|
Delaware
|
33-0311631
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer Identification No.)
|
|
Large
accelerated filer ¨
|
Accelerated
Filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
|
Page
|
||||
|
PART
I
|
||||
|
Item
1.
|
Business
|
2
|
||
|
Item
1A.
|
Risk
Factors
|
14
|
||
|
Item
1B.
|
Unresolved
Staff Comments
|
18
|
||
|
Item
2.
|
Properties
|
18
|
||
|
Item
3.
|
Legal
Proceedings
|
19
|
||
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
19
|
||
|
PART II
|
||||
|
Item
5.
|
Market
for Common Equity, Related Stockholder Matters and Small Business Issuer
Purchases of Equity Securities
|
20 | ||
|
Item
6.
|
Selected
Financial Data
|
21
|
||
|
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
21
|
||
|
Item
7A.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
25
|
||
|
Item
8.
|
Financial
Statements and Supplementary Data
|
F-1
|
||
|
Item
9.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
26
|
||
|
Item
9A.
|
Controls
and Procedures
|
26
|
||
|
Item
9B.
|
Other
Information
|
28
|
||
|
PART III
|
||||
|
Item
10.
|
Directors
and Executive Officers of the Registrant
|
28
|
||
|
Item
11.
|
Executive
Compensation
|
30
|
||
|
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
33
|
||
|
Item
13.
|
Certain
Relationships and Related Transactions
|
36
|
||
|
Item
14.
|
Principal
Accountant Fees and Services
|
37
|
||
|
PART
IV
|
||||
|
Item
15.
|
Exhibits
and Financial Statement Schedules
|
38
|
||
|
Signatures
|
||||
|
Item 1.
|
Business
|
|
|
|
•
|
combine properties of different
proteins found in nature;
|
|
|
|
•
|
reproduce and amplify selected
activities of natural
proteins;
|
|
|
|
•
|
eliminate undesired properties of
natural proteins; and
|
|
|
|
•
|
incorporate synthetic properties
via chemical modifications
|
|
|
|
·
|
Sets quickly to an adhesive
hydrogel.
|
|
|
|
·
|
Adheres well to tissue, seals gas
and fluid
leaks.
|
|
|
|
·
|
Minimal material
swelling.
|
|
|
|
·
|
Resorbable and non-resorbable
formulations.
|
|
|
|
·
|
Two absorption
rates.
|
|
|
|
·
|
Reduces post-operative
adhesions.
|
|
|
º
|
performance,
|
|
|
º
|
cost,
|
|
|
º
|
safety,
|
|
|
º
|
reliability,
|
|
|
º
|
convenience,
and
|
|
|
º
|
commercial production
capabilities.
|
|
Name
|
Age
|
Position
with the Company
|
||
|
James
B. McCarthy, M.B.A., J.D.
|
57
|
Interim
Chief Executive Officer, Interim Principal Accounting Officer, and Interim
Corporate Secretary
|
||
|
Joseph
Cappello, Ph.D.
|
52
|
Vice
President, Research and Development, Chief Technical Officer and Director,
Clinical Research
|
||
|
Franco
A. Ferrari, Ph.D.
|
57
|
Vice
President, Laboratory Operations and Polymer Production and Director,
Molecular
Genetics
|
|
Item 1A.
|
Risk
Factors
|
|
|
º
|
we will be able to complete the
clinical trials successfully, if at
all;
|
|
|
º
|
we will be able to demonstrate
the safety and efficacy necessary to obtain the requisite regulatory
approvals of product candidates;
or
|
|
|
º
|
the product candidates will
result in marketable
products.
|
|
|
o
|
FDA’s
Good Laboratory Practices;
|
|
|
o
|
FDA Quality System
Regulations;
|
|
|
o
|
Food,
Drug & Cosmetic Act, as amended;
and
|
|
|
o
|
Occupational
Safety and Health Act;
|
|
|
º
|
patents issued to us may be
challenged, invalidated or
circumvented;
|
|
|
º
|
patents may not issue from any of
our pending patent applications or, if issued, may not be sufficiently
broad to protect our technology and products or provide us with any
proprietary protection or competitive
advantage;
|
|
|
º
|
our competitors may have filed
patent applications or may have obtained patents and other proprietary
rights relating to products or processes similar to and competitive with
ours. The scope and validity of such patents may not be known or the
extent to which we may be required to obtain licenses under these patents
or other proprietary rights. If required, we may not be able to obtain any
licenses on acceptable terms, if at
all;
|
|
|
º
|
certain foreign intellectual
property laws may not be as protective as those of the United States;
or
|
|
|
º
|
we may enter into collaborative
research and development arrangements with our strategic partners that may
result in the development of new technologies or products, but may also
get us involved in a dispute over the ownership of rights to any
technology or products that may be so
developed.
|
|
Item 1B.
|
Unresolved Staff
Comments
|
|
Item 2.
|
Properties
|
|
Item 3.
|
Legal
Proceedings
|
|
Item 4.
|
Submission of Matters to a Vote
of Security Holders
|
|
Item 5.
|
Market for Common Equity, Related
Stockholder Matters and Small Business Issuer Purchases of Equity
Securities.
|
|
Trade Prices
|
||||||||
|
2008
|
High
|
Low
|
||||||
|
First
Quarter
|
$ | 0.08 | $ | 0.04 | ||||
|
Second
Quarter
|
0.07 | 0.03 | ||||||
|
Third
Quarter
|
0.06 | 0.02 | ||||||
|
Fourth
Quarter
|
0.04 | 0.01 | ||||||
|
2007
|
||||||||
|
First
Quarter
|
$ | 0.18 | $ | 0.12 | ||||
|
Second
Quarter
|
0.19 | 0.10 | ||||||
|
Third
Quarter
|
0.21 | 0.11 | ||||||
|
Fourth
Quarter
|
0.16 | 0.06 | ||||||
|
Plan Category
|
Number of
securities
to be issued upon
exercise of
outstanding
options, warrants
and
rights
|
Weighted-average
exercise price of
outstanding
options, warrants
and rights
|
Number of
securities
remaining available
for future issuance
under equity
compensation plans
(excluding
securities reflected
in column (a))
|
|||||
|
(a)
|
(b)
|
(c)
|
||||||
|
Equity
Compensation Plans approved by security holders
|
||||||||
|
Stock
Option Plans1
|
3,333,200
|
$
|
0.678
|
6,380,000
|
||||
|
Employee
Stock Purchase Plan2
|
—
|
—
|
—
|
|||||
|
Equity
Compensation Plans not approved by security holders3
|
174,300
|
$
|
0.749
|
n/a
|
||||
|
Item 6.
|
Selected Financial
Data
|
|
Item 7.
|
Management’s Discussion and
Analysis of Financial Condition and Results of
Operations
|
|
Item 7A.
|
Quantitative and Qualitative
Disclosures about Market
Risk
|
|
Item
8.
|
Financial
Statements and Supplementary
Data
|
|
Description
|
Page
|
||
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
||
|
Balance
Sheets at December 31, 2008 and 2007
|
F-3
|
||
|
Statements
of Operations for the years ended December 31, 2008 and
2007
|
F-4
|
||
|
Statements
of Stockholders’ Deficit for the years ended December 31, 2008 and
2007
|
F-5
|
||
|
Statements
of Cash Flows for the years ended December 31, 2008 and
2007
|
F-6
|
||
|
Notes
to Financial Statements
|
F-7
|
|
/s/
SQUAR, MILNER, PETERSON, MIRANDA & WILLIAMSON, LLP
|
|
San
Diego, California
|
|
July
24, 2009
|
|
December
31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Assets
|
||||||||
|
Current
assets:
|
||||||||
|
Cash
|
$ | 1,291 | $ | 21,936 | ||||
|
Prepaid
expenses and other current assets
|
35,011 | 33,419 | ||||||
|
Total
current assets
|
36,302 | 55,355 | ||||||
|
Deposits
|
29,679 | 29,679 | ||||||
|
Equipment
and leasehold improvements, net
|
24,429 | 128,100 | ||||||
|
Investment
|
520,000 | 520,000 | ||||||
|
Total
assets
|
$ | 610,410 | $ | 733,134 | ||||
|
Liabilities
and stockholders' deficit
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 969,435 | $ | 827,626 | ||||
|
Accrued
liabilities
|
844,073 | 794,312 | ||||||
|
Secured
note payable - related party
|
6,414,837 | 5,876,000 | ||||||
|
Notes
payable – Surgica
|
519,071 | 419,071 | ||||||
|
Notes
payable – other, net of unamortized debt discount
|
158,589 | - | ||||||
|
Total
current liabilities
|
8, 906,005 | 7,917,009 | ||||||
|
Notes
payable, net of current maturities
|
- | 100,000 | ||||||
|
Commitments
and contingencies (Note 9)
|
||||||||
|
Stockholders'
deficit:
|
||||||||
|
Convertible
preferred stock, $0.01 par value; 5,000,000 shares authorized; 20,237 and
65,645 shares issued and outstanding at December 31, 2008 and 2007 -
liquidation preference of $2,082,930 and $9,464,500 at December 31, 2008
and 2007, respectively.
|
1,834,299 | 6,019,917 | ||||||
|
Common
stock, $0.01 par value; 1,000,000,000 authorized; 109,387,843 and
73,722,232 shares issued and outstanding at December 31, 2008
and 2007, respectively
|
1,093,878 | 737,222 | ||||||
|
Additional
paid-in capital
|
61,982,390 | 56,227,221 | ||||||
|
Accumulated
deficit
|
(73,206,162 | ) | (70,268,235 | ) | ||||
|
Total
stockholders' deficit
|
(8,295,595 | ) | (7,283,875 | ) | ||||
|
Total
liabilities and stockholders’ deficit
|
$ | 610,410 | $ | 733,134 | ||||
|
Years
ended December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Revenues:
|
||||||||
|
Contract
revenue
|
$ | 24,868 | $ | 287,118 | ||||
|
Total
revenues
|
24,868 | 287,118 | ||||||
|
Operating
Expenses:
|
||||||||
|
Research
and development
|
1,256,662 | 2,503,035 | ||||||
|
Selling,
general and administrative
|
1,040,363 | 809,446 | ||||||
|
Total
expenses
|
2,297,025 | 3,312,481 | ||||||
|
Loss
from operations
|
(2,272,157 | ) | (3,025,363 | ) | ||||
|
Other
expense:
|
||||||||
|
Interest
and other income
|
3,413 | 21,513 | ||||||
|
Interest
expense
|
(709,829 | ) | (442,235 | ) | ||||
|
Gain
from sale of assets
|
40,646 | - | ||||||
|
Gain
on settlement of accounts payable
|
- | 193,917 | ||||||
|
Total
other expense
|
(665,770 | ) | (226,805 | ) | ||||
|
Net
loss
|
(2,937,927 | ) | (3,252,168 | ) | ||||
|
Undeclared
and imputed and/or paid dividends on preferred stock
|
208,973 | 285,976 | ||||||
|
Net
loss applicable to common shareholders
|
$ | (3,146,900 | ) | $ | (3,538,144 | ) | ||
|
Basic
and diluted net loss per common share
|
$ | (0.03 | ) | $ | (0.05 | ) | ||
|
Shares
used in computing basic and diluted net loss per common
share
|
97,409,563 | 68,316,641 | ||||||
|
Additional
|
Total
|
|||||||||||||||||||||||||||
|
Common Stock
|
Preferred Stock
|
Paid-in
|
Accumulated
|
Stockholders'
|
||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Deficit
|
||||||||||||||||||||||
|
Balance
at December 31, 2006
|
67,409,204 | 674,092 | 65,645 | 6,019,917 | 55,760,511 | (67,007,742 | ) | (4,553,222 | ) | |||||||||||||||||||
|
Share
based compensation expense
|
– | – | – | – | (109,552 | ) | – | (109,552 | ) | |||||||||||||||||||
|
Imputed
dividend on extension of warrant
|
– | – | – | – | 8,325 | (8,325 | ) | – | ||||||||||||||||||||
|
Issuance
of common stock for dispute settlement
|
400,000 | 4,000 | – | – | 57,067 | – | 61,067 | |||||||||||||||||||||
|
Issuance
of common stock pursuant to stock purchase agreement
|
5,913,028 | 59,130 | – | – | 510,870 | – | 570,000 | |||||||||||||||||||||
|
Net
loss
|
– | – | – | – | – | (3,252,168 | ) | (3,252,168 | ) | |||||||||||||||||||
|
Balance
at December 31, 2007
|
73,722,232 | $ | 737,222 | 65,645 | $ | 6,019,917 | $ | 56,227,221 | $ | (70,268,235 | ) | $ | (7,283,875 | ) | ||||||||||||||
|
Share
based compensation expense
|
– | – | – | – | 4,255 | – | 4,255 | |||||||||||||||||||||
|
Imputed
dividend on extension of warrant
|
– | – | – | – | 18,231 | – | 18,231 | |||||||||||||||||||||
|
Debt
discount for warrants issued
|
196,221 | – | 196,221 | |||||||||||||||||||||||||
|
Issuance
of common stock pursuant to stock purchase agreement
|
36,586,091 | 365,861 | – | – | 1,346,639 | – | 1,712,500 | |||||||||||||||||||||
|
Stock
repurchase
|
(920,480 | ) | (9,205 | ) | (45,408 | ) | (4,185,618 | ) | 4,189,823 | – | (5,000 | ) | ||||||||||||||||
|
Net
loss
|
– | – | – | – | – | (2,937,927 | ) | (2,937,927 | ) | |||||||||||||||||||
|
Balance
at December 31, 2008
|
109,387,843 | $ | 1,093,878 | 20,237 | $ | 1,834,299 | $ | 61,982,390 | $ | (73,206,162 | ) | $ | (8,295,595 | ) | ||||||||||||||
|
Years
ended December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Operating
activities
|
||||||||
|
Net
loss
|
$ | (2,937,927 | ) | $ | (3,252,168 | ) | ||
|
Adjustments
to reconcile net loss to net cash used for operating
activities:
|
||||||||
|
Gain
on sale of assets
|
(40,646 | ) | - | |||||
|
Gain
on settlement of accounts payable
|
- | (193,917 | ) | |||||
|
Depreciation
and amortization
|
43,317 | 100,375 | ||||||
|
Debt
discount amortization
|
143,041 | - | ||||||
|
Share-based
compensation expense
|
4,255 | (109,552 | ) | |||||
|
Other
income
|
- | (21,368 | ) | |||||
|
Changes
in operating assets and liabilities:
|
||||||||
|
Contracts
receivable
|
- | 21,068 | ||||||
|
Rent
receivable
|
- | 39,527 | ||||||
|
Prepaid
expenses and other current assets
|
(1,593 | ) | 16,521 | |||||
|
Accounts
payable
|
141,809 | (210,127 | ) | |||||
|
Accrued
liabilities
|
588,599 | 578,047 | ||||||
|
Deferred
rent
|
- | (4,449 | ) | |||||
|
Net
cash used for operating activities
|
(2,059,145 | ) | (3,036,043 | ) | ||||
|
Investing
activities
|
||||||||
|
Proceeds
from sale of equipment
|
101,000 | - | ||||||
|
Net
cash provided by investing activities
|
101,000 | - | ||||||
|
Financing
activities
|
||||||||
|
Net
proceeds from sale of common stock
|
1,712,500 | - | ||||||
|
Repurchase
of common and preferred stock
|
(5,000 | ) | - | |||||
|
Net
proceeds from subscriptions to purchase common stock
|
- | 570,000 | ||||||
|
Proceeds
from issuance of debt - related party
|
- | 2,414,484 | ||||||
|
Proceeds
from issuance of notes payable
|
230,000 | - | ||||||
|
Net
cash provided by financing activities
|
1,937,500 | 2,984,484 | ||||||
|
Net
decrease in cash
|
(20,645 | ) | (51,559 | ) | ||||
|
Cash
at beginning of the period
|
21,936 | 73,495 | ||||||
|
Cash
at end of the period
|
$ | 1,291 | $ | 21,936 | ||||
|
Supplemental
disclosures of cash flow information
|
||||||||
|
Interest
paid
|
$ | 2,703 | $ | 5,263 | ||||
|
Non
cash investing and financing activity
|
||||||||
|
Imputed
dividend on extension of warrants
|
$ | 18,231 | $ | 8,325 | ||||
|
Debt
discount recorded related to warrants issued in connection with notes
payable - other
|
$ | 79,000 | $ | - | ||||
|
Debt
discount recorded related to warrants issued in connection with extension
of tern of secured note payable – related party
|
$ | 135,000 | $ | - | ||||
|
Reclassification
of accrued interest to secured note payable – related
party
|
$ | 538,837 | $ | - | ||||
|
1.
|
Organization
and Significant Accounting
Policies
|
|
2.
|
Equipment
and Leasehold Improvements
|
|
December
31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Laboratory
equipment
|
$ | 298,000 | $ | 1,378,000 | ||||
|
Office
equipment
|
60,000 | 220,000 | ||||||
|
Leasehold
improvements
|
- | 360,000 | ||||||
| 358,000 | 1,958,000 | |||||||
|
Less
accumulated depreciation and amortization
|
(334,000 | ) | (1,830,000 | ) | ||||
| $ | 24,000 | $ | 128,000 | |||||
|
3.
|
Investment
|
|
4.
|
Accrued
Liabilities
|
|
December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Payroll
and employee benefits
|
$ | 67,000 | $ | 82,000 | ||||
|
Professional
fees
|
- | 23,000 | ||||||
|
Accrued
interest
|
610,000 | 585,000 | ||||||
|
Insurance
premium financing
|
27,000 | 22,000 | ||||||
|
Directors
fees
|
100,000 | 60,000 | ||||||
|
Other
|
40,000 | 22,000 | ||||||
| $ | 844,000 | $ | 794,000 | |||||
|
5.
|
Secured
Notes Payable – Related Party
|
|
April 2006
Issuance
|
January 2008
Modification
|
January 2008
Issuance
|
||||||
|
|
4/13/06
Warrant
|
4/13/06
Warrant
|
1/09/08
Warrant
|
|||||
|
Expected
annual dividends
|
0
|
%
|
0
|
%
|
0
|
%
|
||
|
Risk-free
interest rate
|
4.9
|
%
|
3.0
|
%
|
2.7
|
%
|
||
|
Expected
term (in years)
|
3.0
|
1.3
|
3.1
|
|||||
|
Expected
Volatility
|
90.0
|
%
|
157.0
|
%
|
157.0
|
%
|
||
|
6.
|
Notes
Payable - Other
|
|
Date
|
Amount
|
|||
|
October
2, 2008
|
$ | 100,000 | ||
|
November
3, 2008
|
105,000 | |||
|
December
11, 2008
|
25,000 | |||
|
Total
|
$ | 230,000 | ||
|
Date
|
Amount
|
Exercise
Price
|
||||||
|
October
2, 2008
|
2,000,000 | $ | 0.05 | |||||
|
November
3, 2008
|
2,625,000 | 0.04 | ||||||
|
December
11, 2008
|
625,000 | 0.04 | ||||||
|
Total
|
5,250,000 | |||||||
|
10/02/08
Warrant
|
11/03/08
Warrant
|
12/11/08
Warrant
|
||||||||||
|
Expected
annual dividends
|
0 | % | 0 | % | 0 | % | ||||||
|
Risk-free
interest rate
|
1.9 | % | 1.5 | % | 1.1 | % | ||||||
|
Expected
term (in years)
|
3.0 | 3.0 | 3.0 | |||||||||
|
Expected
Volatility
|
111.9 | % | 63.7 | % | 56.7 | % | ||||||
|
Total
|
||||
|
Principal
value of notes
|
$ | 230,000 | ||
|
Less:
Unamortized debt discount
|
(71,400 | ) | ||
| $ | 158,600 | |||
|
Year Ending
December 31,
|
Notes Payable
Maturities
|
|||
|
2008
|
419,000
|
|||
|
2009
|
100,000
|
|||
|
Total
maturities
|
$
|
519,000
|
||
|
7.
|
Stockholders’
Deficit
|
|
Options
Outstanding
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
||||||||||
|
Outstanding at
December 31, 2006
|
12,454,582 | 0.66 | 6.5 | |||||||||
|
Issued
|
- | - | ||||||||||
|
Cancelled/Expired
|
(957,096 | ) | 0.52 | |||||||||
|
Exercised
|
— | — | ||||||||||
|
Outstanding
at December 31, 2007
|
11,497,486 | $ | 0.65 | 5.3 | ||||||||
|
Issued
|
- | - | ||||||||||
|
Cancelled/Expired
|
(7,989,986 | ) | 0.64 | |||||||||
|
Exercised
|
— | — | ||||||||||
|
Outstanding
at December 31, 2008
|
3,507,500 | $ | 0.68 | 4.4 | ||||||||
|
Exercisable
at December 31, 2008
|
3,485,436 | $ | 0.68 | 4.4 | ||||||||
|
Number of
Warrants
Outstanding
and
Exercisable
|
Weighted-
Average
Exercise
Price
|
|||||||
|
Outstanding, December 31, 2006
|
17,178,494 | $ | 0.55 | |||||
|
Granted
|
5,913,028 | $ | 0.10 | |||||
|
Exercised
|
— | $ | — | |||||
|
Expired
|
(1,320,302 | ) | $ | (0.92 | ) | |||
|
Outstanding,
December 31, 2007
|
21,771,220 | $ | 0.41 | |||||
|
Granted
|
44,274,091 | $ | 0.05 | |||||
|
Exercised
|
— | $ | — | |||||
|
Expired
|
(2,798,997 | ) | $ | (0.64 | ) | |||
|
Outstanding,
December 31, 2008
|
63,246,314 | $ | 0.14 | |||||
|
8.
|
Stockholder
Protection Agreement
|
|
9.
|
Commitments
and Contingencies
|
|
Year Ending
December 31,
|
Operating
Leases
|
|||
|
2009
|
$
|
2,340
|
||
|
2010
|
720
|
|||
|
Total
minimum operating lease payments
|
$
|
3,060
|
||
|
2008
|
2007
|
|||||||
|
Deferred
tax assets:
|
||||||||
|
Allowances
|
174,000 | 161,000 | ||||||
|
Stock-based
compensation/warrants
|
511,000 | 509,000 | ||||||
|
Amortization/impairment
of license
|
308,000 | 334,000 | ||||||
|
Basis
difference fixed assets
|
639,000 | 790,000 | ||||||
|
Accrued
expenses
|
40,000 | - | ||||||
|
Other,
net
|
15,000 | 25,000 | ||||||
|
Total
deferred tax assets
|
1,687,000 | 1,819,000 | ||||||
|
Valuation
allowance for deferred tax assets
|
(1,687,000 | ) | (1,819,000 | ) | ||||
|
Net
deferred tax assets
|
$ | - | $ | - | ||||
|
2008
|
2007
|
|||||||
|
Expected
federal income tax benefit
|
$ | (999,000 | ) | $ | (1,105,900 | ) | ||
|
Expected
state income tax benefit, net of federal benefit
|
76,000 | (181,600 | ) | |||||
|
Decrease
in valuation allowance
|
(132,000 | ) | 171,500 | |||||
|
FIN
48 adjustments
|
1,006,900 | 1,069,100 | ||||||
|
Stock
options
|
- | 53,900 | ||||||
|
Other
|
48,100 | (7,000 | ) | |||||
|
Provision
for income taxes
|
$ | - | $ | - | ||||
|
|
·
|
Pervasive,
entity-level control deficiencies across key COSO components in the
Company’s control environment,
including:
|
|
|
o
|
Controls
over the period-end financial closing and reporting
processes;
|
|
|
o
|
Controls
over managerial override;
|
|
|
o
|
Controls
to prevent or reduce the risk of fraudulent
activity;
|
|
|
o
|
Controls
to monitor other controls, including the role of the Board of Directors;
and
|
|
|
o
|
Controls
related to risk assessment.
|
|
|
·
|
An
absence of independence and financial expertise on the Board of Directors,
limiting its ability to provide effective
oversight.
|
|
|
·
|
An
absence of a formalized process to manage the Company’s internal controls
over financial reporting and become compliant with Section 404 of the
Sarbanes-Oxley Act.
|
|
|
·
|
Inadequate
controls over the period-end financial close and reporting
processes;
|
|
|
·
|
Insufficient
personnel resources and technical accounting expertise within the
accounting function to provide for adequate segregation of duties and to
properly account for non-routine or complex accounting matters;
and
|
|
|
·
|
Inadequate
documentation of policies, procedures, and controls related to finance and
accounting, including inadequate procedures for appropriately identifying,
assessing, and applying accounting
principles.
|
|
|
·
|
Working
with the Board of Directors to recruit an independent financial expert who
will formalize roles and responsibilities over the Company’s internal
controls over financial reporting for the Board and
Management.
|
|
|
·
|
Implementing
a formal process to manage its internal controls over financial reporting
as part of its efforts to become compliant with Section 404 of the
Sarbanes-Oxley Act. Management has retained the services of a
third-party consulting firm to assist Company management with compliance
with Section 404 of the Sarbanes-Oxley Act of 2002 (SOX);
and
|
|
|
·
|
Retaining
the services of a third-party consulting firm with sufficient expertise to
assist Company management with:
|
|
o
|
Overseeing the daily
accounting function, including cash receipts and disbursements, billing,
payroll, and month-end bookkeeping
processes;
|
|
|
o
|
Identifying
and resolving non-routine or complex accounting
matters;
|
|
|
o
|
Controlling
period-end financial closing and reporting processes;
and
|
|
|
o
|
Identifying,
assessing, and applying accounting
principles.
|
|
|
o
|
Formalizing
its accounting policies and procedures, including defined roles and
responsibilities and required managerial reviews and
approvals,
|
|
Name
|
Age
|
Position
with the Company
|
||
|
James
B. McCarthy, M.B.A., J.D. (2)
|
57
|
Director,
Interim Chief Executive Officer, Interim Principal Accounting Officer, and
Interim Corporate Secretary
|
||
|
Allan
Farber (1)(2)
|
62
|
Director
|
||
|
Kerry
L. Kuhn, M.D. (1)
|
59
|
Director
|
||
|
Richard
Adelson (1)(2)
|
52
|
Director
|
||
|
William
N. Plamondon III
|
61
|
Director
|
||
|
Joseph
Cappello, Ph.D.
|
52
|
Vice
President, Research and Development, Chief Technical Officer and Director,
Clinical Research
|
||
|
Franco
A. Ferrari, Ph.D.
|
57
|
Vice
President, Laboratory Operations and Polymer Production and Director,
Molecular Genetics
|
|
Name and Principal
Position
|
Salary
|
Bonus
|
Stock
Award
|
Option
Award
|
Non-Equity
Incentive Plan
Compensation
|
Change in
Pension Value
and
Nonqualified
Deferred
Compensation
Earnings
|
All Other
Compensation
|
Total
|
||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||
|
James
B. McCarthy, Interim Chief Executive Officer/ Interim Principal Accounting
Officer/ Interim Corporate Secretary, effective November 29,
2007
|
- | - | - | - | - | - | 180,000 | (1) | 180,000 | |||||||||||||||||||||||
|
Joseph
Cappello, Ph.D, VP, Research and Development, Chief Technical Officer and
Director, Clinical Research
|
167,860 | - | - | - | - | - | - | 167,860 | ||||||||||||||||||||||||
|
Franco
A. Ferrari, Ph.D, VP, Laboratory Operations and Polymer Production and
Director, Molecular Genetics
|
154,780 | - | - | - | - | - | - | 154,780 | ||||||||||||||||||||||||
|
(1)
|
Mr.
McCarthy’s compensation for the year ended December 31, 2008 consisted of
consulting fees payable to Gemini Consulting Group, Inc., of which he is
the chief executive officer. The monthly fee is $15,000 of which the
entire annual fee of $180,000 was paid in cash during
2008.
|
|
Option/Warrants
Awards
|
Stock
Awards
|
|||||||||||||||||||||||
|
Name
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
Equity
Incentive
Plan
Awards
Number
of
Securities
Underlying
Unexercised
Unearned
Options
(#)
|
Option
Exercise
Price
|
Option
Expiration
Date
|
Number
of
Shares
or
Units
of
Stock
That
Have
Not
Vested
(#)
|
Market
Value
of
Shares
or
Unit
That
Have
Not
Vested
|
Equity
Incentive
Plan
Awards:
Number
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
(#)
|
Equity
Incentive
Plan
Awards:
Market
or
Payout
Value
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
|
|||||||||||||||
|
James
B.
McCarthy
|
80,000
|
0
|
0
|
0.77
|
6/01/2015
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
80,000
|
0
|
0
|
0.20
|
6/01/2016
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
Joseph
Cappello, Ph.D.
|
10,000
|
0
|
0
|
0.88
|
9/26/2010
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
50,000
|
0
|
0
|
0.80
|
4/12/2011
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
20,000
|
0
|
0
|
0.85
|
5/29/2011
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
50,000
|
0
|
0
|
0.37
|
11/25/2012
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
1,350,000
|
0
|
0
|
0.73
|
4/25/2013
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
25,000
|
0
|
0
|
0.65
|
1/03/2015
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
Franco
A. Ferrari, Ph.D.
|
10,000
|
0
|
0
|
0.88
|
9/26/2010
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
50,000
|
0
|
0
|
0.80
|
4/12/2011
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
20,000
|
0
|
0
|
0.85
|
5/29/2011
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
50,000
|
0
|
0
|
0.37
|
11/25/2012
|
||||||||||||||||||||
|
1,200,000
|
0
|
0
|
0.73
|
4/25/2013
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
25,000
|
0
|
0
|
0.65
|
1/03/2015
|
||||||||||||||||||||
|
Item 12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
|
(i)
|
all persons known by the Company
to be the beneficial owner of more than 5% of the common stock, Series D
Preferred Stock (on an as converted basis), Series F Preferred Stock (on
an as converted basis), Series G Preferred Stock (on an as converted
basis), Series H Preferred Stock (on an as converted basis) and Series I
Preferred Stock (on an as converted
basis),
|
|
(ii)
|
all directors and nominees for
directors,
|
|
(iii)
|
each executive officer named
below, and
|
|
(iv)
|
all directors and executive
officers as a group.
|
|
Name and Address
|
Amount & Nature
of Beneficial
|
Approximate
|
||||||
|
of Beneficial Owner
|
Ownership
|
Percentage*
|
||||||
|
William
N. Plamondon, III(1)
|
-0- | ** | ||||||
|
Richard
Adelson(1)
|
389,181 |
(3)
|
** | |||||
|
Allan
Farber(1)
|
985,607 |
(4)
|
** | |||||
|
Kerry
L. Kuhn, MD(1)
|
820,000 |
(5)
|
** | |||||
|
James
B. McCarthy(1)(2)
|
160,000 |
(6)
|
** | |||||
|
Joseph
Cappello, Ph.D.(2)
|
1,580,748 |
(7)
|
1.4 | % | ||||
|
Franco
A. Ferrari, Ph.D.(2)
|
1,456,359 |
(8)
|
1.3 | % | ||||
|
Redec
& Associates, LLC
c/o
Protein Polymer Technologies, Inc.
11494
Sorrento Valley Road
San
Diego, California 92121
|
11,432,036 |
(9)
|
10.1 | % | ||||
|
Hunter
& Co.
c/o
Protein Polymer Technologies, Inc.
11494
Sorrento Valley Road
San
Diego, California 92121
|
27,940,935 |
(10)
|
20.3 | % | ||||
|
Matthew
Szulik
c/o
Protein Polymer Technologies, Inc.
11494
Sorrento Valley Road
San
Diego, California 92121
|
89,027,350 |
(11)
|
57.8 | % | ||||
|
All
Officers and Directors as a Group
|
5,391,895 |
(3)-(8)
|
4.7 | % | ||||
|
*
|
Based upon 112,959,272 shares
issued and outstanding as of June 30, 2009 except as otherwise provided in
the footnotes.
|
|
**
|
Less than
1%.
|
|
(1)
|
Director.
|
|
(2)
|
Executive
Officer.
|
|
(3)
|
Includes i) 50,000 shares subject
to options exercisable within 60 days and ii) 3,400 shares owned by the
stockholder’s spouse. Excludes 1,392,372 shares of common stock held in
trust for the stockholder’s mother. The stockholder disclaims beneficial
ownership of the shares owned in trust for his
mother.
|
|
(4)
|
All shares are owned by the
stockholder’s spouse. Includes 45,455 shares issuable upon conversion of
Series I Preferred Stock within 60
days.
|
|
(5)
|
Includes (i) 365,000 shares
subject to options exercisable within 60 days and (ii) 80,000 shares
issuable upon conversion of Series G Preferred Stock convertible within 60
days.
|
|
(6)
|
Includes 160,000 shares subject
to options exercisable within 60
days.
|
|
(7)
|
Includes 1,505,000 shares subject
to options exercisable within 60
days.
|
|
(8)
|
Includes 1,355,000 shares subject
to options exercisable within 60
days.
|
|
(9)
|
Includes 554,545 shares issuable
upon conversion of shares of Series I Preferred Stock convertible within
60 days.
|
|
(10)
|
Includes
24,369,506 shares subject to warrants exercisable within 60
days.
|
|
(11)
|
Includes (i) 127,273 shares
issuable upon conversion of the Company’s Series I Preferred Stock
convertible within 60 days and (ii) 40,946,038 shares subject to warrants
exercisable within 60 days.
|
|
|
·
|
Audit
Fees: Aggregate fees billed for professional services rendered for the
audit of our annual financial statements for the fiscal years ended
December 31, 2007 and December 31, 2008, for review of our financial
statements included in our quarterly reports on Form 10-QSB or Form 10-Q
for those years, and services normally provided in connection with
statutory and regulatory filings and engagements for those years, were
approximately $136,100 and $112,900,
respectively.
|
|
|
·
|
Audit-Related
Fees: There were no fees billed for assurance and related services
reasonably related to the performance of the audit or review of our
financial statements and not reported under “Audit Fees” above in the
fiscal years ended December 31, 2007 and December 31,
2008.
|
|
|
·
|
Tax
Fees. Aggregate fees billed for tax services were approximately $5,900 and
$6,800 in the fiscal years ended December 31, 2007 and December 31, 2008,
respectively. These fees were primarily for compliance fees for the
preparation of tax returns, assistance with tax planning strategies, and
tax advice.
|
|
|
·
|
All
Other Fees: There were no fees billed for services other than those
described above in the fiscal years ended December 31, 2007 and December
31, 2008.
|
|
Exhibit Number
|
Description
|
|
|
3.1.1
(1)
|
Certificate
of Incorporation of the Company, as amended through September 30,
1995.
|
|
|
3.1.2
(26)
|
Amendment
to the Certificate of Incorporation, dated September 20,
2007.
|
|
|
3.2
(2)
|
Bylaws
of the Company, as amended through December 31, 1998.
|
|
|
4.1
(26)
|
Registration
Rights Agreement between the Company and TAG Virgin Islands, Inc., as
Agent for the Purchasers named therein, dated as of September 27,
2007.
|
|
|
10.1
(3)
|
1989
Stock Option Plan, together with forms of Incentive Stock Option Agreement
and Nonstatutory Option Agreement.
|
|
|
10.2
(4)
|
1992
Stock Option Plan of the Company, together with forms of Incentive Stock
Option Agreement and Nonstatutory Option Agreement.
|
|
|
10.3
(3)
|
Form
of Employee’s Proprietary Information and Inventions
Agreement.
|
|
|
10.4
(3)
|
Form
of Consulting Agreement.
|
|
|
10.5
(3)
|
Form
of Indemnification Agreement.
|
|
|
10.6
(4)
|
License
Agreement, dated as of April 15, 1992, between the Board of Trustees of
the Leland Stanford Junior University and the Company.
|
|
|
10.7
(5)
|
Securities
Purchase Agreement related to the sale of the Company’s Series D Preferred
Stock.
|
|
|
10.8
(6)
|
1996
Non-Employee Directors’ Stock Option Plan.
|
|
|
10.9
(7)
|
Stockholder
Protection Agreement, dated August 22, 1997, between the Company and
Continental Stock Transfer & Trust Company as rights
agent.
|
|
|
10.10
(8)
|
Employee
Stock Purchase Plan, together with Form of Stock Purchase
Agreement.
|
|
|
10.11
(9)
|
Lease,
with rider and exhibits, dated April 13, 1998, between the Company and
Sycamore/San Diego Investors.
|
|
|
10.12
(10)
|
First
Amendment to Stockholder Protection Agreement dated April 24, 1998,
between the Company and Continental Stock Transfer & Trust Company as
rights agent.
|
|
|
10.13
(11)
|
Letter
of Agreement dated April 13, 1998 between the Company and Johnson &
Johnson Development Corporation for the exchange of up to 27,317 shares of
Series D Preferred Stock for a like number of shares of Series F Preferred
Stock.
|
|
|
10.14
(12)
|
Securities
Purchase Agreement related to the sale of the Company’s Series G
Convertible Preferred Stock.
|
|
|
10.15
(12)
|
Second
Amendment to Stockholder Protection Agreement, dated July 26, 1999 between
the Company and Continental Stock Transfer and Trust Company as rights
agent.
|
|
|
10.16
(13)**
|
License
and Development Agreement dated as of January 26, 2000 between the Company
and Prospectivepiercing Limited, to be known as Femcare Urology
Limited.
|
|
|
10.17
(13)**
|
Supply
Agreement dated as of January 26, 2000 between the Company and Femcare
Urology Limited.
|
|
|
10.18
(13)**
|
Escrow
Agreement dated as of January 26, 2000 between the Company and Femcare
Urology Limited.
|
|
|
10.19
(13)
|
License
Agreement dated as of February 18, 2000 between the Company and Sanyo
Chemical Industries, Ltd.
|
|
|
10.20
(14)**
|
License
Agreement dated December 21, 2000 between the Company and Genencor
International, Inc.
|
|
10.21
(14)
|
Form
of Warrant to Purchase Common Stock issued in connection with License
Agreement between the Company and Genencor International,
Inc.
|
|
|
10.22
(15)
|
Securities
Purchase Agreement related to the sale of the Company’s Series H Preferred
Stock.
|
|
|
10.23
(17)**
|
Founder
Stock Purchase Agreement dated April 12, 2001 between the Company and
Spine Wave Inc.
|
|
|
10.24
(17)**
|
License
Agreement dated April 12, 2001 between the Company and Spine Wave,
Inc.
|
|
|
10.25
(17)**
|
Escrow
Agreement dated April 12, 2001 between the Company and Spine Wave,
Inc.
|
|
|
10.26
(17)**
|
Supply
and Services Agreement dated April 12, 2001 between the Company and Spine
Wave, Inc.
|
|
|
10.27
(18)**
|
Amendment
No. 1 to Supply and Services Agreement dated February 12, 2002 between the
Company and Spine Wave, Inc.
|
|
|
10.28
(18)**
|
Stock
Purchase and Vesting Agreement dated March 21, 2002 between the Company
and Spine Wave, Inc.
|
|
|
10.29
(16)
|
Warrant
to Purchase Shares of Common Stock of Spine Wave, Inc. issued to the
Company.
|
|
|
10.30
(19)
|
First
Amendment to the License Agreement dated October 1, 2002 between the
Company and Genencor International, Inc.
|
|
|
10.31
(19)
|
Employment
Agreement, dated as of December 31, 2002, between the Company and J.
Thomas Parmeter.
|
|
|
10.32
(19)
|
Employment
Agreement, dated as of December 31, 2002, between the Company and John E.
Flowers.
|
|
|
10.33
(19)
|
Employment
Agreement, dated as of December 31, 2002, between the Company and Joseph
Cappello.
|
|
|
10.34
(19)
|
Employment
Agreement, dated as of December 31, 2002, between the Company and Franco
A. Ferrari.
|
|
|
10.35
(20)
|
2002
Stock Option Plan, and forms of Incentive Stock Option Agreement and
Non-Statutory Stock Option Agreement.
|
|
|
10.36
(21)**
|
Amendment
No. 2 to Supply and Services Agreement dated October 1, 2003 between the
Company and Spine Wave, Inc.
|
|
|
10.37
(22)
|
Securities
Purchase Agreement, dated as of March 31, 2005, by and among the Company
and certain investors.
|
|
|
10.38
(22)
|
Form
of Warrant to Purchase Shares of Common Stock of the Company in connection
with Securities Purchase Agreement dated as of March 31,
2005.
|
|
|
10.39
(23)
|
Form
of Warrant to Purchase Shares of Common Stock of the Company issued to
William N. Plamondon, III.
|
|
|
10.44
(24)
|
Irrevocable
Proxy, dated as of November 23, 2005, executed by Louis R. Matson in favor
of the Company.
|
|
|
10.40
(25)**
|
Asset
Purchase Option Agreement, dated as of November 23, 2005, by and between
the Company and Surgica Corporation.
|
|
|
10.41
(25)**
|
License
Agreement, dated as of December 19, 2005, between the Company and Surgica
Corporation.
|
|
|
10.42
(25)**
|
Supply
and Services Agreement, dated as of December 19, 2005, between the Company
and Surgica Corporation.
|
|
|
10.43
(25)**
|
Voting
Agreement, dated as of November 23, 2005, between the Company and Louis R.
Matson.
|
|
|
10.44
(26)
|
Common
Stock Purchase Agreement between the Company and TAG Virgin Islands, Inc.,
as Agent for the Purchasers named therein, dated as of September 27,
2007.
|
|
|
10.45
(26)
|
Amendment
No. 7 to Secured Promissory Note issued to Matthew J. Szulik, dated
November 10, 2007.
|
|
10.46
(27)
|
Amendment
1 to the Common Stock Purchase Agreement between the Company and TAG
Virgin Islands, Inc., as Agent for the Purchasers named therein, dated as
of November 28, 2007.
|
|
10.47
(27)
|
Secured
Promissory Note Replacement Agreement, dated as of January 9, 2008,
between the Company and Matthew J. Szulik.
|
|
10.48
(27)
|
Secured
Promissory Note issued to Matthew J. Szulik, dated as of January 9,
2008.
|
|
10.49
(27)
|
Form
of Warrant to Purchase Shares of Common Stock of the Company in connection
with the Secured Promissory Note issued to Matthew J. Szulik, dated as of
January 9. 2008.
|
|
10.50
(28)
|
Form
of Promissory Note issued to noteholders on October 2, 2008, November 3,
2008, December 11, 2008, February 6, 2009, March 18, 2009, April 20, 2009,
May 7, 2009, and June 5, 2009.
|
|
10.51
(28)
|
Form
of Warrant to Purchase Shares of Common Stock of the Company in connection
with the Promissory Notes issued to noteholders on October 2, 2008,
November 3, 2008, December 11, 2008, February 6, 2009, March 18, 2009,
April 20, 2009, May 7, 2009, and June 5, 2009.
|
|
10.52**
|
Technology
License Agreement between the Company and Sanyo Chemical Industries, Ltd.,
dated as of June 18, 2009.
|
|
14.1
(29)
|
Code
of Conduct.
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
31.2
|
Certification
of Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
|
32.2
|
Certification
of Principal Financial Officer pursuant to Section 960 of the
Sarbanes-Oxley Act of 2002.
|
|
(1)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the quarter ended September 30,
1995, SEC File No. 000-19724, as filed with the Commission on October 25,
1995.
|
|
(2)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
1998, as filed with the Commission on March 5,
1999.
|
|
(3)
|
Incorporated by reference to the
Company's Registration Statement on Form S-1 (No. 33-43875), SEC File No.
033-43875, filed with the Commission on November 12, 1991, as amended by
Amendments Nos. 1, File No. 033-43875, 2, SEC File No. 033-43875, 3, SEC
File No. 033-43875, and 4, SEC File No. 033-43875, thereto filed on
November 25, 1991, December 23, 1991, January 17, 1992 and January 21,
1992, respectively.
|
|
(4)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
1992, SEC File No. 000-19724, as filed with the Commission on March 31,
1993.
|
|
(5)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the quarter ended September 30,
1995, SEC File No. 000-19724, as filed with the Commission on October 25,
1995.
|
|
(6)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
1996, SEC File No. 000-19724, as filed with the Commission on March 27,
1997.
|
|
(7)
|
Incorporated by reference to
Registrant’s Current Report on Form 8-K, SEC File No. 000-19724, as filed
with the Commission on August 27,
1997.
|
|
(8)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
1997, SEC File No. 000-19724, as filed with the Commission on April 15,
1998.
|
|
(9)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the quarter ended March 31, 1998,
SEC File No. 000-19724, as filed with the Commission on May 15,
1998.
|
|
(10)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the Quarter ended June 30, 1998,
SEC File No. 000-19724, as filed with the Commission on August 14,
1998.
|
|
(11)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
1998, as filed with the Commission on March 5,
1999.
|
|
(12)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the quarter ended September 30,
1999, SEC File No. 000-19724, as filed with the Commission on November 12,
1999.
|
|
(13)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
1999, SEC File No. 000-19724, as filed with the Commission on March 24,
2000.
|
|
(14)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
2000, SEC File No. 000-19724, as filed with the Commission on February 22,
2001.
|
|
(15)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the quarter ended September 30,
2001, SEC File No. 000-19724, as filed with the Commission on November 14,
2001.
|
|
(16)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the quarter ended September 30,
2002, SEC File No. 000-19724, as filed with the Commission on November 13,
2002.
|
|
(17)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB/A for the fiscal year ended December
31, 2001, SEC File No. 000-19724, as filed with the Commission on March 5,
2003.
|
|
(18)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB/A for the period ended September 30,
2002, SEC File No. 000-19724, as filed with the Commission on March 5,
2003.
|
|
(19)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
2002, SEC File No. 000-19724, as filed with the Commission on March 28,
2003.
|
|
(20)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the period ended March 31, 2003,
SEC File No. 000-19724, as filed with the Commission on May 14,
2003.
|
|
(21)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
2003, SEC File No. 000-19724, as filed with the Commission on March 28,
2003.
|
|
(22)
|
Incorporated by reference to
Registrant’s Current Report on Form 8-K, SEC File No. 000-19724, as filed
with the Commission on April 7,
2005.
|
|
(23)
|
Incorporated by reference to
Registrant’s Report on Form 10-QSB for the quarter ended June 30, 2005,
SEC File No. 000-19724, as filed with the Commission on August 17,
2005.
|
|
(24)
|
Incorporated by reference to
Registrant's Current Report on Form 8-K, SEC File No. 000-19724, as filed
with the Commission on December 22,
2005.
|
|
(25)
|
Incorporated by reference to
Registrant's Report on Form 10-KSB for the fiscal year ended December 31,
2005, SEC File No. 000-19724, as filed with the Commission on March 31,
2006.
|
|
(26)
|
Incorporated by reference to
Registrant's Report on Form 10-QSB for the quarter ended September 30,
2007, SEC File No. 000-19724, as filed with the Commission on November 19,
2007.
|
|
27)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
2007, SEC File No. 000-19724, as filed with the Commission on May 12,
2008.
|
|
(28)
|
Incorporated by reference to
Registrant’s Report on Form 10-Q for the quarter ended September 30, 2008,
SEC File No. 000-19724, as filed with the Commission on November 19,
2008.
|
|
(29)
|
Incorporated by reference to
Registrant’s Report on Form 10-KSB for the fiscal year ended December 31,
2004, SEC File No. 000-19724, as filed with the Commission on March 31,
2005.
|
|
**
|
Portions of this document have
been redacted pursuant to a Request for Confidential Treatment filed with
the Securities and Exchange
Commission.
|
|
PROTEIN
POLYMER TECHNOLOGIES, INC.
|
||
|
July
24, 2009
|
By:
|
/S/ JAMES B. MCCARTHY
|
|
James
B. McCarthy
|
||
|
Interim
Chief Executive Officer
|
||
|
Signature
|
Capacity
|
Date
|
||
|
/S/ JAMES B. MCCARTHY
|
Interim
Chief Executive Officer,
|
July
24, 2009
|
||
|
James
B. McCarthy
|
Interim
Principal Financial Officer, and
|
|||
|
Interim
Corporate Secretary
|
||||
|
/S/ ALLAN FARBER
|
Director
|
July
24, 2009
|
||
|
Allan
Farber
|
||||
|
/S/ KERRY L. KUHN
|
Director
|
July
24, 2009
|
||
|
Kerry
L. Kuhn, M.D.
|
||||
|
/S/ RICHARD ADELSON
|
Director
|
July
24, 2009
|
||
|
Richard
Adelson
|
||||
|
/S/ WILLIAM N. PLAMONDON
III
|
Director
|
July
24, 2009
|
||
|
William
N. Plamondon III
|
|
10.1
|
Technology
License Agreement between the Company and Sanyo Chemical Industries, Ltd.,
dated as of June 18, 2009.
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
31.2
|
Certification of Principal
Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
|
32.1
|
Certification of Chief Executive
Officer pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
32.2
|
Certification of Principal
Financial Officer pursuant to Section 960 of the Sarbanes-Oxley Act of
2002.
|
|
1.
|
I
have reviewed this annual report on Form 10-K of Protein Polymer
Technologies, Inc.;
|
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
|
4.
|
The
registrant's other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and
have:
|
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
|
|
(b)
|
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
|
(c)
|
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
|
(d)
|
Disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting; and
|
|
5.
|
The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s
board of directors (or persons performing the equivalent
functions):
|
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
|
1.
|
I
have reviewed this annual report on Form 10-K of Protein Polymer
Technologies, Inc.;
|
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
|
4.
|
The
registrant's other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and
have:
|
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
|
|
(b)
|
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
|
(c)
|
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
|
(d)
|
Disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting; and
|
|
5.
|
The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s
board of directors (or persons performing the equivalent
functions):
|
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
|
(1)
|
The
Report fully complies with the requirements of section 13(a) or 15(d) of
the Securities Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the
Company.
|
|
(1)
|
The
Report fully complies with the requirements of section 13(a) or 15(d) of
the Securities Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the
Company.
|