|
x
|
ANNUAL
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the fiscal year ended December 31, 2007
|
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OR
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|
o
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the transition period from ______________________________ to
______________________________
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Delaware
|
33-0311631
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(State
or other jurisdiction of
incorporation
or organization)
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(I.R.S.
Employer Identification No.)
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Page
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PART
I
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|||
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Item
1.
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Business
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2
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Item
2.
|
Properties
|
14
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|
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Item
3.
|
Legal
Proceedings
|
14
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
14
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|
|
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||
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PART
II
|
|||
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|
Item
5.
|
Market
for Common Equity, Related Stockholder Matters and Small Business
Issuer
Purchases of Equity Securities
|
15
|
|
|
Item
6.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
16
|
|
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Item
7.
|
Financial
Statements
|
F-1
|
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|
Item
8.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
25
|
|
|
Item
8A.
|
Controls
And Procedures
|
25
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|
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Item
8B.
|
Other
Information
|
27
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|
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||
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PART
III
|
|||
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Item
13.
|
Exhibits
|
27
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|
|
Signatures
|
|
33
|
|
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.
|
|
|
|
|
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|
|
Name
|
|
Age
|
|
Position with the Company
|
|
James
B. McCarthy, M.B.A., J.D.
|
|
56
|
|
Interim
Chief Executive Officer, Interim President and Interim Principal
Accounting Officer
|
|
Joseph
Cappello, Ph.D.
|
|
51
|
|
Vice
President, Research and Development, Chief Technical Officer and
Director,
Clinical Research
|
|
Franco
A. Ferrari, Ph.D.
|
|
56
|
|
Vice
President, Laboratory Operations and Polymer Production and Director,
Molecular Genetics
|
|
Item
2.
|
Properties
|
|
|
|
|
Legal
Proceedings
|
|
|
|
|
|
Submission
of Matters to a Vote of Security Holders
|
|
|
|
|
|
Market
for Common Equity, Related Stockholder Matters and Small Business
Issuer
Purchases of Equity Securities.
|
|
|
|
|
|
|
Trade Prices
|
||||||
|
|
High
|
Low
|
|||||
|
2007
|
|||||||
|
First
Quarter
|
$
|
0.18
|
$
|
0.12
|
|||
|
Second
Quarter
|
0.19
|
0.10
|
|||||
|
Third
Quarter
|
0.21
|
0.12
|
|||||
|
Fourth
Quarter
|
0.16
|
0.06
|
|||||
|
|
|||||||
|
2006
|
|||||||
|
First
Quarter
|
$
|
0.33
|
$
|
0.19
|
|||
|
Second
Quarter
|
0.28
|
0.15
|
|||||
|
Third
Quarter
|
0.21
|
0.12
|
|||||
|
Fourth
Quarter
|
0.23
|
0.12
|
|||||
|
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
|
10,173,162
|
$
|
0.646
|
1,711,268
|
||||||
|
Employee
Stock Purchase Plan2
|
—
|
—
|
—
|
|||||||
|
Equity
Compensation Plans not approved by security holders3
|
1,324,324
|
$
|
0.712
|
n/a
|
||||||
|
1
Includes
shares of common stock to be issued upon exercise of stock options
granted
under the 1989 Employee Stock Option Plan, the 1992 Employee Stock
Option
Plan, the 2002 Employee Stock Option Plan, and the 1996 Non-employee
Director’s Stock Option Plan.
|
|
2
Includes shares of common stock available for future issuance under
the
Employee Stock Purchase Plan.
|
|
3
Includes
shares of common stock to be issued upon exercise of out-of-plan
non-qualified options granted.
|
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
|
|
|
|
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.
|
|
Financial
Statements
|
|
Description
|
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|
Balance
Sheets at December 31, 2007 and 2006
|
F-3
|
|
Statements
of Operations for the years ended December 31, 2007 and
2006
|
F-4
|
|
Statements
of Stockholders’ Deficit for the years ended December 31, 2007 and
2006
|
F-5
|
|
Statements
of Cash Flows for the years ended December 31, 2007 and
2006
|
F-6
|
|
Notes
to Financial Statements
|
F-7
|
|
December 31,
|
|||||||
|
2007
|
2006
|
||||||
|
Assets
|
|||||||
|
Current
assets:
|
|||||||
|
Cash
and cash equivalents
|
$
|
21,936
|
$
|
73,495
|
|||
|
Contract
receivable
|
-
|
21,068
|
|||||
|
Rent
receivable, net of reserve of $147,150 and $128,273 at December 31,
2007
and 2006, respectively
|
-
|
39,527
|
|||||
|
Prepaid
expenses and other current assets
|
33,419
|
49,940
|
|||||
|
Total
current assets
|
55,355
|
184,030
|
|||||
|
|
|||||||
|
Deposits
|
29,679
|
29,679
|
|||||
|
Equipment
and leasehold improvements, net
|
128,100
|
228,475
|
|||||
|
Investment
|
520,000
|
520,000
|
|||||
|
Total
assets
|
$
|
733,134
|
$
|
962,184
|
|||
|
|
|||||||
|
Liabilities
and stockholders' deficit
|
|||||||
|
Current
liabilities:
|
|||||||
|
Accounts
payable
|
$
|
827,626
|
$
|
1,098,820
|
|||
|
Accrued
liabilities
|
794,312
|
431,550
|
|||||
|
Secured
note payable - related party
|
5,876,000
|
3,461,516
|
|||||
|
Current
maturities of notes payable
|
419,071
|
146,697
|
|||||
|
Total
current liabilities
|
7,917,009
|
5,138,583
|
|||||
|
|
|||||||
|
Notes
payable, net of current maturities
|
100,000
|
372,374
|
|||||
|
Deferred
rent, net of current portion
|
-
|
4,449
|
|||||
|
Total
liabilities
|
8,017,009
|
5,515,406
|
|||||
|
|
|||||||
|
Commitments
and contingencies (Note 10)
|
|||||||
|
|
|||||||
|
Stockholders'
deficit:
|
|||||||
|
Convertible
preferred stock, $0.01 par value; 5,000,000 shares authorized; 65,645
shares issued and outstanding at December 31, 2007 and 2006 - liquidation
preference of $9,464,500 and $9,191,500 at December 31, 2007 and
2006,
respectively.
|
6,019,917
|
6,019,917
|
|||||
|
Common
stock, $0.01 par value; 1,000,000,000 and 120,000,000 shares authorized
at
December 31, 2007, and 2006, respectively; 73,722,232 and 67,409,204
shares issued and outstanding at December 31, 2007 and 2006,
respectively
|
737,222
|
674,092
|
|||||
|
Additional
paid-in capital
|
56,227,221
|
55,760,511
|
|||||
|
Accumulated
deficit
|
(70,268,235
|
)
|
(67,007,742
|
)
|
|||
|
Total
stockholders' deficit
|
(7,283,875
|
)
|
(4,553,222
|
)
|
|||
|
Total
liabilities and stockholders’ deficit
|
$
|
733,134
|
$
|
962,184
|
|||
|
|
Years ended December 31,
|
||||||
|
|
2007
|
2006
|
|||||
|
Revenues:
|
|||||||
|
Contract
revenue
|
$
|
287,118
|
$
|
533,301
|
|||
|
Product
and other income
|
-
|
71,551
|
|||||
|
Total
revenues
|
287,118
|
604,852
|
|||||
|
|
|||||||
|
Operating
Expenses:
|
|||||||
|
Research
and development
|
2,503,035
|
3,692,091
|
|||||
|
Selling,
general and administrative
|
809,446
|
4,758,970
|
|||||
|
Total
expenses
|
3,312,481
|
8,451,061
|
|||||
|
Loss
from operations
|
(3,025,363
|
)
|
(7,846,209
|
)
|
|||
|
|
|||||||
|
Other
income (expense):
|
|||||||
|
Interest
and other income
|
21,513
|
50,417
|
|||||
|
Interest
expense
|
(442,235
|
)
|
(221,472
|
)
|
|||
|
Gain
on extinguishment of indemnification obligation
|
-
|
138,933
|
|||||
|
Gain
on settlement of accounts payable
|
193,917
|
-
|
|||||
|
Total
other expense
|
(226,805
|
)
|
(32,122
|
)
|
|||
|
|
|||||||
|
Net
loss
|
(3,252,168
|
)
|
(7,878,331
|
)
|
|||
|
|
|||||||
|
Undeclared
and imputed and/or paid dividends on preferred stock
|
285,976
|
366,589
|
|||||
|
|
|||||||
|
Net
loss applicable to common shareholders
|
$
|
(3,538,144
|
)
|
$
|
(8,244,920
|
)
|
|
|
|
|||||||
|
Basic
and diluted net loss per common share
|
$
|
(0.05
|
)
|
$
|
(0.12
|
)
|
|
|
|
|||||||
|
Shares
used in computing basic and diluted net loss per common
share
|
67,737,971
|
67,370,405
|
|||||
|
Total
|
||||||||||||||||||||||
|
Additional
|
Stockholders'
|
|||||||||||||||||||||
|
Common Stock
|
Preferred Stock
|
Paid-in
|
Accumulated
|
equity
|
||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
(deficit)
|
||||||||||||||||
|
Balance
at December 31, 2005
|
67,311,408
|
$
|
673,114
|
66,045
|
$
|
6,059,917
|
$
|
54,122,011
|
$
|
(59,040,461
|
)
|
$
|
1,814,581
|
|||||||||
|
Conversion
of Series G preferred stock into common stock
|
80,000
|
800
|
(400
|
)
|
(40,000
|
)
|
39,200
|
–
|
–
|
|||||||||||||
|
Share
based compensation expense
|
–
|
–
|
–
|
–
|
1,507,350
|
–
|
1,507,350
|
|||||||||||||||
|
Imputed
dividend on extension of warrant
|
–
|
–
|
–
|
–
|
88,950
|
(88,950
|
)
|
–
|
||||||||||||||
|
Issuance
of common stock under stock purchase plan
|
17,796
|
178
|
–
|
–
|
3,000
|
–
|
3,178
|
|||||||||||||||
|
Net
loss
|
–
|
–
|
–
|
–
|
–
|
(7,878,331
|
)
|
(7,878,331
|
)
|
|||||||||||||
|
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
|
)
|
||||||||
|
Years ended December 31,
|
|||||||
|
|
2007
|
2006
|
|||||
|
Operating
activities
|
|||||||
|
Net
loss
|
$
|
(3,252,168
|
)
|
$
|
(7,878,331
|
)
|
|
|
Adjustments
to reconcile net loss to net cash used for operating
activities:
|
|||||||
|
Provision
for impairment of note receivable
|
-
|
257,133
|
|||||
|
Provision
impairment of license agreement
|
-
|
1,046,503
|
|||||
|
Gain
on extinguishment of indemnification obligation
|
-
|
(138,933
|
)
|
||||
|
Gain
on settlement of accounts payable
|
(193,917
|
)
|
|||||
|
Depreciation
and amortization
|
100,375
|
161,145
|
|||||
|
Share-based
compensation expense
|
(109,552
|
)
|
1,507,350
|
||||
|
Non-cash
gain on stock received
|
-
|
(20,000
|
)
|
||||
|
Amortization
of loan fees
|
-
|
69,608
|
|||||
|
Other
income
|
(21,368
|
)
|
(33,528
|
)
|
|||
|
Changes
in operating assets and liabilities:
|
|||||||
|
Contracts
receivable
|
21,068
|
92,724
|
|||||
|
Rent
receivable
|
39,527
|
75,000
|
|||||
|
Prepaid
expenses and other current assets
|
16,521
|
(31,749
|
)
|
||||
|
Accounts
payable
|
(210,127
|
)
|
678,148
|
||||
|
Accrued
liabilities
|
578,047
|
144,446
|
|||||
|
Deferred
rent
|
(4,449
|
)
|
4,449
|
||||
|
Net
cash used for operating activities
|
(3,036,043
|
)
|
(4,066,035
|
)
|
|||
|
|
|||||||
|
Investing
activities
|
|||||||
|
Purchase
of equipment and improvements
|
-
|
(36,912
|
)
|
||||
|
Purchase
of common stock of Spinewave, Inc.
|
-
|
(500,000
|
)
|
||||
|
Net
cash used for investing activities
|
-
|
(536,912
|
)
|
||||
|
|
|||||||
|
Financing
activities
|
|||||||
|
Net
proceeds from subscriptions to purchase common stock
|
570,000
|
3,178
|
|||||
|
Proceeds
from issuance of debt - related party
|
2,414,484
|
3,461,516
|
|||||
|
Net
cash provided by financing activities
|
2,984,484
|
3,464,694
|
|||||
|
|
|||||||
|
Net
decrease in cash and cash equivalents
|
(51,559
|
)
|
(1,138,253
|
)
|
|||
|
Cash
and cash equivalents at beginning of the period
|
73,495
|
1,211,748
|
|||||
|
Cash
and cash equivalents at end of the period
|
$
|
21,936
|
$
|
73,495
|
|||
|
|
|||||||
|
Supplemental
disclosures of cash flow information
|
|||||||
|
Interest
paid
|
$
|
5,263
|
$
|
5,253
|
|||
|
Non
cash investing and financing activity
|
|||||||
|
Imputed
dividend on extension of warrants
|
$
|
8,325
|
$
|
88,950
|
|||
|
Conversion
of Series G preferred stock to common stock
|
$
|
-
|
$
|
40,000
|
|||
|
1.
|
Organization
and Significant Accounting
Policies
|
|
2.
|
Equipment
and Leasehold Improvements
|
|
|
December 31,
|
||||||
|
|
2007
|
2006
|
|||||
|
Laboratory
equipment
|
$
|
1,378,000
|
$
|
1,378,000
|
|||
|
Office
equipment
|
220,000
|
220,000
|
|||||
|
Leasehold
improvements
|
360,000
|
360,000
|
|||||
|
|
1,958,000
|
1,958,000
|
|||||
|
Less
accumulated depreciation and amortization
|
(1,830,000
|
)
|
(1,730,000
|
)
|
|||
|
|
$
|
128,000
|
$
|
228,000
|
|||
|
3.
|
Rent
Receivable
|
|
4.
|
Investment
|
|
5.
|
Accrued
Liabilities
|
|
|
December 31,
|
||||||
|
|
2007
|
2006
|
|||||
|
Payroll
and employee benefits
|
$
|
82,000
|
$
|
94,000
|
|||
|
Accounting
and professional fees
|
23,000
|
25,000
|
|||||
|
Accrued
interest
|
585,000
|
147,000
|
|||||
|
Property
tax
|
-
|
21,000
|
|||||
|
Insurance
premium financing
|
22,000
|
39,000
|
|||||
|
Indemnification
obligation
|
-
|
61,000
|
|||||
|
Directors
fees
|
60,000
|
-
|
|||||
|
Other
|
22,000
|
45,000
|
|||||
|
|
$
|
794,000
|
$
|
432,000
|
|||
|
6.
|
Secured
Notes Payable – Related
Party
|
|
7.
|
Notes
Payable
|
|
Year Ending
December 31,
|
Notes
Payable
Maturities
|
|||
|
2008
|
419,000
|
|||
|
2009
|
100,000
|
|
||
|
Total
maturities
|
$
|
519,000
|
||
|
8.
|
Stockholders’
Deficit
|
|
|
2006
|
|||
|
Expected
volatility
|
90
|
%
|
||
|
Weighted-average
volatility
|
90
|
%
|
||
|
Expected
dividends
|
$
|
0.00
|
||
|
Expected
term (in years)
|
3.6
|
|||
|
Risk-free
interest rate
|
5.1
|
%
|
||
|
Options
Outstanding
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
|
Outstanding
at December 31, 2005
|
12,638,082
|
$
|
0.72
|
$
|
—
|
||||||||
|
Issued
|
330,000
|
0.20
|
—
|
||||||||||
|
Cancelled
|
(513,500
|
)
|
(1.83
|
)
|
—
|
||||||||
|
Exercised
|
-
|
-
|
—
|
||||||||||
|
Outstanding
at December 31, 2006
|
12,454,582
|
0.66
|
6.5
|
—
|
|||||||||
|
Issued
|
-
|
-
|
—
|
||||||||||
|
Cancelled
|
(957,096
|
)
|
0.52
|
—
|
|||||||||
|
Exercised
|
—
|
—
|
—
|
||||||||||
|
Outstanding
at December 31, 2007
|
11,497,486
|
$
|
0.65
|
5.3
|
—
|
||||||||
|
Exercisable
at December 31, 2007
|
11,302,667
|
$
|
0.66
|
5.3
|
$
|
—
|
|||||||
|
Number
of
Warrants
Outstanding
and
Exercisable
|
Weighted-
Average
Exercise
Price
|
||||||
|
Outstanding,
December 31, 2005
|
16,678,494
|
$
|
0.56
|
||||
|
Granted
|
500,000
|
$
|
0.25
|
||||
|
Exercised
|
—
|
$
|
—
|
||||
|
Expired
|
—
|
$
|
—
|
||||
|
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
|
||||
|
9.
|
Stockholder
Protection Agreement
|
|
10.
|
Commitments
and Contingencies
|
|
Year
Ending
December
31,
|
Operating
Leases
|
|||
|
2008
|
$
|
228,000
|
||
|
Total
minimum operating lease payments
|
$
|
228,000
|
||
|
11.
|
Income
Taxes
|
|
2007
|
2006
|
||||||
|
Deferred
tax assets:
|
|||||||
|
Net
operating loss carry-forwards
|
$
|
-
|
$
|
17,688,000
|
|||
|
Federal
& state tax credits
|
-
|
2,807,000
|
|||||
|
Allowances
|
161,000
|
145,800
|
|||||
|
Stock-based
compensation/warrants
|
509,000
|
615,400
|
|||||
|
Amortization/impairment
of license
|
334,000
|
360,000
|
|||||
|
Basis
difference fixed assets
|
790,000
|
783,000
|
|||||
|
Other,
net
|
25,000
|
40,800
|
|||||
|
Total
deferred tax assets
|
1,819,000
|
22,440,000
|
|||||
|
Valuation
allowance for deferred tax assets
|
(1,819,000
|
)
|
(22,440,000
|
)
|
|||
|
Net
deferred tax assets
|
$
|
-
|
$
|
-
|
|||
|
2007
|
2006
|
||||||
|
Expected
federal income tax benefit
|
$
|
(1,105,900
|
)
|
$
|
(2,690,000
|
)
|
|
|
Expected
state income tax benefit, net of federal benefit
|
(181,600
|
)
|
(462,000
|
)
|
|||
|
Decrease
in valuation allowance
|
171,500
|
2,114,000
|
|||||
|
Expiration
of net operating losses & credits
|
1,069,100
|
699,000
|
|||||
|
Stock
options
|
53,900
|
491,000
|
|||||
|
Business
credits
|
-
|
(204,000
|
)
|
||||
|
Other
|
(7,000
|
)
|
52,000
|
||||
|
Provision
for income taxes
|
$
|
-
|
$
|
-
|
|||
|
12.
|
Employee
Benefits Plan
|
|
13.
|
Subsequent
Events
|
|
·
|
Our
facilities lease had expired. We are currently exploring arrangements
to
relocate our administrative offices and outsource our laboratory
and
production facilities. In the interim, we will continue to occupy
our
current facilities on a month-to-month
basis.
|
|
·
|
We
had reduced staff to two full-time employees, both of whom hold Ph.D.
degrees.
|
|
·
|
Our
sub-lessee owed us approximately $205,000 for accrued unpaid rent,
and we
had delivered notice to the Sublessee to pay the unpaid rent within
3 days
or quit the premises.
|
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
|
|
|
|
|
Controls
And Procedures
|
|
|
|
|
|
·
|
Pervasive,
entity-level control deficiencies across key COSO components in the
Company’s control environment, including:
|
|
·
|
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.
|
|
·
|
Insufficient
personnel resources and technical accounting expertise within the
accounting function to provide for adequate segregation of duties
and
resolve 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
|
Formalizing
its accounting policies and procedures, including defined roles and
responsibilities and required managerial reviews and
approvals,
|
|
Item
13.
|
Exhibits
|
|
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
|
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
|
Secured
Promissory Note Replacement Agreement, dated as of January 9, 2008,
between the Company and Matthew J. Szulik.
|
|
10.48
|
Secured
Promissory Note issued to Matthew J. Szulik, dated as of January
9,
2008.
|
|
10.49
|
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.
|
|
14.1
(27)
|
Code
of Conduct.
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Securities Exchange Act Rules
13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
of Principal Financial Officer pursuant to Securities Exchange Act
Rules
13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
32.2
|
Certification
of Principal Financial Officer pursuant to 18 U.S.C. Section 1350
as adopted 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, 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.
|
|||
|
May
12, 2008
|
By:
|
/S/ JAMES B. MCCARTHY
|
|
|
James
B. McCarthy
|
|||
|
Interim
Chief Executive Officer
|
|||
|
Signature
|
|
Capacity
|
|
Date
|
|
|
|
|
|
|
|
/S/
JAMES B. MCCARTHY
James
B. McCarthy
|
|
Interim
Chief Executive Officer
and
Interim Principal Financial Officer
|
|
May
12, 2008
|
|
|
|
|
|
|
|
/S/
ALLAN FARBER
Allan
Farber
|
|
Director
|
|
May
12, 2008
|
|
|
|
|
|
|
|
/S/
KERRY L. KUHN
Kerry
L. Kuhn, M.D.
|
|
Director
|
|
May
12, 2008
|
|
|
|
|
||
|
/S/
RICHARD ADELSON
Richard Adelson |
|
Director
|
|
May
12, 2008
|
|
/S/
WILLIAM N. PLAMONDON III
William N. Plamondon III |
|
Director
|
|
May
12, 2008
|
|
10.1.1
|
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.
|
|
10.1.2
|
Secured
Promissory Note Replacement Agreement, dated as of January 9, 2008,
between the Company and Matthew J.
Szulik.
|
|
10.1.3
|
Secured
Promissory Note issued to Matthew J. Szulik, dated as of January
9,
2008.
|
|
10.1.4
|
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.
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Securities Exchange Act Rules
13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
of Principal Financial Officer pursuant to Securities Exchange Act
Rules
13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
32.2
|
Certification
of Principal Financial Officer pursuant to 18 U.S.C. Section 1350
as adopted pursuant to Section 960 of the Sarbanes-Oxley Act of
2002.
|