8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 15, 2011

CORTEX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	1-16467	33-0303583
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

15241 Barranca Parkway, Irvine, California	92618
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code:(949) 727-3157

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01 Entry into a Material Definitive Agreement.

(a) Asset Purchase from Biovail Laboratories International SRL

As previously reported on a Current Report on Form 8-K, in March 2010 Cortex Pharmaceuticals, Inc., a Delaware corporation (the “Company”), entered into an asset purchase agreement (the “2010 Agreement”) with Biovail Laboratories International SRL, an international society with restricted liability organized under the laws of Barbados (“Biovail”). Pursuant to the 2010 Agreement, Biovail acquired the Company’s interests in certain pharmaceutical compounds and related intellectual property (the “Asset Sale”) for use in the field of respiratory depression or vaso-occlusive crises associated with sickle cell disease (the “Field”). The assets acquired by Biovail in the Asset Sale included: (i) the Phase II compound CX717, the preclinical compounds CX1763 and CX1942, and the injectable dosage form of CX1739 (collectively, the “primary AMPAKINE® compounds”), (ii) certain other AMPAKINE® compounds, specifically, the molecules disclosed in, claimed in or otherwise covered by the patent families acquired pursuant to the 2010 Agreement (other than the primary AMPAKINE® compounds), which are being or may be developed, among other things, for use in the Field, and (iii) certain method of use patents and related assets (the “Acquired Assets”). In connection with the Asset Sale, Biovail agreed to assume certain liabilities and obligations of the Company related to the Acquired Assets. Pursuant to the terms of the 2010 Agreement, Biovail paid the Company the lump sum of $9,000,000 upon the execution of the Agreement, and an additional $1,000,000 upon the Company’s completion of the specified transfer plan in September 2010. In addition, the 2010 Agreement provided that the Company would have 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 Acquired Assets.

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 the Company in March 2010. Following that announcement, the Company immediately entered into discussions with Biovail regarding the future of the respiratory depression project.

On March 15, 2011, the Company entered into a new asset purchase agreement with Biovail (the “2011 Agreement”) to reacquire the Acquired Assets that Biovail acquired from the Company in March 2010. In connection with the transactions contemplated by the 2011 Agreement, the Company agreed to assume certain liabilities and obligations of Biovail related to the Acquired Assets. The 2011 Agreement includes an upfront payment by the Company of $200,000 and potential future payments to Biovail 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.

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 AMPAKINE 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.

Effective March 15, 2011, the 2010 Agreement was terminated (with the exception of certain indemnification obligations) by the terms of the 2011 Agreement. Following the execution of the 2011 Agreement, Biovail was renamed “Valeant International (Barbados) SRL.”

On March 16, 2011, the Company issued a press release describing this transaction. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K.

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The foregoing summary of the 2011 Agreement is qualified in its entirety by reference to such Agreement, a copy of which will be filed as an exhibit to the Company’s Form 10-Q for the quarterly period ended March 31, 2011. The Company intends to submit a FOIA confidential treatment request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the 2011 Agreement. The omitted material will be included in the request for confidential treatment.

(b) Amendment to License Agreement with the Regents of the University of California

On March 15, 2011, the Company entered into a Fifth Amendment (the “Amendment”) to License Agreement between Cortex and the Regents of the University of California (the “License Agreement”) in order to, among other things, clarify the current scope of patent coverage of the License Agreement following the consummation of the transactions contemplated by the 2011 Agreement described above as well as to extend the required date for filing regulatory approval of an AMPAKINE compound covered by the License Agreement to October 11, 2015.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which is attached hereto as Exhibit 10.121 and is incorporated herein by reference. The Amendment is not intended as a document for investors and the public to obtain factual information about the current state of affairs of the Company. Rather, investors and the public should look to other disclosures contained in the Company’s reports filed with the Securities and Exchange Commission pursuant to the Securities Exchange Act of 1934, as amended.

Item 1.02 Termination of a Material Definitive Agreement.

See the disclosure set forth in Item 1.01(a), which is incorporated by reference into this Item 1.02.

Item 2.01 Completion of Acquisition or Disposition of Assets.

See the disclosure set forth in Item 1.01(a), which is incorporated by reference into this Item 2.01.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
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.
99.1	Press Release dated March 16, 2011.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Current Report to be signed on its behalf by the undersigned, hereunto duly authorized.

	CORTEX PHARMACEUTICALS, INC.
Dated: March 21, 2011	By:	/s/ Maria S. Messinger
		Maria S. Messinger, Vice President and Chief Financial Officer

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EXHIBIT INDEX

Exhibit No.	Description
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.
99.1	Press Release dated March 16, 2011.

EX-10.121

Exhibit 10.121

EXECUTION COPY

FIFTH AMENDMENT TO LICENSE AGREEMENT 1993-04-0412

BETWEEN

CORTEX PHARMACEUTICALS

AND

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

This Fifth Amendment (“Fifth Amendment”) to License Agreement Control No. 1993-04-0412 (“License Agreement”) between Cortex Pharmaceuticals, Inc. (“CORTEX”) and The Regents of the University of California (“THE REGENTS”) is effective as of the 15th day of March 2011.

WHEREAS, CORTEX and THE REGENTS entered into the License Agreement effective as of June 25, 1993, covering certain inventions developed by THE REGENTS as identified therein;

WHEREAS, pursuant to a Fourth Amendment dated as of August 24, 2010, THE REGENTS and CORTEX agreed, among other things, to (i) remove certain UC Case Nos. from the License Agreement, and (ii) remove certain indications related to respiratory depression and vaso-occlusive crises associated with sickle cell disease from CORTEX’s exclusive field of use;

WHEREAS, CORTEX and THE REGENTS now desire to reverse certain changes made by such Fourth Amendment:

NOW THEREFORE, CORTEX and THE REGENTS agree as follows:

1. Section 1.1 of the License Agreement shall be revised as follows:

ADD:

UC Case No.	Issued US Patent No.
2000-006-1	6110935
2000-006-2	6313115
2000-006-5	6730677

2. Section 2.3 of the License Agreement is amended to read in full as follows:

“2.3 Except as otherwise provided herein, the license granted in Section 2.1 shall be exclusive for the life of this Agreement.”

In light of the foregoing change to Section 2.3, the parties agree that the consent of CORTEX to permit THE REGENTS to grant to Biovail Laboratories International SRL a non-exclusive license to certain patent rights under UC Case No. 1991-207 for certain indications related to respiratory depression and vaso-occlusive crises associated with sickle cell disease, as set forth in the Agreement between CORTEX and THE REGENTS dated March 23, 2010, is terminated.

3. Section 7.4(c) of the License Agreement shall be amended to read as follows:

“by October 11, 2015, file a New Drug Application (NDA) in the U.S., or its equivalent in a foreign country, for a Licensed Product;”

4. All other terms of the License Agreement, as amended, remain unchanged.

IN WITNESS WHEREOF, the parties hereto have executed this Fifth Amendment.

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA		CORTEX PHARMACEUTICALS
By:	/s/ Ronnie Hanecak	By:	/s/ Mark A. Varney
Name:	Ronnie Hanecak	Name:	Mark A. Varney
Title:	Assistant Vice Chancellor	Title:	President & CEO
Date:	March 15, 2011	Date:	March 15, 2011

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EX-99.1

Exhibit 99.1

Press Release

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

Cortex Reacquires All Ampakine® Compounds, Related Patents and Exclusive Global Rights for

Respiratory Depression From Biovail

– 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 AMPAKINE® 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 AMPAKINE 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 AMPAKINE 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 AMPAKINE, CX717; the rights to an injectable form of CX1739 and all dosage forms of CX1942, the first water soluble intravenous pro-drug for an AMPAKINE compound; along with the exclusive global patent rights for the use of AMPAKINE 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 AMPAKINE 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 AMPAKINE 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 AMPAKINE® 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 AMPAKINE 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. AMPAKINE 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.

More information at www.cortexpharm.com

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