road, 3rd Floor, Hamilton HM08
Bermuda
|
74
|
12.51%
|
||
|
Common
|
XMark
Opportunity Fund Ltd.
|
2,500,000(8)
|
16.53%
|
||
|
Preferred
|
301
Tresser Blvd., Suite 1320, Stamford, CT
|
100(9)
|
16.90%
|
||
|
Common
|
XMark
Opportunity Fund, L.P.
|
2,500,000(8)
|
16.53%
|
||
|
Preferred
|
301
Tresser Blvd., Suite 1320, Stamford, CT
|
100(9)
|
16.90%
|
||
|
Common
|
XMark
JV Investment Partners, LLC
|
2,500,000(8)
|
16.53%
|
||
|
Preferred
|
301
Tresser Blvd., Suite 1320, Stamford, CT
|
100(9)
|
16.90%
|
||
|
* less
than 1%
|
|||||
157
|
___________________
|
|
|
(1)
|
Dr.
Epenetos is a beneficiary of Walbrook Trustees (Jersey Ltd. REK33)
(“Walbrook Trustees”), PO Box 248, Lord Coutanche House, 66-68 Esplanade
St. Helier, Jersey JE4 5PS, Channel Islands. Walbrook Trustees holds
3,869,152 shares of Somanta’s common stock; however, Dr. Epenetos has no
voting or dispositive power with respect to such
shares.
|
|
|
|
|
(2)
|
Consists
of (i) 786,500 shares of Somanta common stock held by Lake End Capital,
LLC (“Lake End”); (ii) 25 shares of Series A Convertible Preferred
Stock, with such shares of Series A Convertible Preferred Stock being
initially convertible into 416,667 shares of Somanta common stock,
held by
Lake End; (iii) an immediately exercisable Series A Warrant to
purchase 208,333 shares of Somanta common stock at $0.75 per share,
held
by Lake End; and (iv) a PA Warrant to purchase 197,544 shares of
Somanta
common stock at $0.60 per share assigned to Lake End by SCO Securities,
LLC. Pursuant to the terms of the Certificate of Designations for
the
Series A Convertible Preferred Stock, the number of shares of Somanta
common stock that may be acquired on less than 61 days notice by
Lake End
upon any conversion of Series A Convertible Preferred Stock or the
number
of shares of Somanta common stock that shall be entitled to voting
rights
upon any conversion of Series A Convertible Preferred Stock is limited,
to
the extent necessary, to ensure that following such conversion, the
number
of shares of Somanta common stock then beneficially owned by Lake
End and
any other persons or entities whose beneficial ownership of common
stock
would be aggregated with Lake End’s for purposes of the Exchange Act does
not exceed 9.99% of the total number of shares of Somanta common
stock
then outstanding. In addition, all of the warrants held by Lake End
also provide that the number of shares of Somanta common stock that
may be
acquired on less than 61 days notice by Lake End upon exercise of
such
warrants is limited, to the extent necessary, to ensure that following
such exercise, the number of shares of Somanta common stock then
beneficially owned by Lake End and any other persons or entities
whose
beneficial ownership of common stock would be aggregated with Lake
End’s
for purposes of the Exchange Act does not exceed 9.99% of the total
number
of shares of Somanta common stock then outstanding. Accordingly, in
light of the beneficial ownership cap, Lake End is entitled to acquire
1,508,198 shares of Somanta common stock on less than 61 days
notice. Lake End is the record owner of the securities listed in the
table. Mr. Jeffrey Davis, as managing member of Lake End, has sole
dispositive and voting power with respect to all shares held of record
by
Lake End. Mr. Davis disclaims beneficial ownership of these
shares.
|
|
|
|
|
(3)
|
Consists
of 98,554 shares of Somanta common stock held by Dr.
Gibson.
|
|
|
|
|
(4)
|
Consists
of 3,869,152 held in the name of Walbrook Trustees of which Dr. Epenetos
is a beneficiary. Dr. Epenetos has no voting or dispositive power
with respect to such shares. Katarina Le Vesconte is the Managing
Director
of Walbrook and as such has the power to direct the vote and disposition
of these shares. Ms. Le Vesconte disclaims beneficial ownership of
these
shares.
|
|
|
|
|
(5)
|
Consists
of (i) 6,016,725 shares of Somanta’s common stock held by SCO Capital
Partners LLC; (ii) 328.6318 shares of Series A Convertible Preferred
Stock, with such shares of Series A Convertible Preferred Stock being
initially convertible into 5,477,196 shares of Somanta common stock,
held
by SCO Capital Partners LLC; (iii) an immediately exercisable Series
A
Warrant to purchase 2,738,598 shares of Somanta common stock at $0.75
per
share held by SCO Capital Partners LLC; (iv) a seven year warrant
to
purchase 866,534 shares of common shares at $0.01 per share held
by SCO
Capital Partners LLC; and (v) a PA Warrant to purchase 592,732 shares
of
Somanta common stock at $0.60 per share assigned to SCO Capital Partners
LLC by SCO Securities, LLC, an affiliate of SCO Capital Partners
LLC. Mr. Rouhandeh, in his capacity as Chairman and sole member of
SCO Capital Partners LLC has sole investment and voting power with
respect
to these shares. SCO Capital Partners LLC has opted out of the
beneficial ownership cap applicable to holders of shares of Somanta
Series
A Convertible Preferred Stock, Series A Warrants and PA
Warrants.
|
|
|
|
|
(6)
|
Consists
of 40 shares of Series A Convertible Preferred Stock acquired by
Alpha
Capital AG (“Alpha”) on January 31, 2006, with such shares being initially
convertible into 666,667 shares of Somanta common stock. Alpha also
acquired an immediately exercisable Series A Warrant to purchase
333,333
shares of Somanta common stock at $0.75 per share in connection with
the
acquisition of the Series A Convertible Preferred Stock. Konrad Ackermann
is the Director of Alpha and as such has the power to direct the
vote and
disposition of these shares. Mr. Ackermann disclaims beneficial ownership
of these shares.
|
|
(7)
|
Consists
of 74 shares of Series A Convertible Preferred Stock acquired by
Whalehaven Capital Fund Limited (“Whalehaven”) on January 31, 2006, with
such shares being initially convertible into 1,250,000 shares of
Somanta
common stock. Whalehaven also acquired an immediately exercisable
Series A Warrant to purchase 625,000 shares of Somanta common stock
at
$0.75 per share in connection with the acquisition of the Series
A
Convertible Preferred Stock. Pursuant to the terms of the
Certificate of Designations for the Series A Convertible Preferred
Stock,
the number of shares of Somanta common stock that may be acquired
on less
than 61 days notice by Whalehaven upon any conversion of Series A
Convertible Preferred Stock or the number of shares of Somanta common
stock that shall be entitled to voting rights upon any conversion
of
Series A Convertible Preferred Stock is limited, to the extent necessary,
to ensure that following such conversion, the number of shares of
Somanta
common stock then beneficially owned by Whalehaven and any other
persons
or entities whose beneficial ownership of common stock would be aggregated
with Whalehaven’s for purposes of the Exchange Act does not exceed 9.99%
of the total number of shares of Somanta common stock then
outstanding. In addition, all of the warrants held by Whalehaven
also provide that the number of shares of Somanta common stock that
may be
acquired on less than 61 days notice by Whalehaven upon exercise
of such
warrants is limited, to the extent necessary, to ensure that following
such exercise, the number of shares of Somanta common stock then
beneficially owned by Whalehaven and any other persons or entities
whose
beneficial ownership of common stock would be aggregated with Whalehaven’s
for purposes of the Exchange Act of 1934 does not exceed 9.99% of
the
total number of shares of Somanta common stock then outstanding.
Accordingly, in light of the beneficial ownership cap, Whalehaven
is
entitled to acquire 1,490,269 shares of Somanta common stock on less
than
61 days notice. Arthur Jones, Jennifer Kelly and Derek Wood are the
directors of Whalehaven and as such have shared power to direct the
vote
and disposition of these shares. Mr Jones, Ms. Kelly and Mr. Wood
disclaim
beneficial ownership of these shares.
|
|
(8)
|
Consists
of (i) 41.25 shares of Series A Convertible Preferred Stock acquired
by
XMark Opportunity Fund Ltd. (“XMark Ltd.”), an affiliate of XMark L.P. and
XMark JV, on January 31, 2006, with such shares being initially
convertible into 687,500 shares of Somanta common stock; (ii) an
immediately exercisable Series A Warrant to purchase 343,750 shares
of
Somanta common stock at $0.75 per held by XMark Ltd.; (iii) 33.75
shares
of Series A Convertible Preferred Stock acquired by XMark Opportunity
Fund, L.P. (“XMark L.P.”), an affiliate of XMark Ltd. and XMark JV, on
January 31, 2006, with such shares being initially convertible into
562,500 shares of Somanta common stock; (iv) an immediately exercisable
Series A Warrant to purchase 281,250 shares of Somanta common stock
at
$0.75 per share held by XMark L.P.; (v) 25 shares of Series A Convertible
Preferred Stock acquired by XMark JV Investment Partners, LLC (“XMark
JV”), an affiliate of XMark Ltd. and XMark L.P., on January 31, 2006,
with
such shares being initially convertible into 416,667 shares of Somanta
common stock; and (vi) an immediately exercisable Series A Warrant
to
purchase 208,333 shares of Somanta common stock at $0.75 per share
held by
XMark JV. Mitchell Kaye is the Chief Investment Officer of each of
XMark Ltd., XMark L.P. and XMark JV. Pursuant to the terms of the
Certificate of Designations for the Series A Convertible Preferred
Stock,
the number of shares of Somanta common stock that may be acquired
on less
than 61 days notice by any of the XMark entities upon any conversion
of
Series A Convertible Preferred Stock or the number of shares of Somanta
common stock that shall be entitled to voting rights upon any conversion
of Series A Convertible Preferred Stock is limited, to the extent
necessary, to ensure that following such conversion, the number of
shares
of Somanta common stock then beneficially owned by any of the XMark
entities and any other persons or entities whose beneficial ownership
of
common stock would be aggregated with any of the XMark entities’ for
purposes of the Exchange Act does not exceed 9.99% of the total number
of
shares of Somanta’s common stock then outstanding. In addition, all
of the warrants held by the XMark entities also provide that the
number of
shares of Somanta common stock that may be acquired on less than
61 days
notice by any of the XMark entities upon exercise of such warrants
is
limited, to the extent necessary, to ensure that following such exercise,
the number of shares of Somanta common stock then beneficially owned
by
any of the XMark entities and any other persons or entities whose
beneficial ownership of common stock would be aggregated with any
of the
XMark entities’ for purposes of the Exchange Act does not exceed 9.99% of
the total number of shares of Somanta common stock then outstanding.
Accordingly, in light of the beneficial ownership cap, the XMark
entities
are entitled to acquire 1,511,081 shares of Somanta common stock
on less
than 61 days notice. Mitchell D. Kaye is the Chief Investment Officer
of
each of the XMark entities and as such has the power to direct the
vote
and disposition of these shares. Mr. Kaye disclaims beneficial ownership
of these shares.
|
|
|
|
|
(9)
|
Consists
of (i) 41.25 shares of Series A Convertible Preferred Stock acquired
by
XMark Ltd.; (ii) 33.75 shares of Series A Convertible Preferred Stock
acquired by XMark L.P.; and (iii) 25 shares of Series A Convertible
Preferred Stock acquired by XMark
JV.
|
158
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You
should read the following discussion of our financial condition and results
of
operations in conjunction with the financial statements and the notes to those
statements included elsewhere in this report. This discussion may contain
forward-looking statements that involve risks and uncertainties. Our actual
results may differ materially from those anticipated in these forward-looking
statements as a result of certain factors, such as those set forth under “Risk
Factors” and elsewhere in this report. Information in the following
discussion for a yearly period means for the year ended April 30 of the
indicated year.
Background
Somanta
is a biopharmaceutical company engaged in the development of drugs primarily
for
the treatment of cancer. Somanta in-license product development candidates
designed for anti-cancer therapy in order to advance them along the regulatory
and clinical pathway toward commercial approval. Somanta's licenses are
generally worldwide in scope and territory, with the exception of its license
for
Sodium Phenylbutyrate where its rights exclude the U.S. and
Canada. Somanta uses its expertise to manage and perform what it
believes are the most critical aspects of the product development process
which
includes the design and conduct of clinical trials, the development and
execution of strategies for the protection and maintenance of intellectual
property rights and the interaction with drug regulatory authorities
internationally. Somanta concentrates on product development and engage in
a very limited way in product discovery, avoiding the significant investment
of
time and financial resources that is generally required before a compound
is
identified and brought into clinical trials. In addition, Somanta
intends to out-source clinical trials, pre-clinical testing and the manufacture
of clinical materials to third parties. Somanta engages two third
parties to undertake pre-clinical testing with respect to its product
candidates Angiolix, Alchemix and Prodrax. Somanta was formerly known as
Bridge Oncology Products, Inc., a Delaware corporation which was formed on
February 10, 2005. On August 22, 2005 Somanta entered into a
Share Exchange Agreement with Somanta Limited, a company organized under
the
laws of England, pursuant to which Somanta Limited became a wholly-owned
subsidiary of Bridge Oncology Products, Inc., and Bridge Oncology Products,
Inc., changed its name to Somanta Incorporated. Somanta Limited was formed
on April 19, 2001.
Somanta's current portfolio of development candidates in clinical development includes an anti-cancer agent (a small molecule) targeting four different tumors and/or stages of cancer. Somanta has three additional development candidates (two small molecules and a monoclonal antibody) in pre-clinical development targeting eleven different tumor types.
Somanta intends
to license the rights to manufacture and market our product candidates
to other
pharmaceutical companies in exchange for license fees and royalty payments
and
to continue to seek other in-licensing opportunities in pursue of its
business strategy. Somanta does not currently intend to manufacture or
market products although we may, if the opportunity is available on terms
that
are considered attractive, or retain co-development rights to specific
products.
Somanta
has incurred substantial operating losses since its inception due in large
part to expenditures for its research and development activities. At April
30,
2007, Somanta had an accumulated deficit of $15,796,145. Somanta
expects its operating losses to increase for at least the next several
years
as it pursue the clinical development of its lead product candidates
and expand its discovery and development pipeline.
Revenues
Somanta
has not generated any significant revenues from sales to date, and Somanta
does not expect to generate revenues from product sales for at least
the next
several years, if at all. Somanta expects its revenues for the next
several years to consist of payments under certain of its current
agreements and any additional collaborations, including upfront payments
upon
execution of new agreements, research funding and related fees throughout
the
research term of the agreements and milestone payments contingent upon
achievement of agreed-upon objectives. To date, Somanta has received
$10,000 in payments under such agreements.
Critical
Accounting Policies and Estimates
Somanta's discussion
and analysis of its financial condition and results of operations is based
on its consolidated financial statements. Somanta has identified the
accounting policies that it believes require application of management’s
most subjective judgments, often requiring the need to make estimates
about the
effect of matters that are inherently uncertain and may change in subsequent
periods. Somanta's actual results may differ substantially from these
estimates under different assumptions or conditions. Somanta's significant
accounting policies are described in more detail in the notes to consolidated
financial statements included elsewhere in this prospectus. Somanta
believes that the following accounting policies require the application
of
significant judgments and estimates.
Intangible
Assets—Patents and Licenses
All
patent and license costs are charged to expense when incurred.
159
Stock
Based Compensation
On
December 16, 2004, the FASB issued SFAS No. 123 (revised 2004),
“Share-Based Payment” (SFAS 123R). SFAS 123R eliminates the alternative of
applying the intrinsic value measurement provisions of APB 25 to stock
compensation awards issued to employees. Rather, the new standard requires
enterprises to measure the cost of employee services received in exchange
for an
award of equity instruments based on the grant-date fair value of the
award.
That cost will be recognized over the period during which an employee
is
required to provide services in exchange for the award, known as the
requisite
service period (usually the vesting period). On April 14, 2005, the
Securities and Exchange Commission announced the adoption of a rule that
defers
the required effective date of SFAS 123R. The SEC rule provides that
SFAS 123R
is now effective for registrants as of the beginning of the first fiscal
year
beginning after June 15, 2005.
Effective May 1,
2006, Somanta adopted SFAS 123R and accordingly has adopted the modified
prospective application method. Under this method, SFAS 123R is applied
to new
awards and to awards modified, repurchased, or cancelled after the
effective
date. Additionally, compensation cost for the portion of awards that
are
outstanding as of the date of adoption for which the requisite service
has not
been rendered (such as unvested options) is recognized over a period
of time as
the remaining requisite services are rendered.
Prior
to May 1, 2006, Somanta accounted for its employee stock option plan
in accordance with the provisions of SFAS No. 123, “Accounting
for Stock-Based Compensation,”
and
SFAS No. 148, “Accounting
for Stock-Based Compensation - Transition and Disclosure.”
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles in the U.S. requires management to make estimates
and
assumptions that affect the reported amounts of assets and liabilities
at the
date of the consolidated financial statements and the reported amounts
of
revenues and expenses during the reporting period.
On
an
ongoing basis, Somanta evaluates its estimates, including those
related to accruals, valuation of stock options and warrants, and income
taxes
(including the valuation allowance for deferred taxes). Somanta
bases its estimates on historical experience and on various other
assumptions that it believes to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying
values
of assets and liabilities that are not readily apparent from other
sources.
Actual results may materially differ from these estimates under different
assumptions or conditions. Material differences may occur in its results of
operations for any period if Somanta made different judgments or utilized
different estimates.
Fair
Value of Financial Instruments
Statement
of Financial Accounting Standard No. 107, “Disclosures about fair value of
financial instruments,” requires that Somanta disclose estimated fair
values of financial instruments. The carrying amounts reported in the
statements
of financial position for current assets and current liabilities qualifying
as
financial instruments are a reasonable estimate of fair value of such
financial
instruments.
Research
and Development
All
research and development costs consist of expenditures for royalty
payments,
licensing fees, contract research conducted by third parties, and fees
and
expenses to consultants to manage such contract research.
Results
of Operations
Fluctuations
in Operating Results
Somanta's
results of operations are likely to fluctuate from period to
period. Somanta anticipates that its quarterly and annual results of
operations will be impacted for the foreseeable future by several factors,
including the timing and amount of payments received pursuant to Somanta's
current and future collaborations, and the progress and timing of expenditures
related to its discovery and development efforts. Due to these
fluctuations, Somanta believes that the period-to-period comparisons
of its operating results are not a good indication of its future
performance.
160
Year
Ended April 30, 2007 Compared With Year Ended April 30,
2006
For
the
year ended April 30, 2007 and April 30, 2006, Somanta recognized revenue in
the amount of $1,429 and $1,428, respectively, related to an upfront
license fee
paid by Advanced Cardiovascular Devices, LLC, for an exclusive license
to
di-N-oxides of chloroethylaminoanthraquinone as a bioreductive prodrug
for use
in stents and devices in the field of vascular disorders.
Somanta's
net loss applicable to common shareholders was $7,495,637 for the year
ended
April 30, 2007 versus $6,524,408 for the year ended April 30, 2006,
an increase
of $971,229. This increase is primarily due to increases in Operating
Expenses and Change in Fair Value of Warrants, which were offset by
the decrease
in Interest Expense.
Operating
Expenses were $4,551,806 for the year ended April 30, 2007, versus
$4,109,859
for the year ended April 30, 2006, an increase of $441,947. This increase
is due to an increase in both G&A expenses and R&D.
G&A
expenses were $3,312,660 for the year ended April 30, 2007, versus
$2,845,634
for the year ended April 30, 2006, an increase of $467,026. This net
increase reflects primarily:
|
•
|
a
decrease in legal expenses of $463,655, in audit and accounting
expenses
of $203,470, and in investor relations expenses of $39,746;
all related to
the decline in expenses subsequent to its fiscal 2006 merger and
private placement described in Notes 9 and 11 in the attached
Consolidated
Financial Statements.
|
|
|
•
|
an
increase in patent legal expense of $322,157 related to agreements
with the Immunodex, Virium and School of Pharmacy
|
|
|
•
|
an
increase in payroll related expenses of $145,299 for a
full year
employment of Somanta's Executive Chairman and a partial year
for its former Chief Financial Officer.
|
|
|
•
|
an
increase in non-cash expenses of $549,217 to record the
non-cash value of
stock options issued primarily to new directors and officers,
as required
by Statement of Financial Accounting Standards 123.
|
|
|
•
|
an
increase in insurance expenses of $79,672 related to the
on-going
comprehensive insurance program.
|
R&D
expenses were $1,239,146 for the year ended April 30, 2007, versus
$1,264,225
for the year ended April 30, 2006, a decrease of $25,079. This decrease
reflects primarily Somanta's attempt to control costs during the
year.
Interest
expense was $54 for the year ended April 30, 2007 versus $1,016,020
for the year
ended April 30, 2006. The interest expense for the 2006 period includes
the following items related to Somanta's secured convertible note issued to
SCO (see Note 10, Convertible Note in the attached Consolidated
Financial
Statements):
|
•
|
$514,981,
representing the non-cash expense required by Statement
of Financial
Accounting Standards 123 for the fair value of the warrants
issued in
connection with the note.
|
|
|
•
|
$364,721,
representing the non-cash expense required by EITF No.
00-27 for the
non-cash value of the beneficial conversion feature associated
with the
note.
|
|
|
•
|
$100,000,
reflecting the agent fee paid to SCO for issuing the
note.
|
|
|
•
|
$36,318,
reflecting the interest due as of January 31, 2006 on the note, which
interest was converted into Series A Preferred in connection
with
Somanta's private placement of the stock (see Note 11,
Private Placement
in the attached Consolidated Financial
Statements).
|
The
Deemed Dividend on Series A Preferred issued on January 31, 2006 (see Note
11, Private Placement, in the attached Consolidated Financial Statements)
was
$1,522,317. There was no similar expense in the year ended April 30,
2007. The Dividend for the 2006 period reflects:
|
•
|
$1,522,317
of non-cash expense required by EITF No. 00-27 for the
non-cash value of
the beneficial conversion feature associated with the
Series A
Preferred.
|
161
Change
in Functional Currency
From
inception through the fiscal year ended April 30, 2005, Somanta
was located in the United Kingdom, and all business transactions took
place
there. During that period, Somanta's functional currency was the
United Kingdom pound.
On
August 22, 2005, Somanta, then known as Somanta Limited, took part in
a
share exchange with Bridge Oncology Products, Inc., a Delaware
company, and
became a subsidiary of Bridge Oncology Products, Inc., as described
in the
audited financial statements (see Note 9 Share Exchange Agreement
and Plan of
Merger Agreement, in the Somanta, Inc. financial statements included
elsewhere
in this prospectus). As a result of this transaction, Somanta Limited
became a wholly owned subsidiary of a U.S. entity and accordingly
changed its
functional currency to the U.S. dollar as of the fiscal year beginning
May 1, 2005.
See
Note 2, “Related Party Transactions,” in the attached Consolidated Financial
Statements for a discussion of related party transactions.
Liquidity
and Capital Resources
Since
inception, Somanta has funded its operations primarily through sales
of its equity and debt securities. As of April 30, 2007, Somanta
had received $5,199,757 in net proceeds from sales of its equity securities
and $1,355,497 in debt financing. A portion of the debt financing was
repaid in prior fiscal years. The balance was repaid at January 31,
2006.
As
of
April 30, 2007, Somanta had approximately $5,385 in cash and cash
equivalents compared to $1,587,751 at April 30, 2006, the end of our prior
fiscal year.
On
August 23, 2005, Somanta received $1,000,000 in net proceeds from a
debt financing (see Note 10 in the attached Consolidated Financial
Statements). Somanta issued a $1,000,000 secured convertible note to SCO
Capital Partners LLC. The note was secured by Somanta's assets,
carried an annual interest rate of 7.5%, and was due at the earlier
of
(i) Somanta's completion of an equity financing of at least $10,000,000
or
(ii) August 23, 2006. SCO Capital Partners LLC had the option to
be repaid in cash or to purchase shares of the financing at the
lowest price
paid by institutional investors.
On
November 7, 2005, Somanta and SCO Capital Partners LLC agreed to
expand this facility up to $1,250,000. Under the terms of the
revised
arrangement, the security and interest rate remained unchanged. The terms
were amended and restated to require repayment at the earlier
of
(i) Somanta's completion of an equity financing of at least $5,000,000
or
(ii) February 28, 2006. In addition, for each $50,000 borrowed on
the additional $250,000 line of credit, Somanta agreed to issue a six-year
warrant to purchase shares of common stock at $0.01 per share
in the amount of
1% of its fully diluted common shares outstanding. Somanta drew an
additional $250,000 under this arrangement, for a total amount
outstanding of
$1,250,000 and have issued warrants to purchase 866,534 shares
for $0.01 per
share.
On
January 31, 2006, this note and accrued interest was converted in its
entirety to Series A Convertible Preferred Stock and the security
interest
in Somanta's assets was released. On January 31, 2006, Somanta
received $4,095,831 in net proceeds from the sale of Series A
Convertible
Preferred Stock and warrants to purchase common stock (see Note
9 in the
attached Consolidated Financial Statements). Somanta has invested a
substantial portion of its available cash in investment securities
consisting of high quality, marketable debt instruments of corporations
and
financial institutions. Somanta has adopted an investment policy and
established guidelines relating to diversification and maturities
of its
investments to preserve principal and maintain liquidity
Net
cash
used in operating activities for the year ended April 30, 2007,
totaled
$1,617,828 and was used to fund Somanta's net losses in the period which
were partly offset by increases in liabilities and non-cash expenses. In
liabilities, Somanta's accounts payable increased $508,222 and its
accrued liabilities increased $1,052,994 reflecting its declining cash
balance during the current fiscal year. Somanta's non-cash expenses
included expense of $2,931,118 for the change in the fair value
of warrants,
options expense of $739,000 to record the value of options issued
to officers
and directors, and warrants expense of $163,920 to record the
value of warrants
issued to non-employees.
Net
cash
used in operating activities for the year ended April 30, 2006,
totaled
$3,859,408 and was used to fund Somanta's net losses in the period, which
were partly offset by increases in accounts payable of $199,086
and in accrued
liabilities of $137,846 due to an increased level of business
activity. Somanta's non-cash expenses included interest expense of
$514,981 for the value of warrants related to its secured convertible note
and offset by change in fair value of warrant liabilities of
$137,543, interest
expense of $364,721 for the value of beneficial conversion feature
of secured
convertible note (see Note 10, Convertible Note, in attached
Consolidated
Financial Statements), options expense of $300,616 to record the value of
options issued to officers and directors, and warrants expense
of $92,689 to
record the value of warrants issued to non-employees.
For
the
year ended April 30, 2007 Somanta's investing activities provided $2,000
which represented the proceeds from the sale of computer equipment.
For the year
ended April 30, 2006 Somanta used $21,391 in investing activities,
consisting of the acquisition of computer equipment and the proceeds
from an
insurance claim.
For
the
year ended April 30, 2007, Somanta generated $33,462 of cash from financing
activities, from a borrowing under the Note Purchase Agreement
with Access
Pharmaceuticals, Inc. (see Note 12, Secured Note, in attached
Consolidated
Financial Statements). For the year ended April 30, 2006, Somanta
generated $5,365,665 of cash from financing activities, primarily
the net
proceeds from its sale of a secured convertible note and our sale of Series
A Convertible Preferred Stock (see Notes 10 and 11 in the attached
Consolidated
Financial Statements).
162
Somanta
has consumed substantial amounts of capital since its
inception. Somanta does not believe its existing cash resources,
including the net proceeds from its private placement in January 2006 will
be sufficient to fund its anticipated cash requirements beyond April 30,
2007.
On
April
18, 2007, Somanta , a wholly-owned subsidiary of the Company and
Somanta
Limited, a wholly-owned subsidiary of Somanta Incorporated, and
Access
Pharmaceuticals, Inc. (“Access”) and Somanta Acquisition Corporation (“Merger
Sub”), a wholly-owned subsidiary of Access and a Delaware corporation,
entered
into an Agreement and Plan of Merger (the “Merger Agreement”). Pursuant to the
terms and subject to the conditions set forth in the Merger Agreement,
Merger
Sub will merge with and into Somanta, with Somanta continuing as
the surviving
corporation and becoming a wholly-owned subsidiary of Access (the
“Merger”). The
Board of Directors of Somanta has approved the Merger and the Merger
Agreement.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the “Effective Time”) will be converted into
500,000 shares of Access common stock. No fractional shares of
Access common
stock will be issued as a result of the Merger. In addition, all
of Somanta’s
preferred stock that is outstanding at the Effective Time of the
Merger will be
converted into 1,000,000 shares of Access’ common stock. No shares of Access
preferred stock will be issued as a result of the Merger.
On
April
26, 2007, Somanta entered into a Note Purchase Agreement, a Security
Agreement,
a Patent Collateral Assignment and Security Agreement and a Trademark
Collateral
Security and Pledge Agreement (collectively, the “Loan Documents”) with Access.
Under the terms of the Loan Documents, Access initially loaned
the Company
$33,462. Access, in its sole discretion, may from time to time
advance
additional loan amounts to the Company. All amounts loaned to the
Company by
Access are secured by substantially all of the assets of the Company
pursuant to
the terms of the Loan Documents. The Note bears interest at 10%
and is repayable
at the earlier of: (i) August 31, 2007, or (ii) the date of the
termination of
the Agreement and Plan of Merger dated as of April 18, 2007 between
the Company
and Access.
If
the
merger fails to close, Somanta expects that it will no longer be able to
operate its business and will not have the resources to repay the
loan in which
case Access may foreclose on its assets in order to repay the
loan.
See
Note
1, “Recent Accounting Pronouncements,” in the Notes to the attached Consolidated
Financial Statements for a discussion of recent accounting pronouncements
and
their effect, if any, on Somanta.
Competition
The
biopharmaceutical industry is intensely competitive. Many companies,
including other biopharmaceutical companies and biotechnology companies,
are
actively engaged in activities similar to Somanta's, including
research and
development of products for the treatment of cancer. More specifically,
competitors for the development of new therapeutic products to
treat cancer also
focus on mAb-based cancer therapeutics, small molecule discovery
and
development. A 2005 survey by the Pharmaceutical Research and Manufacturers
of America listed nearly 400 new treatments for cancer that are
currently being
tested by researchers.
To Somanta's
knowledge, other companies that are involved in the development
of monoclonal
antibody cancer therapeutics directly related to its efforts include
Abgenix/Amgen, Antisoma, Genmab, ImClone/Bristol-Myers Squibb,
ImmunoGen,
Schering AG, Biogen Idec, Roche, Genentech and Merck.
In
addition, a number of other companies are involved in the development
of
chemotherapeutic products directly related to Somanta's efforts including
Bristol-Myers Squibb, Pfizer, GlaxoSmithKline, Novartis, Eli Lilly,
Wyeth and
Roche.
Somanta expects
to encounter significant competition for the pharmaceutical products it
is developing and plans to develop in the future. Many
of Somanta's competitors have substantially greater financial and
other
resources, larger research and development capabilities and more
extensive
marketing and manufacturing organizations than Somanta does.
In
addition, some such companies have considerable experience in pre-clinical
testing, clinical trials and other regulatory approval procedures. There
are also academic institutions, governmental agencies and other
research
organizations which are conducting research in areas in which Somanta
is working
and they may also market commercial products, either on their own
or through
collaborative efforts. If any of these competitors were to complete
clinical trials, obtain required regulatory approvals and commence
commercial
sales of their products before Somanta does they may achieve a significant
competitive advantage.
163
Historical
Expenditures
Somanta
has historically accounted for costs by company rather than by
product.
Patent
and license expenditures are expenditures that Somanta has not allocated to
particular products. General and administrative expenses include salaries
of the
Chief Executive Officer, finance and administrative staff, rent and occupancy,
telephone and office, corporate legal and audit, and investor
relations. These expenses are not separated by product but are set forth on
our Consolidated Statements of Operations and Deficit under “Expenses—general
and administrative”.
Total
licensing and product development expenses for the last two years are set
forth
on our Consolidated Statements of Operations and Deficit under
“Expenses—licensing and product development.” This line item includes
third-party development, patent and license expenditures, but not allocated
by
product.
Expenditures
to Completion
Somanta's business
strategy is to in-license rights to promising product candidates, further
develop those products by progressing the products toward regulatory approval
by
conducting and managing clinical trials, and finally to out-license rights
to
manufacture and/or market resulting product candidates to other pharmaceutical
firms in exchange for royalties and license fees. The path to
commercialization is varied and uncertain such that Somanta cannot
anticipate the path to be taken for any particular product. It is not
possible for Somanta to predict or even estimate the nature, timing, or
future costs, project completion dates, or when material net cash flows
might be
realized on any particular project. However, Somanta does expect
that its costs will increase as it continues to develop each of the
licensed products and move each licensed product closer to
commercialization. Somanta's expectations could change quickly in the event
that Somanta is able to out-license any product.
Somanta's business
strategy is to use its product development capabilities to bridge
discoveries and research from scientific/academic institutions or other
biopharmaceutical companies, on the one hand, with commercial manufacturing
and
marketing of biopharmaceutical products, on the other hand. Out-license
opportunities could occur at any time. Licensees would be expected, to the
extent necessary, to: participate in the remaining clinical development
required to obtain final regulatory approval for the product; relieve it of
some or all of the costs to finalize development; and/or pay it upfront and
milestone payments. To date, Somanta has out-licensed Alchemix to
Advanced Cardiovascular Devices, LLC, for the development and commercialization
of products for use in vascular disease applications worldwide.
Trend
Information
It
is
important to note that historical patterns of expenditures cannot be taken
as an
indication of future expenditures. The amount and timing of expenditures
and therefore liquidity and capital resources vary substantially from period
to
period depending on the pre-clinical and clinical studies being undertaken
at
any one time and the availability of funding from investors and prospective
commercial partners.
For
example, Somants intends to enter into agreements with other
biopharmaceutical companies for the continued clinical development and
marketing
of its product development candidates. Generally, Somanta intends to
enter into these agreements when Somanta has successfully completed the
Phase II clinical trials and when human clinical data shows the safety
and
efficacy of its product development candidates.
Consistent
with the industry, business, and intellectual property risks disclosed
above in
this registration statement, Somanta's revenue trend in the foreseeable
future
is highly uncertain. Even if Somanta is able to obtain sufficient
funding to conduct all current the programs of its business, it would
not expect to achieve additional revenues in the next fiscal year according
to
the schedules of revenues in its current agreements with other companies
for pre-clinical and clinical development.
Off
Balance Sheet Financing Arrangements
As
of
April 30, 2007, Somanta did not have any off-balance sheet financing
arrangements or any equity ownership interest in any variable interest
entity or
other minority owned ventures.
164
INDEX
TO SOMANTA FINANCIAL STATEMENTS
SOMANTA
PHARMACEUTICALS, INC. AND SUBSIDIARIES
Table
of
Contents
April
30,
2007
|
Report
of Independent Registered Public Accounting
Firm
|
166
|
|
Consolidated
Balance Sheet as of April 30, 2007
|
167
|
|
Consolidated
Statements of Operations for the years ended April
30, 2007 and 2006 and for the period from inception of operations
(April
19, 2001) to April 30, 2007
|
168
|
|
Consolidated
Statements of Stockholders’ Deficit for the period
from inception of operations (April 19, 2001) to April 30, 2007
|
169
|
|
Consolidated
Statements of Cash Flows for the years ended April
30, 2007 and 2006 and for the period from inception of operations
(April
19, 2001) to April 30, 2007
|
171
|
|
Notes
to Consolidated Financial Statements as of April 30,
2007
|
172
|
165
Report
of Independent Registered Public Accounting Firm
To
the
Board of Directors of Somanta Pharmaceuticals, Inc.
Irvine,
California
We
have
audited the accompanying consolidated balance sheet of Somanta Pharmaceuticals,
Inc., formerly Hibshman Optical Corp. (a development stage company) as of April
30, 2007, and the related consolidated statements of operations and consolidated
stockholders’ deficit and consolidated cash flows for the years ended April 30,
2007 and 2006, and for the period from inception of operations (April 19, 2001)
to April 30, 2007. These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements based on our
audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. The Company is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audits included consideration of internal
control over financial reporting as a basis for designing audit procedures
that
are appropriate in the circumstances, but not for the purpose of expressing
an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly, we express no such opinion. An audit includes examining,
on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating the
overall financial statement presentation. We believe that our audits provide
a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Somanta Pharmaceuticals,
Inc. as of April 30, 2007, and the results of its operations and its cash flows
for the years ended April 30, 2007 and 2006, and for the period from inception
of operations (April 19, 2001) to April 30, 2007, in conformity with accounting
principles generally accepted in the United States of America.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company’s operating losses, negative
working capital and stockholders’ deficit raise substantial doubt about its
ability to continue as a going concern. Management’s plans regarding those
matters also are described in Note 1. The consolidated financial statements
do
not include any adjustments that might result from the outcome of this
uncertainty.
As
discussed in Note 2 to the consolidated financial statements, in 2006 the
Company adopted Statement of Financial Accounting Standards No. 123 (Revised
2004), Share-Based Payments.
|
/s/ STONEFIELD
JOSEPHSON,
INC.
|
|
|
Irvine,
California
|
|
|
June
27, 2007
|
166
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Balance Sheet
April 30,
2007
|
Assets
|
||||
|
Current
assets:
|
||||
|
Cash
|
$
|
5,385
|
||
|
Prepaid
expenses
|
43,308
|
|||
|
Total
current assets
|
48,693
|
|||
|
Office
equipment,
net of accumulated depreciation of $6,750
|
16,560
|
|||
|
Other
assets:
|
||||
|
Restricted
funds
|
2,000
|
|||
|
Deposits
|
73
|
|||
|
Total
other assets
|
2,073
|
|||
|
Total
assets
|
$
|
67,326
|
||
|
Liabilities
and Stockholders’ Deficit
|
||||
|
Current
liabilities:
|
||||
|
Accounts
payable
|
$
|
774,022
|
||
|
Due
to related parties
|
241,874
|
|||
|
Accrued
expenses
|
811,539
|
|||
|
Accrued
research and development expenses
|
554,733
|
|||
|
Note
payable
|
33,462
|
|||
|
Liquidated
damages related to Series A preferred stock and warrants
|
35,200
|
|||
|
Deferred
revenue
|
7,143
|
|||
|
Warrant
liabilities
|
5,786,844
|
|||
|
Total
current liabilities
|
8,244,817
|
|||
|
Stockholders’
deficit:
|
||||
|
Preferred
stock,$0.001 par value, 20,000,000 shares authorized Series A Convertible
Preferred Stock, $0.001 par value, 2,000 shares designated, 591.6318
shares issued and outstanding
|
1
|
|||
|
Common
Stock, $0.001 par value, 100,000,000 shares authorized, 14,292,603
shares
issued and outstanding
|
14,293
|
|||
|
Additional
paid-in capital
|
7,604,360
|
|||
|
Deficit
accumulated during the development stage
|
(15,796,145
|
)
|
||
|
Total
stockholders’ deficit
|
(8,177,491
|
)
|
||
|
Total
liabilities and stockholders’ deficit
|
$
|
67,326
|
||
The
accompanying notes are an integral part of these consolidated
financial statements.
167
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Statements of Operations
Years
ended April 30, 2007 and 2006 and for the Period from Inception of
Operations
(April
19, 2001) to April 30, 2007
|
From
Inception
of
Operations(April 19, 2001)
to
April
30, 2007
|
||||||||||
|
Year
ended April 30,
|
||||||||||
|
2007
|
2006
|
|||||||||
|
Revenue
|
$
1,429
|
$
1,428
|
$
2,857
|
|||||||
|
Operating
expenses:
|
||||||||||
|
General
and administrative
|
(3,312,660
|
) |
(2,845,634
|
) |
(7,337,118
|
) | ||||
|
Research
and development
|
(1,239,146
|
)
|
(1,264,225
|
)
|
(3,100,647
|
)
|
||||
|
Loss
from operations
|
(4,550,377
|
)
|
(4,108,431
|
)
|
(10,434,908
|
)
|
||||
|
Other
income (expense):
|
||||||||||
|
Interest
income
|
28,084
|
12,348
|
40,432
|
|||||||
|
Interest
expense
|
(54
|
)
|
(1,016,020
|
)
|
(1,016,074
|
)
|
||||
|
Liquidated
damages
|
(35,200
|
)
|
—
|
(35,200
|
)
|
|||||
|
Change
in fair value of warrant liabilities
|
(2,931,118
|
)
|
137,543
|
(2,793,575
|
)
|
|||||
|
Gain
on settlement of debt
|
—
|
5,049
|
5,049
|
|||||||
|
Currency
translation loss
|
(3,255
|
)
|
(30,241
|
)
|
(33,496
|
)
|
||||
|
Loss
before income taxes
|
(7,491,920
|
)
|
(4,999,752
|
)
|
(14,267,772
|
)
|
||||
|
Income
taxes
|
(3,717
|
)
|
(2,339
|
)
|
(6,056
|
)
|
||||
|
Net
loss
|
(7,495,637
|
)
|
(5,002,091
|
)
|
(14,273,828
|
)
|
||||
|
Deemed
dividends on convertible preferred stock
|
—
|
(1,522,317
|
)
|
(1,522,317
|
)
|
|||||
|
Net
loss applicable to common shareholders
|
$
|
(7,495,637
|
)
|
$
|
(6,524,408
|
)
|
$
|
(15,796,145
|
)
|
|
|
Net
loss per share—basic and diluted
|
$
|
(0.56
|
)
|
$
|
(0.47
|
)
|
$
|
(1.24
|
)
|
|
|
Weighted
average number of shares outstanding—basic and
diluted
|
14,278,247
|
14,274,365
|
13,247,052
|
|||||||
The
accompanying notes are an integral part of these consolidated financial
statements.
168
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Statement of Stockholders’ Deficit—(Continued)
For
the Period from Inception of Operations (April 19, 2001) to April 30,
2006
|
|
|
Peferred Stock
|
Common Stock
|
Additional
Paid-in
|
Shares
to be
|
Subscription
|
Deferred
Equity-
Based
|
Accumulated
Other
Comprehensive
Loss-foreign
Currency
|
Deficit
Accumulated
During
Development
|
Total
Stockholders'
Equity/
|
||||||||||||||||||||||||
|
Shares
|
Amount |
Shares
|
Amount |
Capital
|
Issued
|
Receivable
|
Expense
|
Translation
|
Stage
|
(Deficit)
|
||||||||||||||||||||||||
|
Balance
at April 19, 2001(Inception)
|
|
-
|
$
-
|
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
||||||||||||||||||||||
|
Shares
issued for cash at $.0326
|
4,299,860
|
4,300
|
135,680
|
|
(97,245)
|
|
|
|
42,735
|
|||||||||||||||||||||||||
|
Shares
issued for services at $.0139
|
514,674
|
515
|
11,801
|
|
|
(11,177)
|
|
|
1,139
|
|||||||||||||||||||||||||
|
Amortization
of deferred expense
|
521
|
|
|
521
|
||||||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
29,905
|
|
29,905
|
|||||||||||||||||||||||||||||||
|
Net
loss for the period from inception to April 30, 2002
|
(95,901)
|
(95,901)
|
||||||||||||||||||||||||||||||||
|
Balance
at April 30, 2002
|
—
|
—
|
4,814,534
|
4,815
|
147,481
|
—
|
(97,245)
|
(10,656)
|
29,905
|
(95,901)
|
(21,601)
|
|||||||||||||||||||||||
|
Shares
issued for cash at $1.0677
|
14,601
|
15
|
15,575
|
|
|
|
|
|
15,590
|
|||||||||||||||||||||||||
|
Shares
issued for services at $.0214
|
219,010
|
219
|
4,472
|
|
|
(3,127)
|
|
|
1,564
|
|||||||||||||||||||||||||
|
Amortization
of deferred expense
|
3,808
|
|
|
3,808
|
||||||||||||||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
91,517
|
|
|
|
91,517
|
|||||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
1,534
|
|
1,534
|
|||||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2003
|
(111,456)
|
(111,456)
|
||||||||||||||||||||||||||||||||
|
Balance
at April 30, 2003
|
—
|
—
|
5,048,145
|
5,049
|
167,528
|
—
|
(5,728)
|
(9,975)
|
31,439
|
(207,357)
|
(19,044)
|
|||||||||||||||||||||||
|
Shares
issued for cash at $1.2479
|
350,164
|
350
|
436,637
|
|
(81,464)
|
|
|
|
355,523
|
|||||||||||||||||||||||||
|
Shares
issued for services at $1.2587
|
22,233
|
22
|
27,962
|
|
|
(25,216
|
)
|
|
|
2,768
|
||||||||||||||||||||||||
|
Amortization
of deferred expense
|
7,691
|
|
|
7,691
|
||||||||||||||||||||||||||||||
|
Exchange
for loan payment and compensation
|
181,371
|
|
2,909
|
|
|
|
184,280
|
|||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
(51,651
|
)
|
|
(51,651
|
)
|
|||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2004
|
(439,453
|
)
|
(439,453
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2004
|
—
|
—
|
5,420,542
|
5,421
|
813,498
|
—
|
(84,283
|
)
|
(27,500
|
)
|
(20,212
|
)
|
(646,810
|
)
|
40,114
|
|||||||||||||||||||
|
Shares
issued for cash at $1.3218
|
374,073
|
374
|
494,069
|
|
|
|
|
|
494,443
|
|||||||||||||||||||||||||
|
Shares
issued for services at $1.2308
|
21,901
|
22
|
26,933
|
|
|
|
|
|
26,955
|
|||||||||||||||||||||||||
|
3,650
shares to be issued for service at $1.4973
|
5,465
|
|
|
|
|
5,465
|
||||||||||||||||||||||||||||
|
Amortization
of deferred expense
|
26,939
|
|
|
26,939
|
||||||||||||||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
84,283
|
|
|
|
84,283
|
|||||||||||||||||||||||||||||
|
Options
issued for services
|
257,515
|
|
|
|
|
|
257,515
|
|||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
(5,719
|
)
|
|
(5,719
|
)
|
|||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2005
|
(1,129,290
|
)
|
(1,129,290
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2005
|
—
|
—
|
5,816,516
|
5,817
|
1,592,015
|
5,465
|
—
|
(561
|
)
|
(25,931
|
)
|
(1,776,100
|
)
|
(199,295
|
)
|
|||||||||||||||||||
The
accompanying notes are an integral part of these consolidated financial
statements.
169
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Statement of Stockholders’ Deficit—(Continued)
For
the Period from Inception of Operations (April 19, 2001) to April 30,
2007
|
|
|
Preferred
|
Stock
|
Common
|
Stock
|
Additional
Paid-in
|
Shares
to
be
|
Subscription
|
Deferred
Equity
Based-
|
Accumulated
other
Comprehensive
Loss-Foreign
Currency
Translation
|
|
Deficit
Accumulated
During
Development
|
|
Total
Stockholders'
Equity
|
||||||||||||||||||||
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Issued
|
|
Receivable
|
|
Expense
|
|
Adjustments
|
Stage
|
(Deficit)
|
||||||||||||||
|
Write
off foreign currency translation adjustment
|
25,931
|
25,931
|
||||||||||||||||||||||||||||||||
|
Shares
issued for cash at $1.5656
|
12,669
|
13
|
19,821
|
19,834
|
||||||||||||||||||||||||||||||
|
Shares
issued for prior service
|
3,650
|
3
|
5,462
|
(5,465
|
) |
—
|
||||||||||||||||||||||||||||
|
Amortization
of deferred expense
|
561
|
561
|
||||||||||||||||||||||||||||||||
|
Options
issued for services
|
300,616
|
300,616
|
||||||||||||||||||||||||||||||||
|
Recapitalization
with Bridge Oncology
|
7,865,000
|
7,865
|
(92,335
|
) |
(84,470
|
) | ||||||||||||||||||||||||||||
|
Beneficial
conversion feature associated with convertible debt
financing
|
364,721
|
364,721
|
||||||||||||||||||||||||||||||||
|
Convertible
Series A Preferred Stock issued for cash at $10,000 (net of issuance
costs
of $544,169)
|
464.0000
|
0.464
|
4,095,830
|
4,095,830
|
||||||||||||||||||||||||||||||
|
Convertible
Series A Stock issued on conversion of notes payable
|
128.6318
|
0.1286
|
1,286,318
|
1,286,318
|
||||||||||||||||||||||||||||||
|
Deemed
dividend on account of beneficial conversion feature associated
with
issuance of Convertible Series A Preferred Stock
|
1,522,317
|
(1,522,317
|
)
|
—
|
||||||||||||||||||||||||||||||
|
Issuance
costs on warrants issued to placement agent in connection with
the
Convertible Series A Preferred Stock
|
(429,757
|
)
|
(429,757
|
)
|
||||||||||||||||||||||||||||||
|
Discount
on warrant issued with Convertible Series A Preferred
Stock
|
(2,048,531
|
)
|
(2,048,531
|
)
|
||||||||||||||||||||||||||||||
|
Recapitalization
with Hibshman Optical Corp.
|
576,700
|
577
|
(7,708
|
)
|
(7,131
|
)
|
||||||||||||||||||||||||||||
|
Warrant
expense
|
92,689
|
92,689
|
||||||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2006
|
(5,002,091
|
)
|
(5,002,091
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2006
|
592.6318
|
$
|
0.5926
|
14,274,534
|
$
|
14,275
|
$
|
6,701,458
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(8,300,508
|
)
|
$
|
(1,584,775
|
)
|
||||||||||||
|
Options
issued for services
|
739,000
|
739,000
|
||||||||||||||||||||||||||||||||
|
Warrant
expense
|
163,920
|
163,920
|
||||||||||||||||||||||||||||||||
|
Conversion
of preferred stock
|
(1.000
|
)
|
(.0010
|
)
|
18,069
|
18
|
(18
|
)
|
—
|
|||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2007
|
(7,495,637
|
)
|
(7,495,637
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2007
|
591.6318
|
$
|
0.5916
|
14,292,603
|
$
|
14,293
|
$
|
7,604,360
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(15,796,145
|
)
|
$
|
(8,177,492
|
)
|
||||||||||||
170
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Statements of Cash Flows
Years
ended April 30, 2007 and 2006 and for the Period from Inception of
Operations
(April
19, 2001) to April 30, 2007
|
Year
ended April 30,
|
From
Inception
of
operations
(April
19, 2001)
to
|
|||||||||
|
2007
|
2006
|
April
30, 2007
|
||||||||
|
Cash
flows provided by (used for) operating
activities:
|
||||||||||
|
Net
loss
|
$
|
(7,495,637
|
)
|
$
|
(5,002,091
|
)
|
$
|
(14,273,828
|
)
|
|
|
Adjustments
to reconcile net loss to net cash provided by (used for)
operating
activities:
|
||||||||||
|
Depreciation
|
5,462
|
1,496
|
6,994
|
|||||||
|
Gain
on sale of equipment
|
(622
|
)
|
—
|
(622
|
)
|
|
Amortization
of stock based expense
|
—
|
561
|
39,520
|
|||||||
|
Write
off foreign currency translation adjustment
|
—
|
25,931
|
25,931
|
|||||||
|
Change
in fair value of warrant liabilities
|
2,931,118
|
(137,543
|
)
|
2,793,575
|
|
|||||
|
Shares
issued for services and compensation
|
—
|
—
|
219,262
|
|||||||
|
Gain
on settlement of debts
|
—
|
(5,049
|
)
|
(5,049
|
)
|
|||||
|
Options
expense
|
739,000
|
300,616
|
1,297,131
|
|||||||
|
Warrant
expense
|
163,920
|
92,689
|
256,609
|
|||||||
|
Interest
expense related to beneficial conversion feature on convertible
note
|
—
|
364,721
|
364,721
|
|||||||
|
Interest
expense related to warrants issued on convertible note
|
—
|
514,981
|
514,981
|
|||||||
|
Changes
in assets and liabilities:
|
||||||||||
|
(Increase)
decrease in assets—
|
||||||||||
|
VAT
receivable
|
1,628
|
61,952
|
3,444
|
|||||||
|
Restricted
funds
|
150,048
|
(152,048
|
)
|
(2,000
|
)
|
|||||
|
Prepaid
expenses
|
47,767
|
(82,166
|
)
|
(43,037
|
)
|
|||||
|
Deposits
|
2,627
|
(2,700
|
)
|
(73
|
)
|
|||||
|
Increase
(decrease) in liabilities:
|
||||||||||
|
Accounts
payable
|
516,222
|
199,086
|
776,723
|
|||||||
|
Accrued
liabilities
|
1,052,994
|
137,846
|
1,354,412
|
|||||||
|
Liquidated
damages
|
35,200
|
—
|
35,200
|
|||||||
|
Deferred
revenue
|
(1,429
|
)
|
8,572
|
7,143
|
||||||
|
Due
to officer and related party
|
233,874
|
(186,263
|
)
|
95,980
|
||||||
|
Net
cash used for operating activities
|
(1,617,828
|
)
|
(3,859,409
|
)
|
(6,532,983
|
)
|
||||
|
Cash
flows used for investing activities:
|
||||||||||
|
Purchase
of equipment
|
—
|
(21,391
|
)
|
(24,824
|
)
|
|||||
|
Sale
of equipment
|
2,000
|
—
|
2,000
|
|||||||
|
Net
cash used for investing activities
|
2,000
|
(21,391
|
)
|
(22,824
|
)
|
|||||
|
Cash
flows provided by financing activities:
|
||||||||||
|
Loan
payable—related party
|
—
|
—
|
79,402
|
|||||||
|
Loan
payment—related party
|
—
|
—
|
(7,367
|
)
|
||||||
|
Proceeds
from convertible note-related party
|
—
|
1,250,000
|
1,250,000
|
|||||||
|
Proceeds
from note payable - related party
|
33,462
|
—
|
33,462
|
|||||||
|
Proceeds
from issuance of common stock
|
—
|
19,834
|
928,125
|
|||||||
|
Proceeds
from issuance of preferred stock
|
—
|
4,095,831
|
4,095,831
|
|||||||
|
Cash
received for subscription receivable
|
—
|
—
|
175,801
|
|||||||
|
Net
cash provided by financing activities
|
33,462
|
5,365,665
|
6,555,254
|
|||||||
|
Effect
of exchange rate changes on cash
|
—
|
—
|
5,938
|
|||||||
|
Increase
(decrease) in cash
|
(1,582,366
|
)
|
1,484,865
|
5,385
|
||||||
|
Cash,
beginning of year
|
1,587,750
|
102,885
|
—
|
|||||||
|
Cash,
end of year
|
$
|
5,385
|
$
|
1,587,750
|
$
|
5,385
|
||||
|
Supplemental
disclosure of cash flow information:
|
||||||||||
|
Interest
paid
|
54
|
$
|
1,016,020
|
$
|
1,016,074
|
|||||
|
Income
tax paid
|
$
|
3,717
|
$
|
2,339
|
$
|
6,056
|
||||
|
Supplemental
disclosure of non-cash operating and financing
activities:
|
||||||||||
|
Loan
reduction with shares
|
$
|
—
|
$
|
—
|
$
|
2,909
|
||||
|
Issuance
of warrants in conjunction with convertible preferred
stock
|
$
|
—
|
$
|
2,341,785
|
$
|
2,341,785
|
||||
|
Deemed
dividends related to convertible preferred stock
|
$
|
—
|
$
|
1,522,317
|
$
|
1,522,317
|
||||
|
Conversion
of note and accrued interest
|
$
|
—
|
$
|
1,286,318
|
$
|
1,286,318
|
The
accompanying notes are an integral part of these consolidated financial
statements.
171
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
1. ORGANIZATION,
BASIS OF PRESENTATION AND NATURE OF OPERATIONS
Organization
Somanta
Pharmaceuticals, Inc. is a Delaware corporation that was formed for the
purpose
of effecting the reincorporation of Hibshman Optical Corp., a New Jersey
corporation, into the State of Delaware and for the purpose of consummating
a
business combination via a reverse merger of Somanta Incorporated and
Hibshman
Optical Corp. Pursuant to this reverse merger, Somanta Incorporated became
the wholly-owned subsidiary of Somanta Pharmaceuticals, Inc. and the
sole
operating subsidiary of Somanta Pharmaceuticals, Inc. For financial
reporting purposes, this transaction has been reflected in the accompanying
financial statements as a recapitalization of Somanta Incorporated and
the
financial statements of Somanta Pharmaceuticals, Inc. reflect the historical
financial information of Somanta Incorporated. References herein to the
“Company” or “Somanta” are intended to refer to each of Somanta Pharmaceuticals,
Inc. and its wholly owned subsidiary Somanta Incorporated, as well as
Somanta
Incorporated’s wholly-owned subsidiary Somanta Limited.
Hibshman
Optical Corp. was originally incorporated in the State of New Jersey
in 1991
under the name PRS Sub I, Inc. The name was subsequently changed to Service
Lube, Inc., then to Fianza Commercial Corp. and then to Hibshman Optical
Corp. The business plan since that time had been to seek to enter into a
business combination with an entity that had ongoing operations through
a
reverse merger or other similar type of transaction.
Somanta
Incorporated was incorporated as Somantis Limited under the laws of England
and
Wales on April 19, 2001. Somantis Limited changed its name to Somanta
Limited on March 14, 2005, and performed business as a United Kingdom
entity through the fiscal year ending April 30, 2005. On
August 22, 2005, Somanta Limited became a wholly owned subsidiary of Bridge
Oncology Products, Inc. (“BOPI”), a privately held Delaware corporation,
pursuant to a share exchange with BOPI.; however, Somanta Limited was
deemed the
accounting acquirer in this share exchange transaction. On August 24,
2005, the name of BOPI was changed to Somanta Incorporated.
Somanta
Pharmaceuticals, Inc. is a development stage biopharmaceutical company
engaged
in the development of products for the treatment of cancer. The Company
has
in-licensed five product development candidates from academic and research
institutions in the United States and Europe designed for use in anti-cancer
therapy in order to advance them along the regulatory and clinical pathways
toward commercial approval. The Company intends to obtain approval from
the
United States Food and Drug Administration (“FDA”) and from the European
Medicines Evaluation Agency (“EMEA”) for the products.
Somanta
is a development stage enterprise since the Company has not generated
revenue
from the sale of its products, and its efforts have been principally
devoted to
identification, licensing and clinical development of its products as
well as
raising capital through April 30, 2007. Accordingly, the financial
statements have been prepared in accordance with the provisions of Statement
of
Financial Accounting Standards (SFAS) No. 7, “Accounting and Reporting by
Development Stage Enterprises.”
Basis
of Presentation
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that
affect the amounts reported in the financial statements and accompanying
notes. Actual results could differ from those estimates. In the
opinion of management, all adjustments (consisting solely of normal recurring
adjustments) considered necessary for a fair presentation have been
included.
Going
Concern
The
Company reported a net loss and net loss applicable to common shareholders
of
$7,495,637 for the year ended April 30, 2007. The net loss from date of
inception, April 19, 2001 to April 30, 2007, totaled $14,273,828 (net
loss applicable to common shareholders of $15,796,145). The Company’s operating
activities have used cash since its inception. These losses raise substantial
doubt about the Company’s ability to continue as a going concern.
172
On
April
18, 2007, the Company, Somanta Incorporated, a wholly-owned
subsidiary of the
Company and Somanta Limited, a wholly-owned subsidiary of Somanta
Incorporated,
and Access Pharmaceuticals, Inc. (“Access”) and Somanta Acquisition Corporation
(“Merger Sub”), a wholly-owned subsidiary of Access and a Delaware corporation,
entered into an Agreement and Plan of Merger (the “Merger Agreement”). Pursuant
to the terms and subject to the conditions set forth in the
Merger Agreement,
Merger Sub will merge with and into Somanta, with Somanta continuing
as the
surviving corporation and becoming a wholly-owned subsidiary
of Access (the
“Merger”). The Board of Directors of Somanta has approved the Merger
and the
Merger Agreement.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the “Effective Time”) will be converted into
500,000 shares of Access common stock. No fractional shares
of Access common
stock will be issued as a result of the Merger. In addition,
all of Somanta’s
preferred stock, included accrued and unpaid dividends, that
is outstanding at
the Effective Time of the Merger will be converted into 1,000,000
shares of
Access’ common stock. No shares of Access preferred stock will be issued
as a
result of the Merger.
On
April
26, 2007, the Company entered into a Note Purchase Agreement,
a Security
Agreement, a Patent Collateral Assignment and Security Agreement
and a Trademark
Collateral Security and Pledge Agreement (collectively, the
“Loan Documents”)
with Access Pharmaceuticals, Inc. as more fully described in
Note 15. Under the
terms of the Loan Documents, Access initially loaned the Company
$33,462.
Access, in its sole discretion, may from time to time advance
additional loan
amounts to the Company. All amounts loaned to the Company by
Access are secured
by substantially all of the assets of the Company pursuant
to the terms of the
Loan Documents. The Note bears interest at 10% and is repayable
at the earlier
of: (i) August 31, 2007, or (ii) the date of the termination
of the Agreement
and Plan of Merger dated as of August 18, 2007 between the
Company and
Access.
If
the
merger fails to close, the Company expects that it will no
longer be able to
operate its business and will not have the resources to repay
the
loan.
The
financial statements do not include any adjustments to reflect
the possible
future effects on the recoverability and classification of
assets or the amounts
and classification of liabilities that may result from the
possible inability of
the Company to continue as a going concern.
Reclassifications
For
comparative purposes, prior periods’ consolidated financial statements have been
reclassified to conform with report classifications of the
current
period.
2. Significant
Accounting Policies
Cash
and Cash Equivalents
The
Company considers all highly liquid financial instruments with
a maturity of
three months or less when purchased to be cash equivalents.
At April 30,
2007, there were no cash equivalents.
Office
Equipment
Office
equipment is recorded at cost, net of accumulated depreciation.
Depreciation on
equipment is calculated using the straight-line method over
the estimated useful
lives of the assets, five years. The Company recorded depreciation
expense for
the years ended April 30, 2007 and 2006 of $5,462 and $1,496,
respectively.
Intangible
Assets—Patents and Licenses
All
patent and license costs are charged to expense when incurred.
Revenue
Recognition
The
Company recognizes revenue from licensing its proprietary technology
in
accordance with SEC staff Accounting Bulletin No. 104 (“SAB 104”). SAB 104
requires revenue to be recognized when all of the following
criteria are met:
persuasive evidence of an arrangement exists, delivery has
occurred or services
have been rendered, the price is fixed or determined, and collection
is
reasonably assured. Licensing fees, including upfront payments
upon execution of
a new agreement, are recognized ratably over the license term
of such
agreement.
173
Research
and Development
All
research and development costs consist of expenditures
for royalty payments,
licensing fees, contracted research by third parties and
the fees and expense of
consultants to manage the research and development efforts.
Stock
Based Compensation
On
December 16, 2004, the FASB issued SFAS No. 123 (revised 2004),
“Share-Based Payment” (SFAS 123R). SFAS 123R eliminates the alternative of
applying the intrinsic value measurement provisions of
APB 25 to stock
compensation awards issued to employees. Rather, the new
standard requires
enterprises to measure the cost of employee services received
in exchange for an
award of equity instruments based on the grant-date fair
value of the award.
That cost will be recognized over the period during which
an employee is
required to provide services in exchange for the award,
known as the requisite
service period (usually the vesting period). On April 14, 2005, the
Securities and Exchange Commission announced the adoption
of a rule that defers
the required effective date of SFAS 123R. The SEC rule
provides that SFAS 123R
is now effective for registrants as of the beginning of
the first fiscal year
beginning after June 15, 2005.
Effective May 1,
2006, the Company adopted SFAS 123R and accordingly has adopted the
modified prospective application method. Under this method,
SFAS 123R is applied
to new awards and to awards modified, repurchased, or cancelled
after the
effective date. Additionally, compensation cost for the
portion of awards that
are outstanding as of the date of adoption for which the
requisite service has
not been rendered (such as unvested options) is recognized
over a period of time
as the remaining requisite services are rendered. The amounts
recorded as
expense in the years ended April 30, 2007 and 2006 was
$739,000 and $300,615,
respectively. As of April 30, 2007, there were 3,483,163 options
outstanding.
Prior
to May 1, 2006, the Company accounted for its employee stock option
plan in accordance with the provisions of SFAS No. 123, “Accounting
for Stock-Based Compensation,”
and
SFAS No. 148, “Accounting
for Stock-Based Compensation - Transition and Disclosure.”
Translation
of Foreign Currency in Financial Statements
From
inception through the fiscal year ended April 30, 2005, the functional
currency of the Company was the United Kingdom pound and
its reporting currency
was United States dollar.
Assets
and liabilities of foreign operations where the functional
currency is other
than the U.S. dollar are translated at fiscal year-end
rates of exchange, and
the related revenue and expense amounts are translated
at the weighted average
rates of exchange during the fiscal year. Translation adjustments
arising from
differences in exchange rates from these transactions are
reported as
accumulated other comprehensive loss—foreign currency translation adjustment in
the statement of stockholders’ deficit. The currency exchange rate as of
April 30, 2005 was $1.9122.
On
August 22, 2005, the Company, then known as Somanta Limited, took
part in a
share exchange with Bridge Oncology Products, Inc., a Delaware
company, and
became a subsidiary of Bridge Oncology Products, Inc. (Note
10). As a
result of this transaction, Somanta Limited became a wholly
owned subsidiary of
a U.S. entity and accordingly changed its functional currency
to the U.S. dollar
as of the fiscal year beginning May 1, 2005.
Use
of Estimates
The
preparation of financial statements in conformity with
accounting principles
generally accepted in the United States of America requires
management to make
estimates and assumptions that affect the reported amounts
of assets and
liabilities at the date of the consolidated financial statements
and the
reported amounts of revenues and expenses during the reporting
period. Actual
results could differ from those estimates.
Income
Taxes
Deferred
taxes are provided for on a liability method for temporary
differences between
the financial reporting and tax basis of assets and liabilities
that will result
in taxable or deductible amounts in the future. Deferred
tax assets are reduced
by a valuation allowance when, in the opinion of management,
it is more likely
than not that some portion or all of the deferred tax assets
will be
realized.
174
Income
taxes are calculated in accordance with the tax laws of the
United States for
the years ended April 30, 2007 and April 30, 2006. Since the Company
had net losses for the years ended April 30, 2007 and 2006, provisions for
income taxes in the financial statements include only state
minimum taxes for
the year ended April 30, 2007.
Segment
Reporting
The
Company has adopted SFAS No. 131, “Disclosures about Segments of an
Enterprise and Related Information.” Since the Company operates in one business
segment dedicated to development of therapeutic candidates
for the treatment of
cancers, segment disclosure has not been presented.
Fair
Value of Financial Instruments
Statement
of Financial Accounting Standard No. 107, Disclosures about Fair Value of
Financial Instruments, requires that the company disclose
estimated fair values
of financial instruments. The carrying amounts reported in
the balance sheets
for current assets and current liabilities qualifying as
financial instruments
are a reasonable estimate of fair value.
Basic
and diluted net loss per share
Net
loss
per share is calculated in accordance with the Statement
of Financial Accounting
Standards No. 128 (SFAS No. 128), Basic net loss per share is based
upon the weighted average number of common shares outstanding.
Diluted net loss
per share is based on the assumption that all potential dilutive
convertible
shares and stock options or warrants were converted or exercised.
The
calculation of diluted net loss per share excludes potential
common stock
equivalents if the effect is anti-dilutive. The Company’s weighted common shares
outstanding for basic and dilutive were the same since the
effect of common
stock equivalents was anti-dilutive.
The
Company has the following dilutive convertible shares, stock
options and
warrants as of April 30, 2007 and 2006 which were excluded from the
calculation since the effect is anti-dilutive.
|
2007
|
2006
|
|
|
Convertible
preferred stock
|
9,859,125
|
9,877,194
|
|
Stock
options
|
3,483,163
|
3,825,249
|
|
Warrants
|
7,102,838
|
6,952,838
|
|
Total
|
20,445,126
|
20,655,281
|
The
Company’s undeclared dividend on it’s Preferred Stock amounting to $115,604 was
included in the computation of net loss per share in accordance
with SFAS
No. 129 for the year ended April 30, 2006.
The
Company’s undeclared dividends on its Preferred Stock amounting to
$474,104 for
the year ended April 30, 2007 was included in the computation
of net loss per
share in accordance with SFAS No. 129.
Aggregate
undeclared dividends on Preferred Stock amounting to $589,708
are included in
the computation of net loss per share for the period from
inception (April 19,
2001) to April 30, 2007.
Recent
Accounting Pronouncements
In
February 2006, the FASB issued SFAS 155 “Accounting
for Certain Hybrid Financial Instruments,”
an
amendment of FASB Statements No. 133 and in February 2006, the FASB issued
SFAS 155, “Accounting for Certain Hybrid Financial Instruments,” an amendment of
FASB Statements No. 133 and 140. This Statement amends FASB Statements
No. 133, “Accounting for Derivative Instruments and Hedging Activities,”
and No. 140, “Accounting for Transfers and Servicing of Financial Assets
and Extinguishments of Liabilities”. This Statement resolves issues addressed in
Statement 133 Implementation Issue No. D1, Application of Statement 133 to
Beneficial Interests in Securitized Financial Assets. This
Statement:
|
a.
|
Permits
fair value remeasurement for any hybrid financial
instrument that contains
an embedded derivative that otherwise would require
bifurcation;
|
|
|
b.
|
Clarifies
which interest-only strips and principal-only strips
are not subject to
the requirements of Statement
133;
|
175
|
c.
|
Establishes
a requirement to evaluate interests in securitized
financial assets to
identify interests that are freestanding derivatives
or that are hybrid
financial instruments that contain an embedded
derivative requiring
bifurcation;
|
|
|
d.
|
Clarifies
that concentrations of credit risk in the form
of subordination are not
embedded derivatives; and
|
|
|
e.
|
Amends
Statement 140 to eliminate the prohibition on
a qualifying special-purpose
entity from holding a derivative financial instrument
that pertains to a
beneficial interest other than another derivative
financial
instrument.
|
This
Statement is effective for all financial instruments acquired
or issued after
the beginning of an entity’s first fiscal year that begins after
September 15, 2006. The fair value election provided for in paragraph
4(c)
of this Statement may also be applied upon adoption of
this Statement for hybrid
financial instruments that had been bifurcated under paragraph
12 of Statement
133 prior to the adoption of this Statement. Earlier adoption
is permitted as of
the beginning of an entity’s fiscal year, provided the entity has not yet issued
financial statements, including financial statements for
any interim period for
that fiscal year. Provisions of this Statement may be applied
to instruments
that an entity holds at the date of adoption on an instrument-by-instrument
basis. The Company is currently evaluating the impact of SFAS
155.
In
March
2006, the FASB issued SFAS No. 156 (“FAS 156”), “Accounting
for Servicing of Financial
Assets-An Amendment of FASB Statement No. 140.”
Among
other requirements, FAS 156 requires a company to recognize
a servicing asset or
servicing liability when it undertakes an obligation to
service a financial
asset by entering into a servicing contract under certain
situations. Under FAS
156 an election can also be made for subsequent fair value
measurement of
servicing assets and servicing liabilities by class, thus
simplifying the
accounting and providing for income statement recognition
of potential
offsetting changes in the fair value of servicing assets,
servicing liabilities
and related derivative instruments. The Statement will
be effective beginning
the first fiscal year that begins after September 15, 2006. The Company
does not expect the adoption of FAS 156 will have a material
impact on the
financial position or results of operations.
In
June
2006, the FASB issued FASB Interpretation (FIN) No. 48, “Accounting
for Uncertainty in
Income
Taxes”
that
provides guidance on the accounting for uncertainty in
income taxes recognized
in financial statements. The interpretation will be adopted
by us on May 1,
2007. We are currently evaluating the impact of adopting
FIN 48; however, we do
not expect the adoption of this provision to have a material
effect on our
financial position, results of operations or cash flows.
In
July
2006, the FASB issued FASB Staff Position (FSP) No. FAS
13-2, “Accounting
for a Change or Projected Change in the Timing of Cash
Flows Relating to Income
Taxes Generated by a Leveraged
Lease
Transaction,”
that
provides guidance on how a change or a potential change
in the timing of cash
flows relating to income taxes generated by a leveraged
lease transaction
affects the accounting by a lessor for the lease. This
staff position will be
adopted by us on May 1, 2007. The Company is currently evaluating the
impact of adopting this FSP; however, the Company does
not expect the adoption
of this provision to have a material effect on the financial
position, results
of operations or cash flows.
In
September 2006, the FASB issued Statement No. 157, “Fair
Value Measurements”
(SFAS
157). This Statement defines fair value, establishes a
framework for measuring
fair value in generally accepted accounting principles
(GAAP), and expands
disclosures about fair value measurements. This Statement
applies under other
accounting pronouncements that require or permit fair value
measurements, the
Board having previously concluded in those accounting pronouncements
that fair
value is the relevant measurement attribute. Accordingly,
this Statement does
not require any new fair value measurements. However, for
some entities, the
application of this Statement will change current practice.
This Statement is
effective for financial statements issued for fiscal years
beginning after
November 15, 2007, and interim periods within those fiscal years.
The
Company does not expect the adoption of SFAS No. 157 to have a material
impact on the consolidated financial statements.
In
September 2006, the FASB issued Statement No. 158, “Employers’
Accounting for Defined Benefit Pension and Other Postretirement
Plans—an
amendment of FASB Statements No. 87, 88, 106, and 132(R)”
(SFAS
158). This Statement improves financial reporting by requiring
an employer to
recognize the over funded or under funded status of a defined
benefit
postretirement plan (other than a multiemployer plan) as
an asset or liability
in its statement of financial position and to recognize
changes in that funded
status in the year in which the changes occur through comprehensive
income of a
business entity or changes in unrestricted net assets of
a not-for-profit
organization. This Statement also improves financial reporting
by requiring an
employer to measure the funded status of a plan as of the
date of its year-end
statement of financial position, with limited exceptions.
This Statement is
effective as of the end of the fiscal year ending after
December 15, 2006.
The Company does not have any defined benefit plans, or
other post-retirement
plans. Therefore, the Company does not expect SFAS No. 158 to have any
impact on the consolidated financial statements.
176
In
February 2007, the FASB issued SFAS No. 159, “The
Fair Value Option for Financial Assets and Financial
Liabilities”.
The
objective of this statement is to improve financial reporting
by providing
entities with the opportunity to mitigate volatility
in reported earnings caused
by measuring related assets and liabilities differently
without having to apply
complex hedge accounting provisions. This Statement is
expected by the Board to
expand the use of fair value measurement, consistent
with the Board’s long-term
measurement objectives for accounting for financial instruments.
This statement
is effective for fiscal years beginning after November
15, 2007. The Company is
currently evaluating the impact of adopting this statement;
however, the Company
does not expect the adoption of this provision to have
a material effect on its
financial position, results of operations or cash flow.
3. ACCRUED
EXPENSES
Accrued
expenses consist of the following at April 30, 2007:
|
Payroll
& vacation
|
$
|
472,014
|
||
|
Accounting
& legal
|
326,325
|
|||
|
Consultant
|
13,200
|
|||
|
$
|
811,539
|
4. WARRANT
LIABILITIES
The
Company issued 6,792,852 warrants in conjunction with
convertible note (Note 10)
and private placement (Note 11). These warrants have
registration rights for the
underlying shares. EITF 00-19 provides that contracts
that include any provision
that could require net-cash settlement cannot be accounted
for as equity of the
Company. The warrant agreements require net cash settlement,
at the option of
the holders, in the event the Company fails to issue
and deliver common stock on
exercise of the warrants within three business days of
receipt of a written
exercise notice by a holder. Pursuant to EITF 00-19,
the fair value of the
warrants revalued at April 30, 2007 was recorded as a warrant liability
amounting $5,786,844. The change in fair value of warrant
liabilities from April
30, 2006 to April 30, 2007 in the amount of $2,931,118
was recorded as other
expense in the consolidated statements of operations
for the year ended April
30, 2007. The change in fair value from the issuance
date to April 30, 2006 in
the amount of $137,543 was recorded as other income in
the consolidated
statements of operations for the year ended April 30,
2006.
In
the
year ended April 30, 2007, the Company issued warrants
to non-employees to
purchase up to 150,000 common shares over a period of
six years at a price of
$.01. The Company recorded $163,920 to permanent equity
as, pursuant to EITF
00-19, no criteria were met requiring liability classification.
5. RELATED
PARTY TRANSACTIONS
Fees
Paid to Related Parties
Pursuant
to a financial advisory agreement dated March 2005 between
Bridge Oncology and
SCO Financial Group LLC (SCO), which the Company has
assumed, the Company
compensates SCO with a monthly fee of $12,500 and an
annual grant of warrants
(Note 4) to purchase 150,000 shares of Company common
stock at an exercise price
of $.01 for the term of the agreement for financial advisory
services.
The
Company recorded advisory service fees totaling $150,000
and $112,500 to SCO for
the years ended April 30, 2007 and 2006, respectively.
The Company recorded
non-cash advisory service fees to SCO related to the
warrant grants totaling
$163,920 (Note 4) and $88,734 for the years ended April
30, 2007 and 2006,
respectively.
The
Company recorded board of director fees of $76,000 and
$38,187 for the years
ended April 30, 2007 and 2006, respectively.
Agreement
with Related Party
Virium
Pharmaceuticals, Inc.
The
Company entered into an exclusive co-development and
sublicense agreement in
February 2005 with a related entity, Virium Pharmaceuticals,
Inc. These two
entities share a common director and their largest single
shareholder, SCO
Capital Partners LLC. On May 19, 2005, the Company paid $50,000 to this
related party to in-license phenylbutyrate and expensed
this
amount.
177
6. LEASES
The
lease
on the Company’s London office space of approximately 500 sq. ft. for
its United
Kingdom operations is an operating lease which expired
on May 16, 2007.
Lease expense for the years ended April 30, 2007 and 2006 were $22,370 and
$26,724, respectively.
7. INCOME
TAXES
The
significant components of the Company’s income tax provision (benefit) at
April 30, 2007 and April 30, 2006 are as follows:
|
April
30,
2007
|
April
30,
2006
|
||||||
|
Current
Taxes:
|
|||||||
|
Federal
|
$
|
—
|
$
|
—
|
|||
|
State
|
3,717
|
2,339
|
|||||
|
Foreign
|
—
|
—
|
|||||
|
Total
|
$
|
3,717
|
$
|
2,339
|
|||
|
Deferred
Taxes:
|
|||||||
|
Federal
|
—
|
—
|
|||||
|
State
|
—
|
—
|
|||||
|
Foreign
|
—
|
—
|
|||||
|
Total
|
—
|
—
|
The
principal components of the Company’s deferred tax assets at April 30, 2007
and April 30, 2006 are as follows:
|
April
30,
2007
|
April
30,
2006
|
||||||
|
US
Net Operating Loss Carryforwards at statutory
rate
|
$
|
2,602,000
|
$
|
1,107,000
|
|
UK
Net Operating Loss Carryforwards at statutory
rate
|
703,000
|
703,000
|
|
Total
|
3,305,000
|
1,810,000
|
|
Less
Valuation Allowance
|
(3,305,000
|
)
|
(1,810,000
|
)
|
|
Net
Deferred Tax assets
|
$
|
—
|
$
|
—
|
A
reconciliation of the provision (benefit) for income
taxes to the amount
computed by applying the statutory income tax rate to
the loss before income
taxes is as follows:
|
April
30,
2007
|
April
30, 2006
|
||||||
|
Income
tax (benefit) expense at statutory rate
|
$
|
(2,549,000
|
)
|
(1,701,000
|
)
|
|
Non
Deductible Expenses at statutory rate
|
1,050,000
|
335,000
|
|
Other
|
4,000
|
18,000
|
|
Change
in valuation allowance at statutory rate
|
1,495,000
|
1,348,000
|
|||||
| $ | - | $ |
The
Company has established a valuation allowance against
its deferred tax asset,
due to the uncertainty of the realization of the asset.
Management periodically
evaluates the recoverability of the deferred tax asset.
At such time as it is
determined that it is more likely than not that deferred
tax assets are
realizable, the valuation allowance will be reduced.
At
April 30, 2007 and 2006, the Company had US net operating loss
carryforwards of approximately $7,652,000 and $3,256,000
respectively, which may
be available to offset future taxable income for tax
purposes. These net
operating loss carryforwards expire through 2026. At
April 30, 2007 and
2006, the Company also had UK net operating loss carryforwards
of approximately
$2,696,000.
The
Internal Revenue Code limits the availability of net
operating losses that arose
prior to certain cumulative changes in a corporation’s ownership resulting in a
change of control of the Company. The Company’s use of $167,000 of its prior net
operating loss carryforwards will be significantly limited,
because the Company
underwent “ownership changes” during the fiscal year ended April 30, 2006.
Further, the use of UK net operating loss carryforwards
may be
limited.
178
8. STOCKHOLDERS’
TRANSACTIONS
Common
Stock
From
inception through April 30, 2003, the Company financed its operations
through the sale of 4,314,461 shares of common stock
to individual investors at
prices in United Kingdom Pounds translated into US Dollars
ranging from
approximately $0.03, to $1.10, for a total of $155,570.
Of this total, $5,728
remained unpaid at the end April 30, 2003 and was recorded as subscription
receivable. In addition, 733,684 shares were issued at
$0.03 for the services of
consultants, for a total of $17,007. Of this total, $9,975 was recorded to
deferred equity-based expense, because some services
were performed in the
subsequent years. The services were accounted for at the fair value of
the
common stock issued, measured at the dates the commitments
for service were
reached with the contractors. The fair value of these shares was determined
as equal to the value at which shares were being sold
to unaffiliated investors
at the times of the commitments for service.
For
the
year ending April 30, 2004, the Company completed additional sales of
350,164 shares of common stock at approximately $1.23
for a total of $436,987.
At the end of April 30, 2004, the amount remaining unpaid for all prior
equity sales was $84,283 and was recorded as subscription
receivable. The
Company issued 22,233 shares of common stock at approximately
$1.23 for the
services of a consultant, for a total of $27,985. Of this total, $25,216
was recorded as deferred equity-based expense. During
the year ended
April 30, 2004, 146,007 issued shares were purchased by the
President and
Chief Executive Officer of the Company from an individual
who had not paid for
the shares. The fair value of these shares was determined as equal
to the
value at which shares were being sold to all other unaffiliated
investors at the
time of this share purchase. The Company recorded the
difference between the
purchase price and the fair value of the shares as compensation
expense
amounting to $181,371.
For
the
year ending April 30, 2005, the Company sold 374,074 shares to individual
investors at approximately $1.33, for a total of $494,443. In this period,
21,901 shares of common stock were issued at approximately
$1.23 per share for
the services of a consultant, for a total of $26,955.
During
the year ended April 30, 2006, the Company sold 12,669 shares to an
individual investor at approximately $1.57, for a total
of $19,834. In this
period, 3,650 shares of common stock were issued at approximately
$1.50 in
satisfaction of the shares to be issued at April 30, 2005 for a balance of
$5,465.
Stock-Based
Compensation
The
Board
of Directors adopted and the stockholders approved the
2005 Equity Incentive
Plan in June 2005. The plan was adopted to recognize the contributions made
by the Company’s employees, officers, consultants, and directors, to
provide
those individuals with additional incentive to devote
themselves to its future
success, and to improve the Company’s ability to attract, retain and motivate
individuals upon whom the Company’s growth and financial success
depends. Under the plan, stock options may be granted as approved
by the
Board of Directors or the Compensation Committee. There are 8,000,000
shares reserved for grants of options under the plan,
of which 2,204,701 have
been issued as substitutions with the exact same terms
for the 2,204,701
previously issued options outstanding as of April 30, 2005. Stock options
vest pursuant to individual stock option agreements. No options granted
under the plan are exercisable after the expiration of
ten years (or less in the
discretion of the Board of Directors or the Compensation
Committee) from the
date of the grant. The plan will continue in effect until terminated or
amended by the Board of Directors or until expiration
of the plan on
August 31, 2015.
On
April
13, 2007, the Company’s Board of Directors approved a merger agreement with
Access Pharmaceuticals, Inc, as more fully described
in Note 15. Under the terms
of that agreement Access will not assume, or provide
a substitute option, for
any of the Company’s stock options. Rather, all of the outstanding options
to purchase Company common stock issued pursuant to the
Company’s 2005 Equity
Incentive Plan will be cancelled prior to the closing
of the transaction in
accordance with Section 11.3(d) of the Equity Incentive
Plan. As a result,
pursuant to the terms of Section 11.3(d) of the Equity
Incentive Plan, the
Company’s Board of Directors has resolved to: (i) allow the immediate
and
accelerated vesting of all of the options granted, and
(ii) allowed the exercise
of the option in whole or in part until May 31, 2007.
Based on FAS 123(R), no
incremental expense was recorded for these options with
accelerated vesting as
the fair value of the modified options was less than
the fair value of the
original options calculated immediately before the terms
were modified. None of
the options were exercised thru May 31, 2007. Additional
expenses of $507,284
was due to the acceleration of the vesting.
FAS
123(R) requires the use of a valuation model to calculate
the fair value of each
stock-based award. Since May 1, 2003, the Company has used the
Black-Scholes model to estimate the fair value of stock
options granted. For the
valuation of stock-based awards granted in the years
ended April 30, 2007 and
2006, respectively, the Company used the following significant
assumptions:
179
Compensation
Amortization Period.
All
stock-based compensation is amortized over the requisite
service period of the
options, which is generally the same as the vesting
period of the options. For
all stock options, the Company amortizes the fair value
on a straight-line basis
over the service periods.
Expected
Term or Life.
The
expected term or life of stock options granted or stock
purchase rights issued
represents the expected weighted average period of
time from the date of grant
to the estimated date that the stock option would be
fully exercised. To
calculate the expected term, the Company used the total
of one-half of the
option term and one-half of the vesting periods.
Expected
Volatility.
Expected volatility is a measure of the amount by which
the Company’s stock
price is expected to fluctuate. The Company’s stock is currently traded on the
over-the -counter bulletin board under the trading
symbol “SMPM”. The Company
estimated the expected volatility of the stock options
at grant date using the
daily stock price of three comparable companies over
a recent historical period
equal to the Company’s expected term.
Risk-Free
Interest Rate. The
risk-free interest rate used in determining the fair
value of our stock-based
awards is based on the implied yield on U.S. Treasury
zero-coupon issues with
remaining terms equivalent to the expected term of
our stock-based
awards.
Expected
Dividends. The
Company has never paid any cash dividends on common
stock and does not
anticipate paying any cash dividends in the foreseeable
future. Consequently,
the Company used an expected dividend yield of zero
in valuation
models.
Expected
Forfeitures. As
stock-based compensation expense recognized in the
consolidated statements of
operations for year ended April 30, 2007 is based on
awards that are ultimately
expected to vest, it should be reduced for estimated
forfeitures.
FAS 123(R) requires forfeitures to be estimated at the
time of grant and
revised, if necessary, in subsequent periods if actual
forfeitures differ from
those estimates. Pre-vesting forfeitures were estimated
to be 0% for stock
options granted for the year ended April 30, 2007 based
upon historical
forfeitures.
Summary
of Significant Assumptions of the Valuation of Stock-Based
Awards.
The
weighted-average estimated fair value of stock options
granted during the year
ended April 30, 2007 and 2006 was $0.43 and $0.42 per
share, respectively. The
fair value for these stock options was estimated at
the date of grant with the
following weighted-average assumptions for the years
ended April 30, 2007 and
April 30, 2006, respectively:
|
Year
ended
April
30,
|
||
|
2007
|
2006
|
|
|
Expected
volatility
|
80.17
to 81.38%
|
101.80%
|
|
Weighted-average
volatility
|
80.41%
|
101.80%
|
|
Expected
dividend yield
|
0%
|
0%
|
|
Expected
term in years
|
6.0
|
6.0
to 7.0
|
|
Risk-free
interest rate
|
4.8%
to 5.1%
|
4.1%
to 4.6%
|
During
the years ended April 30, 2007 and 2006, the Company
recognized compensation
costs related to stock options of $739,000 and $300,615,
respectively.
180
The
following table summarizes activity for stock options
issued to employees,
consultants and directors for the years ended April
30, 2007 and
2006:
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
|
Outstanding
at April 30, 2005
|
2,204,701
|
$
|
1.23
|
7.6
|
$
|
44,094
|
|||||||
|
Granted
|
1,781,170
|
0.60
|
|||||||||||
|
Exercised
|
—
|
||||||||||||
|
Forfeited
|
(160,622
|
)
|
1.23
|
||||||||||
|
Expired
|
—
|
||||||||||||
|
Outstanding
at April 30, 2006
|
3,825,249
|
0.94
|
7.9
|
$
|
65,696
|
||||||||
|
Granted
|
122,500
|
0.60
|
|||||||||||
|
Exercised
|
—
|
||||||||||||
|
Forfeited
|
(339,417
|
)
|
0.60
|
||||||||||
|
Expired
|
(125,169
|
)
|
1.15
|
||||||||||
|
Outstanding
at April 30, 2007
|
3,483,163
|
$
|
0.95
|
0.1
|
$
|
1,040,399
|
|||||||
|
Exercisable
at April 30, 2007
|
3,483,163
|
$
|
0.95
|
0.1
|
$
|
1,040,399
|
|||||||
The
aggregate intrinsic value represents the difference
between the stock price on
the last day of the fiscal year, April 30, 2007,
which was $1.25, and the
exercise price multiplied by the number of options
outstanding.
The
following table summarizes information about non-vested
Company stock options as
of April 30, 2007 (unaudited):
|
Shares
|
Weighted
Average
Grant
Date Fair Value
|
||||||
|
Non-vested
at April 30, 2006
|
1,849,128
|
$
|
0.43
|
|
Granted
|
122,500
|
$
|
0.43
|
||||
|
Vested
|
(1,632,211
|
)
|
$
|
0.48
|
|||
|
Forfeited
|
(339,417
|
)
|
$
|
0.18
|
|||
|
Non-vested
at April 30, 2007
|
-0-
|
Stock
Warrants
Through
the year ended April 30, 2005, the Company issued no warrants. During
the
year ended April 30, 2006, the Company issued warrants to non-employees
to
purchase up to 6,952,838 common shares over periods
ranging from 5 to 7 years at
prices ranging from $0.01 to $2.25. Included in the
warrants issued were
warrants to a non-employee to purchase up to 9,987
common shares over a five
year period at a price of $2.25. In the year ended
April 30, 2007, the Company
issued warrants to non-employees to purchase up to
150,000 common shares over a
period of six years at a price of $.01 (Note 4).
In accordance with EITF 96-18,
the Company determined that the fair value of the
equity instrument issued was
more reliably measured because it was difficult to
determine the value of the
services performed. In accordance with FASB Statement
No. 123R, the Company
has expensed the fair value of all the warrants issued
during the year. The fair
value was estimated using the Black-Scholes valuation
method. The assumptions
utilized in the valuation model were a dividend yield
of zero, volatility
factors ranging from 76.5 to 97.2%, the risk-free
interest rates prevailing at
the warrant issuance dates, which ranged from 4.1
to 4.9%, and expected warrant
lives ranging from 2.5 to 3.5 years. The fair market
value of the warrants used
in the Black-Scholes valuation model was equal to
the most recent value at which
shares were being sold to unaffiliated investors.
181
The
following table summarizes the activity for warrants
issued during the years
ended April 30, 2007 and 2006.
|
Shares
|
Wtd.
Avg.
Exercise
Price
|
||||||
| Outstanding April 30, 2005 |
—
|
||||||
|
Granted
|
6,952,838
|
$
|
.62
|
||||
|
Exercised
|
—
|
| Forfeited |
—
|
||||||
|
Expired
|
—
|
||||||
|
Outstanding
April 30, 2006
|
6,952,838
|
$
|
.62
|
||||
|
Granted
|
150,000
|
$
|
.01
|
||||
|
Exercised
|
—
|
||||||
|
Forfeited
|
—
|
||||||
|
Expired
|
—
|
||||||
|
Outstanding
April 30, 2007
|
7,102,838
|
$
|
.61
|
The
following table summarizes information about warrants
outstanding as of
April 30, 2007:
|
Warrants
Outstanding
|
Warrants
Exercisable
|
||||
|
Exercise
Prices
|
Number
Outstanding
|
Wtd.
Avg
Remaining
Contr.
Life
|
Wtd.
Avg
Exercise
Price
|
Number
Exercisable
|
Wtd.
Avg
Exercise
Price
|
|||||||||||
|
$0.01
|
1,166,534
|
5.8
years
|
$
|
0.01
|
1,166,534
|
$
|
0.01
|
|||||||||
|
$0.60
|
987,720
|
4.8
years
|
$
|
0.60
|
987,720
|
$
|
0.60
|
|||||||||
|
$0.75
|
4,938,597
|
4.8
years
|
$
|
0.75
|
4,938,597
|
$
|
0.75
|
|||||||||
|
$2.25
|
9,987
|
3.1
years
|
$
|
2.25
|
9,987
|
$
|
2.25
|
9. SHARE
EXCHANGE AGREEMENT AND PLAN OF MERGER AGREEMENT
On
August 22, 2005, Somanta Limited, a company organized under
the laws of
England and Wales, became a wholly-owned subsidiary of
Bridge Oncology Products,
Inc. (“BOPI”), a privately held Delaware corporation pursuant to
a share
exchange with BOPI. BOPI was formed in February 2005, and its only
operation was to in-license a product development candidate
for development
outside the United States and Canada.
Under
the
terms of a Share Exchange Agreement by and among BOPI,
Somanta Limited, and the
shareholders and option holders of Somanta Limited, BOPI
(i) issued
5,832,834 shares of BOPI to the twenty-five holders of
79,898,686 ordinary
shares of Somanta Limited and (ii) issued substitute options to purchase
2,032,166 shares of BOPI to the eleven holders of Somanta
Limited options
covering 27,836,800 ordinary shares of Somanta Limited.
The exchange ratio in
the share exchange was 1 share of BOPI for each 13.698
shares of Somanta
Limited. As a result of this share exchange, the shareholders
of Somanta Limited
owned 50% of the fully diluted ownership of BOPI, and
the holders of BOPI owned
the remaining 50%.
Somanta
Limited options were all priced at 5 pence pursuant to
Somanta Limited’s Board
resolution dated May 18, 2005. These option grant prices were converted
into US dollars at the exchange rate on June 13, 2005, to $0.09 per
share. After the exchange ratio from the share exchange was
applied, these
options now have an exercise price of $1.232828 per share
for each BOPI option
issued in the share exchange.
The
acquisition was accounted for as a recapitalization,
as described in FASB 141,
17-3. This transaction is treated as a capital transaction
in substance, rather
than a business combination. That is, the transaction
is equivalent to Somanta
Limited issuing stock for the net monetary assets of
BOPI, accompanied by a
recapitalization. The assets of BOPI were recorded at
the historical value. The
intangible asset on BOPI’s books was written off to the income statement on the
date of the acquisition (August 22, 2005). Accordingly, the historical
financial statements of Somanta Limited became the historical
financial
statements of BOPI after this transaction. In accounting
for this transaction,
since Somanta Limited is deemed to be the purchaser and
surviving company, its
net assets have been included in the consolidated balance
sheets at their
historical book values.
On
August 24, 2005, the name of BOPI was changed to Somanta Incorporated
(“SI”).
182
On
September 7, 2005, SI entered into a letter of intent to effect
a merger
with Hibshman Optical Corp (“Hibshman”), a New Jersey corporation, and a public
reporting company that did not have a market for its
common stock. Hibshman
was formed in 1991 under the name PRS Sub I, Inc.,
as a subsidiary of People
Ridesharing Systems, Inc. (“PRS”), a public corporation that had filed for
Bankruptcy in 1989. In March 1992, the name of PRS
Sub I was changed to Service
Lube, Inc., in anticipation of becoming an operating
business. In April 1992 the
name was changed to Fianza Commercial Corp. Again in
April 1992 the name was
changed to Hibshman. Hibshman never had an operating
business, its stock never
traded publicly, and its shareholders never received
stock
certificates.
On
September 27, 2005, Hibshman, pursuant to an action taken by
the written
consent of its board and shareholders, adopted an
Agreement and Plan of Merger
to effect the reincorporation of Hibshman into Delaware
prior to the merger with
SI. Hibshman formed a new Delaware corporation which
was a wholly owned
subsidiary of Hibshman (“Delaware NewCo”). At the closing of the
reincorporation, Hibshman merged into Delaware NewCo
and each outstanding
Hibshman share was exchanged for .01305340 of Delaware
NewCo shares with each
registered holder of a fractional share being issued
50 Delaware NewCo shares in
lieu of such fractional share. Delaware NewCo was the surviving entity and
the successor issuer under the Exchange Act and had
576,700 outstanding
shares. Delaware NewCo was named “Somanta Pharmaceuticals,
Inc.”
On
January 31, 2006, pursuant to an Agreement and Plan of Merger
by and among
Delaware NewCo, SI, and Somanta Merger Sub (“Merger Sub”), a wholly-owned
subsidiary of Delaware NewCo, SI merged with Merger
Sub and became a
wholly-owned subsidiary of Delaware NewCo. In connection with this merger
transaction, Delaware NewCo issued to the holders
of SI capital stock an
aggregate of 13,697,834 shares of Delaware NewCo
common stock and assumed the SI
2005 Equity Incentive Plan and all options outstanding
thereunder which options
became options to purchase 3,831,864 shares of Delaware
NewCo common stock. As a
result, (i) the shareholders and optionholders of SI owned approximately
97% of the total outstanding common stock of Delaware
NewCo on a fully diluted
basis, (ii) Delaware NewCo assumed the SI 2005 Equity Incentive
Plan and
reserved 8,000,000 common shares for issuance under
the Plan, and
(iii) Delaware NewCo changed its name to Somanta Pharmaceuticals,
Inc.
The
acquisition was accounted for as a recapitalization,
as described in FASB 141,
17-3. This transaction is treated as a capital transaction
in substance, rather
than a business combination. That is, the transaction
is equivalent to Somanta
Incorporated issuing stock for the net monetary assets
of Hibshman Optical
Corp., accompanied by a recapitalization. Accordingly,
the historical financial
statements of Somanta Incorporated became the historical
financial statements of
Hibshman Optical Corp. after this transaction. In
accounting for this
transaction, since Somanta Incorporated is deemed
to be the purchaser and
surviving company, its net assets have been included
in the consolidated balance
sheets at their historical book values. Somanta Pharmaceuticals,
Inc., elected
to change the fiscal year end from December 31 to April 30 of Somanta
Incorporated.
10. CONVERTIBLE
NOTE
On
August 23, 2005, Bridge Oncology Products, Inc. (“BOPI”) issued a
$1,000,000 secured convertible note to SCO Capital
Partners LLC
(“SCO”). The note was secured by BOPI’s assets, carries an annual interest
rate of 7.5%, and was due at the earlier of (i) BOPI’s completion of a
qualified equity financing of at least $10,000,000 or (ii) August 23,
2006. SCO had the option to be repaid in cash or to convert
the debt into
the shares of a qualified equity financing at the
lowest price paid by
institutional investors.
On
November 7, 2005, SCO agreed to expand its secured convertible
note to SI
from $1,000,000 up to $1,250,000. Under the terms
of the revised arrangement
with SI, the security and interest rate remained
unchanged. The terms were
amended to require repayment at the earlier of (i) SI’s completion of an
equity financing of at least $5,000,000 or (ii) February 28,
2006. Consistent with the secured convertible note above,
SCO had the
option to be repaid in cash or to convert the debt
into the shares of a
qualified equity financing at the lowest price paid
by institutional
investors.
In
addition, for each $50,000 borrowed on the additional
$250,000 line of credit,
the Company agreed to issue a six-year warrant to
purchase 173,307 shares of
common stock in the amount of 1% of the Company’s fully diluted common shares
outstanding at an exercise price of $0.01 per share. SI has drawn an
additional $250,000 under this arrangement, for a
total amount outstanding of
$1,250,000 and has issued warrants to purchase a
total of 866,534 shares of
common stock to SCO. These warrants are immediately
exercisable upon issuance
and expire on November 8, 2012. The fair market value of these warrants,
as
discussed further below, was estimated to be $0.59
per share at the issuance
date and re-measured at $0.59 as of April 30, 2006. The assumptions used in
the Black-Scholes model were risk-free interest rate
of 4.5% at the time of
issuance and 4.95% at April 30, 2006, volatility factors of 97.24% at the
issuance and 76.63% at April 30, 2006, calculated as the weighted average
of the stock price volatility of ranked comparable
public companies, and
contractual terms equal to the exercise periods of
the respective warrants. The
fair value of the common stock as used in this calculation
was $.60 per share,
as negotiated between the Company and the Series
A Convertible Preferred Stock
investors. None of these warrants have been exercised
as of April 30,
2007.
183
These
warrants have registration rights for the underlying
shares. The investor rights
agreement for the warrant requires the Company
pay a penalty in cash as
liquidated damages if the underlying shares are
not registered in a Registration
Statement and such Registration Statement is not
declared effective on or prior
to the 90th
day
following the initial closing date. The Company
will be required to pay, in
cash, liquidated damages for such failure, equal
to 1% of the holder’s
subscription amount. Pursuant to Emerging Issues Task Force (EITF) No.
00-19, Accounting
for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a
Company’s Own Stock,
the
fair value of the warrants at the issuance was
recorded as a warrant liability,
as 1) the shares are required to be registered
and 2) net cash settlement could
occur. EITF 00-19 provides that contracts that include
any
provision that could require net-cash settlement
cannot be accounted for as
equity of the Company. The warrant agreements require
net cash settlement, at
the option of the holders, in the event the Company
fails to issue and deliver
common stock on exercise of the warrants within
three business days of receipt
of a written exercise notice by a holder and the
holder purchases shares of
common stock to deliver in satisfaction of a sale
of the shares of warrants
stock which the holder anticipated to receive upon
exercise.
In
accordance with Statement of Financial Accounting
Standards No. 133,
Accounting
for Derivative Instruments and Hedging Activities,
(“FASB
133”), the Company determined that the conversion feature
of the notes did not
meet the criteria for bifurcation of the conversion
option, as the debt met the
definition of “conventional convertible debt”, as defined under EITF 00-19, and
therefore the conversion feature of the debt did
not need to be bifurcated and
accounted for as a derivative.
In
accordance with EITF No. 00-27, Application
of Issue No. 98-5 to Certain Convertible Instruments, which
provides guidance on the calculation of a beneficial
conversion feature on a
convertible instrument, the Company has determined
that the convertible note
payable had a non-cash beneficial conversion feature
of $364,721, which was
determined once the qualified equity financing
was finalized. The beneficial
conversion feature was calculated on the note commitment
date but recognized
when the contingency of conversion was resolved
and was determined based on the
difference between the calculated conversion value
after the allocation of the
full fair value of the warrants of $514,981 to
the debt as debt discount and the
fair value of the Company’s common stock of $0.60 per share. The value of
the Company’s common stock of $0.60 per share was based on
the value of common
stock obtained through negotiation for independent
sales of common stock to
unaffiliated investors. After the allocation of proceeds between the debt
and warrants are made, conversion price of $0.425
was calculated based on the
allocated amount to debts divided by 2,083,333,
the total number of shares into
which the note is convertible. The calculated amount
of $0.175, the difference
of the fair value of the common stock of $0.60
and the effective conversion
price of $0.425, represents the beneficial value
per share. This beneficial
value was applied to the total shares into which
the note is convertible, to
calculate the beneficial conversion feature. The
proceeds of $1,250,000 on the
note were recorded net of the discount of $364,721
on account of the beneficial
conversion feature and discount of $514,981 on
account of the full fair value of
the warrants. In conjunction with the private placement
(Note 12), the debt and
accrued interest was converted into 128.6318 shares
of Series A Convertible
Preferred Stock. The discounts on account of the
beneficial conversion feature
and fair value of the warrants have been recognized
as additional interest
expense on conversion.
11. PRIVATE
PLACEMENT
On
January 31, 2006, Somanta Pharmaceuticals, Inc. completed a private
placement of 592.6318 shares of its Series A Convertible Preferred
Stock (“Series A Preferred”) at a price of $10,000 per share, including six-year
warrants to purchase an additional 4,938,598 shares
of its common
stock. The Series A Preferred shares consisted of 464
shares purchased by
investors which are convertible into 7,733,333
shares of common stock and
128.6318 shares that gave effect to the conversion
amount of $1,286,318,
representing the value of the converted note of
$1,250,000 (Note 11) and the
associated accrued interest of $36,318. The total 592.6318 preferred shares
are convertible into 9,877,197 common shares. Gross
proceeds to Somanta were
$4,640,000, including $3,671,209 in cash, payments
to various vendors amounting
$968,791, which included cash payment of $624,105
to SCO Securities, LLC, its
placement agent.
The
Series A Preferred is initially convertible into
9,877,197 shares of the
Company’s common stock at a conversion price of $0.60 per
share. The conversion
value is subject to adjustment. The exercise price
for the warrants is $0.75 per
share and they are immediately exercisable upon
issuance. The fair market value
of these warrants, as discussed further below,
was estimated to be $0.41 per
share at the issuance date. The warrants expire on January 31,
2012. None of the warrants have been exercised as of
April 30,
2007.
Holders
of the Series A Preferred stock are entitled to
receive dividends at 8% per
annum. Dividends will accrue and will be cumulative
from the date of issuance,
whether or not earned or declared by the Board
of Directors. Dividends can be
paid at the Company’s option either in cash or shares of the Company’s common
stock on April 30 and October 31 of each year. The holders of the
Series A Preferred stock have full voting rights
and powers, subject to the
Beneficial Ownership Cap, equal to the voting rights
and powers of the Common
stock holders.
184
The
Series A Preferred stockholders have a liquidation
preference, in the event of
any voluntary or involuntary liquidation, dissolution
or winding up of the
Corporation, senior to the holders of common
stock in an amount equal to $10,000
per share of preferred stock plus any accumulated
and unpaid dividends on the
preferred stock. In the alternative, the holders of the Series
A Preferred
may elect to receive the amount per share that
would be distributed among the
holders of the preferred stock and common stock
pro rata based on the number of
shares of the common stock held by each holder
assuming conversion of all
preferred stock, if such amount is greater than
the amount such holder would
receive pursuant to the liquidation preference.
A change of Control of the
Corporation will not be deemed a liquidation.
The
Series A Preferred Stock is not redeemable for
cash. The holder of any
share or shares of Series A Preferred can, at
the holder’s option, at any time
convert all or any lesser portion of such holder’s shares of Series A Preferred
stock into such number of shares of common stock
as is determined by dividing
the aggregate liquidation preference of the shares
of preferred stock to be
converted plus accrued and unpaid dividends thereon
by the conversion value then
in effect for such Preferred Stock (“Conversion Value”). The Company can, on the
occurrence of a conversion triggering event,
elect to convert all of the
outstanding preferred stock into common stock.
A conversion triggering event is
(i) a time when the registration statement covering
the shares of common
stock into which the Series A Preferred is convertible
is effective and sales
may be made pursuant thereto or all of the shares
of common stock into which the
Series A Preferred is convertible may be sold
without restriction pursuant to
Rule 144(k) promulgated by the SEC and the daily
market price of the common
stock, after adjusting for stock splits, reverse
splits, stock dividends and the
like is $5 or more for a period of 30 of the immediately preceding 60
consecutive trading days and the volume of common
stock traded on the applicable
stock exchange on each such trading day is not
less than 100,000 shares, or
(ii) a time when the Company consummates a sale of
common stock in a firm
commitment underwritten public offering in which
the offering price before
deduction of expenses of the common stock is
greater than 200% of the Conversion
Value and the aggregate gross proceeds of the
offering to the Company are
greater than $25 million.
All
the
outstanding preferred stock will be automatically
converted to common stock upon
an occurrence of a qualified change of control
provided that upon consummation
of a qualified change of control the holders
of the shares issuable on automatic
conversion shall be entitled to receive the same
per share consideration as the
qualified change of control transaction consideration.
The holders of the Series
A Preferred may require the Company to redeem
the shares upon the Company’s
failure or refusal to convert any shares of Preferred
Stock in accordance with
the terms of issue, or by providing a written
notice to that
effect.
The
Series A Preferred has been classified as equity,
as the Series A Preferred
stock is not redeemable. In accordance with EITF No. 00-27, Application
of Issue No. 98-5 to Certain Convertible Instruments, the
Company has determined that the Series A Preferred
had a beneficial conversion
feature of $1,522,317 as of the date of issuance.
As such, the Company recorded
a non-cash deemed dividend of $1,522,317 resulting
from the difference between
the conversion price determined after allocation
of the full fair value of the
warrants of $0.41 at the issuance date, revalued
at $0.78 as of April 30,
2007, and the fair value of common stock of $0.60.
The carrying value of the
Series A Preferred of $5,926,318 was recorded
net of the deemed dividend of
$1,522,317 and a discount of $2,048,531 at the
issuance date. The change in fair
value of the warrants was recorded as other income
in the consolidated statement
of operations for the year ended April 30, 2007.
The
holders of the Series A Preferred and warrants
have registration rights which
obligate the Company to file a registration statement
with the Securities and
Exchange Commission (“SEC”) covering the resale of the common stock issuable
upon conversion of the Series A Preferred and
the common stock issuable upon
exercise of the warrants (as well as certain
other securities of the Company)
within 30 days after the closing of the private
placement. In the event the
registration statement is not filed within such
thirty day period or if the
registration statement is not effective within
120 days after the date it is
filed, or a registration statement, once declared
effective ceases to remain
effective during the period that the securities
covered by the agreement are not
sold, the Company will be required to pay, in
cash, liquidated damages for such
failure, equal to 1% of the holders of the Series
A Preferred investment amount
for each thirty day period in which the registration
statement is not filed or
effective, or maintained effective, as the case
may be. This penalty obligation
expired on January 31, 2007 since the SEC declared the Registration
Statement effective on August 10, 2006.
In
accordance with EITF Issue 05-4, The
Effect of a Liquidated Damages Clause on a Freestanding
Financial Instrument
Subject to Issue No. 00-19,
the
Company believes that the effect of the liquidated
damages should be treated
under the first view (View A), which states that
a registration rights agreement
should be treated as a combined unit together
with the underlying financial
instruments, warrants and derivative debenture
and evaluated as a single
instrument under EITF Issue 00-19 and FAS 133.
The Company concluded that this
view is the most appropriate for the transaction. The Registration Rights
Agreement and the financial instruments to which
it pertains (the warrants and
the preferred stock) were considered a combined
instrument and accounted for
accordingly. The SEC declared the Registration Statement effective
on
August 10, 2006. As a result, during the quarter ended
July 31, 2006,
the Company accrued a liability of liquidated
damages of $120,502. During the
quarter ended October 31, 2006 an agreement was reached with SCO on
the
liquidated damages matter. The agreement concluded
that since the securities
owned by SCO Capital Partners,
LLC were not registered because SCO voluntarily
withdrew them from the
Registration because of the resale restrictions
required by the SEC, the Company
is not obligated for any liquidated damages pertaining
specifically to SCO
Capital Partners, LLC. Accordingly, the Company
reversed out $85,302 of
liquidated damages in the prior quarter ended
October 31,
2006.
185
The
Company also issued six year warrants to its
placement agent to purchase 987,720
common shares at $0.60 per share to SCO Securities
LLC, as part of the success
fees of 10% of the aggregate value of the transaction
at sales price of common
stock. These warrants are immediately exercisable
upon issuance. The fair value
of these warrants at the date of issuance was
estimated to be $0.44 per share
and revalued at $0.41 as of April 30, 2006 and has been recorded as
issuance costs and offset against the proceeds
of the Series A Preferred. On
February 27, 2007, the Company issued a six
year warrant to SCO Financial Group
to purchase 150,000 common shares at $.01 per
share.
The
fair
value of warrants issued in connection with
the issue of convertible debt and
convertible preferred stock, including the
agent warrants, was estimated at the
date of grant and revalued at April 30, 2007
using a Black Scholes option
pricing model with the following assumptions:
a risk free interest rate of
approximately 4.5% at the issuance date and
4.6% on April 30, 2007, no dividend
yield, volatility factors of 81.89% to 97.24%
at the issuance date
and 50.89% to 60.56% at April 30, 2007, contractual
terms of 6 and 7 years
and expected terms based upon the formula prescribed
in SEC Staff Accounting
Bulletin 107 of 3 years and 3.5 years. These assumptions use the interest
rate prevailing at the time of issuance, volatility
factors calculated as the
weighted average of the stock price volatility
of ranked comparable public
companies, and contractual terms equal to the
exercise periods of the respective
warrants. The fair value of the common stock
as used in this calculation was
$.60 per share at the issuance date, as negotiated
between the Company and
unaffiliated third party Series A investors,
and $1.25 on April 30, 2007. The
change in fair value of the warrants for the
year ended April 30, 2007 of
$2,931,118 was reported in other expense and
disclosed in the financial
statements.
The
fair
value of the above warrants has been classified
as a liability pursuant to EITF
00-19 as described in Note 4 for the years
ended April 30, 2007.
The
fair
value of the warrants was reassessed at the
end of the fiscal year 2007 with
changes in fair value recorded in other income
(expense) and disclosed in the
financial statements.
The
holders of the Series A Preferred Stock are
entitled to receive, when, if and as
declared by the Board, dividends at 8% per annum cumulative from the date
of issuance of the shares of Preferred Stock.
The board did not declare the
dividends as of April 30 2007. Therefore, a dividend of $589,708
and
$115,604 for the year ended April 30, 2007
and 2006, respectively,
on the Preferred Stock has not been recorded
in the consolidated financial
statements, but in accordance with SFAS No. 129, the dividend amount has
been included in the calculation of net loss
per share.
12. SECURED
NOTE
On
April
26, 2007, the Company entered into a Note Purchase
Agreement, a Security
Agreement, a Patent Collateral Assignment and
Security Agreement and a Trademark
Collateral Security and Pledge Agreement (collectively,
the “Loan Documents”)
with Access Pharmaceuticals, Inc. (“Access”). Under the terms of the Loan
Documents, Access initially loaned the Company
$33,462. Access, in its sole
discretion, may from time to time advance additional
loan amounts to the
Company. All amounts loaned to the Company
by Access are secured by
substantially all of the assets of the Company
pursuant to the terms of the Loan
Documents. The Note bears interest at 10% and
is repayable at the earlier of:
(i) August 31, 2007, or (ii) the date of the
termination of the Agreement and
Plan of Merger dated as of August 18, 2007
between the Company and
Access.
13. COMMITMENTS—EMPLOYMENT
AND CONSULTING AGREEMENTS
In
January 2006, the Company entered into employment
agreements with the Company’s
President and Chief Executive Officer (“CEO”), and with the Company’s Executive
Chairman, for one year terms. These agreements
were automatically renewed for an
additional on year term on January 31, 2007.
Under these agreements, the
President and Executive Chairman are to be
paid annual base salaries of $275,000
and $248,000, respectively. Both officers are
eligible to receive annual bonuses
and additional stock option grants at the discretion
of the Company’s board of
directors. In July 2006, the Company’s CEO and Executive Chairman agreed to
defer 50% of their base salaries until the
completion of the Company’s next fund
raising at which time the deferred amounts
would be repaid and the deferrals
would cease. Effective October 1, 2006, the Company’s CEO and Executive
Chairman agreed to defer 100% of their base
salaries until the completion of the
Company’s next fund raising, or the completion of a
merger or other
consolidation with another company, at which
time the deferred amounts would be
repaid and the deferrals would cease. Effective
June 30, 2006, our
Executive Chairman was appointed by our Board
to be our Chief Financial Officer,
Secretary and Treasurer.
186
In
January 2006, the Company entered into an employment
agreement with the
Company’s Chief Financial Officer (“CFO”). Under the agreement, the CFO was
to be paid an annual base salary of $215,000
and also entitled to receive an
annual bonus and additional stock option grants
at the discretion of the
Company’s board of directors. In June 2006, the Company’s CFO resigned. The
Company is not obligated to pay him any severance
or other payments as the
result of his departure; however, the board
agreed to amend the terms of his
stock option agreement to immediately vest
him in twenty five percent
(25%) of the shares covered by the option, or 101,668
shares, and enable
him to exercise such option until June 30, 2007. Based on FAS 123R, no
incremental expense was recorded for these
options with accelerated vesting as
the fair value of the modified options was
less than the fair value of the
original options calculated immediately before
the terms were
modified.
In
November 2005, the Company entered into two
consulting agreements: (i) a
Service Provision Agreement with Pharma Consultancy
Limited, a UK company
controlled by Luiz Porto, one of the Company’s stockholders pursuant to which
the Company will pay Dr. Porto approximately $278,000 per year, for
services rendered by Dr. Porto to the Company as an independent consultant
in connection with the management of the Company’s clinical activities, that
will terminate on December 31, 2006 unless extended by a mutual written
agreement of the parties and may be terminated,
with or without cause, by giving
the other party thirty (30) days’ prior written notice; and (ii) a
Service Provision Agreement with Gary Bower pursuant
to which the Company
will pay Mr. Bower approximately $156,000 per year for services
rendered by
Mr. Bower to the Company as an independent consultant
in connection with
the pre-clinical activities related to the
manufacturing of the Company’s
product candidates, that will terminate on
December 31, 2006 unless
extended by a mutual written agreement of the
parties and that may be
terminated, with or without cause, by giving
the other party thirty
(30) days’ prior written notice.
The
agreement with Mr. Bower was amended in April 2006 to include
GTE
Consultancy Limited, a company organized under
the laws of United Kingdom and
owned by Mr. Bower, as the service provider pursuant to
the agreement. With
the approval of the Company’s board of directors, both Dr. Porto and
Mr. Bower may also be granted cash bonuses and
stock options in the future.
In July 2006, Pharma Consultancy Limited and
GTE Consultancy Limited amended
their agreements to reduce, effective September 1, 2006, their consulting
services to the Company by 33%, which in turn,
will reduce the Company’s
payments by approximately $91,000 and $51,000,
respectively, on an annualized
basis. Both agreements expired by there terms
on December 31, 2006 and were not
renewed.
The
Company’s former CFO resigned in August 2005, in connection
with the closing of
the share exchange agreement with Bridge Oncology. In January 2006, he
entered into a consulting arrangement with
the Company under which he is paid
$5,000 per month retroactive to June 2005.
Effective June 1, 2006, the
former CFO agreed to modify his consulting
arrangement to provide his services
for $100 per hour in lieu of a fixed retainer
and was granted options to acquire
25,000 of the Company’s common stock at $.60 per share vesting quarterly
over
twenty four months. Those options expired as of May 31, 2007.
14. SIGNIFICANT
CONTRACTS AND LICENSES
IN-LICENSING
AGREEMENTS
De
Montfort University
In
November 2001, the Company entered into a Patent
and Know-how Assignment and
License Agreement with De Montfort University
of Leicester, England, pursuant to
which De Montfort University agreed to assign
to the Company the key patent
related to chloroethylaminoanthraquinone, a
cytotoxic small molecule and to
exclusively license to the Company certain
know-how related to this molecule for
use in field of the treatment of cancer. In
March 2003, the Company amended and
restated that agreement to extend the time
period in which the assignment and
license would be triggered. In October 2005,
De Montfort University formally
assigned the patent that covers the molecule
to the Company. Pursuant to the
agreement with De Montfort University, the
Company paid De Montfort an initial
assignment fee of $42,815 in March 2004 and
issued 219,010 shares of common
stock to De Montfort valued at $4,677 in December
2001. The Company is not
obligated to make any royalty payments to De
Montfort based on the sale of any
product that is based on this small molecule,
but it is obligated to pay De
Montfort certain milestone payments based on
the achievement of agreed upon
clinical milestones. If the Company successfully
achieves each of these
milestones, it would be obligated to pay De
Montfort a total aggregate amount of
milestone payments of GBP 250,000, or approximately
$500,000. The Company is
obligated to use its commercial best efforts
to achieve these agreed upon
clinical milestones. The Company has the right
to terminate its agreement with
De Montfort on 90 days advance notice, and
either party has the right to
terminate the agreement for breach by the other
party upon 90 days advance
notice (60 days for payment failures), if such
breach is not cured within the
notice period.
187
Immunodex,
Inc.
On
January 25, 2002, the Company entered into a Patent
Know-How and License
Option Agreement with Immunorex, Inc. (later
renamed Immunodex, Inc.) giving it
a worldwide, exclusive sublicense, with the
right to further sublicense, to all
human radioimmunotherapy applications of
certain patents on BrE3 and Mc3
monoclonal antibodies for use in breast cancer
and other types of cancer.
Pursuant to this agreement, the Company paid
Immunodex an initial license fee of
$10,000 and sold 292,012 shares of common
stock to Immunodex for $5,638. On
August 16, 2005, the Company entered into
a Patent and Know-how Exclusive
Sublicense Agreement with Immunodex, Inc.
which had essentially the same terms
and conditions as the 2002 agreement and
which superseded that agreement. It
also superseded prior agreements dated March 1, 2002 and September 17,
2002 related to the same subject matter.
Pursuant to this August 2005 agreement,
the Company paid Immunodex an initial license
fee of $300,000. In addition, the
Company is obligated to pay Immunodex $150,000
upon the delivery by Immunodex of
each cell line that is necessary to manufacture
each of the BrE3 and Mc3
monoclonal antibodies. The Company is further
obligated to pay Immunodex annual
license maintenance fees and all costs and
expenses associated with the
prosecution and maintenance of each of the
patents licensed to the Company under
the agreement. The Company’s obligation to pay this fee is reduced at
such time
as it begins to sell a product based on either
of the antibodies, and terminates
in its entirety at such time as the Company
is selling products based on both
antibodies. As noted below, on November 3,
2006 we terminated our license with
respect on one of the monoclonal antibodies
(huBrE-3 mAb), and continue to
develop on Angiolix.
Assuming
that we begin to sell products based on Angiolix
fifteen (15) years after the
date of the August 2005 agreement, or August
2020, which is our anticipated
development timetable, we would have to pay
to Immunodex an additional
$2,600,000 in maintenance fees during that
time period. In addition, we are
obligated to pay Immunodex a royalty based
on the net sales, if any, of products
based on Angiolix. Further, we are obligated
to develop Angiolix on an agreed
upon timetable. If we fail to achieve any
of the agreed upon clinical
development and regulatory milestones, Immunodex
would then have the right to
terminate the August 2005 agreement, and
if such a termination occurs, we would
be obligated to pay Immunodex a termination
fee of up to $500,000. We are also
entitled to terminate the agreement with
respect to Angiolix upon ninety (90)
days advance notice to Immunodex. If we do
so without cause, we would also be
required to pay a termination fee of up to
$500,000. Notwithstanding the
foregoing, we do not have to pay a termination
fee with respect to Angiolix if
the agreement is terminated due to: (i) negative
results of toxicity testing for
the applicable drug candidate that the FDA
indicates would preclude further
testing of such drug candidate, (ii) a third
party being granted orphan drug
status by the FDA for a drug that would preclude
us from receiving orphan drug
status with respect to the applicable drug
candidate, or (iii) our inability to
achieve commercially viable yields with respect
to the manufacture of the
applicable drug candidate.
If
we
sublicense our rights with respect to Angiolix,
we would be obligated to pay to
Immunodex a sublicensing fee not to exceed
$1,000,000 for each such sublicense
granted based on payments received from each
such sublicensee.
The
term
of the August 2005 agreement expires on the
latter to occur of: (i) the
expiration of the last to expire licensed
patent, or (ii) fifteen (15) years
after the first commercial sale of a product
covered by the licensed patents.
The August 2005 agreement superseded prior
agreements with Immunodex dated
January 25, 2002, March 1, 2002 and September 17, 2002, in each case
related to the same subject matter.
In
February 2006, the Company made a deposit
of $150,000 into an escrow account
pursuant to the agreement. This amount was
released on November 7,
2006.
Effective
November 3, 2006, the Company entered into a Side
Amendment to Patent and
Know-how Exclusive Sublicense Agreement with
Immunodex and the Cancer Research
Institute of Contra Costa (“CRICC”) (the “Side Amendment”). Pursuant to the
Side Amendment, the Company has agreed with
Immunodex and CRICC to reduce the
amount of the annual maintenance fee under
the License Agreement from $250,000
to $200,000 and to defer the annual maintenance
fee that was due in August 2006
until the earlier of (i) the closing of a fundraising resulting in
gross
proceeds to us of at least $5,000,000, or
(ii) January 31, 2007 (the
“2006 Annual Maintenance Fee”). If the Company is unable to timely pay
the 2006
Annual Maintenance Fee, the annual maintenance
fee due under the License
Agreement would revert to $250,000.
The
Company has retained its rights with respect
to huMc-3 mAb and its product
candidate Angiolix; however, the Company
has agreed to suspend the development
of Angiolix until such time as the Company
has paid the 2006 Annual Maintenance
Fee. In addition, each of the product development
milestones with respect to
Angiolix set forth in the License Agreement
has been reset to begin at such time
as we make the 2006 Annual Maintenance Fee
payment.
In
addition, the Company agreed to reimburse
Immunodex for certain out of pocket
expenses in the aggregate amount of approximately
$21,000, which amount was
payable upon the execution of the Side Amendment.
188
On
January 18, 2007 the Company entered into
an Amendment to the Side Amendment
which defers the amounts due on January 31,
2007, including the 2006 Annual
Maintenance Fee, until July 31, 2007. In
consideration for the deferral, the
Company will pay $12,000 for each month of
the deferral. In addition, the
Company paid $2,050 of patent annuity payments.
On
November 8, 2006, the Company made application to
the National Institutes
of Health for a non-exclusive license to
certain patents held by NIH related to
the humanization of Angiolix (huMc-3 mAb). On December 5, 2006 NIH
provided the Company with proposed terms
for a non-exclusive license. On May 15,
2007, the NIH terminated Somanta’s non-exclusive license application since
Somanta had not accepted the terms and had
not executed the proposed license
agreement.
The
School of Pharmacy, University of London
(SOP)
In
March
2004, the Company entered into a Patent and
Know-how Assignment and License
Option Agreement with The School of Pharmacy,
University of London. The
Agreement granted to the Company an option
to acquire the rights to the key
patent application related to di-N-oxides
of chloroethylaminoanthraquinone as a
bioreductive prodrug and an exclusive worldwide
license to the related know-how
for development and commercialization in
the field of the treatment of cancer.
Pursuant to this agreement, the Company paid
an initial option fee of $44,575
and issued 131,505 shares of common stock
valued at $2,630 to The School of
Pharmacy. In September 2005, The School of
Pharmacy formally assigned to the
Company the rights to the key patent application
and the relevant know-how in
the field of the treatment of cancer. The
Agreement obligate the Company to pay
The School of Pharmacy certain milestone
payments based on the achievement of
agreed upon clinical milestones with respect
to the prodrug. If the Company
successfully achieve each of these milestones,
it would be obligated to pay The
School of Pharmacy a total aggregate amount
of milestone payments of
GBP 275,000, or approximately $550,000. The Company
is obligated to use its
commercial best efforts to achieve these
agreed upon clinical milestones. If the
Company fails to achieve any of these agreed
upon clinical milestones, The
School of Pharmacy would have the right to
terminate the know-how license under
the agreement. In addition, the Company is
obligated to pay The School of
Pharmacy a royalty on net sales, if any,
of products based on the prodrug. The
Company has the right to terminate the agreement
with the The School of Pharmacy
on 90 days advance notice, and either party
has the right to terminate the
agreement for breach by the other party upon
90 days advance notice (60 days for
payment failures), if such breach is not
cured within the notice period. In
February, 2006, SOP waived the condition
in the agreement that the Company
assign the patent back to SOP if the Company
was unable to complete a
substantial funding by December 31, 2005.
Virium
Pharmaceuticals, Inc. (Virium)
In
February 2005, Bridge Oncology Products,
Inc. (BOPI), entered into a
Phenylbutyrate Co-development and Sublicense
Agreement with Virium
Pharmaceuticals, Inc. covering the worldwide
rights, excluding the United States
and Canada, for the treatment of cancer,
autoimmune diseases and other clinical
indications. BOPI paid an upfront license
fee of $50,000. As a result of the
exchange agreement with BOPI, the Company
has succeeded to the rights and
obligations under this Agreement. The Company’s single largest stockholder, SCO
Capital Partners, LLC, is also the single
largest stockholder of Virium
Pharmaceuticals, Inc., and the companies
share a common director.
Virium
is
also a party to a sublicense agreement with
VectraMed, Inc. for the rights to
develop and commercialize PB worldwide for
the treatment of cancer, autoimmune
diseases and other clinical indications.
In turn, VectraMed has obtained its
rights to the product under an Exclusive
Patent License Agreement dated
May 25, 1995 with the U.S. Public Health Service
(“PHS”) representing the
National Institutes of Health. VectraMed
subsequently assigned all its rights to
PB to Virium pursuant to a novation agreement
dated May 10, 2005. Virium is
in the process of obtaining PHS approval
for this agreement.
The
Company is responsible for the conduct of
clinical trials and patent prosecution
outside the United States and Canada and
payment of royalties to Virium on net
product sales until such time as the patents
covering such products
expire. These patents expire at various times between
2011 and
2016.
The
Company’s agreement with Virium does not fully comply
with the sublicensing
requirements set forth in Virium’s agreement with the National Institutes
of
Health because it does not expressly incorporate
by reference all of the
relevant sections of Virium’s license with NIH. The Company is currently
seeking to amend its agreement with Virium
to bring it into full compliance with
such sublicensing requirements and to permit
the Company to become a direct
licensee of the NIH, should Virium default
on its license with the
NIH.
On
October 20, 2006, NIH conditionally consented to
the sublicense to the
Company. However, the NIH conditions include
an amendment to the Virium license
to reflect an updated Virium development
plan and milestones, the payment of
$216,971 in past due patent expenses and
the payment of a $5,000 sublicense
royalty. Based on the information provided
by NIH, it appears that about
$200,000 relates to foreign patent expenses
for calendar 2005 which would be the
Company’s responsibility under its license agreement
with Virium. Of that amount, approximately
$12,000 relates to foreign patent
maintenance fees and $197,000 largely relates
to foreign patent legal
expenses. Somanta accrued an additional approximately
$38,700 as patent
annuity and legal expense for the year ended
April 30, 2007. Virium advised
Somanta that they satisfied two of the three
conditions to obtaining final NIH
approval for Somanta’s sublicense. Virium is in the process of
negotiating an
installment payment plan with respect to
the past due patent
expenses.
189
On
December 6, 2006, the Company signed a
letter of intent (LOI) pertaining to a
license and collaboration agreement with
Virium covering all formulations or
drug combinations where Phenylbutyrate
is an active ingredient. Pursuant
to the LOI, in addition to current worldwide
rights, excluding North America,
involving the current formulation of Phenylbutyrate,
Somanta would obtain a
participation in any revenue or royalties
derived from sales in North
America. In return, we would grant Virium a reciprocal
participation in
Europe. In the rest of the world, Somanta and Virium
would share revenues
and royalties equally. The LOI’s terms provide that both companies will,
among
other things, share data and jointly undertake
the necessary pre-clinical and
clinical studies, seek regulatory approvals
and file for patent protection in
all territories. It also provides for the
formation of a joint development
committee to oversee all aspects of the
development and commercialization of
Phenylbutyrate. Completion of the transaction
contemplated by the LOI remains
subject to the negotiation and execution
of a definitive agreement.
COLLABORATIONS
Cancer
Research Institute of Contra Costa (CRICC)
In
August
2005, the Company entered into an Agreement
Regarding Academic Clinical Study
with the Cancer Research Institute of Contra
Costa to provide financial support
for an on-going Phase I-II clinical trial
of patients with recurrent, metastatic
breast cancer using the humanized monoclonal
antibody BrE-3, labeled with
Yttrium-90. In this trial, the antibody
is being administered to patients in
combination with the chemotherapeutic drug,
Xeloda®.
This
agreement superseded a similar agreement
signed in October 2003, which related
to the same subject matter. Pursuant to
this agreement, the Company is obligated
to reimburse the Cancer Research Institute
of Contra Costa over the twenty-four
moths after the date of the agreement for
the costs associated with the
treatment of at least 10 patients with
recurrent, metastatic breast cancer that
are enrolled in the current Phase I/II
clinical trial of Phoenix, which is being
conducted at New York University/Bellevue
Hospital. The Company does not expect
these reimbursement payments to exceed
$300,000 in the aggregate.
Effective
November 3, 2006, the Company entered into a Side
Amendment to Patent and
Know-how Exclusive Sublicense Agreement
with Immunodex and the Cancer Research
Institute of Contra Costa (“CRICC”) (the “Side Amendment”). Pursuant to the
Side Amendment, the Company elected to
terminate the License Agreement with
respect to huBrE-3 mAb product candidate.
As a result, the Company has
terminated all development activities with
respect to huBrE-3 mAb and returned
the related cell lines to Immunodex. In
connection therewith, the Company has
terminated its financial support of the
clinical trial currently being conducted
at New York University with respect to
huBrE-3 mAB (the “huBrE-3 mAb Clinical
Trial”). The Company has agreed to pay a total
of $31,400 to CRICC for the two
patients that were dosed in the huBrE-3
mAb Clinical Trial, which amount shall
become due and payable at the time the
Company becomes obligated to make the
2006 Annual Maintenance Fee payment.
University
of Bradford (“UoB”)
On
March 1, 2006, the Company entered into an agreement
with the University of
Bradford, Leeds, United Kingdom for the
Company to fund a two-year research and
development project staffed by UoB scientists
to evaluate di-N-oxides of
chloroethylaminoanthraquinones as a bioreductive
prodrug and to evaluate and
provide data on chloroethylaminoanthraquinones
to support the requirements to
initial clinical trials. The Company paid
$84,835 and accrued $180,000 for
project costs based on this agreement as
of April 30, 2007. In May 2007, UoB
threaten suit for non-payment of the amounts
owed.
Imperial
College of Science, Technology and Medicine
(“Imperial
College”)
On
July 27, 2006, the Company entered into an agreement
with Imperial College
and a post-graduate student for the Company
to fund a three-year pre-clinical
research project staffed by Imperial College
scientists to evaluate Angiolix
(huMc-3 mAb) for anti-vascular cancer therapy.
The Company has accrued $10,000
for the project costs in the year ended
April 30, 2007.
190
OUT-LICENSING
AGREEMENT
Advanced
Cardiovascular Devices LLC (ACD)
On
August 31, 2004, the Company entered into a
research collaboration and
license agreement with ACD. Under the
agreement Somanta granted to ACD an
exclusive license to use Somanta’s intellectual property, including the
licensed
patent and know-how related to chloroethlylaminoanthraquinone
(see De Montfort
University), a cytotoxic small molecule,
in the field of vascular disorders
using stents and devices in that field.
The term of this agreement expires when
the underlying patent expires in 2015.
ACD agreed to pay Somanta a licensing
fee
at such time as ACD had received funding,
plus milestones, and royalties on
future product sales. In August, 2005,
ACD paid the Company a non-refundable
licensing fee of $10,000. In addition,
ACD is obligated to develop a product
based on the small molecule pursuant
to an agreed-upon timetable. If ACD fails
to achieve any of the agreed upon milestones,
the Company would have the right
to terminate the agreement; provided,
however, that ACD could prevent the
Company from so terminating the agreement
with respect to the applicable failure
by paying the Company a fee not to exceed
$500,000 to reinstate its rights under
the agreement. In addition, ACD is also
obligated to pay the Company a royalty
based on net sales, if any, of products
based on the small molecule. Either
party may terminate this agreement on
30 days advance notice for breach by
the
other party if the breach is not cured
within such 30 day period. In addition,
ACD may terminate the agreement upon
written notice to the Company and without
any further obligation if the licensed
technology does not perform to the
reasonable satisfaction of ACD or cannot
be commercialized because of safety or
efficacy reasons or because ACD is unable
to raise the funds necessary to
develop a product based on the licensed
technology.
15. MERGER
AGREEMENT
On
April
18, 2007, the Company, Somanta Incorporated,
a wholly-owned subsidiary of the
Company and Somanta Limited, a wholly-owned subsidiary of Somanta
Incorporated, and Access Pharmaceuticals,
Inc. (“Access”) and Somanta
Acquisition Corporation (“Merger Sub”), a wholly-owned subsidiary of Access
and
a Delaware corporation, entered into
an Agreement and Plan of Merger (the
“Merger Agreement”). Pursuant to the terms and subject
to the conditions set
forth in the Merger Agreement, Merger
Sub will merge with and into Somanta,
with
Somanta continuing as the surviving corporation
and becoming a wholly-owned
subsidiary of Access (the “Merger”). In addition, Access has received voting
agreements with certain executive officers,
directors and affiliates of Somanta
representing approximately 81% of Somanta’s outstanding common and approximately
60% of its outstanding preferred shares
under which the parties, subject to
certain limited exceptions, have granted
an irrevocable proxy to Access to vote
their shares in favor of the merger.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the
“Effective Time”) will be converted into
500,000 shares of Access common stock.
No fractional shares of Access common
stock will be issued as a result of the
Merger. In addition, all of Somanta’s
preferred stock, including accrued and
unpaid dividends, that is outstanding
at
the Effective Time of the Merger will
be converted into 1,000,000 shares of
Access’ common stock. No shares of Access preferred
stock will be issued as a
result of the Merger.
As
of
April 18, 2007, there were (i) 15,459,137
shares of Somanta’s common stock
outstanding, including 1,166,534 shares
issuable upon the exercise of warrants
that are expected to be exercised prior
to the Effective Time, and (ii) 591.6
shares of Somanta’s preferred stock outstanding. Also as
of April 18, 2007,
there were outstanding warrants to purchase
5,936,304 shares of Somanta’s common
stock that are not expected to be exercised
prior to the Effective Time and are
expected to be converted into warrants
to purchase approximately 192,000 shares
of Access’ common stock (subject to adjustment as
provided in the Merger
Agreement).
The
completion of the Merger is subject to
various conditions to closing, including,
without limitation, obtaining the approval
of the Somanta stockholders. The
Merger is intended to qualify as reorganization
for federal income tax
purposes.
191
UNAUDITED
PRO FORMA CONDENSED COMBINED FINANCIAL
STATEMENTS
The
following unaudited pro forma condensed combined financial statements apply
to
the merger between Somanta, a Delaware corporation, and Access, a Delaware
corporation, by which Somanta will become a wholly owned subsidiary of Access,
and are based upon the historical condensed consolidated financial statements
and notes thereto (as applicable) of Access and Somanta, which are incorporated
by reference into this proxy statement/prospectus. The unaudited pro forma
condensed combined balance sheet gives pro forma effect to the merger as if
the
merger had been completed on March 31, 2007 and combines Access’s March 31, 2007
audited consolidated balance sheet with Somanta’s April 30,
2007 audited consolidated balance sheet. The unaudited pro forma condensed
combined statement of operations gives pro forma effect to the merger as if
it
had been completed on January 1, 2006 and combines Access’
audited consolidated statement of operations for the year ended December
31, 2006, with Somanta’s unaudited consolidated statement of operations for the
twelve months ended January 31, 2007.
Somanta
preferred and common stockholders are expected to receive 1,500,000 shares
of
Access common stock for Somanta common stock they own at the completion of
the
merger.
The
pro
forma adjustments are based upon available information and certain assumptions
that Access believes are reasonable under the circumstances. A final
determination of fair values relating to the merger, which cannot be made prior
to the completion of the merger, may differ materially from the preliminary
estimates and will include management’s final valuation of the fair value of
assets acquired and liabilities assumed. This final valuation will be based
on
the actual net tangible assets of Somanta that exist as of the date of the
completion of the merger. The final valuation may change the allocations of
the
purchase price, which could affect the fair value assigned to the assets and
liabilities and could result in a change to the unaudited pro forma condensed
combined financial statements data.
These
unaudited pro forma condensed combined financial statements should be read
in
conjunction with the historical consolidated financial statements and related
notes contained in the annual, quarterly and other reports filed by Access
and
Somanta with the SEC. See “Additional Information—Where You Can Find More
Information” beginning on page 205.
192
Pro
Forma Condensed Combined Balance Sheet
As
of March 31, 2007
(Unaudited)
Historical
|
Access
|
Somanta
|
Pro
Forma
Adjustments
|
Pro
Forma
Combined
|
|||||||||||||
|
ASSETS
|
||||||||||||||||
|
Current
assets
|
||||||||||||||||
|
Cash
and cash equivalents
|
$
|
359,000
|
$
|
5,000
|
$
|
364,000
|
||||||||||
|
Short
term investments, at cost
|
2,724,000
|
-
|
2,724,000
|
|||||||||||||
|
Receivables
|
356,000
|
-
|
356,000
|
|||||||||||||
|
Prepaid
expenses and other current
expenses
|
357,000
|
43,000
|
400,000
|
|||||||||||||
|
Total
current assets
|
3,796,000
|
48,000
|
3,844,000
|
|||||||||||||
|
Property
and equipment, net
|
207,000
|
17,000
|
224,000
|
|||||||||||||
|
Patents
net
|
836,000
|
-
|
836,000
|
|||||||||||||
|
Licenses,
net
|
12,000
|
-
|
12,000
|
|||||||||||||
|
Other
assets
|
25,000
|
2,000
|
27,000
|
|||||||||||||
|
Total
assets
|
$
|
4,876,000
|
$
|
67,000
|
$
|
4,943,000
|
||||||||||
|
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||||||||||
|
Current
liabilities
|
||||||||||||||||
|
Accounts
payables and accrued expenses
|
$
|
1,232,000
|
$
|
2,141,000
|
488,000
|
(c,d
|
)
|
$
|
3,861,000
|
|||||||
| Due to related parties | - | 242,000 |
242,000
|
|||||||||||||
|
Liquidated
damages related to Series A
|
-
|
35,000
|
(35,000
|
)
|
(b
|
)
|
-
|
|||||||||
|
Accrued
interest payable
|
899,000
|
-
|
899,000
|
|||||||||||||
|
Deferred
revenues
|
173,000
|
7,000
|
180,000
|
|||||||||||||
|
Warrant
liabilities
|
-
|
5,787,000
|
1,000,000
|
|
|
(a
|
)
|
1,000,000
|
||||||||
| (5,787,000 | ) |
(b
|
) | |||||||||||||
|
Current
portion of long-term debt
net
of discount
|
10,794,000
|
33,000
|
(33,000
|
) | (d | ) |
10,794,000
|
|||||||||
|
Total
current liabilities
|
13,098,000
|
8,245,000
|
16,976,000
|
|||||||||||||
|
Long-term
debt
|
5,500,000
|
-
|
5,500,000
|
|||||||||||||
|
Total
liabilities
|
18,598,000
|
8,245,000
|
22,476,000
|
|||||||||||||
|
Stockholders’
deficit
|
||||||||||||||||
|
Preferred
stock
|
-
|
-
|
-
|
|||||||||||||
|
Common
stock
|
35,000
|
14,000
|
15,000
(14,000
|
)
|
(a
(b
|
)
)
|
50,000
|
|||||||||
|
Additional
paid-in capital
|
69,091,000
|
7,604,000
|
6,485,000
(7,604,000
|
)
|
(a
(b
|
)
)
|
75,576,000
|
|||||||||
|
Notes
receivable from stockholders
|
(1,045,000
|
)
|
-
|
(1,045,000
|
)
|
|||||||||||
|
Treasury
stock, at cost
|
(4,000
|
)
|
-
|
(4,000
|
)
|
|||||||||||
| Accumulated deficit | (81,799,000 | ) | (15,796,000 | ) | (7,500,000 | ) | (a | ) | (92,110,000 | ) | ||||||
|
|
|
|
|
|
(2,356,000
15,796,000
(455,000
|
)
)
|
(b
(b
(c
|
)
)
)
|
|
|||||||
|
Total
stockholders’ deficit
|
(13,722,000
|
)
|
(8,178,000
|
)
|
(17,533,000
|
)
|
||||||||||
|
Total
liabilities and stockholders’ deficit
|
$
|
4,876,000
|
$
|
67,000
|
$
|
4,943,000
|
||||||||||
See
accompanying Notes to Pro Forma Condensed Combined Balance Sheet
193
Notes
to Pro Forma Condensed Combined Balance Sheet
Note
1:
The above statement gives effect to the following pro forma adjustments
necessary to reflect the merger of Access and Somanta, as if the transaction
had
occurred January 1, 2007. Somanta statements used were January 31,
2007.
| a) |
To
record the exchange, for accounting purposes, by Somanta shareholders
of
their common stock (valued at $7,500,000) for 1,500,000 shares of
Access
(or 1,500,000 shares valued at the estimated stock price of $5.00
per
share) and record $1,000,000 in new warrant liability. The value
placed on
the shares was determined based on negotiation between the companies
of
the amount of Access shares to issue to Somanta shareholders and
the
estimated stock price of $5.00 per share. The excess purchase price
over
the fair value of Somanta's assets acquired is being charged to
deficit.
|
| b) |
To
eliminate the shareholders equity section and warrant liabilities
of
Somanta in connection with the merger and credit the net equity to
combined deficit.
|
| c) |
Accrual
of $455,000 of estimated legal, accounting and other professional
fees
relating to the merger.
|
After
the
consummation of the transactions described herein, Access will have 100,000,000
common shares authorized, approximately 5,041,394 common shares issued and
outstanding, 2,000,000 preferred shares authorized and no preferred shares
issued.
194
Pro
Forma Condensed Combined Statement of Operations
For
the Three Months Ended March 31, 2007
(Unaudited)
Historical
|
Access
|
Somanta
|
Pro
Forma
Combined
|
||||||||
|
Revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
|
Expenses
|
||||||||||
|
Research
and development
|
413,000
|
214,000
|
624,000
|
|||||||
|
General
and administrative
|
1,139,000
|
450,000
|
1,589,000
|
|||||||
|
Depreciation
and amortization
|
75,000
|
-
|
75,000
|
|||||||
|
Total
expenses
|
1,627,000
|
664,000
|
2,291,000
|
|||||||
|
Loss
from operations
|
(1,627,000
|
)
|
(664,000
|
)
|
(2,291,000
|
)
|
||||
|
Interest
and miscellaneous income
|
35,000
|
2,000
|
37,000
|
|||||||
|
Interest
and other expenses
|
(2,535,000
|
)
|
-
|
(2,535,000
|
)
|
|||||
|
Change
in fair value of warrant
liabilities
|
-
|
(2,775,000
|
)
|
(2,775,000
|
)
|
|||||
|
Currency
translation loss
|
-
|
(1,000
|
)
|
(1,000
|
)
|
|||||
|
(2,500,000
|
)
|
(2,774,000 |
)
|
(5,274,000
|
)
|
|||||
| Loss From Operations | (4,127,000 | ) | (3,438,000 | ) | (7,565,000 | ) | ||||
| Income Tax | - | - | - | |||||||
|
Net
loss
|
$
|
(4,127,000
|
)
|
$
|
(3,438,000
|
)
|
$
|
(7,565,000
|
)
|
|
|
Basic
and diluted loss per
common
share
|
$
|
(1.17
|
)
|
$
|
(0.25
|
)
|
$
|
(1.50
|
)
|
|
|
Weighted
average basic and
diluted
common shares
outstanding
|
3,535,197
|
14,274,534
|
5,035,197
|
|||||||
Notes
to
Pro Forma Condensed Combined Statement of Operations
Note
1:
The above statement gives effect to the merger of Access and Somanta, as if
the
merger had occurred on January 1, 2006. Somanta statements used were for the
three months ended January 31, 2007.
Note
2:
The pro forma combined-weighted average number of common outstanding shares
is
based on the weighted average number of shares of common stock of Access during
the period plus those shares to be issued in conjunction with the merger. A
reconciliation between Access' historical weighted average shares outstanding
and pro forma weighted average shares outstanding and pro forma weighted average
shares outstanding is as follows:
| Historical | 3,535,197 | |
| Somanta equivalent shares giving effect to the merger | 1,500,000 | |
| Total | 5,035,197 |
195
Pro
Forma Condensed Combined Statement of Operations
For
the Twelve Months Ended December 31, 2006
(Unaudited)
Historical
|
Access
|
Somanta
|
Pro
Forma
Combined
|
||||||||
|
Revenue
|
$
|
-
|
$
|
1,000
|
$
|
1,000
|
||||
|
Expenses
|
||||||||||
|
Research
and development
|
2,053,000
|
1,362,000
|
3,415,000
|
|||||||
|
General
and administrative
|
2,813,000
|
3,392,000
|
6,205,000
|
|||||||
|
Depreciation
and amortization
|
309,000
|
-
|
309,000
|
|||||||
|
Total
expenses
|
5,175,000
|
4,754,000
|
9,929,000
|
|||||||
|
Loss
from operations
|
(5,175,000
|
)
|
(4,753,000
|
)
|
(9,928,000
|
)
|
||||
|
Interest
and miscellaneous income
|
294,000
|
43,000
|
337,000
|
|||||||
|
Interest
and other expenses
|
(7,436,000
|
)
|
-
|
(7,436,000
|
)
|
|||||
|
Liquidated
damages
|
-
|
(35,000
|
)
|
(35,000
|
)
|
|||||
|
Change
in fair value of warrant
liabilities
|
(1,107,000
|
)
|
(2,243,000
|
)
|
(3,350,000
|
)
|
||||
|
Currency
translation loss
|
-
|
(4,000
|
)
|
(4,000
|
)
|
|||||
|
(8,249,000
|
)
|
(2,239,000
|
)
|
(10,488,000
|
)
|
|||||
|
Net
loss before discontinued
operations
and before tax benefit
|
(13,424,000
|
)
|
(6,992,000
|
)
|
(20,416,000
|
)
|
||||
|
Income
tax benefit
|
173,000
|
(2,000
|
)
|
171,000
|
||||||
|
Loss
from continuing operations
|
(13,251,000
|
)
|
(6,994,000
|
)
|
(20,245,000
|
)
|
||||
|
Discontinued
operations, net of
taxes
of $173,000
|
377,000
|
-
|
377,000
|
|||||||
|
Net
loss
|
$
|
(12,874,000
|
)
|
$
|
(6,994,000
|
)
|
$
|
(19,868,000
|
)
|
|
|
Basic
and diluted loss per common share
|
||||||||||
|
Loss
from continuing operations
allocable
to common
stockholders
|
|
(3.76
|
)
|
|
(0.53
|
)
|
|
(4.02
|
)
|
|
|
Discontinued
operations
|
0.11
|
-
|
0.07
|
|||||||
|
Net
loss allocable to common
Stockholders
|
$
|
(3.65
|
)
|
$
|
(0.53
|
)
|
$
|
(3.95
|
)
|
|
|
Weighted
average basic and
diluted
common shares
outstanding
|
3,531,934
|
14,274,534
|
5,031,934
|
|||||||
Notes
to
Pro Forma Condensed Combined Statement of Operations
Note
1:
The above statement gives effect to the merger of Access and Somanta, as if
the
merger had occurred on January 1, 2006. Somanta statements used were for the
twelve months ended January 31, 2007.
Note
2:
The pro forma combined-weighted average number of common outstanding shares
is
based on the weighted average number of shares of common stock of Access during
the period plus those shares to be issued in conjunction with the merger. A
reconciliation between Access' historical weighted average shares outstanding
and pro forma weighted average shares outstanding and pro forma weighted average
shares outstanding is as follows:
| Historical | 3,531,934 | |
| Somanta equivalent shares giving effect to the merger | 1,500,000 | |
| Total | 5,031,934 |
196
COMPARISON
OF STOCKHOLDER RIGHTS AND CORPORATE GOVERNANCE MATTERS
Both
Access and Somanta are incorporated under the laws of the State of Delaware
and,
accordingly, the rights of the stockholders of each are governed by the DGCL.
Before the completion of the merger, the rights of Somanta stockholders are
also
governed by the Somanta certificate of incorporation, and the Somanta bylaws.
Upon completion of the merger, Somanta stockholders will receive Access common
stock in exchange for their shares of Somanta common stock. As a result, upon
completion of the merger, the rights of Somanta stockholders who become Access
stockholders in the merger will be governed by the DGCL, the Access certificate
of incorporation, and the Access bylaws.
The
following is a summary of material differences between the current rights of
Access stockholders and the current rights of Somanta stockholders. While we
believe that this summary covers the material differences between the two,
this
summary may not contain all of the information that is important to you. This
summary is not intended to be a complete discussion of the respective rights
of
Access and Somanta stockholders and it is qualified in its entirety by reference
to the various documents of Access and Somanta to which we refer in this
summary. We urge you to carefully read this entire proxy statement/prospectus,
the relevant provisions of the DGCL and the other documents to which we refer
in
this proxy statement/prospectus for a more complete understanding of the
differences between being an Access stockholder and being a Somanta stockholder.
Access and Somanta have filed with the SEC their respective documents referenced
in this summary of stockholder rights and will send copies of these documents
to
you, without charge, upon your request. See “Additional Information—Where You
Can Find More Information” beginning on page 205.
|
Provision
|
Access
Common Stock and
Preferred
Stock
|
Somanta
Common Stock and Preferred
Stock
|
|
|
||
|
ELECTIONS;
VOTING PROCEDURAL MATTERS
|
||
|
|
|
|
|
Authorized Capital Stock
|
Access’ certificate of incorporation
authorizes the issuance of up to 102,000,000 shares, each with a
par value
of $0.01 per share. Of the total authorized shares, 100,000,000 shares
shall be common stock and 2,000,000 shares shall be preferred
stock.
|
Somanta’s certificate of incorporation
authorizes the issuance of up to 120,000,000 shares, each with a
par value
of $0.001 per share. Of the total authorized shares, 100,000,000
shares
shall be common stock and 20,000,000 shares shall be preferred
stock.
|
|
|
|
|
|
Number of Directors
|
Access’ bylaws provide that the board of
directors shall consist of between five (5) and fifteen (15) directors,
and unless otherwise provided in the certificate of incorporation,
the
board of directors shall have the exclusive power to establish the
size of
the board of directors. Currently there are 12 members on the board
of Access.
|
Somanta’s bylaws provide that the board
of directors shall have the exclusive power to establish the size
of the
board of directors. Currently there are five (5) members on the
board of Somanta.
|
|
|
|
|
|
Stockholder Nominations and
Proposals
|
Access’ most recent proxy statement dated
April 16, 2007, provides that the 2008 annual meeting of stockholders
is
expected to be held on or about May 15, 2008. The Access board will
make
provisions for the presentation of proposals submitted by eligible
stockholders who have complied with the relevant rules and regulations
of
the SEC. Proposals must be received by Access no later than December
14,
2007 to be considered for inclusion on the Access proxy statement
and form
of proxy relating to that meeting, and no later than March 4, 2008
for all
other proposals.
|
Somanta’s bylaws provide that, in order
for a stockholder to make a director nomination or propose business
at an
annual meeting of the stockholders, the stockholder must give timely
written notice to Somanta’s secretary not later than the close of business
on the 90th day nor earlier than the 120th day prior to the first
anniversary of the preceding year’s annual meeting (with certain
adjustments if the date of the annual meeting is advanced by more
than 30
days or delayed by more than 30 days from the first anniversary of
the
preceding year’s annual meeting).
|
197
|
|
|
|
|
Classified Board of Directors
|
Except as otherwise provided in Access’
bylaws or in its certificate of incorporation, the board of directors
shall be divided into three (3) classes as nearly equal in number
as
possible. Each director will be elected at the appropriate annual
meeting and will hold officer for a term of three (3) years and until
his
successor is elected and qualified or until his earlier resignation
or
removal.
|
Somanta’s certificate of incorporation
and bylaws do not provide for the division of the board of directors
into
classes.
|
|
Removal of Directors
|
Access’ certificate of incorporation
provides that any director of the entire board of directors may be
removed
from office at any time, but only for cause and only upon the affirmative
vote of the holders of at least 66 2/3% of the shares entitled to
vote in
the election of directors.
|
Under Somanta’s bylaws, subject to the
certificate of incorporation, the board of directors or any individual
director may be removed from office at any time without cause by
the
affirmative vote of the holders of at least a majority of the outstanding
shares entitled to vote on such removal.
|
|
|
|
|
|
Special Meetings of Stockholders
|
Access’ bylaws provide that a special
meeting of the board of directors or any committee designated by
the board
may be called at any time by the chairman of the board, if any, by
the
president or by a majority of the members of the board of directors
or any
such committee as the case may be.
|
Somanta’s bylaws provide that a special
meeting of the stockholders may be called by the board of directors
pursuant to a resolution adopted by a majority of the total number
of
authorized directors.
|
|
|
|
|
|
Cumulative Voting
|
Access’ bylaws provide that every
stockholder entitled to vote for the election of directors shall
have the
right to vote the number of shares owned by him for as many persons
as
there are directors to be elected and cumulative voting in the election
of
such directors shall be permitted.
|
Somanta’s bylaws provide that no person
entitled to vote at an election for directors may cumulate their
votes,
unless at the time of the election, Somanta is subject to Section
2115(b)
of the CGCL.
|
|
|
|
|
|
Vacancies
|
Access’ bylaws provide that, any vacancy
or newly created directorships on the board of directors will be
filled by
the affirmative vote of a majority of the directors in office, although
less than a quorum.
|
Somanta’s bylaws provide that, unless
otherwise provided in the certificate of incorporation, and subject
to the
rights of the holders of any series of preferred stock, any vacancy
or
newly created directorships on the board of directors will be filled
by
the affirmative vote of a majority of the directors in office even
if less
than a quorum.
|
198
|
Voting Stock
|
Under Access’ certificate of
incorporation, each stockholder of common stock shall have one vote
for
each share of stock standing in his name on the books of Access and
entitled to vote.
Under Access’ certificate of designation,
a holder of Access Series A preferred stock (none of which is currently
outstanding) would be entitled to 100 votes, for each share of Series
A
preferred stock held, on all matters submitted to a vote of the
stockholders of Access, voting together with the common as a single
class.
The number of shares a holder of
Series A
preferred stock would be entitled to vote is subject to adjustment
for any
dividends on common stock which are paid in common stock or combination
or
consolidation of the outstanding shares of common stock by
reclassification or otherwise into a greater or lesser number of
shares of
common stock.
|
Under Somanta’s certificate of
incorporation the holders of common stock have the right to one vote
per
share of common stock.
Under Somanta’s certificate of
designations, each holder of outstanding Series A preferred stock
shall be
entitled to cast the number of votes equal to the number of whole
shares
of common stock into which the Series A preferred stock is
convertible. Except as provided in certain provisions in the
certificate of designation with respect to the Series A preferred
stock,
the Series A preferred stock shall vote together with the holders
of
common stock as single class.
|
|
|
|
|
|
Stockholder Action by Written
Consent
|
Access bylaws provide that, any action
required to be taken at a meeting of stockholders, or any action
which may
be taken at a meeting of stockholders, may be taken without a meeting,
without prior notice and without a vote, if a consent in writing
setting
for the action so taken, shall be signed by the holders of outstanding
stock having not less than the minimum number of votes that would
be
necessary to authorize or take such action at a meeting at which
all
shares entitled to vote thereon were present and voted.
|
Somanta’s bylaws provide that, unless
otherwise provided in the certificate of incorporation, any action
to be
taken at any annual meeting of the stockholders, may be taken without
a
meeting, without prior notice and without a vote, if a consent in
writing,
setting forth the action, is signed by the holders of outstanding
stock
having not less that the minimum number of votes that would be necessary
to take such action at a meeting at which all shares entitled to
vote were
present and voted. Prompt notice of the taking of the corporate
action without a meeting by less than unanimous consent will be given
to
those stockholders who have not consented in writing.
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Notice of Meetings
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Under Access bylaws, written notice
of
each stockholder meeting must include the date, time and place of
such
meeting. Notice will be given not less than 10 nor more than 60 days
prior to the date of the meeting to each stockholder entitled to
vote at
such meeting.
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Under Somanta’s bylaws, written notice of
each stockholder meeting must include the date, time and place of
such
meeting. Notice will be given not less than 10 nor more than 60 days
prior to the date of the meeting to each stockholder entitled to
vote at
such meeting. In the case of a special meeting the purpose or
purposes of the meeting shall be provided.
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199
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Stockholders Rights Plan
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Access is a party to a stockholder
rights agreement under which holders of Access common stock as of
a
certain date are entitled to the right to purchase Access Series
A
preferred stock. The right will become exercisable only if a person
or
group (a) acquires 15% (20% in the case of Heartland Advisors, Inc,
or
Oracle Partners LP) or more of Access’ common stock or (b) announces a
tender offer that would result in ownership of 15% (20% in the case
of
Heartland Advisors, Inc, or Oracle Partners LP) or more of the common
stock. Each right may entitle its holder (other than the 15% person
or
group) to receive upon exercise of the right, a one one-hundredth
of a
share of Series A preferred Stock. Holders of such Series A preferred
stock shall be entitled to certain rights including a minimum quarterly
dividend payments, voting rights, and consideration upon a change
in
control of Access.
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Conversion Rights and Protective
Provisions
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Under Access’ certificate of designation,
each share of Series A preferred stock (none of which is currently
outstanding) would be convertible into 100 shares of Access common
stock
subject to adjustment for any dividends on common stock which are
paid in
common stock or combination or consolidation of the outstanding shares
of
common stock by reclassification or otherwise into a greater or lesser
number of shares of common stock.
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Under Somanta’s certificate of
designations, each share of Series A preferred stock is convertible,
at
the option of the holder thereof at any time and shall convert at
Somanta’s election upon a Conversion Triggering Event (as defined in the
certificate of designation) and shall automatically convert upon
a
Qualified Change in Control (as defined in the certificate of
designation).
Somanta’s certificate of designations
provides that, upon certain terms and conditions, the holders of
Somanta
Series A preferred stock shall have a right to participate with respect
to
the issuance or possible issuance by Somanta of any future equity
or
equity linked securities.
Somanta’s certificate of designations
provides that upon a change in control (as defined in the certificate
of
designations) the successor corporation shall expressly assume the
due and
punctual observance and performance of each and every covenant and
condition contained in the certificate of designations.
In accordance with the certificate
of
designations of Somanta’s Series A preferred stock, holders of a majority
of the Series A preferred stock of Somanta have acknowledged and
agreed
that if the stockholders of Somanta approve the merger agreement
and the
transactions contemplated thereby, then each share of preferred stock
will
be exchanged for common stock of Access and all the rights, preferences
and privileges associated with such Series A preferred stock will
cease to
exist as of the closing of the merger.
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200
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INDEMNIFICATION
OF OFFEICERS AND DIRECTORS AND ADVANCEMENT OF
EXPENSES; LIMITATION ON PERSONAL LIABILITY
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Indemnification
|
Access’ certificate of incorporation
provides that Access shall indemnify all persons to the extent and
in the
manner permitted by the provisions of the DGCL, subject to any permissible
expansion or limitation of such indemnification as may be set forth
in the
bylaws or any stockholder or director resolution or by contract.
Additionally, no director of Access shall be liable to Access or
its
stockholders for monetary damages for a breach of fiduciary duty
as a
director, except for liability for: (i) breach of the director’s duty of
loyalty, (ii) acts or omissions not in good faith or which involve
intentional misconduct, (iii) unlawful payment of dividends or unlawful
repurchases or redemptions, or (iv) any transaction from which the
directors derived an improper personal benefit.
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Somanta’s bylaws provide that Somanta
shall indemnify any director or officer and shall have the power
to
indemnify any employee or agent, to the fullest extent not
prohibited by the DGCL or any other applicable law. Somanta shall
not be required to indemnify any director or officer in connection
with
any proceeding initiated by such person unless (i) such indemnification
is
expressly required by law, (ii) the proceeding was authorized by
the board
of directors, (iii) such indemnification is provided by Somanta,
in its
sole discretion, pursuant to the powers vested in Somanta under DGCL
or
other applicable law, and (iv) such indemnification is order by any
court
of competent jurisdiction.
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Advancement of Expenses
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Somanta’s bylaws provide that Somanta
shall advance expenses to any person who was or is made a party or
is
threatened to be made a party to or is otherwise involved in any
action,
suit or proceeding, whether civil, criminal, administrative or
investigative, by reason of being or having been a director or officer,
of
Somanta, or is or was serving at the request of Somanta as a director
or
officer of another corporation, partnership, joint venture, trust
or other
enterprise, provided, however, that if the DGCL so requires, such
advancement of expenses shall be made only upon delivery to Somanta
of any
undertaking by such person to repay all amounts so advanced if there
is a
final judgment that such person is not entitled to be indemnified
for such
expenses.
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201
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DIVIDENDS
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Declaration and Payment of
Dividends
|
Access’ bylaws provide that dividends
shall be declared and paid out of any surplus or net profits for
the
fiscal year in which the dividend is declared, and/or the preceding
fiscal
year as often and at such times as the board of directors may
determine. If the capital of Access is diminished by depreciation of
property, or by losses, or otherwise, to an amount less than the
aggregate
amount of the capital represented by the issued and outstanding stock;
the
board of directors shall not declare and pay out of net profits any
dividends upon any shares of its capital stock until the deficiency
in the
amount of capital represented by issued and outstanding stock shall
have
been repaired.
While dividends will accrue on
outstanding shares of preferred stock, subject to the provisions
of
Access’ certificate of designation, Access shall be under no obligation to
pay such accruing dividends, provided, however, that Access shall
not
declare, pay or set aside any dividends on any other shares of capital
stock of Access unless the holders of preferred stock then outstanding
shall first receive the dividend to which they are entitled pursuant
to
the terms of Access’ certificate of designation.
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Somanta’s certificate of incorporation
provides that when determined by the board of directors and subject
to the
preferential dividend rights of the preferred stock, dividends may
be paid
on the common stock from funds lawfully available for such purpose.
While dividends will accrue on outstanding shares of preferred
stock, subject to the provisions of Somanta’s certificate of designation,
Somanta shall be under no obligation to pay such accruing dividends,
provided, however, that Somanta shall not declare, pay or set aside
any
dividends on any other shares of capital stock of Somanta unless
the
holders of preferred stock then outstanding shall first receive the
dividend to which they are entitled pursuant to the terms of Somanta’s
certificate of designation.
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202
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AMENDMENTS
TO ARTICLES OF INCORPORATION, CERTIFICATE OF
DESIGNATION OR BYLAWS
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General Provisions
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Access’ certificate of incorporation
provides that Access reserves the right to amend or repeal any provision
of the certificate of incorporation. Certain provision of the
certificate of incorporation may not be altered or amended without
the
affirmative vote of the holders of at least 66-2/3% of the shares
entitled
to vote.
Access’ bylaws provide that subject to
repeal or change by action of the stockholders in accordance with
the
certificate of incorporation, the board of directors may amend, supplement
or repeal the bylaws.
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Somanta’s certificate of incorporation
provides that Somanta reserves the right to amend or repeal any provision
of the certificate of incorporation. Certain provision of the
certificate of incorporation may not be altered or amended without
the
affirmative vote of the holders of at least 66-2/3% of the voting
power of
all the then outstanding shares of capital stock of Somanta entitled
to vote, voting together as a single class.
Somanta’s certificate of designation
provides that the certificate may be amended, altered or repealed
upon the
affirmative vote of the holders of at least a majority of the shares
of
preferred stock outstanding.
Somanta’s certificate of incorporation
provides that Somanta’s board of directors is expressly empowered to
adopt, amend or repeal the bylaws. The stockholders shall also have
the power to adopt, amend or repeal the bylaws. Any adoption,
amendment or repeal of the bylaws by the stockholders shall require,
in
addition to any vote of the holders of any class of series of stock
of
Somanta required to vote, the affirmative vote of 66-2/3% of the
voting
power of all the then outstanding shares of capital stock of Somanta
entitled to vote, voting together as a single class.
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203
ADDITIONAL
INFORMATION
Pursuant
to Rule 14a-8 under the Exchange Act, stockholders may present proposals for
inclusion in a company’s proxy statement and for consideration at the next
annual meeting of its stockholders by submitting their proposals to the company
in a timely manner.
Somanta
If
the
merger is not completed or if it would otherwise be required to do so under
applicable law, Somanta will hold its 2007 annual meeting of stockholders.
For
any proposal to be considered for inclusion in the Somanta proxy statement
and
form of proxy for submission to the Somanta stockholders at the Somanta 2007
annual meeting, it must comply with the requirements of Rule 14a-8 under the
Exchange Act and be submitted in writing by notice delivered or mailed by
first-class United States mail, postage prepaid, to Somanta Pharmaceuticals,
Inc., 19200 Von Karman Avenue, Suite 400, Irvine, California 92612, Attention:
Secretary. The submission of a stockholder proposal does not guarantee that
it
will be included in the Somanta 2007 proxy statement.
In
accordance with Somanta’s bylaws and SEC rule 14a-8, in order to be properly
brought before the Somanta 2007 annual meeting, a stockholder’s notice of the
matter the stockholder wishes to present, or the person or persons the
stockholder wishes to nominate as a director, must be delivered to Somanta’s
secretary at Somanta’s principal executive offices not less than 90 nor more
than 120 days before Somanta’s 2007 annual meeting. As a result, any notice
given by a stockholder pursuant to these provisions must be received no earlier
than May 9, 2007 and no later than June 8, 2007, unless Somanta’s 2007
annual meeting date is more than 30 days before or after September 6, 2007.
If
Somanta’s 2007 annual meeting date is advanced or delayed by more than 30 days
from September 6, 2007, then proposals must be received not less than 90 nor
more than 120 before Somanta’s 2007 annual meeting or the 10th
day following the date on which the meeting date is publicly announced.
To
be in
proper form, a stockholder’s notice must include the specified information
concerning the proposal or nominee as described in Somanta’s bylaws. A
stockholder who wishes to submit a proposal or nomination is encouraged to
seek
independent counsel about Somanta’s bylaws and SEC requirements. Somanta will
not consider any proposal or nomination that does not meet the bylaw
requirements and the SEC’s requirements for submitting a proposal or nomination.
Notices
of intention to present proposals at Somanta’s 2007 annual meeting should be
addressed to Somanta Pharmaceuticals, Inc., Attention: Secretary, 19200 Von
Karman Avenue, Suite 400, Irvine, California 92612. Somanta reserve the right
to
reject, rule out of order, or take other appropriate action with respect to
any
proposal that does not comply with these and other applicable requirements.
The
consolidated financial statements for
the
Access Annual Report on Form 10-KSB for the year ended December 31, 2006
included in this registration statement have been audited by Whitley Penn
LLP, independent registered public accountants, as indicated in their
report with respect thereto, and are included herein in reliance upon the
authority of said firm as experts in auditing and accounting.
The
consolidated financial statements as of December 31, 2005 and for each of
the
two years in the period ended December 31, 2005 included in this registration
statement have been audited by Grant Thornton LLP, independent registered
public
accountants, as indicated in their report with respect thereto, and are included
herein in reliance upon the authority of said firm as experts in accounting
and
auditing.
The
consolidated financial statements of Somanta as of April 30, 2007 and for
each of the two years in the period ended April 30, 2007 included in
this registration statement have been audited by Stonefield
Josephson, Inc., independent registered public accountants, as indicated in
their report with respect thereto, and are included herein in reliance upon
the
authority of said firm as experts in accounting and auditing.
None
of
the independent public registered accounting firms named above have any interest
in the merger.
204
Householding
of Proxy Materials
The
SEC
has adopted rules that permit companies and intermediaries (e.g. brokers)
to
satisfy the delivery requirements for proxy statements and annual reports
to two
or more stockholders sharing the same address by delivering a single proxy
statement addressed to those stockholders. This process, which is commonly
referred to as "householding," potentially means extra convenience for
stockholders and cost savings for companies.
This
year, a number of brokers with account holders who are our stockholders will
be
"householding" our proxy materials. A single proxy statement will be delivered
to multiple stockholders sharing an address unless contrary instructions
have
been received from affected stockholders. Once you have received notice from
your broker that they will be "householding" communications to your address,
"householding" will continue until you are notified otherwise or until you
revoke your consent. If, at any time, you no longer wish to participate in
"householding" and would prefer to receive a separate proxy statement and
annual
report, please notify your broker, and direct your written request to Somanta
Pharmaceuticals, Inc., 19200 Von Karman Avenue, Suite 400, Irvine, California
or
call us at (949) 477-8090. Stockholders who currently receive multiple copies
of
the proxy statement at their address and would like to request "householding"
of
their communications should contact their broker.
Access
and Somanta file annual, quarterly and current reports, proxy statements and
other information with the SEC. You may read and copy these reports, statements
or other information filed by either Access or Somanta at the SEC’s Public
Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. Please call
the SEC at 1-800-SEC-0330 for further information on the public reference rooms.
The SEC filings of Access and Somanta are also available to the public from
commercial document retrieval services and at the website maintained by the
SEC
at www.sec.gov.
Access
has filed a registration statement on Form S-4 to register with the SEC the
Access common stock to be issued to Somanta stockholders in the merger. This
proxy statement/prospectus is a part of that registration statement and
constitutes a prospectus of Access, in addition to being a proxy statement
of
Somanta for Somanta’s special meeting. The registration statement, including the
attached annexes, exhibits and schedules, contains additional relevant
information about Access, Access common stock and Somanta. As allowed by SEC
rules, this proxy statement/prospectus does not contain all the information
you
can find in the registration statement or the exhibits to the registration
statement.
Access
and Somanta incorporate by reference the agreement and plan of merger attached
to this proxy statement/prospectus as Annex A.
Access
has supplied all information contained in or incorporated by reference into
this
proxy statement/prospectus relating to Access and Somanta has supplied all
information contained in or incorporated by reference into this proxy
statement/prospectus relating to Somanta.
You
may
obtain copies of the information relating to Access, without charge, by sending
an e-mail to akc@accesspharma.com or by calling (214) 905-5100.
You
may
obtain copies of the information relating to Somanta, without charge, by sending
an e-mail to t.bruggeman@somanta.com or by calling (949) 477-8090.
IN
ORDER FOR YOU TO RECEIVE TIMELY DELIVERY OF THE DOCUMENTS IN ADVANCE OF THE
SOMANTA SPECIAL MEETING, ACCESS OR SOMANTA, AS APPLICABLE, SHOULD RECEIVE YOUR
REQUEST NO LATER THAN AUGUST 14, 2007.
We
have
not authorized anyone to give any information or make any representation about
the merger or the companies that is different from, or in addition to, that
contained in this proxy statement/prospectus or in any of the materials that
are
incorporated into this proxy statement/prospectus. Therefore, if anyone does
give you information of this sort, you should not rely on it. If you are in
a
jurisdiction where offers to exchange or sell, or solicitations of offers to
exchange or purchase, the securities offered by this proxy statement/prospectus
or the solicitation of proxies is unlawful, or if you are a person to whom
it is
unlawful to direct these types of activities, then the offer presented in this
proxy statement/prospectus does not extend to you. The information contained
in
this proxy statement/prospectus is accurate only as of the date of this document
unless the information specifically indicates that another date applies.
205
Annex
A
AGREEMENT
AND PLAN OF MERGER
DATED
AS OF April 18, 2007
BY
AND AMONG
ACCESS
PHARMACEUTICALS, INC.,
SOMANTA
ACQUISITION CORPORATION,
SOMANTA
PHARMACEUTICALS, INC.,
SOMANTA
INCORPORATED,
AND
SOMANTA
LIMITED
TABLE
OF CONTENTS
Page
ARTICLE I. THE
MERGER................................................................................
2
1.01.... The
Merger..........................................................................................
2
1.02....
Closing................................................................................................
2
1.03.... Effective Time of the
Merger.............................................................. 2
1.04.... Effects of the
Merger..........................................................................
2
1.05.... Certificate of Incorporation;
By-Laws; Purposes............................... 2
1.06....
Directors.............................................................................................
3
1.07....
Officers...............................................................................................
3
ARTICLE II. EFFECT
OF THE MERGER
ON THE CAPITAL STOCK OF THE
CONSTITUENT
CORPORATIONS............................................... 3
2.01.... Effect on Capital
Stock........................................................................
3
2.02.... Exchange of
Certificates......................................................................
4
2.03.... Treatment of Company Options
and
Company Warrants..................... 6
2.04.... Dissenting
Shares................................................................................
7
2.05.... Withholding
Rights..............................................................................
7
ARTICLE III. REPRESENTATIONS
AND
WARRANTIES.............................. 7
3.01.... Representations and Warranties
of the Company and its Subsidiaries7
3.02.... Representations and Warranties
of Parent and Merger Sub.............. 15
ARTICLE IV. COVENANTS
RELATING TO
CONDUCT OF BUSINESS PRIOR
TO
MERGER..............................................................................
19
4.01.... Conduct of Business by the
Company............................................... 19
ARTICLE V. ADDITIONAL
AGREEMENTS.................................................. 21
5.01.... Preparation of Form S-4
and
Stockholder Statement; Stockholder
Meeting...................................................................................
21
5.02.... Access to Information;
Confidentiality............................................. 21
5.03.... Reasonable Best
Efforts...................................................................
22
5.04....
Indemnification.................................................................................
22
5.05.... Public
Announcements......................................................................
23
5.06.... No
Solicitation..................................................................................
23
5.07.... Letters of the Company's
Accountants............................................... 24
-
i -
TABLE
OF CONTENTS
(continued)
Page
5.08.... Letters of Parent's
Accountants.......................................................... 24
5.09.... Information
Supplied.........................................................................
24
5.10.... Exemption from Liability
Under
Section 16(b)................................. 24
5.11.... Repayment of Certain Company
Payables......................................... 24
5.12.... Affiliates
Letters................................................................................
24
5.13.... Termination of Company
Plans......................................................... 25
ARTICLE VI. CONDITIONS
PRECEDENT..................................................... 25
6.01.... Conditions to each Party's
Obligation to Effect the Merger............... 25
6.02.... Conditions to Obligations
of
Parent and Merger Sub........................ 26
6.03.... Conditions to Obligations
of the
Company........................................ 28
ARTICLE VII. TERMINATION,
AMENDMENT, AND WAIVER................... 29
7.01....
Termination........................................................................................
29
7.02.... Effect of
Termination.........................................................................
30
7.03....
Amendment........................................................................................
30
7.04.... Extension;
Waiver..............................................................................
30
7.05.... Procedure for Termination,
Amendment, Extension or Waiver.......... 30
ARTICLE VIII. GENERAL
PROVISIONS......................................................... 30
8.01.... Nonsurvival of Representations
and Warranties................................ 30
8.02.... Fees and
Expenses.............................................................................
30
8.03....
Notices...............................................................................................
31
8.04....
Definitions..........................................................................................
32
8.05....
Interpretation......................................................................................
34
8.06....
Counterparts.......................................................................................
34
8.07.... Entire Agreement; No Third-Party
Beneficiaries............................... 34
8.08.... Governing Law; Consent to
Jurisdiction; Waiver of Jury Trial.......... 35
8.09....
Assignment.........................................................................................
35
8.10....
Remedies............................................................................................
35
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ii -
AGREEMENT AND PLAN OF MERGER (this
"Agreement"), dated as of April 18, 2007, by and among Access
Pharmaceuticals, Inc., a Delaware corporation ("Parent"), Somanta
Acquisition Corporation, a Delaware corporation and a direct wholly-owned
Subsidiary of Parent ("Merger Sub"), Somanta Pharmaceuticals, Inc., a
Delaware corporation (the "Company"), Somanta Incorporated, a Delaware
corporation and a wholly-owned Subsidiary of the Company, and Somanta Limited,
a
company organized under the laws of England and a wholly-owned Subsidiary
of
Somanta Incorporated. Certain capitalized terms used herein are defined in
Section 8.04.
WHEREAS, the respective Boards of Directors
of
Parent, Merger Sub and the Company have deemed it advisable and in the
best
interests of each corporation and their respective stockholders that Parent
acquire the Company in order to advance the long-term business interests
of
Parent and the Company;
WHEREAS, the acquisition of the Company
shall
be effected through the merger (the "Merger") of Merger Sub with and into
the Company, upon the terms and subject to the conditions set forth in
this
Agreement and in accordance with the Delaware General Corporation Law
("Delaware Law"), as a result of which the Company shall become a
wholly-owned Subsidiary of Parent;
WHEREAS, the Merger and this Agreement
require
the vote of a (i) majority of the outstanding shares of Company Common
Stock
(including, for these purposes, all shares of Company Common Stock issuable
upon
conversion of Company Preferred Stock) and (ii) majority of the
outstanding shares of Company Preferred Stock, voting as a separate class,
for
the approval thereof (the "Company Stockholder Approval");
WHEREAS, concurrently with the execution
and
delivery of this Agreement and as a condition and inducement to Parent's
willingness to enter into this Agreement, certain stockholders of the Company
have entered into a Voting Agreement, dated as of the date of this Agreement,
in
the form attached hereto as Exhibit A, pursuant to which such
stockholders have, among other things, granted certain officers of Parent
an
irrevocable proxy to vote shares of capital stock of the Company that such
stockholders own in favor of this Agreement, the Merger and the transactions
contemplated herein;
WHEREAS, Parent, Merger Sub and the Company
desire to make certain representations, warranties, covenants and agreements
in
connection with the Merger and also to prescribe various conditions to
the
Merger; and
WHEREAS, for federal income Tax purposes,
it
is intended that the Merger shall qualify as a reorganization under the
provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended
(the "Code").
NOW, THEREFORE, in consideration of the
representations, warranties, covenants and agreements contained in this
Agreement, and for other good and valuable consideration, the receipt of
sufficiency of which are hereby acknowledged, the parties agree as
follows:
A-1
1.03.
Effective
Time
of the Merger. Upon the Closing, the parties shall file with the
Secretary of State of the State of Delaware a certificate of merger (the
"Certificate of Merger") executed in accordance with the relevant
provisions of Delaware Law and shall make all other filings or recordings
required under Delaware Law. The Merger shall become effective at such
time as the Certificate of Merger is duly filed with the Secretary of State
of
the State of Delaware, or at such other time as is permissible in accordance
with Delaware Law and as Merger Sub and the Company shall agree should
be
specified in the Certificate of Merger (the time the Merger becomes effective
being the "Effective Time of the Merger").
1.05.
Certificate
of
Incorporation; By-Laws; Purposes. (a) At the Effective Time of the
Merger, and without any further action on the part of the Company or Merger
Sub,
the certificate of incorporation of Merger Sub as in effect at the Effective
Time of the Merger shall be the certificate of incorporation of the Surviving
Corporation until thereafter amended as provided therein or by applicable
law.
(b)
At the Effective Time of the Merger, and
without any further action on the part
of the Company or Merger Sub, the by-laws of Merger Sub as in effect at
the
Effective Time of the Merger shall be the by-laws of the Surviving Corporation
until thereafter changed or amended as provided therein or by applicable
law.
(c)
The purposes of the Surviving Corporation
shall be the purposes set forth in the
certificate of incorporation of Merger Sub in effect immediately prior to the
Effective Time of the Merger.
A-2
(d)
The capitalization of the Surviving Corporation
shall be as set forth in the
certificate of incorporation of Merger Sub in effect immediately prior
to the
Effective Time of the Merger.
(a)
Common Stock of Merger Sub. Each share of common stock of
Merger
Sub issued and outstanding immediately prior to the Effective Time of the
Merger
shall be converted into one share of the common stock, par value $0.001
per
share, of the Surviving Corporation.
(b)
Cancellation of Treasury Stock, Parent-Owned
Company Stock and Company
Preferred Stock. Each share of Company Common Stock and Company
Preferred Stock that is owned by the Company or by any Subsidiary of the
Company, and each share of Company Common Stock and Company Preferred Stock
that
is owned by Parent, Merger Sub or any other Subsidiary of Parent shall
automatically be cancelled and retired and shall cease to exist, and no
cash,
Parent Common Stock or other consideration shall be delivered or deliverable
in
exchange therefor.
(c)
Conversion of Company Common Stock
and Company Preferred Stock.
(i)
Each
issued and outstanding share of Company
Common Stock (excluding shares cancelled pursuant to Section 2.01(b) and
any
Dissenting Shares to the extent provided in Section 2.04 but including
all
shares of Company Common Stock issued upon conversion of any Company Preferred
Stock or exercise of Company Options or Company Warrants occurring after
the
date of this Agreement) shall be converted into the right to receive a
number of
shares of Parent Common Stock equal to: (x) 500,000, divided by (y) the
total number of shares of Company Common Stock outstanding at the Effective
Time, such quotient to be carried out to eight decimal points (the "Common
Stock Exchange Ratio");
A-3
(ii)
Each issued and outstanding
share of Company Preferred Stock (excluding shares
cancelled pursuant to Section 2.01(b) and any Dissenting Shares to the
extent
provided in Section 2.04) shall be converted into the right to receive
a number
of shares of Parent Common Stock equal to: (x) 1,000,000, divided by (y)
the total number of shares of Company Preferred Stock outstanding at the
Effective Time, such quotient carried out to eight decimal points (the
"Preferred Stock Exchange Ratio");
(iii)
The total number of
shares of Parent Common Stock issuable in exchange for the
Company Common Stock and Company Preferred Stock shall be referred to herein
collectively as the “Merger Consideration.” In no event shall the
aggregate number of shares of Parent Common Stock to be issued or issuable
hereunder in exchange for Company Common Stock and Company Preferred Stock
exceed 1,500,000 (or such lesser number if decreased in accordance with
Section
2.04). Except as set forth in this Article II, no other amounts shall be
payable with respect to such Company Common Stock.
(d)
Cancellation and Retirement of Company
Common Stock and Company Preferred
Stock. As of the Effective Time of the Merger, all shares of Company
Common Stock and Company Preferred Stock issued and outstanding immediately
prior to the Effective Time of the Merger shall no longer be outstanding
and
shall automatically be cancelled and retired and shall cease to exist,
and each
holder of a certificate representing any such shares of Company Common
Stock and
Company Preferred Stock (collectively, the "Certificates") shall, to the
extent such Certificate represents such shares, cease to have any rights
with
respect thereto, except the right to receive the Merger Consideration (and
cash
in lieu of fractional shares of Parent Common Stock) to be issued or paid
in
consideration therefor upon surrender of such Certificate in accordance
with
Section 2.02.
(a)
Exchange Agent. As of the Effective Time of the
Merger, Parent
shall enter into an agreement with such bank or trust company as may be
designated by Parent (the "Exchange Agent") which shall provide that
Parent shall deposit with the Exchange Agent, for the benefit of the holders
of
Certificates, for exchange in accordance with this Article II, certificates
representing the shares of Parent Common Stock (such shares of Parent Common
Stock, together with any dividends or distributions with respect thereto
with a
record date after the Effective Time of the Merger, and any cash payable
in lieu
of any fractional shares of Parent Common Stock being hereinafter referred
to as
the "Exchange Fund") issuable pursuant to Section 2.01 in exchange for
outstanding shares of Company Common Stock.
(i)
Exchange Procedures. As soon as reasonably practicable
after the
Effective Time of the Merger, the Exchange Agent shall mail to each holder
of
record of Certificates immediately prior to the Effective Time of the Merger
whose shares of Company Common Stock were converted into shares of Parent
Common
Stock pursuant to Section 2.01 (i) a letter of transmittal (which shall
specify
that delivery shall be effected, and risk of loss and title to the Certificates
shall pass only upon delivery of the Certificates to the Exchange Agent,
and
which shall be in such form and have such other provisions as Parent may
reasonably specify) and (ii) instructions for use in effecting the surrender
of
the Certificates in exchange for certificates representing shares of Parent
Common Stock. Upon surrender of a Certificate for cancellation (or
indemnity reasonably satisfactory to Parent and the Exchange Agent, if
any of
such Certificates are lost, stolen or destroyed) to the Exchange Agent
together
with such letter of transmittal, duly executed, the holder of such Certificate
shall be entitled to receive in exchange therefor a certificate representing
that number of whole shares of Parent Common Stock which such holder has
the
right to receive in respect of all Certificates surrendered by such holder
pursuant to the provisions of this Article II (after taking into account
all
shares of Company Common Stock then held by such holder), and the Certificates
so surrendered shall forthwith be cancelled. In the event of a transfer of
ownership of shares of Company Common Stock which is not registered in
the
transfer records of the Company, a certificate representing the proper
number of
shares of Parent Common Stock may be issued to a transferee if the Certificate
is presented to the Exchange Agent, accompanied by all documents required
to
evidence and effect such transfer and by evidence that any applicable stock
transfer Taxes have been paid. Until surrendered as contemplated by this
Section 2.02, subject to the provisions of Section 2.04, each Certificate
shall
be deemed at any time after the Effective Time of the Merger to represent
only
the Parent Common Stock into which the shares of Company Common Stock
represented by such Certificate have been converted as provided in this
Article
II and the right to receive upon such surrender cash in lieu of any fractional
shares of Parent Common Stock as contemplated by this Section 2.02.
A-4
(ii)
Distributions with Respect to Unexchanged
Shares. No dividends or
other distributions with respect to Parent Common Stock with a record date
after
the Effective Time of the Merger shall be paid to the holder of any
unsurrendered Certificate with respect to the shares of Parent Common Stock
represented thereby, and no cash payment in lieu of fractional shares shall
be
paid to any such holder pursuant to Section 2.02(e) until the surrender
of such
Certificate in accordance with this Article II. Subject to the effect of
applicable laws, following surrender of any such Certificate, there shall
be
paid to the holder of the certificate representing the whole shares of
Parent
Common Stock issued in exchange therefor without interest, (i) at the time
of
such surrender, the amount of any cash payable in lieu of any fractional
share
of Parent Common Stock to which such holder is entitled pursuant to Section
2.02(e) and the amount of any dividends or other distributions with a record
date after the Effective Time of the Merger theretofore paid (but withheld
pursuant to the immediately preceding sentence) with respect to such whole
shares of Parent Common Stock, and (ii) at the appropriate payment date,
the
amount of any dividends or other distributions with a record date after
the
Effective Time of the Merger and a payment date subsequent to such surrender
payable with respect to such whole shares of Parent Common Stock.
(iii)
No Further Ownership Rights in Company
Common Stock or Company Preferred
Stock. All shares of Parent Common Stock issued upon conversion of
shares of Company Common Stock or Company Preferred Stock in accordance
with the
terms hereof, and all cash paid pursuant to Sections 2.02(c) and 2.02(e),
shall
be deemed to have been issued in full satisfaction of all rights pertaining
to
such Company Common Stock or Company Preferred Stock, and there shall be
no
further registration of transfers on the stock transfer books of the Surviving
Corporation of the Company Common Stock or Company Preferred Stock which
were
outstanding prior to the Effective Time of the Merger. If, after the
Effective Time of the Merger, Certificates are presented to the Surviving
Corporation for any reason, they shall be cancelled and exchanged as provided
in
this Article II.
(iv)
No Fractional Shares. (i) No certificate or scrip representing
fractional shares of Parent Common Stock shall be issued upon the surrender
for
exchange of Certificates, and such fractional share interests shall not
entitle
the owner thereof to vote or to any rights of a stockholder of Parent.
In
lieu of such issuance of fractional shares, Parent shall pay each holder
of
Certificates an amount in cash equal to the product obtained by multiplying
(a)
the fractional share interest to which such holder would otherwise be entitled
(after taking into account all shares of Company Common Stock or Company
Preferred Stock held immediately prior to the Effective Time of the Merger
by
such holder) by (b) the average of the closing sale prices for a share
of Parent
Common Stock on the OTC Bulletin Board for the ten trading days immediately
preceding the date of the Effective Time of the Merger.
(b)
As soon as reasonably practicable after
the determination of the amount of cash,
if any, to be paid to holders of Certificates with respect to any fractional
share interests, the Exchange Agent shall make available such amounts to
such
holders of Certificates, subject to and in accordance with the terms of
Section
2.02(c).
(i)
Termination of Exchange Fund. Any portion of the Exchange Fund
deposited with the Exchange Agent pursuant to this Section 2.02 which remains
undistributed to the holders of the Certificates six months after the Effective
Time of the Merger shall be delivered to Parent, upon demand, and any holders
of
Certificates who have not theretofore complied with this Article II shall
thereafter look only to Parent and only as general creditors thereof for
payment
of their claim for Parent Common Stock, cash in lieu of fractional shares
of
Parent Common Stock and any dividends or distributions with respect to
Parent
Common Stock to which such holders may be entitled pursuant to this Article
II.
(ii)
No Liability. None of Parent, Merger Sub, the
Company or the
Exchange Agent shall be liable to any Person in respect of any shares of
Parent
Common Stock (or dividends or distributions with respect thereto) or cash
from
the Exchange Fund delivered to a public official pursuant to any applicable
abandoned property, escheat or similar law. If any Certificates shall not
have been surrendered prior to three years after the Effective Time of
the
Merger, or immediately prior to such earlier date on which any Merger
Consideration, any cash in lieu of fractional shares of Parent Common Stock
or
any dividends or distributions with respect to Parent Common Stock would
otherwise escheat to or become the property of any Governmental Entity,
any such
Merger Consideration or cash shall, to the extent permitted by applicable
law,
become the property of the Surviving Corporation, free and clear of all
claims
or interest of any Person previously entitled thereto.
A-5
(iii)
Investment of Exchange Fund. The Exchange Agent shall invest
any
cash included in the Exchange Fund, as directed by Parent on a daily basis.
Any interest and other income resulting from such investments shall be
paid to Parent.
(iv)
Adjustment Provisions. In the event Parent changes (or
establishes
a record date for changing) the number of shares of Parent Common Stock
issued
and outstanding prior to the Effective Time of the Merger as a result of,
including, without limitation, a forward or reverse stock split, stock
dividend,
recapitalization or similar transaction with respect to the outstanding
Parent
Common Stock and the record date therefor shall be prior to the Effective
Time
of the Merger, the Common Stock Exchange Ratio shall be proportionately
adjusted. In the event Parent changes (or establishes a record date for
changing) the number of shares of Parent Common Stock issued and outstanding
prior to the Effective Time of the Merger as a result of, including, without
limitation, a forward or reverse stock split, stock dividend, recapitalization
or similar transaction with respect to the outstanding Parent Common Stock
and
the record date therefor shall be prior to the Effective Time of the Merger,
the
Preferred Stock Exchange Ratio shall be proportionately adjusted. If,
between the date hereof and the Effective Time of the Merger, Parent shall
merge, be acquired or consolidate with, by or into any other corporation
(a
"Business Combination") and the terms thereof shall provide that Parent
Common Stock shall be converted into or exchanged for the shares of any
other
corporation or entity, then provision shall be made as part of the terms
of such
Business Combination so that securityholders of the Company who would be
entitled to receive shares of Parent Common Stock pursuant to this Agreement
shall be entitled to receive, in lieu of each share of Parent Common Stock
issuable to such securityholders as provided herein, the same kind and
amount of
securities or assets as shall be distributable upon such Business Combination
with respect to one share of Parent Common Stock (provided that nothing
herein
shall be construed so as to release the acquiring entity in any such Business
Combination from its obligations under this Agreement as the successor
to
Parent).
At the Effective Time of the Merger, Parent
shall assume all issued and outstanding Company Warrants other than the
Company
Warrants to be exercised pursuant to Section 6.02(m), including, without
limitation, all rights and obligations related thereto (except as otherwise
provided in the waivers to be executed and delivered pursuant to Section
6.02(h)), in accordance with the terms of the applicable warrant agreement,
in
each case as adjusted to take into account the effect resulting from the
Merger
as follows. At the Effective Time of the Merger, each such Company
Warrant, whether or not vested, shall, by virtue of the Merger, be assumed
by
Parent. Each such Company Warrant so assumed by Parent hereunder will
continue to have, and be subject to, the same terms and conditions of such
Company Warrant immediately prior to the Effective Time of the Merger
(including, without limitation, any repurchase rights or vesting provisions
and
provisions regarding the acceleration of vesting and exercisability on
certain
transactions), except that (i) each such Company Warrant will be exercisable
(or
will become exercisable in accordance with its terms) for that number of
whole
shares of Parent Common Stock equal to the number of shares of Company
Common
Stock that were issuable upon exercise of such Company Warrant (assuming
full
vesting), immediately prior to the Effective Time of the Merger, multiplied
by
the Common Stock Exchange Ratio and rounded down to the nearest whole share,
and
(ii) the per share exercise price for the shares of Parent Common Stock
issuable
upon exercise of each such assumed Company Warrant will be divided by the
Common
Stock Exchange Ratio and rounded up to the nearest whole cent. At the
Effective Time of the Merger, (x) all references in the related warrant
agreements to the Company shall be deemed to refer to Parent and (y) Parent
shall assume all of the Company's obligations with respect to such Company
Warrants as so amended. As promptly as reasonably practicable after the
Effective Time of the Merger, Parent shall issue to each holder of any
such
Company Warrant a document evidencing the foregoing adjustments and assumption
by Parent.
A-6
(a)
Subject to the provisions of Section 6.02(i)
and notwithstanding any provision
of this Agreement to the contrary, the shares of any holder of Company
Common
Stock or Company Preferred Stock who has demanded and perfected appraisal
rights
of such shares in accordance with Delaware Law and who, as of the Effective
Time
of the Merger, has not effectively withdrawn or lost such appraisal rights
("Dissenting Shares") shall not be converted into or represent a right to
receive Parent Common Stock pursuant to Section 2.01(c), but the holder
thereof
shall only be entitled to such rights as are granted by Delaware Law, and
the
total number of shares of Parent Common Stock issuable as Merger Consideration
as provided in Section 2.01(c)(i) or (ii), as applicable, shall be
proportionately decreased.
(b)
Notwithstanding the foregoing, if any
holder of shares of Company Common Stock
or Company Preferred Stock who demands appraisal of such shares under Delaware
Law shall effectively withdraw the right to appraisal, then, as of the
later of
the Effective Time of the Merger and the occurrence of such event, such
holder's
shares shall automatically be converted into and represent only the right
to
receive Parent Common Stock, without interest thereon, upon surrender of
the
Certificate representing such shares as provided in Section 2.01(c), and,
subject to Section 2.01(c)(iii), the total number of shares of Parent
Common Stock issuable as Merger Consideration as provided in
Section 2.01(c)(i) or (ii), as applicable, shall be proportionally
increased to the extent such number was previously decreased pursuant to
Section 2.04(a) with respect to such shares.
(c)
The Company shall give Parent (i) prompt
notice of any written demands for
appraisal of any shares of Company Common Stock or Company Preferred Stock,
withdrawals of such demands, and any other instruments served pursuant
to
Delaware Law and received by the Company which relate to any such demand
for
appraisal and (ii) the opportunity to participate in all negotiations and
proceedings which take place prior to the Effective Time of the Merger
with
respect to demands for appraisal under Delaware Law. The Company shall
not, except with the prior written consent of Parent or as may be required
by
applicable law, voluntarily make any payment with respect to any demands
for
appraisal of the Company Common Stock or Company Preferred Stock or offer
to
settle or settle any such demands.
(a)
Organization; Standing and Corporate
Power. Each of the Company and
each of its Subsidiaries is duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is organized and
has the
requisite corporate power and authority to carry on its business as now
being
conducted. Except as set forth in Section 3.01(a) of the Company
Disclosure Schedule, each of the Company and each of its Subsidiaries is
duly
qualified or licensed to do business and is in good standing in each
jurisdiction (domestic or foreign) in which the nature of its business
or the
ownership or leasing of its properties makes such qualification or licensing
necessary, other than in such jurisdictions where the failure to be so
qualified
or licensed (individually or in the aggregate) would not have a Material
Adverse
Effect with respect to the Company. The Company has delivered to Parent
complete and correct copies of the certificate of incorporation (including
any
Certificate of Designations thereto) (the "Certificate of Incorporation")
and by-laws (the "By-laws") of the Company, in each case as amended and
as currently in effect. The Company has delivered to Parent complete and
correct copies of the certificates of incorporation and by-laws (or other
organizational documents) of each of its Subsidiaries, in each case as
amended
and currently in effect.
A-7
(b)
Subsidiaries. All of the Subsidiaries of the
Company are listed in
Section 3.01(b) of the Company Disclosure Schedule. All of the outstanding
shares of capital stock of each Subsidiary of the Company have been validly
issued and are fully paid and nonassessable and are owned (of record and
beneficially) by the Company or by another wholly-owned Subsidiary of the
Company, free and clear of all pledges, claims, liens, charges, encumbrances
and
security interests of any kind or nature whatsoever except for Permitted
Liens
(collectively, "Liens"). The Company does not own, directly or
indirectly, any capital stock or other ownership interest in any Person.
(c)
Capital Structure. The authorized capital stock of
the Company
consists of (x) 100,000,000 shares of Company Common Stock and
(y) 20,000,000 shares of preferred stock, par value $0.001 per share, of
which 2,000 shares are designated as Company Preferred Stock. As of the
close of
business on April 16, 2007, there were: (i) 14,292,603 shares of
Company Common Stock issued and outstanding; (ii) 591.6318 shares of
Company Preferred Stock issued and outstanding which are convertible into
9,860,135 shares of Company Common Stock; (iii) accrued but undeclared
dividends on the Company Preferred Stock which are convertible into 634,871
shares of Company Common Stock pursuant to the Certificate of Designations
of
the Company Preferred Stock; (iv) no shares of Company Common Stock held
in the
treasury of the Company; (v) 4,516,837 shares of Company Common Stock
Options available for grant pursuant to the Company Stock Option Plan;
(vi) 3,483,163 shares of Company Common Stock reserved for issuance
pursuant to outstanding options granted pursuant to the Company Stock Option
Plan; and (vii) Company Warrants listed in Section 3.01(c) of the Company
Disclosure Schedule, representing the right to purchase 7,102,838 shares
of
Company Common Stock. Except as set forth above, as of the close of
business on April 16 2007, there were no shares of capital stock or other
equity securities of the Company issued, reserved for issuance or outstanding.
All outstanding shares of capital stock of the Company are, and all shares
which
may be issued pursuant to the Company Stock Option Plan shall be, when
issued,
duly authorized, validly issued, fully paid and nonassessable and not subject
to
preemptive rights. All securities issued by the Company were issued in
compliance in all material respects with all applicable federal and state
securities laws and all applicable rules and regulations promulgated thereunder.
There are no outstanding bonds, debentures, notes or other indebtedness
or
debt securities of the Company or any of its Subsidiaries that have the
right to
vote (or that are convertible into, or exchangeable for, securities having
the
right to vote) on any matters on which stockholders of the Company may
vote
(collectively, "Voting Debt"). Except as set forth above, there are
no outstanding securities, options, warrants, calls, rights, commitments,
agreements, arrangements or undertakings of any kind to which the Company
or any
of its Subsidiaries is a party or by which any of them is bound obligating
the
Company or any of its Subsidiaries to issue, deliver or sell, or cause
to be
issued, delivered or sold, additional shares of capital stock or other
equity or
voting securities of the Company or of any of its Subsidiaries or obligating
the
Company or any of its Subsidiaries to issue, grant, extend, accelerate
the
vesting of or enter into any such security, option, warrant, call, right,
commitment, agreement, arrangement or undertaking. There are no
outstanding contractual obligations, commitments, understandings or arrangements
of the Company or any of its Subsidiaries to repurchase, redeem or otherwise
acquire or make any payment in respect of any shares of capital stock of
the
Company or any of its Subsidiaries. To the knowledge of the Company,
except as provided in Section 3.01(c) of the Company Disclosure Schedule,
there
are no irrevocable proxies with respect to shares of capital stock of the
Company or any Subsidiary of the Company. There are no agreements or
arrangements pursuant to which the Company is or could be required to register
shares of Company Common Stock or other agreements or arrangements with
or, to
the knowledge of the Company, among any securityholders of the Company
with
respect to securities of the Company. Except as set forth in Section
3.01(c) of the Company Disclosure Schedule, the Company has complied in
all
respects with any obligation to register shares of Company Common Stock
and has
not incurred any liability in connection with its failure to register such
shares.
Except as set forth in Section 3.01(c)
of the
Company Disclosure Schedule, since April 30, 2006, the Company has not (A)
issued or permitted to be issued any shares of capital stock, or securities
exercisable for or convertible into shares of capital stock, of the Company
or
any of its Subsidiaries; (B) repurchased, redeemed or otherwise acquired,
directly or indirectly through one or more Subsidiaries, any shares of
capital
stock of the Company or any of its Subsidiaries or (C) declared, set aside,
made
or paid to the stockholders of the Company dividends or other distributions
on
the outstanding shares of capital stock of the Company.
A-8
(d)
Authority; Noncontravention. Each of the Company and each of
its
Subsidiaries has the requisite corporate power and authority to enter into
this
Agreement and, subject to the Company Stockholder Approval in the case
of the
Agreement, to consummate the transactions contemplated hereby. The
execution and delivery of this Agreement by the Company and each of its
Subsidiaries and the consummation by the Company and each of its Subsidiaries
of
the transactions contemplated hereby have been duly authorized by all necessary
corporate action on the part of the Company and each of its Subsidiaries,
subject, in the case of this Agreement, to the Company Stockholder Approval.
This Agreement has been duly executed and delivered by the Company and
each of its Subsidiaries and (assuming due authorization, execution and
delivery
by Parent and Merger Sub) constitutes a valid and binding obligation of
the
Company and each of its Subsidiaries, enforceable against the Company and
each
of its Subsidiaries in accordance with its respective terms, subject to
the
effects of bankruptcy, insolvency, fraudulent conveyance, reorganization,
moratorium and other similar laws affecting creditors' rights generally,
general
equitable principles (whether considered in a proceeding in equity or at
law)
and an implied covenant of good faith and fair dealing. Except as set
forth in Section 3.01(d) of the Company Disclosure Schedule, the execution
and
delivery of this Agreement does not, and the consummation by the Company
and
each of its Subsidiaries of the transactions contemplated by this Agreement
and
compliance by the Company and each of its Subsidiaries with the provisions
hereof shall not, conflict with, or result in any breach or violation of,
or any
default (with or without notice or lapse of time, or both) under, or give
rise
to a right of termination, cancellation or acceleration of, or a "put"
right
with respect to any obligation under, or to a loss of a material benefit
under,
or result in the creation of any Lien upon any of the properties or assets
of
the Company or any of its Subsidiaries under, (i) the Certificate of
Incorporation or By-laws, or the comparable charter or organizational documents
of any of its Subsidiaries, (ii) any loan or credit agreement, note, note
purchase agreement, bond, mortgage, indenture, lease or other agreement,
instrument, permit, concession, franchise or license applicable to the
Company
or any of its Subsidiaries or their respective properties or assets or
(iii)
subject to the governmental filings and other matters referred to in the
following sentence, any judgment, order, decree, statute, law, ordinance,
rule,
regulation or arbitration award applicable to the Company or any of its
Subsidiaries or their respective properties or assets. No consent,
approval, order or authorization of, or registration, declaration or filing
with, or notice to, any federal, state or local government or any court,
administrative agency or commission or other governmental authority or
agency,
domestic or foreign (a "Governmental Entity"), is required by or with
respect to the Company or any of its Subsidiaries in connection with the
execution and delivery of this Agreement by the Company or the consummation
by
the Company of the transactions contemplated hereby or the performance
by the
Company and each of its Subsidiaries of their respective obligations hereunder,
except for (i) such filings, if any, as may be required under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR
Act") and the filing of applications by the Company pursuant to antitrust
or
similar laws in such foreign jurisdictions as necessary, (ii) the filing
with
the SEC of (A) a proxy statement relating to the Company Stockholder Approval
(such proxy statement as amended or supplemented from time to time, the
"Stockholder Statement") and (B) such reports under the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), as may be required
in connection with this Agreement and the transactions contemplated hereby
and
(iii) the filing of the Certificate of Merger with the Secretary of State
of the
State of Delaware and appropriate documents with the relevant authorities
of
other states in which the Company or any of its Subsidiaries is qualified
to do
business.
(e)
SEC Documents; Undisclosed Liabilities. The Company has filed with
the SEC all reports, schedules, forms, statements and other documents required
pursuant to the Securities Act of 1933, as amended (the "Securities Act")
and the Exchange Act since April 30, 2004 (collectively, and in each case
including all exhibits and schedules thereto and documents incorporated
by
reference therein, the "SEC Documents"). As of their respective
dates, the SEC Documents (other than the SEC Financial Statements) comply
in all
material respects with the requirements of the Securities Act or the Exchange
Act, as the case may be, and the rules and regulations of the SEC promulgated
thereunder applicable to such SEC Documents. Except to the extent that
information contained in any SEC Document has been revised or superseded
by a
later filed SEC Document, none of the SEC Documents (including any and
all SEC
Financial Statements included therein) contains any untrue statement of
a
material fact or omits to state a material fact required to be stated therein
or
necessary in order to make the statements therein, in the light of the
circumstances under which they were made, not misleading. The consolidated
financial statements of the Company included in all SEC Documents filed
since
April 30, 2004 (the "SEC Financial Statements") comply as to form in all
material respects with applicable published accounting requirements and
the
published rules and regulations of the SEC with respect thereto, have been
prepared in accordance with generally accepted accounting principles as
applied
in the United States (except, in the case of unaudited consolidated quarterly
statements, as permitted by Form 10-QSB of the SEC), applied on a consistent
basis during the periods involved (except as may be indicated in the notes
thereto) and fairly present the consolidated financial position of the
Company
and its consolidated Subsidiaries as of the dates thereof and the consolidated
results of their operations and cash flows for the periods then ended (subject,
in the case of unaudited quarterly statements, to normal recurring year-end
audit adjustments). Neither the Company nor any of its Subsidiaries has
any liabilities or obligations of any nature (whether accrued, absolute,
contingent or otherwise) required by generally accepted accounting principles
as
applied in the United States to be recognized or disclosed on a consolidated
balance sheet of the Company and its Subsidiaries or in the notes thereto,
except (i) liabilities reflected in the consolidated balance sheet of the
Company as of January 31, 2007 (the "2007 Balance Sheet") and (ii)
liabilities incurred since January 31, 2007 in the ordinary course of business
consistent with past practice, which, if in an amount in excess of $10,000,
are
listed in Section 3.01(e) of the Company Disclosure Schedule.
A-9
(f)
Disclosure Controls and Procedures;
Internal Control Over Financing
Reporting. The Company maintains disclosure controls and procedures
required by Rule 13a-15 and 15d-15 under the Exchange Act. Such
disclosure controls and procedures are designed to ensure that all material
information relating to the Company and its Subsidiaries is made known
to the
Company's chief executive officer and chief financial officer by others
within
those entities, particularly during the period in which the Company's applicable
Exchange Act report is being prepared, and effective, in that they provide
reasonable assurance that information required to be disclosed by the Company
in
the reports that it files or submits under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in
the
SEC's rules and forms. The Company's management is responsible for
establishing and maintaining adequate internal control over <?xml:namespace
prefix = st1 ns = "schemas-workshare-com/workshare" />financial reporting as
required by Rule 13a-15 or 15d-15 under the Exchange Act. The
Company's internal control over financial reporting was effective as of
January 31, 2007.
(g)
Information Supplied. None of the information supplied
or to be
supplied by the Company in writing for inclusion or incorporation by reference
in (i) the registration statement on Form S-4 to be filed with the SEC
by Parent
in connection with the issuance of Parent Common Stock in the Merger (the
"Form S-4") shall, at the time the Form S-4 becomes effective under the
Securities Act, contain any untrue statement of a material fact or omit
to state
any material fact required to be stated therein or necessary to make the
statements therein not misleading or (ii) the Stockholder Statement shall,
at
(A) the date it is first mailed to the Company's stockholders and/or (B)
at the
time of the Stockholder Meeting, contain any untrue statement of a material
fact
or omit to state any material fact required to be stated therein or necessary
in
order to make the statements therein, in the light of the circumstances
under
which they are made, not misleading. The Stockholder Statement shall
comply as to form in all material respects with the requirements of the
Exchange
Act and the rules and regulations promulgated thereunder, except that no
representation is made by the Company with respect to statements made or
incorporated by reference therein based on information supplied in writing
by
Parent or Merger Sub specifically for inclusion or incorporation by reference
therein.
(h)
Absence of Certain Changes or Events. Except as set forth in
Section 3.01(h) of the Company Disclosure Schedule, since April 30, 2006,
there
is not and has not been: (i) any Material Adverse Change with respect to
the
Company; (ii) any condition, event or occurrence which, individually or
in the
aggregate, could reasonably be expected to have a Material Adverse Effect
or
give rise to a Material Adverse Change with respect to the Company; (iii)
any
condition, event or occurrence which, individually or in the aggregate,
could
reasonably be expected to prevent or materially delay the ability of the
Company
or any of its Subsidiaries to consummate the transactions contemplated
by this
Agreement or perform their respective obligations hereunder. On the date
of this Agreement, the Company is not engaged in any discussions nor does
it
have any intention to engage in a Transaction Proposal.
(i)
Litigation; Labor Matters; Compliance
with Laws.
(i)
Except as set forth in Section 3.01(i)(i)
of the Company Disclosure Schedule,
there is no suit, action, claim, charge, arbitration, investigation or
proceeding pending before a Governmental Entity and, to the knowledge of
the
Company, no suit, claim, charge, action, arbitration, investigation or
proceeding threatened against or investigation pending, in each case with
respect to the Company or any of its Subsidiaries, that, individually or
in the
aggregate, could reasonably be expected to have a Material Adverse Effect
with
respect to the Company or prevent or materially delay the ability of the
Company
or any of its Subsidiaries to consummate the transactions contemplated
by this
Agreement or to perform their respective obligations hereunder, nor is
there any
judgment, decree, citation, injunction, rule or order of any Governmental
Entity
or arbitrator outstanding against the Company or any of its Subsidiaries
which,
individually or in the aggregate, could reasonably be expected to have
a
Material Adverse Effect with respect to the Company.
(ii)
(1) Neither the Company nor any of its
Subsidiaries is a party to, or bound by,
any collective bargaining agreement, contract or other agreement or
understanding with a labor union or labor organization; (2) to the knowledge
of
the Company, neither the Company nor any of its Subsidiaries is the subject
of
any strike, grievance or other proceeding asserting that the Company or
any
Subsidiary has committed an unfair labor practice or seeking to compel
it to
bargain with any labor organization as to wages or conditions of employment;
(3)
there is no strike, work stoppage or other labor dispute involving it or
any of
its Subsidiaries pending or, to its knowledge, threatened; (4) no grievance
is
pending or, to the knowledge of the Company, threatened in writing against
the
Company or any of its Subsidiaries which, individually or in the aggregate,
could reasonably be expected to have a Material Adverse Effect with respect
to
the Company; (5) to the knowledge of the Company, the Company and each
of its
Subsidiaries is in material compliance with all applicable laws (domestic
and
foreign), agreements, contracts and policies relating to employment, employment
practices, wages, hours, immigration matters and terms and conditions of
employment; (6) except as set forth in Section 3.01(i)(ii)(6) of the Company
Disclosure Schedule, the Company (or one of its Subsidiaries) has paid
in full
to all employees of the Company and its Subsidiaries all wages, salaries,
commissions, bonuses, benefits and other compensation due and payable to
such
employees under any policy, practice, agreement, plan, program, statue
or other
law except for failures, if any, that, individually or in the aggregate,
would
not have a Material Adverse Effect with respect to the Company; (7) except
as
set forth in Section 3.01(i)(ii)(7) of the Company Disclosure Schedule,
neither
the Company nor any of its Subsidiaries is liable for any severance pay
or other
payments to any employee or former employee arising from the termination
of
employment under any benefit or severance policy, practice, agreement,
plan, or
program of the Company or any of its Subsidiaries, nor to the knowledge
of the
Company shall the Company or any of its Subsidiaries have any liability
which
exists or arises, or may be deemed to exist or arise, under any applicable
law
or otherwise, as a result of or in connection with the transactions contemplated
hereunder or as a result of the termination by the Company of any Persons
employed by the Company or any of its Subsidiaries on or prior to the Effective
Time of the Merger; and (8) the Company and its Subsidiaries are in compliance
with their respective obligations pursuant to the Worker Adjustment and
Retraining Notification Act of 1988 ("WARN") and any similar state or
local laws, and all other employee notification and bargaining obligations
arising under any collective bargaining agreement, statute or otherwise.
A-10
(j)
Employee Benefit Plans.
(i)
Section 3.01(j)
of the Company Disclosure Schedule contains a true and complete
list of each "employee benefit plan" (within the meaning of Section 3(3)
of the
Employee Retirement Income Security Act of 1974, as amended ("ERISA")
(including, without limitation, multiemployer plans within the meaning
of
Section 3(37) of ERISA or any of its foreign equivalents)), stock purchase,
stock option, severance, employment, change-in-control, fringe benefit,
collective bargaining, bonus, incentive, deferred compensation and all
other
employee benefit plans, agreements, programs, policies or other arrangements
relating to employment, benefits or entitlements, whether or not subject
to
ERISA (including any funding mechanism therefor now in effect or required
in the
future as a result of the transactions contemplated by this Agreement or
other
activities taken by the Company or any of its Subsidiaries on or prior
to the
date of this Agreement), sponsored by the Company, any of its Subsidiaries
or
any other entity such as a co-employer, whether formal or informal, oral
or
written, legally binding or not under which any employee or former employee
of
the Company or any of its Subsidiaries has any present or future right
to
benefits based on such employee's employment with the Company or one of
its
Subsidiaries and under which the Company or any of its Subsidiaries has
any
present or future liability. All such plans, agreements, programs,
policies and arrangements are herein collectively referred to as the "Company
Plans."
(ii)
With respect to each Company Plan, the
Company has delivered to Parent a
current, accurate and complete copy (or, to the extent no such copy exists,
an
accurate description) thereof and, to the extent applicable, (A) any related
trust agreement, annuity contact or other funding instrument; (B) the most
recent determination letter issued by the U.S. Internal Revenue Service
("IRS"); (C) any summary plan description and other material written
communications (or a description of any material oral communications) by
the
Company or any of its Subsidiaries to its employees concerning the extent
of the
benefits provided under a Company Plan; and (D) for the three most recent
years
(I) the Form 5500 and attached schedules; (II) audited financial statements;
(III) actuarial valuation reports; and (IV) attorney's response to an auditor's
request for information.
(iii)
(A) Each Company Plan has been established
and administered in accordance with
its terms, and in compliance with the applicable provisions of ERISA, the
Code
and other applicable laws, rules and regulations (including the applicable
laws,
rules and regulations of foreign jurisdictions), in each case, in all material
respects; (B) each Company Plan which is intended to be qualified within
the
meaning of Code Section 401(a) is so qualified and has received a favorable
determination letter as to its qualification and, to the Company's knowledge,
nothing has occurred, whether by action or failure to act, which would
cause the
loss of such qualification; (C) with respect to any Company Plan, no actions,
suits or claims (other than routine claims for benefits in the ordinary
course)
are pending or, to the best knowledge of the Company, threatened; (D) to
the
Company's knowledge, no facts or circumstances exist which could give rise
to
any such actions, suits or claims and the Company shall promptly notify
Parent
in writing of any pending claims or, to the knowledge of the Company, any
threatened claims arising between the date hereof and the Effective Time
of the
Merger; (E) neither the Company nor, to the Company's knowledge, any other
party
has engaged in a prohibited transaction, as such term is defined under
Code
Section 4975 or ERISA Section 406, which would subject the Company or Parent
or
its respective Subsidiaries to any material Taxes, penalties or other
liabilities under the Code or ERISA; (F) no event has occurred and no condition
exists that could reasonably be expected to subject the Company, either
directly
or by reason of its relationship to any member of its "Controlled Group"
(defined as any organization which is deemed to be a single employer with
the
Company within the meaning of Code Sections 414(b), (c), (m) or (o) or
ERISA
Section 4001), to any material Tax, fine or penalty imposed by ERISA, the
Code
or other applicable laws, rules and regulations (including the applicable
laws,
rules and regulations of any foreign jurisdiction); (G) all contributions
and
payments accrued under each Company Plan, determined in accordance with
prior
funding and accrual practices, as of the Effective Time of the Merger have
been
or shall be timely paid or made prior thereto and adequate reserves have
been
provided for in the Company's SEC Financial Statements for any premiums
(or
portions thereof) and for all benefits attributable to service on or prior
to
the Effective Time of the Merger; (H) for each Company Plan with respect
to
which a Form 5500 has been filed, no material change has occurred with
respect
to the matters covered by the most recent Form 5500 since the date thereof;
and
(I) no Company Plan provides for an increase in the rate of contribution,
benefit accrual or vesting of benefits on or after the date of this
Agreement.
(iv)
Except as disclosed in Section 3.01(j)(iv)
of the Company Disclosure Schedule:
(A) no Company Plan nor any "pension plan" (as defined in ERISA Section
3
(2)) maintained or contributed to by any member of the Company's Controlled
Group has incurred any "accumulated funding deficiency" as such term is
defined
in ERISA Section 302 and Code Section 412 (whether or not waived); (B)
no event
or condition exists which could be deemed a reportable event within the
meaning
of ERISA Section 4043 which could result in a liability to the Company
or any
member of its Controlled Group and no condition exists which could subject
the
Company or any member of its Controlled Group to a fine under ERISA Section
4071; (C) as of the Effective Time of the Merger, the Company and all members
of
its Controlled Group have made all required premium payments when due to
the
Pension Benefit Guaranty Corporation (the "PBGC"); (D) neither the
Company nor any member of its Controlled Group is subject to any liability
to
the PBGC for any plan termination occurring on or prior to the Effective
Time of
the Merger; (E) no amendment has occurred which has required or could require
the Company or any member of its Controlled Group to provide security pursuant
to Code Section 401(a)(29); and (F) neither the Company nor any member
of its
Controlled Group has engaged in a transaction which could subject it to
liability under ERISA Section 4069.
A-11
(v)
As of the Effective Time of the Merger,
the assets of each Company Plan are at
least equal in value to the present value of all accrued benefits (vested
and
unvested) of the participants in such Company Plan on a termination basis
using
the assumptions established by the PBGC as in effect on the most recent
valuation date.
(vi)
(A) the Company and each member of its
Controlled Group has or shall have, as of
the Effective Time of the Merger, made all contributions to each multiemployer
plan (within the meaning of 54001(a)(3) of ERISA) to which the Company or
any member of its Controlled Group has any liability or contribution (or
has at
any time contributed or had an obligation to contribute) required by the
terms
of such multiemployer plan or any collective bargaining agreement; (B)
neither
the Company nor any member of its Controlled Group has incurred any material
withdrawal liability under Title IV of ERISA or would be subject to such
liability if, as of the Effective Time of the Merger, the Company or any
member
of its Controlled Group were to engage in complete withdrawal (as defined
in
ERISA Section 4203) or partial withdrawal (as defined in ERISA Section
4205)
from any such multiemployer plan; (C) no such multiemployer plan is in
reorganization or insolvent (as those terms are defined in ERISA Sections
4241
and 4245, respectively); and (D) neither the Company nor any member of
its
Controlled Group has engaged in a transaction which could subject it to
liability under ERISA Section 4212(c).
(vii) (A)
Each Company Plan which is intended to meet the requirements for Tax-favored
treatment under Subchapter B of Chapter 1 of Subtitle A of the Code meets
such
requirements; and (B) the Company has received a favorable determination
from
the Internal Revenue Service with respect to any trust intended to be qualified
within the meaning of Code Section 501(c)(9).
(viii) Each
plan, program, arrangement or agreement which constitutes in any part a
nonqualified deferred compensation plan within the meaning of Section 409A
of
the Code is identified as such in Section 3.01(j)(viii) of the Company
Disclosure Schedule. Since April 30, 2004, each plan, program, arrangement
or agreement there identified has been operated and maintained in accordance
with a good faith, reasonable interpretation of Section 409A of the Code
and its
purpose, as determined under applicable guidance of the Department of Treasury
and Internal Revenue Service, with respect to amounts deferred (within
the
meaning of Section 409A of the Code) after April 30, 2004.
(ix)
Except as set forth in Section 3.01(j)(ix)
of the Company Disclosure Schedule,
no Company Plan exists which could result in the payment to any Company
employee
of any money or other property or rights or accelerate or provide any other
rights or benefits to any Company employee as a result of the transaction
contemplated by this Agreement, whether or not such payment would constitute
a
parachute payment within the meaning of Code section 280G.
(x)
The Company has not undertaken to maintain
any Company Plan for any period of
time and each Company Plan is terminable at the sole discretion of the
sponsor
thereof, subject only to such constraints as may imposed by applicable
law.
(k)
Taxes. The Company has timely filed all
Tax Returns required to be
filed by it, each such Tax Return has been prepared in compliance with
all
applicable laws and regulations, and all such Tax Returns are true, accurate
and
complete in all respects. The Company has paid all Taxes shown to be due
on such Tax Returns. The Company has made accruals for Taxes on the SEC
Financial Statements that are adequate to cover any Tax liability of the
Company
determined in accordance with generally accepted accounting principles
through
the date of the applicable SEC Financial Statements, and any Taxes of the
Company arising after the date of the most recent SEC Financial Statements
and
at or before the Effective Time of the Merger have been or will be incurred
in
the ordinary course of the Company's business. Except as set forth in
Section 3.01(k) of the Company Disclosure Schedule, the Company has timely
withheld and timely paid all Taxes that are required to have been withheld
and
paid by it in connection with amounts paid or owing to any employee, independent
contractor, creditor or other person. No outstanding deficiency or
adjustment in respect of Taxes has been proposed, asserted or assessed
by any
Tax authority against the Company. The Company has not granted any
outstanding extensions of the time in which any Tax may be assessed or
collected
by any Tax authority. There is no action, suit, proceeding, or audit with
respect to any Tax now in progress, pending or, to the knowledge of the
Company,
threatened against or with respect to the Company. Neither the Company nor
any of its Subsidiaries has ever been a member of any affiliated group
of
corporations (as defined in Section 1504(a) of the Code) other than a group
of
which the Company was the common parent. Neither the Company nor any of
its Subsidiaries has ever filed or been included in a combined, consolidated
or
unitary Tax Return other than with respect to a group of which the Company
was
the common parent. The Company is neither a party to nor bound by any Tax
sharing agreement or Tax allocation agreement. Neither the Company nor any
of its Subsidiaries is presently liable, nor does the Company or any of
its
Subsidiaries have any potential liability, for the Taxes of another person
(i)
under Treasury Regulations Section 1.1502-6 or comparable provision of
state,
local or foreign law, except with respect to a group of which the Company
was
the common parent, (ii) as transferee or successor, or (iii) by contract
or
indemnity or otherwise (other than pursuant to contracts entered into with
customers, vendors, real property lessors, or other third parties the principal
purpose of which is not to address Tax matters). The Company has not
participated, within the meaning of Treasury Regulations Section 1.6011-4(c),
in
(i) any "reportable transaction" within the meaning of Section 6011 of
the Code
and the Treasury Regulations thereunder, (ii) any "confidential corporate
tax
shelter" within the meaning of Section 6111 of the Code and the Treasury
Regulations thereunder, (iii) any "potentially abusive tax shelter" within
the
meaning of Section 6112 of the Code and the Treasury Regulations thereunder,
or
(iv) any transaction identified as a "transaction of interest" within the
meaning of proposed Treasury Regulations Section 1.6011-4(b)(6). The
Company will not be required, as a result of a change in method of accounting
for any period ending on or before or including the Effective Time of the
Merger, to include any adjustment under Section 481(c) of the Code (or
any
similar or corresponding provision or requirement under any other Tax law)
in
Taxable income for any period ending on or after the Effective Time of
the
Merger. The Company will not be required to include any item of income in
Taxable income for any Taxable period (or portion thereof) ending after
the
Closing Date as a result of any (i) prepaid amount received on or prior
to the
Closing Date, or (ii) "closing agreement" described in Section 7121 of
the Code
(or any similar or corresponding provision of any other Tax law). The
Company has never been either a "distributing corporation" or a "controlled
corporation" in connection with a distribution of stock qualifying for
Tax-free
treatment, in whole or in part, pursuant to Section 355 of the Code. The
Company is not and has not been a United States real property holding
corporation within the meaning of Code Section 897(c)(2), during the applicable
period specified in Code Section 897(c)(1)(A)(ii). For purposes of this
Section 3.01(k), references to the Company shall be deemed to include the
Company and all of its Subsidiaries except where the context indicates
otherwise.
A-12
(l)
Properties. The Company or one of its Subsidiaries
(i) has good and
marketable title to all the properties and assets (A) reflected in the
2007
Balance Sheet as being owned by the Company or one of its Subsidiaries
(other
than any such properties or assets sold or disposed of since such date
in the
ordinary course of business consistent with past practice) or (B) acquired
after
January 31, 2007 which are material to the Company's business on a consolidated
basis, free and clear of all Liens. Except as set forth in Section 3.01(l)
of the Company Disclosure Schedule, the Company or one of its Subsidiaries
has
good and valid leasehold interests in all real property leases, subleases
and
occupancy agreements to which the Company or any of its Subsidiaries is
a party
(the "Leases") and is in sole possession of the properties purported to
be leased thereunder. Except as set forth in Section 3.01(l) of the
Company Disclosure Schedule, each Lease is in full force and effect and
constitutes a legal, valid and binding obligation of, and is legally enforceable
against, the respective parties thereto. Except as set forth in Section
3.01(l) of the Company Disclosure Schedule, there is no uncured breach,
and no
default exists, on the part of landlord under any of the Leases, and the
Company
has no knowledge of breach or default or any event, condition or state
of facts,
which with the giving of notice or the passage of time, or both, would
constitute a breach or default by the Company or any of its Subsidiaries
under
any Lease. There is no suit, action, arbitration or other proceeding with
respect to the Leases or the premises leased under the Leases. Neither the
Company nor or any of its Subsidiaries has received notice and does not
otherwise have knowledge of any pending, threatened or contemplated condemnation
proceeding affecting any premises owned or leased by the Company or any
of its
Subsidiaries or any part thereof or of any sale or other disposition of
any such
owned or leased premises or any part thereof in lieu of condemnation. The
real property leased to the Company or any of its Subsidiaries under the
Leases
encompasses all real property used by the Company and its Subsidiaries,
and
neither the Company nor or any of its Subsidiaries owns any real property
and
does not have any options to purchase real property. The landlord under
each of the Leases has performed all initial improvements required to be
performed by it under such Lease and all tenant improvements allowances
have
been paid to the Company or any of its Subsidiaries as tenant under such
Lease.
All insurance required to be maintained by the Company or any of its
Subsidiaries under each of the Leases is in full force and effect.
(m)
Environmental Matters. Except as could not be reasonably
expected
to result in any liability under Environmental Laws to the Company or any
of its
Subsidiaries which, individually or in the aggregate, could reasonably
be
expected to have a Material Adverse Effect with respect to the Company:
(i)
the Company
and its Subsidiaries hold and are in compliance with all
Environmental Permits and the Company and its Subsidiaries are, and have
been,
otherwise in compliance with all Environmental Laws and, to the knowledge
of the
Company, there are no conditions that might prevent or interfere with such
compliance in the future;
(ii)
neither the Company nor any of its Subsidiaries
has received any Environmental
Claim, and to the knowledge of the Company there is no threatened Environmental
Claim;
(iii)
neither the Company nor any of its Subsidiaries
has entered into any consent
decree, order or agreement under any Environmental Law;
(iv)
there are no (A) underground storage tanks,
(B) polychlorinated biphenyls, (C)
friable asbestos or asbestos-containing materials, (D) sumps, (E) surface
impoundments, (F) landfills, or (G) sewers or septic systems present at
any
facility currently owned, leased, operated or otherwise used by the Company
or
any of its Subsidiaries that could reasonably be expected to give rise
to
liability of the Company or any of its Subsidiaries under any Environmental
Laws;
(v)
there are no past (including, without
limitation, with respect to assets or
businesses formerly owned, leased or operated by the Company or any of
its
Subsidiaries) or present actions, activities, events, conditions or
circumstances, including, without limitation, the release, threatened release,
emission, discharge, generation, treatment, storage or disposal of Hazardous
Materials, that could reasonably be expected to give rise to liability
of the
Company or any of its Subsidiaries under any Environmental Laws;
(vi)
no modification, revocation, reissuance,
alteration, transfer, or amendment of
the Environmental Permits, or any review by, or approval of, any third
party of
the Environmental Permits is required in connection with the execution
or
delivery of this Agreement or the consummation of the transactions contemplated
hereby or the continuation of the business of the Company or its Subsidiaries
following such consummation;
A-13
(vii)
Hazardous Materials have not been generated,
transported, treated, stored,
disposed of, arranged to be disposed of, released or threatened to be released
at, on, from or under any of the properties or facilities currently owned,
leased or otherwise used by the Company or any of its Subsidiaries, in
violation
of or so as could result in liability under, any Environmental Laws; and
(viii) neither
the Company nor any of its Subsidiaries has contractually assumed any
liabilities or obligations under any Environmental Laws.
(n)
Contracts; Debt Instruments.
(i)
Except as set
forth in Section 3.01(n) of the Company Disclosure Schedule,
neither the Company nor any of its Subsidiaries is, or has received any
notice
or has any knowledge that any other party is, in default in any respect
under
any contract, agreement, commitment, arrangement, lease, policy or other
instrument to which it or any of its Subsidiaries is a party or by which
it or
any such Subsidiary is bound, except for those defaults which would not,
either
individually or in the aggregate, have a Material Adverse Effect with respect
to
the Company; and, to the knowledge of the Company, there has not occurred
any
event that with the lapse of time or the giving of notice or both would
constitute such a default.
(ii)
The Company has delivered to Parent (x)
true, complete and correct copies of all
loan or credit agreements, notes, bonds, mortgages, indentures and other
agreements and instruments pursuant to which any Indebtedness of the Company
or
any of its Subsidiaries is outstanding and (y) accurate information regarding
the respective principal amounts currently outstanding thereunder.
(iii)
Neither the Company nor any of its Subsidiaries
is party to or bound by any
agreement which, pursuant to the requirements of Form 10-KSB under the
Exchange
Act, would be required to be filed as an exhibit to an Annual Report on
Form
10-KSB of the Company except (A) agreements included or incorporated by
reference as exhibits to the Company's Annual Report on Form 10-KSB for
the
fiscal year ended April 30, 2006 and (B) agreements entered into after
the date
of this Agreement in compliance with Section 4.01 hereof.
(o)
Brokers. No broker, investment banker,
financial advisor or other
Person (including, without limitation, SCO Capital Partners LLC and its
affiliates) is entitled to any broker's finder's, financial advisor's or
other
similar fee or commission in connection with the transactions contemplated
by
this Agreement based upon arrangements made by or on behalf of the Company
or
any of its Subsidiaries. The Company hereby indemnifies Parent and Merger
Sub and holds Parent and Merger Sub harmless from and against any and all
claims, liabilities or obligations with respect to any other fee, commission
or
expense asserted by any Person on the basis of any act or statement alleged
to
have been made by the Company or its affiliates.
(p)
Board Recommendation; Section 203
of the Delaware Law. The Board of
Directors of the Company, at a meeting duly called and held, has by unanimous
vote of those directors present (i) approved this Agreement and the Merger
and
has taken all actions necessary on the part of the Company to render the
restrictions applicable to business combinations contained in Section 203
of the
Delaware Law inapplicable to this Agreement and the Merger and (ii) resolved
to
recommend that the holders of shares of the Company's capital stock approve
this
Agreement and the transactions contemplated herein, including the Merger.
(q)
Required Company Vote. The Company Stockholder Approval
is the only
vote of the holders of any class or series of securities of the Company
of any
of its Subsidiaries necessary to approve this Agreement, the Merger and
the
other transactions contemplated hereby.
(r)
Intellectual Property. (i) Section 3.01(r)(i) of the
Company
Disclosure Schedule sets forth all Intellectual Property owned by the Company
or
its Subsidiaries, which is registered or filed with, or has been submitted
to,
any Governmental Entity, and all Intellectual Property licensed from third
parties by the Company or any of its Subsidiaries, and the nature of the
Company's or its Subsidiaries' rights therein.
A-14
(ii)
Except as set forth in Section 3.01(r)
of the Company Disclosure Schedule, the
Company and its Subsidiaries own or have the right to use all Intellectual
Property necessary for the Company and its Subsidiaries to conduct their
business as it is currently conducted and consistent with past practice.
(iii)
Except as set forth on Section 3.01(r)
of the Company Disclosure Schedule: (1)
all of the Intellectual Property used by the Company or any of its Subsidiaries
is subsisting and unexpired, free of all Liens, has not been abandoned
and, to
the knowledge of the Company, does not infringe the intellectual property
rights
of any third party; (2) none of the Intellectual Property used by the Company
or
any of its Subsidiaries is the subject of any license, security interest
or
other agreement to which the Company is a party granting rights therein
to any
third party; (3) no judgment, decree, injunction, rule or order has been
rendered by any U.S. federal or state or foreign Governmental Entity which
would
limit, cancel or question the validity of, or the Company's or its Subsidiaries
' rights in and to any Intellectual Property in any respect that could
reasonably be expected to have, individually or in the aggregate, a Material
Adverse Effect with respect to the Company; (4) neither the Company nor
or any
of its Subsidiaries has received written notice of any pending or threatened
suit, action or proceeding that seeks to limit, cancel or question the
validity
of, or the Company's or its Subsidiaries ' rights in and to any Intellectual
Property; and (5) the Company and its Subsidiaries take reasonable steps
to
protect, maintain and safeguard their Intellectual Property, including
any
Intellectual Property for which improper or unauthorized disclosure would
impair
its value or validity, and have executed appropriate agreements and made
appropriate filings and registrations in connection with the foregoing.
(s)
Permits. The Company and each of its Subsidiaries
have all permits,
licenses and franchises from Governmental Entities required to conduct
their
businesses as now being conducted, except for such permits, licenses and
franchises the absence of which, individually or in the aggregate, could
reasonably be expected to have a Material Adverse Effect with respect to
the
Company (the "Company Permits"). The Company and each of its
Subsidiaries are in compliance with the terms of the Company Permits. No
Company Permit shall cease to be effective as a result of the consummation
of
the transactions contemplated by this Agreement.
(t)
Insurance. Each of the Company and its Subsidiaries
maintains
insurance policies (each, an "Insurance Policy") with reputable insurance
carriers against all risks of a character and in such amounts as are usually
insured against by similarly situated companies in the same or similar
businesses. Each Insurance Policy is in full force and effect and is set
forth in Section 3.01(t) of the Company Disclosure Schedule.
(u)
Parent SEC Documents. The Company has received and reviewed
all of
the Parent SEC Documents.
(a)
Organization, Standing and Corporate
Power. Each of Parent and
Merger Sub is duly organized, validly existing and in good standing under
the
laws of the jurisdiction in which it is organized and has the requisite
corporate power and authority to carry on its business as now being conducted.
Each of Parent and Merger Sub is duly qualified or licensed to do business
and is in good standing in each jurisdiction (domestic or foreign) in which
the
nature of its business or the ownership or leasing of its properties makes
such
qualification or licensing necessary, other than in such jurisdictions
where the
failure to be so qualified or licensed (individually or in the aggregate)
would
not have a Material Adverse Effect with respect to Parent. Parent has made
available to the Company complete and correct copies of its certificate
of
incorporation and by-laws and the certificate of incorporation and by-laws
of
Merger Sub.
A-15
(b)
Capital Structure. As of the date of this Agreement,
the authorized
capital stock of Parent consists of (i) 100,000,000,000 shares of Parent
Common
Stock and (ii) 2,000,000 shares of Parent Preferred Stock. As of the close
of
business on April 16, 2007, there were: (i) 3,535,358 shares of Parent
Common
Stock issued and outstanding; (ii) no shares of Parent Preferred Stock
issued
and outstanding, (iii) 163 shares of Parent Common Stock held in the treasury
of
Parent; (iv) 75,146 shares of Parent Common Stock reserved for issuance
upon
exercise of options available for grant pursuant to Parent's stock option
plans
(collectively, the "Parent Stock Plans"); (v) 1,888,704 shares of Parent
Common Stock issuable upon exercise of awarded but unexercised stock options;
(vi) warrants representing the right to purchase 4,826,517 shares of Parent
Common Stock; (vii) 6,457,544 shares of Parent Common Stock reserved for
issuance upon conversion of Parent Voting Debt; and (viii) 31,985 shares
of
Parent Common Stock reserved for capitalized interest on Parent Voting
Debt. Except as set forth above, as of the close of business on April 16,
2007 there were no shares of capital stock or other equity securities of
Parent
issued, reserved for issuance or outstanding. All outstanding shares of
capital stock of Parent are, and all shares which may be issued as described
above shall be, when issued, duly authorized, validly issued, fully paid
and
nonassessable and not subject to preemptive rights. The shares of Parent
Common Stock to be issued in connection with the Merger (x) shall, when
issued, be duly authorized, validly issued, fully paid and nonassessable
and not
subject to preemptive rights, and (y) shall be issued in compliance in
all
material respects with all applicable federal and state securities laws
and
applicable rules and regulations promulgated thereunder. As of the
Effective Time of the Merger, the Board of Directors of Parent shall have
reserved for issuance a number of shares of Parent Common Stock as is required
by the Company Warrants to be assumed by Parent pursuant to Section 2.03.
Except as set forth in Section 3.02(b) of the Parent Disclosure Schedule,
there is no outstanding Voting Debt of Parent. Except as set forth above
and in the Rights Agreement, dated as of October 31, 2001, between Parent
and
the American Stock Transfer & Trust Company, there are no outstanding
securities, options, warrants, calls, rights, commitments, agreements,
arrangements or undertakings of any kind to which Parent is a party or
by which
it is bound obligating Parent to issue, deliver or sell, or cause to be
issued,
delivered or sold, additional shares of capital stock or other equity or
voting
securities of Parent or obligating Parent to issue, grant, extend, accelerate
the vesting of or enter into any such security, option, warrant, call,
right,
commitment, agreement, arrangement or undertaking. There are no
outstanding contractual obligations, commitments, understandings or arrangements
of Parent to repurchase, redeem or otherwise acquire or make any payment
in
respect of any shares of capital stock of Parent.
As of the date hereof, the authorized
capital
stock of Merger Sub consists of 1,000 shares of common stock, par value
$0.01
per share, 100 of which have been validly issued, are fully paid and
nonassessable and are owned by Parent, free and clear of any Lien, and
as of the
Closing Date, all the issued and outstanding shares of the common stock
of
Merger Sub shall be owned by Parent free and clear of any Lien.
(c)
Authority; Noncontravention. Parent and Merger Sub have all
requisite corporate power and authority to enter into this Agreement and
to
consummate the transactions contemplated hereby. The execution and
delivery of this Agreement by Parent and Merger Sub and the consummation
by
Parent and Merger Sub of the transactions contemplated hereby have been
duly
authorized by all necessary corporate action on the part of Parent and
Merger
Sub. This Agreement has been duly executed and delivered by each of Parent
and Merger Sub, as applicable, and (assuming due authorization, execution
and
delivery by the Company) constitute valid and binding obligations of Parent
and
Merger Sub, as applicable, enforceable against them in accordance with
their
terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance,
reorganization, moratorium and other similar laws affecting creditors'
rights
generally, general equitable principles (whether considered in a proceeding
in
equity or at law) and an implied covenant of good faith and fair dealing.
The execution and delivery of this Agreement does not, and the
consummation by Parent and Merger Sub of the transactions contemplated
by this
Agreement and compliance by Merger Sub with the provisions of this Agreement
shall not, conflict with, or result in any breach or violation of, or default
(with or without notice or lapse of time, or both) under, or give rise
to a
right of termination, cancellation or acceleration of, or a "put" right
with
respect to any obligation under, or to a loss of a material benefit under,
or
result in the creation of any Lien upon any of the properties or assets
of
Parent or Merger Sub under (i) the certificate of incorporation or by-laws
of
Parent or Merger Sub, (ii) any loan or credit agreement, note, bond,
mortgage, indenture, lease or other agreement, instrument, permit, concession,
franchise or license applicable to Parent or Merger Sub or any of their
respective properties or assets or (iii) subject to the governmental filings
and
other matters referred to in the following sentence, any judgment, order,
decree, statute, law, ordinance, rule, regulation or arbitration award
applicable to Parent or Merger Sub or their respective properties or assets,
other than, in the case of clauses (ii) and (iii), any such conflicts,
breaches,
violations, defaults, rights, losses or Liens that individually or in the
aggregate would not have a Material Adverse Effect with respect to Parent
or
prevent or materially delay the ability of Parent and Merger Sub to consummate
the transactions contemplated by this Agreement or perform their respective
obligations hereunder. No consent, approval, order or authorization of, or
registration, declaration or filing with, or notice to, any Governmental
Entity
is required by or with respect to Parent or Merger Sub in connection with
the
execution and delivery of this Agreement by Parent and Merger Sub or the
consummation by Parent and Merger Sub of any of the transactions contemplated
hereby, except for (i) such filings, if any, may be required under the
HSR Act
and the filing of any required applications, if any, by Parent and Merger
Sub
pursuant to antitrust or similar laws in such foreign jurisdictions as
necessary, (ii) the filing with the SEC of (A) the Form S-4 and (B) such
reports
under the Exchange Act as may be required in connection with this Agreement
and
the transactions contemplated hereby, (iii) the filing of the Certificate
of
Merger with the Secretary of State of the State of Delaware and appropriate
documents with the relevant authorities of other states in which Parent
is
qualified to do business, (iv) such other consents, approvals, orders,
authorizations, registrations, declarations, filings or notices as may
be
required under the "takeover" or "blue sky" laws of various states and
(v) such
other consents, approvals, orders, authorizations, registrations, declarations,
filings or notices the failure of which to make or obtain, individually
or in
the aggregate, could not reasonably be expected to (x) prevent or
materially delay consummation of the Merger or the other transactions
contemplated hereby or performance of Parent's and Merger Sub's obligations
hereunder or (y) have a Material Adverse Effect with respect to
Parent.
A-16
(d)
Parent SEC Documents; Undisclosed
Liabilities. Parent has filed
with the SEC all reports, schedules, forms, statements and other documents
required pursuant to the Securities Act and the Exchange Act since January
1,
2005 (collectively, and in each case including all exhibits and schedules
thereto and documents incorporated by reference therein, the "Parent SEC
Documents"). As of their respective dates, the Parent SEC Documents
(other than the Parent SEC Financial Statements) complied in all material
respects with the requirements of the Securities Act or the Exchange Act,
as the
case may be, and the rules and regulations of the SEC promulgated thereunder
applicable to such Parent SEC Documents. Except to the extent that
information contained in any Parent SEC Document has been revised or superseded
by a later filed Parent SEC Document, none of the Parent SEC Documents
(including any Parent SEC Financial Statements included therein) contains
any
untrue statement of a material fact or omits to state a material fact required
to be stated therein or necessary in order to make the statements therein,
in
the light of the circumstances under which they were made, not misleading.
The consolidated financial statements of Parent included in all Parent
SEC
Documents filed since January 1, 2005 (the "Parent SEC Financial
Statements") comply as to form in all material respects with applicable
published accounting requirements and the published rules and regulations
of the
SEC with respect thereto, have been prepared in accordance with generally
accepted accounting principles as applied in the United States (except,
in the
case of unaudited consolidated quarterly statements, as permitted by Form
10-Q
of the SEC), applied on a consistent basis during the periods involved
(except
as may be indicated in the notes thereto) and fairly present the consolidated
financial position of Parent and its consolidated subsidiaries as of the
dates
thereof and the consolidated results of their operations and cash flows
for the
periods then ended (subject, in the case of unaudited quarterly statements,
to
normal recurring year-end audit adjustments). Neither Parent nor any of
its Subsidiaries has any liabilities or obligations of any nature (whether
accrued, absolute, contingent or otherwise) required by generally accepted
accounting principles as applied in the United States to be recognized
or
disclosed on a consolidated balance sheet of Parent and its Subsidiaries
or in
the notes thereto, except (i) liabilities reflected in the audited consolidated
balance sheet of Parent as of December 31, 2006 and (ii) liabilities incurred
since December 31, 2006, in the ordinary course of business consistent
with past
practice.
(e)
Information Supplied. None of the information supplied
or to be
supplied by Parent or Merger Sub in writing for inclusion or incorporation
by
reference in (i) the Form S-4 shall, at the time the Form S-4 becomes effective
under the Securities Act, contain any untrue statement of a material fact
or
omit to state any material fact required to be stated therein or necessary
to
make the statements therein not misleading or (ii) the Stockholder Statement
shall, (A) at the date it is first mailed to the Company's stockholders
and/or
(B) at the time of the Stockholder Meeting, contain any untrue statement
of a
material fact or omit to state any material fact required to be stated
therein
or necessary to make the statements therein, in the light of the circumstances
under which they are made, not misleading. The Form S-4 shall comply as to
form in all material respects with the requirements of the Securities Act
and
the rules and regulations promulgated thereunder, except that no representation
is made by Parent or Merger Sub with respect to statements made or incorporated
by reference therein based on information supplied in writing by the Company
specifically for inclusion or incorporation by reference therein.
(f)
Absence of Certain Changes or Events. Since December 31, 2006,
there is not and has not been: (i) any Material Adverse Change with respect
to
Parent; (ii) any condition, event or occurrence which, individually or
in the
aggregate, could reasonably be expected to have a Material Adverse Effect
or
give rise to a Material Adverse Change with respect to Parent; (iii) any
condition, event or occurrence which, individually or in the aggregate,
could
reasonably be expected to prevent or materially delay the ability of Parent
and
Merger Sub to consummate the transactions contemplated by this Agreement
or
perform their respective obligations hereunder.
(g)
Litigation; Compliance with Laws.
(i)
Except as set
forth on Schedule 3.02(g) of the Parent Disclosure Schedules,
there is no suit, action, claim, charge, arbitration, investigation or
proceeding pending before a Governmental Entity, and, to the knowledge
of
Parent, no suit, action, claim, charge, arbitration, investigation or proceeding
pending, in each case with respect to Parent or any of its Subsidiaries
that,
individually or in the aggregate, could reasonably be expected to have
a
Material Adverse Effect with respect to Parent or prevent or materially
delay
the ability of Parent and Merger Sub to consummate the transactions contemplated
by this Agreement or to perform their respective obligations hereunder,
nor is
there any judgment, decree, citation, injunction, rule or order of any
Governmental Entity or arbitrator outstanding against Parent or any of
its
Subsidiaries which, individually or in the aggregate, could reasonably
be
expected to have, a Material Adverse Effect with respect to Parent.
A-17
(ii)
The businesses of Parent and its Subsidiaries
are not being conducted in
violation of any law (domestic or foreign), ordinance or regulation of
any
Governmental Entity, except for possible violations which, individually
or in
the aggregate, do not and would not have a Material Adverse Effect with
respect
to Parent.
(h)
Interim Operations of Merger Sub. Merger Sub was formed on
April 13, 2007 solely for the purpose of engaging in the transactions
contemplated hereby, has engaged in no other business activities and has
conducted its operations only as contemplated hereby.
(i)
Required Vote. This Agreement has been approved
by Parent, as the
sole stockholder of Merger Sub. No other vote of holders of any class or
series
of securities of Parent or Merger Sub is necessary to approve this Agreement,
the Merger and the transactions contemplated hereby.
(j)
Taxes. Parent has timely filed all Tax
Returns required to be filed
by it, each such Tax Return has been prepared in compliance with all applicable
laws and regulations, and all such Tax Returns are true, accurate and complete
in all respects. Parent has paid all Taxes shown to be due on such Tax
Returns. Parent has made accruals for Taxes on the Parent SEC Financial
Statements that are adequate to cover any Tax liability of Parent determined
in
accordance with generally accepted accounting principles through the date
of the
applicable Parent SEC Financial Statements, and any Taxes of Parent arising
after the date of the most recent Parent SEC Financial Statements and at
or
before the Effective Time of the Merger have been or will be incurred in
the
ordinary course of Parent's business. Parent has timely withheld and
timely paid all Taxes that are required to have been withheld and paid
by it in
connection with amounts paid or owing to any employee, independent contractor,
creditor or other person. No outstanding deficiency or adjustment in
respect of Taxes has been proposed, asserted or assessed by any Tax authority
against Parent. Parent has not granted any outstanding extensions of the
time in which any Tax may be assessed or collected by any Tax authority.
There is no action, suit, proceeding, or audit with respect to any Tax
now in
progress, pending or, to the knowledge of Parent, threatened against or
with
respect to Parent. Neither Parent nor any of its Subsidiaries has ever
been a member of any affiliated group of corporations (as defined in Section
1504(a) of the Code) other than a group of which Parent was the common
parent. Neither Parent nor any of its Subsidiaries has ever filed or been
included in a combined, consolidated or unitary Tax Return other than with
respect to a group of which Parent was the common parent. Parent is
neither a party to nor bound by any Tax sharing agreement or Tax allocation
agreement. Neither Parent nor any of its Subsidiaries is presently liable,
nor does Parent or any of its Subsidiaries have any potential liability,
for the
Taxes of another person (i) under Treasury Regulations Section 1.1502-6
or
comparable provision of state, local or foreign law, except with respect
to a
group of which Parent was the common parent, (ii) as transferee or successor,
or
(iii) by contract or indemnity or otherwise (other than pursuant to contracts
entered into with customers, vendors, real property lessors, or other third
parties the principal purpose of which is not to address Tax matters).
Parent has not participated, within the meaning of Treasury Regulations
Section
1.6011-4(c), in (i) any "reportable transaction" within the meaning of
Section
6011 of the Code and the Treasury Regulations thereunder, (ii) any "confidential
corporate tax shelter" within the meaning of Section 6111 of the Code and
the
Treasury Regulations thereunder, (iii) any "potentially abusive tax shelter"
within the meaning of Section 6112 of the Code and the Treasury Regulations
thereunder, or (iv) any transaction identified as a "transaction of interest"
within the meaning of proposed Treasury Regulations Section
1.6011-4(b)(6). Parent will not be required, as a result of a change in
method of accounting for any period ending on or before or including the
Effective Time of the Merger, to include any adjustment under Section 481(c)
of
the Code (or any similar or corresponding provision or requirement under
any
other Tax law) in Taxable income for any period ending on or after the
Effective
Time of the Merger. Parent will not be required to include any item of
income in Taxable income for any Taxable period (or portion thereof) ending
after the Closing Date as a result of any (i) prepaid amount received on
or
prior to the Closing Date, or (ii) "closing agreement" described in Section
7121
of the Code (or any similar or corresponding provision of any other Tax
law). Parent has never been either a "distributing corporation" or a
"controlled corporation" in connection with a distribution of stock qualifying
for Tax-free treatment, in whole or in part, pursuant to Section 355 of
the
Code. Parent is not and has not been a United States real property holding
corporation within the meaning of Code Section 897(c)(2), during the applicable
period specified in Code Section 897(c)(1)(A)(ii). For purposes of this
Section 3.02(j), references to Parent shall be deemed to include Parent
and all
of its Subsidiaries except where the context indicates otherwise.
(k)
Brokers. Except as set forth on Schedule
3.02(k) of the Parent
Disclosure Schedules, no broker, investment banker, financial advisor or
other
Person (including, without limitation, SCO Capital Partners LLC and its
affiliates) is entitled to any broker's finder's, financial advisor's or
other
similar fee or commission in connection with the transactions contemplated
by
this Agreement based upon arrangements made by or on behalf of Parent.
Parent hereby indemnifies the Company and holds the Company harmless from
and against any and all claims, liabilities or obligations with respect
to any
other fee, commission or expense asserted by any Person on the basis of
any act
or statement alleged to have been made by Parent or its affiliates.
A-18
(a)
During the period from the date of this
Agreement to the Effective Time of the
Merger (except as otherwise expressly contemplated by the terms of this
Agreement or agreed to in writing by Parent), the Company shall, and shall
cause
its Subsidiaries to, act and carry on their respective businesses in the
ordinary course of business consistent with past practice and use its and
their
respective reasonable best efforts to preserve substantially intact their
current business organizations, keep available the services of their current
officers and employees and preserve their relationships with customers,
supplies, licensors, licensees, advertisers, distributors and others having
significant business dealings with them. Without limiting the generality
of the foregoing, during the period from the date of this Agreement to
the
Effective Time of the Merger, except as otherwise expressly contemplated
by the
terms of this Agreement, the Company Disclosure Schedule or agreed to in
writing
by Parent, the Company shall not, and shall not permit any of its Subsidiaries
to:
(i)
(x) except for the payment of dividends
on the Company Preferred Stock (by the
issuance of shares of Company Common Stock solely to the extent permitted
pursuant to the terms of this Agreement), declare, set aside or pay any
dividends on, or make any other distributions in respect of, any of its
capital
stock, other than dividends and distributions by a direct or indirect
wholly-owned domestic Subsidiary of the Company to its parent, (y) split,
combine or reclassify any capital stock of the Company or any Subsidiary
or
issue or authorize the issuance of any other securities in respect of,
in lieu
of or in substitution for shares of capital stock of the Company or any
Subsidiary, or (z) purchase, redeem or otherwise acquire any shares of
capital
stock of the Company or any of its Subsidiaries or any other securities
thereof
or any rights, warrants or options to acquire any such shares or other
securities;
(ii)
authorize for issuance, issue, deliver,
sell, pledge or otherwise encumber any
such shares of its capital stock or the capital stock of any of its
Subsidiaries, any other voting securities or any securities convertible
into, or
any rights, warrants or options to acquire, any shares, voting securities
or
convertible securities or any other securities or equity equivalents (including,
without limitation, stock appreciation rights), other than the issuance
of
Company Common Stock upon (a) the exercise of Company Stock Options awarded
but
unexercised on the date of this Agreement in accordance with their present
terms, or (b) the conversion of the Company Preferred Stock;
(iii)
amend the Certificate of Incorporation,
By-laws or other comparable charter or
organizational documents of the Company or any Subsidiary;
(iv)
acquire or agree to acquire by merging
or consolidating with, or by purchasing a
substantial portion of the stock or assets of, or by any other manner,
any
business or any corporation, partnership, joint venture, association or
other
business organization or division thereof;
(v)
sell, lease, license, mortgage or otherwise
encumber or subject to any Lien or
otherwise dispose of any of its properties or assets, except sales of inventory
and receivables in the ordinary course of business consistent with past
practice;
(vi)
(A) incur any Indebtedness or guarantee
any Indebtedness of another Person or
amend, terminate or seek a waiver with respect to any existing agreement
of the
Company evidencing Indebtedness of the Company, issue or sell any debt
securities or warrants or other rights to acquire any debt securities of
the
Company or any of its Subsidiaries, guarantee any debt securities of another
Person, enter into any "keep well" or other agreement to maintain any financial
statement condition of another Person or enter to any arrangement having
the
economic effect of any of the foregoing, except for intercompany Indebtedness
between the Company and its wholly-owned Subsidiaries or between such
wholly-owned Subsidiaries, or (B) make any loans, advances or capital
contributions to, or investments in, any other Person;
(vii)
acquire or agree to acquire any assets,
other than inventory in the ordinary
course of business consistent with past practice, or make or agree to make
any
capital expenditures;
A-19
(viii) pay,
discharge or satisfy any claims (including claims of stockholders), liabilities
or obligations (absolute, accrued, asserted or unasserted, contingent or
otherwise), except for the payment, discharge or satisfaction of (x) liabilities
or obligations in the ordinary course of business consistent with past
practice
or in accordance with their terms as in effect on the date hereof or (y)
claims
settled or compromised to the extent permitted by Section 4.01(a)(xii),
or,
except as set forth in the Company Disclosure Schedule, waive, release,
grant,
or transfer any rights of material value or modify or change in any material
respect any existing material license, lease, contract or other document;
(ix)
adopt a plan of complete or partial liquidation
or resolutions providing for or
authorizing such a liquidation or a dissolution, merger, consolidation,
restructuring, recapitalization or reorganization;
(x)
enter into or amend any collective bargaining
agreement;
(xi)
change any material accounting principle
used by it, except as required by
generally accepted accounting principles as applied in the United States;
(xii)
settle or compromise any litigation (whether
or not commenced prior to the date
of this Agreement);
(xiii) engage in
any transaction with, or enter into any agreement, arrangement, or understanding
with, directly or indirectly, any of the Company's affiliates (other than
Subsidiaries of the Company);
(xiv)
transfer to any Person any rights to its
Intellectual Property;
(xv)
enter into or amend any agreement pursuant
to which any other party is granted
exclusive marketing or other exclusive rights of any type or scope with
respect
to any of its products or technology;
(xvi) make
any material Tax election or settle or compromise any material federal,
state,
local or foreign Tax liability; or
(xvii) authorize, or
commit or agree to take, any of the foregoing actions.
(b)
Changes in Employment Arrangements. Except as otherwise agreed to
in writing by Parent, neither the Company nor any of its Subsidiaries shall
adopt or amend (except as may be required by law) any bonus, profit sharing,
compensation, stock option, pension, retirement, deferred compensation,
employment or other employment benefit plan, agreement, trust, fund or
other
arrangement for the benefit or welfare of any employee, director or former
director or employee or increase the compensation or fringe benefits of
any
director, employee or former director or employee or pay any benefit not
required by any existing plan, arrangement or agreement.
(c)
Severance. Neither the Company nor any of
its Subsidiaries shall
grant any new or modified severance or termination arrangement or increase
or
accelerate any benefits payable under its severance or termination pay
policies
in effect on the date hereof.
(d)
WARN. Neither the Company nor any of
its Subsidiaries shall
effectuate a "plant closing" or "mass layoff," as those terms are defined
in
WARN, affecting in whole or in part any site of employment, facility, operating
unit or employee of the Company or any Subsidiary, without notifying Parent
in
advance and without complying with the notice requirements and other provisions
of WARN and any similar state or local law.
(e)
Tax Free Reorganization Treatment. The Company and Parent shall
not, and shall not permit any of their respective Subsidiaries to, intentionally
take or cause to be taken any action not otherwise consistent with the
transactions contemplated by this Agreement which could reasonably be expected
to prevent the Merger from qualifying as a "reorganization" within the
meaning
of Section 368(a) of the Code.
A-20
(f)
Other Actions. Neither the Company nor Parent
shall, or shall
permit any of its Subsidiaries to, intentionally take any action that could
reasonably be expected to result in any of its representations and warranties
set forth in this Agreement being or becoming untrue in any material respect,
or
in any of the conditions to the Merger set forth in Article VI not being
satisfied; provided that the Company and its Board of Directors shall not
be
required to take or be prohibited from taking any action to the extent
that such
action is not required to be taken or is permitted, as applicable, pursuant
to
Section 5.06 of this Agreement. The Company and Parent shall promptly
advise the other party orally and in writing of (i) any representation
or
warranty becoming untrue, (ii) the failure by such party to comply with
any
covenant, condition or agreement hereunder and (iii) any event which could
reasonably be expected to cause the conditions set forth in Article VI
not being
satisfied; provided, however, that no such notice shall affect the
representations, warranties, covenants and agreement of the parties or
the
conditions to their obligations hereunder.
(a)
As soon as practicable following the date
of this Agreement, Parent and the
Company shall prepare the Stockholder Statement and the Form S-4, and Parent
shall file with the SEC the Form S-4, in which the Stockholder Statement
shall
be included. Each party shall notify the other party promptly upon the
receipt of any comments from the SEC or its staff and of any request by
the SEC
or its staff or any government officials for amendments or supplements
to the
Form S-4 or the Stockholder Statement, or for any other filing or for additional
information and shall supply the other party with copies of all correspondence
between such party or any of its representatives, on the one hand, and
the SEC,
or its staff or any other government officials, on the other hand, with
respect
to the Form S-4, the Stockholder Statement, the Merger or any other filing.
Parent and the Company shall each use its reasonable best efforts to have
the Form S-4 declared effective under the Securities Act as promptly as
practicable after such filing. The Company shall use its reasonable best
efforts to cause the Stockholder Statement to be mailed to the Company's
stockholders as promptly as practicable after the Form S-4 is declared
effective
under the Securities Act. Parent shall also take any action (other than
qualifying to do business in any state in which it is not now so qualified
or
filing a general consent to service of process) required to be taken under
any
applicable state securities laws in connection with the registration and
qualification of the Parent Common Stock to be issued in the Merger, and
the
Company shall furnish all information relating to the Company and its
stockholders as may be reasonably requested in connection with any such
action.
(b)
The Company shall, as promptly as practicable
following the date of this
Agreement and in consultation with Parent, duly call, give notice of, convene
and hold a meeting of its stockholders (the "Stockholder Meeting") for
the purpose of approving this Agreement and the transactions contemplated
by
this Agreement to the extent required by Delaware Law. The Company shall,
through its Board of Directors, recommend to its stockholders approval
of the
foregoing matters, as set forth in Section 3.01(p); provided, however,
that the
Board of Directors of the Company may fail to make or withdraw or modify
such
recommendation, but only to the extent that the Board of Directors of the
Company shall have concluded in good faith on the basis of advice from
outside
counsel that such action is required in order to satisfy its fiduciary
duties to
the stockholders of the Company under applicable law. Any such
recommendation shall be included in the Stockholder Statement. The Company
shall use its reasonable best efforts to hold the Stockholder Meeting as
soon as
practicable after the Form S-4 shall have been declared effective.
(a)
Each of the Company and Parent shall,
and shall cause its Subsidiaries,
officers, employees, counsel, financial advisors and other representatives
to,
afford to the other party and its representatives reasonable access during
normal business hours, during the period prior to the Effective Time of
the
Merger to its properties, books, contracts, commitments, personnel and
records,
and, during such period, each of the Company and Parent shall, and shall
cause
its Subsidiaries, officers, employees and representatives to, furnish promptly
to the other documents filed by it during such period pursuant to the
requirements of federal or state securities laws and (ii) all other information
concerning its business, properties, financial condition, operations and
personnel as such other party may from time to time reasonably request.
Each of
the Company and Parent shall hold, and shall cause its respective directors,
officers, employees, accountants, counsel, financial advisors and other
representatives and affiliates to hold, any nonpublic information in confidence
to the extent required by, and in accordance with, the provisions of the
confidentiality agreement, dated February 23, 2007, between Parent and
the
Company (the "Confidentiality Agreement").
A-21
(b)
No investigation pursuant to this Section
5.02 shall affect any representations
or warranties of the parties herein or the conditions to the obligations
of the
parties hereto.
(a)
Upon the terms and subject to the conditions
set forth in this Agreement, each
of the parties agrees to use its reasonable best efforts to take, or cause
to be
taken, all actions, and to do, or cause to be done, and to assist and cooperate
with the other parties in doing, all things necessary, proper or advisable
under
applicable laws and regulations to consummate and make effective, in the
most
expeditious manner practicable, the Merger and the other transactions
contemplated by this Agreement, including (i) obtaining all consents, approvals,
waivers, licenses, permits or authorizations as are required to be obtained
(or,
which if not obtained, would result in an event of default, termination
or
acceleration of any agreement or any put right under any agreement) under
any
applicable law or regulation or from any Governmental Entities or third
parties
in connection with the transactions contemplated by this Agreement, (ii)
defending any lawsuits or other proceedings challenging this Agreement
and (iii)
accepting and delivering additional instruments necessary to consummate
the
transaction contemplated by this Agreement, (iv) in the case of the Company,
delivering proper notice to its stockholders in accordance with Delaware
Law of
such stockholders' appraisal rights under Delaware Law and (v) satisfying
the
conditions to closing set forth under Article VI hereof.
(b)
In furtherance of the foregoing, if required
by the HSR Act, Parent and the
Company agree to file with the Antitrust Division of the United States
Department of Justice and the Federal Trade Commission a Notification and
Report
Form in accordance with the notification requirements of the HSR Act, and
to use
their reasonable best efforts to achieve the prompt termination or expiration
of
the waiting period or any extension thereof provided for under the HSR
Act as a
prerequisite to the consummation of the transactions provided for herein.
Nothing in this paragraph shall be construed as requiring any party to
this
Agreement or its affiliates to (i) sell or otherwise dispose of any of
its
assets or voting securities other than as otherwise contemplated by this
Agreement or (ii) take any action which either would result in a Material
Adverse Change with respect to any such party.
(a)
From and after the Effective Time of the
Merger, Parent and the Surviving
Corporation shall jointly and severally indemnify, defend and hold harmless
each
person who is now, or has been at any time prior to the date hereof or
who
becomes prior to the Effective Time of the Merger eligible for indemnification
pursuant to the Certificate of Incorporation and By-laws (or comparable
organizational documents) of the Company or any agreement of indemnification
with the Company, in each case as the same existed on the date of this
Agreement
(the "Indemnified Parties") against (i) all losses, claims, fines,
damages, costs, expenses (including, without limitation, reasonable attorneys'
fees), liabilities or judgments, or amounts that are paid in settlement
of or in
connection with any claim, action, suit, proceeding or investigation (whether
civil, criminal or administrative) based in whole or in part on or arising
in
whole or in part out of the fact that such person is or was a director,
officer
or employee of the Company or such Subsidiary, pertaining to any matter
existing
or occurring at or prior to the Effective Time of the Merger, whether asserted
or claimed prior to, or at or after, the Effective Time of the Merger
("Indemnified Liabilities") and (ii) all Indemnified Liabilities based in
whole or in part on, or arising in whole or in part out of, or pertaining
to
this Agreement or the transaction contemplated hereby, in each case to
the
extent the Company or its Subsidiaries would have been permitted under
the
Certificate of Incorporation and By-laws (or comparable organizational
documents) or any agreement of indemnification with the Company to indemnify
such person, in each case as the same existed on the date of this Agreement.
In the event any such claim, action, suit, proceeding or investigation
is
brought against any Indemnified Parties (whether arising before or after
the
Effective Time of the Merger), (i) any counsel retained by the Indemnified
Parties for any period after the Effective Time of the Merger shall be
reasonably satisfactory to Parent; (ii) after the Effective Time of the
Merger,
Parent or the Surviving Corporation shall pay all reasonable fees and expenses
of such counsel for the Indemnified Parties promptly as statements therefor
are
received; and (iii) after the Effective Time of the Merger, Parent and
the
Surviving Corporation shall cooperate in the defense of any such matter,
provided that neither Parent nor the Surviving Corporation shall be liable
for
any settlement of any claim effected without its written consent, which
consent
shall not be unreasonably withheld. Any Indemnified Party wishing to claim
indemnification under this Section 5.04, upon learning of any such claim,
action, suit, proceeding or investigation, shall notify Parent and the
Surviving
Corporation (but the failure so to notify Parent and the Surviving Corporation
shall not relieve either from any liability which it may have under this
Section
5.04 except to the extent such failure materially prejudices Parent and
the
Surviving Corporation). Parent and the Surviving Corporation shall be
liable for the fees and expenses hereunder with respect to only one law
firm to
represent the Indemnified Parties as a group with respect to each such
matter
unless there is, under applicable standards of professional conduct, a
conflict
between the positions of any two or more Indemnified Parties that would
preclude
or render inadvisable joint or multiple representation of such parties.
A-22
(b)
If Parent or the Surviving Corporation
or any of their respective successors or
assigns (i) shall consolidate with or merge into any other corporation
or entity
and shall not be the continuing or surviving corporation or entity of such
consolidation or merger or (ii) shall transfer all or substantially all of
its properties and assets to any individual, corporation or other entity,
then,
and in each such case, proper provisions shall be made so that the successors
and assigns of Parent or the Surviving Corporation shall assume all of
the
obligations set forth in this Section 5.04.
(c)
The provisions of this Section 5.04 are
intended to be for the benefit of, and
shall be enforceable by, each of the Indemnified Parties.
(d)
The rights of the Indemnified Parties
under this Section 5.04 shall be in
addition to any rights such Indemnified Parties may have under the certificates
of incorporation or by-laws of the Company or any of its Subsidiaries,
or under
any applicable contracts or laws.
(e) Parent
shall pay the reasonable costs to obtain a tail Director and Officer insurance
policy selected by Parent and covering the officers and directors of the
Company
effective as of the Effective Time and for a period of six (6) years following
the Effective Time, provided that Parent shall not be required to pay
more than $150,000 for such policy.
5.06.
No
Solicitation. Neither the Company nor any of its Subsidiaries shall
(whether directly or indirectly through advisors, agents or other
intermediaries), nor shall the Company or any of its Subsidiaries authorize
or
permit any of its or their officers, directors, agents, representatives,
advisors or Subsidiaries to, (a) solicit, initiate or take any action knowingly
to facilitate the submission of inquiries, proposals or offers from any
Person
(other than Merger Sub or Parent) relating to (i) any acquisition or purchase
of
33.33% or more of the consolidated assets of the Company and its Subsidiaries
or
of over 33.33% of any class of equity securities of the Company or any
of its
Subsidiaries, (ii) any tender offer (including a self tender offer) or
exchange
offer that if consummated would result in any Person beneficially owning
33.33%
or more of any class of equity securities of the Company or any of its
Subsidiaries, (iii) any merger, consolidation, business combination, sale
of
substantially all assets, recapitalization, liquidation, dissolution or
similar
transaction involving the Company or any of its Subsidiaries whose assets,
individually or in the aggregate, constitute more than 33.33% of the
consolidated assets of the Company other than the transactions contemplated
by
this Agreement, or (iv) any other transaction the consummation of which
would or
could reasonably be expected to impede, interfere with, prevent or materially
delay the Merger (collectively, "Transaction Proposals"), or agree to or
endorse any Transaction Proposal, or (b) enter into or participate in any
discussions or negotiations regarding any of the forgoing, or furnish to
any
other Person any information with respect to its business, properties or
assets
or any of the foregoing, or otherwise cooperate in any way with, or knowingly
assist or participate in, facilitate or encourage, any effort or attempt
by any
other Person (other than Merger Sub or Parent) to do or seek any of the
foregoing; provided, however, that the foregoing shall not prohibit the
Company
(either directly or indirectly through advisors, agents or other intermediaries)
from (i) furnishing information pursuant to an appropriate confidentiality
letter (which letter shall not be less favorable to the Company in any
material
respect than the Confidentiality Agreement, a copy of which shall be
provided for informational purposes only to Parent) concerning the Company
and
its businesses, properties or assets to a third party who has made a bona
fide
Transaction Proposal, (ii) engaging in discussions or negotiations with
such a
third party who has made a bona fide Transaction Proposal, (iii) following
receipt of a bona fide Transaction Proposal, taking and disclosing to its
stockholders a position contemplated by Rule 14d-9 or Rule 14e-2(a) under
the
Exchange Act or otherwise making disclosure to its stockholders, (iv) following
receipt of a bona fide Transaction Proposal, failing to make or withdrawing
or
modifying its recommendation referred to in Section 3.01(p), and/or (v)
taking
any action required to be taken by the Company pursuant to a non-appealable,
final order by any court of competent jurisdiction, but in each case referred
to
in the foregoing clauses (i) through (iv) only to the extent that the Board
of
Directors of the Company shall have concluded in good faith on the basis
of
advice from outside counsel that such action is required in order to satisfy
its
fiduciary duties to the stockholders of the Company under applicable law;
provided, further, that the Board of Directors of the Company shall not
take any
of the foregoing actions referred to in clauses (i) through (iv) until
after
prompt advance notice to Parent (which notice shall in no event be given
less
than two (2) business day prior to furnishing such information or entering
into
such discussions) with respect to such action and that such Board of Directors
shall, to the extent consistent with its fiduciary duties, continue to
advise
Parent after taking such action and, in addition, if such Board of Directors
receives a Transaction Proposal, then the Company shall promptly inform
Parent
of the terms and conditions of such proposal and the identity of the Person
making it. The Company shall immediately cease and cause its advisors,
agents
and other intermediaries to cease any and all existing activities, discussions
or negotiations with any parties conducted heretofore with respect to any
of the
foregoing, and shall use its reasonable best efforts to cause any such
parties
in possession of confidential information about the Company that was furnished
by or on behalf of the Company to return or destroy all such information
in the
possession of any such party or in the possession of any agent or advisor
of any
such party.
A-23
(a)
The Board of Directors of Parent, or a
committee thereof consisting of
non-employee directors (as such term is defined for purposes of Rule 16b-3(d)
under the Exchange Act), shall adopt a resolution in advance of the Effective
Time of the Merger providing that the receipt by any Company Insiders of
options
to purchase Parent Common Stock, in each case pursuant to the transactions
contemplated hereby and to the extent such securities are listed in the
Section 16 Information, is intended to be exempt pursuant to Rule 16b-3
under the Exchange Act.
(b)
For purposes of this Agreement, "Section 16 Information" means information
regarding the Company Insiders and the number of shares of Company Common
Stock
or other Company equity securities deemed to be beneficially owned by each
such
Company Insider and expected to be exchanged for options to purchase Parent
Common Stock in connection with the Merger, which shall be provided by
the
Company to Parent at least ten (10) business days prior to the Closing.
(c)
For purposes of this Agreement, "Company
Insiders" means those officers and
directors of the Company who immediately after the Closing become subject
to the
reporting requirements of Section 16(a) of the Exchange Act with respect to
equity securities of Parent.
A-24
5.13.
Termination
of
Company Plans. Effective no later than the day immediately
preceding the Closing Date but contingent upon the Closing, the Company
shall
terminate any and all Company Plans intended to include a Code
Section 401(k) arrangement (collectively, the "Terminated Company
Plans"). The Company shall provide Parent with evidence that such
Terminated Company Plan(s) have been terminated (effective no later than
the day
immediately preceding the Closing Date) in accordance with each such Terminated
Company Plan’s respective terms. The Company also shall take such other
actions in furtherance of terminating such Terminated Company Plan(s) as
Parent
may reasonably require.
(a)
Company Stockholder Approval. The Company Stockholder Approval
shall have been obtained.
(b)
HSR Act. The waiting period (and any extension
thereof), if any,
applicable to the Merger under the HSR Act shall have been terminated or
shall
have expired.
(c)
No Injunctions or Restraints. No temporary restraining order,
preliminary or permanent injunction or other order issued by any court
of
competent jurisdiction or other legal restraint or prohibition preventing
the
consummation of the Merger shall be in effect; provided, however, that
the
parties hereto shall use their best efforts to have any such injunction,
order,
restraint or prohibition vacated.
(d)
Form S-4. The Form S-4 shall have become
effective under the
Securities Act and shall not be the subject of any stop order or proceedings
seeking a stop order, and any material "blue sky" and other state securities
laws applicable to the registration and qualification of Parent Common
Stock
issuable or required to be reserved for issuance pursuant to this Agreement
shall have been complied with.
(e)
Governmental Approvals. Other than the filing of the Certificate
of
Merger, all authorizations, consents, orders or approvals of, or declarations
or
filings with, or expirations of waiting periods imposed by, any Governmental
Entity in connection with the Merger and the consummation of the other
transactions contemplated by this Agreement, the failure of which to file,
obtain or occur is reasonably likely to have a Material Adverse Effect
with
respect to Parent or a Material Adverse Effect with respect to the Company,
shall have been filed, been obtained or occurred on terms and conditions
which
would not reasonably be likely to have a Material Adverse Effect with respect
to
Parent or a Material Adverse Effect with respect to the Company.
(f)
Stockholder Statement. No stop order suspending the use
of the
Stockholder Statement shall have been issued and no proceeding for that
purpose
shall have been initiated or threatened in writing by the SEC or its
staff.
(g)
Flow of Funds Memorandum. Parent and the Company shall have
executed and delivered a mutually agreeable Flow of Funds Memorandum setting
forth certain payments to be made by Parent concurrently with the Closing
(the
“Flow of Funds Memorandum”).
A-25
(a)
Representations and Warranties. The representations and warranties
of the Company set forth in this Agreement shall be true and correct in
each
case as of the date of this Agreement and (except to the extent such
representations and warranties speak as of an earlier date) as of the Closing
Date as though made on and as of the Closing Date, except where the failure
of
such representations and warranties to be so true and correct (without
giving
effect to any limitation as to "materiality" or "Material Adverse Effect"
set
forth therein) would not individually or in the aggregate have a Material
Adverse Effect. Parent shall have received a certificate dated as of the
Closing
Date signed on behalf of the Company by the chief executive officer and
the
chief financial officer of the Company to the effect set forth in this
paragraph.
(b)
Performance of Obligations of the
Company. The Company shall have
performed in all material respects all obligations required to be performed
by
it under this Agreement at or prior to the Closing Date. Parent shall have
received a certificate signed on behalf of the Company by the chief executive
officer and the chief financial officer of the Company to the effect set
forth
in this paragraph.
(c)
Consents, Etc. Parent and Merger Sub shall have
received evidence,
in form and substance reasonably satisfactory to Parent, that such licenses,
permits, consents, approvals, authorizations, qualifications, and orders
of
governmental authorities and other third parties as are necessary (in Parent's
sole discretion) in connection with the transactions contemplated hereby
have
been obtained, except where the failure to obtain such licenses, permits,
consents, approvals, authorizations, qualifications, and orders would not,
individually or in the aggregate with all other failures, have a Material
Adverse Effect with respect to the Company.
(d)
No Litigation. There shall not be pending by
any Governmental
Entity or any other Person or solely with respect to any Governmental Entity,
threatened by any suit, action, or proceeding, (i) challenging or seeking
to
restrain or prohibit the consummation of the Merger or any of the other
transactions contemplated by this Agreement or seeking to obtain from any
party
hereto or any of their affiliates any damages that are material in relation
to
the Company and its Subsidiaries taken as a whole; (ii) seeking to prohibit
or
limit the ownership or operation by the Company or any of its Subsidiaries
of
any material portion of the business or assets of the Company and its
Subsidiaries taken as a whole or to dispose of or hold separate any material
portion of the business or assets of the Company and its Subsidiaries taken
as a
whole, as a result of the Merger or any of the other transactions contemplated
by this Agreement; (iii) seeking to impose limitations on the ability of
Parent
to acquire or hold, or exercise full rights of ownership of, any shares
of the
common stock of the Surviving Corporation, including, without limitation,
the
right to vote such common stock on all matters properly presented to the
stockholders of the Surviving Corporation; or seeking to prohibit Parent
or any
of its Subsidiaries from effectively controlling in any material respect
the
business or operations of the Company and its Subsidiaries taken as a
whole.
(e)
Termination of Company Options. The Company shall have (i) entered
into a termination agreement with each holder of a Company Option pursuant
to
which all outstanding Company Options held by each such holder shall be
terminated and each such holder shall no rights thereunder to purchase
shares of
Company Common Stock or (ii) in accordance with Section 11.3(d) of the
Company
Stock Plan, accelerate the expiration date of all such Company Options
to a date
no later than April 30, 2007 and required each such holder to exercise
all such
Company Options held by such holder (including, if the Company so elects
in
accordance thereunder, to accelerate the vesting of such Company Options)
by
such date.
(f)
Opinion of Counsel. Foley & Lardner LLP, counsel to the
Company, shall have delivered to Parent a written legal opinion addressed
to
Parent, dated on and as of the Closing Date, and in form reasonably satisfactory
to Parent.
A-26
(g)
Resignation of Directors and Officers. The directors and officers
of the Company, in office immediately prior to the Effective Time of the
Merger
shall have resigned as directors and officers of the Surviving Corporation
effective as of the Effective Time of the Merger.
(h)
Termination of Agreements; SCO Waiver;
Other Waivers. The Company
and each other party thereto shall have terminated each agreement set forth
on
Schedule 6.02(h) attached hereto. SCO Partners LLC and its affiliates
shall have executed and delivered to the Company a waiver, in form satisfactory
to Parent, of any rights to (i) liquidated or other damages in respect
of any
failure by the Company to timely satisfy any such obligation or (ii) any
fees
resulting from the Merger or any financing, under any agreement with Parent
or
the Company. Each holder of a Company Warrant to be assumed by Parent
pursuant to Section 2.03 shall have executed and delivered to Parent a
waiver,
in form satisfactory to Parent, of any rights to require Parent to register
for
resale under the Securities Act any such Company Warrants held by such
Person or
Parent Common Stock issuable upon exercise of such Company Warrants. The
employment agreement between the Company and Agamemnon A. Epenetos, dated
January 31, 2006 shall have been amended and restated to be in the form
of the
standard Parent executive employment agreement and acceptable to Parent.
(i)
Dissenters' Rights. Any applicable period during which
stockholders
of the Company have the right to exercise appraisal, dissenters' or other
similar rights under Section 262 of Delaware Law or other applicable law
shall
have expired and stockholders of the Company holding in the aggregate more
than
five percent (5%) of the outstanding shares of Company Common Stock or
Company
Preferred Stock shall not have exercised appraisal, dissenters' or similar
rights under Section 262 of Delaware Law or other applicable law with respect
to
such shares by virtue of the Merger.
(j)
No Material Adverse Effect. Since the date of this Agreement,
there
shall not have occurred any Material Adverse Effect with respect to the
Company.
(k)
FIRPTA Certificate. The Company shall have delivered
a properly
executed statement, dated as of the Closing Date, in a form reasonably
acceptable to Parent, conforming to the requirements of Treasury Regulations
Section 1.1445-2(c)(3).
(l)
Outstanding Liabilities of the Company. Parent shall have received
evidence, satisfactory to it, that as of the Closing Date the amount of
the
Company's then outstanding accounts payable and other liabilities (including,
without limitation, all amounts owed (i) to employees, officers and consultants
of the Company (and its Subsidiaries) and (ii) to any Person in respect
of any
failure by the Company to timely satisfy any obligation to register for
resale
under the Securities Act any securities of the Company held by such Person)
does
not exceed $1,000,000 in the aggregate.
(m)
Exercise or Termination of Company
Warrants. The Company shall have
required each holder of the Company Warrants listed in Section 6.02(m)
of the
Company Disclosure Schedule to exercise each such Company Warrant held
by such
holder prior to the Closing Date, or such holder and the Company shall
have
executed and delivered a termination agreement terminating each such Company
Warrant and all of such holder's rights thereunder, including any right
to
purchase shares of Company Common Stock.
(n)
Opinion of Financial Advisor. Parent shall have received the
opinion of TSG Partners to the effect that the payment by it of the Merger
Consideration is fair to Parent's stockholders from a financial point of
view.
(o)
License Agreements. The Company shall have obtained
letter
certifications from each licensor of the Company or any of its Subsidiaries
(including, without limitation, Virium Pharmaceuticals, Inc. and Immunodex,
Inc.), in form satisfactory to Parent, that any agreement between such
Person
and the Company (or the Company's Subsidiary, if applicable) is in full
force
and effect, that such agreement constitutes a legal, valid and binding
obligation of, and is legally enforceable against, it and the Company (or
the
Company's Subsidiary, if applicable), that there exists no uncured breach
or
default by either it or the Company (or the Company's Subsidiary, if applicable)
under any such agreement and that any consents required under such agreement
have been obtained, are valid and are currently in effect.
A-27
(p)
Virium Pharmaceuticals, Inc. All conditions to the approval
by NIH
of the Phenylbutyrate Co-development and Sublicense Agreement between the
Company and Virium Pharmaceuticals, Inc. (“Virium”) shall have been
met. Virium shall have executed and delivered to the Company each of the
two amendments previously negotiated and executed by the Company, copies
of
which have been provided to Parent. The Company and Virium shall have
negotiated, and each shall have executed and delivered to the other party,
the
letter of intent previously executed by the Company in the form previously
provided to Parent with such changes as may be approved by Parent in its
sole
discretion.
(a)
Representations and Warranties. The representations and warranties
of Parent and Merger Sub set forth in this Agreement shall be true and
correct,
in each case as of the date of this Agreement and (except to the extent
such
representations and warranties speak as of an earlier date) as of the Closing
Date as though made on and as of the Closing Date, except where the failure
of
such representations and warranties to be so true and correct (without
giving
effect to any limitation as to "materiality" or "material adverse effect"
set
forth therein) would not individually or in the aggregate have a Material
Adverse Effect with respect to Parent. The Company shall have received a
certificate signed on behalf of Parent and Merger Sub by an authorized
officer
of Parent and Merger Sub to the effect set forth in this paragraph.
(b)
Performance of Obligations of Parent
and Merger Sub. Parent and
Merger Sub shall have performed in all material respects all obligations
required to be performed by each of them under this Agreement at or prior
to the
Closing Date. The Company shall have received a certificate signed on
behalf of Parent and Merger Sub by an authorized officer of Parent and
Merger
Sub to the effect set forth in this paragraph.
(c)
Opinion of Counsel. Bingham McCutchen LLP, counsel
to Parent and
Merger Sub, shall have delivered to the Company a written legal opinion
addressed to the Company, dated on and as of the Closing Date, and in form
reasonably satisfactory to the Company.
(d)
No Litigation. There shall not be pending by
any Governmental
Entity or any other Person or solely with respect to any Governmental Entity,
threatened by any suit, action, or proceeding, (i) challenging or seeking
to
restrain or prohibit the consummation of the Merger or any of the other
transactions contemplated by this Agreement or seeking to obtain from any
party
hereto or any of their affiliates any damages that are material in relation
to
Parent and its Subsidiaries taken as a whole; (ii) seeking to prohibit
or limit
the ownership or operation by Parent or any of its Subsidiaries of any
material
portion of the business or assets of Parent and its Subsidiaries taken
as a
whole or to dispose of or hold separate any material portion of the business
or
assets of Parent and its Subsidiaries taken as a whole, as a result of
the
Merger or any of the other transactions contemplated by this Agreement;
(iii)
seeking to impose limitations on the ability of Parent to acquire or hold,
or
exercise full rights of ownership of, any shares of the common stock of
the
Surviving Corporation, including, without limitation, the right to vote
such
common stock on all matters properly presented to the stockholders of the
Surviving Corporation; or seeking to prohibit Parent or any of its Subsidiaries
from effectively controlling in any material respect the business or operations
of the Company and its Subsidiaries taken as a whole.
(e)
Outstanding SCO and Oracle Debt. The applicable maturity date of
all of Parent's outstanding debt (whether principal or interest) owed to
each of
SCO Partners LLC (and its affiliates) and Oracle Partners LP (and its
affiliates) shall have been extended to a date on or after April 27, 2008,
or
such debt shall have been converted into Parent Common Stock.
A-28
(a)
by mutual written consent of Parent and
the Company;
(b)
by either Parent or the Company if any
Governmental Entity shall have issued an
order, decree, or ruling or taken any other action permanently enjoining,
restraining, or otherwise prohibiting the Merger and such order, decree,
ruling,
or other action shall have become final and nonappealable;
(c)
by either Parent or the Company if the
Merger shall not have been consummated on
or before August 31, 2007 (other than due to the failure of the party seeking
to
terminate this Agreement to perform in any material respect its obligations
under this Agreement required to be performed at or prior to the Effective
Time
of the Merger);
(d)
by either Parent or the Company if at
the Stockholder Meeting (including any
adjournment thereof) the Company Stockholder Approval shall not have been
obtained;
(e)
by Parent, if the Company or its Board
of Directors shall have (1) withdrawn,
modified, or amended in any respect adverse to Parent its approval or
recommendation of this Agreement or any of the transactions contemplated
herein;
(2) failed as promptly as reasonably practicable after the Form S-4 is
declared
effective to mail the Stockholder Statement to its stockholders or failed
to
include in such statement such recommendation; (3) recommended any Transaction
Proposal from a Person other than Parent or any of its affiliates; (4)
resolved
to do any of the foregoing; or (5) in response to the commencement of any
tender
offer or exchange offer for more than 10% of the outstanding shares of
Company
Common Stock or Company Preferred Stock, not recommended rejection of such
tender offer or exchange offer at the time of filing of the requisite Schedule
14d-9 with the SEC;
(f)
by the Company, if, pursuant to and in
compliance with Section 5.06 hereof, the
Board of Directors of the Company concludes in good faith, based on advice
from
outside counsel, that in order to satisfy its fiduciary duties to the
stockholders of the Company under the Delaware Law, such Board of Directors
must
not make or must withdraw or modify its recommendation referred to in Section
3.01(p), and the Board of Directors does not make or withdraws or modifies
such
recommendation;
(g)
by Parent, upon a breach of any representation,
warranty, covenant or agreement
on the part of the Company set forth in this Agreement, or if any representation
or warranty of the Company shall have become untrue, in either case such
that
the conditions set forth in Section 6.02(a) or Section 6.02(b) (other than
with
respect to the delivery of the officers' certificates required thereunder)
would
not be satisfied at the time of such breach or as of the time such
representation or warranty shall have become untrue; provided that if such
inaccuracy in the Company's representations and warranties or breach by
the
Company is curable by the Company through the exercise of its commercially
reasonable efforts within ten (10) business days of the time such representation
or warranty shall have become untrue or such breach, Parent may not terminate
this Agreement under this Section 7.01(g) during such ten-day period, provided
Company continues to exercise such commercially reasonable efforts; or
(h)
by the Company, upon a breach of any representation,
warranty, covenant or
agreement on the part of Parent or Merger Sub set forth in this Agreement,
or if
any representation or warranty of Parent shall have become untrue, in either
case such that the conditions set forth in Section 6.03(a) or Section 6.03(b)
(other than with respect to the delivery of the officers' certificates
required
thereunder) would not be satisfied at the time of such breach or as of
the time
such representation or warranty shall have become untrue; provided that
if such
inaccuracy in Parent's representations and warranties or breach by Parent
is
curable by Parent through the exercise of its commercially reasonable efforts
within ten (10) business days of the time such representation or warranty
shall
have become untrue or such breach, the Company may not terminate this Agreement
under this Section 7.01(h) during such ten-day period provided Parent continues
to exercise such commercially reasonable effort.
A-29
7.02.
Effect
of
Termination. In the event of termination of this Agreement by either
the Company or Parent as provided in Section 7.01, this Agreement shall
forthwith become void and have no effect, without any liability or obligation
on
the part of Parent, Merger Sub, or the Company, provided that (a) any such
termination shall not relieve a party from liability for any willful breach
of
this Agreement and (b) the last sentence of Section 5.02(a), this Section
7.02,
Section 8.02, Section 8.07 and the Confidentiality Agreement shall remain in
full force and effect and survive any such termination. Nothing contained
in
this paragraph shall relieve any party for any breach of the covenants
or
agreements set forth in this Agreement or the Confidentiality Agreement.
(a)
Except as set forth in this Section 8.02, all fees and expenses incurred in
connection with this Agreement and the transactions contemplated hereby
shall be
paid by the party incurring such fees and expenses, whether or not the
Merger is
consummated; provided however, that the Company and Parent shall share
equally
all fees and expenses, other than accountants' and attorneys' fees, incurred
with respect to the printing, filing and mailing of the S-4 and the Stockholder
Statement (including any related preliminary materials) and any amendments
or
supplements thereto.
(b)
The Company shall pay Parent up to $750,000
as reimbursement for expenses of
Parent actually incurred relating to the transactions contemplated by this
Agreement prior to termination (including, but not limited to, reasonable
fees
and expenses of Parent's counsel, accountants and financial advisors, but
excluding any discretionary fees paid to such financial advisors), in the
event
of the termination of this Agreement:
A-30
(i)
by Parent or the Company pursuant to Section 7.01(c) if the failure to
satisfy any of the conditions set forth in Sections 6.02(a)-(c), (e)-(j),
(o) and (p) by August 31, 2007 shall have resulted in the Closing not
occurring; or
(ii)
by Parent pursuant to Section 7.01(g).
The expenses payable pursuant to this
Section 8.02(b) shall be paid by wire transfer of same-day funds within
five (5) business days after demand therefor following the occurrence of
the
termination event giving rise to the payment obligation described in this
Section 8.02(b).
(c)
The Company shall pay Parent a termination
fee of $750,000 in the event of the
termination of this Agreement (i) by Parent pursuant to Section 7.01(d)
or (ii)
by Parent or the Company pursuant to Sections 7.01(e)-(g) (except in the
case of a termination by Parent due to the failure of the Company to satisfy
the
condition set forth in Section 6.02(l)).
Any fee due under this Section 8.02(c)
shall be paid to Parent by wire transfer of same-day funds within two (2)
business days after the date of termination of this Agreement.
(d)
Parent shall pay the Company up to $100,000
as reimbursement for expenses of the
Company actually incurred relating to the transactions contemplated by
this
Agreement prior to termination (including, but not limited to, reasonable
fees
and expenses of the Company's counsel, accountants and financial advisors,
but
excluding any discretionary fees paid to such financial advisors), in the
event
of the termination of this Agreement:
(i)
by the Company or Parent pursuant to Section 7.01(c) as a result of the
failure to satisfy the conditions set forth in Section 6.03(a) or (b);
or
(ii)
by the Company pursuant to Section 7.01(h).
The expenses payable pursuant to this
Section 8.02(d) shall be paid by wire transfer of same-day funds within
five (5) business days after demand therefor following the occurrence of
the
termination event giving rise to the payment obligation described in this
Section 8.02(d).
(e)
The parties acknowledge that the agreements
contained in this Section 8.02
are an integral part of the transactions contemplated by this Agreement,
and
that, without these agreements, the parties would not enter into this
Agreement. Payment of the fees and expenses described in this
Section 8.3 shall not be in lieu of damages incurred in the event of a
breach of this Agreement described in clause (a) of Section 7.02 but is
otherwise the sole and exclusive remedy of the parties in connection with
any
termination of this Agreement.
(a)
if to Parent or
Merger Sub, to
Access Pharmaceuticals, Inc.
2600 Stemmons Freeway, Suite 176
Dallas, Texas75207
Attention: Stephen Seiler
Telecopier No.: (214) 905-5101
A-31
with
a
copy to:
Bingham
McCutchen LLP
150
Federal
Street
Boston, MA 02110
Attention: John J. Concannon III,
Esq.
Telecopier No.: (617) 951-8736
(b)
if to the Company or its Subsidiaries,
to
Somanta Pharmaceuticals, Inc.
19200 Von Karman Avenue, Suite 400
Irvine, CA92612
Attention: Terrance Bruggeman
Telecopier No.: (949) 706-3698
with
a
copy to:
Foley & Lardner LLP
402 W. Broadway, Suite 2100
San Diego, CA 92101
Attention: Adam Lenain, Esq.
Telecopier No.: (619) 234-3510
(a)
"Affiliate" of any Person means another
Person that directly or
indirectly, through one or more intermediaries, controls, is controlled
by, or
is under common control with, such first Person;
(b)
"Company Common Stock" means the common stock, par
value $0.001 per
share, of the Company.
(c)
"Company Preferred Stock" means the Series A Convertible
Preferred Stock,
par value $0.001 per share, of the Company.
(d)
"Company Stock Option Plan" means the Company's 2005 Equity
Incentive
Plan.
(e)
"Company Warrants" means warrants to purchase shares
of Company Common
Stock as listed in Section 3.01(c) of the Company Disclosure Schedule.
(f)
"Environmental Claim" means any written or oral notice,
claims, demand,
action, suit, complaint, proceeding or other communication by any Person
alleging liability or potential liability (including without limitation
liability or potential liability for investigatory costs, cleanup costs,
governmental response costs, natural resource damages, property damage,
personal
injury, fines or penalties) arising out of, relating to, based on or resulting
from (A) the presence, discharge, emission, release or threatened release
of any
Hazardous Materials at any location, whether or not owned, leased or operated
by
the Company or any of its Subsidiaries or (B) circumstances forming the
basis of
any violation or alleged violation of any Environmental Law or Environmental
Permit or (C) otherwise relating to obligations or liabilities under any
Environmental Laws;
A-32
(g)
"Environmental Permits" means all permits, licenses,
registrations and
other governmental authorizations required under Environmental Laws for
the
Company and its Subsidiaries to conduct their operations and businesses
on the
date hereof and consistent with past practices;
(h)
"Environmental Laws" means all applicable federal,
state and local
statutes, rules, regulations, ordinances, orders, decrees and common law
relating in any manner to contamination, pollution or protection of the
environment, including, without limitation, the Comprehensive Environmental
Response, Compensation and Liability Act, the Solid Waste Disposal Act,
the
Clean Air Act, the Clean Water Act, the Toxic Substances Control Act, the
Occupational Safety and Health Act, the Emergency Planning and
Community-Right-to-Know Act, the Safe Drinking Water Act, all as amended,
and
similar state laws;
(i)
"Hazardous Materials" means all hazardous or toxic
substances, wastes,
materials or chemicals, petroleum (including crude oil or any fraction
thereof)
and petroleum products, friable asbestos and asbestos-containing materials,
pollutants, contaminants and all other materials, and substances regulated
pursuant to, or that could reasonably be expected to provide the basis
of
liability under, any Environmental Law;
(j)
"Indebtedness" means, with respect to any Person,
without duplication,
(A) all obligations of such Person for borrowed money, (B) all obligations
of
such Person evidenced by bonds, debentures, notes or similar instruments,
(C)
all obligations of such Person under conditional sale or other title retention
agreements relating to property purchased by such Person, (D) all obligations
of
such Person issued or assumed as the deferred purchase price of property
or
services (excluding obligations of such Person to creditors for raw materials,
inventory, services and supplies incurred in the ordinary course of such
Person's business), (E) all capitalized lease obligations of such Person,
(F)
all obligations of others secured by any Lien on property or assets owned
or
acquired by such Person, whether or not the obligations secured thereby
have
been assumed, (G) all obligations of such Person under interest rate or
currency
hedging transactions (valued at the termination value thereof), (H) all
letters
of credit issued for the account of such Person and (I) all guarantees
and
arrangements having the economic effect of a guarantee of such Person of
any
Indebtedness of any other Person;
(k)
"Intellectual Property" means all rights, privileges
and priorities
provided under federal, state, foreign and multinational law relating to
intellectual property, including, without limitation, all (i)(a) inventions,
discoveries, processes, formulae, designs, methods, techniques, procedures,
concepts, developments, technology, new and useful improvements thereof
and
know-how relating thereto, whether or not patented or eligible for patent
protection; (b) copyrights and copyrightable works, including computer
applications, programs, software, databases and related items (except for
off-the-shelf commercial software); (c) trademarks, service marks, trade
names,
brand names, corporate names, logos and trade dress, the goodwill of any
business symbolized thereby, and all common-law rights relating thereto;
and (d)
trade secrets and other confidential information; and (ii) all registrations,
applications, recordings, and licenses or other similar agreements related
to
the foregoing;
(l)
"knowledge of the Company" means the actual knowledge of
any officer of
the Company or any Subsidiary of the Company.
(m)
"Material Adverse Change" or "Material Adverse Effect" means, when
used in connection with the Company or Parent, any change, effect, event
or
occurrence that either individually or in the aggregate with all other
such
changes, effects, events and occurrences is materially adverse to the business,
properties, financial condition or results of operations of the Company
or
Parent, as the case may be, and its Subsidiaries taken as a whole, provided
that
(i) with respect to Section 3.01(g)(i) and (ii) hereof, shall exclude any
material adverse change in the Company's results of operations for any
fiscal
period prior to the Closing Date that is directly attributable to a disruption
in the conduct of the Company's business arising from the transactions
contemplated by this Agreement or the public announcement thereof and (ii)
with
respect to Section 3.02(f)(i) and (ii) hereof, shall exclude any material
adverse change in Parent's results of operations for any fiscal period
prior to
the Closing Date that is directly attributable to a disruption in the conduct
of
Parent's business arising from the transactions contemplated by this Agreement
or the public announcement thereof; and provided, further, that Material
Adverse
Effect and Material Adverse Change shall not be deemed to include the impact
of
(a) any change in laws and regulations or interpretations thereof by courts
or
governmental authorities generally applicable to the Company and Parent,
(b) any
change in generally accepted accounting principles as applied in the United
States or regulatory accounting principles generally applicable to the
Company
and Parent, (c) any change arising or resulting from general industry,
economic
or capital market conditions or conditions in markets relevant to the Company
or
Parent, as applicable, that affects Parent or the Company, as applicable
(or the
markets in which Parent or the Company, as applicable, compete) in a manner
not
disproportionate to the manner in which such conditions affect comparable
companies in the industries or markets in which Company or Parent, as
applicable, compete, (d) any act or omission of the Company (or any of
its
Subsidiaries) taken with the prior written consent of Parent or (e) the
expenses
reasonably incurred by the Company in entering into this Agreement and
consummating the transactions contemplated by this Agreement and the expenses
associated with the termination of any Company Plan as and to the extent
contemplated herein.
A-33
(n)
"Parent Common Stock" means the common stock, par
value $0.01 per share,
of Parent.
(o)
"Parent Preferred Stock" means the preferred stock, par
value $0.01 per
share, of Parent.
(p)
"Permitted Lien" means statutory Liens securing
payments not yet due and
such Liens as do not materially affect the use of the properties or assets
subject thereto or affected thereby or otherwise materially impair business
operations at such properties.
(q)
"Person" means an individual, corporation,
partnership, joint venture,
association, trust, unincorporated organization or other entity;
(r)
"SEC" means the United States Securities
and Exchange Commission.
(s)
"Subsidiary" of any Person means another
Person, an amount of the voting
securities, other voting ownership or voting partnership interests of which
is
sufficient to elect at least a majority of its Board of Directors or other
governing body (or, if there are no such voting interests, 50% or more
of the
equity interests of which) is owned directly or indirectly by such first
Person.
(t)
"Tax" or "Taxes" (and with correlative
meaning, "Taxable"
and "Taxing") means any United States federal, state or local, or
non-United States, income, gross receipts, franchise, estimated, alternative
minimum, add-on minimum, sales, use, transfer, registration, value added,
excise, natural resources, severance, stamp, withholding, occupation, premium,
windfall profit, environmental, customs, duties, real property, personal
property, capital stock, net worth, intangibles, social security, unemployment,
disability, payroll, license, employee or other Tax or similar levy, of
any kind
whatsoever, including any interest, penalties or additions to Tax in respect
of
the foregoing.
(u)
"Tax Return" means any return, declaration,
report, claim for refund,
information return or other document (including any related or supporting
estimates, elections, schedules, statements or information) filed or required
to
be filed in connection with the determination, assessment or collection
of any
Tax or the administration of any laws, regulations or administrative
requirements relating to any Tax.
A-34
8.08.
Governing
Law;
Consent to Jurisdiction; Waiver of Jury Trial. This Agreement
shall be governed by, and construed in accordance with, the laws of the
STATE OF
NEW YORK, regardless of the laws that might otherwise govern under applicable
principles of conflicts of laws. Each of the parties to this Agreement
(a) consents to submit itself to the personal jurisdiction of any state or
federal court sitting in THE BOROUGH OF MANHATTAN in any action or proceeding
arising out of or relating to this Agreement or any of the transactions
contemplated by this Agreement, (b) agrees that all claims in respect of
such action or proceeding may be heard and determined in any such court,
(c)
agrees that it shall not attempt to deny or defeat such personal jurisdiction
by
motion or other request for leave from any such court, and (d) agrees not
to bring any action or proceeding arising out of or relating to this Agreement
or any of the transaction contemplated by this Agreement in any other
court. Each of the parties hereto waives any defense of inconvenient forum
to the maintenance of any action or proceeding so brought and waives any
bond,
surety or other security that might be required of any other party with
respect
thereto. Any party hereto may make service on another party by sending or
delivering a copy of the process to the party to be served at the address
and in
the manner provided for the giving of notices in Section 8.03.
Nothing in this Section 8.08, however, shall affect the right of any party
to serve legal process in any other manner permitted by law. EACH party
hereto HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION,
PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE)
ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED
HEREBY OR THE ACTIONS OF any party hereto IN THE NEGOTIATION, ADMINISTRATION,
PERFORMANCE AND ENFORCEMENT OF THIS AGREEMENT.
[REMAINDER
OF
PAGE INTENTIONALLY LEFT BLANK]
A-35
IN WITNESS WHEREOF, the parties have caused
this Agreement to be signed by their respective officers thereunto duly
authorized, all as of the date first written above.
ACCESS PHARMACEUTICALS, INC.
By: /s/ Stephen R.
Seiler
Name: Stephen
R. Seiler
Title:
President and Chief
Executive Officer
Somanta acquisition corporation
By: /s/ Stephen R.
Seiler
Name: Stephen
R. Seiler
Title:
President and Chief
Executive Officer
SOMANTA PHARMACEUTICALS, INC.
By: /s/ Terrance J.
Bruggeman
Name: Terrance
J. Bruggeman
Title:
Executive Chairman
SOMANTA INCORPORATED
By: /s/ Terrance J.
Bruggeman
Name:
Terrance
J.
Bruggeman
Title:
Executive Chairman
Somanta Limited
By: /s/ Terrance J.
Bruggeman
Name:
Terrance
J.
Bruggeman
Title:
Secretary
[Signature
page to Merger Agreement]
A-36
Annex
B
CHAPTER
1. DELAWARE GENERAL CORPORATION LAW
Subchapter
IX. Merger, Consolidation or Conversion
§
262. Appraisal rights.
(a)
Any
stockholder of a corporation of this State who holds shares of stock on the
date
of the making of a demand pursuant to subsection (d) of this section with
respect to such shares, who continuously holds such shares through the effective
date of the merger or consolidation, who has otherwise complied with subsection
(d) of this section and who has neither voted in favor of the merger or
consolidation nor consented thereto in writing pursuant to § 228 of this title
shall be entitled to an appraisal by the Court of Chancery of the fair value
of
the stockholder’s shares of stock under the circumstances described in
subsections (b) and (c) of this section. As used in this section, the word
“stockholder” means a holder of record of stock in a stock corporation and also
a member of record of a nonstock corporation; the words “stock” and “share” mean
and include what is ordinarily meant by those words and also membership or
membership interest of a member of a nonstock corporation; and the words
“depository receipt” mean a receipt or other instrument issued by a depository
representing an interest in one or more shares, or fractions thereof, solely
of
stock of a corporation, which stock is deposited with the depository.
(b)
Appraisal rights shall be available for the shares of any class or series of
stock of a constituent corporation in a merger or consolidation to be effected
pursuant to § 251 (other than a merger effected pursuant to § 251(g) of this
title), § 252, § 254, § 257, § 258, § 263 or § 264 of this title:
(1)
Provided, however, that no appraisal rights under this section shall be
available for the shares of any class or series of stock, which stock, or
depository receipts in respect thereof, at the record date fixed to determine
the stockholders entitled to receive notice of and to vote at the meeting of
stockholders to act upon the agreement of merger or consolidation, were either
(i) listed on a national securities exchange or designated as a national market
system security on an interdealer quotation system by the National Association
of Securities Dealers, Inc. or (ii) held of record by more than 2,000 holders;
and further provided that no appraisal rights shall be available for any shares
of stock of the constituent corporation surviving a merger if the merger did
not
require for its approval the vote of the stockholders of the surviving
corporation as provided in subsection (f) of § 251 of this title.
(2)
Notwithstanding paragraph (1) of this subsection, appraisal rights under this
section shall be available for the shares of any class or series of stock of
a
constituent corporation if the holders thereof are required by the terms of
an
agreement of merger or consolidation pursuant to §§ 251, 252, 254, 257, 258, 263
and 264 of this title to accept for such stock anything except:
a.
Shares
of stock of the corporation surviving or resulting from such merger or
consolidation, or depository receipts in respect thereof;
b.
Shares
of stock of any other corporation, or depository receipts in respect thereof,
which shares of stock (or depository receipts in respect thereof) or depository
receipts at the effective date of the merger or consolidation will be either
listed on a national securities exchange or designated as a national market
system security on an interdealer quotation system by the National Association
of Securities Dealers, Inc. or held of record by more than 2,000 holders;
c.
Cash
in lieu of fractional shares or fractional depository receipts described in
the
foregoing subparagraphs a. and b. of this paragraph; or
d.
Any
combination of the shares of stock, depository receipts and cash in lieu of
fractional shares or fractional depository receipts described in the foregoing
subparagraphs a., b. and c. of this paragraph.
(3)
In
the event all of the stock of a subsidiary Delaware corporation party to a
merger effected under § 253 of this title is not owned by the parent
corporation immediately prior to the merger, appraisal rights shall be available
for the shares of the subsidiary Delaware corporation.
(c)
Any
corporation may provide in its certificate of incorporation that appraisal
rights under this section shall be available for the shares of any class or
series of its stock as a result of an amendment to its certificate of
incorporation, any merger or consolidation in which the corporation is a
constituent corporation or the sale of all or substantially all of the assets
of
the corporation. If the certificate of incorporation contains such a provision,
the procedures of this section, including those set forth in subsections (d)
and
(e) of this section, shall apply as nearly as is practicable.
B-1
(d)
Appraisal rights shall be perfected as follows:
(1)
If a
proposed merger or consolidation for which appraisal rights are provided under
this section is to be submitted for approval at a meeting of stockholders,
the
corporation, not less than 20 days prior to the meeting, shall notify each
of
its stockholders who was such on the record date for such meeting with respect
to shares for which appraisal rights are available pursuant to subsection (b)
or
(c) hereof that appraisal rights are available for any or all of the shares
of
the constituent corporations, and shall include in such notice a copy of this
section. Each stockholder electing to demand the appraisal of such stockholder’s
shares shall deliver to the corporation, before the taking of the vote on the
merger or consolidation, a written demand for appraisal of such stockholder’s
shares. Such demand will be sufficient if it reasonably informs the corporation
of the identity of the stockholder and that the stockholder intends thereby
to
demand the appraisal of such stockholder’s shares. A proxy or vote against the
merger or consolidation shall not constitute such a demand. A stockholder
electing to take such action must do so by a separate written demand as herein
provided. Within 10 days after the effective date of such merger or
consolidation, the surviving or resulting corporation shall notify each
stockholder of each constituent corporation who has complied with this
subsection and has not voted in favor of or consented to the merger or
consolidation of the date that the merger or consolidation has become effective;
or
(2)
If
the merger or consolidation was approved pursuant to § 228 or § 253 of this
title, then either a constituent corporation before the effective date of the
merger or consolidation or the surviving or resulting corporation within 10
days
thereafter shall notify each of the holders of any class or series of stock
of
such constituent corporation who are entitled to appraisal rights of the
approval of the merger or consolidation and that appraisal rights are available
for any or all shares of such class or series of stock of such constituent
corporation, and shall include in such notice a copy of this section. Such
notice may, and, if given on or after the effective date of the merger or
consolidation, shall, also notify such stockholders of the effective date of
the
merger or consolidation. Any stockholder entitled to appraisal rights may,
within 20 days after the date of mailing of such notice, demand in writing
from
the surviving or resulting corporation the appraisal of such holder’s shares.
Such demand will be sufficient if it reasonably informs the corporation of
the
identity of the stockholder and that the stockholder intends thereby to demand
the appraisal of such holder’s shares. If such notice did not notify
stockholders of the effective date of the merger or consolidation, either (i)
each such constituent corporation shall send a second notice before the
effective date of the merger or consolidation notifying each of the holders
of
any class or series of stock of such constituent corporation that are entitled
to appraisal rights of the effective date of the merger or consolidation or
(ii)
the surviving or resulting corporation shall send such a second notice to all
such holders on or within 10 days after such effective date; provided, however,
that if such second notice is sent more than 20 days following the sending
of
the first notice, such second notice need only be sent to each stockholder
who
is entitled to appraisal rights and who has demanded appraisal of such holder’s
shares in accordance with this subsection. An affidavit of the secretary or
assistant secretary or of the transfer agent of the corporation that is required
to give either notice that such notice has been given shall, in the absence
of
fraud, be prima facie evidence of the facts stated therein. For purposes of
determining the stockholders entitled to receive either notice, each constituent
corporation may fix, in advance, a record date that shall be not more than
10
days prior to the date the notice is given, provided, that if the notice is
given on or after the effective date of the merger or consolidation, the record
date shall be such effective date. If no record date is fixed and the notice
is
given prior to the effective date, the record date shall be the close of
business on the day next preceding the day on which the notice is given.
(e)
Within 120 days after the effective date of the merger or consolidation, the
surviving or resulting corporation or any stockholder who has complied with
subsections (a) and (d) hereof and who is otherwise entitled to appraisal
rights, may file a petition in the Court of Chancery demanding a determination
of the value of the stock of all such stockholders. Notwithstanding the
foregoing, at any time within 60 days after the effective date of the merger
or
consolidation, any stockholder shall have the right to withdraw such
stockholder’s demand for appraisal and to accept the terms offered upon
the
merger or consolidation. Within 120 days after the effective date of the merger
or consolidation, any stockholder who has complied with the requirements of
subsections (a) and (d) hereof, upon written request, shall be entitled to
receive from the corporation surviving the merger or resulting from the
consolidation a statement setting forth the aggregate number of shares not
voted
in favor of the merger or consolidation and with respect to which demands for
appraisal have been received and the aggregate number of holders of such shares.
Such written statement shall be mailed to the stockholder within 10 days after
such stockholder’s written request for such a statement is received by the
surviving or resulting corporation or within 10 days after expiration of the
period for delivery of demands for appraisal under subsection (d) hereof,
whichever is later.
B-2
(f)
Upon
the filing of any such petition by a stockholder, service of a copy thereof
shall be made upon the surviving or resulting corporation, which shall within
20
days after such service file in the office of the Register in Chancery in which
the petition was filed a duly verified list containing the names and addresses
of all stockholders who have demanded payment for their shares and with whom
agreements as to the value of their shares have not been reached by the
surviving or resulting corporation. If the petition shall be filed by the
surviving or resulting corporation, the petition shall be accompanied by such
a
duly verified list. The Register in Chancery, if so ordered by the Court, shall
give notice of the time and place fixed for the hearing of such petition by
registered or certified mail to the surviving or resulting corporation and
to
the stockholders shown on the list at the addresses therein stated. Such notice
shall also be given by 1 or more publications at least 1 week before the day
of
the hearing, in a newspaper of general circulation published in the City of
Wilmington, Delaware or such publication as the Court deems advisable. The
forms
of the notices by mail and by publication shall be approved by the Court, and
the costs thereof shall be borne by the surviving or resulting corporation.
(g)
At
the hearing on such petition, the Court shall determine the stockholders who
have complied with this section and who have become entitled to appraisal
rights. The Court may require the stockholders who have demanded an appraisal
for their shares and who hold stock represented by certificates to submit their
certificates of stock to the Register in Chancery for notation thereon of the
pendency of the appraisal proceedings; and if any stockholder fails to comply
with such direction, the Court may dismiss the proceedings as to such
stockholder.
(h)
After
determining the stockholders entitled to an appraisal, the Court shall appraise
the shares, determining their fair value exclusive of any element of value
arising from the accomplishment or expectation of the merger or consolidation,
together with a fair rate of interest, if any, to be paid upon the amount
determined to be the fair value. In determining such fair value, the Court
shall
take into account all relevant factors. In determining the fair rate of
interest, the Court may consider all relevant factors, including the rate of
interest which the surviving or resulting corporation would have had to pay
to
borrow money during the pendency of the proceeding. Upon application by the
surviving or resulting corporation or by any stockholder entitled to participate
in the appraisal proceeding, the Court may, in its discretion, permit discovery
or other pretrial proceedings and may proceed to trial upon the appraisal prior
to the final determination of the stockholder entitled to an appraisal. Any
stockholder whose name appears on the list filed by the surviving or resulting
corporation pursuant to subsection (f) of this section and who has submitted
such stockholder’s certificates of stock to the Register in Chancery, if such is
required, may participate fully in all proceedings until it is finally
determined that such stockholder is not entitled to appraisal rights under
this
section.
(i)
The
Court shall direct the payment of the fair value of the shares, together with
interest, if any, by the surviving or resulting corporation to the stockholders
entitled thereto. Interest may be simple or compound, as the Court may direct.
Payment shall be so made to each such stockholder, in the case of holders of
uncertificated stock forthwith, and the case of holders of shares represented
by
certificates upon the surrender to the corporation of the certificates
representing such stock. The Court’s decree may be enforced as other decrees in
the Court of Chancery may be enforced, whether such surviving or resulting
corporation be a corporation of this State or of any state.
(j)
The
costs of the proceeding may be determined by the Court and taxed upon the
parties as the Court deems equitable in the circumstances. Upon application
of a
stockholder, the Court may order all or a portion of the expenses incurred
by
any stockholder in connection with the appraisal proceeding, including, without
limitation, reasonable attorney’s fees and the fees and expenses of experts, to
be charged pro rata against the value of all the shares entitled to an
appraisal.
(k)
From
and after the effective date of the merger or consolidation, no stockholder
who
has demanded appraisal rights as provided in subsection (d) of this section
shall be entitled to vote such stock for any purpose or to receive payment
of
dividends or other distributions on the stock (except dividends or other
distributions payable to stockholders of record at a date which is prior to
the
effective date of the merger or consolidation); provided, however, that if
no
petition for an appraisal shall be filed within the time provided in subsection
(e) of this section, or if such stockholder shall deliver to the surviving
or
resulting corporation a written withdrawal of such stockholder’s demand for an
appraisal and an acceptance of the merger or consolidation, either within 60
days after the effective date of the merger or consolidation as provided in
subsection (e) of this section or thereafter with the written approval of the
corporation, then the right of such stockholder to an appraisal shall cease.
Notwithstanding the foregoing, no appraisal proceeding in the Court of Chancery
shall be dismissed as to any stockholder without the approval of the Court,
and
such approval may be conditioned upon such terms as the Court deems just.
(l)
The
shares of the surviving or resulting corporation to which the shares of such
objecting stockholders would have been converted had they assented to the merger
or consolidation shall have the status of authorized and unissued shares of
the
surviving or resulting corporation. (8 Del. C. 1953, § 262; 56 Del. Laws, c. 50;
56 Del. Laws, c. 186, § 24; 57 Del. Laws, c. 148, §§ 27-29; 59 Del. Laws, c.
106, § 12; 60 Del. Laws, c. 371, §§ 3-12; 63 Del. Laws, c. 25, § 14; 63 Del.
Laws, c. 152, §§ 1, 2; 64 Del. Laws, c. 112, §§ 46-54; 66 Del. Laws, c. 136, §§
30-32; 66 Del. Laws, c. 352, § 9; 67 Del. Laws, c. 376, §§ 19, 20; 68 Del. Laws,
c. 337, §§ 3, 4; 69 Del. Laws, c. 61, § 10; 69 Del. Laws, c. 262, §§ 1-9; 70
Del. Laws, c. 79, § 16; 70 Del. Laws, c. 186, § 1; 70 Del. Laws, c. 299, §§ 2,
3; 70 Del. Laws, c. 349, § 22; 71 Del. Laws, c. 120, § 15; 71 Del. Laws, c. 339,
§§ 49-52; 73 Del. Laws, c. 82, § 21.)
B-3
Annex
C
FORM
OF VOTING AGREEMENT
Voting
Agreement
This
Voting
Agreement (this "Agreement") is made and entered into as of
April 18, 2007, by and among Access Pharmaceuticals, Inc., a Delaware
corporation ("Parent"), Somanta Acquisition Corporation, a Delaware
corporation and a wholly-owned subsidiary of Parent ("Merger Sub"), and
the undersigned holders (the "Holders") of securities of Somanta
Pharmaceuticals, Inc., a Delaware corporation (the
"Company").
Recitals
A. Each
Holders owns beneficially and of record (i) shares of the Company's capital
stock and/or (ii) stock options, convertible securities or warrants (whether
or
not vested) to acquire shares of the Company's capital stock, in each case
in
that number and class of shares of the Company's capital stock set forth
on
Schedule 1 attached hereto opposite the name of such Holder (such
options, convertible securities, warrants and/or shares of the Company's
capital
stock, together with any other such options, convertible securities, warrants
and/or shares of capital stock of the Company acquired by any Holder after
the
date hereof and during the term of this Agreement, including following
the
exercise of any such options, convertible securities and/or warrants, being
referred to herein as such Holder's "Subject Securities").
B. Upon
the fulfillment of the terms and conditions of the Agreement and Plan of
Merger
by and among Parent, Merger Sub, the Company and the other parties named
therein, dated as of the date hereof (as amended, restated or supplemented
from
time to time, the "Merger Agreement"), Merger Sub shall be merged (the
"Merger") with and into the Company, with the Company continuing as the
surviving corporation. Capitalized terms used but not defined herein
are used as they are defined in the Merger Agreement.
C. Each
Holder believes that the terms of the Merger and the Merger Agreement are
fair
and that it is in such Holder's best interest as a holder of securities
of the
Company that the Merger be consummated.
D. Parent
has advised the Company that Parent is not prepared to execute the Merger
Agreement unless Parent believes that it is reasonably likely that the
Merger
will be consummated, and therefore Parent is requiring that certain holders
of
capital stock of the Company undertake in advance to vote their securities
in
favor of the Merger.
E. For
the above reasons, in order to induce Parent to enter into the Merger and
in
consideration of the execution of the Merger Agreement by Parent and to
enhance
the likelihood that the Merger will be consummated, each Holder, solely
in such
Holder's capacity as a holder of securities of the Company, agrees to vote
such
Holder's Subject Securities that are entitled to vote on the Merger (or
execute
and deliver a written consent) so as to facilitate consummation of the
Merger.
Now,
Therefore, in consideration
of the foregoing and the promises and the covenants and agreements set
forth
below, the receipt and adequacy of which are hereby acknowledged, the parties
hereto hereby agree as follows:
C-1
1. Transfer
of Shares. During the term of this Agreement, each Holder shall
not cause or permit any Transfer (as defined below) of any of such Holder's
Subject Securities or enter into any agreement, option or arrangement with
respect to a Transfer; provided, that nothing contained in this Agreement
shall be deemed to restrict the ability of any Holder to exercise any stock
options, convertible securities or warrants of the Company held by such
Holder
prior to the termination hereof. Except as otherwise provided herein,
no Holder shall deposit (or permit the deposit of) any of such Holder's
Subject
Securities in a voting trust or grant any proxy or enter into any voting
agreement or similar agreement with respect to any of such Subject Securities
or
in any way grant any other Person any right whatsoever with respect to
the
voting or disposition of such Subject Securities. For purposes
hereof, a Person shall be deemed to have effected a "Transfer" of Subject
Securities if such Person directly or indirectly: (i) sells, pledges, encumbers,
grants an option with respect to, transfers, assigns, or otherwise disposes
of
such security, or any interest in such security; or (ii) enters into an
agreement or commitment providing for the sale of, pledge of, encumbrance
of,
grant of an option with respect to, transfer of or disposition of such
shares or
any interest therein.
2. Agreement
to Vote Shares. At any meeting of stockholders of the Company or
at any adjournment thereof, in any action by written consent or in any
other
circumstances upon which any Holder's vote, consent or other approval is
sought
in connection with the Merger, such Holder shall vote (or cause to be voted)
all
of such Holder's Subject Securities that are then entitled to be voted
on the
Merger (i) in favor of the Merger and each of the terms of the Merger Agreement
and the transactions and other agreements reflected therein, (ii) against
any
proposal, amendment or agreement that would in any manner impede, frustrate,
prevent or nullify the Merger Agreement, the Merger or this Agreement or
change
in any manner the voting rights of any class of capital stock of the Company
and
(iii) against any proposed Transaction Proposal. Each Holder shall
execute and deliver to the Company a written consent in favor of the Merger
and
the terms of the Merger Agreement and the transactions and other agreements
reflected therein as soon as practicable and in any event, within two business
days after the date of receipt from the Company of a written consent in
proper
form if no meeting of the Company stockholders has then been called for
such
purpose.
3. Director
Matters Excluded. No provision of this Agreement shall limit or
otherwise restrict any Holder with respect to any vote that such Holder
or any
of such Holder's representatives may make solely in his or her capacity
as a
director of the Company with respect to a matter presented to the Company's
board of directors.
4. Irrevocable
Proxy.
(a) Concurrently
with the execution of this Agreement, each Holder has executed and delivered
to
Parent and Merger Sub an irrevocable proxy in the form attached hereto
as
Exhibit A (the "Proxy"), which shall be irrevocable to the fullest
extent permissible by law, with respect to such Holder's Subject
Securities.
(b) If
for
any reason the proxy granted pursuant to this Agreement by a Holder is
not
irrevocable, then such Holder agrees to vote such Holder's Subject Securities
that are then entitled to vote on the Merger in accordance with Section
2
hereof.
C-2
5. Representations
and Warranties of Holders. Each Holder hereby represents and
warrants as to itself, severally and not jointly with any other Holder,
to
Parent, Merger Sub and the Company as follows:
(a) Such
Holder (i) is the record and beneficial owner of the Subject Securities
set
forth opposite the name of such Holder on Schedule 1 attached hereto,
free and clear of any liens, adverse claims, charges or other encumbrances
of
any nature whatsoever (other than pursuant to (x) applicable restrictions
on
transfer under applicable securities laws or (y) this Agreement), and (ii)
does
not beneficially own any securities of the Company other than such Subject
Securities.
(b) Except
as
set forth on Schedule 1 attached hereto, such Holder has the sole right
to Transfer, to vote and to direct the voting of the Subject Securities
set
forth opposite the name of such Holder on Schedule 1 attached hereto, and
none of such Subject Securities are subject to any voting trust or other
agreement, arrangement or restriction with respect to the Transfer or the
voting
of such Subject Securities, except as set forth in this Agreement.
(c) Such
Holder: (i) is duly organized, validly existing and in good standing
under the laws of its jurisdiction of organization; and (ii) has the requisite
corporate, company, partnership or other power and authority to execute
and
deliver this Agreement and the Proxy, to consummate the transactions
contemplated hereby and thereby and to comply with the terms hereof and
thereof. The execution and delivery by such Holder of this Agreement
and the Proxy, the consummation by such Holder of the transactions contemplated
hereby and thereby and the compliance by such Holder with the provisions
hereof
and thereof have been duly authorized by all necessary corporate, company,
partnership or other action on the part of such Holder, and no other corporate,
company, partnership or other proceedings on the part of such Holder are
necessary to authorize this Agreement and the Proxy, to consummate the
transactions contemplated hereby and thereby or to comply with the provisions
hereof or thereof.
(d) Each
of
this Agreement and the Proxy has been duly executed and delivered by such
Holder, constitutes a valid and binding obligation of such Holder and is
enforceable against such Holder in accordance with its terms.
(e) The
execution and delivery of this Agreement and the Proxy, the consummation
of the
transactions contemplated hereby and thereby and compliance with the provisions
hereof and thereof do not and will not conflict with, or result in any
violation
or breach of, or default (with or without notice or lapse of time, or both)
under, any provision of (i) the certificate of incorporation or by-laws,
partnership agreement or limited liability company agreement (or similar
organizational documents) of such Holder, if applicable, (ii) any (A) statute,
law, ordinance, rule or regulation or (B) judgment, order or decree, in
each
case, applicable to such Holder or its properties or assets, or (iii) any
contract, trust, commitment, agreement, understanding, arrangement or
restriction of any kind to which such Holder is a party or by which such
Holder
or such Holder's assets are bound.
C-3
(f) Such
Holder has such knowledge and experience in financial and business matters
that
it is capable of evaluating the merits and risks of the investment in Parent
Common Stock that such Holder is making by reason of the Merger and the
other
transactions contemplated by the Merger Agreement and by reason of executing
and
delivering this Agreement, and, in connection therewith, has performed
a due
diligence review of Parent and its business and financial condition satisfactory
to such Holder. Such Holder's financial condition is such that it is
able to bear all economic risks of such investment in Parent Common Stock,
including a complete loss of such Holder's investment therein.
6. Termination. This
Agreement shall terminate upon the earliest to occur of (i) the termination
of
the Merger Agreement in accordance with its terms and (ii) the Effective
Time of
the Merger. In the event of the termination of this Agreement, this
Agreement and the Proxy shall forthwith become null and void, there shall
be no
liability on the part of any of the parties hereto, and all rights and
obligations of each party hereto shall cease; provided, however,
that no such termination of this Agreement shall relieve any party hereto
from
any liability for any breach of any provision of this Agreement prior to
termination.
7. Further
Covenants and Assurances.
(a) Each
Holder shall not, and such Holder shall not permit any of its affiliates,
directors, officers, employees, investment bankers, attorneys or other
advisors
or representatives to, directly or indirectly (i) solicit, initiate or
knowingly
encourage the submission of any proposal regarding a Transaction Proposal
or
(ii) take any action to facilitate the making of any proposal that constitutes,
or may reasonably be expected to lead to, a proposal regarding a Transaction
Proposal. Each Holder shall, from time to time, execute and deliver,
or cause to be executed and delivered, such additional or further consents,
documents and other instruments as Parent may reasonably request for the
purpose
of effectively carrying out the provisions of this Agreement and the
transactions contemplated hereby.
(b) If
any
Holder (in such capacity or otherwise) receives an unsolicited inquiry,
proposal
or offer relating to a Transaction Proposal from any Person, such Holder
shall
(i) promptly notify Parent of the same and the details thereof (including
the
identity of the Person making same), (ii) provide to Parent a copy of any
written inquiry, proposal or offer and all correspondence related thereto,
and
(iii) keep Parent informed of the status thereof. Each Holder shall
immediately cease and cause to be terminated any existing activities,
discussions or negotiations with any Persons conducted prior to the date
hereof
with respect to any Transaction Proposal.
8. Successors,
Assigns and Transferees Bound. Without limiting Section 1 hereof
in any way, each Holder agrees that this Agreement and the obligations
hereunder
shall attach to such Holder's Subject Securities from the date hereof through
the termination of this Agreement and shall be binding upon any Person
to which
legal or beneficial ownership of such Subject Securities shall pass, whether
by
operation of law or otherwise, including such Holder's heirs, guardians,
administrators or successors, and such Holder further agrees to take all
actions
necessary to effectuate the foregoing. Any shares of the Company's
capital stock or any stock options, convertible securities, or warrants
(whether
or not vested) to acquire shares of the Company's capital stock received
by any
Holder in connection with any stock split, stock dividend, reclassification,
merger, reorganization, recapitalization or other change in the capital
structure of the Company affecting the capital stock of the Company shall
be
Subject Securities of such Holder, and this Agreement and the representations,
warranties, covenants, agreements and obligations hereunder shall attach
to any
such additional Subject Securities of such Holder.
9. Deposit. Each
Holder shall cause a counterpart of this Agreement to be deposited with
the
Company at its principal place of business or registered office where it
shall
be subject to the same right of examination by a stockholder of the Company,
in
person or by agent or attorney, as are the books and records of the
Company.
C-4
10. Public
Disclosure. Except as contemplated by the Merger Agreement or as
otherwise required by applicable law (including applicable securities laws)
no
disclosure (whether or not in response to an inquiry) of the subject matter
of
this Agreement or the Merger Agreement shall be made prior to the Effective
Time
of the Merger by any Holder (including any third party representatives
of any
Holder) (other than disclosures to managers, advisors or equity holders
of a
Holder in connection with the approval of the Merger Agreement, if applicable)
unless approved by Parent prior to release; provided that such approval
shall
not be unreasonably withheld, conditioned or delayed. Notwithstanding
the immediately preceding sentence, in the event that a Holder is required
by
applicable law to make any such disclosure, such Holder may make such
disclosure; provided that such Holder shall notify Parent prior to making
such
disclosure and shall use its commercially reasonable efforts to give Parent
an
opportunity (as is reasonable under the circumstances) to comment on such
disclosure.
11. Remedies. Each
Holder acknowledges that money damages would be both incalculable and an
insufficient remedy for any breach of this Agreement by it, and that any
such
breach would cause Parent irreparable harm. Accordingly, each Holder
agrees that in the event of any breach or threatened breach of this Agreement,
Parent, in addition to any other remedies at law or in equity it may have,
shall
be entitled to seek immediate equitable relief, including injunctive relief
and
specific performance, without the necessity of proving the inadequacy of
money
damages as a remedy and without the necessity of posting any bond or other
security, to prevent breaches of this Agreement and to enforce specifically
the
terms and provisions hereof in any court of the United States or any state
having jurisdiction.
12. Severability. The
invalidity or unenforceability of any provision of this Agreement in any
jurisdiction shall not affect the validity or enforceability of any other
provision of this Agreement in such jurisdiction, or the validity or
enforceability of any provision of this Agreement in any other
jurisdiction.
13. Entire
Agreement/Amendment. This Agreement represents the entire
agreement of the parties with respect to the subject matter
hereof. This Agreement may not be amended, modified, altered or
supplemented except by means of a written instrument executed and delivered
by
each of the parties hereto.
14. Governing
Law. This Agreement shall be construed in accordance with, and
governed in all respects by, the internal laws of the Commonwealth of
Massachusetts. Unless otherwise explicitly provided in this
Agreement, any action, claim, suit or proceeding relating to this Agreement
or
the enforcement of any provision of this Agreement shall be brought or
otherwise
commenced in any state or federal court located in Suffolk County,
Massachusetts. Each party hereto (i) expressly and irrevocably
consents and submits to the jurisdiction of each such court, and each appellate
court located in Suffolk County, Massachusetts, in connection with any
such
proceeding; (ii) agrees that each such court shall be deemed to be a convenient
forum; and (iii) agrees not to assert, by way of motion, as a defense or
otherwise, in any such proceeding commenced in any such court, any claim
that
such party is not subject personally to the jurisdiction of such court,
that
such proceeding has been brought in an inconvenient forum, that the venue
of
such proceeding is improper or that this Agreement or the subject matter
of this
Agreement may not be enforced in or by such court.
C-5
15. Counterparts. For
the convenience of the parties hereto, this Agreement may be executed in
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
[Remainder
of page intentionally left blank]
C-6
In
Witness Whereof, each of the
parties hereto has caused this Voting Agreement to be executed as of the
date
first above written.
Holders:
Parent:
Access
Pharmaceuticals, Inc.
By:
Name:
Title:
Merger
Sub:
Somanta
Acquisition Corporation
By:
Name:
Title:
C-7
Schedule
1
Subject
Securities
C-8
Exhibit
A
Irrevocable
Proxy
The
undersigned holder (the "Holder") of outstanding securities of Somanta
Pharmaceuticals, Inc., a Delaware corporation (the "Company"), solely in
its capacity as a holder of securities of the Company, hereby irrevocably
appoints Stephen Seiler and Stephen Thompson of Access Pharmaceuticals,
Inc., a
Delaware corporation ("Parent"), and each of them, as the sole and
exclusive attorneys and proxies of the Holder, with full power of substitution
and resubstitution, to vote and exercise all voting, consent and similar
rights
with respect to all of the Holder's Subject Securities (as defined in the
Voting
Agreement (as defined below)) until the Expiration Date (as defined below),
on
the terms and conditions specified below. Upon the Holder's execution
of this Irrevocable Proxy, any and all prior proxies given by the Holder
with
respect to any of the Holder's Subject Securities are hereby revoked and
the
Holder agrees not to grant any subsequent proxies with respect to any of
the
Holder's Subject Securities until after the Expiration Date.
This
Irrevocable Proxy is irrevocable, is coupled with an interest sufficient
in law
to support an irrevocable power made for the benefit of third parties,
and is
granted pursuant to that certain Voting Agreement (the "Voting
Agreement"), of even date herewith, by and among Parent, Merger Sub (as
defined below), the Holder and the other parties named therein, and is
granted
solely in furtherance of the Holder's undertaking to vote the Holder's
Subject
Securities as required by the Voting Agreement contemplated by that certain
Agreement and Plan of Merger of even date herewith (as amended, restated
or
supplemented from time to time, the "Merger Agreement"), by and among
Parent, Somanta Acquisition Corporation, a Delaware corporation and a
wholly-owned subsidiary of Parent ("Merger Sub"), the Company and the
other parties named therein. The Merger Agreement provides for the
merger (the "Merger") of Merger Sub with and into the Company, with the
Company continuing as the surviving corporation, in accordance with its
terms. As used herein, the term "Expiration Date" shall mean
the date of termination of the Voting Agreement in accordance with its
terms.
The
attorneys and proxies named above are hereby authorized and empowered by
the
Holder, at any time prior to the Expiration Date, to act as the Holder's
attorneys and proxies to vote the Holder's Subject Securities, and to exercise
all voting, consent and similar rights of the Holder with respect to the
Holder's Subject Securities (including, without limitation, the power to
execute
and deliver written consents) at every annual, special or adjourned meeting
of
stockholders of the Company and in every written consent in lieu of such
meeting
(i) in favor of the Merger and each of the terms of the Merger Agreement
and the
transactions and other agreements reflected therein, (ii) against any proposal,
amendment or agreement that would in any manner impede, frustrate, prevent
or
nullify the Merger Agreement, the Merger or the Voting Agreement or change
in
any manner the voting rights of any class of capital stock of the Company
and
(iii) against any Transaction Proposal (as defined in the Merger
Agreement). The Holder may vote the Holder's Subject Securities on
all other matters not referred to in this Irrevocable Proxy, and the attorneys
and proxies named above may not exercise this Irrevocable Proxy with respect
to
such other matters.
Any
obligation hereunder of the Holder shall be binding upon the successors
and
assigns of the Holder. This Irrevocable Proxy shall terminate, and be
of no further force or effect, automatically upon the Expiration
Date.
[Remainder
of page intentionally left blank]
C-9
In
Witness Whereof, the
undersigned Holder has caused this Irrevocable Proxy to be executed as
of April
___, 2007.
Holder:
Name:
By:
Name:
Title:
C-10
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
ITEM
20. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The
Registrant is incorporated under the laws of the State of Delaware. The Delaware
General Corporation Law (the “DGCL”) provides that a Delaware corporation may
indemnify any persons who are, or are threatened to be made, parties to any
threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative (other than an action by or in the
right of such corporation), by reason of the fact that such person was an
officer, director, employee or agent of such corporation, or is or was serving
at the request of such person as an officer, director, employee or agent of
another corporation or enterprise. The indemnity may include expenses (including
attorneys’ fees), judgments, fines and amounts paid in settlement actually and
reasonably incurred by such person in connection with such action, suit or
proceeding, provided that such person acted in good faith and in a manner he
reasonably believed to be in or not opposed to the corporation’s best interests
and, with respect to any criminal action or proceeding, had no reasonable cause
to believe that his conduct was illegal. A Delaware corporation may indemnify
any persons who are, or are threatened to be made, a party to any threatened,
pending or completed action or suit by or in the right of the corporation by
reason of the fact that such person was a director, officer, employee or agent
of such corporation, or is or was serving at the request of such corporation
as
a director, officer, employee or agent of another corporation or enterprise.
The
indemnity may include expenses (including attorneys’ fees) actually and
reasonably incurred by such person in connection with the defense or settlement
of such action or suit provided such person acted in good faith and in a manner
he reasonably believed to be in or not opposed to the corporation’s best
interests except that no indemnification is permitted without judicial approval
if the officer or director is adjudged to be liable to the corporation. Where
an
officer or director is successful on the merits or otherwise in the defense
of
any action referred to above, the corporation must indemnify him against the
expenses which such officer or director has actually and reasonably incurred.
Access’ certificate of incorporation provides for the indemnification of
directors and officers of the Access to the fullest extent permitted by DGCL.
Section 102(b)(7)
of the DGCL permits a corporation to provide in its certificate of incorporation
that a director of the corporation shall not be personally liable to the
corporation or its stockholders for monetary damages for breach of fiduciary
duties as a director, except for liability (i) for any transaction from
which the director derives an improper personal benefit, (ii) for acts or
omissions not in good faith or that involve intentional misconduct or a knowing
violation of law, (iii) for improper payment of dividends or redemptions of
shares, or (iv) for any breach of a director’s duty of loyalty to Access or
its stockholders. Access’ Certificate of Incorporation includes such an
indemnification provision under which Access has agreed to indemnify its
directors and officers from and against certain claims arising from or related
to future acts or omissions as directors or officers. Insofar as indemnification
for liabilities arising under the Securities Act of 1933 may be permitted to
its
directors, officers and controlling persons pursuant to the foregoing, or
otherwise, Access has been advised that in the opinion of the SEC such
indemnification is against public policy as expressed in the Securities Act
of
1933 and is, therefore, unenforceable.
As
permitted by Delaware law, Access has entered into employment agreements each
of
which contains indemnity provisions with each of its executive officers that
require Access to indemnify such persons against loss, costs and expenses
(including reasonable attorney’s fees) in connection with any proceeding,
whether actual or threatened, to which any such person may be made a party
by
reason of the fact that such person is or was a director or an executive officer
of Access or any of its affiliated enterprises.
Access
maintains directors’ and officers’ liability insurance for the benefit of its
directors and certain of its officers.
II-1
The
merger agreement provides that, from the effective time of the merger, the
combined company shall jointly and severally indemnify, defend and hold harmless
each Indemnified Party (as defined in the merger agreement) against (i) all
losses claims, fines, damages, costs, expenses, liabilities or judgments based
in whole or in part out of the fact that such person is or was a director,
officer, or employee of Somanta or any of its subsidiaries, pertaining to any
matter existing or occurring at or prior to the effective time of the merger,
whether asserted or claimed prior to, or at or after, the effective time of
the
merger and (ii) all losses claims, fines, damages, costs, expenses, liabilities
or judgments based in whole or in part out of, or pertaining to the merger
agreement or the transaction contemplated by the merger agreement. The merger
agreement also provides that the combined company shall extend coverage under
Somanta’s directors’ and officers’ liability insurance policy covering the
directors and officers of Somanta as of the date of the merger agreement by
obtaining a six-year “tail” policy, if the “tail” policy does not cost more than
$150,000 in the aggregate.
Access’
certificate of incorporation automatically provides for the elimination of
the
personal liability of Access’ directors for monetary damages resulting from
breaches of their fiduciary duty to the fullest extent permitted under
applicable law.
ITEM
21. EXHIBITS
Exhibit
|
Number
|
Description
of Document
|
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization between
Access
Pharmaceuticals, Inc. and Chemex Pharmaceuticals, Inc., dated as
of
October 31, 1995 (Incorporated by reference to Exhibit A of the our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031)
|
|
2.2
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., Somanta
Acquisition Corporation, Somanta Pharmaceuticals, Inc. Somanta
Incorporated and Somanta Limited, dated April 18, 2007. (Incorporated
by
reference to Exhibit 2.1 to our Form 8-K dated April 18,
2007)
|
| 3.0 |
Articles
of incorporation and bylaws
|
|
3.1
|
Certificate
of Incorporation (Incorporated by Reference to Exhibit 3(a) of our
Form
8-B dated July 12, 1989, Commission File Number
9-9134)
|
| 3.2 |
Certificate
of Amendment of Certificate of Incorporation filed August 21,
1992
|
|
3.3
|
Certificate
of Merger filed January 25, 1996. (Incorporated by reference to Exhibit
E
of our Registration Statement on Form S-4 dated December 21, 1995,
Commission File No. 33-64031)
|
|
3.4
|
Certificate
of Amendment of Certificate of Incorporation filed January 25, 1996.
(Incorporated by reference to Exhibit E of our Registration Statement
on
Form S-4 dated December 21, 1995, Commission File No.
33-64031)
|
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996.
(Incorporated by reference to Exhibit 3.8 of our Form 10-K for the
year
ended December 31, 1996)
|
|
3.6
|
Certificate
of Amendment of Certificate of Incorporation filed June 18, 1998.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the
quarter
ended June 30, 1998
|
|
3.7
|
Certificate
of Amendment of Certificate of Incorporation filed July 31, 2000.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the
quarter
ended March 31, 2001)
|
|
3.8
|
Certificate
of Designations of Series A Junior Participating Preferred Stock
filed
November 7, 2001 (Incorporated by reference to Exhibit 4.1.h of our
Registration Statement on Form S-8, dated December 14, 2001, Commission
File No. 333-75136)
|
|
3.9
|
Amended
and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of
our Form
10-Q for the quarter ended June 30,
1996)
|
| 5.0 | Legal Opinion of Bingham McCutchen LLP (Previously filed) |
|
10.1*
|
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031
|
|
10.2*
|
Amendment
to 1995 Stock Option Plan (Incorporated by reference to Exhibit 10.25
of
our Form 10-K for the year ended December 31,
2001)
|
|
10.3
|
Lease
Agreement between Pollock Realty Corporation and us dated July 25,
1996
(Incorporated by reference to Exhibit 10.19 of our Form 10-Q for
the
quarter ended September 30, 1996)
|
|
10.4
|
Platinate
HPMA Copolymer Royalty Agreement between The School of Pharmacy,
University of London and the Company dated November 19, 1996 (Incorporated
by reference to Exhibit 10.19 of our Form 10-Q for the quarter ended
September 30, 1996)
|
II-2
|
10.5*
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated by reference to
Exhibit
10.19 of our Form 10-K for the year ended December 31,
1999)
|
|
10.6*
|
401(k)
Plan (Incorporated by reference to Exhibit 10.20 of our Form 10K
for the
year ended December 31, 1999)
|
|
10.7*
|
2000
Special Stock Option Plan and Agreement (Incorporated by reference
to
Exhibit 10.24 of our Form 10-Q for the quarter ended September 30,
2000)
|
|
10.8
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24 of
our
Form 10-Q for the quarter ended September 30,
2000)
|
|
10.9
|
Rights
Agreement, dated as of October 31, 2001 between the us and American
Stock
Transfer & Trust Company, as Rights Agent (incorporated by reference
to Exhibit 99.1 of our Current Report on Form 8-K dated October 19,
2001)
|
|
10.10
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us and
American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
|
10.11*
|
2001
Restricted Stock Plan (incorporated by reference to Appendix A of
our
Proxy Statement filed on April 16,
2001)
|
|
10.12*
|
2005
Equity Incentive Plan (incorporated by reference to Exhibit 1 of
our Proxy
Statement filed on April 18, 2005
(2)
|
10.13* Agreement,
dated as of May 10, 2005 by and between us and Kerry P. Gray (1)
|
10.14*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen
B.
Thompson (1)
|
| 10.15 |
Asset
Sale Agreement, dated as of October 12, 2005, between us and Uluru,
Inc.
(1)
|
|
10.16
|
Amendment
to Asset Sale Agreement, dated as December 8, 2006, between us and
Uluru,
Inc.
|
| 10.17 |
License
Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
|
10.18
|
Amendment
to 7% (Subject to Adjustment) Convertible Promissory Notes Due September
13, 2005, dated as of November 3, 2005, between us and Oracle Partners
LP,
Oracle Institutional Holders LP, SAM Oracle Investments Inc. and
Oracle
Offshore Ltd. (1)
|
|
10.19
|
Note
and Warrant Purchase Agreement, dated February 16, 2006 between us
and
certain Secured Parties (3)
|
10.20 Security
Agreement, dated February 16, 2006, between us and certain Secured Parties
(2)
|
10.21
|
Form
of 7.5% Secured Convertible Promissory Note, dated February 16, 2006,
issued by us and to certain Purchasers
(2)
|
| 10.22 |
Form
of Warrant, dated February 16, 2006, issued by us to certain Purchasers
(2)
|
|
10.23
|
Investor
Rights Agreement, dated February 16, 2006, between us and certain
Purchasers (2)
|
|
10.24
|
Note
and Warrant Purchase Agreement, dated October 24, 2006 between us
and
certain Secured Parties (3)
|
| 10.25 |
Security
Agreement, dated October 24, 2006, between us and certain Secured
Parties
(3)
|
|
10.26
|
Form
of 7.5% Secured Convertible Promissory Note, dated October 24, 2006,
issued by us and to certain Purchasers
(3)
|
| 10.27 |
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
| 10.28 |
Investor
Rights Agreement, dated October 24, 2006, between us and certain
Purchasers (3)
|
|
10.29
|
Note
and Warrant Purchase Agreement, dated December 6, 2006 between us
and
certain Secured Parties (3)
|
| 10.30 |
Security
Agreement, dated December 6, 2006, between us and certain Secured
Parties
(3)
|
|
10.31
|
Form
of 7.5% Secured Convertible Promissory Note, dated December 6, 2006,
issued by us and to certain Purchasers
(3)
|
| 10.32 |
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
| 10.33 |
Investor
Rights Agreement, dated December 6, 2006, between us and certain
Purchasers (3)
|
|
10.35
|
2007
Special Stock Option Plan and Agreement, dated January 4, 2007, by
and
between us and Stephen R. Seiler, President and Chief Executive Officer
(4)
|
|
10.36
|
Employment
Agreement, dated January 4, 2007 by and between us and Stephen R.
Seiler,
President and Chief Executive Officer
(4)
|
|
10.37
|
Amendment
to 7.0% (Subject to Adjustment) Convertible Promissory Notes Due
April 28,
2007, dated April 24, 2007 by and between us and Oracle Partners
LP and
affiliates (4)
|
|
10.38
|
Amendment
to Amended and Restated 7.5% Secured Convertible Promissory Notes
Due
April 27, 2007, dated April 26, 2007 by and between us and SCO Capital
Partners LLC, Beach Capital LLC and Lake End Capital LLC
(4)
|
II-3
|
10.39
|
Amendment
To Investor Rights Agreements, dated April 30, 2007 by and between
us and
SCO Capital Partners LLC and Lake End Capital LLC
(4)
|
| 23.1 |
Consent
of Whitley Penn LLP
|
| 23.2 |
Consent
of Grant Thornton LLP
|
| 23.3 | Consent of Stonefield Josephson Inc. |
| 23.4 | Consent of Bingham McCutchen LLP (Previously filed) |
Exhib
|
*
|
Management
contract or compensatory plan required to be filed as an Exhibit
to this
Form pursuant to Item 15(c) of the
report.
|
| (1) |
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005.
|
| (2) |
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
| (3) |
Incorporated
by reference to our Form 10-K for the year ended December 31,
2006.
|
| (4) |
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2007.
|
ITEM
22. UNDERTAKINGS
The
undersigned Registrant hereby undertakes:
Each
prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule
430B
or other than prospectuses filed in reliance on Rule 430A, shall be deemed
to be
part of and included in the registration statement as of the date it is first
used after effectiveness. Provided, however, that no statement made in a
registration statement or prospectus that is part of the registration statement
or made in a document incorporated or deemed incorporated by reference into
the
registration statement or prospectus that is part of the registration statement
will, as to a purchaser with a time of contract of sale prior to such first
use,
supersede or modify any statement that was made in the registration statement
or
prospectus that was part of the registration statement or made in any such
document immediately prior to such date of first use.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
(the
“Act”) may be permitted to directors, officers and controlling persons of the
small business issues pursuant to the foregoing provisions, or otherwise, the
small business issuer has been advised that in the opinion of the Securities
and
Exchange Commission such indemnification is against public policy as expressed
in the Act and is, therefore, unenforceable.
The
undersigned registrant hereby undertakes to respond to requests for information
that is incorporated by reference into the prospectus pursuant to Item 4, 10(b),
11, or 13 of this form, within one business day of receipt of such request,
and
to send the incorporated documents by first class mail or other equally prompt
means. This includes information contained in documents filed subsequent to
the
effective date of the registration statement through the date of responding
the
request.
The
undersigned registrant hereby undertakes to supply by means of a post-effective
amendment all information concerning a transaction, and the company being
acquired involved therein, that was not the subject of and included in the
registration statement when it became effective.
II-4
|
SIGNATURES
|
||||
|
|
|
|
||
|
|
|
|
||
|
Pursuant
to the requirements of the Securities Act, the registrant has duly
caused
this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Dallas, State of Texas,
on July
20, 2007.
|
||||
|
|
|
|
||
|
|
Access
Pharmaceuticals, Inc.
|
|||
|
|
|
|
||
|
Date: July
20, 2007
|
By
|
/s/ Stephen
R. Seiler
|
|
|
|
|
Stephen
R. Seiler
|
|
||
|
|
Chief
Executive Officer and President
|
|||
|
|
(Principal
Executive Officer)
|
|||
|
|
|
|
||
|
Date: July
20, 2007
|
By
|
/s/ Stephen
B. Thompson
|
|
|
|
|
Stephen
B. Thompson
|
|
||
|
|
Chief
Financial Officer and Treasurer
|
|||
|
|
(Principal
Financial and Accounting Officer)
|
|||
POWER
OF ATTORNEY
We,
the
undersigned directors of Access Pharmaceuticals, Inc., hereby severally
constitute and appoint Stephen R. Seiler and Stephen B. Thompson, and both
or
either one of them, our true and lawful attorneys-in-fact and agents, with
full
power of substitution and re-substitution in for him and in his name, place
and
stead, and in any and all capacities, to sign any and all amendments (including
post-effective amendments) to this Registration Statement, and any subsequent
registration statements pursuant to Rule 462 of the Securities Act, and to
file
the same, with all exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and authority to
do
and perform each and every act and thing requisite and necessary to be done
in
and about the premises, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that each of said
attorneys-in-fact or his substitute or substitutes, may lawfully do or cause
to
be done by virtue hereof.
In
accordance with the Securities Exchange Act of 1934, this report has been signed
below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated.
|
Date: July
20, 2007
|
/s/
Stephen R. Seiler
|
|
|
|
Stephen
R. Seiler, President and
Chief
Executive Officer, Director
|
|
|
|
|
|
|
Date:
July 20, 2007
|
*
|
|
|
|
Mark
J. Ahn, Director
|
|
| Date: July 20, 2007 |
*
|
|
|
Mark
J. Alvino, Director
|
||
II-5
|
Date:
July 20, 2007
|
*
|
|
|
Esteban
Cvitkovic, MD
|
||
|
Date:
July 20, 2007
|
*
|
|
|
|
Jeffrey
B. Davis, Director
|
|
| Date: July 20, 2007 |
*
|
|
|
Stephen
B. Howell, MD, Director
|
||
| Date: July 20, 2007 |
*
|
|
|
David
P. Luci, Director
|
||
| Date: July 20, 2007 |
*
|
|
|
Rosemary
Mazanet, MD, PhD, Director
|
||
| Date: July 20, 2007 |
*
|
|
|
John
J. Meakem, Jr., Director
|
||
* - Executed July 20, 2007 by Stephen B. Thompson as
attorney-in-fact under power of attorney granted in Registration Statement
previously filed on June 8, 2007.
II-6
EXHIBIT
INDEX
Exhibit
|
Number
|
Description
of Document
|
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization between
Access
Pharmaceuticals, Inc. and Chemex Pharmaceuticals, Inc., dated as
of
October 31, 1995 (Incorporated by reference to Exhibit A of the
our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031)
|
|
2.2
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc.,
Somanta
Acquisition Corporation, Somanta Pharmaceuticals, Inc. Somanta
Incorporated and Somanta Limited, dated April 18, 2007. (Incorporated
by
reference to Exhibit 2.1 to our Form 8-K dated April 18,
2007)
|
| 3.0 |
Articles
of incorporation and bylaws
|
|
3.1
|
Certificate
of Incorporation (Incorporated by Reference to Exhibit 3(a) of
our Form
8-B dated July 12, 1989, Commission File Number
9-9134)
|
| 3.2 |
Certificate
of Amendment of Certificate of Incorporation filed August 21,
1992
|
|
3.3
|
Certificate
of Merger filed January 25, 1996. (Incorporated by reference to
Exhibit E
of our Registration Statement on Form S-4 dated December 21, 1995,
Commission File No. 33-64031)
|
|
3.4
|
Certificate
of Amendment of Certificate of Incorporation filed January 25,
1996.
(Incorporated by reference to Exhibit E of our Registration Statement
on
Form S-4 dated December 21, 1995, Commission File No.
33-64031)
|
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996.
(Incorporated by reference to Exhibit 3.8 of our Form 10-K for
the year
ended December 31, 1996)
|
|
3.6
|
Certificate
of Amendment of Certificate of Incorporation filed June 18, 1998.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for
the quarter
ended June 30, 1998
|
|
3.7
|
Certificate
of Amendment of Certificate of Incorporation filed July 31, 2000.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for
the quarter
ended March 31, 2001)
|
|
3.8
|
Certificate
of Designations of Series A Junior Participating Preferred Stock
filed
November 7, 2001 (Incorporated by reference to Exhibit 4.1.h of
our
Registration Statement on Form S-8, dated December 14, 2001, Commission
File No. 333-75136)
|
|
3.9
|
Amended
and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of
our Form
10-Q for the quarter ended June 30,
1996)
|
| 5.0 | Opinion of Bingham McCutchen LLP (Previously filed) |
|
10.1*
|
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031
|
|
10.2*
|
Amendment
to 1995 Stock Option Plan (Incorporated by reference to Exhibit
10.25 of
our Form 10-K for the year ended December 31,
2001)
|
|
10.3
|
Lease
Agreement between Pollock Realty Corporation and us dated July
25, 1996
(Incorporated by reference to Exhibit 10.19 of our Form 10-Q for
the
quarter ended September 30, 1996)
|
|
10.4
|
Platinate
HPMA Copolymer Royalty Agreement between The School of Pharmacy,
University of London and the Company dated November 19, 1996 (Incorporated
by reference to Exhibit 10.19 of our Form 10-Q for the quarter
ended
September 30, 1996)
|
|
10.5*
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated by reference
to Exhibit
10.19 of our Form 10-K for the year ended December 31,
1999)
|
|
10.6*
|
401(k)
Plan (Incorporated by reference to Exhibit 10.20 of our Form
10K for the
year ended December 31, 1999)
|
|
10.7*
|
2000
Special Stock Option Plan and Agreement (Incorporated by reference
to
Exhibit 10.24 of our Form 10-Q for the quarter ended September
30,
2000)
|
|
10.8
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24
of our
Form 10-Q for the quarter ended September 30,
2000)
|
|
10.9
|
Rights
Agreement, dated as of October 31, 2001 between the us and American
Stock
Transfer & Trust Company, as Rights Agent (incorporated by reference
to Exhibit 99.1 of our Current Report on Form 8-K dated October
19,
2001)
|
|
10.10
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us
and American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
|
10.11*
|
2001
Restricted Stock Plan (incorporated by reference to Appendix
A of our
Proxy Statement filed on April 16,
2001)
|
|
10.12*
|
2005
Equity Incentive Plan (incorporated by reference to Exhibit 1
of our Proxy
Statement filed on April 18, 2005
(2)
|
10.13* Agreement,
dated as of May 10, 2005 by and between us and Kerry P. Gray (1)
|
10.14*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen
B.
Thompson (1)
|
| 10.15 |
Asset
Sale Agreement, dated as of October 12, 2005, between us and
Uluru, Inc.
(1)
|
|
10.16
|
Amendment
to Asset Sale Agreement, dated as December 8, 2006, between us
and Uluru,
Inc.
|
| 10.17 |
License
Agreement, dated as of October 12, 2005, between us and Uluru,
Inc.
(1)
|
|
10.18
|
Amendment
to 7% (Subject to Adjustment) Convertible Promissory Notes Due
September
13, 2005, dated as of November 3, 2005, between us and Oracle
Partners LP,
Oracle Institutional Holders LP, SAM Oracle Investments Inc.
and Oracle
Offshore Ltd. (1)
|
1
|
10.19
|
Note
and Warrant Purchase Agreement, dated February 16, 2006 between
us and
certain Secured Parties (3)
|
10.20 Security
Agreement, dated February 16, 2006, between us and certain Secured Parties
(2)
|
10.21
|
Form
of 7.5% Secured Convertible Promissory Note, dated February 16,
2006,
issued by us and to certain Purchasers
(2)
|
| 10.22 |
Form
of Warrant, dated February 16, 2006, issued by us to certain
Purchasers
(2)
|
|
10.23
|
Investor
Rights Agreement, dated February 16, 2006, between us and certain
Purchasers (2)
|
|
10.24
|
Note
and Warrant Purchase Agreement, dated October 24, 2006 between
us and
certain Secured Parties (3)
|
| 10.25 |
Security
Agreement, dated October 24, 2006, between us and certain Secured
Parties
(3)
|
|
10.26
|
Form
of 7.5% Secured Convertible Promissory Note, dated October 24,
2006,
issued by us and to certain Purchasers
(3)
|
| 10.27 |
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
| 10.28 |
Investor
Rights Agreement, dated October 24, 2006, between us and certain
Purchasers (3)
|
|
10.29
|
Note
and Warrant Purchase Agreement, dated December 6, 2006 between
us and
certain Secured Parties (3)
|
| 10.30 |
Security
Agreement, dated December 6, 2006, between us and certain Secured
Parties
(3)
|
|
10.31
|
Form
of 7.5% Secured Convertible Promissory Note, dated December 6,
2006,
issued by us and to certain Purchasers
(3)
|
| 10.32 |
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
| 10.33 |
Investor
Rights Agreement, dated December 6, 2006, between us and certain
Purchasers (3)
|
|
10.35
|
2007
Special Stock Option Plan and Agreement, dated January 4, 2007,
by and
between us and Stephen R. Seiler, President and Chief Executive
Officer
(4)
|
|
10.36
|
Employment
Agreement, dated January 4, 2007 by and between us and Stephen
R. Seiler,
President and Chief Executive Officer
(4)
|
|
10.37
|
Amendment
to 7.0% (Subject to Adjustment) Convertible Promissory Notes
Due April 28,
2007, dated April 24, 2007 by and between us and Oracle Partners
LP and
affiliates (4)
|
|
10.38
|
Amendment
to Amended and Restated 7.5% Secured Convertible Promissory Notes
Due
April 27, 2007, dated April 26, 2007 by and between us and SCO
Capital
Partners LLC, Beach Capital LLC and Lake End Capital LLC
(4)
|
|
10.39
|
Amendment
To Investor Rights Agreements, dated April 30, 2007 by and between
us and
SCO Capital Partners LLC and Lake End Capital LLC
(4)
|
| 23.1 |
Consent
of Whitley Penn LLP
|
| 23.2 |
Consent
of Grant Thornton LLP
|
| 23.3 | Consent of Stonefield Josephson Inc. |
| 23.4 | Consent of Bingham McCutchen LLP (Previously filed) |
Exhib
|
*
|
Management
contract or compensatory plan required to be filed as an Exhibit
to this
Form pursuant to Item 15(c) of the
report.
|
| (1) |
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005.
|
| (2) |
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
| (3) |
Incorporated
by reference to our Form 10-K for the year ended December 31,
2006.
|
| (4) |
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2007.
|
2