Unassociated Document
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20649
Form
10-Q
(Mark
One)
þ
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
|
For the quarterly period ended March
31, 2009
or
¨
|
TRANSACTION REPORT PURSUANT TO
SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the transition period from
______________________ to_______________________
Commission
File Number 1-10113
Acura
Pharmaceuticals, Inc.
(Exact name of registrant as
specified in its charter)
New
York
|
|
11-0853640
|
(State
or other Jurisdiction of
|
|
(I.R.S.
Employer Identification No.)
|
incorporation
or organization)
|
|
|
616
N. North Court, Suite 120
|
|
|
Palatine,
Illinois
|
|
60067
|
(Address
of Principal Executive Offices)
|
|
(Zip
Code)
|
847
705 7709
(Registrant's
telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last
report.)
Indicate by check mark whether the
registrant (1) has filed all reports required to be filed by Section 13 or 15
(d) of the Securities Exchange Act of 1934 during the preceding 12 months, and
(2) has been subject to such filing requirements for the past 90
days. Yes þ No o
Indicate by check mark whether the
registrant is a large accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of “large” filer,
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one):
Large
accelerated filer o
|
|
Accelerated
filer þ
|
Non-accelerated
filer o
|
|
Smaller
reporting company o
|
Indicate by check mark whether the
registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). Yes o No þ
As of April 29, 2009 the registrant had
42,742,532 shares of common stock, $.01 par value, outstanding.
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
INDEX
PART
1. FINANCIAL INFORMATION
|
|
|
Page
No.
|
|
|
|
|
Item
1.
|
Financial
Statements (Unaudited)
|
|
|
|
|
|
|
|
Consolidated
Balance Sheets
March
31, 2009 and December 31, 2008
|
|
1
|
|
|
|
|
|
Consolidated
Statements of Operations
Three
months ended March 31, 2009 and March 31, 2008
|
|
2
|
|
|
|
|
|
Consolidated
Statement of Stockholders’ Equity
Three
months ended March 31, 2009
|
|
3
|
|
|
|
|
|
Consolidated
Statements of Cash Flows
Three
months ended March 31, 2009
|
|
4
|
|
|
|
|
|
Notes
to Consolidated Financial Statements
|
|
5
|
|
|
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
11
|
|
|
|
|
Item
4.
|
Controls
and Procedures
|
|
15
|
|
|
|
|
PART
II. OTHER INFORMATION
|
|
|
|
|
|
|
Item
1A.
|
Risk
Factors Relating to the Company
|
|
16
|
|
|
|
|
Item
6.
|
Exhibits
|
|
17
|
|
|
|
|
Signatures
|
|
|
18
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial
Statements
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
BALANCE SHEETS
UNAUDITED
(in
thousands, except par values)
|
|
March 31,
2009
|
|
|
December 31,
2008
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
37,013 |
|
|
$ |
30,398 |
|
Short
term investments
|
|
|
- |
|
|
|
5,039 |
|
Collaboration
revenue receivable
|
|
|
117 |
|
|
|
3,529 |
|
Prepaid
expense and other current assets
|
|
|
231 |
|
|
|
431 |
|
Deferred
income taxes
|
|
|
3,323 |
|
|
|
2,491 |
|
Total
current assets
|
|
|
40,684 |
|
|
|
41,888 |
|
Non-current
assets
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net
|
|
|
1,069 |
|
|
|
1,073 |
|
Total
assets
|
|
$ |
41,753 |
|
|
$ |
42,961 |
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
- |
|
|
$ |
382 |
|
Accrued
expenses
|
|
|
1,052 |
|
|
|
883 |
|
Deferred
program fee revenue
|
|
|
3,368 |
|
|
|
4,632 |
|
Total
liabilities
|
|
|
4,420 |
|
|
|
5,897 |
|
Commitments
and contingencies (Note 10)
|
|
|
|
|
|
|
|
|
Stockholders’
equity
|
|
|
|
|
|
|
|
|
Common stock - $.01 par value; 650,000 shares authorized;
42,740
and 42,723 shares issued and outstanding at
March
31, 2009 and December 31, 2008, respectively
|
|
|
427 |
|
|
|
427 |
|
Additional
paid-in capital
|
|
|
345,569 |
|
|
|
344,023 |
|
Accumulated
deficit
|
|
|
(308,663 |
) |
|
|
(307,386 |
) |
Total
stockholders’ equity
|
|
|
37,333 |
|
|
|
37,064 |
|
Total
liabilities and stockholders’ equity
|
|
$ |
41,753 |
|
|
$ |
42,961 |
|
See
accompanying notes to the consolidated financial statements.
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS
UNAUDITED
(in
thousands, except share and per share data)
|
|
Three Months
Ended March 31,
|
|
|
|
2009
|
|
|
2008
|
|
Revenue
|
|
|
|
|
|
|
Program
fee revenue
|
|
$ |
1,263 |
|
|
$ |
13,707 |
|
Collaboration
revenue
|
|
|
117 |
|
|
|
3,377 |
|
Total
revenue
|
|
|
1,380 |
|
|
|
17,084 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Research
and development expenses
|
|
|
1,129 |
|
|
|
4,082 |
|
Marketing,
general and administrative expenses
|
|
|
2,448 |
|
|
|
870 |
|
Total
operating expenses
|
|
|
3,577 |
|
|
|
4,952 |
|
Operating
(loss) income
|
|
|
(2,197 |
) |
|
|
12,132 |
|
Other
income – interest, net
|
|
|
69 |
|
|
|
297 |
|
(Loss)
income before income tax
|
|
|
(2,128 |
) |
|
|
12,429 |
|
Income
tax (benefit) expense
|
|
|
(851 |
) |
|
|
4,980 |
|
Net
(loss) income
|
|
$ |
(1,277 |
) |
|
$ |
7,449 |
|
|
|
|
|
|
|
|
|
|
(Loss)
earnings per share
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.03 |
) |
|
$ |
0.16 |
|
Diluted
|
|
$ |
(0.03 |
) |
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computation
|
|
|
|
|
|
|
|
|
Basic
|
|
|
45,708 |
|
|
|
45,657 |
|
Diluted
|
|
|
45,708 |
|
|
|
49,439 |
|
See
accompanying notes to the consolidated financial statements.
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENT OF STOCKHOLDERS' EQUITY
THREE
MONTHS ENDED MARCH 30, 2009
UNAUDITED
(in
thousands, except par values)
|
|
Common
Stock
$0.01 Par
Value -
Shares
|
|
|
Common
Stock
$0.01 Par
Value -
Amount
|
|
|
Additional
Paid-in
Capital
|
|
|
Accumulated
Deficit
|
|
|
Total
|
|
Balance
at December 31, 2008
|
|
|
42,723 |
|
|
$ |
427 |
|
|
$ |
344,023 |
|
|
$ |
(307,386 |
) |
|
$ |
37,064 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,277 |
) |
|
|
(1,277 |
) |
Stock
based compensation
|
|
|
- |
|
|
|
- |
|
|
|
1,546 |
|
|
|
- |
|
|
|
1,546 |
|
Exercise
of warrants
|
|
|
17 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at March 31, 2009
|
|
|
42,740 |
|
|
$ |
427 |
|
|
$ |
345,569 |
|
|
$ |
(308,663 |
) |
|
$ |
37,333 |
|
See
accompanying notes to the consolidated financial statements.
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE THREE MONTHS ENDED MARCH 31,
UNAUDITED
(in
thousands, except supplemental disclosures)
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities
|
|
|
|
|
|
|
Net
(loss) income
|
|
$ |
(1,277 |
) |
|
$ |
7,449 |
|
Adjustments
to reconcile net (loss) income to net cash provided by (used in) operating
activities
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
32 |
|
|
|
42 |
|
Deferred
income taxes
|
|
|
(832 |
) |
|
|
4,980 |
|
Non-cash
stock compensation expense
|
|
|
1,546 |
|
|
|
121 |
|
Impairment
reserve against fixed assets
|
|
|
- |
|
|
|
(51 |
) |
|
|
|
|
|
|
|
|
|
Changes
in assets and liabilities
|
|
|
|
|
|
|
|
|
Collaboration
revenue receivable
|
|
|
3,413 |
|
|
|
(400 |
) |
Prepaid
expenses and other current assets
|
|
|
198 |
|
|
|
232 |
|
Accounts
payable
|
|
|
(382 |
) |
|
|
- |
|
Accrued
expenses
|
|
|
168 |
|
|
|
(24 |
) |
Deferred
program fee revenue
|
|
|
(1,263 |
) |
|
|
(13,708 |
) |
Net
cash provided by (used in) operating activities
|
|
|
1,603 |
|
|
|
(1,359 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities
|
|
|
|
|
|
|
|
|
Purchase
of investments
|
|
|
- |
|
|
|
(4,000 |
) |
Investment
maturities
|
|
|
5,039 |
|
|
|
- |
|
Capital
expenditures
|
|
|
(27 |
) |
|
|
(7 |
) |
Net
cash provided by (used in) investing activities
|
|
|
5,012 |
|
|
|
(4,007 |
) |
|
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents
|
|
|
6,615 |
|
|
|
(5,366 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
30,398 |
|
|
|
31,368 |
|
Cash
and cash equivalents at end of period
|
|
$ |
37,013 |
|
|
$ |
26,002 |
|
|
|
|
|
|
|
|
|
|
Cash
paid for income taxes
|
|
$ |
74 |
|
|
$ |
- |
|
SUPPLEMENTAL
DISCLOSURES OF NONCASH INVESTING AND FINANCING ACTIVITIES
Three Months Ended March 31,
2009
1.
|
Warrants
to purchase 38,000 shares of common stock were exercised at exercise price
of $3.40 per share in a series of cashless exercise transactions resulting
in the issuance of 17,000 shares of common
stock.
|
Three Months Ended March 31,
2008
1.
|
Fixed
assets having a net book value of $51,000 were disposed under the
impairment reserve.
|
See
accompanying notes to the consolidated financial statements.
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2009 AND 2008
NOTE
1 - BASIS OF PRESENTATION
Acura
Pharmaceuticals, Inc., a New York corporation, and its wholly-owned subsidiary
Acura Pharmaceutical Technologies, Inc. (the “Company” or “We”) is a specialty
pharmaceutical company engaged in research, development and manufacture of
product candidates providing abuse deterrent features and benefits utilizing our
proprietary Aversion®
Technology. Our portfolio of product candidates includes opioid
analgesics intended to effectively relieve pain while simultaneously
discouraging common methods of pharmaceutical product misuse and abuse
including:
|
·
|
intravenous
injection of dissolved tablets or
capsules;
|
|
·
|
nasal
snorting of crushed tablets or capsules;
and
|
|
·
|
intentional
swallowing of excess quantities of tablets or
capsules.
|
The
accompanying unaudited consolidated financial statements of the Company have
been prepared in accordance with generally accepted accounting principles for
interim financial information and with the instructions to Form 10-Q and Rule
10-01 of Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by accounting principles generally accepted
in the United States of America for complete financial statements. In
the opinion of management, all adjustments, consisting of normal recurring
accrual adjustments, considered necessary to present fairly the financial
position as of March 31, 2009 and results of operations and cash flows for the
three month periods ended March 31, 2009 and 2008 have been made. The
results of operations for the three month period ended March 31, 2009 are not
necessarily indicative of results that may be expected for the full year ending
December 31, 2009. The unaudited consolidated financial statements
should be read in conjunction with the audited consolidated financial statements
and footnotes thereto for the year ended December 31, 2008 included in the
Company's Annual Report on Form 10-K filed with the Securities and Exchange
Commission. The year-end consolidated balance sheet was derived from the audited
consolidated financial statements, but does not include all disclosures required
by generally accepted accounting principles. Amounts presented have been rounded
to the nearest thousand, where indicated, except per share data and par
values.
NOTE
2 – NEW ACCOUNTING PRONOUNCEMENTS
Derivative
Instruments and Hedging Activities
In March
2008, the Financial Accounting Standards Board (“FASB”) issued Statement of
Financial Accounting Standards (“SFAS”) No. 161 “Disclosures about Derivative
Instruments and Hedging Activities” (“SFAS 161”). SFAS 161 is intended to
improve financial reporting about derivative instruments and hedging activities
by requiring enhanced disclosures to enable investors to better understand their
effects on an entity’s financial position, financial performance, and cash
flows. SFAS No. 161 also improves transparency about the location and
amounts of derivative instruments in an entity’s financial statements; how
derivative instruments and related hedged items are accounted for under
Statement 133; and how derivative instruments and related hedged items affect
its financial position, financial performance, and cash flows. SFAS 161 is
effective for financial statements issued for fiscal years and interim periods
beginning after November 15, 2008, with early application encouraged.
The Company’s adoption of SFAS 161 at January 1, 2009 had no effect on the
Company’s consolidated financial statements as we had no derivative or hedging
activities.
NOTE
3 – RESEARCH AND DEVELOPMENT
Research
and development (“R&D”) expenses include internal R&D activities,
external contract research organization (“CRO”) activities, and other
activities. Internal R&D activity expenses include facility overhead,
equipment and facility maintenance and repairs, depreciation, laboratory
supplies, pre-clinical laboratory experiments, depreciation, salaries, benefits,
and incentive compensation expenses. CRO activity expenses include preclinical
laboratory experiments and clinical trial studies. Other activity expenses
include clinical trial studies and regulatory consulting, and regulatory
counsel. Internal R&D activities and other activity expenses are charged to
operations as incurred. The Company makes payments to the CROs based on
agreed upon terms and may include payments in advance of the study starting
date. The Company reviews and accrues CRO expenses and clinical trial study
expenses based on work performed and relies upon estimates of those costs
applicable to the stage of completion of a study as provided by the CRO. Accrued
CRO costs are subject to revisions as such trials progress to completion.
Revisions are charged to expense in the period in which the facts that give rise
to the revision become known. Advance payments are amortized to expense based on
work performed. At March 31, 2009 we have less than $0.1 million of unfunded CRO
obligations which is expected to be incurred during our second quarter 2009. We
had unfunded CRO obligations of $1.0 million at December 31, 2008 which was
incurred and charged to R&D expenses as the clinical studies progressed
during the three month period ended March 31, 2009.
NOTE
4 – REVENUE RECOGNITION AND DEFERRED PROGRAM FEE REVENUE
We
recognize revenue in accordance with Securities and Exchange Commission Staff
Accounting Bulletin No. 104, “Revenue Recognition in Financial Statements” (“SAB
104”). We have also adopted the provisions of Emerging Issues Task Force, Issue
No. 00-21, “Revenue Arrangements with Multiple Deliverables”
(“EITF 00-21”). Revenue is recognized when there is persuasive evidence
that an arrangement exists, delivery has occurred, the price is fixed and
determinable, and collection is reasonably assured.
In
connection with our License, Development and Commercialization Agreement dated
October 30, 2007 (the “King Agreement”) with King Pharmaceuticals Research and
Development, Inc. (“King”), we recognize program fee revenue, collaboration
revenue and milestone revenue.
Program
fee revenue is derived from amortized upfront payments, such as the $30.0
million upfront payment from King received in December 2007, and license fees
upon the exercise of options to license a opioid analgesic product candidates
under the King Agreement. We have assigned an equal portion of the King upfront
payment to each of three product candidates identified in the King Agreement and
recognize the upfront payment as program fee revenue ratably over our estimate
of the development period for each identified product candidate. We
recognized $1.3 million and $13.7 million of program fee revenue for the three
months ended March 31, 2009 and 2008, respectively.
Collaboration
revenue is derived from reimbursement of development expenses, which are
invoiced quarterly in arrears, and are recognized when costs are incurred
pursuant to the King Agreement. The ongoing research and development
services being provided to King under the collaboration are priced at fair value
based upon the reimbursement of expenses incurred pursuant to the collaboration
with King. We recognized $0.1 million and $3.4 million of collaboration revenue
during the three months ended March 31, 2009 and 2008,
respectively.
Milestone
revenue is contingent upon the achievement of certain pre-defined events in the
development of Acurox® Tablets
and other product candidates licensed to King under the King Agreement.
Milestone payments from King are recognized as revenue upon achievement of the
“at risk” milestone events, which represent the culmination of the earnings
process related to that milestone. Milestone payments are triggered either by
the results of our research and development efforts or by events external to us,
such as regulatory approval to market a product. As such, the milestones are
substantially at risk at the inception of the King Agreement, and the amounts of
the payments assigned thereto are commensurate with the milestone achieved. In
addition, upon the achievement of a milestone event, we have no future
performance obligations related to that milestone payment. Each milestone
payment is non-refundable and non-creditable when made. No milestone
revenue was recognized for the three months ended March 31, 2009.
NOTE
5 – INCOME TAXES
The
Company accounts for income taxes under the liability method in accordance with
Statement of Financial Accounting Standards No. 109 ("SFAS No. 109"),
"Accounting for Income Taxes." Under this method, deferred income tax assets and
liabilities are determined based on differences between financial reporting and
income tax basis of assets and liabilities and are measured using the enacted
income tax rates and laws that will be in effect when the differences are
expected to reverse. Additionally, net operating loss and tax credit
carryforwards are reported as deferred income tax assets. The
realization of deferred income tax assets is dependent upon future earnings.
SFAS 109 requires a valuation allowance against deferred income tax assets if,
based on the weight of available evidence, it is more likely than not that some
or all of the deferred income tax assets may not be realized. At both
March 31, 2009 and December 31, 2008, the Company determined that it was more
likely than not that a portion of the Company’s net operating loss carryforwards
may not be realized and accordingly a valuation allowance was provided. If in
the future it is determined that additional amounts of our deferred income tax
assets would likely be utilized, the valuation allowance would be reduced in the
period in which such determination is made and an additional benefit from income
taxes in such period would be recognized.
NOTE
6 – ACCRUED EXPENSES
Accrued
expenses are summarized as follows (in thousands):
|
|
Mar
31,
|
|
|
Dec
31,
|
|
|
|
2009
|
|
|
2008
|
|
Payroll,
bonus, taxes and benefits
|
|
$ |
326 |
|
|
$ |
77 |
|
Legal
fees
|
|
|
43 |
|
|
|
35 |
|
Audit
and tax professional services
|
|
|
59 |
|
|
|
89 |
|
Franchise
taxes
|
|
|
232 |
|
|
|
144 |
|
Property
taxes
|
|
|
40 |
|
|
|
39 |
|
State
income taxes
|
|
|
- |
|
|
|
94 |
|
Clinical,
regulatory, trademarks, and patent services
|
|
|
107 |
|
|
|
217 |
|
Other
fees and services
|
|
|
245 |
|
|
|
188 |
|
|
|
$ |
1,052 |
|
|
$ |
883 |
|
NOTE 7 – SHARE-BASED
COMPENSATION
The
Company has share-based compensation plans including stock options and
restricted stock units for its employees and directors. On January 1, 2006, the
Company adopted Financial Accounting Standards Board (“FASB”) release FASB
Statement No. 123 (revised 2004), “Share-Based Payment, (“FASB 123R”)”. FASB
123R requires companies to estimate the fair value of stock-based awards on the
date of grant using an option pricing model. The value of the portion of the
award that is ultimately expected to vest is recognized as expense over the
requisite service periods in the Company’s Consolidated Statement of Operations.
The Company uses the straight line method of attributing the value of
stock-based compensation .The Company selected the Black-Scholes option pricing
model for determining the estimated fair value for share-based awards.
The use of the Black-Scholes model requires the use of assumptions
including expected volatility, risk-free interest rate and expected dividends.
The Company estimated the volatility factor of the market price of its
stock as determined by reviewing its historical public market closing prices.
The Company did not consider implied volatility because there are no options
traded in its stock. The risk – free interest rate assumption is based on
observed interest rates appropriate for the estimated term of the employee stock
options and restricted stock units. The dividend yield assumption is based on
the Company’s history and expectation of dividend payouts on common stock. The
expected term of the award represents the period that the employees and
directors are expected to hold the award before exercise and issuance.
Forfeitures are accounted for as they occur. Included in the three month periods
ended March 31, 2009 and 2008 is $1.5 million and $0.1 million, respectively of
share-based compensation expense.
Restricted Stock Unit Award
Plan
The
Company has a Restricted Stock Unit Award Plan (the “2005 RSU Plan”) for its
employees and non-employee directors. A Restricted Stock Unit (“RSU”)
represents the contingent obligation of the Company to deliver a share of its
common stock to the holder of the RSU on a distribution date. RSUs for up to 3.5
million shares of common stock are authorized for issuance under the 2005 RSU
Plan. Absent a change of control, one-fourth of vested shares of
common stock underlying an RSU award will be distributed (after payment of $0.01
par value per share) on January 1 of each of 2011, 2012, 2013 and 2014. If a
change in control occurs (whether prior to or after 2011), an acceleration of
unvested shares will occur and all shares underlying the RSU award will be
distributed at or about the time of the change in control and any unrecognized
share-based compensation expense will be recognized.
At March
31, 2009 and December 31, 2008, 3.02 million and 3.00 million RSU awards were
outstanding, respectively and 2.98 million and 2.95 million were fully vested,
respectively. During the three months ended March 31, 2009, an award of 24,000
RSUs was granted with 1,000 common shares vesting per month from March 2009
through February 2011. The Black-Scholes value of the award was $0.14 million
which will be recognized as share-based compensation expense over the vesting
period of the award under a straight-line amortization method. Included in the
three month period ended March 31, 2009 is $0.1 million of share-based
compensation expense from all RSU awards. There was no share-based compensation
expense from RSU awards during the three months ended March 31, 2008. As of
March 31, 2009, the Company had $0.3 million of unrecognized share-based
compensation expense from RSU awards which will be recognized over the remaining
period of twenty-two months. The assumptions used in the Black-Scholes model to
determine fair value for the 2009 RSU grant was:
|
|
2009
|
|
Dividend
yield
|
|
|
0.00 |
% |
Risk-free
interest rate
|
|
|
1.50 |
% |
Volatility
|
|
|
107 |
% |
Forfeitures
|
|
|
0.00 |
% |
Expected
life of option
|
|
3.4
years
|
|
Grant
date fair value
|
|
$ |
5.69 |
|
The
weighted average fair value of all RSU grants is $3.51 per share of common stock
underlying each RSU. As of March 31, 2009 and December 31, 2008, the aggregate
intrinsic value of the RSU awards outstanding and vested was $19.1 million and
$21.8 million, respectively.
Stock Option Plans
The
Company has stock options outstanding under three stock option
plans. The Company’s 1995 and 1998 Stock Option Plans have expired
but options granted under such plans remain outstanding under the terms of those
plans. On April 30, 2008 the Company's shareholders approved a 2008 Stock Option
Plan authorizing the granting of options to purchase up to 6.0 million shares of
the Company’s common stock.
Stock
options to purchase 3.1 million and 3.0 million shares with a weighted-average
exercise price of $4.89 and $6.95 were outstanding at March 31, 2009 and
December 31, 2008, respectively, of which 2.4 million and 2.2 million options
were vested at March 31, 2009 and December 31, 2008,
respectively. During the three month periods ended March 31, 2009 and
2008, options to purchase 0.2 million and 0.1 million shares of common stock
having a weighted average exercise price of $6.49 and $6.50, respectively, were
granted. During the three month periods ended March 31, 2009 and 2008, stock
options to purchase 17,000 shares and 44,000 shares expired. No stock options
were exercised during either period. Included in the three month periods ending
March 31, 2009 and 2008 are $1.4 million and $0.1 million, respectively of
share-based compensation expense from stock option awards. The assumptions used
in the Black-Scholes model to determine fair value for the 2009 stock option
grants were:
|
|
2009
|
|
Dividend
yield
|
|
|
0.0 |
% |
Average
risk-free interest rate used
|
|
|
2.77 |
% |
Average
volatility used
|
|
|
124 |
% |
Forfeitures
|
|
|
0.0 |
% |
Expected
life of option
|
|
10
years
|
|
Weighted
average grant date fair value
|
|
$ |
6.28 |
|
As of
March 31, 2009 the Company had $6.7 million of unrecognized share-based
compensation expense, net of estimated forfeitures, related to stock option
grants, which will be recognized over the remaining vesting period
of twenty-two months. Total intrinsic value of stock options
outstanding and exercisable at March 31, 2009 and December 31, 2008 was $8.8
million and $10.5 million, respectively.
NOTE
8 – COMMON STOCK WARRANTS
At March
31, 2009, the Company had outstanding common stock purchase warrants,
exercisable for an aggregate of approximately 3.9 million shares of common
stock, all of which contain cashless exercise features. During the three month
period ended March 31, 2009, warrants to purchase 38,000 shares of common stock
were exercised at $3.40 per share in a series of cashless exercise transactions
resulting in the issuance of 17,000 shares of common stock. At March 31, 2009,
outstanding stock purchase warrants to acquire 0.4 million, 0.1 million, and 3.4
million common shares will expire if unexercised during 2009, 2010 and years
thereafter, respectively, and have a weighted average remaining term of 4.6
years. The exercise prices of these warrants range from $1.29 to $3.40 per
share, with a weighted average exercise price of $3.17.
NOTE 9– EARNINGS (LOSS) PER
SHARE
The
computation of basic earnings (loss) per share of common stock is based upon the
weighted average number of both common shares and vested RSUs outstanding during
the period. A RSU represents the contingent obligation of the Company to deliver
a share of its common stock to the holder of a vested RSU on a distribution
date. The computation of diluted earnings (loss) per share is based on the same
number of both common shares and vested RSUs used in the basic earning (loss)
computation, but adjusted for the effect of other potentially dilutive
securities. Excluded from the diluted earnings (loss) per share computation at
March 31, 2009 are 7.1 million of potentially dilutive securities, as the effect
of including them would be antidilutive. Accordingly, the loss per share is the
same result for both basic and diluted computations.
|
|
Three Months Ended
|
|
|
|
March 31,
|
|
(in
thousands, except per share data)
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Basic
(loss) earnings per share
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
Net
(loss) income allocable to common shareholder
|
|
$ |
(1,277 |
) |
|
$ |
7,449 |
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
Common
shares (weighted)
|
|
|
42,736 |
|
|
|
42,707 |
|
Vested
restricted stock units (weighted)
|
|
|
2,972 |
|
|
|
2,950 |
|
Weighted
average shares used in computing basic (loss) earnings per share allocable
to common
shareholder
|
|
|
45,708 |
|
|
|
45,657 |
|
Basic
(loss) earnings per share allocable to common
shareholder
|
|
$ |
(0.03 |
) |
|
$ |
0.16 |
|
|
|
|
|
|
|
|
|
|
Diluted
(loss) earnings per share
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
Common
shares (weighted)
|
|
|
42,736 |
|
|
|
42,707 |
|
Vested
restricted stock units (weighted)
|
|
|
2,972 |
|
|
|
2,950 |
|
Stock
options
|
|
|
- |
|
|
|
1,448 |
|
Common
stock warrants
|
|
|
- |
|
|
|
2,334 |
|
Weighted
average shares used in computing diluted (loss) earnings per share
allocable to common shareholder
|
|
|
45,708 |
|
|
|
49,439 |
|
Diluted (loss) earnings per share allocable to common
shareholder
|
|
$ |
(0.03 |
) |
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
Excluded
potentially dilutive securities:
|
|
|
|
|
|
|
|
|
Common
stock issuable (see #1 below):
|
|
|
|
|
|
|
|
|
Stock
options (vested and nonvested)
|
|
|
3,138 |
|
|
|
86 |
|
Nonvested
restricted stock units
|
|
|
46 |
|
|
|
- |
|
Common
stock warrants
|
|
|
3,870 |
|
|
|
47 |
|
Total
excluded dilutive common stock equivalents
|
|
|
7,054 |
|
|
|
133 |
|
(1)
Number of shares issuable represents those securities which were either i)
nonvested at quarter end or ii) were vested but antidilutive. The number of
shares is based on maximum number of shares issuable on exercise or conversion
of the related securities as of year end. Such amounts have not been adjusted
for the treasury stock method or weighted average outstanding calculations as
required if the securities were dilutive.
NOTE
10 – COMMITMENTS AND CONTINGENCIES
Employment
Agreement
On March
23, 2009 we entered into an agreement with Garth Boehm, Ph.D., to be employed as
our Vice President of Modified Release Dosage Form Development. Dr. Boehm is
expected to commence employment with us in May 2009.
Financial
Advisor Agreement
In
connection with the Company’s August 2007 Unit Offering, the Company is
obligated to pay a fee to the Company’s financial advisor upon each exercise of
the warrants issued in the Unit Offering, in proportion to the number of
warrants exercised. The maximum amount of such fee assuming 100% exercise of
such warrants is $0.3 million. The Company has not reflected this obligation as
a liability in its unaudited financial statements as the payment is contingent
upon the timing and exercise of the warrants by each of the warrant
holders. Such fee, if any, will be paid and charged against earnings
as and if the warrants are exercised. No warrants have been exercised
under the August 2007 Unit Offering.
Item
2. Management's
Discussion and Analysis of Financial Condition and Results of
Operations
This
discussion and analysis should be read in conjunction with the Company's
financial statements and accompanying notes included elsewhere in this
Report. Historical operating results are not necessarily indicative
of results in future periods.
Forward
Looking Statements
Certain
statements in this Report constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors which may cause our actual results, performance or achievements to
be materially different from any future results, performance, or achievements
expressed or implied by such forward-looking statements. The most significant of
such factors include, but are not limited to, our ability and the ability of
King Pharmaceuticals Research and Development, Inc. (“King”) (to whom we have
licensed our Aversion®
Technology for certain opioid analgesic products in the
United States, Canada and Mexico) and the ability other
pharmaceutical companies, if any, to whom we may license our Aversion®
Technology, to obtain necessary regulatory approvals and commercialize products
utilizing Aversion®
Technology, the ability to avoid infringement of patents, trademarks and other
proprietary rights of third parties, and the ability to fulfill the U.S. Food
and Drug Administration’s (“FDA”) requirements for approving our product
candidates for commercial manufacturing and distribution in the United States,
including, without limitation, the adequacy of the results of the laboratory and
clinical studies completed to date and the results of other laboratory and
clinical studies, to support FDA approval of our product candidates, the
adequacy of the development program for our product candidates, changes in
regulatory requirements, adverse safety findings relating to our product
candidates, the risk that the FDA may not agree with our analysis of our
clinical studies and may evaluate the results of these studies by different
methods or conclude that the results of the studies are not statistically
significant, clinically meaningful or that there were human errors in the
conduct of the studies or the risk that further studies of our product
candidates are not positive or otherwise do not support FDA approval or
commercially viable product labeling, and the uncertainties inherent in
scientific research, drug development, clinical trials and the regulatory
approval process. Other important factors that may also affect future
results include, but are not limited to: our ability to attract and retain
skilled personnel; our ability to secure and protect our patents, trademarks and
other proprietary rights; litigation or regulatory action that could require us
to pay significant damages or change the way we conduct our business; our
ability to compete successfully against current and future competitors; our
dependence on third-party suppliers of raw materials; our ability to secure U.S.
Drug Enforcement Administration ("DEA") quotas and source the active ingredients
for our products in development; difficulties or delays in clinical trials for
our product candidate or in the commercial manufacture and supply of our
products; and other risks and uncertainties detailed in this Report and in our
2008 Annual Report on Form 10-K filed with the Securities and Exchange
Commission. When used in this Report, the words "estimate," "project,"
"anticipate," "expect," "intend," "believe," and similar expressions identify
forward-looking statements.
Company
Overview
We are a
specialty pharmaceutical company engaged in research, development and
manufacture of product candidates providing abuse deterrent features and
benefits utilizing our proprietary Aversion®
Technology. Our innovative Aversion®
Technology platform has been successfully utilized in developing multiple opioid
analgesic products candidates. Development of Acurox® (oxycodone
HCl/niacin) Tablets, our lead product candidate, is supported by numerous
laboratory studies and statistically significant and clinically meaningful Phase
II and Phase III study results. Additional product candidates in
development are supported by laboratory and bioequivalence
studies. Our portfolio of product candidates includes opioid
analgesics intended to effectively relieve pain while simultaneously
discouraging common methods of pharmaceutical product misuse and abuse
including:
|
·
|
intravenous
injection of dissolved tablets or
capsules;
|
|
·
|
nasal
snorting of crushed tablets or capsules;
and
|
|
·
|
intentional
swallowing of excess quantities of tablets or
capsules.
|
Acurox®, our lead
product candidate, is an orally administered immediate release tablet containing
oxycodone HCl as its sole active analgesic ingredient. On December
30, 2008, we submitted a 505(b)(2) New Drug Application (“NDA”) for Acurox® Tablets
to the FDA including a request for Priority review. On March 3, 2009 we
announced such NDA was accepted for filing by the FDA with a Priority review
classification. The user fee goal date for the Acurox® Tablets
NDA under the Prescription Drug User Fee Act (PDUFA) is June 30, 2009. The
FDA's timelines described in the PDUFA guidance are flexible and subject to
change based on workload and other potential review issues. In
addition to Acurox®, we have
numerous Aversion®
Technology opioid analgesic product candidates in various stages of development
containing the active analgesic ingredients found in widely prescribed and
frequently abused products. All of our product candidates utilize
Aversion®
Technology and are covered by issued US patents, which in combination with our
anticipated product labeling and drug product listing strategies are anticipated
to provide our opioid products with protection from generic competition in the
U.S. through the expiration of our patents in 2025.
King
Agreement
We have
entered into a license agreement (the “King Agreement”) dated October 30, 2007
with King Pharmaceuticals Research and Development, Inc. (“King”), a
wholly-owned subsidiary of King Pharmaceuticals, Inc., to develop and
commercialize in the United States, Canada and Mexico (the "King Territory")
Acurox®,
Acuracet®
(oxycodone HCI/niacin/APAP) Tablets, Vycavert™
(hydrocodone bitartrate/niacin/APAP) Tablets and a fourth undisclosed opioid
analgesic product candidate utilizing our proprietary Aversion®
Technology. King has an option to license in the King Territory all
future opioid analgesic products developed utilizing Aversion®
Technology. The King Agreement provides that we or King may develop additional
opioid analgesic product candidates utilizing our Aversion®
Technology and, if King exercises its option to license such additional product
candidates, they will be subject to the milestone and royalty payments and other
terms of the King Agreement.
We are
responsible, using commercially reasonable efforts, for all Acurox® Tablet
development activities through FDA approval of a 505(b)(2) NDA, the expenses for
which are reimbursed by King. After NDA approval King will be responsible for
manufacturing and commercializing Acurox® Tablets
in the U.S. With respect to all other products licensed by King
pursuant to the King Agreement in all King Territories, King will be
responsible, at its own expense, for development, regulatory, manufacturing and
commercialization activities. Subject to the King Agreement, King
will have final decision making authority with respect to all development and
commercialization activities for all licensed products.
As of
March 31, 2009, we had received aggregate payments of $55.4 million from King,
consisting of a $30.0 million non-refundable upfront cash payment, $14.4 million
in reimbursed research and development expenses relating to Acurox® Tablets,
$6.0 million in fees relating to King’s exercise of its option to license an
undisclosed opioid analgesic tablet product and Vycavert™ Tablets,
and a $5.0 million milestone fee for successful achievement of the primary
endpoints for our pivotal Phase III clinical study for Acurox®
Tablets. The King Agreement provides for King to pay us: (a) a $3.0
million option exercise fee for each future opioid product candidate King
licenses, (b) up to $23 million in regulatory milestone payments for each King
licensed product candidate, including Acurox® Tablets,
across specific countries in the King Territory, and (c) a one-time $50 million
sales milestone payment upon the first attainment of an aggregate of $750
million in net sales of all of our licensed products combined in all King
Territories. In addition, for sales occurring following the one year
anniversary of the first commercial sale of the first licensed product sold,
King will pay us a royalty at one of 6 rates ranging from 5% to 25% based on the
level of combined annual net sales for all products licensed by us to King in
all King Territories, with the highest applicable royalty rate applied to such
combined annual sales. No minimum annual fees are payable by either
party under the King Agreement.
The
foregoing description of the King Agreement contains forward-looking statements
about Acurox® Tablets,
and other product candidates pursuant to the King Agreement. As with
any pharmaceutical products under development or proposed to be developed,
substantial risks and uncertainties exist in development, regulatory review and
commercialization process. There can be no assurance that any product
developed, in whole or in part, pursuant to the King Agreement will receive
regulatory approval or prove to be commercially
successful. Accordingly, investors in the Company should recognize
that there is no assurance that the Company will receive the milestone payments
or royalty revenues described in the King Agreement or even if such milestones
are achieved, that the related products will be successfully commercialized and
that any royalty revenues payable to us by King will materialize.
Patents
and Patent Applications
In April
2007, the United States Patent and Trademark Office (“USPTO”), issued to us a
patent titled “Methods and Compositions for Deterring Abuse of Opioid Containing
Dosage Forms” (the “920 Patent”). The 54 allowed claims in the 920
Patent encompass certain pharmaceutical compositions intended to deter the most
common methods of prescription opioid analgesic product misuse and
abuse. These patented pharmaceutical compositions include specific
opioid analgesics such as oxycodone HCl and hydrocodone bitartrate among
others.
In March
2009, the USPTO issued to us a patent (the “726 Patent”) with 20 allowed
claims. The 726 Patent encompasses a wider range of abuse deterrence
compositions than our 920 Patent. The USPTO previously issued to us a
Notice of Allowance for a 21st claim
in our 726 Patent application. Upon consideration of a potential
interference proceeding between the 726 Patent application and a third party
patent application, we filed with the USPTO a Request for Continued Examination
of the 726 Patent application and cancelled from such application the claim
similar to the claim included in the third party patent
application.
In
January 2009, the USPTO issued to us a patent (the “402 Patent”) with 18 allowed
claims. The 402 Patent encompasses certain combinations of kappa and mu opioid receptor agonists
and other ingredients intended to deter opioid analgesic product misuse and
abuse.
In
addition to our three issued U.S. patents, we also have five U.S.
non-provisional pending patent applications and multiple international patent
applications filed relating to compositions containing abuseable active
pharmaceutical ingredients. Except for those rights conferred in the
King Agreement, we have retained all intellectual property rights to our
Aversion®
Technology and related product candidates.
Company’s
Present Financial Condition
At April
29, 2009, we had cash, cash equivalents and short term investments of
approximately $36.5 million. We estimate that our current cash reserves will be
sufficient to fund operations and the development of Aversion® Technology and
related product candidates through at least the next 12 months.
In
December, 2007, we and King Research and Development Inc., ("King") closed a
License, Development and Commercialization Agreement (the “King Agreement”) to
develop and commercialize certain opioid analgesic products utilizing our
proprietary Aversion® Technology in the United States, Canada and
Mexico. During the three months ended March 31, 2009, we recognized
revenues of $1.3 million of the $30.0 million upfront cash payment received from
King in December 2007 and recognized $0.1 million of revenues for reimbursement
by King of our Acurox® Tablet
development expenses. We have yet to generate any royalty revenues from product
sales. We expect to rely on our current cash resources and additional
payments that may be made under the King Agreement and under similar license
agreements with other pharmaceutical company partners, of which there can be no
assurance, in funding our continued operations. Our cash requirements
for operating activities may increase in the future as we continue to conduct
pre-clinical studies and clinical trials for our product candidates, maintain,
defend, if necessary and expand the scope of our intellectual property, hire
additional personnel, or invest in other areas.
Results of Operations for
the Three Month Period Ended March 31, 2009 and 2008
|
|
March
31,
|
|
|
Change
|
|
($ in thousands):
|
|
2009
|
|
|
2008
|
|
|
Dollars
|
|
|
%
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
Program
fee revenue
|
|
$ |
1,263 |
|
|
$ |
13,707 |
|
|
$ |
(12,444 |
) |
|
|
(91 |
)
% |
Collaboration
revenue
|
|
|
117 |
|
|
|
3,377 |
|
|
|
(3,260 |
) |
|
|
(97 |
) |
Total
revenue
|
|
|
1,380 |
|
|
|
17,084 |
|
|
|
(15,704 |
) |
|
|
(92 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development expenses
|
|
|
1,129 |
|
|
|
4,082 |
|
|
|
(2,953 |
) |
|
|
(72 |
) |
Marketing,
general and administrative expenses
|
|
|
2,448 |
|
|
|
870 |
|
|
|
1,578 |
|
|
|
181 |
|
Total
operating expenses
|
|
|
3,577 |
|
|
|
4,952 |
|
|
|
(1,375 |
) |
|
|
- |
|
Operating
(loss) income
|
|
|
(2,197 |
) |
|
|
12,132 |
|
|
|
(14,329 |
) |
|
|
(118 |
) |
Other
income - interest, net
|
|
|
69 |
|
|
|
297 |
|
|
|
(228 |
) |
|
|
(77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)
income before income tax
|
|
|
(2,128 |
) |
|
|
12,429 |
|
|
|
(14,557 |
) |
|
|
(117 |
) |
Income
tax (benefit) expense
|
|
|
(851 |
) |
|
|
4,980 |
|
|
|
5,831 |
|
|
|
(117 |
) |
Net
(loss) income
|
|
$ |
(1,277 |
) |
|
$ |
7,449 |
|
|
$ |
(8,726 |
) |
|
|
(117 |
)
% |
Revenue
King paid
us a $30.0 million upfront fee in connection with the closing of the King
Agreement in December 2007. Revenue recognized in the three month periods ended
March 31, 2009 and 2008 from amortization of this upfront fee was $1.3 million
and $13.7 million, respectively. We have assigned a portion of the program fee
revenue to each of three product candidates identified under the King Agreement
and expect to recognize the remainder of the program fee revenue ratably over
our estimate of the development period for each of these product candidates
identified in the King Agreement. We currently estimate the development period
to extend through November, 2009.
Collaboration
revenue recognized in the three month periods ended March 31, 2009 and 2008 was
$0.1 million and $3.4 million for billed reimbursement of our Acurox® Tablet
development expenses incurred pursuant to the King Agreement. We invoice
King in arrears on a calendar quarter basis for our reimbursable development
expenses under the King Agreement. We expect the amount and timing of
collaboration revenue to fluctuate in relation to the amount and timing of the
underlying research and development expenses.
Operating
Expenses
Research
and development expense during the three month periods ended March 31, 2009 and
2008 were for product candidates utilizing our Aversion®
Technology, including costs of preclinical, clinical trials, clinical supplies
and related formulation and design costs, salaries and other personnel related
expenses, and facility costs. Included in the 2009 result are
non-cash stock-based compensation charges of $0.3 million. There was a nominal
amount of stock-based compensation charges in the 2008 result. Excluding the
stock-based compensation expense, there is a $3.3 million decrease in
development expenses primarily attributable to clinical study costs for Acurox®
Tablets.
Marketing
expenses during the three month periods ended March 31, 2009 and 2008 consisted
of Aversion®
Technology primary market data research studies. Our general and administrative
expenses primarily consisted of legal, audit and other professional fees,
corporate insurance, and payroll. Included in the 2009 and 2008 results are
non-cash stock-based compensation charges of $1.3 million and $0.1 million,
respectively. Excluding the stock-based compensation expense, there is a $0.4
million increase in general, administrative and marketing expenses primarily in
areas such as $0.1 million for patent legal services, $0.1 million for state
franchise taxes and $0.2 million for incentive compensation
accruals.
Other Income
(Expense)
During
the three month periods ended March 31, 2009 and 2008, the cash was
invested in accordance with the investment policy approved by our Board of
Directors resulting in interest income of $0.1 million and $0.3 million,
respectively.
Net Income (Loss)
The
Company records its tax provision using a 40% effective tax rate. The net loss
for the three months ended March 31, 2009 includes a provision for an income tax
benefit of $0.9 million. The Company’s net income for the three month period
ended March 31, 2008 includes a tax provision of $5.0 million.
Liquidity
and Capital Resources
At March
31, 2009, the Company had unrestricted cash and cash equivalents of $37.0
million compared to $35.4 million in cash, cash equivalents and short-term
investments at December 31, 2008. The Company had working capital of $36.3
million at March 31, 2009 compared to $36.0 million at December 31, 2008. The
increase in our cash position of $1.6 million is primarily due to the collection
of our collaboration revenue receivable during the three month period ending
March 31, 2009. Cash flows generated in operating activities were $1.6 million
for the three month period ended March 31, 2009 primarily representing the
collection of the collaboration revenue receivable offset by the period’s net
loss adjusted for certain non cash items such as deferred program fee revenue,
deferred income taxes, and charges for stock compensation. Cash flow used in
operating activities for the three month period ended March 31, 2008 primarily
represented our recognition of deferred program fee revenue offset by
the period’s net income and change in deferred income taxes. The cash flow from
investing activities resulted from the maturity of our short term investments
during the 2009 period and the purchase of short term investments for the 2008
period.
At April
29, 2009, the Company had cash, cash equivalents, and short-term investments of
approximately $36.5 million. The Company estimates that such cash reserves will
be sufficient to fund the development of Aversion® Technology product candidates
and related operating expenses at least through the next 12 months.
The
following table presents our expected cash payments on contractual obligations
outstanding as of March 31, 2009:
|
|
Payments due by period
|
|
(in thousands)
|
|
Total
|
|
|
Less than 1
year
|
|
|
1-3 years
|
|
|
3-5 years
|
|
|
More than 5
years
|
|
Operating
leases
|
|
$ |
31 |
|
|
$ |
23 |
|
|
$ |
8 |
|
|
|
— |
|
|
|
— |
|
Clinical
studies
|
|
|
37 |
|
|
|
37 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Employment
agreements
|
|
|
855 |
|
|
|
735 |
|
|
|
120 |
|
|
|
— |
|
|
|
— |
|
Total
|
|
$ |
923 |
|
|
$ |
795 |
|
|
$ |
128 |
|
|
|
— |
|
|
|
— |
|
Critical
Accounting Policies
Note A of
the Notes to Consolidated Financial Statements, in the Company’s 2008 Annual
Report on Form 10-K, includes a summary of the Company's significant accounting
policies and methods used in the preparation of the financial statements. The
application of these accounting policies involves the exercise of judgment and
use of assumptions as to future uncertainties and, as a result, actual results
could differ from these estimates. The Company does not believe there
is a consequential likelihood that materially different amounts would be
reported under different conditions or using different assumptions. The
Company's critical accounting policies described in the 2008 Annual Report are
also applicable to 2009.
Item
4. Controls and
Procedures
(a) Disclosure
Controls and Procedures. The Company’s
management, with the participation of the Company’s Chief Executive Officer and
Chief Financial Officer, has evaluated the effectiveness of the Company’s
disclosure controls and procedures (as such term is defined on Rules 13a – 13(e)
and 15(d) – 15(e) under the Exchange Act) as of the end of the period covered by
this report. The Company’s disclosure controls and procedures are designed to
provide reasonable assurance that information is recorded, processed, summarized
and reported accurately and on a timely basis in the Company’s periodic reports
filed with the SEC. Based upon such evaluation, the Company’s Chief Executive
Officer and Chief Financial Officer have concluded that, as of the end of such
period, the Company's disclosure controls and procedures are effective to
provide reasonable assurance. Notwithstanding the foregoing, a control system,
no matter how well designed and operated, can provide only reasonable, not
absolute assurance that it will detect or uncover failures within the Company to
disclose material information otherwise require to be set forth in the Company’s
periodic reports.
(b) Changes
in Internal Controls over Financial Reporting. There were no changes in
our internal controls over financial reporting during the first fiscal quarter
of 2009 that have materially affected, or are reasonably likely to materially
affect, our internal controls over financial reporting.
PART
II
Item
1A. Risk Factors
Relating To The Company
In
addition to the Risk Factors set forth in Item 1A of the Company’s Annual Report
on Form 10-K for the year ended December 31, 2008, shareholders and prospective
investors in the Company’s common stock should carefully consider the following
risk factors (which update the risk factors having similar caption
descriptions in our 2008 Form 10-K).
If
King is not successful in commercializing Acurox® Tablets
and other licensed product candidates incorporating the Aversion®
Technology our revenues and our business will suffer.
Pursuant
to our License, Development and Commercialization Agreement for certain of our
opioid analgesic product candidates, King is responsible for manufacturing,
marketing, pricing, promoting, selling, and distributing such product candidates
in the US., Canada and Mexico. If such agreement is terminated in
accordance with its terms, including due to a party’s failure to perform its
obligations or responsibilities under the agreement, then we would need to
commercialize the products ourselves for which we currently have no
infrastructure or alternatively enter into a new agreement with another
pharmaceutical company, of which no assurance can be given. In this
event our revenues and/or royalties for these products could be adversely
impacted.
King’s
manufacturing facility is currently the sole commercial source of supply for
Acurox® and our other product candidates licensed to King. If King’s
manufacturing facility fails to obtain sufficient DEA quotas for the opioid
active ingredients contained in such product candidates, fails to source
adequate quantities of active and inactive ingredients, fails to comply with
regulatory requirements, or otherwise experiences disruptions in commercial
supply of our product candidates, product revenue and our royalties could be
adversely impacted.
King has
a diversified product line for which Acurox® and our other product candidates
licensed to King will vie for King’s promotional, marketing, and selling
resources. If King fails to commit sufficient promotional, marketing
and selling resources to our products, product revenue and our royalties could
be adversely impacted.
The
market for our opioid product candidates is highly competitive with many
marketed non abuse deterrent brand and generic products and other abuse
deterrent product candidates in development. If King prices our
product candidates inappropriately, fails to position our products properly,
targets inappropriate physician specialties, or otherwise does not provide
sufficient promotional support, product revenue and our royalties could be
adversely impacted.
We
or our licensees may not obtain required FDA approval; the FDA approval process
is time-consuming and expensive.
The
development, testing, manufacturing, marketing and sale of pharmaceutical
products are subject to extensive federal, state and local regulation in the
United States and other countries. Satisfaction of all regulatory requirements
typically takes years, is dependent upon the type, complexity and novelty of the
product candidate, and requires the expenditure of substantial resources for
research, development and testing. Substantially all of our operations are
subject to compliance with FDA regulations. Failure to adhere to applicable FDA
regulations by us or our licensees would have a material adverse effect on our
operations and financial condition. In addition, in the event we are successful
in developing product candidates for distribution and sale in other countries,
we would become subject to regulation in such countries. Such foreign
regulations and product approval requirements are expected to be time consuming
and expensive.
We or our
licensees may encounter delays or rejections during any stage of the regulatory
review and approval process based upon the failure of clinical or laboratory
data to demonstrate compliance with, or upon the failure of the product
candidates to meet, the FDA’s requirements for safety, efficacy and quality; and
those requirements may become more stringent due to changes in regulatory agency
policy or the adoption of new regulations. After submission of an NDA, or a
505(b)(2) NDA, the FDA may refuse to file the application, deny approval of the
application, require additional testing or data and/or require post-marketing
testing and surveillance to monitor the safety or efficacy of a product. The FDA
commonly takes more than a year to grant final approval for an NDA, or 505(b)(2)
NDA. The Prescription Drug User Fee Act (“PDUFA”) sets time standards for FDA’s
review of NDA’s. The FDA's timelines described in the PDUFA guidance are
flexible and subject to change based on workload and other potential review
issues and may delay the FDA’s review of an NDA. Further, the terms
of approval of any NDA, including the product labeling, may be more restrictive
than we or our licensees desire and could affect the marketability of products
utilizing our Aversion®
Technology.
Even if
we comply with all the FDA regulatory requirements, we or our licensees may
never obtain regulatory approval for any of our product candidates. If we or our
licensees fail to obtain regulatory approval for any of our product candidates,
we will have fewer commercialized products and correspondingly lower revenues.
Even if regulatory approval of our products is received, such approval may
involve limitations on the indicated uses or promotional claims we or our
licensees may make for our products, or otherwise not permit labeling that
sufficiently differentiates our product candidates from competitive products
with comparable therapeutic profiles but without abuse deterrent
features. Such events would have a material adverse effect on our
operations and financial condition.
The FDA
also has the authority to revoke or suspend approvals of previously approved
products for cause, to debar companies and individuals from participating in the
drug-approval process, to request recalls of allegedly violative products, to
seize allegedly violative products, to obtain injunctions to close manufacturing
plants allegedly not operating in conformity with current Good Manufacturing
Practices (“cGMP”) and to stop shipments of allegedly violative
products. In the event the FDA takes any such action relating to our
products (if any are approved by FDA), such actions would have a material
adverse effect on our operations and financial condition.
Item
6. Exhibits
The exhibits required to be filed as
part of this Report are listed below.
10.1
|
Employment
Agreement dated as of March 23, 2009 between Acura Pharmaceuticals, Inc.
and Garth Boehm.
|
31.1
|
Certification
of Periodic Report by Chief Executive Officer pursuant to Rule 13a-14 and
15d-14 of the Securities Exchange Act of
1934.
|
31.2
|
Certification
of Periodic Report by Chief Financial Officer pursuant to Rule 13a-14 and
15d-14 of the Securities Exchange Act of
1934.
|
32.1
|
Certification
of Periodic Report by the Chief Executive Officer and Chief Financial
Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of
2002.
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
April
29, 2009
|
ACURA
PHARMACEUTICALS, INC.
|
|
|
|
/s/ Andrew D. Reddick
|
|
Andrew
D. Reddick
|
|
President
& Chief Executive Officer
|
|
|
|
/s/ Peter A. Clemens
|
|
Peter
A. Clemens
|
|
Senior
VP & Chief Financial
Officer
|
Unassociated Document
EMPLOYMENT
AGREEMENT
This EMPLOYMENT AGREEMENT (the
"Agreement") made as of
the 23th day of
March, 2009 by and between ACURA PHARMACEUTICALS, INC., a
New York corporation (the "Company"), with an
administrative office at 616 N. North Court, Suite 120, Palatine,
IL 60067 and GARTH
BOEHM, Ph.D., residing at 530 Mountain Avenue, Westfield, NJ 07090 (the
"Employee").
WITNESSETH
WHEREAS, the Company desires
to employ the Employee to engage in such activities and to render such services
as are required under the terms and conditions hereof and the Company's Board of
Directors has authorized and approved the execution of this Agreement;
and
WHEREAS, the Employee desires
to be employed by the Company under the terms and conditions hereinafter
provided.
NOW, THEREFORE, in
consideration of the mutual covenants and undertakings herein contained, the
parties agree as follows:
1. Employment, Duties,
Responsibilities, Office Location, Travel, and Acceptance.
1.1 Duties and
Responsibilities. Commencing on the Commencement Date (as
defined below) the Company shall employ the Employee for the Term (as herein
defined), to render exclusive and full-time paid services (as herein defined) as
the Company's Vice President of Modified Release Dosage Form
Development. The Employee's duties and responsibilities shall include
(i) in conjunction with Company's outside patent counsel, evaluating the
Company's issued patents and filed patent applications; (ii) developing,
authoring, and/or co-authoring new patent applications intended to encompass and
protect commercially viable pharmaceutical products with abuse deterrent
features and benefits; (iii) reviewing draft patent applications authored by
other Company staff; (iv) in conjunction with Company patent counsel, evaluating
competitive patents and published patent applications for freedom to operate and
other relevant considerations; (v) evaluating technical aspects of competitive
and potentially competitive products in development with abuse deterrent
features and benefits; and (vi) collaborating with the Company's technical staff
regarding development of new modified-release oral solid dosage forms with abuse
deterrent features using previously approved active and inactive pharmaceutical
ingredients. In connection therewith, commencing on the Commencement
Date the Employee shall perform the duties and responsibilities set forth
here-in and others as may be further reasonably and customarily requested by the
Chief Executive Officer (CEO) (collectively, the "Services"), to whom the
Employee shall report and to use his commercially reasonable best efforts, skill
and abilities to promote the interests of the Company and its
subsidiaries. For purposes hereof, “Commencement Date” shall mean
May 4th, 2009, unless the Company and the Employee expressly agree in writing to
another date, in which case such other date shall be deemed the Commencement
Date.
1.2 Office Location and
Travel. The Employee shall perform the Services from his home
office. In addition, the Employee may be required to travel from
time-to-time to the Company's Culver, IN research, development, and
manufacturing facility, and Palatine, IL administrative office, offices of the
Company's existing and potentially new legal counsel currently located in
Newark, NJ (general and SEC counsel), Philadelphia, PA (patent counsel),
Washington, DC (regulatory counsel), existing and potentially new licensees
(currently including King Pharmaceuticals, Inc.) Bridgewater, NJ, RTP, NC, and
Bristol, TN, existing and potentially new contract research organizations,
contract manufacturing organizations, and contract laboratory service providers,
Company board of directors and staff meetings and such other locations as shall
be required as the CEO shall determine to be in the best business interests of
the Company.
1.3 Acceptance. The
Employee hereby accepts such employment and agrees to render the Services
described in Section 1 hereof.
2. Term of
Employment. The term of the Employee’s employment under
this Agreement shall commence on the Commencement Date of this Agreement and
shall expire twenty-four months thereafter (the “Initial Term”), unless sooner
terminated pursuant to Section 6 of this Agreement; provided, however, that the
term of the Employee’s employment hereunder shall automatically be extended for
successive one (1) year periods (each, a “Renewal Period” and together
with the Initial Term, the “Term”) unless either the
Company or the Employee provides written notice of non-renewal of the Employee’s
employment with the Company ninety (90) days prior to the expiration of the
Initial Term or any Renewal Period.
3. Compensation. In
consideration of the services to be rendered by the Employee pursuant to this
Agreement, the Employee shall receive from the Company the following
compensation:
(a) Base
Salary. The Company shall pay the Employee an aggregate base
salary at the initial annual rate of Two Hundred Sixty-Five Thousand Dollars
($265,000) (the "Base
Salary"), commencing on the Commencement Date and payable in equal weekly
installments, or other periods at the Company's discretion, less such deductions
or amounts to be withheld as shall be required by applicable laws and
regulations. The Employee’s Base Salary shall be reviewed at least
annually and be subject to increase by the Board of Directors of the Company in
its sole and absolute discretion.
(b) Annual
Bonus. The Employee will be eligible to receive from the
Company an annual bonus (the “Bonus”) in the amount of up to
thirty-five percent (35%) of the Employee’s then current annual Base Salary
during such calendar year (with eligibility prorated for calendar year 2009 from
the Commencement Date to December 31, 2009). The Bonus will be based
upon the relative achievement of such targets, conditions or parameters (the
“Bonus Criteria”) as
will be agreed upon by the Employee and the Board of Directors or the
Compensation Committee of the Board of Directors of the Company. The
Bonus shall be paid at the same time as the bonuses are paid to other executive
officers of the Company, but in any event within seventy five (75) days
following the end of each calendar year for which the Employee is awarded a
Bonus which has been approved and authorized by the Board of Directors to be
paid. Except as provided in Section 7, Employee must be actively
employed by the Company on the date that the Bonus is paid to be eligible for
such Bonus.
(c) Business
Expenses. The Company shall pay or reimburse the Employee for
all reasonable expenses which are in accordance with the Company’s expense
policy in force from time to time and which are actually incurred or paid by the
Employee during the Term in the performance of his Services under this
Agreement, upon presentation of expense statements or vouchers or such other
supporting information as the Company may reasonably require. Such
expenses shall include, but not be limited to, business travel, related meals
and lodging for overnight stays, home office supplies, cell phone and home
telephone line, internet service provider, laptop computer and associated
software, and home printer and associated supplies.
(a) Insurance and Retirement
Plans. The Employee shall be entitled to medical, dental,
disability, and life insurance and retirement plan benefits for which he may be
eligible as adopted from time to time by the Company's Board of Directors in its
sole and absolute discretion for the benefit of employees of the
Company.
(b) Stock
Options. Upon the Commencement Date, the Employee shall be
granted stock options to purchase 96,000 shares of the Company’s common stock
(the "Commencement Date
Option") at an exercise price per share equal to the last sale price as
reported by the NASDAQ Capital Market of the Company’s common stock on the
trading day immediately preceding the Commencement Date. The
Commencement Date Option shall vest and be exercisable at the rate of 4,000
shares on the last day of each calendar month during the Initial
Term. The Commencement Date Option shall be evidenced by the Stock
Option Agreement substantially in the form of Exhibit
A attached hereto and governed by the Company’s 2008 Stock Option
Plan. The Employee will also be eligible in the future to receive
stock option grants based on performance or on achievement milestones as
determined by the Board of Directors or the Compensation
Committee. The Commencement Date Option and any other stock option
granted to the Employee by the Company during the Term are referred to herein
collectively as the “Options”.
(c) Restricted Stock
Units. Upon the Commencement Date, the Company shall grant to
the Employee a Restricted Stock Unit Award for 24,000 shares of the Company’s
common stock (the “Commencement
Date Restricted Stock
Units”). The Commencement Date Restricted Stock Units shall
vest at the rate of 1,000 restricted stock units on the last day of each
calendar month during the Initial Term. The Commencement Date
Restricted Stock Units shall be evidenced by the Restricted Stock Unit Award
Agreement substantially in the form of Exhibit
B attached hereto and governed by the Company’s 2005 Restricted Stock
Unit Award Plan. The Commencement Date Restricted Stock Units and any
other restricted stock units granted to the Employee by the Company during the
Term are referred to herein collectively as “Restricted Stock
Units”.
5. Vacation. The
Employee shall be entitled to four weeks of vacation during each calendar year
of the Term (pro-rated for calendar year 2009) to be taken at a time or times
mutually agreed upon by the Employee and the Company; provided, however, that
not more than one week of accrued but unused vacation period may be carried over
to the calendar year immediately following the calendar year in which such
vacation was to be taken, unless otherwise required by applicable
law. The Company acknowledges the Employee will be travelling to
South East Asia for two (2) weeks in June 2009.
6.1 Death. If
during the Term the Employee shall die, the Employee’s employment under this
Agreement shall terminate as of the date of the Employee's
death. Upon such termination under this Section 6.1 the Company shall
pay to or for the benefit of the Employee to such person or persons as the
Employee shall designate by notice to the Company from time to time or, in the
absence of such designation, the Employee’s spouse (the “Employee’s Designees”), in a
lump sum in cash within thirty (30) days from the date of the Employee's death
the accrued but unpaid portion of the Base Salary payable hereunder through the
date of death, and any accrued and unpaid vacation. Except as set
forth in any Stock Option Agreements and Restricted Stock Unit Award Agreements,
the Company shall not have any further obligations to provide the Employee with
any further payments, benefits, or remuneration upon a termination under this
Section 6.1.
6.2 Disability. In
the event of the Employee’s "mental or physical disability" (as defined herein)
which continues for (i) a period of longer than sixty (60) consecutive days,
(ii) such periods aggregating one hundred twenty (120) days during any 365
consecutive days, or (iii) such additional period as may be required by law,
such that the Employee is unable to substantively perform the essential
functions of his position for said periods even with reasonable accommodation if
necessary, the determination of which shall be confirmed by the Board of
Directors in the manner hereinafter provided, this Agreement shall terminate
upon thirty (30) days' prior written notice to the Employee from the Company
(the "Disability Termination
Date"). The Company shall continue to pay to the Employee
during the period of his mental or physical disability the Base Salary provided
in Section 3 of this Agreement and provide the benefits described herein;
provided, however, that the Base Salary shall be reduced by any disability
insurance payments paid to the Employee by a policy paid for by the
Company. On the Disability Termination Date, (a) the Employee’s Base
Salary shall cease, and (b) the Company shall pay to the Employee, in a lump sum
in cash, any accrued and unpaid vacation. As used herein, the term
"mentally or physically
disabled" shall mean any mental or physical condition that precludes the
Employee from being able to perform the essential functions of his duties and
responsibilities even with reasonable accommodation if necessary. The
Company may require the Employee to undergo an independent medical examination
by a reputable health care professional of the Company’s selection as part of
its determination of whether the Employee is mentally or physically
disabled. The Employee hereby consents to, and agrees to make himself
available for, such examination. Except as set forth in any Stock
Option Agreements and Restricted Stock Unit Award Agreements, the Company shall
not have any further obligations to provide the Employee with any further
payments, benefits, or remuneration upon a termination under this Section
6.2.
6.3 Termination for
Cause. The Company may at any time during the Term, by written
notice, and after affording the Employee the opportunity to be heard in person
by the Board of Directors, terminate this Agreement and discharge the Employee
for "Cause", whereupon the Company's obligation to pay compensation or any other
amounts payable hereunder to or for the benefit of the Employee shall terminate
on the date of such discharge except for accrued and unpaid Base Salary and
expenses to the date of discharge. For purposes of this Agreement,
the term "Cause" shall mean: (i) any act of the Employee’s
constituting willful misconduct which is materially detrimental to the Company’s
best interests, including misappropriation of, or intentional damage to, the
funds, property, business or reputation of the Company; (ii) conviction of a
felony or of a crime involving moral turpitude or conviction of any crime
involving dishonesty or fraud;; (iii) material failure of the Employee to
perform his duties in accordance with this Agreement after written notice to the
Employee by the Board of Directors specifying such failure and giving the
Employee fourteen (14) days to correct the defects in performance; or (iv)
breach by the Employee of any material provision hereof which, if capable of
remedy, remains unremedied for more than fourteen (14) days after written
notice. In the event the Employee is terminated by the Company for
Cause or if the Employee resigns other than for Good Reason (as defined in
Section 6.5), the Employee shall be entitled to exercise the vested portion of
the Options within forty (40) days of such termination or
resignation. At the expiration of such forty (40) day exercise
period, the unexercised Options shall terminate. Except as set forth
in any Stock Option Agreements and Restricted Stock Unit Award Agreements, the
Company shall not have any further obligations to provide the Employee with any
further payments, benefits, or remuneration upon a termination under this
Section 6.3.
6.4 Termination Without
Cause. The Company may terminate the Employee's employment
with the Company at any time "without Cause", upon thirty (30) days' written
notice to the Employee. A termination "without Cause" shall mean a
termination of the Employee's employment other than due to death, disability or
for Cause as provided in Sections 6.1, 6.2, and 6.3, respectively.
6.5 Termination by the Employee
for Good Reason. The Employee may terminate his employment for
"Good Reason", upon
thirty (30) days' written notice to Company. "Good Reason" shall mean a
termination of employment by the Employee following, without the Employee's
express prior written consent: (i) any material diminution in the
Employee's duties, status, offices, reporting requirements, or job title, except
in connection with termination of the Employee's employment for Cause as
provided in Section 6.3 or death or disability as provided in Sections 6.1 and
6.2 provided that the Employee has given the Company written notice of the
alleged basis for Good Reason and such basis remains uncured after twenty (20)
day following the Company's receipt of the notice; (ii) the failure of the
Company timely to pay the Employee's salary, bonus or benefits due the Employee
or any material breach by the Company of this Agreement, provided that the
Employee has given the Company written notice of the alleged basis for Good
Reason and such basis remains uncured after twenty (20) day following the
Company's receipt of the notice; (iii) any change in the Company's pay plan or
employment agreement with the Employee that results in a material diminution of
the Employee's annual Base Salary or eligible Bonus amounts provided that the
Employee has given the Company written notice of the alleged basis for Good
Reason and such basis remains uncured after twenty (20) day following the
Company's receipt of the notice; (iv) notice by the Company to not renew this
Agreement pursuant to Section 2, or (v) the failure of the Company to obtain an
agreement from any successor to the Company to assume and agree to perform this
Agreement. Employee must provide notice of termination for Good
Reason within thirty (30) days of the date Employee becomes aware of grounds for
such termination.
6.6 Payment Upon Termination
Without Cause or for Good Reason.
(a) Cash Payments and
Severance. In the event of a termination without Cause or for
Good Reason the Company shall pay the Employee, subject to applicable
withholdings and deductions:
(i) each of the following amounts (x)
the Employee’s accrued and unpaid Base Salary through and including the date of
termination; (y) the Employee’s then accrued and unused vacation through and
including the date of termination; and; (z) the Employee’s then accrued and
unpaid Bonus for such year, calculated by pro-rating the annual Bonus, which
would have been payable to the Employee but for his termination and assuming
full achievement of the Bonus Criteria for such year, based on the number of
days that the Employee remained in the employ of the Company during the year for
which the Bonus is due. The payments provided in subsections (x), (y)
and (z) shall be paid in a single lump sum in cash within thirty (30) days after
the date of termination; and
(ii) one (1) year of the Employee's
Base Salary in effect immediately prior to the date of termination (”Severance Pay”). The amount of
such Severance Pay together with the payment under 6.6(a)(i)(z) that does not
exceed the Applicable Limit, shall be paid in equal monthly installments over
the Severance Period (as defined in Section 6.6(b)). To the extent
the Severance Pay together with the payment under Section 6.6(a)(i)(z) exceeds
the Applicable Limit, (A) one-half of the amount exceeding the Applicable Limit
shall be paid six months and one day after the date of termination, and (B)
one-half of the amount exceeding the Applicable Limit shall be paid in six equal
monthly installments commencing with the seventh month after the date of
termination. The Applicable Limit is the amount which may not be
exceeded as specified in Treasury Regulation 1-.409A-1(b)(iii)(A) (generally the
lesser of $490,000 (for 2009) and two times Employee’s
compensation).
(b) Insurance
Benefits. In the event of a termination without Cause or for
Good Reason, for twelve (12) months from the date of such termination (the
“Severance Period”), the
Employee will, at the Employee’s option, (i) continue to receive all insurance
benefits to which he was entitled pursuant to Section 4(a) of this Agreement as
of the date of termination including continued medical, dental, disability, and
life insurance coverage on terms substantially as in effect on the date of
termination, subject to the payment by the Employee of all applicable employee
contributions, or (ii) receive a payment in cash following his termination
without Cause or for Good Reason representing the value of such continued
benefits, plus any income tax payable by the Employee on such
value. The amount provided in subsection (ii) shall be paid (A) in a
single lump sum payment within thirty (30) days of the date of termination if
such termination is by the Company without Cause, and (B) in a single lump sum
payment six months and one day following the date of termination if such
termination is by the Employee for Good Reason. If the Employee
elects option (i) above and for any reason at any time the Company is unable to
treat the Employee as being or having been an employee of the Company under any
benefits plan in which he is entitled to participate and as a result thereof the
Employee receives reduced benefits under such plan during the period that the
Employee is continuing to receive payments pursuant to this Section 6.6(b), then
the Company shall provide the Employee with such benefits by direct payment or,
at the Company’s option, by making available equivalent benefits from other
sources. During the Severance Period, the Employee shall not be
entitled to receive salary and/or benefits except as provided herein and shall
not be entitled to participate in any employee benefit plan of, or receive any
other benefit from, the Company that is introduced after the date of
termination, except that an appropriate adjustment shall be made if such new
employee benefit or employee benefit plan is a replacement for or amendment to
an employee benefit or employee benefit plan in effect as of the date of
termination.
(c) Stock
Options. In the event of a termination without Cause or for
Good Reason, the Company shall accelerate fully the vesting of any outstanding
Options granted to the Employee and the Employee shall be entitled to exercise
his vested Options for twelve (12) months following the date of termination
without Cause or resignation for Good Reason. At the expiration of
such twelve (12) month period, all Options shall terminate.
(d) Restricted Stock
Units. In the event of a termination without Cause or for Good
Reason, the terms of the Company’s 2005 Restricted Stock Unit Award Plan and the
Restricted Stock Unit Award Agreement(s) between the Company and the Employee
issued pursuant to the 2005 Restricted Stock Unit Award Plan shall govern the
vesting and distribution relating to any Restricted Stock Units.
(e) The
Company shall not have any further obligations to provide the Employee with any
further payments, benefits, or remuneration upon a termination without Cause of
for Good Reason.
6.7 Change of
Control. In the event that (i) a Change of Control (as
hereinafter defined) occurs during the Term and (ii) the
Employee's employment with the Company is terminated without Cause or for Good
Reason, the Employee shall be entitled to the accrued salary, unused vacation,
bonus, Severance Pay, benefits, and stock option treatment as are provided in
Sections 6.6(a), (b), and (c) above, except, that the
Severance Pay shall be payable in a lump sum in cash (x) within thirty-one (31)
days after the date of such termination; provided such termination occurs within
two years after the Change of Control and such Change of Control meets the
requirements for a “change of control” under Section 409A of the Code, or (y)
six months and one day after such termination if the requirements of subsection
(x) are not met. The Employee shall give the Company not less than
sixty (60) days' prior written notice of a termination of employment with the
Company following a Change of Control transaction if the Employee is terminating
for Good Reason. Notwithstanding any language to the contrary
contained in any Option agreement with the Employee, the Employee shall be
entitled to exercise his vested Option shares for twelve (12) months following
the date of termination without Cause or resignation for Good
Reason. At the expiration of such twelve (12) month period, all
Options shall terminate. For purposes of this Section 7.7, the term
"Change of Control"
means the occurrence of any of the following, in one or a series of related
transactions: (v) the sale or transfer of fifty percent (50%) or more of the
Outstanding Shares of the Company to any person or entity other than (i) a
transfer to a wholly-owned subsidiary of the Company, or (ii) a transfer by a
holder or holders of the Company's common stock or convertible securities as of
the date hereof to Affiliates (as defined below); or (w) the sale, lease or
other transfer of all or substantially all of the assets or earning power of the
Company to any person or entity other than (i) to a
wholly-owned subsidiary of the Company, (ii) to an Affiliate whereby the purpose
or effect of such transfer is to provide for the transfer by a holder or holders
of the Company’s common stock or convertible securities as of the date hereof of
such holders’ direct or indirect interests in the assets of the Company to
Affiliates and so long as such transfer does not result in a transaction
described by one of the other clauses of this paragraph of Section 6.7, or (iii)
the license of all or any portion of the Company’s Aversion® Technology and
product related assets, in one or more transactions; or (x) merger,
consolidation, reorganization, recapitalization, share exchange, business
combination or a similar transaction which results in any person or entity
(other than the persons who are shareholders or security holders of the Company
immediately prior to such transaction (or their Affiliates as of the date of
such transaction)) owning fifty percent (50%) or more of the Outstanding Shares
or combined voting power of the Company; or (y) merger, consolidation,
reorganization, business combination or a similar transaction in which the
Company is not the surviving entity; or (z) a transaction commonly known as
“going private” whereby the Company engages one or a series of transactions
which results in the Company not being required to file periodic reports with
the Securities and Exchange Commission, unless the Employee is a participant in
such transaction. "Outstanding
Shares" shall mean the total number of common shares and common share
equivalents of the Company outstanding at the time the Change of Control,
including, without limitation, shares of common stock underlying debentures,
preferred stock, options, warrants and other convertible
securities. "Affiliate" shall mean (i) any
person or entity controlling, controlled by or under the common control of the
existing holders of common stock or convertible securities of the Company and
(ii) any partner, shareholder or member of the existing holders of common stock
or convertible securities of the Company. For the purposes hereof,
“control” shall mean the
direct or indirect ownership of at least fifty (50%) percent of the outstanding
shares or other voting rights of the subject entity or if it possesses, directly
or indirectly, the power to direct or cause the direction of management and
policies of such other entity. In the event that the Employee resigns
or terminates his employment following a Change of Control as described above,
the Employee acknowledges and agrees that upon the request of the Company, he
will execute and deliver a release in customary form releasing all claims of the
Employee arising out of his employment with the Company except for the
obligations of the Company under this Agreement.
7. Protection of Confidential
Information. In view of the fact that the Employee's work for
the Company will bring him into close contact with all the confidential affairs
thereof, and plans for future developments, the Employee agrees to the
following:
7.1 Secrecy. During
the Term and after the date of termination of the Employee’s employment, to
preserve the confidential nature of, and not use, disclose, reveal, or make
accessible to anyone other than the Company’s officers, directors, employees,
consultants or agents, otherwise than within the scope of his employment duties
and responsibilities hereunder, any and all documents, information, knowledge or
data of or pertaining to the Company, its subsidiaries or affiliates, including,
without limitation, the Aversion® Technology, or pertaining to any other
individual, firm, corporation, partnership, joint venture, business,
organization, entity or other person with which the Company or any of its
subsidiaries or affiliates may do business during the Term (including licensees,
licensors, manufacturers, suppliers and customers of the Company or any of its
subsidiaries or affiliates) and which is not in the public domain, including
trade secrets, "know how", names and lists of licensees, licensors,
manufacturers, suppliers and customers, development plans or programs,
statistics, manufacturing and production methods, processes, techniques,
pricing, marketing methods and plans, specifications, advertising plans and
campaigns or any other matters, and all other confidential information of the
Company, its subsidiaries and affiliates (hereinafter referred to as "Confidential
Information"). The restrictions on the disclosure of
Confidential Information imposed by this Section 7.1 shall not apply to any
Confidential Information that was part of the public domain at the time of its
receipt by the Employee or becomes part of the public domain in any manner and
for any reason other than an act by the Employee, unless the Employee is legally
compelled (by applicable law, deposition, interrogatory, request for documents,
subpoena, civil investigative demand or similar process) to disclose such
Confidential Information, in which event the Employee shall provide the Company
with prompt notice of such requirement so that the Company may seek a protective
order or other appropriate remedy, and if such protective order or other remedy
is not obtained, the Employee shall exercise reasonable efforts in good faith to
obtain assurance that confidential treatment will be accorded such Confidential
Information.
7.2 Return Memoranda,
etc. The Employee hereby agrees to deliver promptly to the
Company on termination of his employment, or at any other time the Company may
so request, all memoranda, notes, records, email records, reports, manuals,
drawings, blueprints and other documents (and all hard and soft copies thereof)
relating to the Company's business and all property associated therewith, which
the Employee may then possess or have under his control.
7.3 Non-competition. Provided
that this Agreement has not been breached by the Company, the Employee agrees
that he shall not at any time prior to one (1) year after the expiration or
termination of his employment with the Company for any reason, whether voluntary
or involuntary own, manage, operate, be a director or an employee of, or a
consultant to or provide any services, consultation or advice to any person,
business, corporation, partnership, trust, limited liability company or other
firm or enterprise ("Person") which is engaged in
marketing, selling or distributing products or in developing product candidates
in the United States which contain technology meant to achieve all or some of
the same effects as the Company’s Aversion® Technology or are potentially
competitive with: (a) the Company’s products or product candidates in
development or (b) its licensee’s products or product candidates in development
that contain Aversion® Technology or any similar abuse deterrent
technology. For avoidance of doubt, product candidates are as
evidenced by the current written product development plan and/or business plan
of the Company at the time of termination of the Employee's employment and/or
described in the Company’s most recent filing on Form 8-K, Form 10-K or Form
10-Q with the Securities and Exchange Commission as of the date of the
termination of the Employee’s employment. If any of the provisions of
this section, or any part thereof, is hereinafter construed to be invalid or
unenforceable, the same shall not affect the remainder of such provision or
provisions, which shall be given full effect, without regard to the invalid
portions. If any of the provisions of this section, or any part
thereof, is held to be unenforceable because of the duration of such provision,
the area covered thereby or the type of conduct restricted therein, the parties
agree that the court making such determination shall have the power to modify
the duration, geographic area and/or other terms of such provision and, as so
modified, said provision shall then be enforceable. In the
event that the courts of any one or more jurisdictions shall hold
such provisions wholly or partially unenforceable by reason of the scope thereof
or otherwise, it is the intention of the parties hereto that such determination
not bar or in any way affect the Company's right to the relief provided for
herein in the courts of any other jurisdictions as to breaches or
threatened breaches of such provisions in such other jurisdictions, the above
provisions as they relate to each jurisdiction being, for this purpose,
severable into diverse and independent covenants.
7.4 Injunctive
Relief. The Employee acknowledges and agrees that, because of
the unique and extraordinary nature of his services, any breach or threatened
breach of the provisions of Sections 7.1, 7.2, or 7.3 hereof will cause
irreparable injury and incalculable harm to the Company, and the Company shall,
accordingly, be entitled to injunctive and other equitable relief for such
breach or threatened breach and that resort by the Company to such injunctive or
other equitable relief shall not be deemed to waive or to limit in any respect
any right or remedy which the Company may have with respect to such breach or
threatened breach.
7.5 Expenses of Enforcement of
Covenants. In the event that any action, suit or proceeding at
law or in equity is brought to enforce the covenants contained in Section 7.1,
7.2 or 7.3, hereof or to obtain money damages for the breach thereof, the party
prevailing in any such action, suit or other proceeding shall be entitled upon
demand to reimbursement from the other party for all expenses (including,
without limitation, reasonable attorneys' fees and disbursements) incurred in
connection therewith.
7.6 Non-Solicitation. The
Employee covenants and agrees not to (and not to cause or direct any Person to)
hire or solicit for employment any employee of the Company or any of its
subsidiaries or affiliates. The prohibitions of this Section 7.6
shall apply (i) for six (6) months following the termination of the Employee’s
employment by the Company without Cause or by the Employee for Good Reason,
prior to a Change of Control, (ii) for twelve (12) months following the
termination of the Employee’s employment for Cause, prior to a Change of
Control, or (iii) for twenty-four (24) months following a Change of
Control.
7.7 Assignment of
Inventions. All discoveries, inventions, improvements and
innovations, whether patentable or not (including all data and records
pertaining thereto), which Employee may invent, discover, originate or conceive
during the Term of this Agreement and which directly relate to the business of
the Company or any of its subsidiaries as described in the Company’s filings
with the Securities and Exchange Commission, shall be the sole and exclusive
property of the Company. Employee shall promptly and fully disclose
each and all such discoveries, inventions, improvements or innovations to the
Company. Employee shall assign and hereby does assign to the Company
his entire right, title and interest in and to all of his discoveries,
inventions, improvements and innovation described in this Section 7.7 and any
related U.S. or foreign patent and patent applications, shall execute any
instruments reasonably necessary to convey or perfect the Company’s ownership
thereof, and shall assist the Company in obtaining, defending and enforcing its
rights therein. The Company shall bear all expenses it authorizes to
be incurred in connection with such activity and shall pay the Employee
reasonable compensation for time spent by the Employee in performing such duties
at the request of the Company after the termination of his employment, for a
period not to exceed three (3) years.
8. Indemnification. Except
as provided below, the Company will defend, indemnify and hold harmless the
Employee, to the maximum extent permitted by applicable law and the by-laws of
the Company, against all claims, costs, charges and expenses incurred or
sustained by him in connection with any action, suit or other proceeding to
which he may be made a party by reason of his being an officer, director or
employee of the Company or of any subsidiary or affiliate
thereof. Furthermore, the Company hereby represents that it will
maintain during the Term, Directors and Officers insurance coverage in the
amount of at least Ten Million Dollars ($10,000,000), provided that such ten
million dollars is payable exclusively for claims against the directors and
officers of the Company and not for claims against the
Company. Nothing herein shall require the Company to defend,
indemnify and/or hold harmless, or maintain insurance coverage for, the Employee
against any claims by former employers or companies to whom Employee previously
provided services, consultation, or advice, including, without
limitation, the Consulting Agreement discussed in Section 9 below, alleging that
Employee's performance under this Agreement violates any contractual, legal, or
other duties allegedly owed by Employee to them.
9. Warranties and
Covenants. The Employee hereby warrants that except for a
certain consulting agreement between the Employee and Alpharma as described by
the Employee to the CEO, (the “Consulting Agreement”), as of
the date hereof the Employee is not a party to any other employment contract,
express or implied and as of the Commencement Date will not be employed by or
acting as a consultant to any person or entity (other than the
Company). The Employee warrants that he has no obligation,
contractual, legal, or otherwise, which would prevent him from accepting the
Company’s offer of employment under the terms of this Agreement, from complying
with its provisions, or from fully performing the duties and responsibilities of
his position under this Agreement. The Employee warrants that he will
not utilize or disclose during his employment hereunder any confidential or
other proprietary information obtained through or in connection with his prior
employment or consulting services. The Employee warrants that he
knows of no reason why he would not be able to perform his obligations under
this Agreement. The Employee warrants that he has duly executed and
delivered this Agreement and it is valid, binding and enforceable against the
Employee in accordance with its terms. The Employee covenants that (i) he will
promptly terminate the Consulting Agreement in accordance with the termination
and notice provisions contained therein, and in any event complete the
termination of the Consulting Agreement not later than ninety (90) days from the
date of this Agreement, and (ii) he will not act as an employee or consultant to
any person or entity during the Term, except for any transitional consulting
services provided under the Consulting Agreement pending its termination or
(iii) as authorized by the CEO. The Company warrants to the Employee
that this Agreement has been duly approved and authorized by its Board of
Directors, that this Agreement has been duly executed and delivered on behalf of
the Company and that this Agreement is valid, binding and enforceable against
the Company in accordance with its terms.
10.
Notices. All
notices, requests, consents and other communications required or permitted to be
given hereunder, shall be in writing and shall be deemed to have been duly given
if delivered personally, or transmitted via facsimile, or transmitted via a pdf
copy attached to an email, with confirmation of facsimile or pdf copies
delivered by overnight delivery via FedEx or similar carriers, to the parties at
their respective addresses herein above set forth or to such other address as
either party shall designate by notice in writing to the other in accordance
herewith.
11.1 Governing
Law. This Agreement shall be governed by and construed and
enforced in accordance with the local laws of the State of New York applicable
to agreements made and to be performed entirely in New York.
11.2 Captions. The
section headings contained herein are for reference purposes only and shall not
in any way affect the meaning or interpretation of this Agreement.
11.3 Entire
Agreement. This Agreement sets forth the entire agreement and
understanding of the parties relating to the subject matter hereof, and
supersedes all prior agreements, arrangements and understandings, written or
oral, relating to the subject matter hereof. No representation,
promise or inducement has been made by either party that is not embodied in this
Agreement, and neither party shall be bound by or liable for any alleged
representation, promise or inducement not so set forth.
11.4 Assignability. This
Agreement, and the Employee's rights and obligations hereunder, may not be
assigned by the Employee. The Company may assign its rights, together
with its obligations, hereunder in connection with any sale, transfer or other
disposition of all or substantially all of its business or assets; in any event
the rights and obligations of the Company hereunder shall be binding on its
successors or assigns, whether by merger, consolidation or acquisition of all or
substantially all of its business or assets.
11.5 Amendment. This
Agreement may be amended, modified, superseded, canceled, renewed or extended
and the terms or covenants hereof may be waived, only by a written instrument
executed by both of the parties hereto, or in the case of a waiver, by the party
waiving compliance. No superseding instrument, amendment,
modification, cancellation, renewal or extension hereof shall require the
consent or approval of any person other than the parties hereto. The
failure of either party at any time or times to require performance of any
provision hereof shall in no manner affect the right at a later time to enforce
the same. No waiver by either party of the breach of any term or
covenant contained in this Agreement, whether by conduct or otherwise, in any
one or more instances, shall be deemed to be, or construed as, a further or
continuing waiver of any such breach, or a waiver of the breach of any other
term or covenant contained in this Agreement.
11.6 Counterparts. This
Agreement may be executed in one or more facsimile or original counterparts,
each of which shall be deemed an original, but all of which taken together will
constitute one and the same instrument.
11.7 Severability. The
provisions of this Agreement shall be deemed severable, and if any part of any
provision is held illegal, void or invalid under applicable law, such provision
may be changed to the extent reasonably necessary to make the provision, as so
changed, legal, valid and binding. If any provision of this Agreement
is held illegal, void or invalid in its entirety, the remaining provisions of
this Agreement shall not in any way be affected or impaired but shall
remain binding in accordance with their terms.
IN WITNESS WHEREOF, the
parties have executed this Agreement as of the date first above
written.
ATTEST:
|
|
ACURA
PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
By:
|
/s/ Andrew D. Reddick
|
|
|
|
Andrew
D Reddick
|
|
|
|
President
and Chief Executive Officer
|
|
|
|
|
WITNESS:
|
|
EMPLOYEE
|
|
|
|
|
|
|
By:
|
/s/ Garth Boehm
|
|
|
|
Garth
Boehm, Ph.D.
|
|
|
|
530
Mountain Avenue
|
|
|
|
Westfield,
NJ 07090
|
EXHIBIT
A
ACURA
PHARMACEUTICALS, INC.
STOCK
OPTION AGREEMENT
ACURA PHARMACEUTICALS, INC., a New York
corporation (the "Company"), hereby grants Garth Boehm, Ph.D. (the "Optionee"), an option (the
“Option”) to purchase
Ninety-Six Thousand (96,000) shares (the "Shares") of the Company's
common stock,$.01 par value per share ("Common Stock"), at the
exercise price set forth in Paragraph 2 hereof, and in all respects subject to
the terms, definitions and provisions of the Company’s 2008 Stock Option Plan,
as amended (the "Plan"),
and incorporated herein by reference. Terms not defined herein shall
have the meanings set forth in the Plan. In the event of any
conflict, between the terms of this Agreement and the Plan, the terms of the
Plan shall control.
1. NATURE
OF OPTION. This Option is intended to qualify as an Incentive Stock
Option as defined in Section 422 of the Internal Revenue Code of 1986, as
amended (the "Code"). To the
extent the limits of Code Section 422(d) are exceeded, this Option shall be
deemed a non-Incentive Stock Option.
2. EXERCISE
PRICE. The exercise price of the Shares shall be $_______ per share
of Common Stock subject to this Option, which is equal to the last sale price as
reported by the NASDAQ Capital Market of the Common Stock on the trading day
immediately preceding the Commencement Date (as defined in the Employment
Agreement between the Optionee and the Company dated _________).
3. VESTING
AND EXERCISE OF OPTION. This Option shall vest and be exercisable to
the extent of Four Thousand (4,000) Shares on the last day of each calendar
month commencing April 30, 2009. This Option shall be exercisable by
written notice as set forth in the Plan.
4. RESTRICTIONS
ON EXERCISE. This Option may not be exercised if the issuance of such
Shares upon such exercise or the method of payment of consideration for such
Shares would constitute a violation of any applicable federal or state
securities or other law or regulation, including any rule under Part 207 of
Title 12 of the Code of Federal Regulations ("Regulation G") as promulgated
by the Federal Reserve Board. As a condition to the exercise of this
Option, the Company may require the Optionee to make any representation and
warranty to the Company as may be required by any applicable law or
regulation.
5. TERMINATION
OF STATUS AS AN EMPLOYEE. Except in the case of Optionee’s
termination of employment due to disability (in which case Section 6 below shall
govern) or due to death (in which case Section 9(e) of the Plan shall govern),
if the Optionee ceases to serve as an Employee, he may, but only within the
applicable time periods provided in his Employment Agreement with the Company,
exercise this Option to the extent that he was entitled to exercise it at the
date of such termination. To the extent that he was not entitled to
exercise this Option at the date of such termination, or if he does not exercise
this Option within the time specified herein, this Option shall
terminate.
6. DISABILITY OF
OPTIONEE. Notwithstanding the provisions of Section 5 above,
if the Optionee is unable to continue his employment with the Company as a
result of his total and permanent disability (within the meaning of Section
22(e)(3) of the Code), he may, but only within twelve (12) months from the date
of termination of employment due to such disability, exercise this Option to the
extent he was entitled to exercise it at the date of such
termination. If he does not exercise this Option (which he was
entitled to exercise) within the time specified herein, this Option shall
terminate.
7. TERM
OF OPTION. This Option may not be exercised more than ten (10) years
from the Grant Date of this Option, and may be exercised during such term only
in accordance with the Plan and the terms of this Option.
8. ACCEPTANCE
OF PROVISIONS. The execution of this Option Agreement by Optionee
shall constitute Optionee’s acceptance of and agreement to all of the terms and
conditions of the Plan and this Option Agreement.
9. NOTICES. All
notices and other communications required or permitted under the Plan and this
Agreement shall be in writing and shall be given either by (i) personal delivery
or regular mail, in each case against receipt, or (ii) first class registered or
certified mail, return receipt requested. All such notices or
communications to the Company shall be addressed to the attention of its Chief
Financial Officer, at its then administrative office, and to Optionee at his
last address appearing on the records of the Company or, in each case, to such
other person or address as may be designated by like notice
hereunder.
10. GOVERNING
LAW. This Option shall be governed by and construed in accordance
with the laws of the State of New York, except to the extent pre-empted by
federal law.
11. MISCELLANEOUS. This
Agreement and the Plan contain a complete statement of all the arrangements
between the parties with respect to their subject matter, and this Agreement
cannot be changed except by a writing executed by both parties. All
pronouns and any variations thereof used herein refer to the masculine, feminine
or neuter, singular or plural, as the identity of the person or persons may
require. The headings in this Agreement are for reference purposes
only and shall not in any way affect the meaning or interpretation of this
Agreement.
DATE OF
GRANT: [May
4, 2009]
ACURA
PHAMACEUTICALS, INC.
By:
|
|
|
Peter
A. Clemens
|
|
SVP
and Chief Financial
Officer
|
Acknowledgment
and Acceptance of Optionee
The
Optionee acknowledges receipt of a copy of the Plan and represents that he is
familiar with the terms and provisions thereof, and hereby accepts this Option
subject to all of the terms and provisions of the Plan. The Optionee
hereby agrees to accept as binding, conclusive and final all decisions or
interpretations of the Board upon any questions or disputes arising under the
Plan.
|
Garth
Boehm, Ph.D.
|
530
Mountain Avenue
|
Westfield,
NJ 07090
|
EXHIBIT
B
ACURA
PHARMACEUTICALS, INC.
RESTRICTED
STOCK UNIT AWARD AGREEMENT
Participant
|
|
Garth
Boehm, Ph.D.
|
RSUs
Granted
|
|
Twenty-Four
Thousand (24,000)
|
Award
Date
|
|
[May 4, 2009]
|
Vesting
Schedule
|
|
One
Thousand (1,000) RSUs shall vest on the last day of each calendar month
beginning April 30,
2009
|
This agreement (the “RSU Agreement”) is between
ACURA PHARMACEUTICALS,
INC., a New York corporation (the “Company”) and the participate
named above (the “Participant”), and is made in
accordance with the Company's 2005 Restricted Stock Unit Award Plan as amended
(the “Plan”).
WITNESSETH
WHEREAS, pursuant to the Plan,
the Company has granted to the Participant for services to be rendered to the
Company, effective as of the Award Date, a restricted stock unit award (the
“Award”), upon the terms
and conditions set forth herein and in the Plan.
NOW, THEREFORE, in
consideration of services to be rendered by the Participant and the mutual
promises made herein and the mutual benefits to be derived therefrom, the
parties agree as follows:
1. Defined
Terms. Capitalized terms used herein and not otherwise defined
herein shall have the meaning assigned to such terms in the Plan.
2. Grant. Subject
to the terms of this RSU Agreement and the Plan, the Company hereby grants to
the Participant an Award for the aggregate number of Restricted Stock Units (the
“RSUs”) set forth above.
3. Vesting. The
Award shall vest and become nonforfeitable with respect to the applicable
portion of the total number of RSUs comprising the Award (subject to adjustment
under Section 10 of the Plan), as described in the Vesting Schedule above,
subject to earlier acceleration or termination as provided in Sections 5 and 7
of the Plan. In addition to acceleration of vesting of the Award upon
the occurrence of any events providing for acceleration of vesting under Section
5(c) of the Plan, the Award shall fully and immediately vest and become
nonforfeitable if the Participant terminates his employment with the Company for
“Good Reason” as such term is defined in the Participant’s Employment Agreement
with the Company dated March _____, 2009. Except as provided in this
Section and in Section 5(c) of the Plan, the Participant’s RSUs shall be
forfeited to the extent such RSUs have not become vested upon the date the
Participant’s services as an employee terminates. Except as otherwise
provided in the Plan, the Vesting Schedule above requires the Participant’s full
time continued service through each applicable vesting date as a condition to
the vesting of the applicable installment and rights and benefits under this
Agreement.
4. Plan. The
Award and all rights of the Participant with respect thereto are subject to, and
the Participant agrees to be bound by, all of the terms and conditions of the
provisions of the Plan, incorporated herein by reference. Unless
otherwise expressly provided in this Agreement, provisions of the Plan that
confer discretionary authority on the Board or the Committee do not (and shall
not be deemed to) create any additional rights in the Participant not expressly
set forth in this Agreement. If there is any conflict or
inconsistency between the terms and conditions of this Agreement and of the
Plan, the terms and conditions of the Plan shall govern. The
Participant acknowledges receipt of a copy of the Plan and agrees to be bound by
its terms.
IN WITNESS WHEREOF, the
parties have executed this RSU Agreement as of the Award Date first above
written. By the Participant’s execution of this RSU Agreement, the
Participant agrees to the terms and conditions of this RSU Agreement and of the
Plan.
ACURA
PHARMACEUTICALS, INC.
|
|
PARTICIPANT
|
|
|
|
|
|
By:
|
|
|
By:
|
|
|
Peter
A. Clemens
|
|
|
Garth
Boehm, Ph.D.
|
|
SVP
and Chief Financial Officer
|
|
|
530
Mountain Avenue
|
|
|
|
|
Westfield,
NJ 07090
|
CERTIFICATION
OF PERIODIC REPORT PURSUANT TO RULES 13a-14 AND 15d-14
OF THE
SECURITIES EXCHANGE ACT OF 1934
I, Andrew
D. Reddick, the Chief Executive Officer of Acura Pharmaceuticals, Inc., certify
that:
|
1.
|
I
have reviewed this quarterly report on Form 10-Q of Acura Pharmaceuticals,
Inc.;
|
|
2.
|
Based
on my knowledge, this quarterly 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 quarterly report;
|
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this quarterly 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 quarterly
report;
|
|
4.
|
The
registrant's other certifying officer 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 subsidiary,
is made known to us by others within those entities, particularly during the
period in which this quarterly 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
general 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 registrants most recent fiscal quarter that
has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting.
|
5.
|
The
registrant's other certifying officer and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit
committee of registrant's board of directors (or persons performing the
equivalent function):
|
a) all
significant deficiencies in the design or operation of internal controls which
could adversely affect the registrant's ability to record, process, summarize
and report financial data and have identified for the registrant's auditors any
material weaknesses in internal controls; and
b) any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant's internal controls.
April
29, 2009
|
/s/ Andrew D.
Reddick
|
|
|
Andrew
D. Reddick
|
|
Chief
Executive
Officer
|
CERTIFICATION
OF PERIODIC REPORT PURSUANT TO RULES 13a-14 AND 15d-14
OF THE
SECURITIES EXCHANGE ACT OF 1934
I, Peter
A. Clemens, the Chief Financial Officer of Acura Pharmaceuticals, Inc., certify
that:
|
1.
|
I
have reviewed this quarterly report on Form 10-Q of Acura Pharmaceuticals,
Inc.;
|
|
2.
|
Based
on my knowledge, this quarterly 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 quarterly report;
|
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this quarterly 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 quarterly
report;
|
|
4.
|
The
registrant's other certifying officer 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-(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 subsidiary,
is made known to us by others within those entities, particularly during the
period in which this quarterly 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 registrants most recent fiscal quarter that
has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting.
|
5.
|
The
registrant's other certifying officer and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit
committee of registrant's board of directors (or persons performing the
equivalent function):
|
a. all
significant deficiencies in the design or operation of internal controls which
could adversely affect the registrant's ability to record, process, summarize
and report financial data and have identified for the registrant's auditors any
material weaknesses in internal controls; and
b. any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant's internal controls.
April
29, 2009
|
/s/ Peter A. Clemens
|
|
|
Peter
A. Clemens
|
|
Chief
Financial
Officer
|
CERTIFICATIONS
OF THE CHIEF EXEUTIVE OFFICER AND THE CHIEF FINANCIAL OFFICER
PURSUANT
TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT
TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Acura Pharmaceuticals, Inc. (the
"Company") on Form 10-Q for the period ending March 31, 2009 as filed with the
Securities and Exchange Commission on the date hereof (the "Report"), I, Andrew
D. Reddick, the Chief Executive Officer of the Company, and Peter A. Clemens,
Chief Financial Officer certify, pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
|
(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.
|
April
29, 2009
|
/s/ Andrew D.
Reddick
|
|
|
Andrew
D. Reddick
|
|
Chief
Executive Officer
|
|
|
|
/s/ Peter A. Clemens
|
|
|
Peter
A. Clemens
|
|
Chief
Financial
Officer
|