Delaware
|
3841
|
83-0221517
|
||
(State
or other jurisdiction of
incorporation
or organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer
Identification
Number)
|
|
David
P. Luci
|
|
President
and Chief Business Officer
|
|
MacroChem
Corporation
|
|
80
Broad Street, 22nd
Floor
|
|
New
York, NY 10004
|
(212)
514-8094
|
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
|
2,500,000
(1)
|
$1.00
(1)
|
$2,500,000
|
$98.25
|
1.
|
To
ratify and approve the agreement and plan of merger (“Merger Agreement”)
by and between MacroChem, MACM Acquisition Corp. and Access
Pharmaceuticals, Inc. (“Access”) and the transactions contemplated
thereby.
|
By
Order of the Board of Directors
|
|
/s/
Robert J. DeLuccia
|
|
Robert
J. DeLuccia, Chairman
|
Access
Pharmaceuticals, Inc.
|
MacroChem
Corporation
|
Page
|
|
QUESTIONS
AND ANSWERS ABOUT THE MERGER
|
1
|
SUMMARY
|
3
|
The
Companies
|
3
|
The
Merger
|
7
|
Access
Board of Directors After the Merger
|
7
|
Ownership
of Access After the Merger
|
8
|
Opinion
of Financial Advisor
|
8
|
Share
Ownership of Directors and Executive Officers
|
8
|
Interests
of Directors and Executive Officers of MacroChem in the
Merger
|
8
|
Dissenters’
or Appraisal Rights
|
8
|
Conditions
to Completion of the Merger
|
9
|
Regulatory
Matters
|
9
|
Reasonable
Best Efforts to Complete the Merger
|
9
|
Termination
of the Merger Agreement
|
9
|
Material
United States Federal Income Tax Consequences of the
Merger
|
10
|
Accounting
Treatment
|
10
|
Risk
Factors
|
10
|
Summary
Selected Historical Financial Data
|
10
|
Selected
Unaudited Pro Forma Condensed Combined Financial
Data
|
13
|
Comparative
Per Share Information
|
14
|
Comparative
Per Share Market Price Data
|
15
|
RISK
FACTORS
|
16
|
Risks
Relating to the Merger
|
16
|
Risks
Relating to the Business of Access
|
16
|
Risks
Relating to the Business of MacroChem
|
24
|
CAUTIONARY
STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS
|
32
|
THE
MERGER
|
33
|
General
|
33
|
Background
of the Merger
|
33
|
MacroChem’s
Reasons for the Merger and Recommendation
|
33
|
No
Independent Financial Advisor
|
34
|
Vote
Required
|
34
|
Completion
and Effectiveness of the Merger
|
34
|
Appraisal
Rights
|
34
|
THE
MERGER AGREEMENT
|
35
|
Structure
of the Merger and Conversion of MacroChem Common Stock and In The Money
MacroChem Warrants
|
35
|
General
|
35
|
Exchange
Ratios
|
35
|
Exchange
of MacroChem Common Stock for certificates representing shares of Access
Common Stock
|
35
|
Restriction
on Sales of Shares Held by holders of Access Common
Stock
|
35
|
Conditions
to the Merger
|
36
|
Conditions
to Access’ and MacroChem’s Obligations
|
36
|
Conditions
to Access’ Obligations
|
36
|
Conditions
to MacroChem Obligations
|
37
|
Termination
|
37
|
Conduct
of Business of MacroChem
|
37
|
Representations
and Warranties
|
38
|
Accounting
Treatment
|
40
|
Material
United States Federal Income Tax Consequences
|
40
|
Indemnification
and Insurance
|
41
|
Reasonable
Best Efforts to Complete the Merger
|
41
|
MacroChem
Prohibited from Soliciting Other Offers
|
41
|
INFORMATION
ABOUT ACCESS
|
43
|
Business
|
43
|
Products
|
43
|
Approved
Products
|
44
|
Products
in Development Status
|
44
|
Drug
Development Strategy
|
47
|
Process
|
48
|
Scientific
Background
|
48
|
Core
Drug Delivery Technology Platforms
|
49
|
Synthetic
Polymer Targeted Drug Delivery Technology
|
49
|
Cobalamin-Mediated
Oral Delivery Technology
|
49
|
Cobalamin-Mediated
Targeted Delivery Technology
|
50
|
Angiolix
|
50
|
Prodrax
|
51
|
Alchemix
|
51
|
Other
Key Developments
|
52
|
Patents
|
53
|
Government
Regulation
|
54
|
Competition
|
55
|
Supplies
|
56
|
Employees
|
56
|
Web
Availability
|
56
|
DESCRIPTION
OF PROPERTY
|
57
|
LEGAL
PROCEEDINGS
|
57
|
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
|
58
|
Code
of Business Conduct and Ethics
|
60
|
EXECUTIVE
COMPENSATION
|
60
|
2005
Equity Incentive Plan
|
62
|
Outstanding
Equity Awards at December 31, 2007
|
63
|
Director
Compensation – 2007
|
65
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
|
66
|
SECURITIES
AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION
PLANS
|
67
|
The
2007 Special Stock Option Plan
|
68
|
Annual
Incentive
|
68
|
Stock
Option Plans
|
68
|
Section
162(m)
|
69
|
Section
16(a) Beneficial Ownership Reporting Compliance
|
69
|
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL
PERSONS
|
70
|
MARKET
FOR COMMON STOCK
|
71
|
Price
Range of Common Stock and Dividend Policies
|
71
|
Holders
|
72
|
Options
and Warrants
|
72
|
Shares
Eligible for Future Shares
|
72
|
Dividends
|
72
|
DESCRIPTION
OF SECURITIES
|
73
|
Common
Stock
|
73
|
Preferred
Stock
|
73
|
Transfer
Agent and Registrar
|
74
|
Delaware
Law and Certain Charter and By-Law Provisions
|
74
|
Elimination
of Monetary Liability for Officers and Directors
|
74
|
Indemnification
of Officers and Directors
|
74
|
Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
|
74
|
EXPERTS
|
75
|
LEGAL
MATTERS
|
75
|
WHERE
YOU CAN FIND MORE INFORMATION
|
75
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS
OF
OPERATIONS
|
76
|
Overview
|
76
|
Products
|
76
|
Approved
Products
|
77
|
Products
in Development Status
|
77
|
Recent
Events
|
77
|
Results
of Operations
|
79
|
Liquidity
and Capital Resources
|
82
|
Critical
Accounting Policies and Estimates
|
83
|
Off-Balance
Sheet Transactions
|
85
|
Changes
and Disagreements with Accountants on Accounting and Financial
Disclosures
|
85
|
INDEX
TO ACCESS FINANCIAL STATEMENTS
|
F-1
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-2
|
ACCESS
AUDITED FINANCIAL STATEMENTS
|
|
Consolidated
Balance Sheets
|
F-3
|
Consolidated
Statements of Operations and Comprehensive Loss
|
F-4
|
Consolidated
Statements of Shareholders' Equity (Deficit)
|
F-5
|
Consolidated
Statements of Cash Flows
|
F-6
|
Notes
to Consolidated Financial Statements
|
F-7
|
ACCESS
UNAUDITED QUARTERLY FINANCIAL STATEMENTS
|
|
Condensed
Consolidated Balance Sheets
|
F-23
|
Condensed
Consolidated Statements of Operations
|
F-24
|
Condensed
Consolidated Statements of Cash Flows
|
F-25
|
Notes
to Condensed Consolidated Financial Statements
|
F-26
|
INDEX
TO SOMANTA FINANCIAL STATEMENTS
|
F-30
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-31
|
SOMANTA
AUDITED FINANCIAL STATEMENTS
|
|
Consolidated
Balance Sheet
|
F-32
|
Consolidated
Statements of Operations
|
F-33
|
Consolidated
Statements of Shareholders' Deficit
|
F-34
|
Consolidated
Statements of Cash Flows
|
F-36
|
Notes
to Consolidated Financial Statements
|
F-37
|
SOMANTA
UNAUDITED QUARTERLY FINANCIAL STATEMENTS
|
|
Condensed
Consolidated Balance Sheets
|
F-57
|
Condensed
Consolidated Statements of Operations
|
F-58
|
Condensed
Consolidated Statement of Stockholders’ Deficit
|
F-60
|
Condensed
Consolidated Statements of Cash Flows
|
F-64
|
Notes
to Condensed Consolidated Financial Statements
|
F-66
|
INFORMATION
ABOUT MACROCHEM
|
|
Business
|
86
|
Overview
|
86
|
Drug
Delivery Technology
|
87
|
Product
Candidates
|
88
|
Other
Product Candidates
|
90
|
Competition
|
91
|
Government
Regulation
|
92
|
Research
and Development
|
93
|
Patents,
Trademarks and License Agreements
|
93
|
Employees
|
94
|
Web
Availability
|
94
|
Manufacturing
|
94
|
DESCRIPTION
OF PROPERTY
|
94
|
LEGAL
PROCEEDINGS
|
94
|
SECURITIES
AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION
PLAN
|
94
|
MARKET
FOR COMMON STOCK
|
95
|
Dividend
Policy
|
95
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
|
|
AND
RELATED STOCKHOLDERS MATTERS FOR MACROCHEM PHARMACEUTICALS,
INC.
|
96
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS
OF
OPERATIONS
|
97
|
General
|
97
|
Critical
Accounting Policies and Estimates
|
99
|
Results
of Operations
|
100
|
Liquidity
and Capital Resources
|
101
|
Recent
Accounting Pronouncements
|
102
|
Mergers
|
103
|
Other
Events
|
103
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL
DISCLOSURE
|
103
|
INDEX
TO MACROCHEM FINANCIAL STATEMENTS
|
F-75
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-76
|
MACROCHEM
AUDITED FINANCIAL STATEMENTS
|
|
Consolidated
Balance Sheet
|
F-77
|
Consolidated
Statements of Operations and Comprehensive Loss
|
F-78
|
Consolidated
Statement of Stockholders' Deficit
|
F-79
|
Consolidated
Statements of Cash Flows
|
F-80
|
Notes
to Consolidated Financial Statements
|
F-82
|
MACROCHEM
UNAUDITED FINANCIAL STATEMENTS
|
|
Condensed
Consolidated Balance Sheets
|
F-94
|
Condensed
Consolidated Statements of Operations
|
F-95
|
Condensed
Consolidated Statements of Cash Flows
|
F-96
|
Notes
to Condensed Consolidated Financial Statements
|
F-97
|
VIRIUM FINANCIAL STATEMENTS | |
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTANING FIRM
|
F-110 |
Balance
Sheets March 31, 2008 (Unaudited), December 31, 2007 and December 31,
2006
|
F-111 |
Statement
of Operations Three Months Ended March 31, 2008 (Unaudited), Years Ended
December 31, 2007
|
F-112 |
and 2006 and Period from July 15, 1997 (Inception) to March 31, 2008 (Unaudited) | |
Statements
of Stockholders' Deficiency Years Ended December 31, 2007 and 2006, Three
Months Ended
|
F-113 |
March 31, 2008 (Unaudited), Period from July 15, 1997 (Inception) to March 31, 2008 (Unaudited) | |
Statements
of Cash Flows Three Months Ended March 31, 2008 (Unaudited), Years Ended
December 31, 2007
|
F-114 |
and 2006 and Period from July 15, 1997 (Inception) to March 31, 2008 (Unaudited) | |
Notes
to Financial Statements
|
F-115 |
UNAUDITED
PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
|
F-126
|
Pro
Forma Condensed Combined Balance Sheet
|
F-127
|
Pro
Forma Condensed Combined Statements of Operations
|
F-128
|
Notes
to Pro Formas
|
F-130
|
COMPARISON
OF STOCKHOLDER RIGHTS AND CORPORATE GOVERNANCE
MATTERS
|
|
ADDITIONAL
INFORMATION
|
|
Experts
|
|
Householding
of Proxy Materials
|
|
Where
You Can Find More Information
|
|
Appendix
A Agreement and Plan of Merger
|
|
Appendix
B Written Consent to Action of a Majority-In-Interest of the Stockholders
of MacroChem Corporation
|
|
Appendix
C Notification of Appraisal Rights of MacroChem Corporation Pursuant to
Section 262 of the Delaware General Corporation Law
|
|
Appendix
D Section 262 of the Delaware General Corporation
Law
|
•
|
Each
issued and outstanding share of MacroChem common stock and all shares to
be issued in connection with the exercise or conversion of any and all
options to purchase shares of MacroChem common stock or warrants
(including, without limitation, in-the-money MacroChem warrants) to
purchase shares of MacroChem common stock, in the aggregate, shall be
converted into the right to receive an aggregate of approximately
2,500,000 shares of Access common stock, however, no fractional shares
will be issued and instead Access will pay cash in lieu of any fractional
shares;
|
|
•
|
Certain
of MacroChem’s convertible promissory notes outstanding at the Effective
Time will convert automatically into the right to receive a number of
shares of common stock of Access at the closing price of such shares on
July 10, 2008; all remaining convertible promissory notes of MacroChem
will be assumed by Access at the closing of the merger (the “Effective
Time”);
|
|
•
|
The
in-the-money MacroChem warrants will convert into the right to receive a
portion of the merger consideration (as described above) at the Effective
Time and shall no longer be outstanding and shall be cancelled, retired
and shall cease to exist following the Effective Time;
|
|
•
|
Any
MacroChem options and MacroChem warrants which are not exercised or
converted prior to the Effective Time shall not be assumed by Access and
all such securities either shall be exercised or terminated prior to the
Effective Time.
|
|
•
|
MacroChem’s
officers and directors will resign effective as of the Effective Time of
the merger, except that Jeffrey B. Davis, Access’ CEO and a director of
Access and MacroChem will remain as a director of MacroChem after the
merger . As of the Effective Time, Mr. Davis shall become an
officer of MacroChem.
|
Sincerely,
|
|
|
/s/
Jeffrey B. Davis
|
/s/
David P. Luci
|
|
Jeffrey
B. Davis
|
|
David
P. Luci
|
Chief
Executive Officer
|
|
President
and Chief Business Officer
|
Access
Pharmaceuticals, Inc.
|
|
MacroChem
Corporation
|
Access
Pharmaceuticals, Inc.
|
MacroChem
Corporation
|
2600
Stemmons Freeway, Suite 176
|
80
Broad Street, 22nd
Floor
|
Dallas,
Texas 75207
|
New
York, NY 10004
|
Attn:
Investor Relations
|
Attn:
Chief Business Officer
|
·
|
MuGard™
is Access’ approved product for the management of oral mucositis, a
frequent side-effect of cancer therapy for which there is no established
treatment. The market for mucositis treatment is estimated to be in excess
of $1 billion world-wide. MuGard, a proprietary nanopolymer formulation,
has received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
·
|
Access’
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase 2
clinical trial being conducted in the EU in patients with ovarian cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess
of $2.0 billion.
|
·
|
Pre-clinical
development of Cobalamin™, Access’ proprietary nanopolymer oral drug
delivery technology based on the natural vitamin B12 uptake mechanism. We
are currently developing a product for the oral delivery of
insulin.
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably breast,
ovarian and colorectal cancers.
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration
with MacroChem Corporation.
|
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
2
|
||||
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
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.
|
•
|
the
use of certain executive officers of MacroChem by Access upon completion
of the merger as consultants to
Access;
|
•
|
that
Jeffrey Davis is a director of both MacroChem and Access and that Mr.
Davis is also an affiliate of SCO Capital an entity that beneficially owns
approximately 63% of MacroChem’s common stock and approximately 71% of
Access’ common stock on an as converted basis as of November 24, 2008. Mr.
Davis is also a director of Access and Chief Executive Officer of
Access.
|
·
|
The
Form S-4 shall have become effective under the Securities Act of 1993, as
amended;
|
·
|
The
representations and warranties made by MacroChem in the Merger Agreement
are true and correct;
|
·
|
MacroChem
has performed, in all material respects, all obligations and complied with
all covenants required by the Merger Agreement to be performed or complied
with, in all material respects, by MacroChem prior to the Effective
Time;
|
·
|
Access
and Merger Sub shall have received evidence to its reasonable satisfaction
that such licenses, permits, consents, approvals, authorizations,
qualifications and orders of governmental authorities and other third
parties as are necessary in connection with the transactions contemplated
by the merger have been obtained, except where the failure to do so would
not, individually or in the aggregate, have a material adverse effect with
respect to the MacroChem;
|
·
|
There
shall be no pending third party litigation or pending or threatened
litigation with any governmental entity (i) challenging or seeking to
restrain or prohibit the consummation of the Merger or the transactions
contemplated thereby, or (ii) seeking to prohibit or limit the ownership
or operation by MacroChem of any material portion of the business or
assets of MacroChem, or (iii) seeking to impose limitations on the ability
of Access to acquire or hold any shares of common stock of the Surviving
Corporation;
|
·
|
All
outstanding MacroChem options and MacroChem warrants not exercised prior
to the Effective Time shall be terminated and the in-the-money MacroChem
warrants shall automatically convert into the right to receive the Merger
Consideration (Access Common Stock) as provided in the Merger Agreement;
and
|
·
|
Any
applicable period during which stockholders of MacroChem have the right to
exercise appraisal, dissenters’ or other similar rights under Section 262
of the DGCL or other applicable law shall have expired and stockholders of
MacroChem holding in the aggregate more than five percent of the
outstanding shares of MacroChem Common Stock shall not have exercised
appraisal, dissenters’ or similar rights under Section 262 of the DGCL or
other applicable law with respect to such shares by virtue of the
Merger.
|
·
|
The
representations and warranties made by Access and/or MACM Acquisition
Corp. in the Merger Agreement are true and
correct;
|
·
|
Access
has performed, in all material respects, all obligations and complied with
all covenants required by the Merger Agreement to be performed or complied
with, in all material respects, by it prior to the Effective
Time;
|
·
|
MacroChem
shall have received evidence to MacroChem’s reasonable satisfaction that
such licenses, permits, consents, approvals, authorizations,
qualifications and orders of governmental authorities and other third
parties as are necessary in connection with the transactions contemplated
by the merger have been obtained, except where the failure to do so would
not, individually or in the aggregate, have a material adverse effect with
respect to the Access; and
|
·
|
There
shall be no pending third party litigation or pending or threatened
litigation with any governmental entity challenging or seeking to restrain
or prohibit the consummation of the Merger or any of the other
transactions contemplated thereby.
|
·
|
The
merger has not been consummated by October 31, 2008, provided that the
party seeking to terminate the merger agreement is not then in breach of
the terms of the merger agreement;
|
·
|
By
mutual consent of Access and MacroChem;
and
|
·
|
By
either Access or MacroChem if MacroChem is unable to obtain stockholder
approval.
|
For the Nine Months
Ended
September 30
|
For the Year Ended December
31,
|
|||||||
2008
|
2007
|
2007
|
2006
|
2005
|
2004
|
2003
|
(in
thousands, except per share
amounts)
|
Consolidated
Statement of Operations and Comprehensive Loss Data:
|
Total
revenues
|
$ | 217 | $ | 6 | $ | 57 | $ | - | $ | - | $ | - | $ | - | ||||||||||||||
Operating
loss
|
(15,460 | ) | (4,988 | ) | (6,900 | ) | (5,175 | ) | (9,622 | ) | (6,003 | ) | (5,426 | ) | ||||||||||||||
Interest
and miscellaneous income
|
167 | 72 | 125 | 294 | 100 | 226 | 279 | |||||||||||||||||||||
Interest
and other expense
|
(351 | ) | (3,277 | ) | (3,514 | ) | (7,436 | ) | (2,100 | ) | (1,385 | ) | (1,281 | ) | ||||||||||||||
Loss
on extinguishment of debt
|
- | - | (11,628 | ) | - | - | - | - | ||||||||||||||||||||
Unrealized
loss on fair value of warrants
|
- | - | - | (1,107 | ) | - | - | - | ||||||||||||||||||||
Income
tax benefit
|
- | - | 61 | 173 | 4,067 | - | - | |||||||||||||||||||||
Loss
from continuing operations
|
(15,644 | ) | (8,193 | ) | (21,856 | ) | (13,251 | ) | (7,555 | ) | (7,162 | ) | (6,428 | ) | ||||||||||||||
Preferred
stock dividends
|
(2,873 | ) | - | (14,908 | ) | |||||||||||||||||||||||
Discontinued
operations net of taxes
|
||||||||||||||||||||||||||||
($61
in 2007, $173 in 2006 and
$4,067
in 2005)
|
- | - | 112 | 377 | (5,855 | ) | (3,076 | ) | (507 | ) | ||||||||||||||||||
Net
loss
|
(18,517 | ) | (8,193 | ) | (36,652 | ) | (12,874 | ) | (1,700 | ) | (10,238 | ) | (6,935 | ) | ||||||||||||||
Common
Stock Data:
|
||||||||||||||||||||||||||||
Net
loss per basic and
diluted
common share
|
$ | (3.30 | ) | $ | (2.31 | ) | $ | (10.32 | ) | $ | (3.65 | ) | $ | (0.53 | ) | $ | (3.38 | ) | $ | (2.61 | ) | |||||||
Weighted
average basic and
diluted
common shares
outstanding
|
5,607 | 3,544 | 3,552 | 3,532 | 3,237 | 3,032 | 2,653 | |||||||||||||||||||||
September
30,
|
December
31,
|
|||||||
2008
|
2007
|
2007
|
2006
|
2005
|
2004
|
2003
|
||
(in
thousands)
|
Consolidated
Balance Sheet Data:
|
Cash,
cash equivalents and
short
term investments
|
$ | 4,618 | $ | 1,176 | $ | 6,921 | $ | 4,389 | $ | 474 | $ | 2,261 | $ | 2,587 | ||||||||||||||
Total
assets
|
5,754 | 3,500 | 9,149 | 6,426 | 7,213 | 11,090 | 11,811 | |||||||||||||||||||||
Deferred
revenue
|
2,450 | 1,167 | 978 | 173 | 173 | 1,199 | 1,184 | |||||||||||||||||||||
Convertible
notes, net of discount
|
5,500 | 16,906 | 5,564 | 8,833 | 7,636 | 13,530 | 13,530 | |||||||||||||||||||||
Total
liabilities
|
12,765 | 20,691 | 8,468 | 16,313 | 11,450 | 17,751 | 17,636 | |||||||||||||||||||||
Total
stockholders' equity (deficit)
|
(7,011 | ) | (17,191 | ) | 681 | (9,887 | ) | (4,237 | ) | (6,661 | ) | (5,825 | ) |
Income
Statement Data:
|
Nine
Months
Ended
September
30,
2008
(Unaudited)
|
Year
Ended
December
31,
2007
|
||||||
Revenues
|
$ | 2,652 | $ | 0 | ||||
General
and Administrative Expenses
|
$ | 2,962,453 | $ | 3,717,994 | ||||
Interest
Expense (Income)
|
$ | 160,759 | $ | (84,595 | ) | |||
Net Loss
|
$ | (9,801,622 | ) | $ | (8,866,182 | ) | ||
Loss
Per Common Share
|
$ | (0.27 | ) | $ | (1.66 | ) | ||
Weighted
Average Shares Outstanding
|
36,604,749 | 7,635,313 |
|
September
30, 2008
(Unaudited)
|
December
31,
2007
|
Balance Sheet Data: | ||||||||
Cash | $ | 32,879 | 2,423,519 | |||||
Total
Current Assets
|
$ | 149,003 | $ | 3,313,813 | ||||
Total
Current Liabilities
|
$ | 3,045,508 | $ | 404,634 | ||||
Total
Stockholders' (Deficiency)
|
$ | (2,566,734 | ) | $ | (627,667 | ) |
Unaudited
Pro Forma Condensed Combined
Statement
of
Operations Data:
|
For
the Twelve
Months
Ended
December
31, 2007
|
For
the Nine
Months
Ended
September
30, 2008
|
||||
Total
revenues
|
$
|
63,304
|
$
|
220,978
|
||
Total
expenses
|
16,372,328
|
19,753,737
|
||||
Loss
from operations
|
(16,309,024)
|
(19,532,759)
|
||||
Interest
and miscellaneous income
|
206,595
|
193,097
|
||||
Interest
expense
|
(3,741,011)
|
(664,486)
|
||||
Loss
on extinguishment of debt
|
(11,628,000)
|
-
|
||||
Gain
(loss) in change in value of warrant liabilities
|
(5,119,000)
|
-
|
||||
Gain
on sale of equipment
|
106,000
|
6,466
|
||||
Amortization of debt issuance costs | (117,302) | - | ||||
Loss
before discontinued operations
|
||||||
and before income tax benefit
|
(26,364,742)
|
(19,997,682)
|
||||
Income
tax benefit
|
56,000
|
-
|
||||
Loss
from continuing operations
|
(26,308,742)
|
(19,997,682)
|
||||
Beneficial
conversion feature
|
(3,223,929)
|
-
|
||||
Preferred
stock dividends
|
(15,504,017)
|
(2,873,000)
|
||||
Discontinued
operations, net of
taxes
of $61,000 and $0
|
112,000
|
|||||
Net
loss
|
$
|
(44,924,688)
|
$
|
(22,870,682)
|
Unaudited
Pro Forma Condensed Combined
Balance
Sheet Data:
|
As
of September 30, 2008
|
||||
Cash
and cash equivalents
|
$
|
233,879
|
|||
Short
term investments, at cost
|
4,417,000
|
||||
Receivables
|
105,000
|
||||
Prepaid
expenses and other current assets
|
226,124
|
||||
Total
current assets
|
$
|
4,982,003
|
|||
Property
and equipment, net
|
110,523
|
||||
Patents
net
|
1
,068,099
|
||||
Other
assets
|
62,900
|
||||
Total
assets
|
$
|
6,223,525
|
|||
Accounts
payable and accrued expenses
|
5,086,467
|
||||
Dividends
payable
|
1,799,000
|
||||
Accrued
interest payable
|
453,250
|
||||
Current
portion of deferred revenue
|
169,304
|
||||
Convertible
notes payable, net
|
791,487
|
||||
Long-term
debt
|
5,500,000
|
||||
Long-term
deferred revenue
|
2,311,469
|
||||
Total
liabilities
|
16,110,977
|
||||
Preferred Stock | - | ||||
Common Stock | 90,000 | ||||
Additional
paid-in capital
|
135,759,152
|
||||
Less treasury stock, at cost | (4,000 | ) | |||
Notes
receivable from stockholders
|
(1,045,000
|
) | |||
Accumulated
deficit
|
(144,687,604
|
) | |||
Total
stockholders’ deficiciency
|
(9,887,452
|
) |
Historical
Access
|
Historical
MacroChem
|
Pro
Forma
Combined
|
Pro
Forma
Equivalent
of
One
MacroChem
Share
(1)
|
||||||||||
Net
(loss) per share—basic and diluted:
|
|
|
|
||||||||||
Nine Months ended September 30, 2008
|
|
$
|
(3.30)
|
$
|
(0.27)
|
$
|
(3.49)
|
|
$
|
(0.19)
|
|||
Year ended December 31, 2007
|
|
(10.32)
|
(1.66)
|
(8.15)
|
|
(0.44)
|
|||||||
Cash dividends declared per share (3) | - | - | - | ||||||||||
Weighted average number of shares (in millions): | |||||||||||||
Nine months ended September 30, 2008 | 5.6 | 36.6 | 8.1 | ||||||||||
Year ended December 31, 2007 | 3.6 | 7.6 | 6.1 | ||||||||||
Book
value per share:
|
|
|
|
||||||||||
September 30, 2008 (2)
|
|
$
|
(1.08)
|
$
|
(0.05)
|
|
$
|
(1.04)
|
|
$
|
(0.06)
|
||
December 31, 2007 (2)
|
|
(0.19)
|
(0.03)
|
|
0.01
|
|
(0.00)
|
||||||
Outstanding
shares (in millions):
|
|
|
|
||||||||||
September 30, 2008 (2)
|
|
6.5
|
45.9
|
|
9.0
|
|
|||||||
December 31, 2007 (2)
|
|
3.6
|
22.5
|
|
6.1
|
|
(1)
|
The
Pro Forma Equivalent of one MacroChem Share amounts were calculated by
applying the exchange ratio of 0.05423180 to the pro forma combined
net loss and book value per share. The actual exchange ratio in the merger
is subject to change.
|
(2)
|
As
of September 30, 2008 and December 31, 2008 for Access and
MacroChem.
|
(3) | No dividends have been declared or paid for any period. |
|
Access
Common Stock
|
MacroChem
Common Stock
|
Pro Forma Equivalent
Value
of
MacroChem Common Stock
|
||||||
July
9, 2008
|
|
$3.19
|
$0.25
|
$0.17
|
|||||
November
24, 2008
|
|
$1.00
|
$0.025
|
$0.05
|
•
|
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.
|
·
|
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.
|
·
|
A
mucoadhesive liquid technology product, MuGard™, has received marketing
approval by the FDA.
|
·
|
ProLindac™
is currently in a Phase 2 trial in
Europe.
|
·
|
ProLindac™
has been approved for an additional Phase 1 trial in the US by the
FDA.
|
·
|
Phenylbutrate
is in planning stage for a Phase 2 trial in the United
States.
|
·
|
Cobalamin™
mediated delivery technology is currently in the pre-clinical
phase.
|
·
|
Angiolix®
is currently in the pre-clinical
phase.
|
·
|
Prodrax®
is currently in the pre-clinical
phase.
|
·
|
Alchemix®
is currently in the pre-clinical
phase.
|
·
|
Access
also has other products in the preclinical
phase.
|
•
|
American
Pharmaceutical Partners, Cell Therapeutics, Daiichi, and Enzon are
developing anticancer drugs in combination with polymers and other drug
delivery systems.
|
•
|
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.
|
·
|
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.
|
·
|
Mucoadhesive
technology in 2021,
|
·
|
ProLindac™
in 2021,
|
·
|
Phenylbutyrate
between 2011 and 2016,
|
·
|
Angiolix®
in 2015,
|
·
|
Alchemix®
in 2015,
|
·
|
Cobalamin
mediated technology between 2009 and
2019
|
·
|
inability
to fund clinical trials;
|
·
|
slow
or insufficient patient enrollment;
|
·
|
failure
of the FDA to approve MacroChem clinical trial
protocols;
|
·
|
inability
to manufacture significant amounts of MacroChem product candidates for use
in a trial;
|
·
|
safety
issues; and
|
·
|
government
or regulatory delays.
|
·
|
Changes
in existing regulatory requirements could prevent or affect MacroChem
regulatory compliance. Federal and state laws, regulations and policies
may be changed with possible retroactive effect. In addition, how these
rules actually operate can depend heavily on administrative policies and
interpretations over which MacroChem have no control. MacroChem also may
lack the experience with these policies and interpretations to assess
their full impact upon MacroChem
business.
|
·
|
Obtaining
FDA clearances is time-consuming and expensive and MacroChem cannot
guarantee that such clearances will be granted or, if granted, will not be
withdrawn.
|
·
|
The
FDA review process may prevent MacroChem from marketing MacroChem product
candidates or may involve delays that significantly and negatively affect
MacroChem product candidates. MacroChem also may encounter similar delays
in foreign countries.
|
·
|
Regulatory
clearances may place significant limitations on the uses for which any
approved products may be marketed.
|
·
|
Any
marketed product and its manufacturer are subject to periodic review by
the FDA. Any discovery of previously unrecognized problems with a product
or a manufacturer could result in suspension or limitation of previously
obtained or new approvals.
|
·
|
Novartis
AG, maker of Lamisil®,
an oral therapy;
|
·
|
Johnson
& Johnson, maker of Sporanox®,
an oral therapy; and
|
·
|
Sanofi
Aventis (Dermik Laboratories), maker of Penlac, a topical nail
lacquer.
|
·
|
Solvay
Pharmaceuticals, Inc., maker of Androgel®, a
topical gel therapy;
|
·
|
Auxilium
Pharmaceuticals, Inc., maker of Testim®, a
topical gel therapy;
|
·
|
Watson
Pharmaceuticals, Inc., maker of Androderm®, a
transdermal patch; and
|
·
|
Columbia
Laboratories, Inc., maker of Striant®, a
buccal film which is placed between the patient’s cheek and
gum;
|
·
|
the
lack of any significant trading volume in the trading of MacroChem shares
on the OTC.BB market;
|
·
|
the
discontinuance in August 2005 of all of MacroChem research and product
development activities and MacroChem dependence on additional external
funding in resuming such
activities;
|
·
|
the
results of MacroChem previously conducted clinical trials for MacroChem
SEPA-based formulations;
|
·
|
conditions
and publicity regarding the pharmaceutical industry generally as well as
the specific therapeutic areas MacroChem product candidates seek to
address;
|
·
|
price
and volume fluctuations in the stock market at large which do not relate
to MacroChem operating performance;
and
|
·
|
MacroChem’s
ability to raise additional
capital.
|
|
•
|
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;
|
• |
the
ability 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;
|
•
|
the
ability to timely and cost-effectively integrate the operations of Access
and MacroChem;
|
•
|
the
ability to realize the synergies and other perceived advantages resulting
from the merger;
|
•
|
access
to available and feasible financing on a timely
basis;
|
•
|
the
ability to retain key personnel both before and after the
merger;
|
•
|
the
ability of each company to successfully execute its business
strategies;
|
•
|
the
extent and timing of market acceptance of new products or product
indications;
|
•
|
the
ability of each company to procure, maintain, enforce and defend its
patents and proprietary rights;
|
•
|
changes
in laws, including increased tax rates, regulations or accounting
standards, third party relations and approvals, and decisions of courts,
regulators and governmental bodies;
|
•
|
litigation
outcomes and judicial actions, including costs and existing or additional
litigation associated with the merger, and legislative action, referenda
and taxation;
|
•
|
acts
of war or terrorist incidents; and
|
•
|
the
effects of competition, including locations of competitors and operating
and market competition.
|
·
|
Any
in-the-money MacroChem warrants will convert into the right to receive a
portion of the merger consideration (as described above) at the Effective
Time and shall no longer be outstanding and shall be cancelled, retired
and shall cease to exist following the Effective
Time;
|
·
|
Any
MacroChem options and MacroChem warrants which are not exercised or
converted prior to the Effective Time shall not be assumed by Access and
all such securities either shall be exercised or terminated prior to the
Effective Time.
|
•
|
the
ability of the combined company to potentially secure investor capital and
financing for development of MacroChem product
portfolio;
|
|
•
|
the
cash reserve of Access positioning MacroChem products back in development
in the near term;
|
|
•
|
MacroChem’s
cash reserves were not sufficient for MacroChem to continue operations as
a going concern beyond the third quarter of 2008;
|
|
•
|
leveraging
Access’ existing research and development capabilities and general and
administrative infrastructure to further reduce MacroChem overhead
associated with ongoing development;
|
|
•
|
elimination
of certain contingent liabilities associated with MacroChem’s potential
financing efforts if MacroChem were to remain stand-alone rather than
merge with Access; and
|
|
•
|
The
remote likelihood that potential alternative transactions will be
available to MacroChem or if available if any such transactions would be
likely to close in sufficient time based on the MacroChem’s cash
position.
|
|
Access’
Board of Directors considered the following additional
factors:
|
||
•
|
access
to a rich pipeline of products including those in the late stages of
clinical development and attractive early stage oncology products;
and
|
|
•
|
securing
a rich pipeline of products at an attractive price based upon the stage of
corporate development within which MacroChem is
situated.
|
|
•
|
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 Access and MacroChem shall use
their reasonable best efforts to have any such injunction, order,
restraint or prohibition vacated;
|
|
•
|
Other
than the filing of the Delaware 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 a Material Adverse Effect with respect to MacroChem,
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 MacroChem;
|
|
•
|
This
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 Access Common Stock issuable or
required to be reserved for issuance pursuant to this Merger Agreement
shall have been complied with;
|
|
No
stop order suspending the use of the Information 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;
|
||
The
Merger and the Merger Agreement shall have been approved and adopted by
the requisite vote of the holders of shares of MacroChem Common Stock to
the extent required pursuant to the requirements of the certificate of
incorporation and the DGCL;
|
||
•
|
The
representations and warranties of MacroChem contained in the Merger
Agreement shall be true and correct in all material respects on and as of
the Closing Date, with the same force and effect as if made on and as of
the Closing Date, except for (i) changes contemplated by the Merger
Agreement or in the applicable disclosure schedules,
(ii) representations and warranties that are qualified by materiality
or Material Adverse Effect, in which case such representations and
warranties shall be true and correct in all respects, and
(iii) representations and warranties which address matters only as of
a particular date, in which case such representations and warranties
qualified as to materiality or Material Adverse Effect shall be true and
correct in all respects, and those not so qualified shall be true and
correct in all material respects, on and as of such particular
date;
|
|
•
|
MacroChem
has performed, in all material respects, all obligations and complied with
all covenants required by the Merger Agreement to be performed or complied
with, in all material respects, by MacroChem prior to the Effective
Time;
|
|
•
|
Access
and MACM Acquisition Corp. shall have received evidence to its reasonable
satisfaction that such licenses, permits, consents, approvals,
authorizations, qualifications and orders of governmental authorities and
other third parties as are necessary in connection with the transactions
contemplated by the merger have been obtained, except where the failure to
do so would not, individually or in the aggregate, have a material adverse
effect with respect to the MacroChem;
|
|
•
|
There
shall be no pending third party litigation or pending or threatened
litigation with any governmental entity (i) challenging or seeking to
restrain or prohibit the consummation of the Merger or the transactions
contemplated thereby, (ii) seeking to prohibit or limit the ownership or
operation by MacroChem of any material portion of the business or assets
of MacroChem, or (iii) seeking to impose limitations on the ability of
Access to acquire or hold any shares of common stock of the Surviving
Corporation;
|
|
•
|
MacroChem
shall have complied with the requirements of the 1994 Equity Incentive
Plana and the 2001 Incentive Plan and all outstanding MacroChem options
and MacroChem warrants not exercised prior to the Effective Time shall be
terminated and the in-the-money MacroChem warrants shall automatically
convert into the right to receive the Merger Consideration (Access Common
Stock) as provided in the Merger Agreement;
|
|
•
|
As
of the Effective Time Access and MacroChem’s President & Chief
Business Officer shall have mutually agreed on terms to discharge the
MacroChem’s obligations and agree upon the terms of, if any, a consulting
and transition agreement;
|
|
•
|
Since
the dated of the Merger Agreement, there shall not have occurred any
Material Adverse Effect or Material Adverse Change (in each case as
defined in the Merger Agreement) with respect to
MacroChem;
|
|
•
|
Any
applicable period during which stockholders of MacroChem have the right to
exercise appraisal, dissenters’ or other similar rights under Section 262
of the DGCL or other applicable law shall have expired and stockholders of
MacroChem holding in the aggregate more than five percent of the
outstanding shares of MacroChem common stock shall not have exercised
appraisal, dissenters’ or similar rights under Section 262 of the DGCL or
other applicable law with respect to such shares by virtue of the Merger;
and
|
|
•
|
The
directors and officers of MacroChem, in office immediately prior to the
Effective Time, shall have resigned as directors and officers of the
Surviving Corporation effective as of the Effective
Time.
|
|
•
|
The
MacroChem shall have delivered a properly executed statement, dated as of
the Closing Date, in a form reasonably acceptable to Access, conforming to
the requirements of Treasury Regulations Section
1.1445-2(c)(3).
|
•
|
The
representations and warranties of Access contained in the Merger Agreement
shall be true and correct in all material respects on and as of the
Closing Date, with the same force and effect as if made on and as of the
Closing Date, except for (i) changes contemplated by the Merger
Agreement or in the applicable disclosure schedules,
(ii) representations and warranties that are qualified by materiality
or Material Adverse Effect, in which case such representations and
warranties shall be true and correct in all respects, and
(iii) representations and warranties which address matters only as of
a particular date, in which case such representations and warranties
qualified as to materiality or Material Adverse Effect shall be true and
correct in all respects, and those not so qualified shall be true and
correct in all material respects, on and as of such particular
date;
|
|
•
|
Access
shall have performed, in all material respects, all obligations and
complied with all covenants required by the Merger Agreement to be
performed or complied with, in all material respects, by it prior to the
Closing Date;
|
|
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, challenging or seeking to restrain or prohibit the
consummation of the Merger or any of the other transactions contemplated
by the Merger Agreement; and
|
||
•
|
MacroChem
shall have received evidence to MacroChem’s reasonable satisfaction that
such licenses, permits, consents, approvals, authorizations,
qualifications and orders of governmental authorities and other third
parties as are necessary in connection with the transactions contemplated
by the merger have been obtained, except where the failure to do so would
not, individually or in the aggregate, have a material adverse effect with
respect to Access.
|
|
•
|
declare
or pay any dividends or make other distributions or split, combine or
reclassify, purchase or redeem any capital stock of
MacroChem;
|
|
•
|
authorize
for issuance, issue, deliver, sell, or pledge any capital stock or voting
securities of MacroChem or any Subsidiary;
|
|
•
|
amend
its Certificate of Incorporation or Bylaws or other comparable charter or
organizational documents of MacroChem or any
Subsidiary;
|
|
•
|
acquire
or agree to acquire by merging or consolidating with, or by purchasing all
or a substantial portion of the stock or assets of, or by any other
manner, any business or any corporation or other business organization or
division thereof;
|
|
•
|
sell,
lease, license, mortgage or otherwise encumber any of the properties or
assets of MacroChem other than in the ordinary course of
business;
|
|
•
|
incur
any indebtedness or guarantee any indebtedness of another person or entity
or amend, terminate or seek a waiver with respect to any existing
agreement of the MacroChem evidencing indebtedness of MacroChem or make
any loans, advances or capital contributions to, or investments in, any
other person;
|
|
•
|
acquire
or agree to acquire any assets, other than inventory in the ordinary
course of business, or make or agree to make any capital
expenditures;
|
|
•
|
pay,
discharge or satisfy any claims, liabilities or obligations, except for
payment of liabilities in the ordinary course of business consistent with
past practice and in accordance with their terms in effect on the date of
the Merger Agreement;
|
|
•
|
adopt
a plan of complete or partial liquidation or resolutions providing for or
authorizing such liquidation or a dissolution, merger, consolidation,
restructuring, recapitalization or reorganization;
|
|
•
|
change
any material accounting principle;
|
|
•
|
settle
or compromise any litigation
|
|
•
|
transfer
to any person any rights to its intellectual property;
|
|
•
|
enter
into any agreement pursuant to which any other party is granted exclusive
marketing or other exclusive rights of any type with respect to its
products or technology; and
|
|
•
|
make
any material tax election.
|
•
|
Access’
and Merger Sub’s valid existence and good standing and its corporate power
and authority to carry on its business;
|
|
•
|
Access’
capitalization;
|
|
•
|
Access’
and Merger Sub’s power and authority to enter into and perform its
obligations under the Merger Agreement;
|
|
•
|
Access’
and Merger Sub’s power and authority to enter into and perform its
obligations under the Merger Agreement;
|
|
•
|
the
accuracy of Access’ financial statements, and the absence of any material
liabilities and material claims not disclosed
therein;
|
•
|
the
accuracy of information supplied by Access or Merger Sub included in its
Form S-4;
|
|
•
|
the
absence of any Material Adverse Change with respect to Access since March
31, 2008;
|
|
•
|
the
absence of any pending or threatened litigation against Access, its
properties and its business and Access’ compliance with all applicable
laws, rules and regulations;
|
|
•
|
the
Merger Agreement has been approved by Access as the sole stockholder of
Merger Sub;
|
|
•
|
the
accuracy and timely filing of tax returns by Access;
|
|
•
|
the
absence of any brokers in the Merger transaction; and
|
|
•
|
the
accuracy of statements included in certain certificates of officers of
Access.
|
|
•
|
MacroChem’s
valid existence and good standing and MacroChem corporate power and
authority to carry on MacroChem business;
|
|
•
|
MacroChem’s
ownership of subsidiaries;
|
|
•
|
MacroChem’s
capitalization;
|
|
•
|
MacroChem’s
power and authority to enter into and perform MacroChem obligations under
the Merger Agreement and related agreements;
|
|
•
|
the
accuracy of MacroChem’s financial statements, reports filed with the SEC,
and the lack of any material liabilities and material claims not disclosed
therein;
|
|
•
|
MacroChem’s
maintenance and effectiveness of disclosure controls and
procedures;
|
|
•
|
the
accuracy of information supplied by MacroChem included in Access’ Form
S-4;
|
|
•
|
the
absence of any Material Adverse Change with respect to Access since March
31, 2008;
|
|
•
|
the
absence of any pending or threatened litigation against Access, its
properties and its business and Access’ compliance with all applicable
laws, rules and regulations;
|
|
•
|
the
absence of any work stoppage or labor disputes;
|
|
•
|
the
accuracy of disclosure relating to MacroChem’s employee benefit
plans;
|
|
•
|
the
accuracy and timely filing of tax returns by MacroChem;
|
|
•
|
MacroChem’s
ownership of good and marketable title to all properties and assets and
good and valid leasehold interests in all real property
leases;
|
|
•
|
MacroChem’s
compliance with environmental laws;
|
|
•
|
the
accuracy of information regarding MacroChem’s debts and contractual
obligations;
|
|
•
|
the
absence of any brokers in the Merger transaction;
|
|
•
|
MacroChem
ownership and rights in its intellectual property;
|
|
•
|
MacroChem’s
compliance with regulatory requirements; and
|
|
•
|
MacroChem
maintenance of insurance policies.
|
|
•
|
obtaining
all consents, approvals, waivers, licenses, permits or authorizations as
are required to be obtained in connection with the
merger;
|
•
|
defending
any lawsuit or proceeding seeking to challenge the merger agreement or the
merger contemplated by the merger
agreement;
|
•
|
accepting
and delivering any additional instruments necessary to consummate the
merger;
|
•
|
satisfying
the conditions to closing set forth in the merger
agreement.
|
•
|
solicit,
initiate or take any action knowingly to facilitate the submission of
inquiries, proposals or offers from any person (other than Access or
MacroChem Acquisition Corporation) relating to an acquisition
proposal;
|
•
|
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 MacroChem Acquisition Corporation) to do or seek any
acquisition proposal.
|
•
|
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
securities of MacroChem and/or its
subsidiaries;
|
•
|
a
tender offer or exchange offer that would result in any person owning
33.3% or more of any class of equity securities of MacroChem or any of its
subsidiaries;
|
•
|
any
merger, consolidation, business combination or similar transaction
involving MacroChem or any of its subsidiaries whose assets individually
or in the aggregate, constitute more than 33.3% of MacroChem's
consolidated assets, other than transactions specifically permitted under
the merger agreement; or
|
•
|
any
transaction, the consummation of which would or could reasonably be
expected to impede, interfere with, prevent or materially delay the
merger.
|
•
|
cease
all existing activities or negotiations with respect to any acquisition
proposal; and
|
•
|
not
release any third party from, or waive any provisions of, any existing
confidentiality or standstill agreement with respect to any acquisition
proposal.
|
·
|
MuGard™
is our approved product for the management of oral mucositis, a frequent
side-effect of cancer therapy for which there is no established treatment.
The market for mucositis treatment is estimated to be in excess of US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase 2
clinical trial being conducted in the EU in patients with ovarian cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess
of $2.0 billion.
|
·
|
Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We are
currently developing a product for the oral delivery of
insulin.
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably breast,
ovarian and colorectal cancers.
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
|
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
2
|
||||
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
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.
|
|
|
Sodium
Phenylbutyrate
|
•
|
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;
|
•
|
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.
|
·
|
Synthetic
Polymer Targeted Drug Delivery
Technology;
|
·
|
Cobalamin™-Mediated
Oral Delivery Technology;
|
·
|
Cobalamin™-Mediated
Targeted Delivery Technology;
|
·
|
Angiolix®;
|
·
|
Prodrax®;
and
|
·
|
Alchemix®.
|
▪
|
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. Our 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 receptor 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.
|
-
|
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.
|
·
|
Mucoadhesive
technology in 2021,
|
·
|
ProLindac™
in 2021,
|
·
|
Phenylbutyrate
between 2011 and 2016,
|
·
|
Angiolix®
in 2015,
|
·
|
Alchemix®
in 2015,
|
·
|
Cobalamin
mediated technology between 2008 and
2019
|
|
•
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.
|
•
|
Antigenics
and Regulon are developing liposomal platinum
formulations;
|
•
|
Spectrum
Pharmaceuticals and GPC Biotech are developing oral platinum
formulations;
|
•
|
Poniard
Pharmaceuticals is developing both i.v. and oral platinum
formulations;
|
•
|
Nanocarrier
and Debio are developing micellar nanoparticle platinum formulations;
and
|
▪
|
AmericanPharmaceutical
Partners, Cell Therapeutics, Daiichi, and Enzon are developing alternate
drugs in combination with polymers and other drug delivery
systems.
|
Steven
H. Rouhandeh
|
51
|
Chairman
of the Board
|
Jeffrey
B. Davis
|
45
|
Chief
Executive Officer, Director
|
Esteban
Cvitkovic, M.D.
|
59
|
Vice
Chairman – Europe
|
Mark
J. Ahn, Ph.D.
|
46
|
Director
|
Mark
J. Alvino
|
41
|
Director
|
Stephen
B. Howell, M.D.
|
64
|
Director
|
David
P. Luci
|
42
|
Director
|
David
P. Nowotnik, Ph.D.
|
59
|
Senior
Vice President Research & Development
|
Phillip
S. Wise
|
50
|
Vice
President, Business Development & Strategy
|
Stephen
B. Thompson
|
55
|
Vice
President, Chief Financial Officer, Treasurer,
|
Secretary
|
Name and Principal Position
(8)
|
Year
|
Salary ($)
(1)
|
Bonus
($)
|
Stock
Awards
($) (2)
|
Option
Awards ($)
(3)
|
All Other
Compensation
(4)
|
Total ($)
|
|||||||||||||||||||||
Stephen
R. Seiler (5)
Former
President and CEO
|
2007
|
$ | 350,000 | $ | - | $ | - | $ | 270,000 | $ | 14,840 | $ | 634,840 | |||||||||||||||
Rosemary
Mazanet(6)
Former
Acting CEO
|
2007
2006
|
$
|
8,076 357,385 |
$
|
-
100,000
|
$
|
-
-
|
$
|
263,071 81,464 |
$
|
-
2,594
|
$
|
271,147 541,443 | |||||||||||||||
David
P. Nowotnik, Ph.D.
Senior
Vice President Research
and
Development
|
2007
2006
|
$
|
253,620 253,620 |
$
|
20,000 |
$
|
-
-
|
$
|
40,732 |
$
|
12,225 7,152 |
$
|
265,845 321,504 | |||||||||||||||
Phillip
S. Wise(7)
Vice
President, Business
Development
|
2007
2006
|
$
|
200,000 116,667 |
$
|
-
25,000
|
$
|
-
-
|
$
|
-
40,732
|
$
|
9,876
$ 358
|
$
|
209,876 182,757 | |||||||||||||||
Stephen
B. Thompson
Vice
President, Chief Financial
Officer
|
2007
2006
|
$
|
154,080 154,080 |
$
|
-
20,000
|
$
|
-
-
|
$
|
-
40,732
|
$
|
7,427 4,508 |
$
|
161,507 219,320 |
(1)
|
Includes
amounts deferred under our 401(k)
Plan.
|
(2)
|
There
were no stock awards grants in 2007 and 2006 and no restricted stock
outstanding at December 31, 2007 and
2006.
|
(3)
|
The
value listed in the above table represents the fair value of the options
granted in prior years that was recognized in 2007 and 2006 under FAS
123R. Fair value is calculated as of the grant date using a Black-Scholes
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by our stock price as
well as assumptions regarding a number of complex and subjective
variables. Our assumptions in determining fair value are described in note
10 to our audited financial statements for the year ended December 31,
2007, included in our Annual Report on Form
10-K.
|
(4)
|
Amounts
reported for fiscal years 2007 and 2006 consist of: (i) amounts we
contributed to our 401(k) Plan with respect to each named individual, and
(ii) amounts we paid for group term life insurance for each named
individual.
|
(5)
|
Amounts
listed in 2007 for Mr. Seiler indicate compensation paid to him in
connection with his services as our President and CEO commencing on
January 1, 2007 and ending December 16,
2007.
|
(6)
|
Amounts
listed in 2007 and 2006 for Dr. Mazanet indicate compensation paid to her
in connection with her services as our Acting CEO commencing on May 11,
2005 and ending January 4, 2007.
|
(7)
|
Phillip
S. Wise became our Vice President Business Development June 1,
2006.
|
(8)
|
Jeffrey
B. Davis became our Chief Executive Officer effective December 26, 2007
and his employment agreement started January 4,
2008.
|
·
|
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.
|
·
|
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 $120,000
annually; and
|
·
|
term
life insurance coverage of
$200,000.
|
·
|
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
$155,000.
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of
Securities
Underlying Unexercised
Options
(#) Unexercisable
|
Equity
Incentive
Plan
Awards: Number of
Securities
Underlying Unexercised Unearned
Options
(#)
|
Option
Exercise
Price
($) (1)
|
Option
Expiration
Date
|
Stephen
R. Seiler
|
100,000
|
-
|
-
|
2.90
|
03/12/10
|
Rosemary
Mazanet(2)
|
33,333
200,000
48,251
6,000
|
66,667
-
1,749
-
|
-
|
2.90
0.63
5.45
12.50
|
01/04/17
08/17/16
11/02/15
05/11/15
|
David
P. Nowotnik, Ph.D. (3)
|
100,000
6,000
5,000
7,000
10,000
10,000
10,000
10,000
|
-
2,000
-
-
-
-
-
-
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/16
05/23/15
01/23/14
01/30/13
03/22/12
03/01/10
07/20/09
11/16/08
|
Phillip
S. Wise
|
100,000
|
-
|
-
|
0.63
|
08/17/16
|
Stephen
B. Thompson (3)
|
100,000
3,750
3,000
4,000
6,000
9,000
4,000
4,000
|
-
1,250
-
-
-
-
-
-
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/16
05/23/15
01/23/14
01/30/13
03/22/12
03/01/10
07/20/09
06/18/08
|
(1)
|
On
December 31, 2007, the closing price of our Common Stock as quoted on the
OTC Bulletin Board was $3.25.
|
(2)
|
Options
listed for Dr. Mazanet include options paid to her in connection with her
services as our Acting CEO commencing on May 11, 2005 and ending on
January 4, 2007. Dr. Mazanet’s options stopped vesting when she retired
from the Board of Directors on May 21, 2008. The Board granted her the
right to exercise her vested options up to May 21,
2010.
|
(3)
|
Dr.
Nowotnik and Mr. Thompson’s options to purchase shares of common stock
will be fully vested in April 2009.
|
(4)
|
Jeffrey
B. Davis became our Chief Executive Officer effective December 26, 2007,
and his employment agreement became effective January 4, 2008. Mr. Davis
does not currently have any stock options resulting from his employment
with us.
|
Name
|
Fees
earned or
Paid
in Cash ($)
|
Stock
Awards ($)
|
Option
Awards ($)(1)
|
All
Other Compensation ($)
|
Total
($)
|
|
Mark
J. Ahn, PhD (2)
|
16,000
|
-
|
2,000
|
-
|
18,000
|
|
Mark
J. Alvino
|
16,000
|
-
|
-
|
-
|
16,000
|
|
Esteban
Cvitkovic, MD (3)
|
11,000
|
-
|
256,000
|
153,000
|
420,000
|
|
Jeffrey
B. Davis
|
22,000
|
-
|
-
|
-
|
22,000
|
|
Stephen
B. Howell, MD (4)
|
15,000
|
-
|
2,000
|
67,000
|
84,000
|
|
David
P. Luci (5)
|
13,000
|
-
|
50,000
|
-
|
63,000
|
|
Rosemary
Mazanet, MD, PhD (6)
|
12,000
|
-
|
330,000
|
29,000
|
371,000
|
|
John
J. Meakem, Jr. (7)
|
18,000
|
-
|
2,000
|
-
|
20,000
|
|
(1)
|
|
The
value listed in the above table represents the fair value of the options
recognized as expense under FAS 123R during 2007, including unvested
options granted before 2007 and those granted in 2007. Fair value is
calculated as of the grant date using a Black-Scholes (“Black-Scholes”)
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by our stock price as
well as assumptions regarding a number of complex and subjective
variables. Our assumptions in determining fair value are described in note
10 to our audited financial statements for the year ended December 31,
2007, included in our Annual Report on Form 10-K.
|
(2)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on a grant date fair value of $7,592.
|
||
(3)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on a grant date fair value of $157,027 and an additional 25,000
options to purchase shares based on a grant date fair value of $99,347.
Includes $153,000 Dr. Cvitkovic received for scientific consulting
services in 2007.
|
||
(4)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on a grant date fair value of $5,581. Includes $67,000 Dr. Howell
received for scientific consulting services in 2007.
|
||
(5)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on grant date fair value of $65,768.
|
||
(6)
|
Represents
expense recognized in 2007 in respect of 50,000 options to purchase shares
based on a grant date fair value of $147,737; 200,000 options to purchase
shares based on a grant date fair value of $81,464; and an additional
100,000 options to purchase shares based on a grant date fair value of
$263,071. Includes $29,000 Dr. Mazanet received for scientific consulting
services in 2007.
|
||
(7)
|
Represents
expense recognized in 2007 in respect of 25,000 options to purchase shares
based on a grant date fair value of
$5,581.
|
Title
of Class
|
Name
and Address of Beneficial Owner
|
Amount
and Nature of Beneficial Ownership
|
Percent
of Class
|
|
Common Stock
(1)
|
||||
Steven
H. Rouhandeh(2)
|
-
|
*
|
||
Jeffery
B. Davis (3)
|
31,000
|
*
|
||
Mark
J. Ahn, Ph. D. (4)
|
86,525
|
*
|
||
Mark
J. Alvino (5)
|
156,000
|
1.3%
|
||
Esteban
Cvitkovic, M.D. (6)
|
156,000
|
2.3%
|
||
Stephen
B. Howell, M.D. (7)
|
56,422
|
*
|
||
David
P. Luci (8)
|
35,167
|
*
|
||
David
P. Nowotnik, Ph.D. (9)
|
166,852
|
2.5%
|
||
Phillip
S. Wise (10)
|
100,000
|
1.5%
|
||
Stephen
B. Thompson (11)
|
140,103
|
2.1%
|
||
SCO
Capital Partners LLC, SCO
Capital
Partners LP, and Beach
Capital
LLC (12)
|
6,973,818
|
55.4%
|
||
Larry
N. Feinberg (13)
|
1,025,333
|
14.2%
|
||
Lake
End Capital LLC (14)
|
844,720
|
11.6%
|
||
Perceptive
Life Sciences (15)
|
666,666
|
10.23%
|
||
All
Directors and Executive
Officers
as a group
(consisting
of 10 persons) (16)
|
802,889
|
11.1%
|
||
Preferred
Stock
|
||||
Steven
H. Rouhandeh(2)
|
-
|
*
|
||
Jeffery
B. Davis (3)
|
-
|
*
|
||
David
P. Luci (8)
|
8,333
|
*
|
||
SCO
Capital Partners LLC, SCO
Capital
Partners LP, and Beach
Capital
LLC (12)
|
7,077,100
|
65.5%
|
||
Larry
N. Feinberg (13)
|
1,457,699
|
13.5%
|
||
Lake
End Capital LLC (14)
|
793,067
|
7.3%
|
||
All
Directors and Executive
Officers
as a group
(consisting
of 10 persons) (16)
|
8,333
|
*
|
||
(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 November 24,
2008.
|
(2)
|
Steven
H. Rouhandeh is Chairman of SCO Securities LLC. a wholly-owned subsidiary
of SCO Financial Group 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 LP and Beach Capital
LLC) are known to beneficially own an aggregate of 787,796 shares of
Access’ Common Stock, warrants to purchase an aggregate of 6,032,514
shares of Access’ Common Stock and 7,077,100 shares of Common Stock are
issuable to them upon conversion of Series A Preferred Stock. Mr.
Rouhandeh disclaims beneficial ownership of all such shares except to the
extent of his pecuniary interest
therein.
|
(3)
|
Includes
5,820 shares underlying warrants held directly by Mr. Davis and presently
exercisable options for the purchase of 25,000 shares of Access’ Common
Stock pursuant to the 2005 Equity Incentive Plan. Mr. Davis is President
of SCO Securities LLC, a wholly-owned subsidiary of SCO Financial Group
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 LP and Beach Capital LLC) are known to
beneficially own 787,796 shares of Access’ Common Stock, warrants to
purchase an aggregate of 6,032,514 shares of Access’ Common Stock and
7,077,100 shares of Common Stock are issuable to them upon conversion of
Series A Preferred Stock. Mr. Davis disclaims beneficial ownership of all
such shares except to the extent of his pecuniary interest
therein.
|
(4)
|
Includes
presently exercisable options for the purchase of 31,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(5)
|
Includes
55,525 shares of Common Stock underlying warrants held by Mr. Alvino and
presently exercisable options for the purchase of 31,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive Plan. Mr. Alvino is
Managing Director of Griffin Securities LLC. His address is c/o Griffin
Securities LLC, 17 State St., 3rd
Floor, New York, NY 10004. Mr. Alvino is a designated director of SCO
Securities LLC. SCO Securities LLC and affiliates (SCO Capital Partners LP
and Beach Capital LLC) are known to beneficially own 787,796 shares of
Access’ Common Stock, warrants to purchase an aggregate of 6,032,514
shares of Access’ Common Stock and 7,077,100 shares of Common Stock are
issuable to them upon conversion of Series A Preferred Stock. Mr. Alvino
disclaims beneficial ownership of all such shares except to the extent of
his pecuniary interest therein. Mr. Alvino disclaims beneficial ownership
of all such shares except to the extent of his pecuniary interest
therein.
|
(6)
|
Includes
presently exercisable options for the purchase of 56,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and a warrant to
purchase 50,000 shares of Access’ Common Stock at an exercise price of
$3.15 per share.
|
(7)
|
Includes
presently exercisable options for the purchase of 32,200 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive Plan, 12,500 shares of
Access’ Common Stock pursuant to the 1995 Stock Option Plan, and a warrant
to purchase 2,000 shares of Access’ Common Stock at an exercise price of
$24.80 per share.
|
(8)
|
Includes
warrants to purchase an aggregate of 4,167 shares of Access’ Common Stock,
8,333 shares of Common Stock are issuable to him upon conversion of Series
A Preferred Stock and presently exercisable options for the purchase of
31,000 shares of Access’ Common Stock pursuant to the 2005 Equity
Incentive Plan.
|
(9)
|
Includes
presently exercisable options for the purchase of 100,000 shares of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and 59,167
shares of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
(10)
|
Includes
presently exercisable options for the purchase of 100,000 shares of
Access’ Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
(11)
|
Includes
presently exercisable options for the purchase of 100,000 shares of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and 34,479
shares of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
(12)
|
SCO
Capital Partners LLC, SCO Capital Partner LP, Beach Capital LLC and SCO
Financial Group's address is 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. SCO Capital Partners LLC and affiliates (SCO
Capital Partners LP, Beach Capital LLC and SCO Financial Group) are known
to beneficially own an aggregate of 787,796 shares of Access’ Common
Stock, warrants to purchase an aggregate of 6,032,514 shares of Access’
Common Stock and 7,077,100 shares of Common Stock issuable to them upon
conversion of Series A Preferred Stock. Each of Mr. Rouhandeh. Mr. Davis
and Mr. Alvino, Access’ directors and Mr. Rouhandeh and Mr. Davis a
executives with SCO Capital Partners LLC, disclaim beneficial ownership of
such shares except to the extent of their pecuniary interest
therein.
|
(13)
|
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 296,483 shares of Access’ Common Stock, warrants to purchase
an aggregate of 728,850 shares of Access’ Common Stock and Series A
Preferred Stock which may be converted into an aggregate of 1,457,699
shares of Access’ Common Stock.
|
(14)
|
Lake
End Capital LLC’s address is 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. Lake End Capital LLC is known to beneficially
own an aggregate of 67,694 shares of Access’ Common Stock, warrants to
purchase an aggregate of 777,027 shares of Access’ Common Stock and
793,067 shares of Common Stock issuable to them upon conversion of Series
A Preferred Stock.
|
(15)
|
Midsummer
Investment, Ltd.’s address is 295 Madison Ave., 38th
Fl., New York, NY 10017. Midsummer Investment is known to beneficially own
warrants to purchase an aggregate of 250,000 shares of Access’ Common
Stock and Series A Preferred Stock which may be converted into an
aggregate of 500,000 shares of Access’ Common
Stock.
|
(16)
|
Does
not include shares held by SCO Securities LLC and
affiliates.
|
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
the issuance
under equity
compensation
plans
(excluding
securities
reflected
in column (a)
|
||
Equity
compensation plans
|
|||||
approved
by security holders
|
|||||
2005
Equity Incentive Plan
|
926,386
|
$
1.59
|
717.328
|
||
1995
Stock Awards Plan
|
162,417
|
15.53
|
-
|
||
2001
Restricted Stock Plan
|
-
|
-
|
52,818
|
||
Equity
compensation plans
|
|||||
not
approved by security holders
|
|||||
2007
Special Stock Option Plan
|
100,000
|
2.90
|
350,000
|
||
Total
|
1,188,803
|
$
3.60
|
1,120,146
|
Common
Stock
|
||||
High
|
Low
|
|||
Period
Ended
|
||||
First
quarter March 31, 2008
|
$ 3.50
|
$ 1.35
|
||
Second
quarter June 30, 2008
|
3.30
|
1.40
|
||
Third
quarter September 30, 2008
|
3.49
|
2.50
|
||
Fourth
quarter thru November 24, 2008
|
2.75
|
1.00
|
||
Fiscal
Year Ended December 31, 2007
|
||||
First
quarter
|
$ 10.66
|
$ 2.50
|
||
Second
quarter
|
6.75
|
4.30
|
||
Third
quarter
|
5.16
|
2.10
|
||
Fourth
quarter
|
4.48
|
2.10
|
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
|
||
·
|
MuGard™
is our approved product for the management of oral mucositis, a frequent
side-effect of cancer therapy for which there is no established treatment.
The market for mucositis treatment is estimated to be in excess of US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation, has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase 2
clinical trial being conducted in the EU in patients with ovarian cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess
of $2.0 billion.
|
·
|
Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We are
currently developing a product for the oral delivery of
insulin.
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably breast,
ovarian and colorectal cancers.
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
|
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
2
|
||||
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
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.
|
Territory
|
Partner
|
Date
|
|
United
States & Canada
|
Milestone
Biosciences, LLC
|
August
2008
|
|
Europe
|
SpePharm
IP BV
|
August
2007
|
|
China
(PRC), Hong Kong, Macau, Taiwan, Brunei, Cambodia, Laos, Malaysia,
Myanmar, Phillippines, Singapore, Thailand & Vietnam
|
RHEI,
Pharmaceuticals, Inc.
|
January
2008
|
|
·
|
the
Somanta acquisition resulted in a one-time non-cash in-process research
and development expense in the first quarter of 2008
($8,879,000);
|
·
|
costs
for product manufacturing for a new ProLindac clinical trial
expected to start in early 2009
($1,047,000);
|
·
|
higher
scientific consulting expenses
($306,000);
|
·
|
higher
salary and related cost due to the hiring of additional scientific staff
($219,000); and
|
·
|
other
net increases in research spending
($125,000).
|
·
|
accrual
of liquidated damages that may be due under an investor rights agreement
with certain investors ($415,000);
|
·
|
higher
patent expenses and license fees
($391,000);
|
·
|
higher
general business consulting expenses
($69,000);
|
·
|
lower
salary related expenses due to stock option expenses
($467,000);
|
·
|
lower
salary and other salary related expenses ($213,000);
and
|
·
|
other
net decreases in general and administrative expenses
($75,000).
|
·
|
the
successful development and commercialization of ProLindac™, MuGard™ and
our other product candidates;
|
·
|
the
ability to convert, repay or restructure our outstanding convertible notes
and debentures;
|
·
|
the
ability to integrate Somanta Pharmaceuticals, Inc. assets and programs
with ours;
|
·
|
the
ability to establish and maintain collaborative arrangements with
corporate partners for the research, development and commercialization of
products;
|
·
|
continued
scientific progress in our 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.
|
(in
thousands)
|
Twelve
Months
ended
December
31,
|
Nine
Months
ended
September
30,
|
Inception
To
Date
(1)
|
|||||||||||||
Project
|
2007
|
2008
|
2008
|
|||||||||||||
Polymer
Platinate
(ProLindac™)
|
$ | 2,563 | $ | 2,043 | $ | 3,090 | $ | 25,307 | ||||||||
Mucoadhesive
Liquid
Technology
(MLT)
|
21 | 10 | - | 1,511 | ||||||||||||
Others
(2)
|
18 | - | 206 | 5,268 | ||||||||||||
Total
|
$ | 2,602 | $ | 2,053 | $ | 3,296 | $ | 32,086 | ||||||||
(1)
|
Cumulative
spending from inception of the Company or project through September 30,
2008.
|
(2)
|
Includes: Vitamin
Mediated Targeted Delivery, carbohydrate targeting and other related
projects.
|
PAGE
|
|
Report
of Independent Registered Public Accounting
Firm
|
F-2
|
Consolidated
Balance Sheets at December 31, 2007 and
2006
|
F-3
|
Consolidated
Statements of Operations and Comprehensive Loss for 2007 and
2006
|
F-4
|
Consolidated
Statement of Stockholders' Equity (Deficit) for 2007 and
2006
|
F-5
|
Consolidated
Statements of Cash Flows for 2007 and 2006
|
F-6
|
Notes
to Consolidated Financial Statements (Two years ended December 31,
2007)
|
F-7
|
Condensed
Consolidated Balance Sheets at September 30, 2008
(unaudited)
|
F-23
|
Condensed
Consolidated Statements of Operations for September 30, 2008 and 2007
(unaudited)
|
F-24
|
Condensed
Consolidated Statements of Cash Flows for September 30, 2008 and 2007
(unaudited)
|
F-25
|
Notes
to Condensed Consolidated Financial Statements (Nine Months Ended
September 30, 2008 and 2007) (unaudited)
|
F-26
|
ASSETS
|
December 31, 2007
|
December 31,
2006
|
Current
assets
Cash and cash
equivalents
Short
term investments, at cost
Receivables
Receivables due from Somanta
Pharmaceuticals
Prepaid
expenses and other current assets
|
$
|
159,000
6,762,000
35,000
931,000 410,000
|
$
|
1,194,000
3,195,000
359,000
-
283,000
|
||||
Total
current assets
|
8,297,000 | 5,031,000 |
Property
and equipment, net
|
130,000 | 212,000 | ||||||
Debt
issuance costs, net
|
- | 158,000 | ||||||
Patents,
net
|
710,000 | 878,000 | ||||||
Licenses,
net
|
- | 25,000 | ||||||
Other
assets
|
12,000 | 122,000 | ||||||
Total
assets
|
$ | 9,149,000 | $ | 6,426,000 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
Current
liabilities
Accounts
payable and accrued expenses
Accrued
interest payable
Current
portion of deferred revenue
Current
portion long-term debt, net of discount $0 at December 31,
2007
and
$2,062,000 at December 31, 2006
|
$
|
1,796,000
130,000
68,000
64,000
|
$
|
1,226,000
581,000 173,000
8,833,000
|
Total
current liabilities
|
2,058,000 | 10,813,000 | ||||||
Long-term deferred revenue | 910,000 | - | ||||||
Long-term
debt
|
5,500,000 | 5,500,000 | ||||||
Total
liabilities
|
8,468,000 | 16,313,000 |
Commitments
and contingencies
|
Stockholders'
equity (deficit)
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
3,227.3617
issued at December 31, 2007; none issued at
December
31, 2006
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
3,585,458 at December 31, 2007; issued 3,535,108
at
December 31, 2006
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost – 163 shares
Accumulated
deficit
|
-
36,000
116,018,000
(1,045,000)
(4,000)
(114,324,000)
|
-
35,000
68,799,000
(1,045,000)
(4,000)
(77,672,000)
|
Total
stockholders' equity (deficit)
|
681,000
|
(9,887,000)
|
Total
liabilities and stockholders' equity (deficit)
|
$ | 9,149,000 | $ | 6,426,000 |
2007
|
2006
|
|||||||
Revenues
|
||||||||
License
revenues
|
$ | 23,000 | $ | - | ||||
Sponsored research and
development
|
34,000 | - | ||||||
Total revenues
|
57,000 | - | ||||||
Expenses
|
||||||||
Research and
development
|
2,602,000 | 2,053,000 | ||||||
General and
administrative
|
4,076,000 | 2,813,000 | ||||||
Depreciation and
amortization
|
279,000 | 309,000 | ||||||
Total expenses
|
6,957,000 | 5,175,000 | ||||||
Loss
from operations
|
(6,900,000 | ) | (5,175,000 | ) | ||||
Interest
and miscellaneous income
|
125,000 | 294,000 | ||||||
Interest
and other expense
|
(3,514,000 | ) | (7,436,000 | ) | ||||
Loss
on extinguishment of debt
|
(11,628,000 | ) | - | |||||
Unrealized
loss on fair value of warrants and beneficial
conversion
feature
|
- | (1,107,000 | ) | |||||
(15,017,000 | ) | (8,249,000 | ) | |||||
Loss
before discontinued operations and before tax benefit
|
(21,917,000 | ) | (13,424,000 | ) | ||||
Income
tax benefit
|
61,000 | 173,000 | ||||||
Loss
from continuing operations
|
(21,856,000 | ) | (13,251,000 | ) | ||||
Less preferred stock dividends | (14,908,000 | ) | - | |||||
Loss from continuing operations allocable to common stockholders | (36,764,000 | ) | (13,251,000 | ) | ||||
Discontinued
operations, net of taxes of $61,000 in 2007 and $173,000
in 2006
|
112,000 | 377,000 | ||||||
Net
loss allocable to common stockholders
|
$ | (36,652,000 | ) | $ | (12,874,000 | ) | ||
Basic
and diluted loss per common share
|
||||||||
Loss
from continuing operations allocable to common
stockholders
|
$ | (10.35 | ) | $ | (3.76 | ) | ||
Discontinued
operations
|
0.03 | 0.11 | ||||||
Net
loss allocable to common stockholders
|
$ | (10.32 | ) | $ | (3.65 | ) | ||
Weighted
average basic and diluted common shares
outstanding
|
3,552,006 | 3,531,934 |
Common
Stock
|
Preferred
Stock
|
Additional
paid-in
capital
|
Notes
receivable from stockholders
|
Treasury
stock
|
Accumulated
deficit
|
|||
Shares
|
Amount
|
Shares
|
Amount
|
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 | ) | |||||||||||||||||||||
Common
stock issued for
services
|
19,000 | - | - | - | 83,000 | - | - | - | ||||||||||||||||||||||||
Options
exercised
|
31,000 | 1,000 | - | - | 35,000 | - | - | - | ||||||||||||||||||||||||
Stock
option
compensation
expense
|
- | - | - | - | 1,048,000 | - | - | - | ||||||||||||||||||||||||
Preferred
stock issuances
|
- | - | 954.0001 | - | 5,560,000 | - | - | - | ||||||||||||||||||||||||
Warrants
issued with
preferred
stock
|
- | - | - | - | 3,980,000 | - | - | - | ||||||||||||||||||||||||
Costs
of stock issuances
|
(868,000 | ) | - | - | - | |||||||||||||||||||||||||||
Beneficial
conversion
Feature
|
- | - | - | - | 14,648,000 | - | - | - | ||||||||||||||||||||||||
Preferred
stock dividend
beneficial
conversion
feature
|
- | - | - | - | - | - | - | (14,648,000 | ) | |||||||||||||||||||||||
Conversion
of convertible
debt
into preferred stock
|
- | - | 2,273.3616 | - | 6,472,000 | - | - | - | ||||||||||||||||||||||||
Warrants
issued with
preferred
stock
|
- | - | - | - | 4,633,000 | - | - | - | ||||||||||||||||||||||||
Loss
on extinguishment
of
debt – preferred stock
|
- | - | - | - | 6,777,000 | - | - | - | ||||||||||||||||||||||||
Loss
on extinguishment
of
debt – warrants
|
- | - | - | - | 4,851,000 | - | - | - | ||||||||||||||||||||||||
Preferred
dividends
|
- | - | - | - | - | - | - | (260,000 | ) | |||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (21,744,000 | ) | |||||||||||||||||||||||
Balance,
December 31,
2007
|
3,585,000 | $ | 36,000 | 3,227.3617 | $ | - | $ | 116,018,000 | $ | (1,045,000 | ) | $ | (4,000 | ) | $ | (114,324,000 | ) |
Year ended December
31,
|
||||||||
2007
|
2006
|
|||||||
Cash flows from operating activities: | ||||||||
Net
loss
|
$ | (21,744,000 | ) | $ | (12,874,000 | ) | ||
Adjustments to
reconcile net loss to net cash used
|
||||||||
in operating
activities:
|
||||||||
Unrealized
loss
|
- | 1,107,000 | ||||||
Loss on
extinguishment of debt
|
11,628,000 | - | ||||||
Stock option
expense
|
1,048,000 | 248,000 | ||||||
Stock issued
for compensation/services
|
83,000 | 77,000 | ||||||
Depreciation and amortization
|
279,000 | 309,000 | ||||||
Amortization
of debt costs and
discounts
|
2,316,000 | 6,749,000 | ||||||
Loss (gain) on
sale of assets
|
2,000 | (550,000 | ) | |||||
Change in
operating assets and liabilities:
|
||||||||
Receivables
|
(607,000 | ) | 4,129,000 | |||||
Prepaid
expenses and other current assets
|
(127,000 | ) | 14,000 | |||||
Other
assets
|
14,000 | 127,000 | ||||||
Accounts
payable and accrued expenses
|
310,000 | (1,657,000 | ) | |||||
Accrued
interest payable
|
1,150,000 | 363,000 | ||||||
Deferred
revenues
|
805,000 | - | ||||||
Net cash used in operating activities | 4,843,000 | (1,958,000 | ) | |||||
Cash
flows from investing activities:
|
||||||||
Capital
expenditures
|
(18,000 | ) | (3,000 | ) | ||||
Proceeds from
sale of equipment
|
13,000 | - | ||||||
Proceeds from
sale of oral/topical care assets
|
- | 550,000 | ||||||
Purchases of
short-term investments
|
||||||||
and
certificates of deposit, net
|
(3,567,000 | ) | (3,070,000 | ) | ||||
Net cash used in investing activities | (3,572,000 | ) | (2,523,000 | ) | ||||
Cash
flows from financing activities:
|
||||||||
Payments of
notes payable
|
(1,327,000 | ) | (106,000 | ) | ||||
Proceeds from
secured convertible notes payable
|
- | 5,432,000 | ||||||
Exercise of
stock options
|
35,000 | - | ||||||
Proceeds from
preferred stock issuances, net of costs
|
8,672,000 | - | ||||||
Net cash provided by financing activities | 7,380,000 | 5,326,000 | ||||||
Net increase (decrease) in cash and cash equivalents | (1,035,000 | ) | 845,000 | |||||
Cash and cash equivalents at beginning of year | 1,194,000 | 349,000 | ||||||
Cash and cash equivalents at end of year | $ | 159,000 | $ | 1,194,000 | ||||
Cash paid for interest | $ | 34,000 | $ | 315,000 | ||||
Supplemental disclosure of noncash transactions | ||||||||
Common stock issued for SEDA
and
|
||||||||
Debt issuance
costs
|
- | 568,000 | ||||||
Accrued interest
capitalized
|
511,000 | 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 | ||||||
Preferred stock
dividends
|
260,000 | - | ||||||
Debt exchanged for preferred
stock
|
10,015,000 | - | ||||||
Accrued interest exchanged for
preferred stock
|
1,090,000 | - |
December 31,
2007
|
December 31, 2006
|
|||||||||||||||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
|||||||||||||
Amortizable intangible assets | ||||||||||||||||
Patents
|
$ |
1,680
|
$ | 970 | $ | 1,680 | $ | 802 | ||||||||
Licenses
|
500 | 500 | 500 | 475 | ||||||||||||
Total
|
$ | 2,180 | $ | 1,470 | 2,180 | 1,277 |
2008 | $ |
168
|
2009 |
168
|
|
2010 |
168
|
|
2011 |
168
|
|
Thereafter |
168
|
|
38
|
||
Total | $ |
710
|
2007
|
2006
|
|
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.
|
136%
|
127%
|
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.
|
4.65%
|
4.85%
|
Dividend
yield assumption is based on our history and expectation of dividend
payments.
|
None
|
None
|
Estimated
expected term (average of number years) is based on employee exercise
behavior.
|
5.7
years
|
1.6
years
|
Year
ended
December 31, 2007
|
Year
ended
December 31, 2006
|
|||||||
Research
and development
|
$ | 91 | $ | 68 | ||||
General
and administrative
|
957 | 180 | ||||||
Stock-based
compensation expense included in operating expense
|
1,048 | 248 | ||||||
Total
stock-based compensation expense
|
1,048 | 248 | ||||||
Tax
benefit
|
- | - | ||||||
Stock-based
compensation expense, net of tax
|
$ | 1,048 | $ | 248 |
Two
years ended December 31, 2007
|
Consulting
|
Expense
|
|||||||
Year
|
Fees
|
|
Reimbursement
|
|||||
2007 | $ | 70,000 | $ | 2,000 | ||||
2006 | 69,000 | 5,000 |
Consulting
|
Office
|
Expense
|
Fair
Value
|
|||||||||||||
Year
|
Fees
|
Expenses
|
Reimbursement
|
of
Options
|
||||||||||||
2007 | $ | 153,000 | $ | 15,000 | $ | 12,000 | $ | 99,000 |
Consulting
|
Expense
|
||||||||
Year
|
Fees
|
Reimbursement
|
|||||||
2007
|
$ | 29,000 | $ | 13,000 |
Property and equipment consists of the following: |
December
31,
|
|||||||
2007
|
2006
|
|||||||
Laboratory equipment | $ | 824,000 | $ | 1,090,000 | ||||
Laboratory and building improvements | 58,000 | 167,000 | ||||||
Furniture and equipment | 40,000 | 134,000 | ||||||
922,000 | 1,391,000 | |||||||
Less accumulated depreciation and amortization | 792,000 | 1,179,000 | ||||||
Net property and equipment | $ | 130,000 | $ | 212,000 | ||||
Future
|
||
Maturities
|
Debt
|
|
2008 |
64,000
|
|
2011 |
5,500,000
|
Summary of Warrants
|
Warrants
Outstanding
|
Exercise
Price
|
Expiration
Date
|
||||||
2007 preferred stock offering (a) | 3,649,880 | $ | 3.50 |
11/10/13
|
|||||
2006 convertible note (b) | 3,863,634 | 1.32 |
2/16/12
|
||||||
2006 convertible note (b) | 386,364 | 1.32 |
10/24/12
|
||||||
2006 convertible note (b) | 386,364 | 1.32 |
12/06/12
|
||||||
2006 investor relations advisor (c) | 50,000 | 2.70 |
12/27/11
|
||||||
2004 offering (d) | 89,461 | 35.50 |
2/24/09
|
||||||
2004 offering (d) | 31,295 | 27.00 |
2/24/09
|
||||||
2003 financial advisor (e) | 14,399 | 19.50 |
10/30/08
|
||||||
2002 scientific consultant (f) | 2,000 | 24.80 |
2/01/09
|
||||||
2001 scientific consultant (g) | 3,000 | 15.00 |
1/1/08
|
||||||
Total
|
8,476,397 |
a)
|
In
connection with the preferred stock offering in November 2007, warrants to
purchase a total of 3,649,880 shares of common stock were issued. All of
the warrants are exercisable immediately and expire five years from date
of issue. The fair value of the warrants was $2.50 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 3.84%,
expected volatility 114% and a term of 5
years.
|
b)
|
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.
|
c)
|
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 are
exercisable.
|
d)
|
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.
|
e)
|
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.
|
f)
|
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.
|
g)
|
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.
|
Options
|
Weighted-
average
exercise
Price
|
|||||||
Outstanding options at January 1, 2006 | 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 | ||||||
Granted, fair value of $ 3.27 per share | 230,000 | 3.62 | ||||||
Exercised | (31,286 | ) | 1.11 | |||||
Forfeited | (75,000 | ) | 2.14 | |||||
Outstanding options at December 31, 2007 | 926,386 | 1.59 | ||||||
Exercisable at December 31, 2007 | 698,081 | 1.38 |
Number
of
|
Weighted
average
|
Number
of
|
Weighted average | |||||||||||||||||||||||
Range of exercise
prices
|
options
outstanding
|
Remaining
life in years
|
Exercise
price
|
options
excercisable
|
Remaining
life in years
|
Exercise
Price
|
||||||||||||||||||||
$ |
0.63 -
0.63
|
666,750 | 9.0 | $ | 0.63 | 565,342 | 9.0 | $ | 0.63 | |||||||||||||||||
$ | 2.90 - 7.23 | 259,636 | 9.4 | 4.06 | 132,739 | 9.2 | 4.67 | |||||||||||||||||||
926,386 | 698,081 | |||||||||||||||||||||||||
Options
|
Weighted-
average
exercise
price
|
|||||||
Outstanding options at January 1, 2006 | 430,271 | $ | 18.20 | |||||
Forfeited | (69,354 | ) | 19.12 | |||||
Outstanding options at December 31, 2006 | 18.03 | 18.03 | ||||||
Forfeited | (198,500 | ) | 20.07 | |||||
Exercisable at December 31, 2007 | 162,417 | 15.53 | ||||||
Exercisable at December 31, 2007 | 157,337 | 15.64 |
Number
of
|
Weighted
average
|
Number
of
|
Weighted average | |||||||||||||||||||||||
Range of exercise
prices
|
options
outstanding
|
Remaining
life in years
|
Exercise
price
|
options
excercisable
|
Remaining
life in years
|
Exercise
Price
|
||||||||||||||||||||
$
|
10.00 - 12.50
|
85,140
|
5.3
|
$
|
11.42
|
80,238
|
5.1
|
$ |
11.41
|
|||||||||||||||||
14.05 -
18.65
|
48,717
|
3.3
|
16.33
|
48,717
|
3.3
|
16.33
|
||||||||||||||||||||
$ | 20.25 – 29.25 |
28,560
|
6.1 | 26.42 |
28,382
|
6.1 | 26.41 | |||||||||||||||||||
162,417 | 157,337 |
2007 | 2006 | |||||||
Income taxes at U.S. statutory rate | $ | (7,393,000 | ) | $ | (4,378,000 | ) | ||
Change in valuation allowance | 3,015,000 | 3,972,000 | ||||||
Change in miscellaneous items | - | (130,000 | ) | |||||
Benefit of foreign losses not recognized | 56,000 | 58,000 | ||||||
Expenses not deductible | 3,957,000 | 240,000 | ||||||
Expiration of net operating loss and general | ||||||||
business
credit carryforwards, net of
revisions
|
365,000 | 238,000 | ||||||
Total tax
expense
|
$ |
-
|
$ | - | ||||
December
31,
|
||||||||
2007
|
2006
|
|||||||
Deferred tax assets | ||||||||
Net operating
loss carryforwards
|
$ |
25,693,000
|
$ | 22,634,000 | ||||
General
business credit carryforwards
|
2,469,000 | 2,402,000 | ||||||
Property,
equipment and goodwill
|
87,000 | 46,000 | ||||||
Gross deferred tax assets | 28,249,000 | 25,082,000 | ||||||
Valuation allowance | (28,249,000 | ) | (25,082,000 | ) | ||||
|
||||||||
Net deferred
taxes
|
$ | - | $ | - | ||||
Net
operating
loss
carryforwards
|
General
business
credit
carryforwards
|
|||||||
2008 | $ | 4,004,000 | $ | 138,000 | ||||
2009 | 1,661,000 | 185,000 | ||||||
2010 | 2,171,000 | 140,000 | ||||||
2012 | 4,488,000 | 13,000 | ||||||
2013 | 4,212,000 | 77,000 | ||||||
Thereafter | 59,032,000 | 1,916,000 | ||||||
$ | 75,568,000 | $ | 2,469,000 |
2007
Quarter Ended
|
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
Loss
from continuing operations
|
$ | (4,127 | ) | $ | (2,109 | ) | $ | (1,957 | ) | $ | (13,663 | ) | ||||
Preferred stock dividends | - | - | - | (14,908 | ) | |||||||||||
Discontinued
operations, net of tax
|
- | - | - | 112 | ||||||||||||
Net
loss allocable to common
stockholders
|
$ | (4,127 | ) | $ | (2,109 | ) | $ | (1,957 | ) | $ | (28,459 | ) | ||||
Basic
and diluted loss per
common
share
|
$ | (1.17 | ) | $ | (0.60 | ) | $ | (0.55 | ) | $ | (8.00 | ) | ||||
2006
Quarter Ended
|
March
31
|
June
30
|
September 30
|
December 31
|
|||||||||||||
Loss
from continuing operations
|
$ | (4,856 | ) | $ | (3,331 | ) | $ | (2,015 | ) | $ | (3,049 | ) | ||||
Discontinued
operations, net of tax
|
- | - | - | 377 | ||||||||||||
Net
loss
|
$ | (4,856 | ) | $ | (3,331 | ) | $ | (2,015 | ) | $ | (2,672 | ) | ||||
Basic
and diluted loss per
common share
|
$ | (1.38 | ) | $ | (0.94 | ) | $ | (0.57 | ) | $ | (0.76 | ) | ||||
ASSETS
|
September 30, 2008
(unaudited)
|
December 31,
2007
(audited)
|
|
Current
assets
Cash and cash
equivalents
Short
term investments, at cost
Receivables
Receivables due from Somanta
Pharmaceuticals
Prepaid
expenses and other current assets
|
$ 201,000
4,417,000
330,000
-
110,000
|
$ 159,000
6,762,000
35,000
931,000
410,000
|
|
Total
current assets
|
5,058,000
|
8,297,000
|
Property
and equipment, net
|
100,000
|
130,000
|
|
Patents,
net
|
584,000
|
710,000
|
|
Other
assets
|
12,000
|
12,000
|
|
Total
assets
|
$ 5,754,000
|
$ 9,149,000
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||
Current
liabilities
Accounts
payable and accrued expenses
Dividends
payable
Accrued
interest payable
Current
portion of deferred revenue
Current
portion of long-term debt
|
$ 2,571,000
1,799,000
445,000
164,000
-
|
$ 1,537,000
259,000
130,000
68,000
64,000
|
|
Total
current liabilities
|
4,979,000
|
2,058,000
|
|
Long-term
deferred revenue
Long-term
debt
|
2,286,000
5,500,000
|
910,000
5,500,000
|
|
Total
liabilities
|
12,765,000
|
8,468,000
|
|
Commitments
and contingencies
|
|||
Stockholders'
equity (deficit)
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
3,251.8617 issued at September
30, 2008; 3,227.3617 issued
at December 31,
2007
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
6,485,791 at September 30, 2008 and 3,585,458 at
December
31, 2007
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost – 163 shares
Accumulated
deficit
|
-
65,000
126,814,000
(1,045,000)
(4,000)
(132,841,000)
|
-
36,000
116,018,000
(1,045,000)
(4,000)
(114,324,000)
|
|
Total
stockholders' equity (deficit)
|
(7,011,000)
|
681,000
|
|
Total
liabilities and stockholders' equity (deficit)
|
$ 5,754,000
|
$ 9,149,000
|
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Revenues
|
||||||||||||||||
License
revenues
|
$ | 38,000 | $ | 6,000 | $ | 77,000 | $ | 6,000 | ||||||||
Sponsored research and
development
|
9,000 | - | 140,000 | - | ||||||||||||
Total revenues
|
47,000 | 6,000 | 217,000 | 6,000 | ||||||||||||
Expenses
|
||||||||||||||||
Research and
development
|
1,284,000 | 596,000 | 12,108,000 | 1,532,000 | ||||||||||||
General and
administrative
|
1,439,000 | 1,000,000 | 3,372,000 | 3,252,000 | ||||||||||||
Depreciation and
amortization
|
66,000 | 61,000 | 197,000 | 210,000 | ||||||||||||
Total expenses
|
2,789,000 | 1,657,000 | 15,677,000 | 4,994,000 | ||||||||||||
Loss
from operations
|
(2,742,000 | ) | (1,651,000 | ) | (15,460,000 | ) | (4,988,000 | ) | ||||||||
Interest
and miscellaneous income
|
62,000 | 12,000 | 167,000 | 72,000 | ||||||||||||
Interest
and other expense
|
(126,000 | ) | (318,000 | ) | (351,000 | ) | (3,277,000 | ) | ||||||||
(64,000 | ) | (306,000 | ) | (184,000 | ) | (3,205,000 | ) | |||||||||
Net
loss
|
(2,806,000 | ) | (1,957,000 | ) | (15,644,000 | ) | (8,193,000 | ) | ||||||||
Less
preferred stock dividends
|
523,000 | - | 2,873,000 | - | ||||||||||||
Net
loss allocable to common stockholders
|
$ | (3,329,000 | ) | $ | (1,957,000 | ) | $ | (18,517,000 | ) | $ | (8,193,000 | ) | ||||
Basic
and diluted loss per common share
Net
loss allocable to common shareholders
|
$ | (0.57 | ) | $ | (0.55 | ) | $ | (3.30 | ) | $ | (2.31 | ) | ||||
Weighted
average basic and diluted
common shares
outstanding
|
5,803,457 | 3,575,114 | 5,607,247 | 3,544,181 | ||||||||||||
Nine
Months ended September 30,
|
||||||||
2008
|
2007
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (15,644,000 | ) | $ | (8,193,000 | ) | ||
Adjustments to
reconcile net loss to cash used
in
operating activities:
|
||||||||
Depreciation and
amortization
|
197,000 | 210,000 | ||||||
Stock option
expense
|
244,000 | 810,000 | ||||||
Stock issued for
services
|
307,000 | 44,000 | ||||||
Acquired in-process research
and development
|
8,879,000 | - | ||||||
Amortization of debt costs and
discounts
|
- | 2,316,000 | ||||||
Loss on sale of
asset
|
- | 2,000 | ||||||
Changes in operating assets and
liabilities:
|
||||||||
Receivables
|
(295,000 | ) | (502,000 | ) | ||||
Prepaid
expenses and other current assets
|
(85,000 | ) | (247,000 | ) | ||||
Other assets
|
- | 1,000 | ||||||
Accounts payable and accrued
expenses
|
30,000 | 369,000 | ||||||
Dividends
payable
|
(25,000 | ) | - | |||||
Accrued interest
payable
|
315,000 | 953,000 | ||||||
Deferred
revenue
|
1,472,000 | 994,000 | ||||||
Net cash used in operating
activities
|
(4,605,000 | ) | (3,243,000 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Capital
expenditures
|
(28,000 | ) | (18,000 | ) | ||||
Somanta acquisition, net
of cash acquired
|
(65,000 | ) | - | |||||
Proceeds from sale of
asset
|
- | 13,000 | ||||||
Redemptions of short term
investments and
certificates of
deposit
|
2,345,000 | 2,680,000 | ||||||
Net cash provided by investing
activities
|
2,252,000 | 2,675,000 | ||||||
Cash
flows from financing activities:
|
||||||||
Payments
of notes payable
|
(64,000 | ) | - | |||||
Proceeds
from preferred stock issuances, net of costs
|
2,444,000 | - | ||||||
Proceeds
from exercise of common stock options
|
15,000 | 35,000 | ||||||
Net cash provided by financing
activities
|
2,395,000 | 35,000 | ||||||
Net
increase (decrease) in cash and cash equivalents
|
42,000 | (533,000 | ) | |||||
Cash
and cash equivalents at beginning of period
|
159,000 | 1,194,000 | ||||||
Cash
and cash equivalents at end of period
|
$ | 201,000 | $ | 661,000 | ||||
Supplemental
cash flow information:
|
||||||||
Cash
paid for interest
|
$ | 9,000 | $ | 5,000 | ||||
Supplemental
disclosure of noncash transactions:
|
||||||||
Shares issued for
payables
|
1,576,000 | - | ||||||
Preferred
stock dividends in dividends payable
|
1,799,000 | - | ||||||
Accrued
interest capitalized
|
- | 511,000 | ||||||
Beneficial
conversion feature –
February
2008 preferred stock dividends
November
2007 preferred stock dividends correction
|
857,000 451,000 | - - | ||||||
Preferred
stock issuance costs paid in cash
|
281,000 | - |
September
30, 2008
|
December
31, 2007
|
|||
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
Amortization
|
|
Amortizable
intangible assets
Patents
|
$ 1,680
|
$ 1,096
|
$ 1,680
|
$ 970
|
2008
|
$ 42
|
||
2009 |
168
|
||
2010 |
168
|
||
2011 |
168
|
||
2012 |
38
|
||
Total |
$ 584
|
·
|
Approximately
1.5 million shares of Access common stock were issued to the common and
preferred shareholders of Somanta as consideration having a value of
approximately $4,650,000 (the value was calculated using Access’ stock
price on January 4, 2008, times the number of shares
issued);
|
·
|
exchange
of all outstanding warrants for Somanta common stock for warrants to
purchase 191,991 shares of Access common stock at exercise prices ranging
between $18.55 and $69.57 per share. The warrants were valued at
approximately $281,000. All of the warrants are exercisable immediately
and expire approximately four years from date of issue. The weighted
average fair value of the warrants was $1.46 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 3.26%,
expected volatility 114% and an expected term of approximately 4
years;
|
·
|
paid
an aggregate of $475,000 in direct transaction costs;
and
|
·
|
cancelled
receivable from Somanta of
$931,000.
|
Cash | $ | 1 | ||
Prepaid expenses | 25 | |||
Office equipment | 14 | |||
Accounts payable | (2,582 | ) | ||
In-process research & development | 8,879 | |||
$ | 6,337 |
Three
months ended
September 30,
|
Nine
months ended
September 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Net
loss
|
$ | (3,329 | ) | $ | (2,454 | ) | $ | (18,517 | ) | $ | (14,627 | ) | ||||
Net
loss per common shares (basic and diluted)
|
$ | (0.57 | ) | $ | (0.48 | ) | $ | (3.30 | ) | $ | (2.90 | ) | ||||
Weighted
average common shares outstanding
(basic
and diluted)
|
5,803 | 5,075 | 5,607 | 5,044 |
Three months
ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Research
and development
|
$ | 39,000 | $ | 190,000 | $ | 78,000 | $ | 761,000 | ||||||||
General
and administrative
|
65,000 | 17,000 | 166,000 | 49,000 | ||||||||||||
Stock-based
compensation expense
|
104,000
|
|
207,000
|
244,000 | 810,000 | |||||||||||
included
in operating expense
|
9/30/08
|
||||
Expected
life
|
6.2
|
yrs | ||
Risk
free interest rate
|
3.0
|
%
|
||
Expected volatility(a) |
133
|
%
|
||
Expected
dividend yield
|
0.0
|
%
|
||
(a)
|
Reflects
movements in our stock price over the most recent historical period
equivalent to the expected life.
|
PAGE
|
|
Report
of Independent Registered Public Accounting Firm
|
F-31
|
Consolidated
Balance Sheet as of April 30, 2007
|
F-32
|
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
|
F-33
|
Consolidated
Statements of Stockholders’ Deficit for the period from inception of
operations (April 19, 2001) to April 30, 2007
|
F-34
|
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
|
F-36
|
Notes
to Consolidated Financial Statements as of April 30, 2007
|
F-37
|
Condensed
Consolidated Balance Sheets at October 31, 2007
(unaudited)
|
F-57
|
Condensed
Consolidated Statements of Operations for the Three and Six Months Ended
October 31, 2007 and 2006 and for the Period from Inception of Operations
(April 19, 2001) to October 31, 2007 (unaudited)
|
F-58
|
Condensed
Consolidated Statement of Stockholders’ Deficit for the Period from
Inception of Operations (April 19, 2001) to October 31, 2007
(unaudited)
|
F-60
|
Condensed
Consolidated Statements of Cash Flows for the Six Months Ended October 31,
2007 and 2006 and for the Period from Inception of Operations (April 19,
2001) to October 31, 2007 (unaudited)
|
F-66
|
Notes
to Condensed Consolidated Financial Statements as of October 31,
2007
|
F-68
|
/s/ STONEFIELD
JOSEPHSON, INC.
|
|
Irvine,
California
|
|
June
27, 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
|
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
|
|
|
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
|
)
|
|
|
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
|
)
|
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
|
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
|
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;
|
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.
|
Payroll
& vacation
|
$
|
472,014
|
||
Accounting
& legal
|
326,325
|
|||
Consultant
|
13,200
|
|||
$
|
811,539
|
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
|
—
|
—
|
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
|
$
|
—
|
$
|
—
|
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
|
|||||
$ | - | $ |
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%
|
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
|
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-
|
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
|
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
|
(Unaudited)
October
31, 2007
|
(Audited)
April
30,
2007
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
|
$
|
1,424
|
$
|
5,385
|
|||
Prepaid
expenses
|
25,391
|
43,308
|
|||||
Total
current assets
|
26,815
|
48,693
|
|||||
Office equipment, net of
accumulated depreciation of $9,441 and $6,750 for the period ended October
31, 2007 and April 30, 2007, respectively
|
13,870
|
16,560
|
|||||
Other
assets:
|
|||||||
Restricted
funds
|
—
|
2,000
|
|||||
Deposits
|
73
|
73
|
|||||
Total
other assets
|
73
|
2,073
|
|||||
Total
assets
|
$
|
40,758
|
$
|
67,326
|
|||
Liabilities
and Stockholders’ Deficit
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,027,819
|
$
|
774,022
|
|||
Due
to related parties
|
281,335
|
241,874
|
|||||
Accrued
expenses
|
969,121
|
811,539
|
|||||
Accrued
research and development expenses
|
354,733
|
554,733
|
|||||
Note
payable
|
822,712
|
33,462
|
|||||
Liquidated
damages related to Series A preferred stock and warrants
|
35,200
|
35,200
|
|||||
Deferred
revenue
|
6,429
|
7,143
|
|||||
Warrant
liabilities
|
117,636
|
5,786,844
|
|||||
Total
current liabilities
|
3,614,985
|
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 issued and outstanding as of October 31, 2007 and April 30,
2007
|
1
|
1
|
|||||
Common
stock, $0.001 par value, 100,000,000 shares authorized, 15,459,137 shares
issued and outstanding as of October 31, 2007 and April 30,
2007
|
15,460
|
14,293
|
|||||
Additional
paid-in capital
|
7,614,859
|
7,604,360
|
|||||
Deficit
accumulated during development stage
|
(11,204,549
|
)
|
(15,796,145
|
)
|
|||
Total
stockholders’ deficit
|
(3,574,229
|
)
|
(8,177,491
|
)
|
|||
Total
liabilities and stockholders’ deficit
|
$
|
40,756
|
$
|
67,326
|
|||
From Inception
of
Operations
(April 19, 2001) to
October 31,
2007
|
||||||||||||||||
Three
Months Ended
October 31,
|
Six
Months Ended
October 31,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Revenue
|
$
|
357
|
$
|
357
|
$
|
714
|
$
|
714
|
$
|
3,571
|
||||||
Operating
expenses:
|
||||||||||||||||
General
and administrative
|
(293,809
|
)
|
(874,810
|
)
|
(726,685
|
)
|
(1,700,359
|
)
|
(8,063,803
|
)
|
||||||
Research
and development
|
(269,688
|
)
|
(583,318
|
)
|
(321,827
|
)
|
(901,352
|
)
|
(3,422,474
|
)
|
||||||
Loss
from operations
|
(563,140
|
)
|
(1,457,771
|
)
|
(1,047,798
|
)
|
(2,600,997
|
)
|
(11,482,706
|
)
|
||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
—
|
11,475
|
5
|
28,554
|
40,437
|
|||||||||||
Interest
expense
|
(20,181
|
)
|
—
|
(27,316
|
)
|
—
|
(1,043,390
|
)
|
||||||||
Liquidated
damages
|
—
|
85,302
|
—
|
(35,200
|
)
|
(35,200
|
)
|
|||||||||
Change
in fair value of warrant liabilities
|
88,157
|
119,762
|
5,669,206
|
394,324
|
2,875,631
|
|||||||||||
Gain
on settlement of debt
|
—
|
—
|
—
|
—
|
5,049
|
|||||||||||
Currency
translation loss
|
(589
|
)
|
(768
|
)
|
(710
|
)
|
(2,002
|
)
|
(34,206
|
)
|
||||||
Income
(loss) before income taxes
|
(495,753
|
)
|
(1,242,000
|
)
|
4,593,387
|
(2,215,321
|
)
|
(9,674,385
|
)
|
|||||||
Income
taxes
|
(1,600
|
)
|
—
|
(1,791
|
)
|
(250
|
)
|
(7,847
|
)
|
|||||||
Net
income (loss)
|
(497,353
|
)
|
(1,242,000
|
)
|
4,591,596
|
(2,215,571
|
)
|
(9,682,232
|
)
|
Deemed
dividends on convertible preferred stock
|
—
|
—
|
—
|
—
|
(1,522,317
|
)
|
||||||||||
Net
income (loss) applicable to common shareholders
|
$
|
(497,353
|
)
|
$
|
(1,242,000
|
)
|
$
|
4,591,596
|
$
|
(2,215,571
|
)
|
$
|
(11,204,549
|
)
|
||
Net
income (loss) per share-basic
|
$
|
(0.03
|
)
|
$
|
(0.09
|
)
|
$
|
0.31
|
$
|
(0.16
|
)
|
$
|
(0.84
|
)
|
||
Weighted
average number of shares outstanding—basic
|
14,630,402
|
14,274,534
|
14,630,402
|
14,274,534
|
13,364,892
|
|||||||||||
Net
income (loss) per share-diluted
|
$
|
(0.03
|
)
|
$
|
(0.09
|
)
|
$
|
0.19
|
$
|
(0.16
|
)
|
$
|
(0.84
|
)
|
||
Weighted
average number of shares outstanding—diluted
|
14,630,402
|
14,274,534
|
23,889,527
|
14,274,534
|
13,364,892
|
Preferred
Stock
|
Common Stock
|
|||||||||||||||||||||||
Shares
|
Amount
|
Shares | Amount |
Additional
Paid-in
Capital
|
Shares
to
be
Issued
|
|||||||||||||||||||
Balance
at April 19, 2001 (Inception)
|
— | $ | — | — | $ | — | $ | — | $ | — | ||||||||||||||
Shares
issued for cash at $.0326
|
4,299,860 | 4,300 | 135,680 | — | ||||||||||||||||||||
Shares
issued for services at $.0139
|
514,674 | 515 | 11,801 | |||||||||||||||||||||
Amortization
of deferred expense
|
||||||||||||||||||||||||
Comprehensive
loss—foreign currency translation adjustment
|
||||||||||||||||||||||||
Net
loss for the period from inception to April 30, 2002
|
||||||||||||||||||||||||
Balance
at April 30, 2002
|
— | — | 4,814,534 | 4,815 | 147,481 | — | ||||||||||||||||||
Shares
issued for cash at $1.0677
|
14,601 | 15 | 15,575 | |||||||||||||||||||||
Shares
issued for services at $.0214
|
219,010 | 219 | 4,472 | |||||||||||||||||||||
Amortization
of deferred expense
|
||||||||||||||||||||||||
Receipt
of cash for subscription receivable
|
||||||||||||||||||||||||
Comprehensive
loss—foreign currency translation adjustment
|
||||||||||||||||||||||||
Net
loss for the year ended April 30, 2003
|
||||||||||||||||||||||||
Balance
at April 30, 2003
|
— | — | 5,048,145 | 5,049 | 167,528 | — | ||||||||||||||||||
Shares
issued for cash at $1.2479
|
350,164 | 350 | 436,637 | |||||||||||||||||||||
Shares
issued for services at $1.2587
|
22,233 | 22 | 27,962 | |||||||||||||||||||||
Amortization
of deferred expense
|
||||||||||||||||||||||||
Exchange
for loan payment and compensation
|
181,371 | |||||||||||||||||||||||
Comprehensive
loss—foreign currency translation adjustment
|
||||||||||||||||||||||||
Net
loss for the year ended April 30, 2004
|
||||||||||||||||||||||||
Balance
at April 30, 2004
|
— | — | 5,420,542 | 5,421 | 813,498 | — | ||||||||||||||||||
Shares
issued for cash at $1.3218
|
374,073 | 374 | 494,069 | |||||||||||||||||||||
Shares
issued for services at $1.2308
|
21,901 | 22 | 26,933 | |||||||||||||||||||||
3,650
shares to be issued for service at $1.4973
|
5,465 | |||||||||||||||||||||||
Amortization
of deferred expense
|
||||||||||||||||||||||||
Receipt
of cash for subscription receivable
|
||||||||||||||||||||||||
Options
issued for services
|
257,515 | |||||||||||||||||||||||
Comprehensive
loss—foreign currency translation adjustment
|
||||||||||||||||||||||||
Net
loss for the year ended April 30, 2005
|
||||||||||||||||||||||||
Balance
at April 30, 2005
|
— | — | 5,816,516 | 5,817 | 1,592,015 | 5,465 | ||||||||||||||||||
Write
off foreign currency translation adjustment
|
||||||||||||||||||||||||
Shares
issued for cash at $1.5656
|
12,669 | 13 | 19,821 | |||||||||||||||||||||
Shares
issued for prior service
|
3,650 | 3 | 5,462 | (5,465 | ) | |||||||||||||||||||
Amortization
of deferred expense
|
||||||||||||||||||||||||
Options
issued for services
|
300,616 | |||||||||||||||||||||||
Recapitalization
with Bridge Oncology
|
7,865,000 | 7,865 | (92,335 | ) |
Beneficial
conversion feature associated with convertible debt
financing
|
364,721 | ||||||||||||||||||||
Convertible
Series A Preferred shares issued for cash at $10,000
(net
of issuance costs of $544,169)
|
464 | 0.464 | 4,095,830 | ||||||||||||||||||
Convertible
Series A Shares issued on conversion of notes payable
|
128.6318 | 0.1286 | 1,286,318 | ||||||||||||||||||
Deemed
dividend on account of beneficial conversion feature associated with
issuance of Convertible Series A Preferred Shares
|
1,522,317 | ||||||||||||||||||||
Issuance
costs on warrants issued to placement agent in connection with the
Convertible Series A Preferred stock
|
(429,757 |
)
|
|||||||||||||||||||
Discount
on warrant issued with Convertible Series A Preferred
stock
|
(2,048,531 |
)
|
|||||||||||||||||||
Recapitalization
with Hibshman Optical Corp.
|
576,700 | 577 | (7,708 |
)
|
|||||||||||||||||
Warrant
expense
|
92,689 | ||||||||||||||||||||
Net
loss for the year ended April 30, 2006
|
|||||||||||||||||||||
Balance
at April 30, 2006
|
592.6318 | .5926 | 14,274,535 | 14,275 | 6,701,458 | — | ||||||||||||||||||
Options
issued for services
|
739,000 | |||||||||||||||||||||||
Warrant
expense
|
163,920 | |||||||||||||||||||||||
Conversion
of preferred stock
|
(1.000 | ) | (.0010 | ) | 18,069 | 18 | (18 | ) | ||||||||||||||||
Net
loss for the year ended April 30, 2007
|
||||||||||||||||||||||||
Balance
at April 30, 2007
|
591.6318 | .5916 | 14,292,604 | 14,293 | 7,604,360 | |||||||||||||||||||
Conversion
of warrants
|
1,166,534 | 1,167 | 10,499 | |||||||||||||||||||||
Net
income for the six months ended October 31, 2007
|
||||||||||||||||||||||||
Balance
at October 31, 2007 (unaudited)
|
591.6318 | $ | .5916 | 15,459,138 | $ | 15,460 | $ | 7,614,859 | — | |||||||||||||||
Subscription
Receivable
|
Deferred
Equity-
Based
Expense
|
Accumulated
Other
Comprehensive
Loss
- Foreign
Currency
Translation
Adjustment
|
Deficit
Accumulated
During
Development
Stage
|
Total
Stockholders’
Equity/(Deficit)
|
||||||||||||||||
Balance
at April 19, 2001(Inception)
|
$ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||
Shares
issued for cash at $.0326
|
(97,245 | ) | — | — | — | 42,735 | ||||||||||||||
Shares
issued for services at $.0139
|
(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
|
(97,245 | ) | (10,656 | ) | 29,905 | (95,901 | ) | (21,601 | ) | |||||||||||
Shares
issued for cash at $1.0677
|
15,590 | |||||||||||||||||||
Shares
issued for services at $.0214
|
(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
|
(5,728 | ) | (9,975 | ) | 31,439 | (207,357 | ) | (19,044 | ) | |||||||||||
Shares
issued for cash at $1.2479
|
(81,464 | ) | 355,523 | |||||||||||||||||
Shares
issued for services at $1.2587
|
(25,216 | ) | 2,768 | |||||||||||||||||
Amortization
of deferred expense
|
7,691 | 7,691 | ||||||||||||||||||
Exchange
for loan payment and compensation
|
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
|
(84,283 | ) | (27,500 | ) | (20,212 | ) | (646,810 | ) | 40,114 | |||||||||||
Shares
issued for cash at $1.3218
|
494,443 | |||||||||||||||||||
Shares
issued for services at $1.2308
|
26,955 | |||||||||||||||||||
3,650
shares to be issued for service at $1.4973
|
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 | |||||||||||||||||||
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
|
— | (561 | ) | (25,931 | ) | (1,776,100 | ) | (199,295 | ) | |||||||||||
Write
off foreign currency translation adjustment
|
25,931 | 25,931 | ||||||||||||||||||
Shares
issued for cash at $1.5656
|
19,834 | |||||||||||||||||||
Shares
issued for prior service
|
— | |||||||||||||||||||
Amortization
of deferred expense
|
561 | 561 | ||||||||||||||||||
Options
issued for services
|
300,616 | |||||||||||||||||||
Recapitalization
with Bridge Oncology
|
(84,470 | ) | ||||||||||||||||||
Beneficial
conversion feature associated with convertible debt
financing
|
364,721 | |||||||||||||||||||
Convertible
Series A Preferred shares issued for cash at $10,000 (net of issuance
costs of $544,169)
|
4,095,830 | |||||||||||||||||||
Convertible
Series A Shares issued on conversion of notes payable
|
1,286,318 | |||||||||||||||||||
Deemed
dividend on account of beneficial conversion feature associated with
issuance of Convertible Series A Preferred Shares
|
(1,522,317 | ) | — | |||||||||||||||||
Issuance
costs on warrants issued to placement agent in connection with the
Convertible Series A Preferred stock
|
(429,757 | ) | ||||||||||||||||||
Discount
on warrant issued with Convertible Series A Preferred
stock
|
(2,048,531 | ) | ||||||||||||||||||
Recapitalization
with Hibshman Optical Corp.
|
(7,131 | ) |
Warrant
expense
|
92,689 | |||||||||||||||||||
Net
loss for the year ended April 30, 2006
|
(5,002,091 | ) | (5,002,091 | ) | ||||||||||||||||
Balance
at April 30, 2006
|
— | — | — | (8,300,508 | ) | (1,584,775 | ) | |||||||||||||
Options
issued for services
|
739,000 | |||||||||||||||||||
Warrant
expense
|
163,920 | |||||||||||||||||||
Conversion
of preferred stock
|
— | |||||||||||||||||||
Net
loss for the year ended April 30, 2007
|
(7,495,637 | ) | (7,495,637 | ) | ||||||||||||||||
Balance
at April 30, 2007
|
— | — | — | (15,796,145 | ) | (8,177,492 | ) | |||||||||||||
Conversion
of warrants
|
11,666 | |||||||||||||||||||
Net
income for the six months ended October 31, 2007
|
4,591,596 | 4,591,596 | ||||||||||||||||||
Balance
at October 31, 2007 (unaudited)
|
$ | — | $ | — | — | $ | (11,204,549 | ) | $ | (3,574,229 | ) | |||||||||
From
Inception of
Operations
(April
19, 2001) to
October
31, 2007
|
||||||||||
Six
Months Ended October 31,
|
||||||||||
2007
|
2006
|
|||||||||
Cash
flows provided by (used for) operating activities:
|
||||||||||
Net
income (loss)
|
|
4,591,596
|
|
(2,215,571
|
)
|
|
(9,682,232
|
)
|
||
Adjustments
to reconcile net loss to net cash provided by (used for) operating
activities:
|
||||||||||
Depreciation
|
2,690
|
2,770
|
9,684
|
|||||||
Gain
on sale of equipment
|
—
|
(622
|
)
|
(622
|
)
|
|||||
Amortization
of stock based expense
|
—
|
—
|
39,520
|
|||||||
Write
off foreign currency translation adjustment
|
—
|
—
|
25,931
|
|||||||
Change
in fair value of warrant liabilities
|
(5,669,206
|
)
|
(394,324
|
)
|
(2,875,631
|
)
|
||||
Shares
issued for services and compensation
|
—
|
—
|
219,262
|
|||||||
Gain
on settlement of debts
|
—
|
—
|
(5,049
|
)
|
||||||
Options
expense
|
—
|
124,376
|
1,297,131
|
|||||||
Warrants
expense
|
—
|
—
|
256,609
|
|||||||
Interest
expense related to beneficial conversion feature on convertible
note
|
—
|
—
|
364,721
|
|||||||
Interest
expense related to warrants issued on convertible note
|
—
|
—
|
514,981
|
|||||||
Changes
in assets and liabilities:
|
||||||||||
(Increase)
decrease in assets -
|
||||||||||
VAT
receivable
|
—
|
1,628
|
3,444
|
|||||||
Other
receivable
|
—
|
(22,509
|
)
|
—
|
||||||
Restricted
funds
|
2,000
|
(2,269
|
)
|
—
|
||||||
Prepaid
expenses
|
17,917
|
33,093
|
(25,120
|
)
|
||||||
Deposits
|
—
|
—
|
(73
|
)
|
||||||
Increase
(decrease) in liabilities:
|
||||||||||
Accounts
payable
|
229,784
|
214,931
|
1,012,445
|
|||||||
Accrued
liabilities
|
(42,418
|
)
|
783,221
|
1,311,994
|
||||||
Liquidated
damages
|
—
|
35,200
|
35,200
|
|||||||
Deferred
revenue
|
(714
|
)
|
(714
|
)
|
6,429
|
|||||
Due
to officers and related parties
|
75,140
|
152,003
|
171,120
|
|||||||
Net
cash used for operating activities
|
(793,211
|
)
|
(1,288,787
|
)
|
(7,320,256
|
)
|
||||
Cash
flows used for investing activities:
|
||||||||||
Purchase
of equipment
|
—
|
—
|
(24,824
|
)
|
||||||
Proceeds
from sale of equipment
|
—
|
2,000
|
2,000
|
|||||||
Net
cash used for investing activities
|
—
|
2,000
|
(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
|
|||||||
Proceeds
from note payable
|
789,250
|
—
|
822,712
|
|||||||
Proceeds
from issuance of common stock
|
—
|
—
|
928,125
|
|||||||
Proceeds
from issuance of preferred stock
|
—
|
—
|
4,095,831
|
|||||||
Cash
received for subscription receivable
|
—
|
—
|
175,801
|
|||||||
Net
cash provided by financing activities
|
789,250
|
—
|
7,344,504
|
|||||||
Effect
of exchange rate changes on cash
|
—
|
—
|
—
|
|||||||
Increase
(decrease) in cash
|
(3,961
|
)
|
(1,286,787
|
)
|
1,424
|
|||||
Cash, beginning of
period
|
5,385
|
1,587,751
|
—
|
|||||||
Cash, end of
period
|
1,424
|
|
300,964
|
|
1,424
|
|||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
|
—
|
|
—
|
|
—
|
||||
Income
tax paid
|
|
—
|
|
—
|
|
—
|
||||
Supplemental
disclosure of non-cash operating and financing activities:
|
||||||||||
Loan
reduction with shares
|
|
—
|
|
—
|
|
2,909
|
||||
Receivable
from issuance of convertible stock
|
|
—
|
|
—
|
|
—
|
||||
Issuance
of warrants in conjunction with convertible preferred
stock
|
|
—
|
|
—
|
|
2,341,785
|
||||
Deemed
dividends related to convertible preferred stock
|
|
—
|
|
—
|
|
1,522,317
|
||||
Conversion
of note and accrued interest
|
|
—
|
|
—
|
|
1,286,318
|
||||
Accrued
issuance costs related to convertible stock
|
|
—
|
|
—
|
|
—
|
||||
1.
|
ORGANIZATION,
BASIS OF PRESENTATION, AND NATURE OF OPERATIONS
|
2007
|
||||||||||
Three
Months
Ended
October 31
|
Six
Months
Ended
October 31
|
2006
|
||||||||
Convertible
preferred stock
|
9,859,125
|
9,859,125
|
9,877,194
|
|||||||
Stock
options
|
—
|
—
|
3,642,747
|
|||||||
Warrants
|
5,936,304
|
7,102,838
|
6,952,838
|
|||||||
Total
|
15,795,429
|
16,961,963
|
20,472,779
|
|||||||
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;
|
|
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.
|
2.
|
PRIVATE
PLACEMENT
|
3.
|
LIQUIDATED
DAMAGES AND WARRANT LIABILITIES
|
Number
of
shares
|
Weighted
Average
Exercise
Price
|
||||||
Balance—April
30, 2007
|
7,102,838
|
0.61
|
|||||
Granted
|
—
|
—
|
|||||
Exercised
|
1,166,534
|
0.001
|
|||||
Forfeited
|
—
|
—
|
|||||
Expired
|
—
|
—
|
|||||
Balance—October
31, 2007
|
5,936,304
|
0.61
|
|||||
Warrants
Outstanding
|
Warrants
Exercisable
|
|||||||||||||||||
Exercise
Prices
|
Number
Outstanding
|
Wtd.
Avg
Remaining
Contr.
Life
|
Wtd.
Avg
Exercise
Price
|
Number
Exercisable
|
Wtd.
Avg
Exercise
Price
|
|||||||||||||
$
|
0.60
|
987,720
|
4.2
years
|
$
|
0.60
|
987,720
|
$
|
0.60
|
||||||||||
$
|
0.75
|
4,938,597
|
4.2
years
|
$
|
0.75
|
4,938,597
|
$
|
0.75
|
||||||||||
$
|
2.25
|
9,987
|
2.5
years
|
$
|
2.25
|
9,987
|
$
|
2.25
|
4.
|
EMPLOYMENT
AND CONSULTING AGREEMENTS
|
5.
|
STOCK-
BASED COMPENSATION
|
6.
|
RELATED
PARTY TRANSACTIONS
|
7.
|
SECURED
NOTE
|
8.
|
MERGER
AGREEMENT
|
9.
|
SUBSEQUENT
EVENTS
|
·
|
helps
to avoid inactivation of a drug caused by first pass metabolism in the
liver and gastro-intestinal tract;
|
·
|
can
provide local delivery of appropriate concentrations of a drug to the
intended site of action without systemic
exposure;
|
·
|
helps
avoid gastro-intestinal distress caused by ingesting a drug;
and
|
·
|
simplifies
drug administration to patients who have difficulty swallowing oral dosage
forms or who do not wish to endure the discomfort of
injections.
|
·
|
Reversible: The
alignment of the lipid bilayer within the lipid matrix in the stratum
corneum reverts back to normal after SEPA has diffused through it without
causing permanent changes to the
skin.
|
·
|
Rapidly metabolized:
The human body rapidly metabolizes SEPA into ethylene glycol and decanoic
acid, two metabolites well understood by regulatory
agencies.
|
·
|
Chemically
non-reactive: SEPA does not react chemically with most other
organic molecules and, as a result, is compatible with a wide range of
active pharmaceutical ingredients.
|
·
|
Versatile: The
rate and amount of drug absorbed by the skin or body in a SEPA-based
formulation can be controlled by varying the components in the
formulation.
|
·
|
nail
discoloration;
|
·
|
nail
thickening;
|
·
|
cracking
and fissuring of the nail plate;
and
|
·
|
in
severe cases, inflammation, pain and secondary infection of the nail bed
and adjacent skin.
|
·
|
low
energy levels;
|
·
|
decreased
sexual performance;
|
·
|
loss
of sex drive;
|
·
|
increased
body fat;
|
·
|
loss
of muscle mass;
|
·
|
reduced
bone density; and
|
·
|
mild
depression.
|
·
|
technical
feasibility (formulation, product stability and laboratory
results);
|
·
|
likelihood
of laboratory results translating into a meaningful clinical
benefit;
|
·
|
expected
clinical studies needed and the regulatory pathway required to obtain
marketing approval;
|
·
|
determination
of the product candidate’s expected competitive advantage in the
marketplace;
|
·
|
duration
of development timeline leading to
commercialization;
|
·
|
financial
investment needed for development and availability of necessary financial
resources; and
|
·
|
expected
sales and profitability.
|
EQUITY
COMPENSATION PLAN INFORMATION
|
|||
(a)
|
(b)
|
(c)
|
|
Plan
Category
|
Number of
securities to be issued upon exercise of outstanding options and rights
|
Weighted-average exercise price of outstanding options and rights | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) |
Equity compensation
plans approved by security holders
|
110,693 | $ 79.84 |
1,296,654
|
Equity
compensation plans
not
approved by
security
holders
|
2,646,904(1)
|
$ 1.18 | None |
Total
|
2,757,597
|
$ 4.33 |
1,296,654
|
Date
|
Grantee
|
Number
of Shares
|
June
20, 2003
|
Mr. DeLuccia
|
11,904
|
February
14, 2006
|
Mr.
DeLuccia
|
350,000
|
Mr.
Patriacca
|
175,000
|
|
Mr.
Deegan
|
150,000
|
|
February
22, 2006
|
Dr.
Zabriskie
|
45,000
|
Dr.
Davis
|
45,000
|
|
Mr.
Davis
|
45,000
|
|
Mr.
Martin
|
45,000
|
|
Mr.
Echenberg
|
45,000
|
|
Mr.
Fischer
|
45,000
|
|
February 22, 2007 | Mr. DeLuccia |
400,000
|
Mr. Patriacca |
300,000
|
|
Mr. Davis |
45,000
|
|
Dr. Davis |
45,000
|
|
Mr. Martin |
45,000
|
|
Mr. Fischer |
45,000
|
|
Mr. Echenberg |
45,000
|
|
Mr. Zabriskie |
45,000
|
|
September
5, 2007
|
Mr.
DeLuccia
|
300,000
|
Mr.
Patriacca
|
150,000
|
|
Mr.
Zabriskie
|
45,000
|
|
Dr.
Davis
|
45,000
|
|
Mr.
Davis
|
45,000
|
|
Mr.
Martin
|
45,000
|
|
Mr.
Echenberg
|
45,000
|
|
Mr.
Alvino
|
45,000
|
Common
Stock
MACM
|
||
Year
Ended
|
High
|
Low
|
December
31, 2006
|
||
First
Quarter
|
$2.70
|
$1.08
|
Second
Quarter
|
1.60
|
0.70
|
Third
Quarter
|
0.85
|
0.26
|
Fourth
Quarter
|
0.54
|
0.30
|
December
31, 2007
|
||
First
Quarter
|
$0.75
|
$0.31
|
Second
Quarter
|
1.15
|
0.40
|
Third
Quarter
|
0.84
|
0.55
|
Fourth
Quarter
|
0.90
|
0.45
|
December
31, 2008
|
||
First
Quarter
|
$0.50
|
$0.30
|
Second
Quarter
|
0.32
|
0.17
|
Third
Quarter
|
0.25
|
0.17
|
Fourth
Quarter Thru November 24, 2008
|
0.13
|
0.025
|
Class
of Stock
|
Name and Address
of
Beneficial Owner
|
Number
of shares
Beneficially
Owned
|
Percentage of Class | ||
FIVE
PERCENT STOCKHOLDERS
|
|||||
Common Stock
|
Steven H. Rouhandeh(1)
|
36,056,000
|
66.8%
|
||
Common Stock
|
Joseph Edelman(2)
|
5,372,780 | 9.95%
|
||
Common Stock
|
Franklin Resources,
Inc.(3)
|
2,925,000
|
6.3%
|
||
Common Stock
|
Whalehaven Capital Fund Limited
(4)
|
2,687,921
|
4.95%
|
||
DIRECTORS
AND EXECUTIVE OFFICERS
|
|||||
Common Stock
|
Robert
J. DeLuccia(5)(7)
|
808,900
|
1.8%
|
||
Common Stock
|
Jeffrey
Davis (5)(6)(7)(8)(9)
|
2,199,867
|
4.7%
|
||
Common Stock
|
Mark
J. Alvino(5)(10)
|
355,916
|
*
|
||
Common Stock
|
David
P. Luci(5)
|
676,667
|
1.5% | ||
Common Stock
|
All
directors and officers as a group (5 persons)(7)
|
4,041,350
|
8.8%
|
||
(1)
|
SCO
Capital Partners LLC is the record owner of 15,891,304 shares of common
stock, Beach Capital LLC is the record owner of 1,979,078 shares of common
stock and SCO Capital Partners, L.P. is the record owner of 993,941 shares
of common stock. Mr. Rouhandeh, as Chairman and managing member of SCO
Capital Partners LLC, managing member of Beach Capital LLC, and managing
member of the general partner of SCO Capital Partners, L.P., has sole
dispositive and voting power with respect to all shares listed in the
table. The shares of common stock listed as beneficially owned by Mr.
Rouhandeh include 8,075,498 shares of common stock issuable upon the
exercise of warrants exercisable within 60 days. The Steven H. Rouhandeh
Family Trust, of which Mr. Rouhandeh is a Trustee, is the record owner of
500,000 shares of common stock. The address of SCO
Capital Partners LLC, Beach Capital LLC, SCO Capital Partners,
L.P., The Steven H. Rouhandeh Family Trust and Mr. Rouhandeh is 1285
Avenue of the Americas, 35th Floor, New York, New
York10019.
|
(2)
|
According
to a Schedule 13G/A dated November 16, 2007, Mr. Edelman has sole
dispositive and voting power with respect to the shares listed in the
table. 2,366,780 shares reported as beneficially owned by Mr.
Edelman are held of record by Perceptive Life Sciences Master
Fund Ltd., a Cayman Islands company of which the investment manager is
Perceptive Advisors LLC, a Delaware limited liability company of which Mr.
Edelman is the managing member and 6,000 shares are held by
First New York Trading LLC. These warrants beneficially owned
by Mr. Edelman are subject to restrictions on their exercise, such that as
a result of their exercise, Mr. Edelman, together with his affiliates,
cannot hold more than 9.95% of the issued and outstanding common stock of
the Company. The address of Mr. Edelman is c/o First New York
Securities, LLC, 850 Third Avenue, 8th Floor, New York, NY
10022.
|
(3)
|
According
to a Schedule 13G dated December 11, 2006, Franklin Resources, Inc. has
sole voting and dispositive power with respect to the shares listed in the
table, as investment manager for investment management clients. The
address of Franklin Resources, Inc. is One Franklin Parkway, San Mateo, CA
94403-1906.
|
(4)
|
The
address of Whalehaven Capital Fund Limited is FWS Capital Ltd., Management
for Whalehaven Capital, 160 Summit Avenue, Montvale, NJ
07645. The shares of common stock listed as
beneficially owned by Whalehaven Capital Fund Limited include 1,187,921
shares of common stock beneficially owned by Whalehaven Capital Fund
Limited. 1,500,000 warrants held by Whalehaven Capital Fund
Limited are subject to restrictions on their exercise such that as a
result of their exercise, Whalehaven Capital Fund Limited, together with
its affiliates, cannot hold more than 4.95% of the issued and outstanding
common stock of the Company.
|
(5)
|
The
address of Messrs. DeLuccia and Luci is c/o MacroChem Corporation, 80
Broad Street, Suite 2210, New York, New
York 10004.
|
(6)
|
The
address of Mr. Davis is 1285 Avenue of the Americas, 35th Floor, New York,
New York 10019.
|
(7)
|
Includes
the following numbers of shares issuable upon the exercise of stock
options and/or warrants exercisable within 60 days: Mr.
DeLuccia 516,668 shares; Mr. Davis 1,335,165 shares; Mr. Luci 635,000
shares; and Mr. Alvino 355,916
shares.
|
(8)
|
Lake
End Capital LLC is the record owner of the securities listed in the
table. Mr. Jeffrey Davis, as managing member of Lake End
Capital LLC, has sole dispositive and voting power with respect to all
shares held of record by Lake End Capital LLC. The shares of
common stock listed as beneficially owned by Jeffrey Davis include
1,139,773 shares of common stock issuable upon exercise of the warrants
held by Lake End Capital LLC within 60 days and 60,000 shares of common
stock issuable upon the exercise of options held by Mr. Davis within 60
days. The warrants held by Lake End Capital LLC are subject to
restrictions on their conversion and exercise such that as a result of
their exercise, Lake End Capital LLC, together with
its affiliates, cannot hold more than 4.95% of the
issued and outstanding common stock of the Company. The address
of Lake End Capital LLC is 33 Tall Oaks Drive, Summit, New Jersey
07501.
|
(9)
|
Includes
1,139,773 shares of common stock issuable upon the exercise of a warrant
held of record by Lake End Capital LLC as described in Note 9 above that
is exercisable within 60 days.
|
(10)
|
The
address of Mr. Alvino is c/o Griffin Securities, Inc., 17 State Street,
3rd floor, New York, NY 10004.
|
|
the
progress of clinical trials we conduct;
|
|
|
the
degree of our research, marketing and administrative
efforts;
|
|
|
our
ability to raise additional capital;
|
|
|
the
signing of licenses and product development agreements;
|
|
|
the
timing of revenues recognized pursuant to license agreements;
and
|
|
|
the
achievement of milestones by
licensees.
|
|
payments
to consultants, investigators, contract research organizations and
manufacturers in connection with
our
|
|
costs
associated with conducting our clinical trials;
|
|
|
costs
of developing and obtaining regulatory
approvals
|
PAGE
|
|
Report
of Independent Registered Public Accounting
Firm
|
F-76
|
Consolidated
Balance Sheets at December 31, 2007 and
2006
|
F-77
|
Consolidated
Statements of Operations and Comprehensive Loss for 2007 and
2006
|
F-78
|
Consolidated
Statement of Stockholders' Equity (Deficit) for 2007 and
2006
|
F-79
|
Consolidated
Statements of Cash Flows for 2007 and
2006
|
F-80
|
Notes
to Consolidated Financial Statements (Two years ended December 31,
2007)
|
F-82
|
Condensed
Consolidated Balance Sheets at September 30, 2008 (unaudited) and December
31, 2007
|
F-94
|
Condensed
Consolidated Statements of Operations for the nine months ended September
30, 2008 and 2007 (unaudited)
|
F-95
|
Condensed
Consolidated Statements of Cash Flows for the nine months ended September
30, 2008 and 2007 (unaudited)
|
F-96
|
Notes
to Condensed Consolidated Financial
Statements (unaudited)
|
F-97
|
December
31,
|
|||||||
2007
|
2006
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,423,519
|
$
|
738,264
|
|||
Short-term
investments
|
759,247
|
4,157,038
|
|||||
Prepaid
expenses and other current assets
|
131,047
|
153,660
|
|||||
Total
current assets
|
3,313,813
|
5,048,962
|
|||||
Property
and equipment, net
|
22,042
|
37,391
|
|||||
Patents,
net
|
517,600
|
567,604
|
|||||
Total
assets
|
$
|
3,853,455
|
$
|
5,653,957
|
|||
LIABILITIES
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
94,439
|
$
|
85,473
|
|||
Accrued
expenses and other liabilities
|
310,195
|
183,362
|
|||||
Total
current liabilities
|
404,634
|
268,835
|
|||||
Warrants
liability
|
4,076,488
|
870,098
|
|||||
Total
liabilities
|
4,481,122
|
1,138,933
|
|||||
Commitments
and contingencies (Note 6)
|
|||||||
Preferred
stock, $.01 par value, 6,000,000 shares authorized; liquidation value of
$0 and $8,053,400, 0 and 805 shares Series C Convertible issued and
outstanding at December 31, 2007 and December 31, 2006, respectively (Note
5)
|
——
|
333,783
|
|||||
STOCKHOLDERS’
(DEFICIT) EQUITY
|
|||||||
Common
stock, $.01 par value, 100,000,000 shares authorized;
22,500,026
and 2,620,679 shares issued at December 31, 2007 and December 31, 2006,
respectively
|
225,000
|
26,206
|
|||||
Additional
paid-in capital
|
90,054,421
|
85,599,924
|
|||||
Accumulated
deficit
|
(90,847,978
|
)
|
(81,385,779
|
)
|
|||
Less
treasury stock, at cost, 529 shares at December 31, 2007 and December 31,
2006
|
(59,110
|
)
|
(59,110
|
)
|
|||
Total
stockholders’ (deficit) equity
|
(627,667
|
)
|
4,181,241
|
||||
Total
liabilities and stockholders’ (deficit) equity
|
$
|
3,853,455
|
$
|
5,653,957
|
Fiscal
Year Ended December 31,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
REVENUES:
|
$
|
——
|
$
|
——
|
$
|
——
|
||||
OPERATING
EXPENSES:
|
||||||||||
Research
and development
|
2,135,393
|
679,759
|
2,291,721
|
|||||||
Marketing,
general and administrative
|
3,714,994
|
3,713,006
|
2,988,092
|
|||||||
Costs
associated with staff reduction and transition
agreements
|
——
|
——
|
546,212
|
|||||||
TOTAL
OPERATING EXPENSES
|
5,850,387
|
4,392,765
|
5,826,025
|
|||||||
LOSS
FROM OPERATIONS
|
(5,850,387
|
)
|
(4,392,765
|
)
|
(5,826,025
|
)
|
||||
OTHER
INCOME (LOSS):
|
||||||||||
Interest
income
|
84,595
|
243,429
|
65,550
|
|||||||
(Loss)
Gain on change in value of warrant liability
|
(3,206,390
|
)
|
6,100,615
|
——
|
||||||
Gain
on sale of equipment
|
106,000
|
——
|
——
|
|||||||
TOTAL
OTHER INCOME (LOSS) (NOTES 1 and 5)
|
(3,015,795
|
)
|
6,344,044
|
65,550
|
||||||
NET
(LOSS) INCOME
|
$
|
(8,866,182
|
)
|
$
|
1,951,279
|
$
|
(5,760,475
|
)
|
||
BENEFICIAL
CONVERSION FEATURE (NOTE 5)
|
$
|
(3,223,929
|
)
|
$
|
(11,895
|
)
|
$
|
(330,243
|
)
|
|
DIVIDEND
ON SERIES C CUMULATIVE PREFERRED STOCK
|
$
|
(596,017
|
)
|
$
|
(752,066
|
)
|
$
|
——
|
||
NET
(LOSS) INCOME ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(12,686,128
|
)
|
$
|
1,187,318
|
$
|
(6,090,718
|
)
|
||
BASIC
NET (LOSS) INCOME PER COMMON SHARE
|
$
|
(1.66
|
)
|
$
|
0.84
|
$
|
(6.25
|
)
|
||
DILUTED
NET (LOSS) INCOME
PER
COMMON SHARE
|
$
|
(1.66
|
)
|
$
|
0.24
|
$
|
(6.25
|
)
|
||
WEIGHTED
AVERAGE SHARES USED TO COMPUTE BASIC NET (LOSS) INCOME PER COMMON
SHARE
|
7,635,313
|
1,423,665
|
974,367
|
|||||||
WEIGHTED
AVERAGE SHARES USED TO COMPUTE DILUTED NET (LOSS) INCOME PER COMMON
SHARE
|
7,635,313
|
8,260,510
|
974,367
|
Common
Stock Shares
|
Common
Stock
|
Additional
Paid-In
Capital
|
Accumulated
Deficit
|
Subtotal
|
Cost
of
Treasury
Stock
|
Total
Stockholders’
(Deficit)
Equity
|
|||||||||||||||||
Issued
|
Treasury
|
||||||||||||||||||||||
BALANCE,
DECEMBER 31, 2004
|
926,285
|
(1,482
|
)
|
$
|
9,263
|
$
|
83,320,908
|
$
|
(76,824,517
|
)
|
$
|
6,505,654
|
$
|
(169,150
|
)
|
$
|
6,336,504
|
||||||
Exercise
of warrants
|
6,012
|
——
|
60
|
87,440
|
——
|
87,500
|
——
|
87,500
|
|||||||||||||||
Stock
issued to 401(k) trust
|
——
|
953
|
——
|
(94,431
|
)
|
——
|
(94,431
|
)
|
110,040
|
15,609
|
|||||||||||||
Issuance
of common stock, net
|
65,141
|
——
|
651
|
417,430
|
——
|
418,081
|
——
|
418,081
|
|||||||||||||||
Issuance
of warrants in connection with sale of common stock
|
——
|
——
|
——
|
183,260
|
——
|
183,260
|
——
|
183,260
|
|||||||||||||||
Net
loss
|
——
|
——
|
——
|
——
|
(5,760,475
|
)
|
(5,760,475
|
)
|
——
|
(5,760,475
|
)
|
||||||||||||
BALANCE,
DECEMBER 31, 2005
|
997,438
|
(529
|
)
|
$
|
9,974
|
$
|
83,914,608
|
$
|
(82,584,992
|
)
|
$
|
1,339,590
|
$
|
(59,110
|
)
|
$
|
1,280,480
|
||||||
Non-cash
dividend on preferred stock
|
1,429,700
|
——
|
14,297
|
737,769
|
(752,066
|
)
|
——
|
——
|
——
|
||||||||||||||
Stock-based
compensation expense
|
——
|
——
|
——
|
941,127
|
——
|
941,127
|
——
|
941,127
|
|||||||||||||||
Conversion
of preferred stock to common
|
193,541
|
——
|
1,935
|
6,420
|
——
|
8,355
|
——
|
8,355
|
|||||||||||||||
Net
income
|
——
|
——
|
——
|
——
|
$
|
1,951,279
|
$
|
1,951,279
|
——
|
$
|
1,951,279
|
||||||||||||
BALANCE,
DECEMBER 31, 2006
|
2,620,679
|
(529
|
)
|
$
|
26,206
|
$
|
85,599,924
|
$
|
(81,385,779
|
)
|
$
|
4,240,351
|
$
|
(59,110
|
)
|
$
|
4,181,241
|
||||||
Non-cash
dividend on preferred stock
|
899,437
|
——
|
8,995
|
587,022
|
(596,017
|
)
|
——
|
——
|
——
|
||||||||||||||
Stock-basedcompensation
expense
|
——
|
——
|
——
|
654,747
|
——
|
654,747
|
——
|
654,747
|
|||||||||||||||
Conversion
of preferred stock to common
|
13,050,744
|
——
|
130,507
|
203,275
|
——
|
333,782
|
——
|
333,782
|
|||||||||||||||
Sale
of common stock, net of issuance costs
|
5,891,666
|
——
|
58,917
|
2,987,328
|
——
|
3,046,245
|
——
|
3,046,245
|
|||||||||||||||
Exercise
of warrants
|
37,500
|
——
|
375
|
22,125
|
——
|
22,500
|
——
|
22,500
|
|||||||||||||||
Net
loss
|
——
|
——
|
——
|
——
|
(8,866,182
|
)
|
(8,866,182
|
)
|
——
|
(8,866,182
|
)
|
||||||||||||
BALANCE,
DECEMBER 31, 2007
|
22,500,026
|
(529
|
)
|
$
|
225,000
|
$
|
90,054,421
|
$
|
(90,847,978
|
)
|
$
|
(568,557
|
)
|
$
|
(59,110
|
)
|
$
|
(627,667
|
)
|
|
See
notes to financial statements.
|
Year
Ended December 31,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
|
||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||||
Net (loss) income
|
$
|
(8,866,182
|
)
|
$
|
1,951,279
|
$
|
(5,760,475
|
)
|
||
Adjustments
to reconcile net (loss) income to net cash used by operating
activities:
|
||||||||||
Depreciation
and amortization
|
65,352
|
87,031
|
175,024
|
|||||||
Stock-based
compensation
|
654,747
|
941,127
|
——
|
|||||||
401(k)
contributions in company common stock
|
——
|
——
|
15,610
|
|||||||
Deferred
rent
|
——
|
——
|
(5,509
|
)
|
||||||
Loss
(Gain) on change in value of warrant liability
|
3,206,390
|
(6,100,615
|
)
|
——
|
||||||
Change
in assets and liabilities:
|
||||||||||
Prepaid
expenses and other current assets
|
22,613
|
(46,900
|
)
|
222,147
|
||||||
Accounts
payable and accrued expenses
|
135,799
|
(106,195
|
)
|
(392,821
|
)
|
|||||
Net
cash used in operating activities
|
(4,781,281
|
)
|
(3,274,272
|
)
|
(5,746,024
|
)
|
||||
CASH FLOWS FROM INVESTING
ACTIVITIES:
|
||||||||||
Sales
of short-term investments
|
3,397,791
|
——
|
1,185,406
|
|||||||
Purchases
of short-term investments
|
——
|
(4,157,038
|
)
|
——
|
||||||
Expenditures
for property and equipment
|
——
|
——
|
(14,519
|
)
|
||||||
Additions
to patents
|
——
|
(40,770
|
)
|
(105,080
|
)
|
|||||
Net
cash provided by (used in) investing activities
|
3,397,791
|
(4,197,808
|
)
|
1,065,807
|
||||||
CASH FLOWS FROM FINANCING
ACTIVITIES:
|
||||||||||
Net
proceeds from issuance of Series C
Cumulative
Convertible Preferred Stock
|
——
|
5,186,908
|
2,125,943
|
|||||||
Net
proceeds from sale of common stock
|
3,046,245
|
——
|
601,342
|
|||||||
Proceeds
from exercise of warrants
|
22,500
|
——
|
87,500
|
|||||||
Net
cash provided by financing activities
|
$
|
3,068,745
|
$
|
5,186,908
|
$
|
2,814,785
|
Years
Ended December 31,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
NET
CHANGE IN CASH
AND
CASH EQUIVALENTS
|
$
|
1,685,255
|
$
|
(2,285,172
|
)
|
$
|
(1,865,432
|
)
|
||
CASH
AND CASH EQUIVALENTS,
BEGINNING
OF YEAR
|
738,264
|
3,023,436
|
4,888,868
|
|||||||
CASH
AND CASH EQUIVALENTS,
END
OF YEAR
|
$
|
2,423,519
|
$
|
738,264
|
$
|
3,023,436
|
Cash
paid for taxes
|
$
|
——
|
$
|
——
|
$
|
——
|
||||
Cash
paid for interest
|
$
|
——
|
$
|
——
|
$
|
——
|
||||
Non-cash
dividend to Series C Preferred stockholders
|
$
|
596,017
|
$
|
752,066
|
$
|
——
|
||||
Beneficial
conversion feature associated with Series C Preferred
Stock
|
$
|
3,223,929
|
$
|
11,895
|
$
|
330,243
|
||||
Conversion
of Series C Preferred Stock to Common Stock
|
$
|
333,782
|
$
|
8,355
|
$
|
——
|
1.
|
Nature
of Business and Summary of Significant Accounting
Policies.
|
Year
Ended December 31,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Research
and development
|
$
|
——
|
$
|
——
|
$
|
——
|
||||
Marketing,
general and administrative
|
654,747
|
941,127
|
——
|
|||||||
$
|
654,747
|
$
|
941,127
|
$
|
——
|
Basic
and Diluted Income (Loss) Per Share
|
Year
Ended December 31,
|
|||||||||
2007
|
2006
|
2005
|
||||||||
Basic
net (loss) income attributable to common stockholders
|
$
|
(12,686,128
|
)
|
$
|
1,187,318
|
$
|
(6,090,718
|
)
|
||
Dividend
on Series C Cumulative Preferred Stock
|
$
|
——
|
$
|
752,066
|
$
|
——
|
||||
Net
(loss) income used to compute diluted net (loss) income per common
share
|
$
|
(12,686,128
|
)
|
$
|
1,939,384
|
$
|
(6,090,718
|
)
|
||
Basic
net (loss) income per common share
|
$
|
(1.66
|
)
|
$
|
0.84
|
$
|
(6.25
|
)
|
||
Diluted
net (loss) income per common share
|
$
|
(1.66
|
)
|
$
|
0.24
|
$
|
(6.25
|
)
|
||
Weighted
average shares used to compute basic net (loss) income per common
share
|
7,635,313
|
1,423,665
|
974,367
|
|||||||
Weighted
average shares used to compute diluted net (loss) income per common
share
|
7,635,313
|
8,260,510
|
974,367
|
2007
|
2006
|
||||||
Laboratory
equipment
|
$
|
1,069,282
|
$
|
1,139,249
|
|||
Office
equipment
|
489,459
|
489,459
|
|||||
Leasehold
improvements
|
250,049
|
250,049
|
|||||
Total
|
1,808,790
|
1,878,757
|
|||||
Less: accumulated
depreciation
|
(1,786,748
|
)
|
(1,841,366
|
)
|
|||
Property
and equipment, net
|
$
|
22,042
|
$
|
37,391
|
2007
|
2006
|
||||||
Accrued
professional fees
|
$
|
143,279
|
$
|
98,300
|
|||
Accrued
vacation
|
54,504
|
31,103
|
|||||
Accrued
other
|
112,412
|
53,959
|
|||||
$
|
310,195
|
$
|
183,362
|
Year Ended December 31,
|
||
2007
|
2006
|
|
Risk-free
interest rate
|
3.66%
|
4.86%
|
Expected
life of option grants
|
6
years
|
6
years
|
Expected
volatility of underlying stock
|
115%
|
102%
|
Expected
dividend payment rate, as a percentage of the stock price on the date of
grant
|
0%
|
0%
|
2005
|
||||
Net
loss attributable to common stockholders as reported
|
$
|
(6,090,718
|
)
|
|
Add:
Stock-based employee compensation expense included in reported net
loss
|
——
|
|||
Deduct:
Total stock-based employee compensation measured using the fair value
method
|
(733,414
|
)
|
||
Pro
forma net loss
|
$
|
(6,824,132
|
)
|
|
Basic
and diluted net loss per share - as reported
|
$
|
(6.25
|
)
|
|
Basic
and diluted net loss per share - pro forma
|
$
|
(7.00
|
)
|
Year
Ended
December
31, 2005
|
|
Risk-free
interest rate
|
4.25%
|
Expected
dividend yield
|
0
|
Volatility
|
100%
|
Forfeiture
rate
|
10%
|
Expected
life of option grants (years)
|
6
years
|
Number
of
Shares
|
Weighted
Average
Exercise
Price
Per
Share
|
Weighted-Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||||||
Balance,
January 1, 2005
|
51,223
|
167.16
|
|||||||||
Granted
|
39,319
|
12.67
|
|||||||||
Exercised
|
——
|
——
|
|||||||||
Canceled
|
(17,153
|
)
|
29.85
|
||||||||
Balance,
December 31, 2005
|
118,600
|
132.24
|
|||||||||
Granted
|
988,000
|
1.58
|
|||||||||
Exercised
|
——
|
——
|
|||||||||
Canceled
|
(39,003
|
)
|
136.04
|
||||||||
Balance,
December 31, 2006
|
1,067,597
|
$
|
10.21
|
||||||||
Granted
|
2,095,000
|
0.63
|
|||||||||
Exercised
|
——
|
||||||||||
Canceled
|
(142,348
|
)
|
$
|
2.55
|
|||||||
Outstanding
at, December 31, 2007
|
3,020,249
|
$
|
3.90
|
8.97
|
$
|
——
|
|||||
Exercisable,
December 31, 2007
|
753,391
|
$
|
13.29
|
8.73
|
$
|
——
|
|||||
Exercisable,
December 31, 2006
|
408,436
|
$
|
23.43
|
8.69
|
$
|
——
|
|||||
Exercisable,
December 31, 2005
|
88,360
|
$
|
153.81
|
3.72
|
$
|
——
|
Outstanding
|
Weighted
|
Weighted
|
|||
Weighted-Average
|
Average
|
Exercisable
|
Average
|
||
Number
of
|
Remaining
|
Exercise
|
Number
|
Exercise
|
|
Exercise Price
|
Shares
|
Contractual Life (in Yrs)
|
Price
|
of Shares
|
Price
|
$0.45
- $10.50
|
2,953,350
|
9.00
|
$0.95
|
688,158
|
$1.60
|
$17.22
- $48.30
|
31,181
|
5.98
|
$34.82
|
31,181
|
$34.82
|
$53.34
- $76.44
|
8,696
|
5.67
|
$70.65
|
7,030
|
$70.97
|
$106.30
– $246.75
|
9,616
|
3.10
|
$188.62
|
9,616
|
$188.62
|
$254.94
- $532.90
|
17,406
|
2.21
|
$313.86
|
17,406
|
$313.86
|
2007
|
2006
|
2005
|
|||
Statutory
U.S. federal tax rate
|
(34.0%)
|
(34.0%)
|
(34.0%)
|
||
State
taxes, net of federal tax benefit
|
(6.2%)
|
(6.2%)
|
(6.2%)
|
||
Federal
research and development credits
|
(0.2%)
|
(0.5%)
|
(1.5%)
|
||
Valuation
allowance on deferred tax assets
|
40.4%
|
40.7%
|
41.7%
|
||
---%
|
---%
|
---%
|
2007
|
2006
|
||||||
Deferred
Tax Assets:
|
|||||||
Net
operating loss carryforwards
|
$
|
27,930,000
|
$
|
25,920,000
|
|||
Tax
credit carryforwards
|
2,393,000
|
2,475,000
|
|||||
30,323,000
|
28,395,000
|
||||||
Valuation
allowance
|
(30,323,000
|
)
|
(28,395,000
|
)
|
|||
Deferred
tax asset, net
|
$
|
——
|
$
|
——
|
First
|
Second
|
Third
|
Fourth
|
||||||||||
2007
Quarters
|
|||||||||||||
Revenues
|
$
|
——
|
$
|
——
|
$
|
——
|
$
|
——
|
|||||
Loss
from Operations
|
(1,302,760
|
)
|
(1,155,902
|
)
|
(1,342,713
|
)
|
(2,049,012
|
)
|
|||||
Net
(Loss)
|
(1,528,093
|
)
|
(2,600,293
|
)
|
(739,795
|
)
|
(3,998,001
|
)
|
|||||
Net
(Loss) Attributable to Common Stockholders
|
(1,720,792
|
)
|
(2,793,393
|
)
|
(929,403
|
)
|
(7,242,540
|
)
|
|||||
Basic
Net (Loss) per Common Share
|
$
|
(0.62
|
)
|
$
|
(0.86
|
)
|
$
|
(0.25
|
)
|
$
|
(0.35
|
)
|
|
Diluted
Net (Loss) per Common Share
|
$
|
(0.62
|
)
|
$
|
(0.86
|
)
|
$
|
(0.25
|
)
|
$
|
(0.35
|
)
|
|
2006
Quarters
|
|||||||||||||
Revenues
|
$
|
——
|
$
|
——
|
$
|
——
|
$
|
——
|
|||||
Loss
from Operations
|
(1,207,109
|
)
|
(1,066,803
|
)
|
(1,160,767
|
)
|
(958,086
|
)
|
|||||
Net
Income (Loss)
|
(1,991,360
|
)
|
4,410,432
|
685,163
|
(1,152,956
|
)
|
|||||||
Net
Income (Loss) Attributable to Common Stockholders
|
(2,142,907
|
)
|
4,205,008
|
481,164
|
(1,355,947
|
)
|
|||||||
Basic
Net Income (Loss) per Common Share
|
$
|
(1.98
|
)
|
$
|
3.86
|
$
|
0.33
|
$
|
(0.64
|
)
|
|||
Diluted
Net Income (Loss) per Common Share
|
$
|
(1.98
|
)
|
$
|
0.57
|
$
|
0.08
|
$
|
(0.12
|
)
|
September 30, 2008
|
December 31, 2007
|
||||||
(Unaudited)
|
(Note 1)
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
32,879
|
$
|
2,423,519
|
|||
Short-term
investments
|
—
|
759,247
|
|||||
Prepaid
expenses and other current assets
|
116,124
|
131,047
|
|||||
Total
current assets
|
149,003
|
3,313,813
|
|||||
Property
and equipment, net
|
10,523
|
22,042
|
|||||
Other
assets
|
50,900
|
—
|
|||||
Patents,
net
|
484,099
|
517,600
|
|||||
Total
assets
|
$
|
694,525
|
$
|
3,853,455
|
|||
LIABILITIES
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,428,488
|
$
|
94,439
|
|||
Accrued
expenses and other liabilities
|
586,979
|
310,195
|
|||||
Deferred
revenue
|
5,304
|
—
|
|||||
Accrued
interest on notes payable
|
8,250
|
—
|
|||||
Note
payable - related party
|
225,000
|
||||||
Convertible
notes payable, net
|
791,487
|
—
|
|||||
Total
current liabilities
|
3,045,508
|
404,634
|
|||||
Warrants
liability (Note 4)
|
190,282
|
4,076,488
|
|||||
Deferred
revenue
|
25,469
|
—
|
|||||
Total
liabilities
|
3,261,259
|
4,481,122
|
|||||
Commitments
and contingencies (Note 3)
|
|||||||
STOCKHOLDERS’
DEFICIT
|
|||||||
Cumulative
preferred stock, $.01 par value, 6,000,000 shares authorized, none
issued
|
—
|
—
|
|||||
Common
stock, $.01 par value, 100,000,000 shares authorized; 45,873,412 issued
and 45,872,883 outstanding as of September 30, 2008 and 22,500,026 shares
issued and outstanding as of December 31, 2007
|
458,734
|
225,000
|
|||||
Additional
paid-in capital
|
97,683,242
|
90,054,421
|
|||||
Accumulated
deficit
|
(100,649,600)
|
(90,847,978
|
)
|
||||
Less
treasury stock, at cost, 529 shares at September 30, 2008 and
December 31, 2007
|
(59,110)
|
(59,110
|
)
|
||||
Total
stockholders’ deficit
|
(2,566,734)
|
(627,667
|
)
|
||||
Total
liabilities and stockholders’ deficit
|
$
|
694,525
|
$
|
3,853,455
|
For the Nine Months Ended
September 30,
|
|||||||
2008
|
2007
|
||||||
Other
Income
|
$
|
2,652
|
—
|
||||
TOTAL
OTHER INCOME
|
2,652
|
||||||
OPERATING
EXPENSES:
|
|||||||
Research
and development
|
916,940
|
1,047,187
|
|||||
Marketing,
general and administrative
|
2,962,453
|
2,754,187
|
|||||
In-
process research and development
|
9,656,794
|
—
|
|||||
TOTAL
OPERATING EXPENSES
|
13,536,187
|
3,801,374
|
|||||
LOSS
FROM OPERATIONS
|
(13,533,535
|
)
|
(3,801,374
|
)
|
|||
OTHER
(EXPENSE) INCOME:
|
|||||||
Interest
income (expense), net
|
(160,759
|
)
|
59,590
|
||||
Gain
(loss) on change in value of warrant liability
|
3,886,206
|
(1,194,396
|
)
|
||||
Gain
on sale of equipment
|
6,466
|
68,000
|
|||||
TOTAL
OTHER INCOME (EXPENSE)
|
3,731,913
|
(1,066,806
|
)
|
||||
NET
LOSS
|
(9,801,622
|
)
|
(4,868,180
|
)
|
|||
DIVIDEND
ON SERIES C CUMULATIVE PREFERRED STOCK
|
—
|
(575,407
|
)
|
||||
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(9,801,622
|
)
|
$
|
(5,443,587
|
)
|
|
BASIC
NET LOSS PER COMMON SHARE
|
$
|
(0.27
|
)
|
$
|
(1.63
|
)
|
|
DILUTED
NET LOSS PER COMMON SHARE
|
$
|
(0.27
|
)
|
$
|
(1.63
|
)
|
|
WEIGHTED
AVERAGE SHARES USED TO COMPUTE BASIC NET LOSS PER COMMON
SHARE
|
36,604,749
|
3,334,612
|
|||||
WEIGHTED
AVERAGE SHARES USED TO COMPUTE DILUTED NET LOSS PER COMMON
SHARE
|
36,604,749
|
3,334,612
|
2008
|
2007
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
Net
loss
|
$
|
(9,801,622
|
)
|
$
|
(4,868,180
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
In-process
research and development
|
9,656,794
|
—
|
|||||
Depreciation
and amortization
|
48,202
|
50,295
|
|||||
Stock-based
compensation
|
654,871
|
456,482
|
|||||
Stock
issued for services
|
120,000
|
—
|
|||||
(Gain)/loss
on change in value of warrant liability
|
(3,886,206
|
)
|
1,194,396
|
||||
Changes
in operating assets and liabilities, net of acquisition:
|
|||||||
Prepaid
expenses and other current assets
|
(35,977
|
)
|
(20,478
|
)
|
|||
Accounts
payable and accrued expenses
|
287,473
|
55,144
|
|||||
Net
cash used in operating activities
|
(2,956,465
|
)
|
(3,132,342
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Sales
of short-term investments
|
759,247
|
2,652,192
|
|||||
Addition
to patents
|
(42
|
)
|
—
|
||||
Expenditures
for property and equipment
|
(3,140
|
)
|
—
|
||||
Payments
for acquisition of Virium, net of cash acquired
|
(240,240
|
)
|
—
|
||||
Net
cash provided by investing activities
|
515,825
|
2,652,192
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from debt issuance
|
400,000
|
—
|
|||||
Proceeds
from note payable - related party
|
225,000
|
—
|
|||||
Repayment
of debt
|
(575,000
|
)
|
—
|
||||
Net
cash provided by financing activities
|
50,000
|
—
|
|||||
Net
change in cash and cash equivalents
|
(2,390,640
|
)
|
(480,150
|
)
|
|||
Cash
and cash equivalents at beginning of period
|
2,423,519
|
738,264
|
|||||
Cash
and cash equivalents at end of period
|
$
|
32,879
|
$
|
258,114
|
|
(1) Basis of Presentation
and Operations
|
|
|
|
(2) Stock-Based
Compensation
|
Nine
Months Ended
September 30,
|
|||||
2008
|
2007
|
||||
Risk-free
interest rate
|
2.00%
|
4.16%
|
|||
Expected
life of option grants
|
6
years
|
6
years
|
|||
Expected
volatility of underlying stock
|
110%
|
113%
|
|||
Expected
dividend yield
|
0%
|
0%
|
Number of
Shares
|
Weighted Average
Exercise Price
Per Share
|
Weighted-Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||||||
Outstanding December 31,
2007
|
3,020,249
|
$
|
3.90
|
8.97
|
$
|
—
|
|||||
Granted
|
4,840,000
|
$
|
0.19
|
9.56
|
$
|
—
|
|||||
Exercised
|
—
|
$
|
—
|
—
|
$
|
—
|
|||||
Cancelled
or expired
|
(2,208,261
|
)
|
$
|
0.73
|
8.94
|
$
|
—
|
||||
Outstanding, September 30,
2008
|
5,651,988
|
$
|
2.05
|
8.96
|
$
|
—
|
|||||
Exercisable,
September 30, 2008
|
2,352,940
|
$
|
5.78
|
8.95
|
$
|
—
|
|
(3) Commitments and
Contingencies
|
|
|
Payments
Due in
|
|||||||||||||
Total
|
2008
|
2009
|
2010
|
||||||||||
Occupancy
Leases
|
$
|
213,988
|
$
|
33,788
|
$
|
135,150
|
$
|
45,050
|
|||||
Total
|
$
|
213,988
|
$
|
33,788
|
$
|
135,150
|
$
|
45,050
|
|
(4) Stockholders’
Equity
|
|
|
|
(5) Basic and Diluted
(Loss) Income Per Share-
|
|
|
|
(6) Recent Accounting
Pronouncements
|
|
(7) Mergers
|
Common
stock issued
|
$
|
6,869,618
|
||
Liabilities
and assets assumed, net
|
2,403,916
|
|||
Warrants
related to debt assumed
|
143,020
|
|||
Transaction
costs
|
240,240
|
|||
Total
purchase price
|
$
|
9,656,794
|
Nine Months Ended September 30,
|
|||||||
2008
|
2007
|
||||||
Net
income (loss)
|
$
|
(10,125,596)
|
$
|
(15,151,486)
|
|
||
Net
income (loss) per common share (basic and diluted)
|
$
|
(0.22)
|
$
|
(0.58)
|
|
||
Weighted
average common shares outstanding (basic and diluted)
|
45,714,287
|
26,233,818
|
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
F-110
|
Balance
SheetsMarch 31, 2008 (Unaudited), December 31, 2007 and
December 31, 2006
|
F-111
|
Statements
of Operations Three Months Ended March 31, 2008 (Unaudited), Years
Ended December 31, 2007 and 2006 and Period from July 15,
1997(Inception) to March 31, 2008 (Unaudited)
|
F-112 |
Statements
of Stockholders’ DeficiencyYears Ended December 31, 2007 and
2006Three Months Ended March 31, 2008 (Unaudited), Period from
July 15, 1997(Inception) to March 31,
2008(Unaudited)
|
F-113
|
Statements
of Cash FlowsThree Months Ended March 31, 2008 (Unaudited), Years
Ended December 31, 2007 and 2006 and Period from July 15,
1997(Inception) to March 31, 2008 (Unaudited)
|
F-114
|
Notes
to Financial Statements
|
F-115
|
March 31,
|
December 31,
|
December 31,
|
||||||||
2008
|
2007
|
2006
|
||||||||
(unaudited)
|
(audited)
|
(audited)
|
||||||||
A S S E T S
|
||||||||||
CURRENT
ASSETS:
|
||||||||||
Cash
|
$
|
10,175
|
$
|
117,394
|
$
|
59,992
|
||||
Total
current assets
|
10,175
|
117,394
|
59,992
|
|||||||
Security
deposit
|
5,850
|
4,810
|
2,250
|
|||||||
Debt
issuance costs, net
|
26,873
|
81,381
|
13,750
|
|||||||
Total
assets
|
$
|
42,898
|
$
|
203,585
|
$
|
75,992
|
||||
L I A B I L I T I E S A N D
STOCKHOLDERS’ DEFICIENCY
|
||||||||||
CURRENT
LIABILITIES:
|
||||||||||
Accounts
payable and accrued expenses
|
$
|
1,084,128
|
$
|
1,058,772
|
$
|
682,075
|
||||
Other
current liabilities
|
227,845
|
227,845
|
227,845
|
|||||||
Deferred
revenue
|
5,304
|
5,304
|
5,304
|
|||||||
Accrued
interest on notes payable
|
350,502
|
8,292
|
—
|
|||||||
Convertible
notes payable
|
775,000
|
775,000
|
||||||||
Accrued
interest on notes payable - related party
|
36,082
|
305,017
|
144,607
|
|||||||
Convertible
notes payable - related party
|
1,499,500
|
1,499,500
|
1,327,000
|
|||||||
Total
current liabilities
|
3,978,361
|
3,879,730
|
2,386,831
|
|||||||
Deferred
revenue
|
28,121
|
29,447
|
34,751
|
|||||||
Total
liabilities
|
4,006,482
|
3,909,177
|
2,421,582
|
|||||||
Commitments
and contingencies
|
||||||||||
STOCKHOLDERS’
DEFICIENCY:
|
||||||||||
Preferred
stock - $0.001 par value; 1,000,000 shares authorized; No shares issued
and outstanding as of March 31, 2008, December 31, 2007 and
2006
|
—
|
—
|
—
|
|||||||
Common
stock - $0.001 par value; 50,000,000 shares authorized; 23,941,900 issued
and outstanding as of March 31, 2008 and December 31, 2007,
13,916,900 issued and outstanding as of December 31,
2006
|
23,942
|
23,942
|
13,917
|
|||||||
Additional
paid-in capital
|
695,518
|
695,518
|
522,595
|
|||||||
Deficit
accumulated during the development stage
|
(4,683,044
|
)
|
(4,425,052
|
)
|
(2,882,102
|
)
|
||||
Total
stockholders’ deficiency
|
(3,963,584
|
)
|
(3,705,592
|
)
|
(2,345,590
|
)
|
||||
Total
liabilities and stockholders’ deficiency
|
$
|
42,898
|
$
|
203,585
|
$
|
75,992
|
For
the Three
Months
Ended
March 31,
2008
(unaudited)
|
Year
Ended
December 31,
2007
(audited)
|
Year
Ended
December 31,
2006
(audited)
|
Period
from
July 15,
1997
(date
of
inception)
to
March 31,
2008
(unaudited)
|
||||||||||
REVENUE
|
|||||||||||||
License
revenue
|
$
|
1,326
|
$
|
5,304
|
$
|
5,304
|
$
|
16,575
|
|||||
Total
revenue
|
1,326
|
5,304
|
5,304
|
16,575
|
|||||||||
OPERATING
COSTS
|
|||||||||||||
Research
and development
|
(115,830
|
)
|
316,465
|
714,449
|
1,854,523
|
||||||||
General
and administrative
|
247,365
|
914,476
|
314,001
|
1,939.143
|
|||||||||
Total
operating costs
|
131,535
|
1,230,941
|
1,028,450
|
3,793,666
|
|||||||||
Loss
from operations
|
(130,209
|
)
|
(1,225,637
|
)
|
(1,023,146
|
)
|
(3,777,091
|
)
|
|||||
OTHER
EXPENSES
|
|||||||||||||
Interest
expense
|
73,275
|
200,011
|
106,318
|
417,893
|
|||||||||
Amortization
of debt issuance costs
|
54,508
|
117,302
|
165,000
|
488,060
|
|||||||||
Total
other expenses
|
127,783
|
317,313
|
271,318
|
905,953
|
|||||||||
Net
loss
|
$
|
(257,992
|
)
|
$
|
(1,542,950
|
)
|
$
|
(1,294,464
|
)
|
$
|
(4,683,044
|
)
|
Common
Stock
|
Additional
|
Deficit
Accumulated
During
the
Development
|
|||||||||||||
Shares
|
Amount
|
Paid-in
Capital
|
Stage
|
Totals
|
|||||||||||
Issuance
of shares of common stock
|
10,000,000
|
$
|
10,000
|
$
|
(9,990
|
)
|
—
|
$
|
10
|
||||||
Net
loss
|
—
|
—
|
—
|
(50,000
|
)
|
(50,000
|
)
|
||||||||
Balance
at December 31, 2004
|
10,000,000
|
10,000
|
(9,990
|
)
|
(50,000
|
)
|
(49,990
|
)
|
|||||||
Repurchase
of outstanding common stock from sole stockholder
|
(10,000,000
|
)
|
(10,000
|
)
|
9,999
|
—
|
(1
|
)
|
|||||||
Issuance
of shares of common stock
|
10,000,000
|
10,000
|
(9.999
|
)
|
—
|
1
|
|||||||||
Issuance
of common stock under license agreement
|
1,500,000
|
1,500
|
98,500
|
—
|
100,000
|
||||||||||
Warrant
issued with convertible note
|
—
|
—
|
330,000
|
—
|
330,000
|
||||||||||
Net
loss
|
—
|
—
|
—
|
(1,537,638
|
)
|
(1,537,638
|
)
|
||||||||
Balance
at December 31, 2005
|
11,500,000
|
11,500
|
418,510
|
(1,587,638
|
)
|
(1,157,628
|
)
|
||||||||
Warrant
issued for settlement of accrued consulting services
|
—
|
—
|
102,632
|
—
|
102,632
|
||||||||||
Warrant
for consulting services exercised
|
2,391,900
|
2,392
|
—
|
—
|
2,392
|
||||||||||
Issuance
of common stock under license agreement
|
25,000
|
25
|
1,453
|
—
|
1,478
|
||||||||||
Net
loss
|
—
|
—
|
—
|
(1,294,464
|
)
|
(1,294,464
|
)
|
||||||||
Balance
at December 31, 2006
|
13,916,900
|
13,917
|
522,595
|
(2,882,102
|
)
|
(2,345,590
|
)
|
||||||||
Exercise
of warrant
|
10,000,000
|
10,000
|
90,000
|
—
|
100,000
|
||||||||||
Issuance
of common stock under license agreement
|
25,000
|
25
|
5,615
|
—
|
5,640
|
||||||||||
Warrants
issued with convertible notes
|
—
|
—
|
77,308
|
—
|
77,308
|
||||||||||
Net
loss
|
—
|
—
|
—
|
(1,542,950
|
)
|
(1,542,950
|
)
|
||||||||
Balance
at December 31, 2007
|
23,941,900
|
23,942
|
695,518
|
(4,425,052
|
)
|
(3,705,592
|
)
|
||||||||
Unaudited:
|
|||||||||||||||
Net
loss for the three months ended March 31, 2008
|
—
|
—
|
—
|
(257,992
|
)
|
(257,992
|
)
|
||||||||
Balance
at March 31, 2008
|
23,941,900
|
$
|
23,942
|
$
|
695,518
|
$
|
(4,683,044
|
)
|
$
|
(3,963,584
|
)
|
||||
For
the Three
Months
Ended
March 31,
2008
(unaudited)
|
For
the Year
Ended
December 31,
2007
(audited)
|
For
the Year
Ended
December 31,
2006
(audited)
|
Period
from
July 15,
1997
(date
of
inception)
to
March 31,
2008
(unaudited)
|
||||||||||
OPERATING
ACTIVITIES:
|
|||||||||||||
Net
loss
|
$
|
(257,992
|
)
|
$
|
(1,542,950
|
)
|
$
|
(1,294,464
|
)
|
$
|
(4,683,044
|
)
|
|
Adjustments
to reconcile net loss to cash used in operating
activities:
|
|||||||||||||
Common
stock issued for acquired technologies
|
—
|
5,640
|
1,478
|
107,118
|
|||||||||
Liabilities
assumed with acquired technologies
|
—
|
—
|
—
|
260,167
|
|||||||||
Warrant
issued for services
|
—
|
—
|
105,024
|
105,024
|
|||||||||
Amortization
of debt issuance costs
|
54,508
|
117,302
|
165,000
|
488,060
|
|||||||||
Changes
in operating assets and liabilities:
|
|||||||||||||
Accounts
payable, accrued expenses and other liabilities
|
25,356
|
376,697
|
166,914
|
1,051,806
|
|||||||||
Accrued
interest on convertible notes
|
73,275
|
168,702
|
106,318
|
386,584
|
|||||||||
Deferred
revenue
|
(1,326
|
)
|
(5,304
|
)
|
(5,304
|
)
|
33,425
|
||||||
Security
deposit
|
(1,040
|
)
|
(2,560
|
)
|
—
|
(5,850
|
)
|
||||||
Net
cash used in operating activities
|
(107,219
|
)
|
(882,473
|
)
|
(755,034
|
)
|
(2,256,710
|
)
|
|||||
FINANCING
ACTIVITIES:
|
|||||||||||||
Common
stock issuance
|
—
|
—
|
—
|
10
|
|||||||||
Advances
under convertible note
|
—
|
939,875
|
750,000
|
2,266,875
|
|||||||||
Net
cash provided by financing activities
|
—
|
939,875
|
750,000
|
2,266,885
|
|||||||||
Net
increase (decrease) in cash
|
(107,219
|
)
|
57,402
|
(5,034
|
)
|
10,175
|
|||||||
Cash,
beginning of period
|
117,394
|
59,992
|
65,026
|
—
|
|||||||||
Cash,
end of period
|
$
|
10,175
|
$
|
117,394
|
$
|
59,992
|
$
|
10,175
|
|||||
Supplemental
disclosure of non cash transactions:
|
|||||||||||||
Warrant
issued and exercised for settlement of accrued consulting
services
|
$
|
—
|
$
|
—
|
$
|
105,024
|
$
|
105,024
|
|||||
Warrants
issued with convertible notes
|
—
|
77,308
|
—
|
407,308
|
|||||||||
Warrants
exercised by reduction in note payable
|
—
|
100,000
|
—
|
100,000
|
|||||||||
Supplemental
disclosure of cash flow data:
|
|||||||||||||
Interest
paid
|
$
|
—
|
$
|
31,309
|
$
|
31,309
|
March 31,
2008
|
2007
|
2006
|
||||||||
Licensing
fees and development costs
|
$
|
489,329
|
$
|
489,329
|
$
|
388,027
|
||||
Other
professional fees
|
436,849
|
323,623
|
—
|
|||||||
Consulting
fees
|
70,200
|
38,800
|
15,000
|
|||||||
Patent
costs
|
75,000
|
206,830
|
272,303
|
|||||||
Other
|
12,750
|
190
|
6,745
|
|||||||
Total
|
$
|
1,084,128
|
$
|
1,058,772
|
$
|
682,075
|
Warrant
Right
|
Exercise
Price
|
Expiration
Date
|
|||
250,000
|
$1.00
|
May 30,
2012
|
|||
250,000
|
$1.00
|
November 30,
2012
|
|||
250,000
|
$1.00
|
December 11,
2012
|
March 31,
2008
|
2007
|
2006
|
||||||||
Income
taxes at U.S. statutory rate
|
$
|
(88,000
|
)
|
$
|
(525,000
|
)
|
$
|
(440,000
|
)
|
|
State
income tax benefit
|
(15,000
|
)
|
(92,000
|
)
|
(78,000
|
)
|
||||
Change
in valuation allowance
|
103,000
|
617,000
|
518,000
|
|||||||
Total
tax expense
|
$
|
—
|
$
|
—
|
$
|
—
|
March 31,
2008
|
2007
|
2006
|
||||||||
Deferred
tax assets
|
||||||||||
Net
operating loss carryforwards
|
$
|
956,000
|
889,000
|
$
|
455,000
|
|||||
Intangible
assets
|
354,000
|
383,000
|
327,000
|
|||||||
Deferred
revenue
|
13,000
|
14,000
|
16,000
|
|||||||
Accrued
interest and debt issuance expenses
|
305,000
|
253,000
|
184,000
|
|||||||
Other
deferred expenses
|
246,000
|
231,000
|
171,000
|
|||||||
Total
deferred tax assets
|
1,874,000
|
1,770,000
|
1,153,000
|
|||||||
Less
valuation allowance
|
(1,874,000
|
)
|
(1,770,000
|
)
|
(1,153,000
|
)
|
||||
Net
deferred tax assets
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
·
|
Approximately
2.5 million shares of Access common stock will be issued to the common
shareholders and in-the-money warrant holders of MacroChem as
consideration having a value of approximately $7,975,000 (the value was
calculated using Access’ five day average stock price from July 8, 2008 to
July 14, 2008, times the shares
issued);
|
·
|
an
aggregate of $500,000 in direct transaction costs; and
|
·
|
cancelled
receivable from MacroChem of
$225,000.
|
Common
stock issued
|
$ | 7,975,000 | ||
Liabilities
assumed
|
2,845,977 | |||
Liability forgiven | 225,000 | |||
Assets
acquired
|
(694,525 | ) | ||
Warrants
related to debt assumed
|
995,152 | |||
Estimated
transaction costs
|
500,000 | |||
Total
purchase price
|
$ | 11,846,604 |
Historical
|
|||||||||||||
Access
Pharmaceuticals
|
Macrochem
Corp.
|
Pro
Forma adjustments
|
Pro
Forma combined
|
||||||||||
A S S E T S
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
|||||||||
CURRENT
ASSETS:
|
|||||||||||||
Cash
and cash equivalents
|
$
|
201,000
|
$
|
32,879
|
$
|
233,879
|
|||||||
Short-term
investments, at cost
|
4,417,000
|
-
|
4,417,000
|
||||||||||
Receivables
|
330,000
|
-
|
(225,000)
|
(d)
|
105,000
|
||||||||
Prepaid
expenses and other current assets
|
110,000
|
116,124
|
226,124
|
||||||||||
Total
current assets
|
5,058,000
|
149,003
|
(225,000)
|
4,982,003
|
|||||||||
OTHER
ASSETS:
|
|||||||||||||
Patents,
net
|
584,000
|
484,099
|
1,068,099
|
||||||||||
Property
and equipment, net
|
100,000
|
10,523
|
110,523
|
||||||||||
Other
assets
|
12,000
|
50,900
|
62,900
|
||||||||||
Total
other assets
|
696,000
|
545,522
|
|
1,241,522
|
|||||||||
Total assets
|
$
|
5,754,000
|
$
|
694,525
|
(225,000)
|
$
|
6,223,525
|
||||||
CURRENT
LIABILITIES:
|
|||||||||||||
Accounts
payable and other liabilities
|
$
|
2,571,000
|
$
|
2,015,467
|
$500,000
|
(c)
|
$
|
5,086,467
|
|||||
Dividends
payable
|
1,799,000
|
-
|
1,799,000
|
||||||||||
Accrued
interest payable
|
445,000
|
8,250
|
453,250
|
||||||||||
Convertible
notes payable, net
|
-
|
791,487
|
791,487
|
||||||||||
Current
portion of deferred revenue
|
164,000
|
5,304
|
169,304
|
||||||||||
Note
payable-related party
|
-
|
225,000
|
(225,000)
|
(d)
|
-
|
||||||||
Total
current liabilities
|
4,979,000
|
3,045,508
|
275,000
|
8,299,508
|
|||||||||
NON
CURRENT LIABILITIES
|
|||||||||||||
Warrants
liability
|
-
|
190,282
|
(190,282) | (e) |
-
|
||||||||
Long
term debt
|
5,500,000
|
-
|
5,500,000
|
||||||||||
Deferred
revenue
|
2,286,000
|
25,469
|
|
2,311,469
|
|||||||||
Total
non current liabilities
|
7,786,000
|
215,751
|
(190,282) |
7,811,469
|
|||||||||
Total
liabilities
|
12,765,000
|
3,261,259
|
84,718
|
16,110,977
|
|||||||||
STOCKHOLDERS’
(DEFICIENCY)
|
|||||||||||||
Preferred
stock
|
-
|
-
|
-
|
-
|
|||||||||
Common
stock
|
65,000
|
458,734
|
(458,734)
|
(b)
|
|
||||||||
25,000
|
(a)
|
90,000
|
|||||||||||
Additional
paid-in-capital
|
126,814,000
|
97,683,242
|
(97,683,242)
|
(b)
|
-
|
||||||||
7,950,000
|
(a)
|
||||||||||||
995,152
|
(a)
|
135,759,152
|
|||||||||||
Notes
receivable from stockholders
|
(1,045,000)
|
-
|
(1,045,000)
|
||||||||||
Accumulated
deficit
|
(132,841,000)
|
(100,649,600
|
)
|
100,649,600
|
(b)
|
||||||||
(11,846,604)
|
(a)
|
|
|||||||||||
|
144,687,604 | ||||||||||||
Less
treasury stock, at cost
|
(4,000)
|
(59,110)
|
59,110
|
(b)
|
(4,000)
|
||||||||
Total
stockholders’ (deficiency)
|
(7,011,000)
|
(2,566,734)
|
(309,718)
|
(9,887,452)
|
|||||||||
Total liabilities and stockholders’ (deficiency)
|
$
|
5,754,000
|
$
|
694,525
|
(225,000)
|
(c) |
$
|
6,223,525
|
(in
thousands except per share amounts)
|
Access
Pharmaceuticals
Inc.
|
MacroChem
Corp
|
Virium
Pharmaceuticals Inc.
|
Pro
Forma
Adjustments
|
MacroChem
and Virium Combined
|
Pro
Forma
Adjustments
|
Access
and MacroChem Combined
|
REVENUE
|
$ 217
|
$ 3
|
$ 1
|
$ 4
|
$ 221
|
||
OPERATING
EXPENSES
|
15,677
|
13,536
|
197
|
(9,657) (f)
|
4,076
|
19,753
|
|
LOSS
FROM
OPERATIONS
|
(15,460)
|
(13,533)
|
(196)
|
9,657
|
(4,072)
|
(19,532)
|
|
OTHER
(EXPENSE)
INCOME
|
|||||||
Interest
and
miscellaneous
income
|
167
|
26
|
-
|
26
|
193
|
||
Interest
and other
expenses
|
(351)
|
(187)
|
(127)
|
(314)
|
(665)
|
||
Gain
on change in
value
of warrant
liability
|
-
|
3,886
|
-
|
3,886
|
(3,886) (e)
|
-
|
|
Gain
on sale of
equipment
|
-
|
6
|
-
|
6
|
6
|
||
TOTAL
OTHER
(EXPENSE)
INCOME
|
(184)
|
3,731
|
(127)
|
3,604
|
(3,886)
|
(466)
|
|
NET
LOSS
|
(15,644)
|
(9,802)
|
(323)
|
9,657
|
(468)
|
(3,886)
|
(19,998)
|
LESS
PREFERRED
STOCK
DIVIDENDS
|
2,873
|
-
|
-
|
-
|
2,873
|
||
NET
LOSS
ATTRIBUTABLE
TO
COMMON
STOCKHOLDERS
|
$ (18,517)
|
$ (9,802)
|
$ (323)
|
$ 9,657
|
$ (468)
|
$ (3,886)
|
$ (22,871)
|
LOSS
PER SHARE,
BASIC
AND DILUTED
|
$ 3.30
|
$ (0.27)
|
$ (2.82)
|
||||
WEIGHTED
AVERAGE
NUMBER
OF
SHARES
|
5,607
|
36,605
|
8,107
|
(in
thousands except per share amounts)
|
Access
|
Somanta
|
Pro
Forma
Adjustments
|
Access
and
Somanta
Combined
|
MacroChem
|
Virium
|
Pro
Forma
Adjustments
|
MacroChem
and
Virium
Combined
|
Pro
Forma
Adjustments
|
Access
and MacroChem Combined
|
REVENUE
|
$ 57
|
$ 1
|
$ 58
|
-
|
$ 5
|
$ 5
|
$ 63
|
|||
OPERATING
EXPENSES
|
6,957
|
2,334
|
9,291
|
5,850
|
1,231
|
7,081
|
16,372
|
|||
LOSS
FROM
OPERATIONS
|
(6,900)
|
(2,333)
|
(9,233)
|
(5,850)
|
(1,226)
|
(7,076)
|
(16,309)
|
|||
OTHER
(EXPENSE)
INCOME
|
||||||||||
Interest
and
miscellaneous
income
|
125
|
(3)
|
122
|
84
|
-
|
84
|
206
|
|||
Interest
and other
expenses
|
(3,514)
|
(27)
|
(3,541)
|
-
|
(200)
|
(200)
|
(3,741)
|
|||
Amortization
of
debt
issuance
costs
|
-
|
-
|
-
|
-
|
(117)
|
(117)
|
(117)
|
|||
Loss
on
extinguishment
of debt
|
(11,628)
|
-
|
(11,628)
|
-
|
-
|
-
|
(11,628)
|
|||
Loss
on change in
value
of warrant
liability
|
-
|
5,119
|
5,119
|
(3,206)
|
-
|
(3,206)
|
3,206 (e)
|
5,119
|
||
Currency
translation
loss
|
-
|
(1)
|
(1)
|
-
|
-
|
-
|
(1)
|
|||
Gain
on sale of
equipment
|
-
|
-
|
-
|
106
|
-
|
106
|
106
|
|||
TOTAL
OTHER
(EXPENSE)
INCOME
|
(15,017)
|
5,088
|
(9,929)
|
(3,016)
|
(317)
|
(3,333)
|
3,206
|
(10,056)
|
||
NET
LOSS BEFORE
DISCONTINUED
OPERATIONS
AND
BEFORE
INCOME
TAX
BENEFIT
|
(21,917)
|
(2,755)
|
(19,162)
|
(8,866)
|
(1,543)
|
(10,409)
|
3,206
|
(26,365)
|
||
INCOME
TAX
BENEFIT
|
61
|
(5)
|
56
|
-
|
-
|
-
|
56
|
|||
NET
INCOME
FROM
CONTINUING
OPERATIONS
|
(21,856)
|
2,750
|
(19,106)
|
(8,866)
|
(1,543)
|
(10,409)
|
3,206
|
(26,309)
|
||
BENEFICIAL
CONVERSION
FEATURE
|
-
|
-
|
-
|
(3,224)
|
-
|
(3,224)
|
(3,224)
|
|||
LESS
PREFERRED
STOCK
DIVIDENDS
|
(14,908)
|
-
|
(14,908)
|
(596)
|
-
|
(596)
|
(15,504)
|
|||
NET INCOME
(LOSS)
FROM
CONTINUING
OPERATIONS
ATTRIBUTABLE
TO
COMMON
STOCKHOLDERS
|
(36,764)
|
2,750
|
(34,014)
|
(12,686)
|
(1,543)
|
(14,229)
|
3,206
|
(45,037)
|
||
DISCONTINUED
OPERATIONS
NET
OF TAXES
|
112
|
-
|
112
|
-
|
-
|
-
|
112
|
|||
NET INCOME
(LOSS)
ATTRIBUTABLE
TO
COMMON
STOCKHOLDERS
|
$(36,652)
|
$ 2,750
|
$ (33,902)
|
$ (12,686)
|
$ (1,543)
|
$ (14,229)
|
3,206
|
$ (44,925)
|
||
EARNINGS
(LOSS) PER SHARE, BASIC
AND
DILUTED
|
$
(10.32)
|
$ 0.19
|
$ (6.73)
|
$ (1.66)
|
$ (0.47)
|
$ (7.42)
|
||||
WEIGHTED
AVERAGE
NUMBER
OF
SHARES
|
3,552
|
14,630
|
5,052
|
7,635
|
30,534
|
6,052
|
a)
|
To
record the exchange, for accounting purposes, by Macrochem shareholders of
their common stock for 2,500,000 shares of Access. The fair value of the
shares issued on the five day average closing price between July 8, 2008
and July 14, 2008 to the stockholders of Macrochem was
$7,975,000. Additionally, to record the exchange
of Macrochem warrants for Access
warrants.
|
Common
stock issued
|
$ | 7,975,000 | ||
Liabilities
assumed
|
2,845,977 | |||
Liability forgiven | 225,000 | |||
Assets
acquired
|
(694,525 | ) | ||
Warrants
related to debt assumed
|
995,152 | |||
Estimated
transaction costs
|
500,000 | |||
Total
purchase price
|
$ | 11,846,604 |
b)
|
To
eliminate the stockholders’ deficiency section of Macrochem in connection
with the merger.
|
c)
|
To
reflect estimated transaction
costs.
|
d)
|
To
eliminate receivable/payable between two merger companies. The note is due
upon the earlier of December 31, 2008 or the date of termination of the
agreement and plan of the merger transaction. MacroChem agreed to pay
interest to Access at the rate of 10% per annum. As of September 30, 2008
there was $0 interest recorded.
|
e)
|
To
eliminate gain or loss in MacroChem warrant
liability.
|
f)
|
To
eliminate Virium in-process research and development of
$9,656,794.
|
Provision
|
Access
Common Stock and
Preferred
Stock
|
MacroChem
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.
|
MacroChem’s
certificate of incorporation authorizes the issuance of up to 106,000,000
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 6,000,000 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.
|
MacroChem’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
[six (6)] members on the board of MacroChem.
|
Stockholder
Nominations and Proposals
|
Access’
most recent proxy statement dated April 22, 2008, provides that the 2009
annual meeting of stockholders is expected to be held on or about May 13,
2009. 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 12, 2008 to be considered for inclusion on
the Access proxy statement and form of proxy relating to that meeting, and
no later than March 13, 2009 for all other
proposals.
|
MacroChem’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 MacroChem’s secretary
not less 60 nor more than 90 days prior to the anniversary date of the
immediately preceding annual meeting (with certain adjustments if the date
of the annual meeting is 30 or more days before or after such anniversary
date).
|
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.
|
MacroChem’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
MacroChem’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.
|
MacroChem’s
bylaws provide that a special meeting of the stockholders may be called by
the chairman of the board, the president, a majority of the board of
directors, or by stockholders holding a majority of the issued and
outstanding capital stock of MacroChem.
|
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.
|
All
elections shall be determined by a plurality vote.
|
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.
|
MacroChem’s
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 even if less than a
quorum.
|
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
MacroChem’s bylaws and certificate of incorporation the holders of common
stock have the right to one vote per share of common stock.
Under
MacroChem’s certificate of designations, each holder of outstanding Series
A and Series C preferred stock shall be entitled to cast the number of
votes equal to the number of shares of common stock into which the Series
A and Series C preferred stock is convertible. Except as provided in
certain provisions in the certificate of designation with respect to the
Series C preferred stock, the Series C 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.
|
MacroChem’s
bylaws provide that, any action to be taken at any annual meeting of the
stockholders, may be taken without a meeting, 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.
|
||
Notice
of Meetings
|
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.
|
Under
MacroChem’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.
|
Stockholders
Rights Plan
|
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 other than SCO Capital Partners LLC,
together with its affiliates (a) acquires 15% (20% in the case of
Heartland Advisors, Inc, or 45% in the case of 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 45% in
the case 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.
|
MacroChem
is a party to a stockholder rights agreement pursuant to which holders of
MacroChem common stock as of a certain date are entitled to the right to
purchase MacroChem Series B preferred stock of the Company at an initial
exercise price of $2,100.00, subject to adjustments for stock dividends,
splits and similar events. The Rights are exercisable only if a person or
group acquires 20% or more of the Company’s outstanding common stock, or
announces an intention to commence a tender or exchange offer, the
consummation of which would result in ownership by such person or group of
20% or more of the Company’s outstanding common stock.
On
December 23, 2005, the shareholder rights plan was amended to provide that
the acquisition of the Company’s Series C Cumulative Convertible Preferred
Stock and warrants to acquire shares of its common stock by the purchasers
in the Company’s recent private placement, and any subsequent acquisition
by the purchasers of common stock upon the conversion or exercise of those
securities, would not result in the Rights becoming
exercisable.
The
Board of Directors may, at its option after the occurrence of one of the
events described above, exchange all of the then outstanding and
exercisable Rights for shares of common stock at an exchange ratio of one
share of common stock per Right.
The
Board of Directors may redeem the Rights at the redemption price of $0.01
per Right at any time prior to the expiration of the rights plan on August
13, 2009. Distribution of the Rights is not a taxable event to
shareholders.
The
Board of Directors has authorized 600,000 shares of Series B Preferred
Stock.
The
stockholder rights agreement shall have been terminated prior to
consummation of the merger with Access.
|
||
Conversion
Rights and Protective Provisions
|
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.
|
Holders
of Series A convertible preferred stock shall have the right to convert
each shares of Series A convertible preferred stock into two shares of
common stock and one common stock purchase warrant. Such common
stock purchase warrant shall be at an exercise price of $1.50 per share
and expires on December 31, 1993
Under
MacroChem’s certificate of designations, each share of Series C
convertible preferred stock is convertible, at the option of the holder
thereof at any time and shall convert at MacroChem’s election upon a
Conversion Triggering Event (as defined in the certificate of
designation)
MacroChem’s
certificate of designations provides that, upon certain terms and
conditions, the holders of MacroChem Series C convertible preferred stock
shall have a right to participate with respect to the issuance or possible
issuance by MacroChem of any future equity or equity linked
securities.
MacroChem’s
Series C 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 MacroChem’s Series C
convertible preferred stock, holders of a majority of the Series C
convertible preferred stock of MacroChem have acknowledged and agreed that
if the stockholders of MacroChem 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.
|
INDEMNIFICATION
OF OFFICERS AND DIRECTORS AND ADVANCEMENT OF EXPENSES; LIMITATION ON
PERSONAL LIABILITY
|
||
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.
|
MacroChem’s
bylaws provide that MacroChem shall indemnify any director or officer and
shall have the power to indemnify any employee or agent, to the
fullest extent not prohibited by applicable law.
|
Advancement
of Expenses
|
MacroChem’s
bylaws provide that MacroChem 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 MacroChem, or is or was serving at the request of
MacroChem as a director or officer of another corporation, partnership,
joint venture, trust or other enterprise, provided, however, that if
applicable law so requires, such advancement of expenses shall be made
only upon delivery to MacroChem 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.
|
|
DIVIDENDS
|
||
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.
|
MacroChem’s
Series A convertible preferred stock certificate of designation provides
that when and if determined by the board of directors, the holders of
Series A preferred stock shall be entitled to a dividend of $0.06 per
shares of Series A preferred stock.
MacroChem’s
Series C convertible preferred stock certificate of designation provides
that 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. Dividends on Series C convertible preferred stock
are cumulative and are payable when and if declared by the board of
directors. The dividend rate on Series C convertible preferred
stock is 10% per annum. If at any time a Breach Event (as
defined in the Series C convertible preferred stock certificate of
designation) occurs, then such dividend rate shall be increased to 14% per
annum.
MacroChem
shall not declare, pay or set aside any dividends on any other shares of
capital stock of MacroChem unless the holders of Series C convertible
preferred stock then outstanding shall first receive the dividends to
which they are entitled pursuant to the terms of MacroChem’s certificate
of designation.
|
AMENDMENTS
TO ARTICLES OF INCORPORATION, CERTIFICATE OF DESIGNATION OR
BYLAWS
|
||
General
Provisions
|
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.
|
MacroChem’s
certificate of incorporation provides that MacroChem 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 MacroChem entitled to vote, voting together as a single
class.
MacroChem’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. Currently,
MacroChem does not have any shares of preferred stock
outstanding.
MacroChem’s
certificate of incorporation provides that MacroChem’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 MacroChem required to vote, the affirmative
vote of 66-2/3% of the voting power of all the then outstanding
shares of capital stock of MacroChem entitled to vote, voting together as
a single class.
|
Page
|
|||
ARTICLE
I
|
THE
MERGER
|
||
1.01
|
The
Merger
|
||
1.02
|
Closing
|
||
1.03
|
Effective
Time of the Merger
|
||
1.04
|
Effects
of the Merger
|
||
1.05
|
Certificate
of Incorporation; By-Laws; Purposes
|
||
1.06
|
Directors
|
||
1.07
|
Officers
|
||
ARTICLE
II
|
EFFECT
OF THE MERGER ON THE CAPITAL STOCK AND MEMBERSHIP UNITS OF THE CONSTITUENT
COMPANIES
|
||
2.01
|
Effect
on Capital Stock and Membership Units
|
||
2.02
|
Exchange
of Certificates
|
||
2.03
|
Treatment
of Company Warrants
|
||
2.04
|
Company
Notes
|
||
2.05
|
Withholding
Rights
|
||
ARTICLE
III
|
REPRESENTATIONS
AND WARRANTIES
|
||
3.01
|
Representations
and Warranties of the Company
|
||
3.02
|
Representations
and Warranties of Parent and Merger Sub
|
||
ARTICLE
IV
|
ADDITIONAL
AGREEMENTS
|
||
4.01
|
Company
Financial Statements
|
||
4.02
|
Access
to Information; Confidentiality
|
||
4.03
|
Reasonable
Best Efforts
|
||
4.04
|
Indemnification
of Company Directors and Officers
|
||
4.05
|
Public
Announcements
|
||
4.06
|
Shareholder
Rights Plan
|
||
4.07
|
Tax
Free Reorganization Treatment
|
||
ARTICLE
V
|
CONDITIONS
PRECEDENT
|
||
5.01
|
Conditions
to each Party’s Obligation to Effect the Merger
|
||
5.02
|
Conditions
to Obligations of Parent and Merger Sub
|
||
5.03
|
Conditions
to Obligations of the Company
|
||
ARTICLE
VI
|
TERMINATION,
AMENDMENT, AND WAIVER
|
||
6.01
|
Termination
|
||
6.02
|
Effect
of Termination
|
||
6.03
|
Amendment
|
||
6.04
|
Extension;
Waiver
|
||
6.05
|
Procedure
for Termination, Amendment, Extension or Waiver
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ARTICLE
VII
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GENERAL
PROVISIONS
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7.01
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Nonsurvival
of Representations and Warranties
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7.02
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Notices
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7.03
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Definitions
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7.04
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Interpretation
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7.05
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Counterparts
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7.06
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Entire
Agreement; No Third-Party Beneficiaries
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7.07
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Governing
Law; Consent to Jurisdiction; Waiver of Jury Trial
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7.08
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Assignment
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7.09
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Remedies
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1.01 The
Merger. Upon the terms and subject to the conditions set
forth in this Agreement, and in accordance with the DGCL, Merger Sub shall
be merged with and into the Company at the Effective Time. Upon the
Effective Time, the separate existence of Merger Sub shall cease, and the
Company shall continue as the surviving corporation and a wholly-owned
Subsidiary of Parent (the “Surviving
Corporation”).
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1.02
Closing.
Unless this Agreement shall have been terminated and the transactions
herein contemplated shall have been abandoned pursuant to
Section 7.01, and subject to the satisfaction or waiver of the
conditions set forth in Article VI, the closing of the Merger (the
“Closing”) shall
take place at 10:00 a.m. (New York time) on a date to be specified by
the parties hereto, such date to be no later than the second business day
following satisfaction or waiver of all of the conditions set forth in
Article VI capable of satisfaction prior to Closing (the “Closing
Date”), at the offices of Bingham McCutchen, LLP, 399 Park Avenue,
New York, New York 10019, unless another date, time or place is agreed to
in writing by the parties hereto.
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1.03 Effective
Time. 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”) in such form as required by, and executed and
acknowledged in accordance with, the relevant provisions of the DGCL and
shall, in each case, make all other filings or recordings required
thereby. 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 the DGCL 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”).
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1.04 Effects of the
Merger. The Merger shall have the effects set forth in the
applicable provisions of the DGCL. Without limiting the
generality of the foregoing, and subject thereto, at the Effective Time,
all the properties, rights, privileges, powers and franchises of the
Company and Merger Sub shall vest in the Surviving Corporation, and all
debts, liabilities and duties of the Company and Merger Sub shall become
the debts, liabilities and duties of the Surviving
Corporation.
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1.05 Certificate of
Incorporation; By-Laws;
Purposes.
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(a)
At the Effective Time, 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 shall be the certificate of incorporation
of the Surviving Corporation until thereafter amended as provided therein
or by applicable law.
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(b) At
the Effective Time, 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 shall be the by-laws of the Surviving Corporation until
thereafter changed or amended as provided therein or by applicable
law.
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1.06 Directors.
From and after the Effective Time, the directors of the Surviving
Corporation shall be Jeffrey B. Davis and David P. Luci, until the earlier
of their respective resignation or removal or until their successors are
duly elected and qualified, as the case may
be.
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1.07
Officers.
From and after the Effective Time, the officer of the Surviving
Corporation shall be Jeffrey B. Davis and David Luci, until the earlier of
their resignation or removal or until their respective successors are duly
elected or appointed and qualified, as the case may
be.
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2.01
Effect on
Capital Stock and Company Notes. As of the Effective Time, by
virtue of the Merger and without any action on the part of the Company,
Merger Sub or any holder of any shares of Company Common Stock, Company
Notes, Company Warrants, In the Money Company Warrants or any common stock
of Merger Sub:
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(a) Common Stock of Merger
Sub. Each share of common stock of Merger Sub outstanding
immediately prior to the Effective Time shall be converted into one share
of the common stock, par value $0.001 per share, of the Surviving
Corporation.
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(b)
Cancellation of
Treasury Stock and Parent-Owned Company Stock. Each share of
Company Common Stock that is owned by the Company, and each share of
Company Common 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 Capital Stock or other
consideration shall be delivered or deliverable in exchange
therefor.
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(c) Conversion of Company
Common Stock and In the Money Company
Warrants.
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(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 exercise of
Company Options or Company Warrants occurring after the date of this
Agreement and including all shares issuable upon conversion of any of the
In the Money Company Warrants) shall be converted into the right to
receive a number of shares of Parent Common Stock equal to: (A)
2,500,000, divided by (B) the sum of (1) the total number of shares of
Company Common Stock outstanding at the Effective Time, and (2) the total
number of shares of Company Common Stock issuable upon conversion of the
In the Money Company Warrants assuming a cashless conversion at the
closing price of Company Common Stock on the date of this Agreement, such
quotient to be carried out to eight decimal points (the “Common
Stock Exchange Ratio”); provided, however, that in no event shall
Parent be required to issue more than an aggregate of 2,500,000 shares of
Parent Common Stock as consideration for the Merger and the transactions
contemplated thereby;
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(ii) The
total number of shares of Parent Common Stock issuable in exchange for the
Company Common Stock and shares underlying the In the Money Company
Warrants 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/or In the Money Company Warrants
exceed, in the aggregate, 2,500,000 (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
or In the Money Company Warrants.
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(d) Cancellation and
Retirement of Company Common Stock. As of the Effective Time,
all shares of Company Common Stock issued and outstanding immediately
prior to the Effective Time 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 (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.
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(e)
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Cancellation and
Retirement of In the Money Company Warrants. As of the
Effective Time, all of the In the Money Company Warrants outstanding
immediately prior to the Effective Time shall no longer be outstanding and
shall be cancelled and retired and shall cease to exist, and each holder
of an In the Money Warrant shall 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 In the Money Warrant in
accordance with Section
2.02.
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(f)
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Company Notes.
At the Effective Time, Parent shall assume the due and punctual
performance of all of the terms and conditions of each outstanding Company
Note and each such Company Note shall, unless the conversion rights
thereunder have previously expired, become convertible into the number of
New Securities (as defined in the Company Notes) of Parent and at such
Conversion Price (as defined in the Company Notes) as set forth therein.
The “Company
Notes” shall be the convertible promissory notes made by the
Company listed in Section 2.01(f)
of the Company Disclosure Schedule. The parties acknowledge that certain
of the Company Notes automatically will convert, at the closing price of
Parent Common Stock on the date hereof, to the right to receive Parent
Common Stock at the Effective Time.
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2.02
Exchange of
Certificates.
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(a)
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Exchange
Agent. As of the Effective Time, 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 and In the
Money Company Warrants, 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 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 and In the Money
Company Warrants.
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(i)
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Exchange
Procedures. Promptly after the Effective Time, the Exchange
Agent shall mail to each holder of record of Certificates and In the Money
Company Warrants immediately prior to the Effective Time whose shares of
Company Common Stock and/or In the Money Company Warrants were converted
into shares of Parent Common Stock pursuant to Section 2.01(c)
a letter of transmittal (which shall specify that delivery shall be
effected, and risk of loss and title to the Certificates and/or In the
Money Company Warrants shall pass only upon delivery of the Certificates
and/or In the Money Company Warrants, as applicable, 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 and/or In the Money Company Warrants in
exchange for certificates representing shares of Parent Common
Stock. Upon surrender of a Certificate and/or In the Money
Company Warrants for cancellation (or indemnity reasonably satisfactory to
Parent and the Exchange Agent, if any of such Certificates and/or In the
Money Company Warrants are lost, stolen or destroyed) to the Exchange
Agent together with such letter of transmittal, duly executed, the holder
of such Certificate and/or In the Money Company Warrants 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 and/or In the Money Company
Warrants surrendered by such holder pursuant to the provisions of this
Article II (after taking into account all shares of Company Common Stock
than held by such holder either directly or upon conversion of the In the
Money Company Warrants in a cashless conversion), and the Certificates
and/or In the Money Company Warrants, as applicable, so surrendered shall
forthwith be cancelled. In the event of a transfer of ownership
of shares of Company Common Stock and/or In the Money Company Warrants
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 and/or In the Money
Company Warrants, as applicable, 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 surrender as contemplated by this Section
2.02(b), subject to the provisions of Section 6.02(h)
(Dissenters Rights) each Certificate and In the Money Company Warrants, in
each case, shall be deemed at any time after the Effective Time to
represent only the Parent Common Stock into which the shares of Company
Common Stock represented by such Certificate or In the Money Company
Warrants 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(b).
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(ii)
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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 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 this Section 2.02
until the surrender of such Certificate and/or In the Money Company
Warrants, as applicable, in accordance with this Article
II. Subject to the effect of applicable laws, following
surrender of any such Certificate and/or In the Money Company Warrants, as
applicable, 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 this Section 2.02
and the amount of any dividends or other distributions with a record date
after the Effective Time and a payment date subsequent to such surrender
payable with respect to such whole shares of Parent Common
Stock.
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(iii)
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No further Ownership
Rights in Company Common Stock. All shares of Parent
Common Stock issued upon conversion of shares of Company Common Stock and
In the Money Company Warrants in accordance with the terms hereof, and all
cash paid pursuant to this Section 2.02 in
lieu of fractional shares, shall be deemed to have been issued in full
satisfaction of all rights pertaining to such Company Common Stock and/or
In the Money Company Warrants, and there shall be no further registration
of transfers on the stock transfer books of the Surviving Corporation of
the Company Common Stock and In the Money Company Warrants which were
outstanding prior to the Effective Time. If, after the
Effective Time, Certificates are presented to the Surviving Corporation
for any reason, they shall be cancelled and exchanged as provided in this
Article II.
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(iv)
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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/or In the Money Company
Warrants, 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 and In the Money Company Warrants 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 held immediately prior to the
Effective Time 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.
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(b)
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As
soon as reasonably practicable after the determination of the amount of
cash, if any, to be paid to holders of Certificates and/or In the Money
Company Warrants, as applicable, with respect to any fractional share
interests, the Exchange Agent shall make available such amounts to such
holders of Certificates and/or In the Money Company Warrants, subject to
and in accordance with the terms of this Section
2.02.
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(c)
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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 and/or In
the Money Company Warrants six months after the Effective Time shall be
delivered to Parent, upon demand, and any holders of Certificates and/or
In the Money Company Warrants 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.
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(d)
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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 and/or In the Money Company Warrants
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.
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(e)
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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.
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(f)
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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 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, the Common Stock Exchange Ratio shall be
proportionately adjusted. If between the date hereof and the
Effective Time, Parent shall merge, be acquired or consolidated 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 security holders 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
security holders 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).
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3.01 Representations and
Warranties of the Company and its Subsidiaries. Except as may be
set forth in a disclosure letter (to the extent each disclosure item
therein is clearly marked to indicate the section, paragraph or
subparagraph of this Agreement to which such disclosure is an exception,
referencing the same section, paragraph and subparagraph as used in this
Agreement, in each case, except to the extent that any such disclosure is
reasonably discernable to apply to more than one section, paragraph or
subparagraph of this Agreement) delivered by the Company to Parent and
Merger Sub at the time of execution of this Agreement (the “Company
Disclosure Letter”), the Company hereby represents and warrants to
Parent and Merger Sub as follows:
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(a) Organization; Standing
and Corporate Power. The Company is duly organized, validly
existing and in good standing under the laws of the State of Delaware and
has the requisite corporate power and authority to carry on its business
as it is now being conducted. The Company 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 each of (i) the
certificate of incorporation (including any Certificate of Designations
thereto) (the “Company
Certificate”) and by-laws (the “Company By-laws”)
of the Company, in each case as amended and as currently in effect and
(ii) the minute books of the Company which contain records of all
meetings held of, and other corporate actions taken by, its stockholders,
board of directors and any committees appointed by its board of
directors.
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(b) Subsidiaries.
Except as set forth in Section 3.01(b)
of the Company Disclosure Letter, the Company does not own, directly or
indirectly, any capital stock or other ownership interest in any
Person.
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(c)
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(d) Authority;
Noncontravention. The Company has the 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
the Company and the consummation by the Company of the transactions
contemplated hereby have been duly authorized by all necessary corporate
action on the part of the Company. This Agreement has been duly
executed and delivered by the Company and (assuming due authorization,
execution and delivery by Parent and Merger Sub) constitutes a legal,
valid and binding obligation of the Company, enforceable against the
Company in accordance with its terms, subject to the effects of
bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium
and other similar laws affecting creditors’ rights generally and general
equitable principles (whether considered in a proceeding in equity or at
law). The execution and delivery of this Agreement does not, and the
consummation by the Company of the transactions contemplated by this
Agreement and compliance by the Company with the provisions hereof will
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 pledge, claim,
lien, charge, encumbrance or security interest of any kind or nature
whatsoever except for a Permitted Lien (collectively, “Liens”) upon
any of the properties or assets of the Company under, (i) the Company
Certificate or Company By-laws, (ii) any agreement, contract,
license, 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 its
properties or assets or (iii) subject to the governmental filings and
other matters referred to in the last sentence of this
Section 3.01(d), any judgment, order, decree, statute, law,
ordinance, rule, regulation or arbitration award applicable to the Company
or its properties or assets. Each Lien of the Company in excess of $5,000
is set forth in Section 3.01(d) of the Company Disclosure
Letter. 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 in
connection with the execution and delivery of this Agreement by the
Company or the consummation by the Company of any of the transactions
contemplated hereby or the performance by the Company of its obligations
hereunder, except for the filing of the Delaware 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 is qualified to do
business.
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(e)
Company SEC
Documents; Undisclosed Liabilities. Since January 1,
2005, the Company has filed with the SEC all reports, schedules, forms,
statements and other documents required pursuant to the Securities Act and
the Exchange Act (collectively, and in each case including all exhibits
and schedules thereto and documents incorporated by reference therein, the
“Company
SEC Documents”). As of their respective dates, the Company
SEC Documents 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 Company SEC Documents. Except to the extent that information
contained in any Company SEC Document has been revised or superseded by a
later filed Company SEC Document, none of the Company SEC Documents
(including any and all Company 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 financial statements of Company
included in the Company SEC Documents (the “Company
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 GAAP, applied on a consistent basis
during the periods involved (except as may be indicated in the notes
thereto) and fairly present the financial position of the Company as of
the dates thereof and the results of its operations and cash flows for the
periods then ended (subject, in the case of unaudited quarterly
statements, to normal recurring year-end audit adjustments). The
Company has no liabilities or obligations of any nature (whether accrued,
absolute, contingent or otherwise) required by GAAP to be recognized or
disclosed on a balance sheet of the Company or in the notes thereto,
except (i) liabilities reflected in the audited balance sheet of the
Company as of March 31, 2008, (ii) liabilities incurred since
March 31, 2008, in the ordinary course of business consistent with
past practice and (iii) liabilities that would not be reasonably
likely to have a Material Adverse Effect with respect to the
Company.
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(f) Disclosure Controls
and Procedures. 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 is made known to the
Company’s chief executive officer and chief financial officer by others
within the Company, 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 assessment was that disclosure controls and
procedures were effective as of March 31,
2008.
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(g)
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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 anymaterial fact required to be stated therein or necessary to make
the statements therein not misleading or (ii) the Information 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 Information 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.
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(h) Absence of Certain
Changes or Events. Since March 31, 2008, 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 to consummate the
transactions contemplated by this Agreement or perform its obligations
hereunder.
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(i)
Litigation;
Labor Matters; Compliance with
Laws.
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(i)
Except as set forth in Section 3.01(i)(i) of
the Company Disclosure Letter, there is no suit, action, claim, charge,
arbitration, investigation or proceeding pending before or, to the
knowledge of the Company, threatened by, a Governmental Entity, in each
case with respect to the Company 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 to consummate the transactions contemplated by this Agreement or
to perform its obligations hereunder. There is no judgment, decree,
citation, injunction, rule or order of any Governmental Entity or
arbitrator outstanding against the Company which, individually or in the
aggregate, could reasonably be expected to have a Material Adverse Effect
with respect to the Company.
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(ii)
Except as set forth in Section 3.01(i)(ii) of
the Company Disclosure Letter (1) the Company is not a party to, or
bound by, any collective bargaining agreement, contract or other agreement
or understanding with a labor union or labor organization; (2) the
Company is not the subject of any strike, grievance or other proceeding
asserting that the Company 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 the Company or, to its
knowledge, threatened; (4) no grievance is pending or, to the
knowledge of the Company, threatened against the Company which,
individually or in the aggregate, could reasonably be expected to have a
Material Adverse Effect with respect to the Company; (5) the Company
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) the Company has paid in full to all employees of the
Company all wages, salaries, commissions, bonuses, benefits and other
compensation due and payable to such employees under any policy, practice,
agreement, plan, program, statute or other law; (7) the Company is
not 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, nor will the Company have any liability which exists or arises,
or may be deemed to exist or arise, under any applicable law, contract 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 on or prior to the Effective Time; and
(8) the Company is in compliance with its 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 statute or
otherwise.
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(iii)
The business of the Company is not being conducted in violation of any law
(domestic or foreign), ordinance or regulation of any Governmental Entity
in any material respect.
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(j) Employee Benefit
Plans.
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(i) Section 3.01(j)(i) of
the Company Disclosure Letter contains a true and complete list of each
“employee benefit plan” (within the meaning of Section 3(3) of
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 on or prior to the date of this
Agreement), sponsored by the Company 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 has any
present or future right to benefits based on such employee’s employment
with the Company and under which the Company has any present or future
liability. All such plans, agreements, programs, policies and
arrangements are herein collectively referred to as the “Company
Plans.”
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(ii) With
respect to each Company Plan, the Company has delivered to the 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 contract or other funding
instrument; (B) the most recent determination letter issued by the
IRS; (C) any summary plan description and other material written
communications (or a description of any material oral communications) by
the Company 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.
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(iii) (A) Neither
the Company nor any member of its Controlled Group has or shall have, as
of the Effective Time, any obligation to any multiemployer plan (within
the meaning of 4001(a)(3) of ERISA) 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; and (C) 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).
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(iv) (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 IRS with respect to any trust intended to be
qualified within the meaning of Code
Section 501(c)(9).
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(v) The
Company has complied and currently complies in all material respects with
the applicable continuation requirements for its welfare benefit plans,
including Section 4980B of the Code and Sections 601 through 608,
inclusive, of ERISA and any applicable state statutes maintaining health
insurance continuation coverage for employees and
beneficiaries.
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(vi) Except
as otherwise disclosed in Section 3.01(j)(vi) of
the Company Disclosure Letter, none of the terms of the Company Plans
provides that the consummation of the transactions contemplated by this
Agreement will, either alone or in combination with another event,
(A) entitle any of the Company’s employees or current or former
officers or directors to severance pay, unemployment compensation or any
other payment, except as expressly provided in this Agreement, or
(B) accelerate the time of payment or vesting, or increase the amount
of compensation due any such employee or
officer.
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(vii) Except
as otherwise disclosed in Section 3.01(j)(vii) of
the Company Disclosure Letter, no payment that is owed or may become
due to any director, officer, employee or agent of the Company will be
non-deductible or subject to tax under Section 280G,
Section 4999 or Section 162(m) of the Code; nor will the
Company be required to “gross up” or otherwise compensate any such person
because of the imposition of any excise tax on a payment to such
person.
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(viii) Each
Company Plan is amendable and terminable at the sole discretion of the
sponsor thereof without notice to any participant or
beneficiary.
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(ix)
There is no suit, action, claim, charge, arbitration, investigation or
proceeding (except with respect to benefits payable in the normal
operation of Company Plans and qualified domestic relations orders)
against or involving any Company Plan or asserting any rights or claims to
benefits under any Company Plan that could give rise to any material
liability.
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(x)
Except as disclosed in Section 3.01(j)(x) of
the Company Disclosure Letter, there are no obligations or potential
liability under any Company Plan for providing welfare benefits after
termination of employment to any employee (or any beneficiary of an
employee), including, but not limited to, retiree health and life
insurance coverage, but excluding continuation of health coverage required
to be continued under Section 4980B of the Code or other applicable
law and insurance conversion privileges under state law. The assets of
each Company Plan which is funded are reported on their fair market value
on the books and records of such Company
Plan.
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(xi) No
individuals are currently providing, or have ever provided, services to
the Company pursuant to a leasing arrangement or similar type of
arrangement. The Company has no obligation to provide benefits under any
Company Plan maintained for its employees to or for the benefit of any
individual who has been treated as an independent contractor by the
Company.
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(k)
Taxes.
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(i) The
Company has timely filed with the appropriate Governmental Entity 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 material respects. The
Company has (A) timely paid in full all Taxes required to have been
paid by it (whether or not such Taxes were shown to be due on such Tax
Returns); and (B) made adequate provision for all accrued Taxes not
yet due. The Company has made accruals for Taxes on the Company
SEC Financial Statements that are adequate to cover any Tax liability of
the Company determined in accordance with GAAP through the date of the
applicable Company SEC Financial Statements, and any Taxes of the Company
arising after the date of the most recent Company SEC Financial Statements
and at or before the Effective Time have been or will be incurred in the
ordinary course of the Company’s
business.
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(ii)
As of the date of this Agreement, no federal, state, local or foreign
audits, suits or other administrative proceedings or court proceedings are
presently pending with regard to any Taxes or Tax Returns of Parent, and
the Company has not received a written notice of any material pending or
proposed claims, audits or proceedings with respect to Taxes. 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 or, to the
knowledge of the Company, threatened against or with respect to the
Company. The Company has not received any notice of deficiency
or assessment from any Governmental Entity for any amount of Tax that has
not been fully settled or satisfied, and to the knowledge of the Company
no such deficiency or assessment is
proposed.
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(iii)
No claim has been made in writing by any Governmental Entity in a
jurisdiction where the Company does not file Tax Returns that any such
entity is, or may be, subject to taxation by that
jurisdiction.
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(l) Properties. The
Company (i) has good and marketable title to all the properties and
assets (A) reflected in the Company Financial Statements as being
owned by the Company (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 March 31, 2008 which are
material to the Company’s business, free and clear of all Liens. The
Company has good and valid leasehold interests in all real property
leases, subleases and occupancy agreements to which the Company is a party
(the “Company
Leases”) and is in sole possession of the properties purported to
be leased thereunder. Section 3.01(l) of
the Company Disclosure Letter lists and describes briefly all Company
Leases. Each Company 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. There is no uncured
breach, and no default exists, on the part of landlord under any of
the Company 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 under any Company Lease. There is no suit, action, arbitration
or other proceeding with respect to the Company Leases or the premises
leased under the Company Leases. The Company has not received notice and
does not otherwise have knowledge of any pending, threatened or
contemplated condemnation proceeding affecting any premises leased by the
Company or any part thereof or of any sale or other disposition of
any such leased premises or any part thereof in lieu of condemnation.
The real property leased to the Company under the Company Leases
encompasses all real property used by the Company, and the Company does
not own any real property and does not have any options to purchase real
property. The landlord under each of the Company Leases has performed all
initial improvements required to be performed by it under such Company
Lease and all tenant improvements allowances have been paid to the Company
as tenant under such Company Lease. All insurance required to be
maintained by the Company under each of the Company Leases is in full
force and effect.
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(m) Environmental
Matters.
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(i) The
Company holds and is in compliance in all material respects with all
Environmental Permits and the Company is, and has been, otherwise in
compliance with all Environmental Laws in all material respects and, to
the knowledge of the Company, there are no conditions that might prevent
or interfere with such compliance in the
future.
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(ii) The
Company has not received any Environmental Claim, and to the knowledge of
the Company there is no threatened Environmental
Claim.
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(iii) The
Company has not entered into any consent decree, order or agreement under
any Environmental Law.
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(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
leased, operated or otherwise used by the Company that could reasonably be
expected to give rise to liability of the Company under any Environmental
Laws.
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(v) There
are no past (including, without limitation, with respect to assets or
businesses formerly owned, leased or operated by the Company) 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
under any Environmental Laws.
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(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 following such
consummation.
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(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 leased or
otherwise used by the Company, in violation of or so as could result in
liability under, any Environmental
Laws.
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(viii)
The Company has not contractually assumed any liabilities or obligations
under any Environmental Laws.
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(n) Contracts; Debt
Instruments.
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(i)
The Company is not, and has not received any notice and has no knowledge
that any other party is, in default in any material respect under any
contract, agreement, commitment, arrangement, lease, policy or other
instrument to which it is a party or by which it is bound; 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.
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(ii)
The Company has delivered to Parent and Merger Sub (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 is outstanding and (y) accurate
information regarding the respective principal amounts currently
outstanding thereunder.
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(iii) The
Company has delivered to Parent and Merger Sub true, complete and correct
copies of all other contracts, agreements, commitments, arrangements,
leases, policies or other instruments that are material to the business of
the Company, including, without limitation, any non-compete agreement or
any other agreement requiring expenditures above
$25,000.
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(o) No
Brokers. No broker, investment banker, financial advisor or
other Person (including, without limitation, SCO Capital Partners LLC
and/or 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.
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(p) Intellectual
Property.
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(i)
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Section 3.01(p)(i) of
the Company Disclosure Letter sets forth all Intellectual Property owned
by the Company, 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, and the nature of the Company’s rights
therein.
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(ii) The
Company owns or has the right to use all Intellectual Property necessary
for the Company to conduct its business as it is currently conducted and
consistent with past practice.
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(iii) All
of the Intellectual Property used by the Company 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. None of the Intellectual Property to the extent used by the
Company 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. 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 rights
in and to any Intellectual Property in any material respect. The Company
has not received notice of any pending or threatened suit, action or
proceeding that seeks to limit, cancel or question the validity of, or the
Company’s rights in and to any Intellectual Property. The Company takes
reasonable steps to protect, maintain and safeguard its 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.
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(q) Government Licenses;
Compliance With FDC Act and Other Regulatory
Requirements.
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(i) The
Company holds all material authorizations, consents, approvals,
franchises, licenses and permits required under applicable law or
regulation for the operation of the business of the Company as presently
operated (the “Company
Permits”). All the Company Permits have been duly issued or
obtained and are in full force and effect, and the Company is in material
compliance with the terms of all the Company Permits. The Company
has not engaged in any activity that would cause revocation or suspension
of any such Company Permits. Neither the execution, delivery nor
performance of this Agreement shall adversely affect the status of any of
the Company Permits.
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(ii) Without
limiting the generality of the representations and warranties made in
sub-paragraph (i) above, the Company represents and warrants that
(i) all Pharmaceutical Products that are subject to the jurisdiction
of the United States Food and Drug Administration (the “FDA”) are being developed, labelled,
stored, tested and distributed directly by the Company in substantial
compliance with all applicable requirements under the Federal Food, Drug
and Cosmetic Act of 1938 (the “FDCA”), the Public Health Service Act
of 1944 (the “PHSA”) and all applicable similar
state and foreign Legal Requirements, including those relating to
investigational use, premarket clearance and applications or abbreviated
applications to market a new Pharmaceutical Product. “Pharmaceutical
Products” shall mean
all biological and drug candidates, compounds or products being
researched, tested, developed, manufactured or distributed by the Company,
(ii) all preclinical studies and clinical trials conducted by the
Company have been, and are being, conducted in substantial compliance with
the requirements of Good Laboratory Practice and Good Clinical Practice
and all requirements relating to protection of human subjects contained in
Title 21, Parts 50, 54, and 56 of the United States Code of Federal
Regulations (“C.F.R.”), in each case, to the extent
required by applicable law and regulations, (iii) no Pharmaceutical
Product has been recalled, suspended, or discontinued as a result of any
action by the FDA or any other similar foreign Governmental Entity by the
Company, or (iv) since December 31, 2005, neither the Company
nor, to the knowledge of the Company, any of its officers, key employees
or agents has been convicted of any crime or engaged in any conduct that
has resulted, or would reasonably be expected to result, in debarment
under 21 U.S.C. Section 335a or any similar state law or
regulation under 42 U.S.C.
Section 1320a-7.
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(r) Insurance. The
Company maintains insurance policies (each, a “Company
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
Company Insurance Policy is in full force and effect and is set forth in
Section 3.01(q) of
the Company Disclosure Letter.
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(s) Disclaimer of Other
Representations and Warranties. The representations and
warranties contained in this Section 3.01,
and in the Officer’s Certificate and Secretary’s Certificate to be
delivered by the Company under this Agreement, do not contain any untrue
statement of material fact or omit to state any material fact necessary in
order to make the statements and information contained therein not
misleading. Parent and Merger Sub acknowledge and agree that the
Company has made no representation or warranty in connection with this
Agreement or the transactions contemplated hereby other than as set forth
in this Section 3.01.
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3.02 Representations and
Warranties of Parent and Merger Sub. Except as set forth in
the disclosure letter (to the extent each disclosure item therein is
clearly marked to indicate the section, paragraph or subparagraph of this
Agreement to which such disclosure is an exception, referencing the same
section, paragraph and subparagraph as used in this Agreement, in each
case, except to the extent that any such disclosure is reasonably
discernable to apply to more than one section, paragraph or subparagraph
of this Agreement) delivered by Parent and Merger Sub to Holdings and the
Company at the time of execution of this Agreement (the “Parent
Disclosure Letter”) or in the Parent SEC Documents filed on or
after January 1, 2007, Parent and Merger Sub represent and warrant to
Holdings and the Company as
follows:
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(a)
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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.
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(b)
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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 June 30, 2008, there
were: (i) 5,648,781 shares of Parent Common Stock issued and outstanding,
(ii) 11,666,195 shares of Parent Common Stock issuable upon conversion of
3,227.3617 shares of Parent Preferred Stock, (iii) 163 shares of Parent
Common Stock held in the treasury of Parent; (iv) 52,818 shares of Parent
Common Stock reserved for issuance pursuant to Parent's stock option plans
(collectively, the "Parent
Stock Plans"); (v) 1,293,820 shares of Parent Common Stock issuable
upon exercise of awarded but unexercised stock options; and (vi) warrants
representing the right to purchase 9,461,725 shares of Parent Common
Stock; Except as set forth above, as of the close of business
on June 30, 2008 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 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.
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(c)
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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.
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(d)
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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.
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(e)
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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 Information 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.
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(f)
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Absence of Certain
Changes or Events. Since March 31, 2008, 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.
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(g)
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Litigation; Compliance
with Laws.
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(h)
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Interim Operations of
Merger Sub. Merger Sub was formed on July 10, 2008
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.
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(i)
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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.
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(j)
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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.
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(k)
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No
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 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.
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(l)
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Disclaimer of Other
Representations and Warranties. The representations and
warranties contained in this Section 3.02,
and in the Officer’s Certificate and Secretary’s Certificate to be
delivered by the Parent under this Agreement, do not contain any untrue
statement of material fact or omit to state any material fact necessary in
order to make the statements and information contained therein not
misleading. The Company acknowledges and agrees that the Parent and
Merger Sub have made no representation or warranty in connection with this
Agreement or the transactions contemplated hereby other than as set forth
in this Section 3.02.
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4.01
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Conduct of Business by
the Company.
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(a)
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During
the period from the date of this Agreement to the Effective Time (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, 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:
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(b)
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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.
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(c)
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Severance. Except
as set forth in Section 3.01(i)(ii)
and/or 3.01(j)(vi) or (x) of the Company Disclosure Schedule,
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.
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(d)
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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.
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(e)
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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.
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(f)
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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.
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5.01 Preparation of Form
S-4 and Information Statement; Company Financial
Statements.
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(a)
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As
soon as practicable following the date of this Agreement, Parent and the
Company shall prepare the Information Statement and the Form S-4, and
Parent shall file with the SEC the Form S-4, in which the Information
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 Information 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 Information 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 Information 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.
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(b)
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The
Company’s Board of Directors may withdraw or modify such recommendation if
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 Information
Statement.
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(c)
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The
Company shall use its reasonable best efforts to promptly (i) prepare
all financial statements of the Company required for the Parent to timely
file with the SEC the financial statements required under Items 2.01 and
9.01 of Form 8-K including, without limitation, the Company Financial
Statements in compliance with Regulation S-X promulgated under the
Securities Act and (ii) obtain the consent of Vitale, Caturano &
Company, Ltd. and any other required consents of accountants to use their
opinion with respect to the Company Financial Statements in any SEC
filings that may be necessary in connection with the transactions
contemplated by this Agreement.
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5.02
Access to
Information;
Confidentiality.
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5.03
Reasonable Best
Efforts. 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, (iii) accepting and delivering additional
instruments necessary to consummate the transaction contemplated by this
Agreement, and (iv) satisfying the conditions to closing set forth
under Article V hereof.
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5.04
Indemnification
of Company Directors and
Officers.
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(a)
From and after the Effective Time, 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 eligible for indemnification pursuant
to the Company Certificate and Company 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,
pertaining to any matter existing or occurring at or prior to the
Effective Time, whether asserted or claimed prior to, or at or after, the
Effective Time (“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 would have been permitted under the
Company Certificate and Company 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), (i) any counsel retained by the
Indemnified Parties for any period after the Effective Time shall be
reasonably satisfactory to Parent; (ii) after the Effective Time,
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,
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 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.
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(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.
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(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.
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(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 Company Certificate or Company By-laws, or under any applicable
contracts or laws.
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(e) No Circular
Recovery. The obligations of the Parent and the Surviving
Corporation in this Section 5.04
are subject to the condition that each Indemnified Party will not make any
claim for indemnification against the Parent, the Surviving Corporation or
the Company by reason of the fact that such Indemnified Party was a
controlling person, director, employee or representative of the Company or
the Surviving Corporation or was serving as such for another Person at the
request of the Company (whether such claim is for losses of any kind or
otherwise and whether such claim is pursuant to any statute,
organizational document, contractual obligation or otherwise) with respect
to any claim brought by the Parent or its affiliates relating to this
Agreement that is finally and successfully adjudicated against such
Indemnified Party. With respect to any claim brought by the Parent or its
affiliates against any Indemnified Party relating to this Agreement that
is finally and successfully adjudicated against such Indemnified Party,
the obligations of the Parent and the Surviving Corporation in this Section 5.04
are subject to the condition that any right of subrogation, contribution,
advancement, indemnification or other claim against the Company with
respect to any amounts owed by any Indemnified Party shall not be
applicable.
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5.05 Public
Announcements. Neither Parent and Merger Sub, on the one hand, nor
the Company, on the other hand, shall issue any press release or public
statement with respect to the transactions contemplated by this Agreement,
including the Merger, without the other party’s prior consent (such
consent not to be unreasonably withheld or delayed), except as may be
required by applicable law, court process or by obligations pursuant to
any agreement with any securities exchange or quotation system on which
securities of the disclosing party are listed or quoted. In addition to
the foregoing, Parent, Merger Sub and the Company shall consult with each
other before issuing, and provide each other the opportunity to review and
comment upon, any such press release or other public statements with
respect to such transactions. The parties agree that the initial press
release or releases to be issued with respect to the transactions
contemplated by this Agreement shall be mutually agreed upon prior to the
issuance thereof.
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5.06
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No
Solicitation. The Company shall not (whether directly or
indirectly through advisors, agents or other intermediaries), nor shall
the Company authorize or permit any of its or their officers, directors,
agents, representatives or advisors 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 assets of the Company
or of over 33.33% of any class of equity securities of the Company, (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, (iii) any merger,
consolidation, business combination, sale of substantially all assets,
recapitalization, liquidation, dissolution or similar transaction
involving the Company 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,
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.
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5.06 Shareholder Rights
Plan. The Parent shall take all action necessary to render the
Shareholder Rights Plan inapplicable to the execution, delivery and
performance of this Agreement and the transactions contemplated
hereby.
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5.07 Tax Free
Reorganization Treatment. The Company, Parent and Merger Sub shall
not intentionally take or cause to be taken any action not consistent with
the transactions contemplated by this Agreement or which could reasonably
be expected to prevent the Merger from qualifying as a “reorganization”
within the meaning of Section 368(a) of the
Code.
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5.08
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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.
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6.01
Conditions to
each Party’s Obligation to Effect the Merger. The respective
obligation of each party to effect the Merger is subject to the
satisfaction or waiver on or prior to the Closing Date of the following
conditions:
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(a) 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 reasonable best efforts to have any such
injunction, order, restraint or prohibition
vacated;
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(b)
Governmental
Approvals. Other than the filing of the Delaware 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;
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(c)
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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;
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(d)
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Information
Statement. No stop order suspending the use of the
Information 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;
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(e)
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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”);
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(f)
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Stockholder
Approval. The Merger and this Agreement shall have been
approved and adopted by the requisite vote of the holders of shares of
Company Common Stock to the extent required pursuant to the requirements
of the certificate of incorporation and the
DGCL;
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6.02 Conditions to
Obligations of Parent and Merger Sub. The obligations of Parent and
Merger Sub to effect the Merger are further subject to the following
conditions:
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(a) Representations and
Warranties. The representations and warranties of the Company
contained in this Agreement shall be true and correct in all material
respects on and as of the Closing Date, with the same force and effect as
if made on and as of the Closing Date, except for (i) changes
contemplated by this Agreement or in the Company Disclosure Letter,
(ii) representations and warranties that are qualified by materiality
or Material Adverse Effect, in which case such representations and
warranties shall be true and correct in all respects, and
(iii) representations and warranties which address matters only as of
a particular date, in which case such representations and warranties
qualified as to materiality or Material Adverse Effect shall be true and
correct in all respects, and those not so qualified shall be true and
correct in all material respects, on and as of such particular date; and
Parent shall have received a certificate to such effect signed by the
president of the Company.
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(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 dated as of the Closing Date signed on behalf of the Company
by the president of the Company to the effect set forth in this
paragraph.
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(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
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.
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(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; (ii) seeking to prohibit or limit the
ownership or operation by the Company of any material portion of the
business or assets of the Company or to dispose of or hold separate any
material portion of the business or assets of the Company, 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.
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(e)
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Termination of Company
Options and certain Company Warrants. The Company shall
have complied with the requirements of the 1994 Equity Incentive Plan and
the 2001 Incentive Plan (together, the “Company
Option Plans”) in connection with offering holders of the Company
Options and Company Warrants (other than the In the Money Company
Warrants) the opportunity to exercise all such Company Options and Company
Warrants held by such holder prior to the Effective Time. At
the Effective Time, all outstanding Company Options and Company Warrants
not exercised (other than the In the Money Company Warrants) shall be
terminated and each such holder shall have no further rights thereunder to
purchase shares of Company Common Stock. At the Effective Time,
the In the Money Company Warrants shall automatically convert into the
right to receive Merger Consideration as provided in Article II
above.
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(f) Directors and
Officers. As of the Effective
Time:
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(i)
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Consulting and
Transition Agreement. Parent and the Company’s President &
Chief Business Officer shall have mutually agreed on terms to discharge
the Company’s obligations and agree upon the terms of that certain
Consulting and Transition Agreement, in the form attached as Exhibit
A hereto; and
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(g) No Material Adverse
Effect. Since the date of this Agreement, there shall not have
occurred any Material Adverse Effect or Material Adverse Change with
respect to the Company.
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(h) 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 the DGCL 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
shall not have exercised appraisal, dissenters' or similar rights under
Section 262 of the DGCL or other applicable law with respect to such
shares by virtue of the Merger.
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(i) Resignation of
Directors and Officers. Except as set forth in Sections 1.06 and
1.07, the directors and officers of the Company, in office
immediately prior to the Effective Time shall have resigned as directors
and officers of the Surviving Corporation effective as of the Effective
Time.
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(f)
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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).
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6.03 Conditions to
Obligations of the Company. The obligation of the Company to
effect the Merger is further subject to the following
conditions:
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(a) Representations and
Warranties. The representations and warranties of the Parent
and Merger Sub contained in this Agreement shall be true and correct in
all material respects on and as of the Closing Date, with the same force
and effect as if made on and as of the Closing Date, except for
(i) changes contemplated by this Agreement or in the Parent
Disclosure Letter, (ii) representations and warranties that are
qualified by materiality or Material Adverse Effect, in which case such
representations and warranties shall be true and correct in all respects,
and (iii) representations and warranties which address matters only
as of a particular date, in which case such representations and warranties
qualified as to materiality or Material Adverse Effect shall be true and
correct in all respects, and those not so qualified shall be true and
correct in all material respects, on and as of such particular date; and
the Company shall have received a certificate to such effect signed by an
authorized officer of Parent and Merger
Sub.
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(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. Holdings and the Company shall have received a certificate
dated as of the Closing Date 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.
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(c) 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, challenging or seeking to restrain or prohibit the
consummation of the Merger or any of the other transactions contemplated
by this Agreement.
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(d) Parent Consents,
Etc. The Company shall have received evidence, in form and
substance reasonably satisfactory to the Company, that such licenses,
permits, consents, approvals, authorizations, qualifications and orders of
governmental authorities and other third parties as are necessary 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
Parent.
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7.01
|
Termination. This
Agreement may be terminated and abandoned at any time prior to the
Effective Time:
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(e)
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by
Parent, if the Company or its Board of Directors shall have (1) failed to
approve, 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
Information 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, not recommended rejection of such tender offer or
exchange offer at the time of filing of the requisite Schedule 14d-9 with
the SEC;
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(f)
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by
the Company, if the Company has received a Superior Proposal, which the
Company’s Board of Directors determines in good faith (after consultation
with its financial advisors) continues to constitute a Superior
Proposal. For purposes of this Agreement, a “Superior Proposal”
is an Acquisition Proposal for 100% of the Company Common Stock that
involves consideration to the holders of shares of Company Common Stock
that is superior to the consideration offered to such holders pursuant to
the Merger and that otherwise represents a superior transaction to the
Merger in the reasonable discretion of the Company’s Board of
Directors;
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(g)
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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 6.01(g)
during such ten-day period, provided Company continues to exercise such
commercially reasonable efforts; or
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(h)
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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 6.01(h)
during such ten-day period provided Parent continues to exercise such
commercially reasonable effort.
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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
4.02(a), this Section 7.02,
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.
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7.03
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Amendment. This
Agreement may be amended by the parties at any time before or after any
required approval of matters presented in connection with the Merger by
the stockholders of the Company; provided, however, that after any such
approval, there shall be made no amendment that by law requires further
approval by such stockholders without the further approval of such
stockholders. This Agreement may not be amended except by an instrument in
writing signed on behalf of each of the
parties.
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7.04
|
Extension;
Waiver. At any time prior to the Effective Time, the
parties may (a) extend the time for the performance of any of the
obligations or other acts of the other parties; (b) waive any inaccuracies
in the representations and warranties contained in this Agreement or in
any document delivered pursuant to this Agreement; or (c) subject to the
provisions of Section 7.03,
waive compliance with any of the agreements or conditions contained in
this Agreement. Any agreement on the part of a party to any such extension
or waiver shall be valid only if set forth in an instrument in writing
signed on behalf of such party. The failure of any party to this Agreement
to assert any of its rights under this Agreement or otherwise shall not
constitute a waiver of such rights.
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7.05
|
Procedure for
Termination, Amendment, Extension or Waiver. A
termination of this Agreement pursuant to Section 7.01,
an amendment of this Agreement pursuant to Section 7.03 or
an extension or waiver pursuant to Section 7.04
shall, in order to be effective, require in the case of any party hereto
an action by its Board of Directors or a duly-authorized designee of its
Board of Directors.
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8.01
|
Nonsurvival of
Representations and Warranties. None of the
representations and warranties in this Agreement or in any instrument
delivered pursuant to this Agreement shall survive the Effective Time and
all such representations and warranties shall be extinguished on
consummation of the Merger and no party hereto nor any officer, director
or employee or stockholder of any of them shall be under any liability
whatsoever with respect to any such representation or warranty after such
time. This Section 8.01
shall not limit any covenant or agreement of the parties which by its
terms contemplates performance after Effective
Time.
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8.02
|
Fees and
Expenses.
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8.03
|
Notices. All
notices, requests, claims, demands and other communications under
this Agreement shall be in writing and
shall be deemed given if delivered personally or sent by overnight courier
(providing proof of delivery) to the parties at the following addresses
(or at such other address for a party as shall be specified by like
notice):
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(a)
|
if
to Parent or Merger Sub, to
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8.04 Definitions.
For purposes of this Agreement:
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(a)
|
“Acquisition
Proposal” means any solicitation, initiation, encouragements, discussions,
negotiations and communications regarding a similar transaction with any
third party involving:
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(b)
|
“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;
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(c)
|
“Agreement”
has the meaning set forth in the
preamble;
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(d)
|
“Certificates”
shall have the meaning ascribed thereto in Section
2.01(d);
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(e)
|
Certificate
of Merger” shall have the meaning ascribed thereto in Section
1.03;
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(f)
|
“C.F.R.”
shall have meaning ascribed thereto in Section 3.01(p)(ii);
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(g)
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“Closing”
shall have meaning ascribed thereto in Section 1.02;
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(h)
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“Closing
Date” shall have meaning ascribed thereto in Section 1.02;
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(i)
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“Code”
shall have meaning ascribed thereto in the fourth recital to this
Agreement;
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(j)
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“Common
Stock Exchange Ratio” shall have meaning ascribed thereto in Section 2.01(c)(i);
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(k)
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“Company”
shall have meaning ascribed thereto in the preamble to this
Agreement;
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(l)
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“Company
By-laws” shall have the meaning set forth in Section
3.01(a);
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(m) “Company
Certificate” shall have meaning ascribed thereto in Section 3.01(a);
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(n) “Company
Common Stock” means the common stock, par value $0.001 per share, of the
Company;
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(o) “Company
Disclosure Letter” shall have meaning ascribed thereto in Section 3.01;
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(p) “Company
Financial Statements” shall have meaning ascribed thereto in Section 3.01(e);
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(q) “Company
Insurance Policy” shall have meaning ascribed thereto in Section 3.01(q);
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(r) “Company
Leases” shall have meaning ascribed thereto in Section 3.01(j);
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(s)
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“Company
Note” or “Company Notes” shall have the meaning ascribed thereto in Section
2.01(e);
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(t) “Company
Options” means the options to purchase shares of Company Common Stock
listed in Section 3.01(c)
of the Company Disclosure Letter;
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(u)
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“Company
Option Plans” shall have the meaning set forth in Section
6.02(e);
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(v)
|
“Company
Plans” shall have the meaning set forth in Section
3.01(i)(i);
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(w) “Company
Permits” shall have meaning ascribed thereto in Section 3.01(p)(i);
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(x)
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“Company
SEC Documents” shall have the meaning ascribed thereto in Section
3.01(e);
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(y) “Company
Warrants” means warrants to purchase shares of Company Common Stock as
listed in Section 3.01(c) of
the Company Disclosure Letter;
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(z) “Confidentiality
Agreement” shall have meaning ascribed thereto in Section 4.02(a);
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(aa) “Controlled
Group” shall have meaning ascribed thereto in Section 3.01(h)(iii);
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(bb) “Delaware
Certificate of Merger” shall have meaning ascribed thereto in Section 1.03;
|
(cc)
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“Dissenting
Shares” shall have the meaning set forth in Section
2.04;
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(dd) “DGCL”
shall have meaning ascribed thereto in the second recital to this
Agreement;
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(ee) “Effective
Time” shall have meaning ascribed thereto in Section 1.03;
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(ff) “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 Parent (as applicable) 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;
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(gg) “Environmental
Permits” means all permits, licenses, registrations and other governmental
authorizations required under Environmental Laws for the Company or Parent
(as applicable) to conduct its operations and business on the date hereof
and consistent with past practices;
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(hh) “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 of 1980, the Solid Waste Disposal Act of
1976, the Clean Air Act, the Clean Water Act, the Toxic Substances Control
Act of 1976, the Occupational Safety and Health Act of 1970, the Emergency
Planning and Community-Right-to-Know Act, the Safe Drinking Water Act, all
as amended, and similar state laws;
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(ii) “ERISA”
shall mean the Employee Retirement Income Security Act of 1974 or any
successor law, and regulations and rules issued pursuant to that Act or
any successor law;
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(jj) “Exchange
Act” shall mean the Exchange Act of 1934, as
amended;
|
(kk)
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“Exchange
Agent” shall have the meaning set forth in Section
2.02;
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(ll)
|
“Exchange
Fund” shall have the meaning set forth in Section
2.02;
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(mm) “FDA”
shall have meaning ascribed thereto in Section 3.01(p)(ii);
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(nn) “FDCA”
shall have meaning ascribed thereto in Section 3.01(q)(ii);
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(oo)
|
“Flow
of Funds” shall have the meaning set forth in Section
6.01(e);
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(pp)
|
“Form
S-4” shall have the meaning set forth in Section
3.01(g);
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(qq) “GAAP”
shall have meaning ascribed thereto in Section 3.01(e);
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(rr) “Governmental
Entity” shall have meaning ascribed thereto in Section 3.01(d);
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(ss) “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;
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(tt) “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,
(I) all guarantees and arrangements having the economic effect of a
guarantee of such Person of any Indebtedness of any other Person and
(K) all obligations with respect to compensation or other employee
arrangements which become due or payable as a result of this Agreement or
the transactions contemplated
hereby;
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(uu) “Indemnified
Liabilities” shall have meaning ascribed thereto in Section 4.04(a);
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(vv) “Indemnified
Parties” shall have meaning ascribed thereto in Section 4.04(a);
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(ww) “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, research, works, 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;
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(xx)
|
“In
the Money Company Warrants” shall have the meaning set forth in Section
2.03;
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(yy) “IRS”
shall mean the U.S. Internal Revenue
Service;
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|
(zz) “knowledge
of the Company” means the actual knowledge of any officer of the Company,
including James Pachence as President of the Company, assuming due
inquiry, or those facts which, taking into account the scope and nature of
the responsibilities of the individual in question, should have been known
to such individual;
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(aaa) “knowledge
of Parent” means the actual knowledge of any officer of Parent, assuming
due inquiry, or those facts which, taking into account the scope and
nature of the responsibilities of the individual in question, should have
been known to such individual;
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(bbb) “Licenses”
shall have meaning ascribed thereto in Section 3.01(o)(ii);
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(ccc) “Lien”
or “Liens” shall have meaning ascribed thereto in Section 3.01(d);
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(ddd) “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 has been or is reasonably
likely to be 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(h)(i) and (ii), 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),
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 GAAP 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 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;
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(eee) “Merger”
shall have meaning ascribed thereto in second recital to this
Agreement;
|
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(fff) “Merger
Consideration” shall have meaning ascribed thereto in Section 2.01(c)(ii);
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(ggg) “Merger
Sub” shall have meaning ascribed thereto in the preamble to this
Agreement;
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(hhh) “Parent”
shall have meaning ascribed thereto in the preamble to this
Agreement;
|
|
(iii) “Parent
Common Stock” means the common stock, par value $0.01 per share, of
Parent;
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|
(jjj) “Parent
Disclosure Letter” shall have meaning ascribed thereto in Section 3.02;
|
|
|
(kkk)
|
“Parent
Capital Stock” means the Parent Common Stock and the Parent Preferred
Stock;
|
(lll)
|
“Parent
Common Stock” means the common stock, par value $0.01 per share, of
Parent;
|
|
|
|
(mmm) “Parent
Preferred Stock” means the preferred stock, par value $0.01 per share, of
Parent;
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|
(nnn) “Parent
SEC Documents” shall have meaning ascribed thereto in Section 3.02(d);
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(ooo) “Parent
SEC Financial Statements” shall have meaning ascribed thereto in Section 3.02(d);
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(qqq) “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;
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(rrr) “Person”
means an individual, corporation, partnership, joint venture, association,
trust, unincorporated organization or other
entity;
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(sss) “Pharmaceutical
Products” shall have meaning ascribed thereto in Section 3.01(p)(ii);
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(ttt) “PHSA”
shall have meaning ascribed thereto in Section 3.01(p)(ii);
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(uuu)
“SEC” means the United States Securities and Exchange
Commission;
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(vvv) “Securities
Act” shall mean the Securities Act of 1933, as
amended;
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(www) “Shareholder
Rights Plan” shall have meaning ascribed thereto in Section 3.02(b);
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(xxx) “Subsidiary”
of any Person means another Person, who holds an amount of the voting
securities, other voting ownership or voting partnership interests 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) or is owned directly or indirectly
by such Person;
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(yyy)
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“Superior
Proposal” shall have the meaning ascribed thereto in Section
7.1(f);
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(zzz) “Surviving
Corporation” shall have meaning ascribed thereto in Section 1.01;
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(aaaa) “Tax”
or “Taxes” (and with correlative meaning, “Taxable” and “Taxing” and “Tax
Law”) 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;
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(bbbb) “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;
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(cccc) “Technology”
means all inventions, works, discoveries, innovations, know-how,
information (including ideas, research and development, know-how,
formulas, compositions, processes and techniques, data, designs, drawings,
specifications, customer and supplier lists, pricing and cost information,
business and marketing plans and proposals, documentation and manuals),
computer software, firmware, computer hardware, integrated circuits and
integrated circuit masks, electronic, electrical and mechanical equipment
and all other forms of technology, including improvements, modifications,
works in process, derivatives or changes, whether tangible or intangible,
embodied in any form, whether or not protectible or protected by patent,
copyright, mask work right, trade secret law or otherwise, and all
documents and other materials recording any of the
foregoing;
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(dddd) “WARN”
shall have meaning ascribed thereto in Section 3.01(i)(ii).
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8.05 Interpretation.
When reference is made in this Agreement to an Article or a
Section, such reference shall be to an Article or Section of
this Agreement, unless otherwise indicated. The table of contents,
table of defined terms and headings contained in this Agreement are for
convenience of reference only and shall not affect in any way the meaning
or interpretation of this Agreement. The language used in this
Agreement shall be deemed to be the language chosen by the parties hereto
to express their mutual intent, and no rule of strict construction
shall be applied against any party. Whenever the context may
require, any pronouns used in this Agreement shall include the
corresponding masculine, feminine or neuter forms, and the singular form
of nouns and pronouns shall include the plural, and vice versa. Any
reference to any federal, state, local or foreign statute or law shall be
deemed also to refer to all rules and regulations promulgated
thereunder, unless the context requires otherwise. Whenever the
words “include,” “includes” or “including” are used in this Agreement,
they shall be deemed to be followed by the words “without
limitation.” No summary of this Agreement prepared by any party
shall affect the meaning or interpretation of this
Agreement.
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8.06 Counterparts.
This Agreement may be executed in two or more counterparts, all of
which shall be considered one and the same agreement and shall become
effective when one or more counterparts have been signed by each of the
parties and delivered to the other parties. The delivery of a
signature page of this Agreement by one party to the other via
facsimile or other electronic transmission shall constitute the execution
and delivery of this Agreement by the transmitting
party.
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8.07 Entire Agreement; No
Third-Party Beneficiaries. This Agreement (including the
Company Disclosure Letter and the Parent Disclosure Letter, and the
Schedules and Exhibits attached hereto) and the other agreements and
instruments referred to herein constitute the entire agreement, and
supersede all prior agreements and understandings, both written and oral,
among the parties with respect to the subject matter of this Agreement.
This Agreement, other than Section 5.04 (with respect to which
the Indemnified Parties shall be third-party beneficiaries), is not
intended to confer upon any Person other than the parties any rights or
remedies.
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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 State of New
York in any action 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 7.02. Nothing in
this Section 7.07, 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.
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8.09 Assignment.
Neither this Agreement nor any of the rights, interests or
obligations under this Agreement shall be assigned, in whole or in part,
by operation of law or otherwise by any of the parties without the prior
written consent of the other parties. Subject to the preceding
sentence, this Agreement shall be binding upon, inure to the benefit of
and be enforceable by the parties and their respective successors and
assigns.
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8.10 Remedies.
Except as otherwise provided herein, any and all remedies herein expressly
conferred upon a party shall be deemed cumulative with and not exclusive
of any other remedy conferred hereby, or by law or equity upon such party,
and the exercise by a party of any one remedy shall not preclude the
exercise of any other remedy. The parties hereto agree that
irreparable damage would occur in the event that any of the provisions of
this Agreement were not performed in accordance with their specific terms
or were otherwise breached. It is accordingly agreed that the
parties hereto shall be entitled to an injunction or injunctions to
prevent breaches of this Agreement and to enforce specifically the terms
and provisions of this Agreement, this being in addition to any other
remedy to which they are entitled at law or in
equity.
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[REMAINDER OF PAGE INTENTIONALLY LEFT
BLANK]
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ACCESS
PHARMACEUTICALS, INC.
|
||||
By:
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/s/ Jeffrey B. Davis | |||
Name:
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Jeffrey
B. Davis
|
|||
Title:
|
Chief
Executive Officer
|
|||
MACM
ACQUISITION CORP.
|
||||
By:
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/s/ Jeffrey B. Davis | |||
Name:
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Jeffrey
B. Davis
|
|||
Title:
|
President
|
|||
MACROCHEM
CORPORATION
|
||||
By:
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/s/ David P. Luci | |||
Name:
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David
P. Luci
|
|||
Title:
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President
& Chief Business Officer
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I.
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The
following preambles and Resolutions are adopted effective as of the date
hereof:
|
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)
|
2.3
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., MACM
Acquisition Corporation and MacroChem Corporation, dated July 9, 2008.
(Incorporated by reference to Exhibit 2.3 of our Form 10-Q for the quarter
ended June 30, 2008)
|
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)
|
3.3
|
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)
|
3.10
|
Certificate
of Designation of Series A Cumulative Convertible Preferred Stock filed
November 9, 2007 (Incorporated by reference to Exhibit 3.10 to our Form
10-K for the year ended December 31,
2007)
|
3.11
|
Certificate
of Amendment to Certificate of Designations, Rights and Preferences of
Series A Cumulative Convertible Preferred Stock filed June 11, 2008
(Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the
quarter ended June 30, 2008)
|
5.1
|
Opinion
of Bingham McCutchen LLP
|
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 10.11 of our Form 10-K for the year ended December
31, 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
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24 of our
Form 10-Q for the quarter ended September 30,
2000)
|
10.8
|
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)
|
10.9
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us and American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
10.10
|
Amendment
to Rights Agreement, dated as of November 9, 2007 between us and American
Stock Transfer & Trust Company as Rights
Agent
|
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*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen B.
Thompson (1)
|
10.15
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between us and
Uluru, Inc. (3)
|
10.17
|
Form
of Warrant, dated February 16, 2006, issued by us to certain Purchasers
(2)
|
10.18
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
10.20*
|
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)
|
10.21
|
Note
Purchase Agreement dated April 26, 2007 between us and Somanta
Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42 of our
Form 10-Q for the quarter ended June 30,
2007)
|
10.22
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between us
and certain Purchasers (5)
|
10.23
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers (5)
|
10.24
|
Form
of Warrant Agreement dated November 10, 2007, between us and certain
Purchasers (5)
|
10.25
|
Board
Designation Agreement, dated November 15, 2007, between us and SCO Capital
Partners LLC (5)
|
10.26
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between us and
certain Purchasers (5)
|
10.27
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008 between us
and certain Purchasers (5)
|
10.28*
|
Employment
Agreement, dated January 4, 2008 between us and Jeffrey B. Davis
(5)
|
*
|
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.
|
(5)
|
Incorporated
by reference to our Form S-1,
333-149633.
|
(a)
|
(1)
To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration
statement:
|
(b)
|
The
undersigned registrant hereby undertakes that, for purposes of determining
any liability under the Securities Act of 1933, each filing of the
registrant’s annual report pursuant to Section 13(a) or 15(d) of the
Securities Act of 1934 (and, where applicable, each filing of an employee
benefit plan’s annual report pursuant to Section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
|
(c)
|
(1)
The undersigned Registrant hereby undertakes as follows: that prior to any
public reoffering of the securities registered hereunder through use of a
prospectus which is a part of this registration statement, by any person
or party who is deemed to be an underwriter within the meaning of Rule
145(c), the issuer undertakes that such reoffering prospectus will contain
the information called for by the applicable registration form with
respect to reofferings by persons who may be deemed underwriters, in
addition to the information called for by the other items of the
applicable form.
|
(d)
|
Insofar
as indemnification for liabilities arising under the Securities Act of
1933 may be permitted to directors, officers and controlling persons of
the registrant pursuant to the foregoing provisions, or otherwise, the
registrant 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. In the event that a
claim for indemnification against such liabilities (other than the payment
by the registrant of expenses incurred or paid by a director, officer or
controlling person of the registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the
registrant will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against
public policy as expressed in the Act and will be governed by the final
adjudication of such issue.
|
(e)
|
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.
|
(f)
|
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.
|
(g)
|
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.
|
Number
|
Description of
Document
|
|
Exhibit
Number
|
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)
|
2.3
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., MACM
Acquisition Corporation and MacroChem Corporation, dated July 9, 2008.
(Incorporated by reference to Exhibit 2.3 of our Form 10-Q for the quarter
ended June 30, 2008)
|
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)
|
3.3
|
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)
|
3.10
|
Certificate
of Designation of Series A Cumulative Convertible Preferred Stock filed
November 9, 2007 (Incorporated by reference to Exhibit 3.10 to our Form
10-K for the year ended December 31,
2007)
|
3.11
|
Certificate
of Amendment to Certificate of Designations, Rights and Preferences of
Series A Cumulative Convertible Preferred Stock filed June 11, 2008
(Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the
quarter ended June 30, 2008)
|
5.1
|
Opinion
of Bingham McCutchen LLP
|
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 10.11 of our Form 10-K for the year ended December
31, 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
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24 of our
Form 10-Q for the quarter ended September 30,
2000)
|
10.8
|
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)
|
10.9
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us and American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
10.10
|
Amendment
to Rights Agreement, dated as of November 9, 2007 between us and American
Stock Transfer & Trust Company as Rights
Agent
|
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*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen B.
Thompson (1)
|
10.15
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between us and
Uluru, Inc. (3)
|
10.17
|
Form
of Warrant, dated February 16, 2006, issued by us to certain Purchasers
(2)
|
10.18
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
10.20*
|
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)
|
10.21
|
Note
Purchase Agreement dated April 26, 2007 between us and Somanta
Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42 of our
Form 10-Q for the quarter ended June 30,
2007)
|
10.22
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between us
and certain Purchasers (5)
|
10.23
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers (5)
|
10.24
|
Form
of Warrant Agreement dated November 10, 2007, between us and certain
Purchasers (5)
|
10.25
|
Board
Designation Agreement, dated November 15, 2007, between us and SCO Capital
Partners LLC (5)
|
10.26
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between us and
certain Purchasers (5)
|
10.27
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008 between us
and certain Purchasers (5)
|
10.28*
|
Employment
Agreement, dated January 4, 2008 between us and Jeffrey B. Davis
(5)
|
*
|
Management
contract or compensatory plan required to be filed as an Exhibit to this
Form pursuant to Item 15(c) of the
report.
|
(6)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005.
|
(7)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
(8)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2006.
|
(9)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2007.
|
(10)
|
Incorporated
by reference to our Form S-1,
333-149633.
|