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U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED March 31, 2011

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE TRANSITION PERIOD FROM                  TO                 

Commission file number 1-16467

Cortex Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   33-0303583

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

15241 Barranca Parkway, Irvine, California 92618

(Address of principal executive offices, including zip code)

(949) 727-3157

(Registrant’s telephone number, including area code)

NOT APPLICABLE

(Former name, former address and former fiscal year,

if changed since last report)

Indicate by 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 (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.    YES   x     NO   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    YES   ¨     NO   ¨

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 definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   ¨    Accelerated filer   ¨
Non-accelerated filer   ¨       Smaller reporting company   x

Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2).    YES   ¨      NO   x

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

78,858,197 shares of Common Stock as of May 18, 2011


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CORTEX PHARMACEUTICALS, INC.

INDEX

 

          Page Number  
   PART I. FINANCIAL INFORMATION   

Item 1.

   Financial Statements and Notes (Unaudited)   
   Condensed Balance Sheets — March 31, 2011 and December 31, 2010      3   
   Condensed Statements of Operations — Three months ended March 31, 2011 and 2010      4   
   Condensed Statements of Cash Flows — Three months ended March 31, 2011 and 2010      5   
   Notes to Condensed Financial Statements      6   

Item 2.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations      11   

Item 3.

   Quantitative and Qualitative Disclosures About Market Risk      22   

Item 4.

   Controls and Procedures      22   
PART II. OTHER INFORMATION   

Item 6.

   Exhibits      23   
SIGNATURES         24   

Item 1A of Part II has been omitted based on the Company’s status as a “smaller reporting company.” Items 1 through 5 of Part II have been omitted because they are not applicable with respect to the current reporting period.

 

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PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

Cortex Pharmaceuticals, Inc.

Condensed Balance Sheets

 

     (Unaudited)
March 31, 2011
    (Note)
December 31, 2010
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 1,589,307      $ 1,037,549   

Marketable securities

     —          1,992,952   

Restricted cash

     137,613        155,736   

Other current assets

     108,175        89,807   
                

Total current assets

     1,835,095        3,276,044   

Furniture, equipment and leasehold improvements, net

     224,376        249,831   

Other

     41,373        41,373   
                
   $ 2,100,844      $ 3,567,248   
                

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 478,918      $ 393,781   

Accrued wages, salaries and related expenses

     283,111        275,353   

Unearned revenue

     137,613        155,736   

Advance for MCI project

     320,765        319,761   

Deferred rent

     16,126        11,288   
                

Total current liabilities

     1,236,533        1,155,919   

Deferred rent

     3,225        8,063   
                

Total liabilities

     1,239,758        1,163,982   
                

Contingencies (Note 2)

    

Stockholders’ equity:

    

Series B convertible preferred stock, $0.001 par value; $25,001 liquidation preference; shares authorized: 37,500; shares issued and outstanding: 37,500; shares issuable upon conversion: 3,679

     21,703        21,703   

Common stock, $0.001 par value; shares authorized: 205,000,000; shares issued and outstanding: 78,858,197 (March 31, 2011 and December 31, 2010)

     78,858        78,858   

Additional paid-in capital

     120,830,611        120,816,472   

Unrealized gain, available for sale marketable securities

     —          473   

Accumulated deficit

     (120,070,086     (118,514,240
                

Total stockholders’ equity

     861,086        2,403,266   
                
   $ 2,100,844      $ 3,567,248   
                

See accompanying notes.

Note: The balance sheet as of December 31, 2010 has been derived from the audited financial statements at that date, but does not include all of the information and notes required by accounting principles generally accepted in the United States for complete financial statements.

 

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Cortex Pharmaceuticals, Inc.

Condensed Statements of Operations

(Unaudited)

 

     Three months ended March 31,  
     2011     2010  

Revenues:

    

Sale of A MPAKINE ® assets

   $ —        $ 9,000,000   

Grant revenues

     25,300        —     
                

Total revenues

     25,300        9,000,000   

Operating expenses:

    

Research and development expenses

     643,879        1,623,663   

General and administrative expenses

     940,418        1,708,000   
                

Total operating expenses

     1,584,297        3,331,663   
                

Income (loss) from operations

     (1,558,997     5,668,337   

Interest income (expense), net

     601        (66,965

Gain (loss) on disposals of assets

     2,550        (5,508
                

Net income (loss)

   $ (1,555,846   $ 5,595,864   
                

Basic and diluted net income (loss) per share:

   $ (0.02   $ 0.08   
                

Shares used in calculating per share amounts

    

Basic and diluted

     78,858,197        68,412,618   
                

See accompanying notes.

 

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Cortex Pharmaceuticals, Inc.

Condensed Statements of Cash Flows

(Unaudited)

 

     Three months ended
March 31,
 
     2011     2010  

Cash flows from operating activities:

    

Net income (loss)

   $ (1,555,846   $ 5,595,864   

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

    

Depreciation expense

     25,455        29,730   

Stock option compensation expense

     14,139        116,329   

Amortization of beneficial conversion feature

     —          37,312   

Amortization of capitalized offering costs

     —          9,616   

(Gain) loss on sale of fixed assets

     (2,550     5,507   

Changes in operating assets/liabilities:

    

Restricted cash

     18,123        —     

Accrued interest on marketable securities

     2,519        —     

Accrued interest on convertible promissory note

     —          18,750   

Unearned revenue

     (18,123     —     

Accounts receivable

     —          (139,151

Other current assets

     (18,368     (58,768

Accounts payable and accrued expenses

     92,895        570,234   

Other

     964        11,137   
                

Net cash provided by (used in) operating activities

     (1,440,792     6,196,560   
                

Cash flows from investing activities:

    

Proceeds from sales and maturities of marketable securities

     1,990,000        —     

Purchase of fixed assets

     —          (23,780

Proceeds from sales of fixed assets

     2,550        57,698   
                

Net cash provided by investing activities

     1,992,550        33,918   
                

Cash flows from financing activities:

    

Proceeds from issuance of convertible promissory note

     —          1,500,000   

Costs related to issuance of convertible promissory note

     —          (27,781
                

Net cash provided by financing activities

     —          1,472,219   
                

Increase in cash and cash equivalents

     551,758        7,702,697   

Cash and cash equivalents, beginning of period

     1,037,549        226,466   
                

Cash and cash equivalents, end of period

   $ 1,589,307      $ 7,929,163   
                

Supplemental disclosure of non-cash financing activities:

    

Fair value of beneficial conversion feature on convertible promissory note

   $ —        $ 223,880   

See accompanying notes.

 

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Cortex Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(Unaudited)

Note 1 — Basis of Presentation and Significant Accounting Principles

The accompanying unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three-month period ended March 31, 2011 are not necessarily indicative of the results that may be expected for the full fiscal year. For further information, refer to the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010.

The Company has incurred net losses and cash outflows from operations of approximately $1,556,000 and $1,441,000, respectively, for the three months ended March 31, 2011 and expects to incur additional losses and negative cash flow from operations in fiscal 2011 and for several more years. Management believes the Company has adequate financial resources to conduct operations late into the second quarter of 2011. This raises substantial doubt about the Company’s ability to continue as a going concern, which will be dependent on its ability to obtain additional financing and to generate sufficient cash flows to meet its obligations on a timely basis.

The Company is exploring its strategic and financial alternatives, including, but not limited to, new collaborations for its A MPAKINE ® program which would provide capital to the Company in exchange for exclusive or non-exclusive license or other rights to certain of the technologies and products that the Company is developing. Although the Company is presently engaged in discussions with a number of candidate companies, there can be no assurance that an agreement will arise from these discussions in a timely manner, or at all.

The Company also may need to raise additional capital through the sale of debt or equity. If the Company is unable to obtain additional financing to fund operations beyond the second quarter of 2011, it will need to eliminate some or all of its activities, merge with another company, license or sell some or all of its assets to another company, or cease operations entirely. There can be no assurance that the Company will be able to obtain additional financing on favorable terms or at all, or that the Company will be able to merge with another Company or license or sell any or all of its assets.

Revenue Recognition

The Company recognizes revenue when all four of the following criteria are met: (i) pervasive evidence that an arrangement exists; (ii) delivery of the products and/or services has occurred; (iii) the fees earned can be readily determined; and (iv) collectibility of the fees is reasonably assured.

Amounts received for upfront technology license fees under multiple-element arrangements are deferred and recognized over the period of committed services or performance, if such arrangements require the Company’s on-going services or performance.

 

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Cortex Pharmaceuticals, Inc.

Notes to Condensed Financial Statements—(Continued)

(Unaudited)

 

Revenues from milestone payments are recognized when earned, as evidenced by written acknowledgement from the collaborator, provided that (i) the milestone event is substantive and its achievement was not reasonably assured at the inception of the agreement, and (ii) the Company’s performance obligations, if any, after the milestone achievement will continue to be funded by the collaborator at a comparable level to that before the milestone was achieved. If both of these criteria are not met, the milestone payment would be recognized over the remaining minimum period of the Company’s performance obligations under the arrangement.

The Company records research grant revenues as the expenses related to the grant projects are incurred. Amounts received under research grants are nonrefundable, regardless of the success of the underlying research, to the extent that such amounts are expended in accordance with the approved grant project.

Employee Stock Options and Stock-based Compensation

The Company’s 2006 Stock Incentive Plan (the “2006 Plan”) provides for a variety of equity vehicles to allow flexibility in implementing equity awards, including incentive stock options, nonqualified stock options, restricted stock grants, stock appreciation rights, stock payment awards, restricted stock units and dividend equivalents to qualified employees, officers, directors, consultants and other service providers. The exercise price of stock options offered under the 2006 Plan must be at least 100% of the fair market value of the common stock on the date of grant. If the person to whom an incentive stock option is granted is a 10% stockholder of the Company on the date of grant, the exercise price per share shall not be less than 110% of the fair market value on the date of grant. Options granted generally vest over a three-year period, although options granted to officers may include more accelerated vesting. Options generally expire ten years from the date of grant, but options granted to consultants may expire five years from the date of grant.

The Company recognizes expense in its financial statements for all share-based payments to employees, including grants of employee stock options, based on their fair values.

For options granted during the three months ended March 31, 2011 and 2010, the fair value of each option award was estimated using the Black-Scholes option pricing model and the following assumptions:

 

     Three months ended
March 31,
 
     2011     2010  

Weighted average risk-free interest rate

     2.8     3.2

Dividend yield

     0     0

Volatility factor of the expected market price of the Company’s common stock

     107     108

Weighted average life

     7.0 years        6.9 years   

Expected volatility is based on the historical volatility of the Company’s stock. The Company also uses historical data to estimate the expected term of options granted and employee termination rates. The risk-free rate for periods within the estimated life of the options is based on the U.S. Treasury yield curve in effect at the time of grant.

The weighted-average grant-date fair value per share of options granted during the three months ended March 31, 2011 and 2010 was $0.11 and $0.14, respectively.

 

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Cortex Pharmaceuticals, Inc.

Notes to Condensed Financial Statements—(Continued)

(Unaudited)

 

A summary of option activity for the three months ended March 31, 2011 is as follows:

 

     Shares     Weighted
Average
Exercise Price
     Weighted
Average
Remaining
Contractual Term
     Aggregate
Intrinsic Value
 

Balance, December 31, 2010

     12,141,640      $ 1.39         

Granted

     180,000      $ 0.13         

Exercised

     —          —           

Forfeited

     —          —           

Expired

     (274,884   $ 1.54         
                

Balance, March 31, 2011

     12,046,756      $ 1.37         5.4 years       $ 1,800   

Vested and expected to vest, March 31, 2011

     11,708,082      $ 1.40         5.4 years       $ 1,596   

Exercisable, March 31, 2011

     9,592,761      $ 1.67         4.7 years         —     

As of March 31, 2011, there was approximately $136,000 of total unrecognized compensation cost related to non-vested share-based compensation arrangements. That non-cash cost is expected to be recognized over a weighted-average period of one year.

Stock options and warrants issued as compensation for services to be provided to the Company by non-employees are accounted for based upon the fair value of the services provided or the estimated fair value of the option or warrant, whichever can be more clearly determined. The Company recognizes this expense over the period in which the services are provided. This expense is a non-cash charge and has no impact on the Company’s available cash or working capital.

There were no stock option exercises during the three months ended March 31, 2011 or 2010. The Company issues new shares to satisfy stock option exercises.

Consistent with December 31, 2010, as of March 31, 2011 warrants to purchase up to 24,126,952 shares of the Company’s common stock were outstanding at a weighted-average exercise price of $0.74 per share.

Net Income (Loss) per Share

For the three months ended March 31, 2011, the effect of potentially issuable shares of common stock was not included in the calculation of diluted loss per share given that the effect would be anti-dilutive.

For the three months ended March 31, 2010, the effect of potentially issuable shares of common stock was not included in the calculation of diluted income per share given that the Company’s outstanding options and warrants were not “in-the-money” as of such date.

Comprehensive Income (Loss)

The Company presents unrealized gains and losses on its marketable securities, classified as “available for sale,” in its statement of stockholders’ equity and comprehensive income or loss on an annual basis and in a note in its quarterly reports. Other comprehensive income or loss consists of unrealized gains or losses on the Company’s marketable securities, which are comprised of securities of the U.S. government or its agencies, corporate bonds and other asset backed securities.

 

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Cortex Pharmaceuticals, Inc.

Notes to Condensed Financial Statements—(Continued)

(Unaudited)

 

During the three months ended March 31, 2011 and 2010, total comprehensive income or loss approximated the Company’s net income or loss for the respective period, given that the Company had no significant unrealized gains or losses on marketable securities for either period.

New Accounting Standards

In April 2010, the Financial Accounting Standards Board issued Accounting Standards Update No. 2010-17, “Revenue Recognition—Milestone Method” (ASU 2010-17). ASU 2010-17 includes revenue-related guidance for companies that provide research or development deliverables in an arrangement in which one or more payments are contingent upon achieving uncertain future events or circumstances.

The amendments in the update became effective on a prospective basis for milestones achieved by the Company on or after January 1, 2011. Given that the guidance within the update is generally consistent with the Company’s existing revenue recognition considerations for its milestone payments, adoption of the update did not have a material impact on either the Company’s financial position or its result of operations.

Note 2 — Transactions with Biovail

On March 25, 2010, the Company entered into an asset purchase agreement with Biovail Laboratories International SRL (“Biovail”). Pursuant to the asset purchase agreement, Biovail acquired the Company’s interests in CX717, CX1763, CX1942 and the injectable dosage form of CX1739, as well as certain of its other A MPAKINE compounds and related intellectual property for use in the field of respiratory depression or vaso-occlusive crises associated with sickle cell disease. In connection with the transaction, Biovail paid the Company $9,000,000 upon the execution of the asset purchase agreement in March 2010 and an additional $1,000,000 upon completion of the specified transfer plan in September 2010. In addition, the agreement provided the Company with the right to receive up to three milestone payments in an aggregate amount of up to $15,000,000 plus the reimbursement of certain related expenses, each conditioned upon the occurrence of particular events relating to the clinical development of certain assets that Biovail acquired. None of these events have occurred and accordingly, the Company has not recorded any milestone revenue related to the Biovail transaction.

As part of the transaction, Biovail licensed back to the Company certain exclusive and irrevocable rights to some acquired A MPAKINE compounds, other than CX717, an injectable dosage form of CX1739, CX1763 and CX1942, for use outside of the field of respiratory depression or vaso-occlusive crises associated with sickle cell disease. Accordingly, following the transaction with Biovail, the Company retained its rights to develop and commercialize the non-acquired A MPAKINE compounds as a potential treatment for neurological diseases and psychiatric disorders. Additionally, the Company retained its rights to develop and commercialize the A MPAKINE compounds as a potential treatment for sleep apnea disorders, including an oral dosage form of A MPAKINE CX1739.

In September 2010, Biovail’s parent corporation, Biovail Corporation, combined with Valeant Pharmaceuticals International in a merger transaction and the combined company was renamed “Valeant Pharmaceuticals International, Inc.” (“Valeant”). Following the merger, Valeant and Biovail conducted a strategic and financial review of its product pipeline and, as a result, in November 2010, Biovail announced its intent to exit from the respiratory depression project acquired from the Company in March 2010.

 

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Cortex Pharmaceuticals, Inc.

Notes to Condensed Financial Statements—(Continued)

(Unaudited)

 

Following that announcement, the Company entered into discussions with Biovail regarding the future of the respiratory depression project. In March 2011, the Company entered into a new agreement with Biovail to reacquire the A MPAKINE compounds, patents and rights that Biovail acquired from the Company in March 2010. The new agreement includes an upfront payment by Cortex of $200,000 and potential future payments of up to $15,150,000 based upon the achievement of certain development and New Drug Application submission and approval milestones. Biovail is also eligible to receive additional payments of up to $15,000,000 based upon the Company’s net sales of an intravenous dosage form of the compounds for respiratory depression.

The Company has recorded the $200,000 upfront payment to reacquire the respiratory depression project from Biovail as research and development expense during the quarter ended March 31, 2011.

At any time following the completion of Phase I clinical studies and prior to the end of Phase IIa clinical studies, Biovail retains an option to co-develop and co-market intravenous dosage forms of an A MPAKINE compound as a treatment for respiratory depression and vaso-occlusive crises associated with sickle cell disease. In such an event, the Company would be reimbursed for certain development expenses to date and Biovail would share in all such future development costs with the Company. If Biovail makes the co-marketing election, the Company would owe no further milestone payments to Biovail and the Company would be eligible to receive a royalty on net sales of the compound by Biovail or its affiliates and licensees.

Note 3 — Convertible Promissory Note

In January 2010, the Company completed a private placement of a convertible promissory note in the principal amount of $1,500,000 with a single accredited institutional investor, Samyang Optics Co., Ltd. (“Samyang”) of Korea. The promissory note accrued simple interest at the rate of 6% per annum and was convertible into unregistered shares of the Company’s common stock at Samyang’s election at any time on or after April 15, 2010 and on or before the January 15, 2011 maturity date.

In June 2010, the promissory note and the related accrued interest were converted by Samyang into a total of 10,445,579 unregistered shares of the Company’s common stock at an effective conversion price of $0.147 per share. The number of common shares issuable upon conversion of the promissory note was based upon the greater of: (i) $0.134 per share or (ii) an amount representing a 15% discount to the five-day volume weighted average closing price of the Company’s common stock immediately prior to the conversion date.

In connection with the conversion of the promissory note, the Company was obligated to issue to Samyang two-year warrants to purchase up to 4,081,633 additional unregistered shares of the Company’s common stock at an exercise price of $0.206 per share. The warrants include a call right, in favor of the Company, to the extent the weighted average closing price of the Company’s common stock exceeds $0.309 per share for each of ten consecutive trading days, subject to certain circumstances.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with the Financial Statements and Notes relating thereto appearing elsewhere in this report and with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” presented in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010.

Introductory Note

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and we intend that such forward looking statements be subject to the safe harbors created thereby. These forward-looking statements, which may be identified by words including “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” and similar expressions include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of our proposed products and (iv) the need for, and availability of, additional financing.

The forward-looking statements included herein are based on current expectations, which involve a number of risks and uncertainties and assumptions regarding our business and technology. These assumptions involve judgments with respect to, among other things, future scientific, economic and competitive conditions, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond our control. Although we believe that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the results contemplated in forward-looking statements will be realized and actual results may differ materially. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by us or any other person that our objectives or plans will be achieved. We undertake no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. Readers should carefully review the risk factors described in this and other documents that we file from time to time with the Securities and Exchange Commission, or the SEC, including, without limitation, Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K and subsequent Current Reports on Form 8-K.

About Cortex Pharmaceuticals

We are engaged in the discovery and development of innovative pharmaceuticals for the treatment of psychiatric disorders, neurological diseases and sleep apnea. Our primary focus is to develop novel small molecules that positively modulate AMPA-type glutamate receptors, a complex of proteins involved in communication between nerve cells in the mammalian brain. We are developing a family of proprietary pharmaceuticals known as A MPAKINE ® compounds, which enhance the activity of the AMPA receptor. We believe that A MPAKINE compounds hold promise for the treatment of

 

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neurological and psychiatric diseases and disorders that are known, or thought, to involve depressed functioning of pathways in the brain that use glutamate as a neurotransmitter. Our most advanced clinical compounds are CX717 and CX1739, both of which are in Phase II clinical development.

We previously reported statistically and clinically positive results with CX717 in the treatment of adult patients with Attention Deficit Hyperactivity Disorder, or ADHD, and in the prevention of respiratory depression induced by pain-relieving opiates.

With additional financial resources, we plan to develop an intravenous dosage formulation of CX717, which would provide better treatment options for respiratory depression in a hospital setting.

Our A MPAKINE CX1739 is substantially more potent than CX717 in animal studies. CX1739 has successfully completed human Phase I clinical trials and recently completed testing in a Phase II pilot study in the United Kingdom for the treatment of sleep apnea. We believe that the results from the pilot study warrant pursuing a larger trial to test the response to CX1739 by patients with central forms of sleep apnea.

Given the positive results previously demonstrated with CX717 in adults with ADHD, with additional financial resources we also plan to initiate a Phase II study with CX1739 as a potential treatment for ADHD.

We have filed several new patents for our A MPAKINE compounds that, if granted, will provide patent protection for our new compounds up to 2028. In April 2011, we announced the receipt of a notice of allowance for the patent filed for our lead compound A MPAKINE CX1739 and approximately 80 additional compound structures.

The A MPAKINE platform addresses large potential markets. Our business plan involves partnering with larger pharmaceutical companies for research, development, clinical testing, manufacturing and global marketing of A MPAKINE compounds for those indications that require sizable, expensive Phase III clinical trials and very large sales forces to achieve significant market penetration.

At the same time, subject to availability of sufficient financial resources, we plan to develop compounds internally for a selected set of indications, some of which will allow us to apply for orphan drug status. Such designation by the Food and Drug Administration, or the FDA, is usually applied to products where the number of patients in the United States in the given disease category is typically less than 200,000. These orphan drug indications typically require more modest investment in the development stages, follow a quicker regulatory path to approval, and involve a more concentrated and smaller sales force targeted at selected medical centers and a limited number of medical specialists in the United States and Europe.

In our licensing discussions, we seek to reserve rights that may be viewed as a natural expansion beyond some of the orphan drug uses to selected larger areas of therapy to thereby allow us to potentially further develop our compounds for such larger non-orphan drug indications. If we are successful in the pursuit of this operating strategy, we may be in a position to contain our costs over the next few years, to maintain our focus on the research and early development of novel pharmaceuticals (where we believe that we have the ability to compete) and eventually to participate more fully in the commercial development of A MPAKINE products in the United States.

 

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Critical Accounting Policies and Management Estimates

The SEC defines critical accounting policies as those that are, in management’s view, most important to the portrayal of our financial condition and results of operations and most demanding of our judgment. Our discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures of contingent assets and liabilities.

We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. This process forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Revenue Recognition

We recognize revenue when all four of the following criteria are met: (i) pervasive evidence that an arrangement exists; (ii) delivery of the products and/or services has occurred; (iii) the fees earned can be readily determined; and (iv) collectibility of the fees is reasonably assured.

Amounts received for upfront technology license fees under multiple-element arrangements are deferred and recognized over the period of committed services or performance, if such arrangements require our on-going services or performance.

We record research grant revenues as the expenses related to the grant projects are incurred. Amounts received under research grants are nonrefundable, regardless of the success of the underlying research, to the extent that such amounts are expended in accordance with the approved grant project.

Employee Stock Options and Stock-Based Compensation

We measure our share-based compensation cost at the grant date based on the estimated fair value of the award and recognize it as expense over the vesting period. Determining the fair value of share-based awards at the grant date requires judgment in estimating the amount of share-based awards that are expected to forfeit. Additional key input assumptions used to estimate the fair value of share-based awards include the expected option term, the expected volatility of the Company’ stock over the option’s expected term, the risk-free interest rate over the option’s expected term and the Company’s expected annual dividend yield. If actual results differ significantly from these estimates, stock-based compensation expense and our results of operations could be materially impacted.

Stock options and warrants issued to our consultants and other non-employees as compensation for services to be provided to us are accounted for based upon the fair value of the services provided or the estimated fair market value of the option or warrant, whichever can be more clearly determined. We recognize this expense over the period the services are provided.

 

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Convertible Debt and Equity Instruments

We review the features of our issued financing instruments to determine whether such instruments are appropriately measured and classified as either debt or equity in our financial statements. Generally, instruments that include a provision that may require settlement in cash are recorded as a liability.

The conversion features within our issued convertible instruments are valued separately from the preferred stock or debt securities. We allocate the proceeds received from a financing transaction that includes a convertible instrument to the convertible preferred stock or debt and any detachable instruments, such as warrants, on a relative fair value basis.

The value allocated to the convertible instrument is used to estimate an effective conversion price for the convertible preferred stock or debt, and to measure the intrinsic value, if any, of the conversion feature on the date that we issue the securities.

The above listing is not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of a particular transaction is specifically dictated by accounting principles generally accepted in the United States, with no need for our judgment in their application. There are also areas in which our judgment in selecting any available alternative would not produce a materially different result.

Going Concern

Our independent registered public accounting firm has expressed substantial doubt as to our ability to continue as a going concern, in its report for the fiscal year ended December 31, 2010, given that we do not have adequate working capital to finance our day-to-day operations for at least the following twelve month period. Our continued existence depends upon the success of our efforts to raise additional capital necessary to meet our obligations as they become due and to obtain sufficient capital to execute our business plan. We intend to obtain capital primarily through issuances of debt or equity or entering into collaborative arrangements with corporate partners. There can be no assurance that we will be successful in completing additional financing or collaboration transactions. If we cannot obtain adequate funding, we may be required to significantly curtail or even shut down our operations.

Results of Operations

General

In October 2000, we entered into a research collaboration agreement and a license agreement with Les Laboratoires Servier, or Servier. The agreements will allow Servier to develop and commercialize select A MPAKINE compounds in defined territories of Europe, Asia the Middle East and certain South American countries as a treatment for (i) declines in cognitive performance

 

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associated with aging, (ii) neurodegenerative diseases and (iii) anxiety disorders. The indications covered include, but are not limited to, Alzheimer’s disease, mild cognitive impairment, sexual dysfunction and the dementia associated with multiple sclerosis and Amyotrophic Lateral Sclerosis.

In early December 2006, we terminated the research collaboration with Servier and as a result the worldwide rights for the A MPAKINE technology for the treatment of neurodegenerative diseases were returned to us, other than three compounds selected by Servier for commercialization in its territory. In November 2010, Servier selected a jointly discovered high impact A MPAKINE compound, CX1632 (S47445), to advance into Phase I clinical testing. Should the compound be successfully commercialized by Servier, we would receive payments based upon key clinical development milestones and royalty payments on sales in licensed territories.

In March 2010, we entered into an asset purchase agreement with Biovail Laboratories International SRL (“Biovail”). Pursuant to the asset purchase agreement, Biovail acquired our interests in CX717, CX1763, CX1942 and the injectable dosage form of CX1739, as well as certain of our other A MPAKINE compounds and related intellectual property for use in the field of respiratory depression or vaso-occlusive crises associated with sickle cell disease. In connection with the transaction, Biovail paid us $9,000,000 upon execution of the asset purchase agreement in March 2010 and an additional $1,000,000 upon completion of the specified transfer plan in September 2010. In addition, the agreement provided us with the right to receive up to three milestone payments in an aggregate amount of up to $15,000,000 plus the reimbursement of certain related expenses, each conditioned upon the occurrence of particular events relating to the clinical development of certain assets that Biovail acquired.

As part of the transaction, Biovail licensed back to us certain exclusive and irrevocable rights to some acquired A MPAKINE compounds, other than CX717, an injectable dosage form of CX1739, CX1763 and CX1942, for use outside of the field of respiratory depression or vaso-occlusive crises associated with sickle cell disease. Accordingly, following the transaction with Biovail, we retained rights for the majority of patented compounds in our A MPAKINE drug library, as well as all rights to the non-acquired A MPAKINE compounds for the treatment of neurological diseases and psychiatric disorders that have historically been a focus of our portfolio. Additionally, we retained our rights to develop and commercialize A MPAKINE compounds as a potential treatment for sleep apnea disorders, including an oral dosage form of CX1739.

In September 2010, Biovail’s parent corporation, Biovail Corporation, combined with Valeant Pharmaceuticals International in a merger transaction and the combined company was renamed “Valeant Pharmaceuticals International, Inc.” (“Valeant”). Following the merger, Valeant and Biovail conducted a strategic and financial review of the product pipeline and, as a result, in November 2010, Biovail announced its intent to exit from the respiratory depression project acquired from us in March 2010.

Following that announcement, we entered into discussions with Biovail regarding the future of the respiratory depression project. In March 2011, we entered into a new agreement with Biovail to reacquire the A MPAKINE compounds, patents and rights that Biovail acquired from us in March 2010. The new agreement includes an upfront payment by us of $200,000 and potential future payments of

 

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up to $15,150,000 based upon the achievement of certain development and New Drug Application submission and approval milestones. Biovail is also eligible to receive additional payments of up to $15,000,000 based upon our net sales of an intravenous dosage form of the compounds for respiratory depression.

In addition, at any time following the completion of Phase I clinical studies and prior to the end of Phase IIa clinical studies, Biovail retains an option to co-develop and co-market intravenous dosage forms of an A MPAKINE compound as a treatment for respiratory depression and vaso-occlusive crises associated with sickle cell disease. In such an event, we would be reimbursed for certain development expenses to date and Biovail would share in all such future development costs with us. If Biovail makes the co-marketing election, we would owe no further milestone payments to Biovail and we would be eligible to receive a royalty on net sales of the compound by Biovail or its affiliates and licensees.

From inception (February 10, 1987) through the fiscal quarter ended on March 31, 2011, we have sustained losses aggregating approximately $115,692,000. Continuing losses are anticipated over the next several years. During that time, our ongoing operating expenses will only be offset, if at all, by proceeds from research grants and by possible milestone payments from Servier. Ongoing operating expenses may also be funded by payments under planned strategic alliances that we are seeking with other pharmaceutical companies for the clinical development, manufacturing and marketing of our products. The nature and timing of payments to us under the Servier agreement or other planned strategic alliances, if and when entered into, are likely to significantly affect our operations and financing activities and to produce substantial period-to-period fluctuations in reported financial results. Over the longer term, we will be dependent upon the successful introduction of a new product into the North American market from our internal development, as well as the successful commercial development of our products by Servier or our other prospective partners to attain profitable operations from royalties or other product-based revenues.

Comparison of the Three Months ended March 31, 2011 and 2010

For the quarter ended March 31, 2011, our net loss of approximately $1,556,000 compares to net income of approximately $5,596,000 for the corresponding prior year quarter, with the prior year period reflecting revenues of $9,000,000 from our transaction with Biovail during March 2010, as detailed above.

Grant revenues for the quarter ended March 31, 2011 include amounts awarded by the Michael J. Fox Foundation for Parkinson’s Research. The related grant provides funding to test select A MPAKINE compounds for their ability to restore brain function in animal models of Parkinson’s disease.

Our research and development expenses for the quarter ended March 31, 2011 decreased to $644,000 from approximately $1,624,000, or by 60%, compared to the corresponding prior year quarter, with the decrease primarily reflecting sublicensing fees of $910,000 related to the March 2010 transaction with Biovail. Expense for the 2011 period includes the $200,000 payment to reacquire the A MPAKINE rights and compounds from Biovail in March 2011.

 

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Other costs related to the access and protection of our A MPAKINE technology totaled approximately $116,000 and $119,000 for the three months ended March 31, 2011 and 2010, respectively. For the same periods, our expenses for research and development personnel, outside experts and consultants approximated $209,000 and $366,000, respectively, with most of the decrease due to a decrease in personnel-related expenses. Costs for laboratory facility and supply expenses were approximately $104,000 and $119,000 for the quarters ended March 31, 2011 and 2010, respectively.

Amounts incurred for internal research and development costs, including indirect amounts allocated to research and development, and costs for retaining outside experts for consulting and research activities are deemed to benefit the entire A MPAKINE platform rather than specific A MPAKINE compounds.

For the quarter ended March 31, 2011, our non-cash stock compensation charges for research and development amounted to a credit of approximately $29,000 compared to charges of approximately $32,000 for the corresponding prior year period, with the difference reflecting recovered amounts related to previously forfeited options.

Clinical development expenses of $44,000 for the quarter ended March 31, 2011 include amounts related to our Phase IIa proof of concept study with A MPAKINE CX1739 in sleep apnea. For the quarter ended March 31, 2010, clinical development expenses of $78,000 primarily represented amounts incurred for our completed Phase II studies with A MPAKINE CX717 in respiratory depression. CX717 was sold in our transaction that we completed with Biovail in March 2010 and subsequently reacquired by us in March 2011.

At this time, we are just beginning the clinical development of CX1739 and developing other preclinical backup candidates. Subject to the availability of sufficient finances, as the clinical development of CX1739 expands, our research and development costs are anticipated to increase significantly.

External preclinical and clinical expenses to date through March 31, 2011 for CX717 and CX1739 amounted to approximately $16,000,000 and $3,500,000, respectively.

Our general and administrative expenses for the three months ended March 31, 2011 decreased from approximately $1,708,000 to approximately $940,000, or by 45%, compared to the corresponding prior year period, with the decrease mostly reflecting legal and investment banking fees incurred in the prior year period related to the March 2010 transaction that we completed with Biovail.

For the three months ended March 31, 2011, our non-cash stock compensation charges within general and administrative expenses decreased from approximately $84,000 to approximately $44,000, or by 48%, relative to the corresponding prior year period, primarily due to the completed vesting schedules of earlier granted stock options.

For the three months ended March 31, 2011, net interest income of approximately $1,000 compares with net interest expense of approximately $67,000 for the prior year period. Net interest expense for the three months ended March 31, 2010 includes amounts accruing on our convertible promissory note issued to Samyang, along with amortization of capitalized offering costs and the beneficial conversion feature related to such convertible note transaction.

 

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Liquidity and Capital Resources

Sources and Uses of Cash

Pursuant to the terms of our transaction with Biovail in March 2010, Biovail paid us $10,000,000 during the year ended December 31, 2010, including $9,000,000 during the quarter ended March 31, 2010. Additionally, the March 2010 transaction included rights to receive milestone payments and expense reimbursements from Biovail. However, pursuant to the terms of our March 2011 asset repurchase transaction with Biovail, we are no longer entitled to receive any future milestone payments or expense reimbursements from Biovail. Rather, as disclosed previously in this Quarterly Report on Form 10-Q, as a result of the March 2011 transaction we are obligated to make future payments to Biovail depending upon the occurrence of particular events relating to the clinical development of the repurchased assets.

Under the agreements signed with Servier in October 2000, as amended to date, in November 2010 Servier selected the jointly discovered A MPAKINE compound, CX1632 (S47445), to advance into Phase I clinical trials. We remain eligible to receive payments based upon defined clinical development milestones of the licensed compound and royalties on sales in licensed territories. There can be no assurance that we will receive such milestone payments within our desired timeframe, or if such payments will be received at all.

We also may receive proceeds from the exercise of previously issued warrants to purchase shares of our common stock. The table below summarizes the warrants outstanding as of March 31, 2011 that were issued in connection with prior offerings and placements of our securities.

 

Date of Issuance

   Exercise
Price per
Share
       Number of Warrants
Outstanding as of
March 31, 2011
     Expiration Date      Approximate
Potential Proceeds,
if Fully Exercised

January 2007 (1)

     $1.66         2,996,927      January 21, 2012      $4,975,000

August 2007 (1)

     $2.64         2,830,000      August 28, 2012      $7,471,000

August 2007 (2)

     $3.96         176,875      August 28, 2012      $700,000

April 2009 (1)

     $0.27         6,941,176      October 17, 2012      $1,889,000

April 2009 (2)

     $0.26         433,824      October 17, 2012      $113,000

July 2009 (1)

     $0.27         6,060,470      January 31, 2013      $1,636,000

July 2009 (2)

     $0.37         606,047      January 31, 2013      $222,000

June 2010 (1)(3)

     $0.21         4,081,633      June 7, 2012      $841,000

 

(1)  

Represents warrants issued to the investor(s) in the related transaction.

(2)  

Represents warrants issued to the placement agent(s) in the related transaction.

(3)  

See Note 3 to the Financial Statements.

 

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Warrants outstanding from the January 2007 transaction provide a call right in our favor to the extent that the closing price of our common stock exceeds $3.35 per share for 13 consecutive trading days, subject to certain circumstances.

Similarly, subject to certain circumstances, the warrants issued to the investor in the April 2009 and July 2009 transactions provide a call right in our favor to the extent that the closing price of our common stock exceeds $0.68 per share and $0.54 per share, respectively, for 20 consecutive trading days. Warrants issued to the placement agent for the April 2009 and July 2009 transactions provide a call right in our favor to the extent that the closing price of our common stock exceeds $0.52 per share and $0.54 per share, respectively, for 20 consecutive trading days, subject to certain circumstances.

Warrants issued to the investor in the April 2009 transaction were originally issued with an exercise price of $0.34 per share. In February 2010, the exercise price for these warrants was reduced to $0.27 per share in exchange for the investor’s consent and waiver with respect to our private placement of a convertible promissory note that we completed in January 2010, as explained more fully in Note 3 in the Notes to the Financial Statements.

Warrants issued to Samyang in connection with the conversion of its promissory note in June 2010 provide a call right in our favor to the extent that the weighted average closing price of our common stock exceeds $0.309 per share for each of ten consecutive trading days, subject to certain circumstances.

Warrants detailed above with issuance dates between January 2007 and June 2009 may be settled by a cashless exercise. In such an event, the holder of the warrants would receive a number of unregistered shares representing the gain on exercise of such warrants, divided by the volume weighted average price of the Company’s common stock on the trading day immediately preceding such exercise.

None of the warrants detailed above are “in-the-money” as of March 31, 2011. We can give no assurance that we will receive proceeds from the exercise of any of the outstanding warrants.

As of March 31, 2011, we had cash and cash equivalents totaling approximately $1,589,000 and working capital of approximately $599,000. In comparison, as of December 31, 2010, we had cash, cash equivalents and marketable securities of approximately $3,031,000 and working capital of approximately $2,120,000. The decreases in cash and working capital reflect amounts required to fund our operations.

For the three months ended March 31, 2011, net cash used in operating activities was approximately $1,441,000, and included our net loss for the period of approximately $1,556,000, adjusted for non-cash expenses for depreciation and stock compensation approximating $40,000, and changes in operating assets and liabilities. Net cash provided by operating activities was approximately $6,197,000 for the three months ended March 31, 2010 and included our net income for the period of approximately $5,596,000, adjusted for non-cash expenses for depreciation, amortization and stock compensation approximating $193,000, and changes in operating assets and liabilities.

 

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For the three months ended March 31, 2011, net cash provided by investing activities approximated $1,993,000 and primarily represented the proceeds from the maturity of marketable securities. For the three months ended March 31, 2010, net cash provided by investing activities approximated $34,000 and represented the proceeds from the sales and purchases of fixed assets.

There was no cash provided by or used in financing activities for the three months ended March 31, 2011. Net cash provided by financing activities approximated $1,472,000 during the three months ended March 31, 2010 and resulted from our private placement of a convertible promissory note in January 2010.

Commitments

We lease approximately 32,000 square feet of research laboratory, office and expansion space under an operating lease that expires May 31, 2012. The commitments under the lease agreement for the remaining nine months of the year ending December 31, 2011 and the five months ending May 31, 2012 are approximately $445,000 and $249,000, respectively.

In addition to amounts reflected on the balance sheet as of March 31, 2011, our remaining commitments for preclinical and clinical studies amount to approximately $204,000. Separately, as of March 31, 2011 we are committed to approximately $138,000 for research related to the grant from the Michael J. Fox Foundation for Parkinson’s Research, which costs will be covered by funds awarded and received under the grant. These related funds have been recorded as restricted cash in our financial statements as of March 31, 2011.

In June 2000, we received approximately $247,000 from the Institute for the Study of Aging, or the Institute, a non-profit foundation supported by the Estee Lauder Trust. The advance partially offset our limited costs for our testing in patients with mild cognitive impairment that we conducted with our partner, Servier. Provided that we comply with the conditions of the funding agreement, including the restricted use of the amounts received, repayment of the advance has been extended until we enter an A MPAKINE compound into Phase III clinical trials for Alzheimer’s disease. Upon such potential clinical trials, repayment would include interest computed at a rate equal to one-half of the prime lending rate. In lieu of cash, in the event of repayment the Institute may elect to receive the balance of outstanding principal and accrued interest as shares of our common stock. The conversion price for such form of repayment shall initially equal $4.50 per share, subject to adjustment under certain circumstances.

Staffing

As of March 31, 2011, we had 11 full-time employees. We do not anticipate significant increases in the number of our full-time employees within the coming year.

 

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Outlook

We believe that we have adequate financial resources to conduct our operations late into the second quarter of 2011. Our forecast of the period of time through which our financial resources will be adequate to support our operations is forward-looking information, and actual results could vary.

Our ongoing cash requirements will depend on numerous factors, particularly the progress of our clinical trials involving CX1739 and our ability to negotiate and complete collaborative agreements or out-licensing arrangements. In order to help fund our on-going operating cash requirements, we intend to seek new collaborations for our “low impact” and “high impact” A MPAKINE programs that include initial cash payments and on-going development support. We may also seek to raise additional funds and explore other strategic and financial alternatives, such as a merger or sale of assets transaction.

There are significant uncertainties as to our ability to access potential sources of capital. We may not be able to enter into any collaboration on terms acceptable to us, or at all, due to conditions in the pharmaceutical industry or in the economy in general. Competition for such arrangements is intense, with a large number of biopharmaceutical companies attempting to secure alliances with more established pharmaceutical companies. Although we have been engaged in discussions with candidate companies, there is no assurance that an agreement or agreements will arise from these discussions in a timely manner, or at all, or that revenues that may be generated thereby will offset operating expenses sufficiently to reduce our short-term funding requirements.

Even if we are successful in obtaining a collaboration for our A MPAKINE program, we may have to relinquish rights to technologies, product candidates or markets that we might otherwise seek to develop ourselves. These same risks apply to any attempt to out-license our compounds.

Similarly, due to market conditions and other possible limitations on equity offerings, we may not be able to sell additional securities or raise other funds on terms acceptable to us, if at all. Any additional equity financing, if available, would likely result in substantial dilution to existing stockholders.

Additional Risks and Uncertainties

Our proposed products are in the preclinical or early clinical stage of development and will require significant further research, development, clinical testing and regulatory clearances. They are subject to the risks of failure inherent in the development of products based on innovative technologies. These risks include, but are not limited to, the possibilities that any or all of the proposed products will be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances; that the proposed products, although effective, will be uneconomical to market; that third parties may now or in the future hold proprietary rights that preclude us from marketing them; or that third parties will market superior or equivalent products. Accordingly, we are unable to predict whether our research and development activities will result in any commercially viable products or applications. Further, due to the extended testing and regulatory review process required before marketing clearance can be obtained, we do not expect to be able to commercialize any therapeutic

 

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drug for at least four years, either directly or through our current or prospective partners or licensees. There can be no assurance that our proposed products will prove to be safe or effective or receive regulatory approvals that are required for commercial sale.

Off-Balance Sheet Arrangements

We have not engaged in any “off-balance sheet arrangements” within the meaning of Item 303(a)(4)(ii) of Regulation S-K.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to certain market risks associated with interest rate fluctuations on our advance from the Institute for the Study of Aging, which is due when we enter an A MPAKINE compound into Phase III clinical testing as a potential treatment for Alzheimer’s disease. Potential repayment would include interest accruing at a rate equal to one-half of the prime lending rate. Changes in interest rates generally affect the fair value of such debt, but, based upon historical activity, such changes are not expected to have a material impact on earnings or cash flows. As of March 31, 2011, the principal and accrued interest of the advance amounted to approximately $321,000.

We are not subject to significant risks from currency rate fluctuations as we typically conduct a limited number of transactions in foreign currencies. In addition, we do not utilize hedging contracts or similar instruments.

 

Item 4. Controls and Procedures

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15(d)-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer, or the CEO, and Chief Financial Officer, or the CFO, as appropriate, to allow timely decisions regarding required disclosure.

We performed an evaluation, under the supervision and with the participation of our management, including the CEO and CFO, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report, pursuant to Rules 13a-15(b) and 15d-15(b) under the Exchange Act. Based upon that evaluation, the CEO and CFO have concluded that our disclosure controls and procedures, as of the end of the period covered by this report, were effective in timely alerting them to material information required to be included in our periodic filings under the Exchange Act.

There has been no change in our internal control over financial reporting (as defined in Rules 13(a)-15(f) and 15(d)-15(f) under the Exchange Act) during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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Limitations on the Effectiveness of Controls

Our management, including our CEO and CFO, does not expect that our disclosure controls and internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.

The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, a control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

PART II. OTHER INFORMATION

 

Item 6. Exhibits

Exhibits

 

10.121    Fifth Amendment to the License Agreement between the Company and The Regents of the University of California, dated as of March 15, 2011, incorporated by reference to the same numbered Exhibit to the Company’s Report on Form 8-K filed March 21, 2011.
10.122    Asset Purchase Agreement, dated March 15, 2011, by and between the Company and Biovail Laboratories International SRL. (Portions of this Exhibit are omitted and were filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934)
31.1    Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.
31.2    Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.
32    Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.

 

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SIGNATURES

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.

 

  CORTEX PHARMACEUTICALS, INC.

May 23, 2011

  By:  

/s/    M ARIA S. M ESSINGER        

    Maria S. Messinger
   

Vice President and Chief Financial Officer;

Corporate Secretary

(Chief Accounting Officer)

 

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Exhibit 10.122

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT MARKED WITH [***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

EXECUTION COPY

 

 

 

A SSET P URCHASE A GREEMENT

B Y AND B ETWEEN

C ORTEX P HARMACEUTICALS , I NC ., AS B UYER ,

AND

BIOVAIL LABORATORIES INTERNATIONAL SRL , AS S ELLER


TABLE OF CONTENTS

 

          Page  

ARTICLE I

   DEFINITIONS; INTERPRETATION      1   

Section 1.1.

   Definitions      1   

Section 1.2.

   Interpretation      12   

ARTICLE II

   PURCHASE AND SALE      12   

Section 2.1.

   Purchase and Sale of Assets; Purchase Price; Additional Consideration.      12   

Section 2.2.

   Co-Marketing Election      14   

Section 2.3.

   Assumed Liabilities; Buyer Not Successor to Seller; Excluded Liabilities      15   

Section 2.4.

   Procedures for Certain Assets Not Freely Transferable      15   

ARTICLE III

   REPRESENTATIONS AND WARRANTIES OF SELLER      16   

Section 3.1.

   Organization, Standing and Power      16   

Section 3.2.

   Authority; Binding Agreements      16   

Section 3.3.

   Conflicts; Consents      17   

Section 3.4.

   Governmental Authorizations      17   

Section 3.5.

   Absence of Changes      17   

Section 3.6.

   Intellectual Property      18   

Section 3.7.

   Contracts      19   

Section 3.8.

   Non-Clinical and Clinical Material.      19   

Section 3.9.

   Litigation.      19   

Section 3.10.

   Adverse Information      19   

Section 3.11.

   Brokers      19   

Section 3.12.

   Regulatory Matters      20   

Section 3.13.

   Disclosure      20   

ARTICLE IV

   REPRESENTATIONS AND WARRANTIES OF BUYER      20   

Section 4.1.

   Organization, Standing and Power      20   

Section 4.2.

   Authority; Binding Agreements      20   

Section 4.3.

   Conflicts; Consents      20   

Section 4.4.

   Litigation      20   

Section 4.5.

   Brokers      21   

ARTICLE V

   ADDITIONAL AGREEMENTS      21   

Section 5.1.

   Confidentiality      21   

Section 5.2.

   Certain Tax Matters, Bulk Sales      22   

Section 5.3.

   Covenant Not to Sue.      23   

Section 5.4.

   Public Announcements      23   

Section 5.5.

   Checks; Remittances and Refunds      23   

Section 5.6.

   Cooperation in Litigation      23   

Section 5.7.

   Cooperation in Patent Transfer, Assignment, Prosecution, Maintenance and Enforcement      24   

Section 5.8.

   Required Approvals and Consents      24   

Section 5.9.

   Transfer Period      24   

Section 5.10.

   Compliance with Laws      24   

Section 5.11.

   Post-Closing Filings; Further Assurances      24   

ARTICLE VI

   CONDITIONS PRECEDENT      25   

Section 6.1.

   Conditions to Obligations of Buyer and Seller      25   

Section 6.2.

   Conditions to Obligations of Buyer      26   

Section 6.3.

   Conditions to Obligations of Seller      27   


          Page  

ARTICLE VII

   INDEMNIFICATION      28   

Section 7.1.

   Survival; Expiration      28   

Section 7.2.

   Indemnification by Seller      29   

Section 7.3.

   Indemnification by Buyer      29   

Section 7.4.

   Calculation of Losses; Mitigation of Damages      29   

Section 7.5.

   Certain Procedures for Indemnification      30   

Section 7.6.

   Certain Limitations on Indemnification      31   

Section 7.7.

   Exclusive Remedy      31   

ARTICLE VIII

   MISCELLANEOUS      32   

Section 8.1.

   Governing Law      32   

Section 8.2.

   Notices      32   

Section 8.3.

   Benefits of Agreement      33   

Section 8.4.

   Amendments and Waivers      33   

Section 8.5.

   Cumulative Rights      33   

Section 8.6.

   Expenses      33   

Section 8.7.

   Arbitration      33   

Section 8.8.

   Assignment      34   

Section 8.9.

   Enforceability; Severability      34   

Section 8.10.

   Entire Agreement      35   

Section 8.11.

   Counterparts      35   

Exhibit 1.1(a)

   Non-Clinical and Clinical Material   

Exhibit 1.1(b)

   Assumed Contracts   

Exhibit 1.1(c)

   Certain Compound Definitions   

Exhibit 1.1(d)

   Permitted Liens   

Exhibit 5.4

   Public Announcements   

Exhibit 6.2(d)(i)

   Form of Bill of Sale and Assignment and Assumption Agreement   

Exhibit 6.2(d)(ii)

   Form of Assignments   

Exhibit 6.3(c)(i)

   Seller’s Wire Transfer Instructions   

Schedule 3.3

   Conflicts; Consents   

Schedule 3.4

   Governmental Authorizations   

Schedule 3.5

   Changes   

Schedule 3.6(b)

   Intellectual Property – Communications with Governmental Authority   

Schedule 3.6(e)

   Intellectual Property - Liens   

Schedule 3.12

   Confidential Information   

 

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ASSET PURCHASE AGREEMENT

This Asset Purchase Agreement (this “ Agreement ”), dated as of March 15, 2011 (the “ Effective Date ”), is made by and between Biovail Laboratories International SRL, an international society with restricted liability organized under the laws of Barbados (“ Seller ”) and Cortex Pharmaceuticals, Inc., a Delaware corporation (“ Buyer ”). Buyer and Seller may be referred to herein each individually as a “ Party ” and collectively as the “ Parties ”.

RECITALS

WHEREAS, Buyer and Seller have previously entered into that certain Asset Purchase Agreement, dated as of March 25, 2010, (the “ March 2010 Agreement ”) by and between Buyer and Seller, under which Buyer sold, and Seller purchased, certain assets related to AMPAKINE ® Compounds for use in the prevention and/or treatment of RD (as hereinafter defined) or vaso-occlusive crises associated with sickle cell disease (the “ Field ”); and

WHEREAS , subject to the terms and conditions of this Agreement, Seller desires to transfer back to Buyer, and Buyer desires to reacquire all of the assets obtained by Seller under the March 2010 Agreement, with the intent that upon closing of the transactions contemplated by this Agreement, that Buyer would hold all the rights it held prior to March 25, 2010.

NOW, THEREFORE , in consideration of the mutual benefits to be derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, hereby agree as follows:

ARTICLE I

DEFINITIONS; INTERPRETATION

Section 1.1. Definitions . The capitalized terms used in this Agreement have the respective meanings ascribed to them as follows:

Act ” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules, regulations, guidelines, guidances and requirements promulgated thereunder, as may be in effect from time to time.

Action ” means any claim, action, suit, arbitration, inquiry, audit, proceeding or investigation by or before or otherwise involving, any Governmental Authority.

Affiliate ” means, with respect to any Person, any other Person directly or indirectly controlling or controlled by, or under direct or indirect common control with, such first Person. For purposes of this definition, a Person shall be deemed, in any event, to control another Person if it (a) owns or controls, directly or indirectly, or has the ability to direct or cause the direction or control of, more than 50% of the voting equity of the other Person, or (b) has the ability to direct, cause the direction of, or control the actions of such other Person, whether through direct or indirect ownership of voting equity, by contract or otherwise.

Agreement ” has the meaning set forth in the preamble hereof.


Applicable Law ” means any applicable supra-national, federal, state, regional, local or foreign constitution, treaty, law, statute, ordinance, rule, regulation, interpretation, directive, policy, administrative code, guidance, order, writ, award, decree, injunction, judgment, stay or restraining order of any Governmental Authority, the terms of any Permit, and any other ruling or decision of, agreement with or by, or any other requirement of, any Governmental Authority.

Assets ” means all of Seller’s right, title and interest in and to (i) all properties, rights and assets (tangible or intangible) which Seller acquired from Buyer under the March 2010 Agreement, but excluding any Non-Clinical and Clinical Material acquired by Seller from Buyer under the March 2010 Agreement and any contracts assigned by Buyer to Seller under the March 2010 Agreement, except, in both cases, to the extent expressly included in this definition, (ii) all properties, rights and assets (tangible or intangible) which Seller acquired under license from The University of Alberta under the UofA License Agreement (iii) the Assumed Contracts, (iv) the Books and Records, (v) all inventory of CX1739, CX717 and CX1942 in Seller’s (or Seller’s Affiliates) possession or control as of the Effective Date (including any remaining Non-Clinical and Clinical Material acquired by Seller from Buyer under the March 2010 Agreement that remains in Seller’s or any of its Affiliate’s possession as of the Effective Date) together with all work-in-progress, packaging and all bulk active pharmaceutical ingredient related to CX717 and CX1942 owned by Seller (or its Affiliates, as applicable) as of the Effective Date, as listed on Exhibit 1.1(a) , and (vi) all claims, counterclaims, credits, causes of action, chooses in action, rights of recovery, and rights of indemnification or setoff against third parties and other claims arising out of or relating primarily to any Assets or the Assumed Liabilities and all other intangible property rights that primarily relate to any Assets or the Assumed Liabilities.

Assumed Contracts ” means those contracts set forth on Exhibit 1.1(b) , including but not limited to the UofA License Agreement.

Assumed Liabilities ” has the meaning set forth in Section 2.3(a) and includes, but is not limited to, any and all payment obligations of the Seller under the UofA License Agreement.

Basket ” has the meaning set forth in Section 7.6(a).

Books and Records ” means all books, records, files (including data files) and documents (including research and development and records), correspondence and, to the extent not originals, true and complete copies of all files relating to the Assets or the filing, prosecution, issuance, maintenance, enforcement or defense of any Patents, Trademarks, Copyrights or other Intellectual Property, including file wrappers, written third party correspondence, records and documents included in the Assets, including laboratory notebooks, procedures, tests, dosage information, criteria for patient selection, safety and efficacy and study protocols, investigators brochures and all pharmacovigilance and other safety records) in all forms, including electronic, in which they are stored or maintained, and all data and information included or referenced therein, in each case that are licensed, owned or Controlled by or otherwise in the possession of Seller or any of its Affiliates, as applicable.

Business Day ” means any day excluding Saturdays, Sundays and any day that is a legal holiday under the laws of the United States or Barbados or that is a day on which banking institutions located in New York, New York are authorized or required by Applicable Law or other governmental action to close.

 

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Buyer ” has the meaning set forth in the preamble hereof.

Buyer Confidential Information ” means (a) all financial, technical, commercial, proprietary or other information disclosed by or on behalf of Buyer or an Affiliate of Buyer to Seller, its Affiliates or any of its or their officers, directors, employees or Representatives (each, for purposes of this definition, a “ Seller Recipient ”) in preparation for and in connection with the March 2010 Agreement and related transactions, and in connection with the transactions contemplated by this Agreement, (b) each of the provisions contained in the March 2010 Agreement, this Agreement and the Related Documents, (c) all financial, technical, commercial, proprietary or other information of Buyer or its Affiliates disclosed by or on behalf of Buyer to any Governmental Authority in connection with any filings or review in connection with the transactions contemplated by this Agreement. Notwithstanding the preceding sentence, the definition of Buyer Confidential Information does not include any information that (i) is in the public domain at the time of disclosure to a Seller Recipient or becomes part of the public domain after such disclosure through no fault of a Seller Recipient, (ii) was already in the possession of a Seller Recipient at the time of disclosure to such Seller Recipient and had not been previously provided by Buyer or its Affiliates, (iii) is disclosed to a Seller Recipient by any Person other than by or on behalf of a Buyer Recipient; provided that , no Seller Recipient has actual knowledge that such Person is prohibited from disclosing such information (either by reason of contract or legal or fiduciary obligation) or (iv) is developed independently by a Seller Recipient without the use of any Buyer Confidential Information.

Buyer Recipient ” has the meaning set forth in the definition of Seller Confidential Information.

Cap ” has the meaning set forth in Section 7.6(a).

Code ” means the Internal Revenue Code of 1986, as amended.

Compounds ” means [***], CX717, CX1739, CX1763 and CX1942.

Consent ” means, with respect to an Assumed Contract or a Permit, any consent or approval of any Person other than either Party to this Agreement that, in accordance with the terms of such Assumed Contract or Permit, is required to be obtained for the transfer or assignment thereof to Buyer.

Control ” including its various tenses and derivatives (such as “ Controlled ” and “ Controlling ”) means (a) when used with respect to any Person, the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such entity, whether through the ownership of voting securities, by contract or otherwise, (b) when used with respect to any security, the possession, directly or indirectly, of the power to vote, or to direct the voting of, such security or the power to dispose of, or to direct the disposition of, such security, and (c) when used with respect to any item of Intellectual Property, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to assign or grant a license, sublicense or other right to or under such Intellectual Property.

Copyrights ” means (a) all copyrights (including copyrights in any package inserts, marketing or promotional materials, labeling or other text provided to prescribers or consumers),

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

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whether registered or unregistered throughout the world; (b) any registrations and applications therefor; (c) works of authorship (whether published or unpublished) and rights to databases of any kind under the Applicable Laws of any jurisdiction; (d) all rights and priorities afforded under any international treaty, convention or the like; (e) all extensions and renewals thereof; (f) the right to sue for past, present and future infringements of any of the foregoing, and all proceeds of the foregoing, including licenses, royalties, income, payments, claims, damages (including attorneys’ fees), and proceeds of suit; and (g) any rights similar to the foregoing in any country, including moral rights.

[***] ” shall have the meaning set forth in Exhibit 1.1(c) .

CX717 ” shall have the meaning set forth in Exhibit 1.1(c) .

CX1739 ” shall have the meaning set forth in Exhibit 1.1(c) .

CX1763 ” shall have the meaning set forth in Exhibit 1.1(c) .

CX1942 ” shall have the meaning set forth in Exhibit 1.1(c) .

Dollars ” or “ $ ” means United States dollars.

Effective Date ” has the meaning set forth in the preamble hereto.

Exploit ” or “ Exploitation ” means to make, have made, import, use, sell, offer for sale, or otherwise dispose of, including all discovery, research, development, registration, modification, enhancement, improvement, manufacture, storage, formulation, optimization, importation, exportation, transportation, distribution, commercialization, promotion and marketing activities related thereto.

FDA ” means the United States Food and Drug Administration, or any successor agency thereto.

Field ” has the meaning set forth in the recitals hereto.

Good Manufacturing Practices ” means standards and methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, testing or holding of a drug to assure that such drug meets the requirements of Applicable Law and other requirements of any Governmental Authority as to safety, identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.

Governmental Authority ” means any supra-national, federal, state, local or foreign government, legislature, governmental or administrative agency, department, commission, bureau, board, instrumentality, self-regulatory association or authority, court or other authority of tribunal of competent jurisdiction (including any arbitration or other alternative dispute forum), or any other governmental authority or instrumentality anywhere in the world.

Improvement ” means any modification, variation or revision to a compound, product or technology or any discovery, technology, device, process or formulation related to such compound, product or technology, whether or not patented or patentable, including any enhancement in the

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

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efficiency, operation, manufacture, ingredients, preparation, presentation, formulation, means of delivery, packaging or dosage of such compound, product or technology, any discovery or development of any new or expanded indications for such compound, product or technology, or any discovery or development that improves the stability, safety or efficacy of such compound, product or technology or would, if commercialized, replace or displace such compound, product or technology.

IND ” means (a) an Investigational New Drug Application, as defined in the Act, which is required to be filed with the FDA before beginning clinical testing of a product in human subjects, and its equivalent in other countries or regulatory jurisdictions in the Territory or any successor application or procedure, and (b) all supplements and amendments that may be filed with respect to the foregoing.

Indemnification Claim ” has the meaning set forth in Section 7.5(b).

Indemnified Party ” has the meaning set forth in Section 7.5(a).

Indemnifying Party ” has the meaning set forth in Section 7.5(a).

Information and Inventions ” means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including high-throughput screening and other drug discovery and development technology, pre-clinical and clinical trial results, manufacturing procedures, test procedures and purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form and all Improvements, whether to the foregoing or otherwise, and other discoveries, developments, inventions, and other Intellectual Property (whether or not confidential, proprietary, patented or patentable), but excluding the Regulatory Documentation.

Intellectual Property ” means all intellectual property rights, whether registered or unregistered, including (a) Patents, (b) Information and Inventions, (c) Trademarks, (d) Copyrights, (e) other intellectual property rights, including confidential information, trade secrets, and similar proprietary rights in confidential inventions, discoveries, analytic models, improvements, processes, techniques, devices, methods, patterns, formulations and specifications, (f) all completed or pending registrations, renewals or applications for registration or renewal of any of the foregoing, (g) copies and tangible embodiments of any of the foregoing (in whatever form or media) and (h) other tangible and intangible information or material.

Licensed Product ” has the meaning set forth in Section 2.1(c)(i).

Lien ” means any lien (statutory or otherwise), security interest, pledge, hypothecation, mortgage, assessment, lease, claim, levy, license, defect in title, charge, or any other third party right, license or property interest of any kind, or any conditional sale or other title retention agreement, right of first option, right of first refusal or similar restriction, any covenant not to sue, or any restriction on use, transfer, receipt of income or exercise of any other attribute of ownership or any agreement to give any of the foregoing in the future or similar encumbrance of any kind or nature whatsoever.

 

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Losses ” has the meaning set forth in Section 7.2.

March 2010 Agreement ” has the meaning set forth in the recitals.

Marketing Authorization Application ” or “ MAA ” means a New Drug Application as defined in the Act, and any corresponding foreign application, registration or certification, necessary or reasonably useful to market any product containing any of the Compounds as an active pharmaceutical ingredient in the Territory, but not including pricing and reimbursement approvals.

Material Adverse Effect ” means any effect that (a) is materially adverse to the Assets, in whole or in part, (b) materially impacts, materially delays or prevents the consummation of the transactions contemplated hereby, (c) creates a material limitation on the ability of the Buyer to develop, use or otherwise Exploit the Compounds in the Field, or (d) creates a material limitation on the ability of Buyer to acquire valid and marketable title to the Assets free and clear of all Liens (other than Permitted Liens).

Material Consent ” means any Consent under any Assumed Contract or Permit as designated on Schedule 3.3 .

Milestone Payments ” has the meaning set forth in Section 2.1(b).

NDA ” means a New Drug Application for any product requesting permission to place the product on the market in accordance with the Act, together with all supplements or amendments filed with respect thereto pursuant to the requirements of the Act, including all documents, data and other information concerning the product that are reasonably necessary for the FDA approval to market the product in the United States.

Non-Assignable Right ” has the meaning set forth in Section 2.4(a).

Non-Clinical and Clinical Material ” means all inventory of CX1739, CX717 and CX1942 in Seller’s (or Seller’s Affiliates) possession or control as of the Effective Date together with all work-in-progress, packaging and all bulk active pharmaceutical ingredient related to CX717 and CX1942 owned by Seller (or its Affiliates, as applicable) as of the Effective Date, including without limitation any CX717 100mg and 300mg tablets, and any CX717 sterile injection and corresponding vehicle sterile injection solutions, all as listed on Exhibit 1.1(a) .

Order ” means any writ, judgment, decree, injunction or similar order, including consent orders, of any Governmental Authority (in each such case whether preliminary or final).

Party ” or “ Parties ” has the meaning set forth in the preamble hereto.

Patents ” means (a) all national, regional and international patents and patent applications, including provisional patent applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, substitutions, provisionals, converted provisionals, continued prosecution applications and requests for continued examination applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications described in clauses (a) and (b), including utility models, petty patents and design patents and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and

 

6


extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications described in clauses (a), (b) and (c); (e) any and all causes of action, claims, demands or other rights occasioned from or because of any and all past, present and future infringement of any of the foregoing, including all rights to recover damages (including attorneys’ fees), profits and injunctive or other relief for such infringement; and (f) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent applications and patents.

Permits ” means all licenses, permits, construction permits, approvals, concessions, franchises, certificates, consents, qualifications, registrations, privileges and other authorizations and rights, including the Regulatory Approvals, from or issued by any Governmental Authority held by Seller (or its Affiliates, as applicable) that primarily relate to any Compound in the Field, together with any renewals, extensions, or modifications thereof and any additions thereto.

Permitted Liens ” means (a) Liens for Taxes or assessments that are not yet due or which are being contested in good faith by appropriate Actions and (b) statutory mechanics’, materialmen’s, contractors’, warehousemen’s, repairmen’s and other similar statutory Liens arising in the ordinary course of business and consistent with past practice and that are not delinquent or as set forth on Exhibit 1.1(d) .

Person ” means a human being, labor organization, partnership, firm, enterprise, association, joint venture, corporation, limited liability company, cooperative, legal representative, foundation, society, political party, estate, trust, trustee, trustee in bankruptcy, receiver or any other organization or entity whatsoever, including any Governmental Authority.

Phase I Clinical Study ” means an initial human clinical trial of a compound or product on a limited number of healthy subjects that is designed to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness, which trial may include healthy participants and/or patients.

Phase IIa Clinical Study ” means a human clinical trial of a compound or product on a limited number of subjects that is designed to evaluate dosing requirements to achieve the effectiveness of the drug for a particular indication or indications and to determine the common short-term side effects and risks.

Phase III Clinical Study ” means a human clinical trial of a compound or product on a sufficient number of patients that is designed to establish that the compound or product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with the compound or product in the dosage range to be prescribed, and to support Regulatory Approval of the compound or product or label expansion of the compound or product.

Purchase Price ” shall mean the Initial Payment plus the other contingent payments set forth in Section 2.1.

RD ” or “respiratory depression” means a variety of conditions characterized by reduced frequency and inspiratory drive to cranial and spinal motor neurons. Specifically, respiratory depression refers to conditions where the medullary neural network associated with respiratory rhythm generating activity does not respond to accumulating levels of PCO 2 (or decreasing levels of PO 2 ) in the blood and subsequently under stimulates motor neurons controlling lung musculature.

 

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Regulatory Approval ” means, with respect to a country in the Territory, any and all approvals (including pricing and reimbursement approvals), licenses, registrations or authorizations of any Governmental Authority necessary or useful for the Exploitation of the Compound in such country, including, where applicable, (a) approval of any Compound or any product containing any Compound, including any INDs, MAAs and supplements and amendments thereto; (b) pre- and post-approval marketing authorizations (including any prerequisite manufacturing approval or authorization related thereto); (c) labeling approval; and (d) technical, medical and scientific licenses.

Regulatory Documentation ” means any and all applications (including for “orphan drug” status), registrations, licenses, authorizations and approvals (including all Regulatory Approvals), and non-clinical and clinical study authorization applications or notifications (including all supporting files, writings, data, studies and reports) prepared for submission to a Governmental Authority or research ethics committee with a view to the granting of any Regulatory Approval, and any correspondence to or with the FDA or any other Governmental Authority with respect to the Compounds (including minutes and official contact reports relating to any communications with any Governmental Authority), and all data contained in any of the foregoing, including all INDs, MAAs, regulatory drug lists, advertising and promotion documents, adverse event files, complaint files and manufacturing records.

Related Documents ” means, other than this Agreement, all agreements, certificates and documents signed and delivered by either Party in connection with this Agreement.

Representatives ” has the meaning set forth in Section 5.1(a).

Seller ” has the meaning set forth in the preamble hereof.

Seller Confidential Information ” means (a) all financial, technical, commercial, proprietary or other information of Seller or an Affiliate of Seller disclosed by Seller or an Affiliate of Seller to Buyer, its Affiliates or any of its or their officers, directors, employees (or Representatives for purposes of this definition, each a “ Buyer Recipient ”) in connection with the transactions contemplated by this Agreement that does not primarily relate to the Assets, and (b) each of the provisions contained in the March 2010 Agreement, this Agreement and the Related Documents. Notwithstanding the preceding sentence, the definition of Seller Confidential Information does not include any information that (i) is in the public domain at the time of disclosure to a Buyer Recipient or becomes part of the public domain after such disclosure through no fault of such Buyer Recipient, (ii) is already in the possession of a Buyer Recipient at the time of disclosure to such Buyer Recipient and had not been previously provided by Seller or its Affiliates, including without limitation all Buyer Confidential Information provided in preparation for and in connection with, the March 2010 Agreement, (iii) is disclosed to a Buyer Recipient by any Person other than by or on behalf of a Seller Recipient; provided that , no Buyer Recipient has actual knowledge that such Person is prohibited from disclosing such information (either by reason of contract or legal or fiduciary obligation) or (iv) is developed independently by a Buyer Recipient without the use of any Seller Confidential Information.

Seller Intellectual Property ” means all “Seller Intellectual Property”, as that term is defined in the March 2010 Agreement, acquired by Seller under the March 2010 Agreement, as further described in the definition of “Acquired Assets” thereunder.

 

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Seller License Agreement ” means the license agreement entered into simultaneously with the March 2010 Agreement between Buyer and Seller with respect to the license by Seller to Buyer of certain intellectual property.

Seller Recipient ” has the meaning set forth in the definition of Buyer Confidential Information.

Seller’s Knowledge ” (and similar phrases) means the actual knowledge of any officer or director of Seller or Seller’s Affiliates.

Subsidiary ” means, with respect to any Person, any other Person of which at least a majority of the securities or ownership interests having by their terms ordinary voting power to elect a majority of the board of directors or other persons performing similar functions is directly or indirectly owned or Controlled by such Person and/or by one or more of its Subsidiaries.

Tax ” or “ Taxes ” means any and all taxes, assessments, levies, tariffs, duties or other charges or impositions in the nature of a tax (together with any and all interest, penalties, additions to tax and additional amounts imposed with respect thereto) imposed by any Governmental Authority, including income, estimated income, gross receipts, profits, business, license, occupation, franchise, capital stock, real or personal property, sales, use, transfer, value added, employment or unemployment, social security, disability, alternative or add-on minimum, customs, excise, stamp, environmental, commercial rent or withholding taxes, and shall include any liability for Taxes of any other Person under Applicable Law, as a transferee or successor, by contract or otherwise.

Tax Return ” means any return, declaration, report, claim for refund, information return or statement relating to Taxes, including any schedule or attachment thereto, filed or maintained, or required to be filed or maintained, in connection with the calculation, determination, assessment or collection of any Tax and shall include any amended returns required as a result of examination adjustments made by the Internal Revenue Service or other Tax authority.

Trademark ” means (a) any word, name, symbol, color, designation or device or any combination thereof, including any trademark, trade dress, brand mark, trade name, brand name, logo, domain name or business symbol and (b) all registrations and applications for any of the foregoing; and (c) all rights and priorities connected with the foregoing afforded under Applicable Law.

Transfer Date ” means with respect to an Assumed Contract requiring the Consent, the date such Consent is obtained and such Assumed Contract is duly assigned to Buyer.

Transfer Taxes ” has the meaning set forth in Section 5.2(a).

UofA License Agreement ” means that certain Patent License Agreement, dated as of May 9, 2007, by and between the University of Alberta, as licensor, and Seller, as licensee, as amended as of June 8, 2007, and as of March 25, 2010.

UofC Consent and Termination ” means the written consent of The Regents of the University of California, in form and substance reasonably satisfactory to Buyer, to the termination of the UofC Field-Limited Agreement with Seller.

 

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UofC Patent Assignment Agreement ” means the patent assignment agreement between The Regents of the University of California and Seller, dated March 25, 2010, under which certain patent rights relating to [***] were assigned to Seller in consideration of contingent future payments.

UofC Field-Limited Agreement ” means the Field-limited non-exclusive license granted by The Regents of the University of California to Seller, dated March 25, 2010, relating to [***].

Section 1.2. Interpretation .

(a) Descriptive headings are for convenience only and shall not control or affect the meaning or construction of any provision of this Agreement.

(b) Except as otherwise expressly provided in this Agreement or as the context otherwise requires, the following rules of interpretation apply to this Agreement: (i) the singular includes the plural and the plural includes the singular; (ii) “or” and “any” are not exclusive and the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation;” (iii) a reference to any contract includes supplements and amendments; (iv) a reference to an Applicable Law includes any amendment or modification to such Applicable Law; (v) a reference to a Person includes its successors, heirs and permitted assigns; (vi) a reference to one gender shall include any other gender; (vii) a reference in this Agreement to an Article, Section, Exhibit or Schedule is to the referenced Article, Section, Exhibit or Schedule of this Agreement; (viii) “hereunder,” “hereof,” and words of similar import shall be deemed references to this Agreement as a whole and not to any particular Article, Section or other provision; and (ix) “commercially reasonable efforts” of a Party shall be construed as the efforts that a prudent Person in such Party’s industry, desirous of achieving a result, would use in similar circumstances to achieve that result as expeditiously as possible.

(c) The Parties hereto agree that they have been represented by counsel during the negotiation, drafting, preparation and execution of this Agreement and, therefore, waive the application of any Applicable Law or rule of construction providing that ambiguities in an agreement or other document will be construed against the Party drafting such agreement or document.

ARTICLE II

PURCHASE AND SALE

Section 2.1. Purchase and Sale of Assets; Purchase Price; Additional Consideration, Co-Marketing Election .

(a) Purchase and Sale of Assets; Purchase Price . Pursuant to the terms and subject to the conditions of this Agreement, on the date hereof, Seller shall (and, as applicable, shall cause its Affiliates to) sell, convey, deliver, transfer and assign to Buyer all of the Assets, free and clear of all Liens (other than Permitted Liens), and Buyer shall purchase, take delivery of and acquire from Seller (and its Affiliates, as applicable), all of Seller’s (and, as applicable, its Affiliates’) right, title and interest in, to and under the Assets. In consideration of the sale, conveyance, delivery, transfer, and assignment of the Assets to Buyer and Seller’s other covenants and obligations hereunder, on the date hereof and pursuant to the terms and subject to the conditions hereof, Buyer shall (i) pay Seller two hundred thousand U.S. Dollars (U.S. $200,000) (the “ Initial Payment ”) by wire transfer of immediately available funds to an account designated by Seller and (ii) assume the Assumed Liabilities.

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

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(b) Additional Consideration; Milestone Payments . As additional consideration of the sale, conveyance, delivery, transfer, and assignment of the Assets to Buyer and Seller’s other covenants and obligations hereunder, Buyer shall pay Seller the following amounts (the “ Milestone Payments ”), subject to the following conditions, which amounts shall be due and payable, if at all, as specified below:

(i) [***] U.S. dollars (U.S. $[***]) upon the first dosing of a patient in a Phase IIa Clinical Study in humans of an intravenous dosage form of one of the Compounds in the Field;

(ii) [***] U.S. dollars (U.S. $[***]) upon the first dosing of a patient in a Phase III Clinical Study of an intravenous dosage form of one of the Compounds in the Field;

(iii) [***] U.S. dollars (U.S. $[***]) upon the submission by or on behalf of the Buyer of an NDA with the U.S. Food and Drug Administration for an intravenous dosage form of one the of the Compounds in the Field; and

(iv) [***] U.S. dollars (U.S. $[***]) upon receipt by Buyer of approval of an NDA from the U.S. Food and Drug Administration of an intravenous dosage form of one of the Compounds in the Field.

Each Milestone Payment set forth in clauses (i) through (iv) above shall only be payable once upon the first such milestone event to occur. Each Milestone Payment shall be made within thirty (30) days of achievement of the related event. Notwithstanding anything in this Agreement to the contrary, and except as otherwise may be required pursuant to the terms of an agreement in connection with the Co-Marketing Election, the determination as to whether to proceed with the development of any of the Compounds in the Field shall be in Buyer’s sole and absolute discretion and Buyer shall have no liability whatsoever for not starting, temporarily or permanently abandoning or otherwise ceasing development of any of the Compounds in the Field.

(c) Additional Consideration; Royalties . As additional consideration of the sale, conveyance, delivery, transfer, and assignment of the Assets to Buyer and Seller’s other covenants and obligations hereunder, Buyer shall pay Seller a royalty equal to [***] percent ([***]%) of Buyer’s Net Sales of an intravenous dosage form of one of the Compounds in the Field, subject to the royalty definitions, terms and conditions set forth in this Section 2.1(c). The obligation to pay such royalties shall end on the earlier of (i) such time as the cumulative royalties paid under this Section 2.1(c) equal fifteen million dollars ($15,000,000), or (ii) the expiration of the last Patent included in the Seller Intellectual Property which covers such Compound or use thereof in the Field. The following provisions shall apply to the foregoing royalty obligations:

(i) “ Licensed Product ” shall mean any intravenous dosage form of a Compound in the Field.

(ii) “ Net Sales ” shall mean the sales revenues invoiced or otherwise received by Buyer and its Affiliates and licensees from sales of a Licensed Product sold or otherwise transferred for value to third parties, less the following reasonable and customary deductions to the

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

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extent applicable to such invoiced amounts: (i) trade, cash and quantity discounts; (ii) amounts for allowances or credits for returns, retroactive price reductions, rebates and chargebacks; and (iii) handling fees and prepaid freight, postage or insurance costs on shipments of the Licensed Product, sales, taxes, duties and other governmental charges (including value-added tax), but excluding what is commonly known as income taxes. For the avoidance of doubt, Net Sales shall not include sales by Buyer or its Affiliates licensees to their respective Affiliates or licensees for resale; provided that if Buyer, its Affiliate or licensee sells a Licensed Product to an Affiliate or licensee for resale to a third party, Net Sales shall include the amounts invoiced by such Affiliate or licensees to third parties on the resale or use of such Licensed Product. Net Sales for combination products shall be calculated as set forth in Section 2.1(c)(iii).

(iii) Royalties on Combination Products . In the event that a Licensed Product is sold for a single price in combination with another product, or a combination pharmaceutical product including another active pharmaceutical ingredient in addition to a Compound, for which no royalty would be due hereunder if sold separately, Net Sales from such combination product sales for purposes of calculating the amounts payable by Buyer shall be calculated by multiplying the Net Sales of the combination product by the fraction A/(A + B), where “A” is the average gross selling price during the previous calendar quarter of such Licensed Product sold separately and “B” is the average gross selling price during the previous calendar quarter of the other non-royalty bearing product or the other active ingredients when sold separately. In the event that separate sales of such Licensed Product or such other non-royalty bearing product or active ingredient were not made during the previous calendar quarter, then the Net Sales shall be reasonably allocated between such Licensed Product and such other non-royalty bearing product or active ingredient based on their relative values.

(iv) Records, Audits . Buyer shall, and shall cause its Affiliates and licensees to, keep complete and accurate records in sufficient detail to enable the royalties payable to be determined. Buyer shall permit said records to be examined for three years following the end of the period to which such records pertain and no more than once per calendar year, at Seller’s expense, by authorized representatives of Seller, such representatives having been reasonably approved of by Buyer and bound by confidentiality agreements reasonably acceptable to Buyer, upon reasonable prior notice and during usual business hours, and only to the extent necessary to verify the reports and payments required hereunder. Such examination shall be solely for the purpose of ascertaining the correctness of royalties reported and paid and no period shall be audited more than once.

(v) Payments, Reports . All royalties paid by Buyer shall be in United States dollars. All foreign currency conversions are to be based on the Wall Street Journal published rates as of the last business day preceding the date of payment and report of royalties by Buyer to Seller. Buyer shall furnish written reports to Seller within thirty (30) days following the close of each calendar quarter during the term of this Agreement setting forth the number, gross selling prices, offsets to gross selling prices and net selling prices of each kind of Licensed Product sold by Buyer and its Affiliates and licensees in such calendar quarter, and the royalties due thereon. Each report shall be accompanied by a remittance of any royalties then due hereunder.

 

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Section 2.2. Marketing Rights Election .

(a) Seller may elect, at any time (i) following the successful completion by Buyer (as determined in its sole discretion) of a Phase I Clinical Study in humans of an intravenous dosage form of one of the Compounds in the Field, and (ii) prior to thirty (30) days following receipt by Seller from Buyer of all material data (including final study results and final data from such study) relating to the successful completion by Buyer (as determined in its sole discretion) of a Phase IIa Clinical Study in humans of an intravenous dosage form of one of the Compounds in the Field, to acquire co-marketing rights for an intravenous dosage form of one of the Compounds in the Field (the “ Co-Marketing Election ”). If Seller so elects, the parties shall negotiate in good faith an agreement under which (i) Seller would receive co-marketing rights in North America and, if Seller so elects, in its sole discretion, exclusive marketing rights in the rest of the world, subject to diligence requirements, (ii) Seller would pay Buyer a royalty of [***] percent ([***]%) of its (and its Affiliates’ and licensees’) North American net sales or worldwide net sales, as the case may be, of such product, plus be responsible for (A) if Seller has elected to market outside of North America, [***] percent ([***]%) of any royalties due to the University of California and the University of Alberta for sales outside of North America and (B) [***] percent ([***]%) of any royalties due to the University of California and the University of Alberta for sales within North America (for purposes of (B), such sales shall include sales by both Seller and Buyer and their respective Affiliates), (iii) Seller would pay to Buyer a front-end payment equal to the cumulative development costs Buyer has incurred in connection with such intravenous dosage form of the Compounds in the Field from the Effective Date to the date that Seller makes the Co-Marketing Election, (iv) Buyer would remain responsible for the payment of [***] percent ([***]%) of any royalties due to the University of California and the University of Alberta for sales within North America (for purposes of (iv), such sales shall include sales by both Seller and Buyer and their respective Affiliates), (v) if Seller does not elect to exercise its exclusive marketing right outside of North America, Buyer would remain responsible for [***] percent ([***]%) of any royalties due to the University of California and the University of Alberta for sales outside of North America and (vi) Seller and Buyer would co-develop the Licensed Product(s) to bring it to a successful approval by the FDA, with each party paying for 50% of the on-going development costs. Such agreement shall contain such other terms and conditions as are customary in pharmaceutical marketing agreements. If Seller does not exercise the Co-Marketing Election within the time period set out above, or if Seller has so exercised but the Parties fail to enter into a definitive agreement with respect to the co-marketing rights, then Buyer shall have no further obligation under this Section 2.2(a) and may further develop any Compound in the Field itself or with Third Parties.

(b) Notwithstanding anything to the contrary herein, (i) in the event that Seller makes the Co-Marketing Election pursuant to Section 2.2(a) above, the Milestone Payments in Section 2.1(b) clauses (ii) through (iv), and the royalties in Section 2.1(c) shall not be due and payable, and (ii) Seller’s right to exercise the Co-Marketing Election shall automatically terminate and be of no further force and effect upon the date of the last to expire Patent right that is included in the Assets.

Section 2.3. Assumed Liabilities; Buyer Not Successor to Seller; Excluded Liabilities .

(a) Assumed Liabilities . Pursuant to the terms and subject to the conditions of this Agreement, on the date hereof, Seller shall sell, convey, transfer and assign to Buyer, and Buyer shall assume from Seller, only the Assumed Liabilities. “ Assumed Liabilities ” means any and all liabilities, obligations and commitments related to or in connection with the Assets, including:

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

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(i) any and all liabilities with respect to obligations and commitments in connection with the Regulatory Documentation included in the Assets but excluding any liability, obligation or commitment accrued between March 25, 2010 and the Effective Date, arising out of or resulting from (i) any breach or violation of such Regulatory Documentation, or (ii) any requirement of Applicable Law by Seller;

(ii) any and all liabilities with respect to obligations and commitments under the Assumed Contracts, including any and all payment obligations to the University of Alberta under the UofA License Agreement, but excluding any liability, obligation or commitment arising from or relating to the performance or non-performance thereof after March 25, 2010 and prior to the Effective Date or the Transfer Date (if Consent to assignment thereof is required);

(iii) any and all liabilities to prosecute and maintain the Seller Intellectual Property, including liabilities to defend patents and applications and their foreign counterparts, including in reexamination, reissue, litigation, interference, opposition or nullity actions or the like, but excluding any liability, obligation or commitment arising from or relating to the performance or non-performance thereof after March 25, 2010, and prior to the Effective Date.

(b) Buyer Not Successor to Seller . Notwithstanding anything herein to the contrary, in no event shall Buyer be deemed to have assumed any liability or obligation (including a liability or obligation that, but for this sentence, would be deemed to be an Assumed Liability) where the existence or nature of such liability or obligation constitutes or arises out of a breach or inaccuracy of any representation or warranty or the non-fulfillment or breach of any covenant, agreement or obligation of Seller hereunder.

(c) Excluded Liabilities . Buyer shall not be the successor to Seller, and Buyer expressly does not assume and shall not become liable to pay, perform or discharge, any liability, obligation or commitment whatsoever of Seller or relating the Assets other than the Assumed Liabilities.

Section 2.4. Assumed Contracts; Procedures for Certain Assets Not Freely Transferable .

(a) As of the Effective Date, Seller shall assign and Buyer shall assume the Assumed Contracts, including all rights, title, interest and obligations thereunder, subject to any required Consent. If any Assumed Contract is not assignable or transferable to Buyer either by virtue of the provisions thereof or under Applicable Law without the Consent of one or more third Persons (each, a “ Non-Assignable Right ”), Seller shall promptly notify Buyer and shall use its commercially reasonable efforts, at Buyer’s sole cost and expense, to obtain such Consents. Seller shall provide Buyer the reasonable opportunity to review and comment on each such Consent prior to the execution thereof and shall take into account any comments received by Buyer and incorporate such comments to the extent practicable. If any such Consent cannot be obtained prior to the Effective Date, then, notwithstanding anything to the contrary in this Agreement or any Related Document, this Agreement and the related instruments of transfer shall not constitute an assignment or transfer of the Non-Assignable Right, and Seller and Buyer shall use their commercially reasonable efforts to obtain such Consent as soon as possible after the Effective Date. If any such Consent cannot be obtained prior to the end of the transfer period set forth in Section 5.9 below, at

 

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Seller’s election, (A) the Non-Assignable Right shall not be included as an Asset and Buyer shall have no obligations or rights pursuant to Section 2.3(a) or this Section 2.4(a) or otherwise with respect to any such Non-Assignable Right or any liability with respect thereto or (B) Seller shall use its commercially reasonable efforts to obtain for Buyer substantially all of the practical benefit and burden of such Non-Assignable Right, including by (1) entering into appropriate and reasonable alternative arrangements on terms mutually agreeable to Buyer and Seller and (2) subject to the consent and control of Buyer, enforcement, at the cost and for the account of Buyer, of any and all rights of Seller against the other Party thereto arising out of the breach or cancellation thereof by such other Party or otherwise.

(b) If any of the Permits included in the Assets are not assignable or transferable without obtaining a replacement Permit, then, notwithstanding anything to the contrary in this Agreement or any Related Document, this Agreement and the related instruments of transfer shall not constitute an assignment or transfer of any such Permit, and Seller shall cooperate, to the extent commercially reasonable, with Buyer in its efforts to obtain a replacement Permit issued in Buyer’s name. If any replacement Permit has not been obtained prior to the Effective Date, Seller shall allow Buyer to operate under Seller’s Permit, if permitted by Applicable Law or applicable Governmental Authorities, for a period of up to ninety (90) days after the Effective Date (or such longer period as may be reasonably necessary for Buyer, using its commercially reasonable efforts, to obtain the replacement Permit).

ARTICLE III

REPRESENTATIONS AND WARRANTIES OF SELLER

Seller represents and warrants to Buyer, as of the date hereof, as follows, with each such representation and warranty subject only to such exceptions, if any, as are set forth in the particular disclosure Schedule numbered and captioned to correspond to, and referenced in, such representation or warranty:

Section 3.1. Organization, Standing and Power . Seller is a corporation duly organized, validly existing and in good standing under the laws of Barbados and has all requisite power and authority to own, lease and operate its properties and to carry on its business as now being conducted. Seller is duly qualified to do business and is in good standing in each jurisdiction in which such qualification is necessary because of the property owned, leased or operated by it or because of the nature of its business as now being conducted, except where any failure, individually or in the aggregate, to be so qualified or in good standing does not or could not reasonably be expected to have a Material Adverse Effect.

Section 3.2. Authority; Binding Agreements . The execution and delivery by Seller of this Agreement and the Related Documents to which it is or will become a party and the consummation of the transactions contemplated hereby and thereby have been duly and validly authorized by all necessary action on the part of Seller. Seller has all requisite power and authority to enter into this Agreement and the Related Documents to which it is or will become a party and to consummate the transactions contemplated hereby and thereby, and this Agreement and such Related Documents have been, or upon execution and delivery thereof will be, duly executed and delivered by Seller. This Agreement and the Related Documents to which Seller is or will become a party are, or upon execution and delivery by Seller thereof will be, the valid and binding obligations of Seller, enforceable against Seller in accordance with their respective terms, subject to laws of general application relating to the rights of creditors generally.

 

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Section 3.3. Conflicts; Consents . Except as set forth on Schedule 3.3 , the execution and delivery by Seller of this Agreement and the Related Documents to which it is or will become a party, the consummation of the transactions contemplated hereby and thereby and compliance by Seller with any of the provisions hereof and thereof do not and will not:

(a) conflict with or result in a breach of the certificate of incorporation, bylaws or other constitutive or organizational documents of Seller;

(b) conflict with, result in a default or give rise to any right of termination, cancellation, modification or acceleration under any note, bond, lease, mortgage, indenture, Permit, contract or other instrument or obligation to which Seller or any of its Affiliates is a party, or by which Seller, any of its Affiliates, or any of the Assets may be bound or affected;

(c) violate any Applicable Law with respect to Seller or any of the Assets; or

(d) result in the creation or imposition of any Lien upon any Asset.

Section 3.4. Governmental Authorizations . Except as set forth on Schedule 3.4 , no consent, approval or authorization of, or registration, declaration or other similar action in respect of, or filing with, any Governmental Authority is required to be obtained or made by or with respect to Seller or any of its Affiliates in connection with the execution, delivery and performance of this Agreement, the Related Documents or the consummation of the transactions contemplated hereby and thereby.

Section 3.5. Absence of Changes . Since March 25, 2010, Seller and its Affiliates have maintained the Assets in the ordinary course of business and consistent with past practice, and, except as set forth on Schedule 3.5 , there has not been in connection with or related to the Assets:

(a) to the best of Seller’s knowledge, any Material Adverse Effect or event, development or state of circumstances that individually or in the aggregate could reasonably be expected to result in a Material Adverse Effect;

(b) an incurrence, assumption or guarantee by Seller or any of its Affiliates of any liability or obligation (whether accrued, fixed, absolute, contingent, known, unknown, determined, determinable or otherwise, and whether due or to become due) with respect to the Assets;

(c) any sale, assignment, license, transfer or other disposition of any Asset;

(d) except in the ordinary course of business and consistent with past practice, any amendment, modification or termination of any Assumed Contract;

(e) any creation or other incurrence of any Lien (other than Permitted Liens) on any Asset;

(f) any material damage, destruction or loss (whether or not covered by insurance) affecting any Asset;

(g) any cancellation, delinquency or loss of any Permit;

 

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(h) any institution of, settlement of or agreement to settle any Action related to the Assets;

(i) any change in the customary maintenance of all Regulatory Documentation contained in the Books and Records in the ordinary course of business;

(j) any agreement or action not otherwise referred to in items (a) through (i) above entered into or taken that is materially adverse to the Assets; or

(k) any agreement or commitment, whether in writing or otherwise, to take any of the actions specified in items (a) through (j) above.

Section 3.6. Intellectual Property .

(a) Since March 25, 2010, Seller has continued to own such right, title and interest in and to, or has continued to hold such valid license rights to, the Seller Intellectual Property as was conveyed, transferred and assigned to Seller pursuant to the March 2010 Agreement.

(b) Schedule 3.6(b) sets forth a true, accurate and complete list of all filings and communications with any Governmental Authority relating to the Seller Intellectual Property made or received by Seller or its Affiliates between March 25, 2010 and the Effective Date. Seller has provided true and complete copies of all such filings and communications to Buyer.

(c) Between March 25, 2010 and the Effective Date, Seller or its Affiliates, have taken all action necessary to prosecute all existing applications and to maintain all registrations which are part of the Seller Intellectual Property in full force and effect, and has not taken or failed to take any action that could reasonably be expected to have the effect of waiving any rights to the Seller Intellectual Property. During such period, all issuance, renewal, maintenance and other material payments that are or have become due with respect to the Seller Intellectual Property have been timely paid by or on behalf of Seller.

(d) To the knowledge of Seller, none of the Seller Intellectual Property has been or is the subject of any pending or threatened Action (including, with respect to Patents, inventorship challenges, interferences, reissues, reexaminations and oppositions or similar Actions) commenced or threatened, as the case may be, between March 25, 2010 and the Effective Date.

(e) Except as set forth on Schedule 3.6(e) , neither Seller nor its Affiliates, if applicable, has assigned, transferred, conveyed, or granted any licenses to the Seller Intellectual Property to third parties, or otherwise caused or permitted any Lien to attach to any Seller Intellectual Property or the Compounds.

(f) Neither Seller nor its Affiliates, if applicable, nor to Seller’s Knowledge, any other Person, is party to any agreements with third parties that materially limit or restrict the use of the Seller Intellectual Property or require any payments for their use.

(g) To Seller’s Knowledge, since March 25, 2010, there has been no unauthorized use, infringement, misappropriation or violation of any of the Seller Intellectual Property by any Person.

 

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(h) Between March 25, 2010 and the Effective Date, Seller has taken reasonable measures to protect and preserve the security, confidentiality, value and ownership of the Information and Inventions and other confidential information included in the Assets.

(i) To Seller’s knowledge, between March 25, 2010 and the Effective Date, no employee or agent of either Seller or its Affiliates have developed, discovered, conceived or reduced to practice any Information and Inventions related to the Compounds or their use in the Field which is not part of the Seller Intellectual Property being conveyed to Buyer hereunder.

Section 3.7. Contracts .

(a) Seller owns all right, title and interest in and to, and has valid rights to assign and transfer, all of the Assumed Contracts, provided that, in the case of Assumed Contracts transferred or assigned to Seller pursuant to the March 2010 Agreement, Seller only owns such right, title and interest in and to, and only has such valid rights to assign and transfer, such Assumed Contracts as was conveyed, transferred and assigned to Seller by Buyer pursuant to the March 2010 Agreement.

(b) Between March 25, 2010 and the Effective Date, Seller or its Affiliates, have taken all action necessary to maintain the Assumed Contracts in full force and effect, and have not taken or failed to take any action that could reasonably be expected to have the effect of waiving any material rights under the Assumed Contracts. During such period, all payments or other obligations that are or have become due with respect to Assumed Contracts have been timely paid or performed by or on behalf of Seller.

(c) To the knowledge of Seller, none of the Assumed Contracts has been or is the subject of any pending or threatened Action that commenced or was threatened, as the case may be, between March 25, 2010 and the Effective Date.

(d) Neither Seller nor its Affiliates have assigned, transferred, conveyed, or granted any rights under the Assumed Contracts to third parties.

Section 3.8. Non-Clinical and Clinical Material . Since the date of receipt of the Non-Clinical and Clinical Material by Seller from Buyer pursuant to the March 2010 Agreement, all such Non-Clinical and Clinical Material obtained by Seller from Buyer has been maintained in accordance with the good scientific practices, any written instructions provided by Buyer to Seller, and to the extent required, under Good Manufacturing Practices.

Section 3.9. Litigation . There is no Action pending, or to Seller’s Knowledge, threatened before any Governmental Authority, and there is no claim, investigation or administrative action of any Governmental Authority pending, or to Seller’s Knowledge, threatened, that affects the Assets that was commenced or threatened, as the case may be, between March 25, 2010 and the Effective Date, nor has Seller been notified in writing of any reasonable basis on which any Action may be brought in the future that affects the Assets. There is no Action pending, or to Seller’s Knowledge, threatened before any Governmental Authority, and there is no claim, investigation or administrative action of any Governmental Authority pending, or to Seller’s Knowledge, threatened, that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement or the Related Documents.

 

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Section 3.10. Adverse Information . Since March 25, 2010, Seller has received no material adverse information with respect to the safety and efficacy of the Compounds.

Section 3.11. Brokers . No agent, broker, firm or other Person acting on behalf, or under the authority, of Seller is or will be entitled to any broker’s or finder’s fee or any other commission or similar fee directly or indirectly in connection with any of the transactions contemplated hereby.

Section 3.12. Confidential Information . Neither Seller nor any of its Affiliates has provided access to any Buyer Confidential Information to any third party unless under a confidentiality obligation, all of which are listed on Schedule 3.12 .

Section 3.13. Regulatory Matters . Since March 25, 2010, Seller has (i) not filed any documents with, communicated to, or received any communication from, any Regulatory Authority with respect to the Assets, other than with respect to the transfer of the Regulatory Documentation from Buyer to Seller under the March 2010 Agreement, and from Seller to Buyer hereunder, and (ii) not failed to file any documents with any Regulatory Authority required under Applicable Law or as necessary to maintain in good standing any Regulatory Documentation.

Section 3.14. Disclosure . No representation or warranty of Seller contained in this Agreement or the disclosure Schedules furnished in connection herewith contains any untrue statement of a material fact or omits to state a material fact necessary to make the statement contained herein or therein not misleading.

ARTICLE IV

REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer represents and warrants to Seller, as of the date hereof, as follows, with each such representation and warranty subject only to such exceptions, if any, as are set forth in the particular disclosure Schedule numbered and captioned to correspond to, and referenced in, such representation or warranty:

Section 4.1. Organization, Standing and Power . Buyer is corporation duly organized, validly existing and in good standing under the laws of Delaware and has all requisite power and authority to own, lease and operate its properties and to carry on its business as now being conducted.

Section 4.2. Authority; Binding Agreements . The execution and delivery by Buyer of this Agreement and the Related Documents to which it is or will become a party and the consummation of the transactions contemplated hereby and thereby have been duly and validly authorized by all necessary action on the part of Buyer. Buyer has all requisite power and authority to enter into this Agreement and the Related Documents to which it is or will become a party and to consummate the transactions contemplated hereby and thereby, and this Agreement and such Related Documents have been, or upon execution and delivery thereof will be, duly executed and delivered by Buyer. This Agreement and the Related Documents to which Buyer is or will become a party are, or upon execution and delivery thereof will be, the valid and binding obligations of Buyer, enforceable against Buyer in accordance with their respective terms, subject to laws of general application relating to the rights of creditors generally.

 

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Section 4.3. Conflicts; Consents . The execution and delivery by Buyer of this Agreement and the Related Documents to which it is or will become a party, the consummation of the transactions contemplated hereby and thereby and compliance by Buyer with the provisions hereof and thereof do not and will not (a) conflict with or result in a breach of the constitutive or organizational documents of Buyer, (b) violate any Applicable Law with respect to Buyer or Buyer’s properties or assets, (c) conflict with, result in a default or give rise to any right of termination, cancellation, modification or acceleration under any note, bond, lease, mortgage, indenture, permit, contract or other instrument or obligation to which Buyer or any of its Affiliates is a party, or by which Buyer, any of its Affiliates, may be bound or affected except as would not be expected to have a material impact or delay or prevent the consummation of the transactions contemplated by this Agreement and the Related Documents; or (d) require the Consent of, or any notification to or filing with, any Governmental Authority or other Person.

Section 4.4. Litigation . There is no Action pending, or to Buyer’s Knowledge, threatened before any Governmental Authority, and there is no claim, investigation or administrative action of any Governmental Authority pending, or to Buyer’s Knowledge, threatened, that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Buyer of the transactions contemplated by this Agreement or the Related Documents.

Section 4.5. Brokers . No agent, broker, investment banker, firm or other Person acting on behalf, or under the authority, of Buyer is or will be entitled to any broker’s or finder’s fee or any other commission or similar fee in connection with any of the transactions contemplated hereby.

ARTICLE V

ADDITIONAL AGREEMENTS

Section 5.1. Confidentiality .

(a) Seller Confidentiality Agreement . Seller shall, and shall cause its Affiliates and its and their respective counsel, accountants, financial advisors, lenders and other agents and representatives (collectively, “ Representatives ”) to: (i) protect Buyer Confidential Information with at least the same degree of care, but no less than reasonable care, with which it protects its own most sensitive confidential information and not disclose or reveal any Buyer Confidential Information to any Person other than to Seller’s or its Affiliates’ respective Representatives, including financial advisors, current and prospective lenders and investors who need to know Buyer Confidential Information in connection with any investigation of Seller or the negotiation, preparation or performance of this Agreement or any Related Document or for the purpose of evaluating the transactions contemplated hereby, except to the extent that disclosure of Buyer Confidential Information has been consented to in writing by Buyer; and (ii) not use Buyer Confidential Information for any purpose other than (A) in connection with the evaluation or consummation of the transactions contemplated by this Agreement; (B) to the extent necessary in connection with any filing requirements under Applicable Law or to obtain any Consents from any Governmental Authority or other Person to the transactions contemplated by this Agreement; (C) to enforce Seller’s rights and remedies under this Agreement; or (D) as required to be disclosed under Applicable Law ( provided, that, prompt notice of such disclosure will be given as far in advance as reasonably possible to Buyer to give Buyer an opportunity to determine whether disclosure is required and to assess the extent of Buyer Confidential Information required to be disclosed). The obligations of Seller under this Section 5.1(a) shall survive the Effective Date.

 

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(b) Buyer Confidentiality Agreement . Buyer shall and shall cause its Affiliates and its and their respective Representatives to: (i) protect the Seller Confidential Information with at least the same degree of care, but no less than reasonable care, with which it protects its own most sensitive confidential information and not disclose or reveal any Seller Confidential Information to any Person other than to Buyer’s or its Affiliates’ respective Representatives, including financial advisors, current and prospective lenders and investors who need to know Seller Confidential Information in connection with the performance of this Agreement or any document to be delivered hereunder or for the purpose of evaluating the transactions contemplated hereby, except to the extent that disclosure of such Seller Confidential Information has been consented to in writing by Seller; and (ii) not use Seller Confidential Information for any purpose other than (A) in connection with the evaluation or consummation of the transactions contemplated by this Agreement; (B) to the extent necessary in connection with any filing requirements under Applicable Law or to obtain any Consents from any Governmental Authority or other Person to the transactions contemplated by this Agreement; (C) to enforce Buyer’s rights and remedies under this Agreement; or (D) as required to be disclosed under Applicable Law ( provided , that prompt notice of such disclosure will be given as far in advance as reasonably possible to Seller to give Seller an opportunity to determine whether disclosure is required and to assess the extent of Seller Confidential Information required to be disclosed). The obligations of Buyer under this Section 5.2(b) shall survive the Effective Date.

(c) Equitable Relief . Each Party acknowledges and agrees that a breach of this Section 5.2 will cause irreparable damage and great loss to the other Party or its Affiliates, the exact amount of which will be difficult to ascertain, and that the remedies at law for any such breach will be inadequate. Accordingly, each Party acknowledges and agrees that in the event of such a breach, the other Party shall be entitled to equitable relief, including injunctive relief, without posting bond or other security and without a showing of the inadequacy of monetary damages as a remedy.

Section 5.2. Certain Tax Matters, Bulk Sales .

(a) Transfer Taxes . All recordation, transfer, documentary, excise, sales, value added, use, stamp, conveyance or other similar Taxes, duties or governmental charges, and all recording or filing fees or similar costs, imposed or levied by reason of, in connection with or attributable to this Agreement and the Related Documents or the transactions contemplated hereby and thereby (collectively, “ Transfer Taxes ”) shall be borne equally by Seller and Buyer; provided, however , that Seller shall be solely responsible for any non-U.S. tax liabilities. In the case of Transfer Taxes for which Buyer is liable to the applicable taxing authority, on the Effective Date Seller shall pay to Buyer 50% of the amount of such Transfer Taxes as reasonably estimated by Buyer, with subsequent additional payments by Seller to Buyer or refunds by Buyer to Seller of amounts previously paid by Seller in the event it is subsequently determined that the amount of the subject Transfer Taxes was more or less than the estimated amounts.

(b) Tax Withholding . Buyer and Seller agree that all payments under this Agreement will be made without any deduction or withholding for or on account of any Taxes or other amounts unless required by Applicable Law. In the event Buyer determines that it is required under Applicable Law to withhold and pay any Tax to any revenue authority in respect of any payments made to Seller, the amount of such Tax shall be deducted by Buyer and paid to the relevant revenue authority, and Buyer shall notify Seller thereof and shall promptly furnish to Seller all copies of any Tax certificate or other documentation evidencing such withholding. Buyer shall not be required to pay any additional amounts to Seller in respect of any amounts paid to any revenue authority pursuant to the immediately preceding sentence. In the event that any withholding Tax

 

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shall subsequently be found to be due, payment of such Tax shall be the responsibility of Seller. The Parties agree to reasonably cooperate with each other, including by completing or filing documents required under the provisions of any applicable income tax treaty or Applicable Law, to claim any applicable exemption from, or reduction of, any such applicable Taxes. [***].

(c) Bulk Sales . Seller and Buyer hereby waive compliance with any Applicable Laws with respect to “bulk sales” (including any requirement to withhold any amount from payment of the Purchase Price or any elements thereof) applicable to the sale to Buyer of the Assets by Seller.

(d) Cooperation and Exchange of Information . Each of Seller and Buyer shall provide the other with such assistance as may reasonably be requested by the other Party in connection with the preparation of any Tax Return.

Section 5.3. Covenant Not to Sue . Seller on behalf of itself, its Affiliates and any successors and assigns of Seller or its Affiliates hereby waives any right, remedy or cause of action against Buyer or its Affiliates or any of their respective licensees, transferees, successors or assigns for infringement or use of any Information and Inventions which employees or agents of Seller or its Affiliates developed, discovered, conceived or reduced to practice related to the Compounds or their use in the Field between March 25, 2010, and the Effective Date, which is not part of the Seller Intellectual Property being conveyed to Buyer hereunder.

Section 5.4. Public Announcements . Other than the press release(s) set forth on Exhibit 5.4 hereto (which shall be released promptly following the execution of this Agreement by both Parties), and a Form 8-K (including copies of the Agreement and the Related Documents as required) to be filed by Buyer with the Securities and Exchange Commission with respect to the transactions contemplated hereby (and following reasonable prior review by Seller), neither Party shall issue or permit any of their respective Affiliates to issue any press release or other public announcement with respect to this Agreement or the transactions contemplated hereby or by the Related Documents without the prior consent of the other Party, which consent shall not be unreasonably withheld, except as may be required by Applicable Laws (in which case the Party required to make the release or statement shall allow the other Party reasonable time to comment on such release or statement in advance of such issuance to the extent permitted by Applicable Laws). Each Party shall give the other Party a reasonable opportunity to review all filings of this Agreement and all filings describing the terms of this Agreement with any Governmental Authority, including without limitation the United States Securities and Exchange Commission, prior to submission of such filings, and shall give due consideration to any reasonable comments by the non-filing Party relating to such filing, including the provisions of this Agreement for which confidential treatment should be sought.

Section 5.5. Checks; Remittances and Refunds . If Seller or its Affiliates receive any payment, refund or other amount that is attributable to or results from an Asset and that is properly due and owing to Buyer in accordance with the terms of this Agreement, Seller shall promptly remit, or cause to be remitted, such amount to Buyer. Seller shall promptly endorse and deliver to Buyer any notes, checks, negotiable instruments, letters of credit or other documents received on account of or attributable to the Assets that are properly due and owing to Buyer in accordance with the terms of this Agreement, and Buyer shall have the right and authority to endorse, without recourse, the name of Seller or any of its Affiliates on any such instrument or document.

 

[***] CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

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Section 5.6. Cooperation in Litigation . Buyer and Seller shall cooperate with each other in the defense or prosecution of any Action instituted prior to the Effective Date or that may be instituted thereafter against or by such Parties relating to or arising out of the activities conducted pursuant to the Assets prior to the Effective Date (other than litigation between Buyer and Seller or their respective Affiliates arising out of the transactions contemplated hereby or by the Related Documents). Subject to Article VII, the Party requesting such cooperation shall pay the reasonable and verifiable out-of-pocket costs and expenses of providing such cooperation (including legal fees and disbursements) incurred by the Party providing such cooperation and by its officers, directors, employees and agents, and any applicable Taxes in connection therewith, but shall not be responsible for reimbursing such Party or its officers, directors, managers, employees or agents for their time spent in such cooperation, provided that , the amount of such time is reasonable and consistent with such individual’s other obligations.

Section 5.7. Cooperation in Patent Transfer and Assignment . Upon the reasonable request of Buyer, and at Buyer’s sole expense, Seller and its patent attorneys and agents will cooperate with Buyer following the Effective Date to prepare any additional documentation required to record and give effect to the assignment of the Seller Intellectual Property in accordance with this Agreement.

Section 5.8. Required Approvals and Consents . As soon as reasonably practicable, but in any event, no later than ten (10) Business Days after the Effective Date, Seller shall make all filings required to be made by Seller in order to consummate the transactions contemplated herein. The Parties shall also cooperate with each other with respect to all filings that Buyer elects to make. Seller shall use its commercially reasonable efforts to obtain all Consents, in accordance with its obligations under Section 2.4, required to effect the assignment of the Assumed Contracts and Permits to Buyer.

Section 5.9. Transfer of Assets . Buyer and Seller shall use their commercially reasonable efforts to transfer all tangible Assets and all tangible embodiments of the Seller Intellectual Property and Books and Records included in the Assets (including all files sent to the Mississauga, Ontario office of Seller’s Affiliate and all digital media provided to Seller under the March 2010 Agreement) as soon as reasonably practicable but in any event within forty-five (45) days of the Effective Date. At Buyer’s reasonable request, Seller shall provide assistance to the employees and contractors of Buyer and its Affiliates as may be reasonably required to ensure an efficient and orderly transfer of such Seller Intellectual Property and Books and Records to Buyer. Promptly following the transfer of all tangible embodiments of the Seller Intellectual Property and Books and Records, Seller shall, and shall cause its Affiliates to, destroy all remaining digital or electronic records containing any Buyer Confidential Information and shall provided a certificate of an officer of Seller to such effect. During such period, Seller will cooperate with Buyer to effect physical transfer of all Non-Clinical and Clinical Material to Buyer, or Buyer’s designee, in compliance with Good Manufacturing Practices.

Section 5.10. Compliance with Laws . Each Party shall perform, and shall ensure that its Affiliates, sublicensees and contractors perform, the activities for which such Party is responsible under this Agreement and all other activities required or permitted under this Agreement in compliance with the Foreign Corrupt Practices Act, and, in all material respects, with all other Applicable Laws and regulations.

Section 5.11. Post-Closing Filings .

 

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(a) As promptly as practicable following the Effective Date, Seller shall submit any required filings with the following Governmental Authorities in order to assign ownership of the Regulatory Documentation relating to CX717 to Buyer:

(i) FDA;

(ii) Medicines & Healthcare products Regulatory Agency in the United Kingdom; and

(iii) Bundesinstitut für Arzneimittel und Medizinprodukte (German Federal Institute for Drugs and Medical Devices).

(b) As promptly as practicable following Closing, Buyer shall submit any required filings with the Medicines & Healthcare products Regulatory Agency in the United Kingdom to withdraw Seller’s right to cross-reference Regulatory Documentation relating to CX1739.

(c) As promptly as practicable following Closing, Seller shall use its commercially reasonable efforts, at Seller’s sole cost and expense, to obtain, prior to the 45 th day following the Effective Date, Consent for the assignment of any of the Assumed Contracts to the extent not obtained prior to the Effective Date. Seller shall provide Buyer with the reasonable opportunity to review and comment on each such Consent prior to the execution thereof and shall take into account any comments received by Buyer and incorporate such comments to the extent practicable.

Section 5.12. Terminations . Upon the Effective Date, (i) the March 2010 Agreement (other than Article VII thereto), (ii) the Seller License Agreement, (iii) the UofC Field-Limited License Agreement (subject to the consent of the University of California to the extent required), and (iv) the pharmacovigilance agreement between Buyer and Seller, dated September 1, 2010, shall terminate.

Section 5.13. Assignments . Upon the Effective Date, the patent rights assigned to the Seller under the UofC Patent Assignment Agreement shall be assigned back to the University of California.

Section 5.14. Further Assurances . Each Party shall, and shall cause its Affiliates to, at any time and from time to time, upon the request of the other Party, and at the requesting Party’s expense, do, execute, acknowledge, deliver and file, or cause to be done, executed, acknowledged, delivered and filed, all such further acts, deeds, transfers, conveyances, assignments or assurances as may be reasonably required for carrying out the purposes of this Agreement and the Related Documents and the consummation of the transactions contemplated hereby and thereby.

ARTICLE VI

CONDITIONS PRECEDENT

Section 6.1. Conditions to Obligations of Buyer and Seller . The obligations of Buyer and Seller to complete the transactions contemplated by this Agreement are subject to the satisfaction at or prior to the Effective Date of the following conditions:

(a) No Adverse Law; No Injunction . No Applicable Law shall have been enacted, entered, promulgated or enforced by any Governmental Authority that prohibits the

 

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consummation of all or any part of the transactions contemplated by this Agreement or the Related Documents, and no Action shall be pending or threatened by any Governmental Authority or other Person seeking any such Order or decree or seeking to recover any damages or obtain other relief as a result of the consummation of such transactions;

(b) Governmental Approvals . All required notifications and filings with any Governmental Authority shall have been made and any waiting periods applicable to the transactions contemplated hereby pursuant to any Applicable Law shall have expired or been terminated.

Section 6.2. Conditions to Obligations of Buyer . The obligation of Buyer to complete the transactions contemplated by this Agreement is subject to the satisfaction or waiver by Buyer at or prior to the Effective Date of the following additional conditions:

(a) Representations and Warranties . The representations and warranties of Seller contained herein that are qualified by materiality or subject to thresholds shall be true and correct in all respects, and the representations and warranties of Seller contained herein that are not so qualified shall be true and correct in all material respects, as of the Effective Date.

(b) Covenants; Material Adverse Effect . Seller shall have performed and complied in all material respects with all covenants, agreements and obligations required to be performed or complied with on or prior to the Effective Date. Since March 25, 2010, there shall have been no Material Adverse Effect.

(c) Material Consents . Buyer shall have received duly executed and delivered copies of all Material Consents and, subject to Section 2.4, all such other Consents or approvals required to vest in Buyer good and marketable title in the Assets, free and clear of any and all Liens (other than Permitted Liens).

(d) Certain Deliveries at Signing . Seller shall have delivered or caused to be delivered to Buyer:

(i) subject to Section 2.4, a Bill of Sale and Assignment and Assumption Agreement, substantially in the form of Exhibit 6.2(d)(i) , as may be reasonably necessary, among other things, to effect the assignment to Buyer of all rights of Seller (and its Affiliates, as applicable) in and to the Assumed Contracts, duly executed by Seller (or its Affiliate, as applicable);

(ii) assignments duly executed by Seller for the registrations and applications included in the Seller Intellectual Property in substantially the form attached hereto as Exhibit 6.2(d)(ii) , which shall be recordable in all jurisdictions in which such registrations have been made or such applications have been filed;

(iii) physical possession of all of the other Assets, together with all such other deeds, endorsements or other instruments as shall be reasonably requested by Buyer to vest in Buyer good and marketable title to all of the Assets, free and clear of all Liens (other than Permitted Liens);

(e) Tax Form . Seller shall have delivered to Buyer a properly completed IRS form W-8BEN duly executed by Seller.

 

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(f) UofC Consent and Termination . The University of California shall have duly executed and delivered the UofC Consent and Termination.

(g) AMPAKINE ® Trademark Registration . Seller shall have cancelled or withdrawn all filed Trademark applications for Seller’s use of the AMPAKINE ® Trademark in the Field in the United States.

(h) UofC Patent Assignment Agreement . Seller shall have assigned the patent rights assigned to it under the UofC Patent Assignment Agreement back to the University of California and the University of California shall have entered into a license agreement with the Seller regarding such rights.

(i) Termination of Security Interest . Buyer shall have received satisfactory evidence that any and all Liens on the Assets (other than Permitted Liens), including without limitation those in favor of Goldman Sachs Lending Partners LLC, as administrative agent and collateral agent, shall have been terminated.

(j) Other Documents . Buyer shall have received such other documents, certificates and instruments as it may reasonably request, and all actions hereunder and all documents and other papers required to be delivered by Seller hereunder or in connection with the consummation of the transactions contemplated hereby, and all other related matters, shall be reasonably acceptable to Buyer in form and substance.

Section 6.3. Conditions to Obligations of Seller . The obligation of Seller to consummate the transactions contemplated by this Agreement is subject to the satisfaction or waiver by Seller at or prior to the Effective Date of the following additional conditions:

(a) Representations and Warranties . The representations and warranties of Buyer contained herein that are qualified by materiality or subject to thresholds shall be true and correct in all respects, and the representations and warranties of Buyer contained herein that are not so qualified shall be true and correct in all material respects, as of the Effective Date.

(b) Covenants . Buyer shall have performed and complied in all material respects with all covenants, agreements and obligations required to be performed or complied with on or prior to the Effective Date.

(c) Certain Deliveries at Signing . Buyer shall have delivered or caused to be delivered to Seller:

(i) payment of the Initial Payment by wire transfer of same day funds directly to the account set forth on Exhibit 6.3(c)(i) ; and

(ii) a Bill of Sale and Assignment and Assumption Agreement, substantially in the form of Exhibit 6.2(d)(i) , duly executed by Buyer, as may be reasonably necessary, among other things, to effect the consummation of the transactions contemplated herein;

(d) Other Documents . Seller shall have received such other documents, certificates and instruments as it may reasonably request, and all actions hereunder and all documents and other papers required to be delivered by Buyer hereunder or in connection with the

 

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consummation of the transactions contemplated hereby, and all other related matters, shall be reasonably acceptable to Seller in form and substance.

ARTICLE VII

INDEMNIFICATION

Section 7.1. Survival; Expiration . Notwithstanding any investigation made by or on behalf of Seller or Buyer prior to, on or after the Effective Date, the representations and warranties contained in this Agreement (including the Schedules and Exhibits hereto) and in any Related Document shall survive the Effective Date and shall terminate on the [***] of the Effective Date, except that the representations and warranties:

(a) set forth in Section 3.1 (Organization, Standing and Power); Section 3.2 (Authority; Binding Agreements); Section 3.3 (Conflicts; Consents); Section 3.4 (Governmental Authorizations); Section 3.6(i) (No New Inventions); Section 3.11 (Brokers); Section 4.1 (Organization, Standing and Power); Section 4.2 (Authority; Binding Agreements); Section 4.3 (Conflicts; Consents) and Section 4.4 (Brokers) shall survive [***]; and

(b) that constitute or are based upon fraud or intentional misrepresentation shall survive [***];

The covenants, agreements and obligations of the Parties shall survive until fully performed and discharged, unless otherwise expressly provided herein. For clarity, the covenant set forth in Section 5.3 shall survive [***]. Each Party shall give prompt written notice to the other Party of (x) any event, circumstance or condition that constitutes a breach of, or makes inaccurate, any representation and warranty of such Party hereunder, or (y) the non-fulfillment of any covenant, agreement or obligation of such Party hereunder.

Section 7.2. Indemnification by Seller . Seller shall indemnify and hold harmless Buyer and its Affiliates, and the directors, officers, managers, employees and Representatives of Buyer and its Affiliates, from and against any and all liabilities, judgments, claims, settlements, losses, damages, fees, Liens, Taxes, penalties, obligations and expenses (including reasonable attorneys’ fees and expenses and costs and expenses of investigation) (collectively, “ Losses ”) incurred or suffered, directly or indirectly, by any such Person arising from, by reason of or in connection with:

(a) any breach or inaccuracy of any representation or warranty of Seller in this Agreement or any Related Document;

(b) any failure by Seller to duly and timely perform or fulfill any of its covenants or agreements required to be performed by Seller under this Agreement, any Related Document or under any other document or instrument delivered by Seller pursuant hereto or;

(c) any liabilities, obligations or commitments of Seller and its Affiliates other than the Assumed Liabilities;

(d) the failure of Seller to comply with any Applicable Laws relating to bulk sales or Tax applicable to the transactions contemplated by this Agreement;

 

[***] CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

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(e) any Transfer Taxes allocated to Seller pursuant to Section 5.2;

(f) any Permitted Lien relating to the Assets

Section 7.3. Indemnification by Buyer . Buyer shall indemnify and hold harmless Seller and its Affiliates, and the directors, officers, employees and Representatives of Seller and its Affiliates, from and against any and all Losses incurred or suffered, directly or indirectly, by any such Person arising from, by reason of or in connection with:

(a) any breach or inaccuracy of any representation or warranty of Buyer in this Agreement or any Related Document;

(b) any failure by Buyer to duly and timely perform or fulfill any of its covenants or agreements required to be performed by Buyer under this Agreement or any Related Document or under any other document or instrument delivered by Buyer pursuant hereto or thereto;

(c) the failure of Buyer to comply with any Applicable Laws relating to bulk sales or Tax applicable to the transactions contemplated by this Agreement;

(d) any Transfer Taxes allocated to Buyer pursuant to Section 5.2; and

(e) any Assumed Liability.

Section 7.4. Calculation of Losses; Mitigation of Damages .

(a) The amount of any Losses for which indemnification is provided under this Article VII shall be net of any amounts actually recovered by the Indemnified Party under insurance policies or otherwise with respect to such Losses (net of any Tax or expenses incurred in connection with such recovery). For purposes of clarification, nothing set forth in this provision shall require the Buyer to seek recovery under its insurance policies with respect to such Losses.

(b) Any indemnity payment hereunder shall be treated as an adjustment to the Purchase Price to the extent permitted by Applicable Law. Where the receipt of any such payment is treated for Tax purposes in a manner other than as an adjustment to the Purchase Price, the amount of the payment shall be adjusted to take account of any net Tax cost actually incurred, or benefit actually enjoyed, by the Indemnified Party in respect thereof.

(c) Each Party shall take and shall cause its Affiliates to take all reasonable steps to mitigate any Losses upon becoming aware of any event which would reasonably be expected to, or does, give rise thereto.

(d) Notwithstanding anything to the contrary elsewhere in this Agreement, no Party shall, in any event, be liable to any other Person for any consequential, incidental, indirect, special or punitive damages of such other Person, including loss of revenue, income or profits, loss of business reputation or opportunity relating to the breach or alleged breach hereof.

Section 7.5. Certain Procedures for Indemnification .

(a) If any Person entitled to indemnification under this Agreement (an “ Indemnified Party ”) asserts a claim for indemnification, or receives notice of the assertion of any

 

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claim or of the commencement of any Action by any Person not a party to this Agreement against such Indemnified Party, for which a Party is required to provide indemnification under this Article VII (an “ Indemnifying Party ”), the Indemnified Party shall promptly notify the Indemnifying Party in writing of the claim or the commencement of that Action; provided, however , that the failure to so notify the Indemnifying Party shall not relieve the Indemnifying Party from any liability that it may have to the Indemnified Party, except to the extent that such failure prejudices the Indemnifying Party’s ability to defend such Action.

(b) With respect to third party claims for which indemnification is claimed hereunder (each, an “ Indemnification Claim ”), (i) the Indemnifying Party shall be entitled to participate in the defense of any such Indemnification Claim, and (ii) if, in the reasonable opinion of counsel to the Indemnified Party, such Indemnification Claim can properly be resolved by money damages alone and the Indemnifying Party has the financial resources to pay such damages and commits to diligently and vigorously conduct such defense, then the Indemnifying Party shall be entitled (A) to direct the defense of any Indemnification Claim at its sole cost and expense, but such defense shall be conducted by legal counsel reasonably satisfactory to the Indemnified Party, and (B) to settle and compromise any such Indemnification Claim or Action for money damages alone; provided, however , that if the Indemnified Party has elected to be represented by separate counsel pursuant to the proviso below, or if such settlement or compromise does not include an unconditional release of the Indemnified Party for any liability arising out of such Indemnification Claim or Action, such settlement or compromise shall be effected only with the written consent of the Indemnified Party, which consent will not be unreasonably withheld. Notwithstanding the foregoing, if a settlement or compromise offer solely for money damages is made by the applicable third party claimant, and the Indemnifying Party notifies the Indemnified Party in writing of the Indemnifying Party’s willingness to accept the offer and, subject to the applicable limitations of Sections 7.6, pay the amount called for by such offer, and the Indemnified Party declines to accept such offer, the Indemnified Party may continue to contest such Indemnification Claim, free of any participation by the Indemnifying Party, and the amount of any ultimate liability with respect to such Indemnification Claim that the Indemnifying Party has an obligation to pay hereunder shall be limited to the lesser of (A) the amount of the settlement or compromise offer that the Indemnified Party declined to accept plus the Losses of the Indemnified Party relating to such Indemnification Claim through the date of its rejection of the settlement offer or (B) the aggregate Losses of the Indemnified Party with respect to such Indemnification Claim. After notice from the Indemnifying Party to the Indemnified Party of its election to assume the defense of such claim or Action, the Indemnifying Party shall not be liable to the Indemnified Party under this Section 7.5 for any legal or other expenses subsequently incurred by the Indemnified Party in connection with the defense thereof; provided, however , that if, in the reasonable opinion of counsel to the Indemnified Party, an actual or potential conflict of interest exists between the Indemnifying Party and the Indemnified Party that would make such separate representation advisable, then the Indemnified Party shall have the right to employ counsel to represent it and in that event the reasonable fees and expenses of such separate counsel shall be paid by the Indemnifying Party; provided further , that in no event shall the Indemnifying Party be responsible for the fees of more than one law firm for all Indemnified Parties in connection with any Indemnification Claim. The Indemnified Party and the Indemnifying Party shall each render to each other such assistance as may reasonably be requested in order to ensure the proper and adequate defense of any such Action.

(c) In the event that Seller owes any amounts to Buyer with respect to Seller’s indemnification obligations set forth in this Article VII, then without limiting any other rights or

 

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remedies of Buyer hereunder, and subject to the Cap, the Buyer shall be entitled to offset any unpaid and indemnifiable Losses against any Milestone Payments remaining due to the Seller hereunder.

Section 7.6. Certain Limitations on Indemnification .

(a) Notwithstanding the provisions of this Article VII, no Party shall have any indemnification obligations for Losses under Sections 7.2(a) or 7.3(a) unless the aggregate amount of all such Losses exceeds $[***] (the “ Basket ”), in which case Seller or Buyer, as applicable, shall be liable for all Losses arising from such Indemnification Claim (subject to the Cap, as defined below). In no event shall the aggregate indemnification to be paid by Seller, on the one hand, or Buyer, on the other hand, for any indemnification obligations for Losses under Sections 7.2(a) or 7.3(a) exceed $[***] (the “ Cap ”).

(b) If the Indemnifying Party makes any payment on any Indemnification Claim, the Indemnifying Party shall be subrogated, to the extent of such payment, to all rights and remedies of the Indemnified Party to any insurance benefits or other claims of the Indemnified Party with respect to such Indemnification Claim. For purposes of clarification, nothing set forth in this provision shall require the Indemnifying Party to seek recovery under its insurance policies with respect to such Indemnification Claim.

Section 7.7. Exclusive Remedy . The sole and exclusive remedy for any breach or failure to be true and correct, or alleged breach or failure to be true and correct, of any representation or warranty or any covenant or agreement in this Agreement or the Related Documents, shall be indemnification in accordance with this Article VII. In furtherance of the foregoing, each of the Parties hereby waives, to the fullest extent permitted by Applicable Law, any and all other rights, claims and causes of action (including rights of contributions, if any) known or unknown, foreseen or unforeseen, which exist or may arise in the future, that it may have against the other Party, arising under or based upon any Applicable Law (including any such law relating to environmental matters or arising under or based upon common law or otherwise). Notwithstanding the foregoing, this Section 7.7 shall not operate to limit the rights of the Parties to seek equitable remedies (including specific performance or injunctive relief) or limit the rights of the Parties to pursue claims based upon fraud.

ARTICLE VIII

MISCELLANEOUS

Section 8.1. Governing Law . Construction and interpretation of this Agreement shall be governed by the laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive Applicable Law of another jurisdiction.

Section 8.2. Notices . All notices, requests, demands and other communications that are required or may be given pursuant to the terms of this Agreement shall be in written form, and shall be deemed delivered (a) on the date of delivery when delivered by hand on a Business Day, (b) on the Business Day designated for delivery if sent by reputable overnight courier maintaining records of receipt and (c) on the date of transmission when sent by facsimile, electronic mail or other electronic transmission during normal business hours on a Business Day, with confirmation of transmission by

 

[***] CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

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the transmitting equipment; provided, however , that any such communication delivered by facsimile or other electronic transmission shall only be effective if within two Business Days of such transmission such communication is also delivered by hand or deposited with a reputable overnight courier maintaining records of receipt for delivery on the Business Day immediately succeeding such day of deposit. All such communications shall be addressed to the Parties at the address set forth as follows, or at such other address as a Party may designate upon ten (10) days’ prior written notice to the other Party.

If to Buyer, to:

Cortex Pharmaceuticals, Inc.

15241 Barranca Parkway

Irvine, California 92618

Attention: Chief Executive Officer

Facsimile: (949) 727-3657

with a copy (which shall not constitute notice) to:

Stradling Yocca Carlson & Rauth

660 Newport Center Drive, Suite 1600

Newport Beach, California 92660

Attention: Lawrence B. Cohn

Facsimile: (949) 725-4100

If to Seller to:

Biovail Laboratories International SRL

Welches, Christ Church

Barbados, West Indies BB17154

Attention: Chief Operating Officer

Facsimile: (246) 420-1532

with a copy (which shall not constitute notice) to:

Biovail Corporation

7150 Mississauga Road

Mississauga, ON L5N 8M5

Attention: Legal Department

Facsimile: (905) 286-3370

Section 8.3. Benefits of Agreement . All of the terms and provisions of this Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. Except for the provisions of Article VII, this Agreement is for the sole benefit of the Parties hereto and not for the benefit of any third party.

Section 8.4. Amendments and Waivers . No modification, amendment or waiver of any provision of, or consent or approval required by, this Agreement, nor any consent to or approval of any departure herefrom, shall be effective unless it is in writing and signed by the Party against whom

 

31


enforcement of any such modification, amendment, waiver, consent or approval is sought. Such modification, amendment, waiver, consent or approval shall be effective only in the specific instance and for the purpose for which given. Neither the failure of either Party to enforce, nor the delay of either Party in enforcing, any condition or part of this Agreement at any time shall be construed as a waiver of that condition or part or forfeit any rights to future enforcement thereof. No action taken pursuant to this Agreement, including any investigation by or on behalf of either Party hereto, shall be deemed to constitute a waiver by the Party taking action of compliance by the other Party with any representation, warranty, covenant, agreement or obligation contained herein.

Section 8.5. Cumulative Rights . Except as expressly provided herein, the various rights under this Agreement shall be construed as cumulative, and no one of them is exclusive of any other or exclusive of any rights allowed by Applicable Law.

Section 8.6. Expenses . Except as otherwise specified herein, each Party shall bear any costs and expenses with respect to the transactions contemplated herein incurred by it.

Section 8.7. Arbitration .

(a) Except as otherwise expressly provided in this Agreement, any disputes, claims or controversies arising between the Parties relating to, arising out of or in any way connected with this Agreement or any term or condition hereof, or the performance by either Party of its obligations hereunder, shall be promptly presented to the Chief Executive Officers of Buyer and Seller (or alternative officers designated by Buyer or Seller) for resolution and if such officers cannot promptly resolve such disputes, claims or controversies then such dispute, claim or controversy shall be finally resolved by binding arbitration. Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. The Party giving such notice shall refrain from instituting the arbitration proceedings for a period of sixty (60) days following such notice.

(b) Any arbitration hereunder shall be conducted before the American Arbitration Association, or its successor. The arbitration shall be conducted before a single arbitrator and shall be conducted in accordance with the rules and regulations promulgated by the American Arbitration Association unless specifically modified herein. The arbitration shall be located in New York, New York. The arbitrator shall have the authority to grant specific performance, and to allocate between the Parties the costs of arbitration in such equitable manner as he or she determines.

(c) The parties covenant and agree that the arbitration shall commence within ninety (90) days of the date on which a written demand for arbitration is filed by either Party. In connection with the arbitration proceeding, the arbitrator shall have the power to order the production of documents by each Party and any third-party witnesses. In addition, each Party may take up to three (3) depositions as of right, and the arbitrator may in his or her discretion allow additional depositions upon good cause shown by the moving party. However, the arbitrator shall not have the power to order the answering of interrogatories or the response to requests for admission. In connection with any arbitration, each Party shall provide to the other, no later than seven (7) Business Days before the date of the arbitration, the identity of all persons that may testify at the arbitration and a copy of all documents that may be introduced at the arbitration or considered or used by a Party’s witnesses or experts. The arbitrator’s decision and award shall be made and delivered within thirty (30) days of the closing of the arbitration hearing. The arbitrator’s decision shall set forth a reasoned basis for any award of damages or finding of liability.

 

32


(d) The Parties covenant and agree that they will participate in the arbitration in good faith. Any Party unsuccessfully refusing to comply with an order of the arbitrator shall be liable for costs and expenses, including attorneys’ fees, incurred by the other Party in enforcing the award. Notwithstanding anything to the contrary contained in this Agreement, this Section 8.7 shall not apply to any request by any Party to this Agreement for temporary, preliminary or permanent injunctive relief or other forms of equitable relief.

(e) Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be.

Section 8.8. Assignment . This Agreement and the rights and obligations hereunder shall not be assignable or transferable by either Party hereto without the prior written consent of the other Party hereto, which consent will not be unreasonably withheld; provided, however , that, upon prior written notice to the other Party, either Party may assign, sublicense, subcontract or delegate this Agreement and any or all of its rights and obligations under this Agreement (i) to any of its Affiliates, (ii) in connection with a merger, consolidation, sale of substantially all of such Party’s assets, or sale or transfer of the business to which this Agreement relates, or (iii) otherwise by operation of Applicable Law without the prior written consent of the other Party. Any attempted assignment, sublicense, subcontract or delegation in violation of this Section 8.8 shall be null and void.

Section 8.9. Enforceability; Severability . Without limitation to Section 5.3, (a) if any covenant or provision hereof is determined to be void or unenforceable in whole or in part, it shall not be deemed to affect or impair the validity of any other covenant or provision hereof if the rights and obligations of a Party hereto will not be materially and adversely affected, each of which is hereby declared to be separate and distinct, (b) if any provision of this Agreement is so broad as to be unenforceable, such provision shall be interpreted to be only so broad as is enforceable, and (c) if any provision of this Agreement is declared invalid or unenforceable for any reason other than overbreadth, the Parties hereto agree to modify the offending provision so as to maintain the essential benefits of the bargain (including the rights and obligations hereunder) between the Parties to the maximum extent possible, consistent with Applicable Law and public policy.

Section 8.10. Entire Agreement . This Agreement, together with the Schedules and Exhibits expressly contemplated hereby and attached hereto, the Related Documents and the other agreements, certificates and documents delivered in connection herewith or otherwise in connection with the transactions contemplated hereby and thereby, contain the entire agreement among the Parties with respect to the transactions contemplated by this Agreement and supersede all prior agreements or understandings among the Parties with respect to the subject matter hereof.

Section 8.11. Counterparts . This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.

[Signature Page Follows]

 

33


IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day and year first above written.

 

B IOVAIL L ABORATORIES I NTERNATIONAL SRL
By:    
  Name:
  Title:
C ORTEX P HARMACEUTICALS , I NC .
By:    
  Name:
  Title:


EXHIBIT 1.1(A) – NON-CLINICAL AND CLINICAL MATERIAL

[***]

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.


EXHIBIT 1.1(B) – ASSUMED CONTRACTS

[***]

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.


EXHIBIT 1.1(C) – CERTAIN COMPOUND DEFINITIONS

[***] ” means [***]

CX717 ” means [***]

CX1739 ” means [***]

CX1763 ” means [***]

CX1942 ” means [***]

 

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.


EXHIBIT 1.1(D) – PERMITTED LIENS

None.


EXHIBIT 5.4 – PUBLIC ANNOUNCEMENTS

See attached.


EXHIBIT 6.2(D)(I) – FORM OF BILL OF SALE AND

ASSIGNMENT AND ASSUMPTION AGREEMENT

See attached.


EXHIBIT 6.2(D)(II) – FORMS OF ASSIGNMENTS

See attached.


EXHIBIT 6.3(C)(I) – SELLER’S WIRE TRANSFER INSTRUCTIONS

[***]

 

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

42


SCHEDULE 3.3 – CONFLICTS; CONSENTS

[***]

At Closing, Seller will be (i) terminating the UofC Field-Limited License Agreement and (ii) assigning back to the University of California the patent rights assigned to the Seller under the UofC Patent Assignment Agreement.

 

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.


SCHEDULE 3.4 – GOVERNMENTAL AUTHORIZATIONS

Post-Closing filings by Seller with the following Governmental Authorities in order to assign to Buyer ownership of the Regulatory Documentation relating to CX717: [***].

Post-Closing filings by Buyer with [***] to withdraw Seller’s right to cross-reference Regulatory Documentation relating to CX1739.

Termination by Seller of UofC Field-Limited Agreement.

Assignment by Seller to University of California of the patent rights assigned to the Seller under the UofC Patent Assignment Agreement.

See Schedule 3.3 for those agreements with universities, which require the consent of the applicable university for the assignment of such agreement to Buyer.

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.


SCHEDULE 3.5 – CHANGES

At Closing, Seller to terminate UofC Field-Limited Agreement.

At Closing, Seller to assign to University of California the patent rights assigned to the Seller under the UofC Patent Assignment Agreement.

Security interest granted over Seller Patents (as defined in the March 2010 Agreement) in favour of Goldman Sachs Lending Partners LLC (as collateral agent) pursuant to the Credit and Guaranty Agreement dated as of September 27, 2010 to which Seller is a party, which Credit and Guaranty Agreement was terminated and the security interest released prior to Closing.


SCHEDULE 3.6(B) – INTELLECTUAL PROPERTY – COMMUNICATIONS WITH

GOVERNMENTAL AUTHORITY

 

(i) Filings and Correspondence

[***]

 

(ii) Assignment Recordals

[***]

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.


SCHEDULE 3.6(E) – INTELLECTUAL PROPERTY – LICENSES/LIENS

License granted to UofC by Seller under the UofC Field-Limited Agreement – to be terminated at Closing.

At Closing, Seller to assign to University of California the patent rights assigned to the Seller under the UofC Patent Assignment Agreement.

Security interest granted over Seller Patents (as defined in the March 2010 Agreement) in favour of Goldman Sachs Lending Partners LLC (as collateral agent) pursuant to the Credit and Guaranty Agreement dated as of September 27, 2010 to which Seller is a party, which Credit and Guaranty Agreement was terminated and the security interest released prior to Closing.


SCHEDULE 3.12 – CONFIDENTIAL INFORMATION

Buyer Confidential Information may have been disclosed by Seller under confidentiality agreements (“CDAs”) with the following third parties:

[***}

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.


LOGO

P RESS R ELEASE

 

Company Contact:

  Investor Contact:

Mark A. Varney, Ph.D.

  Erika Moran/ Dian Griesel, Ph.D.

President and CEO

  Media Contact:

Cortex Pharmaceuticals, Inc.

  Janet Vasquez

949.727.3157

  The Investor Relations Group
  212.825.3210

C ORTEX R EACQUIRES A LL A MPAKINE ® C OMPOUNDS , R ELATED

P ATENTS AND E XCLUSIVE G LOBAL R IGHTS FOR R ESPIRATORY

D EPRESSION F ROM B IOVAIL

— The transaction results in a return of all previously transferred assets and rights to Cortex —

IRVINE, CA (March 16, 2011) — Cortex Pharmaceuticals, Inc. (OTCBB (CORX.OB)) announced that it has entered into an agreement with Biovail Laboratories International SRL (“Biovail”), a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc. (“Valeant”), to regain the A MPAKINE ® assets and rights related to respiratory depression.

Under the new agreement, Cortex will make an upfront payment to Biovail of $200,000, and potential future payments of up to $15.15 million based on the achievement of certain development and NDA submission and approval milestones. Biovail is also eligible to receive additional payments based on Cortex’s net sales of an intravenous dosage form of the compounds for respiratory depression up to a maximum of $15 million. In addition, at any time following completion of Phase I clinical studies and prior to the end of Phase IIa clinical studies, Biovail retains an option to co-develop and co-market intravenous dosage forms of an A MPAKINE compound as a treatment for respiratory depression.

Biovail previously purchased these rights and compounds from Cortex in March 2010. Following its merger in September 2010, Valeant and Biovail conducted a strategic and financial review of the product development pipeline. As a result of that review, the decision was made that Biovail would exit this program and discussions were entered into between Biovail and Cortex.

“We are pleased that both companies were able to reach an agreement for the return of all A MPAKINE assets and intellectual property sold early last year to Biovail,” commented Mark A. Varney, Ph.D., President and CEO of Cortex.

The assets repurchased by Cortex include the Phase II A MPAKINE , CX717; the rights to an injectable form of CX1739 and all dosage forms of CX1942, the first water soluble intravenous


pro-drug for an A MPAKINE compound; along with the exclusive global patent rights for the use of A MPAKINE compounds for the treatment of respiratory depression. Under the original agreement with Biovail, Cortex had retained rights to all non-intravenous dosage forms of CX1739 and to the use of A MPAKINE compounds as a treatment for sleep apnea.

Cortex earlier performed two phase IIa studies in Germany to obtain clinical “proof-of-concept” for the prevention of opiate-induced respiratory depression in humans. In these double-blind, placebo-controlled, crossover studies, baseline breathing rates were significantly depressed by the potent opiate, alfentanil. A single oral dose of CX717 prevented alfentanil-induced respiratory depression without interfering with the analgesic effects of the opiate. The opiate antagonist, naloxone, also reversed alfentanil-induced respiratory depression, as expected, but it reversed the pain-relieving properties of the opiate as well. The differentiating effect of the A MPAKINE technology is the ability to prevent respiratory depression, while maintaining the opiate’s analgesic effect.

Cortex Pharmaceuticals, Inc.

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for treating psychiatric disorders, neurological diseases and sleep apnea. Cortex is pioneering a class of proprietary pharmaceuticals called A MPAKINE ® compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain’s neurotransmitter system. These imbalances may be improved by using the A MPAKINE technology. For additional information regarding Cortex, please visit the Company’s website at

Forward-Looking Statement

Note — This press release contains forward-looking statements concerning the Company’s research and development activities. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. The success of such activities depends on a number of factors, including the risks that the Company’s proposed products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that patents may not issue from the Company’s patent applications; that competitors may challenge or design around the Company’s patents or develop competing technologies; that the Company may have insufficient resources to undertake proposed clinical studies and that preclinical or clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly preclinical and clinical testing and regulatory approval. A MPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this press release. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

M ORE INFORMATION AT WWW . CORTEXPHARM . COM

# # # # #


BILL OF SALE AND

ASSIGNMENT AND ASSUMPTION AGREEMENT

This BILL OF SALE AND ASSIGNMENT AND ASSUMPTION AGREEMENT (this “ Assignment Agreement” ) is made as of this             day of                     , 2011, by and between Cortex Pharmaceuticals, Inc., a Delaware corporation (“ Buyer ”) and Biovail Laboratories International SRL, an international society with restricted liability organized under the laws of Barbados (“ Seller ”). Each of Seller and Buyer are sometimes referred to herein, individually, as a (“ Party ”) and, collectively, as the “ Parties ”.

WHEREAS , Seller and Buyer have entered into that certain Asset Purchase Agreement, dated as of                     , 2011 (the “Purchase Agreement”); and

WHEREAS , pursuant to the Purchase Agreement, Seller has agreed to sell the Assets and transfer the Assumed Liabilities to Buyer, and Buyer has agreed to purchase the Assets and assume the Assumed Liabilities from Seller.

NOW THEREFORE , in consideration of the mutual covenants and agreements set forth in this Assignment Agreement, and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties agree as follows:

1.     Definitions. Unless otherwise defined herein, all capitalized terms used in this Assignment Agreement shall have the meanings set forth in the Purchase Agreement.

2.     Conveyance and Acceptance. In accordance with the provisions of the Purchase Agreement, Seller hereby sells, assigns, transfers, sets over, conveys and delivers to Buyer the entire right, title and interest of Seller and each of its respective Affiliates in, to and under each of the Assets, and Buyer hereby purchases the Assets and accepts such assignment, transfer, set over, conveyance and delivery, in each case free and clear of all Liens other than the Permitted Liens.

3.     Assumption of Assumed Liabilities . Seller hereby assigns, delegates and transfers to Buyer the Assumed Liabilities, and Buyer hereby assumes, accepts and agrees to pay, perform and discharge when due, the Assumed Liabilities.

4.     Purchase Agreement Controls . Notwithstanding any other provisions of this Assignment Agreement to the contrary, nothing contained herein shall in any way supersede, modify, replace, amend, change, rescind, waive, exceed, expand, enlarge or in any way affect the provisions, including warranties, covenants, agreements, conditions, representations or, in general any of rights and remedies, and any of the obligations of Buyer or Seller set forth in the Purchase Agreement. This Assignment Agreement is subject to and governed entirely in accordance with the terms and conditions of the Purchase Agreement.


5.     Further Acts . Seller agrees, at Buyer’s expense, to take further action and to execute such additional documents as Buyer may reasonably request to carry out and fulfill the purposes and intent of this Assignment Agreement.

6.     Miscellaneous .

 

  a. This Assignment Agreement shall be binding upon and inure to the benefit of the Parties, and their respective successors and assigns.

 

  b. This Assignment Agreement (including any claim or controversy arising out of or relating to this Assignment Agreement) shall be governed by the law of the State of New York without regard to conflict of law principles that would result in the application of any Law other than the law of the State of New York.

 

  c. This Assignment Agreement may be amended or modified only by a written instrument executed by both Parties.

 

  d. If any term, provision, covenant or restriction of this Assignment Agreement is held by a court of competent jurisdiction or other authority to be invalid, void, unenforceable or against its regulatory policy, in whole or in part, such determination shall not affect or impair the validity or enforceability of any other provision, covenant, or restriction, each of which is hereby declared to be separate and distinct, or of the remainder of this Assignment Agreement.

 

  e. This Assignment Agreement may be executed manually or by facsimile by the Parties, in any number of counterparts, each of which shall be considered one and the same agreement and shall become effective when a counterpart hereof shall have been signed by each Party and delivered to the other Party. Delivery of an executed counterpart or a signature page of this Assignment Agreement or any amendment hereto by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart hereof.

[SIGNATURE PAGE FOLLOWS]


IN WITNESS WHEREOF , the Parties hereto have caused this Assignment Agreement to be executed by their respective officers thereunto duly authorized as of the date first above written.

 

CORTEX PHARMACEUTICALS, INC.

By:

 

 

Name:

 

Title:

 

BIOVAIL LABORATORIES INTERNATIONAL SRL

By:

 

 

Name:

 

Title:

 

[SIGNATURE PAGE TO ASSIGNMENT AGREEMENT]


ASSIGNMENT

WHEREAS, BIOVAIL LABORATORIES INTERNATIONAL SRL , hereinafter referred to as the Assignor, whose full post office address is: Welches, Christ Church, Barbados, BB17154, West Indies possesses the full right, title and interest for an invention entitled:

[                                                                                                                 ]

hereinafter referred to as the “Invention”, as fully set forth and described in the patents and patent applications, hereinafter referred to as the “Applications”, identified in “Schedule A” attached hereto and any subsequent patent applications claiming priority thereto.

AND WHEREAS, CORTEX PHARMACEUTICALS, INC. , hereinafter referred to as the Assignee, whose full post office address is: 15241 Barranca Parkway, Irvine, California, USA, 92618 , desires to acquire the entire right, title and interest in and to the aforementioned Invention.

NOW THEREFORE, in consideration of the sum of One Dollar ($1.00) and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Assignor hereby confirms that it has sold, assigned, transferred and conveyed, and for greater certainty does hereby sell, assign, transfer and convey to the Assignee its successors, assigns, nominees or other legal representatives, the entire right, title and interest in the United States (US) and all other foreign countries throughout the world in and to the Invention, including any tangible materials embodied in or encompassed by the Invention and any trade secrets pertaining to the Invention, and any improvements thereon, together with its entire right title and interest in and to the Applications and any and all Letters Patent that may issue for the Invention, including any and all divisions, reissues, continuations, continuations-in-part, renewals, substitutes and extensions of the Applications, to the full end of the term for which each said Letters Patent may be granted, and including any right to claim priority based on the Applications, the same to be held and enjoyed as fully and completely as the same would have been held and enjoyed by the Assignor had this Assignment not been made. The aforesaid assignment includes the right in and to all income, royalties, damages and payments now or hereafter due or payable with respect to any Letters Patent which is or may be granted, and in and to all causes of action (either in law or in equity), and the right to sue, counterclaim, and recover for past, present and future infringement of the rights assigned or to be assigned under this Assignment.

AND the Assignor hereby authorizes and requests the appropriate governmental officials to issue any and all such US or foreign Letters Patent under said Invention, or resulting from any of said applications thereof, to the Assignee, as the assignee of the entire right, title and interest in and to the same.

AND the Assignor hereby represents, warrants and covenants that it has the full right to convey the entire interest herein assigned, that it has not executed and will not execute any instrument or assignment in conflict herewith, and that the rights assigned herein are not otherwise encumbered by any grant, license or right.

AND the Assignor, on behalf of itself and its executors and administrators, does hereby covenant and agree to do all such lawful acts and things and to execute without further consideration such further lawful assignments, documents, assurances, applications and other instruments as may reasonably be required or deemed necessary by the Assignee, its successors, assigns, nominees or

 

Page 1 of 4


other legal representatives, to secure to and obtain the Invention and related rights, including any and all Letters Patent for the Invention, and vest the same in said Assignee, its successors, assigns, nominees or other legal representatives.

AND the Assignee does hereby confirm and accept this assignment.

 

Page 2 of 4


IN WITNESS WHEREOF the parties hereto have caused this Assignment to be executed by their duly authorized officers the day and year first here written.

DATED at                          this          day of                      , 20      .

 

Executed on behalf of
Biovail Laboratories International SRL
By:    

Name:

 

Capacity:

 

On this          day of                      , 20      , personally appeared before me the above named:                                          being the                                          , to me personally known, and known by me to be the same person described in and who executed the foregoing instrument, and acknowledged that they executed same, and were entitled to do so on this very day, in a right and binding matter, as their free act and deed and for the purposes set forth, on the day and year aforesaid.

 

         
Name:

A Notary Public in and for                                            

 

 

DATED at                      this          day of                      , 20      .

 

Executed on behalf of
Cortex Pharmaceuticals, Inc.
By:    

Name:

 

Capacity:

 

On this          day of                      , 20      , personally appeared before me the above named:                                          being the                                          , to me personally known, and known by me to be the same person described in and who executed the foregoing instrument, and acknowledged that he/she executed same, as his/her free act and deed and for the purposes set forth, on the day and year aforesaid.

 

         
Name:

A Notary Public in and for                                            

 

 

Page 3 of 4


SCHEDULE “A”

TO ASSIGNMENT DATED

__________, 2011

 

Page 4 of 4

EXHIBIT 31.1

Certification of Chief Executive Officer Pursuant to

Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934

I, Mark A. Varney, Ph.D., certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Cortex Pharmaceuticals, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and


5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 23, 2011       / S /    M ARK A. V ARNEY        
      Mark A. Varney, Ph.D.
      President and Chief Executive Officer

EXHIBIT 31.2

Certification of Chief Financial Officer Pursuant to

Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934

I, Maria S. Messinger, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Cortex Pharmaceuticals, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and


  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 23, 2011       / S /    M ARIA S. M ESSINGER        
      Maria S. Messinger
      Vice President, Chief Financial Officer and Secretary

EXHIBIT 32

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Rule 13a-14(b)/15d-14(b)

of the Securities Exchange Act of 1934

and 18 U.S.C. Section 1350

Mark A. Varney, Ph.D., President and Chief Executive Officer of Cortex Pharmaceuticals, Inc. (the “Company”), and Maria S. Messinger, Chief Financial Officer of the Company, each certifies, pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that:

 

(1) the Quarterly Report on Form 10-Q of the Company for the quarterly period ended March 31, 2011 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 780(d)); and

 

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Dated: May 23, 2011       / S /    M ARK A. V ARNEY        
      Mark A. Varney, Ph.D.
      President and Chief Executive Officer
Dated: May 23, 2011       / S /    M ARIA S. M ESSINGER        
      Maria S. Messinger
      Vice President, Chief Financial Officer and Secretary

This certification accompanies the Quarterly Report pursuant to Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350 and shall not be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934.