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): June 10, 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) |
Registrants 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) | Patent Assignment and Option and Amended and Restated Agreement with Les Laboratoires Servier |
As previously reported, in October 2000 Cortex Pharmaceuticals, Inc., a Delaware corporation (the Company), entered into a licensing agreement (the Prior Agreement) with Adir et Compagnie (which entity subsequently merged with its parent, Les Laboratoires Servier and is referred to herein as Servier), under which the Company granted certain license rights to Servier. On June 10, 2011, the Company and Servier entered into a Patent Assignment and Option and Amended and Restated Agreement (the Amended and Restated Agreement) in order to, among other things, provide Servier with an exclusive option (the Option) to purchase the Companys remaining rights to the jointly discovered high impact AMPAKINE® compound, CX1632 (S47445).
Pursuant to the terms of the Amended and Restated Agreement, Servier may, at its discretion, exercise the Option at any time after June 10, 2011 and prior to October 31, 2011 (the Option Period). During the Option Period, the Company and Servier remain joint owners of the patents and patent applications relating to CX1632. The Company currently has rights to develop and market CX1632 in all of North America and selected South American countries as well as Australia and New Zealand. Upon exercise of the Option, (i) the Company will execute a patent assignment, (ii) Servier will acquire sole ownership of the global patent rights to CX1632, along with a sub-license of the Companys rights to all indications licensed from the University of California for use with CX1632, and (iii) the Company will not be entitled to any royalties or further payments from Serviers development and commercialization of CX1632. In the event that Servier does not exercise the Option during the Option Period, certain license rights granted to Servier by the Company, as well as specific rights licensed from the University of California, will automatically terminate. As part of the Amended and Restated Agreement, the Company agreed to waive its rights to any causes of action against Servier for infringement of any patent rights claiming the composition of matter of CX1632 (to the extent of the composition of matter of CX1632 only) that it may have in connection with the development, manufacture, use, commercialization, distribution and sale of any composition for administration to humans containing CX1632 as a pharmaceutically active ingredient.
The Amended and Restated Agreement includes an immediate upfront non-refundable payment by Servier of $1,000,000 for the Option. The Company is also eligible to receive an additional $2,000,000 if Servier exercises the Option to acquire sole ownership of the patent rights to CX1632 prior to the expiration of the Option Period. In the event that Servier exercises the Option, it is also required to pay certain royalties and milestone payments to the University of California (either directly or indirectly through the Company per the terms of the Amended and Restated Agreement).
Effective June 10, 2011, the Prior Agreement was terminated (with the exception of certain provisions which by their terms survive termination) by the terms of the Amended and Restated Agreement.
On June 13, 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.
The foregoing summary of the Amended and Restated Agreement is qualified in its entirety by reference to such Agreement, a copy of which will be filed as an exhibit to the Companys Form 10-Q for the quarterly period ended June 30, 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 Amended and Restated Agreement. The omitted material will be included in the request for confidential treatment.
(b) | Agreement with the Regents of the University of California |
In connection with the Amended and Restated Agreement, on June 10, 2011 the Company entered into an Agreement with the Regents of the University of California (the Related Agreement) in order to, among other things, (i) set forth the Universitys consent to the Companys sublicense to Servier of certain rights under the Option, (ii) establish the consideration due to the University for such consent, (iii) and clarify the Universitys entitlement to all royalties and milestone payments made by Servier under the Amended and Restated Agreement and the Companys obligation to guarantee such payments.
2
The foregoing description of the Related Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Companys Form 10-Q for the quarterly period ended June 30, 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 Related Agreement. The omitted material will be included in the request for confidential treatment.
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 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit No. |
Description | |
99.1 | Press Release dated June 13, 2011. |
3
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: June 14, 2011 | By: | /s/ Maria S. Messinger | ||||
Maria S. Messinger, Vice President and Chief Financial Officer |
S-1
EXHIBIT INDEX
Exhibit No. |
Description | |
99.1 | Press Release dated June 13, 2011. |
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 ENTERS INTO NEW AGREEMENT WITH SERVIER
CORTEX TO RECEIVE UP TO $3 MILLION
IF SERVIER OPTION IS EXERCISED
IRVINE, CA (June 13, 2011) Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) entered into a new agreement with Servier to sell its remaining rights to the jointly discovered high impact AMPAKINE® compound, CX1632 (S47445). Servier, Frances largest privately held pharmaceutical company, has provided an immediate, non-refundable payment of $1,000,000 to Cortex for the option to expand its rights. If Servier exercises the option to acquire sole ownership of the patent rights to CX1632 prior to October 31, 2011, it will pay Cortex an additional $2,000,000, as well as certain royalties and milestone payments to the University of California.
During the option period, Cortex and Servier remain joint owners of the patents and patent applications relating to CX1632.Cortex currently has rights to develop and market CX1632 in all of North America and selected South American countries as well as Australia and New Zealand.
On or before October 31, 2011, Servier may exercise its option to acquire sole ownership of the global patent rights to CX1632, along with a sub-license of Cortexs rights to all indications licensed from the University of California for use with CX1632. Cortex will not be entitled to any royalties or further payments from Serviers development and commercialization of CX1632. Cortex retains all rights for the remaining AMPAKINE technology on a worldwide basis.
We are delighted that Servier has chosen to continue to invest in the AMPAKINE program, said Mark Varney, Ph.D., Cortexs President and CEO. The high-impact AMPAKINE technology, which includes CX1632, may represent a disease-modifying approach to treating memory and cognitive impairments in patients with Alzheimers disease and other disorders, given the demonstrated ability of the compounds to stimulate protective growth factors within the brain. Cortex is continuing to investigate both its low-impact and high-impact AMPAKINE compounds for indications in the psychiatric and neurological space.
We are very pleased to enter into such a new agreement with Cortex. We are committed to find innovative treatments for patients suffering from Alzheimers disease, and AMPA modulation is a promising way to improve cognitive disorders in such patients, said Emmanuel Canet, MD, Head of Servier R&D.
About Servier
Servier is the leading independent French pharmaceutical company, established in 1954 by its founder, Jacques Servier, M.D., Pharm.D. The group is established in 140 countries and 88% of Servier products are prescribed outside of France. Sales turnover in 2010 reached 3.7 billion euros. More than 25% of Serviers turnover is invested in Research and Development. Servier therapeutic research fields are cardiovascular diseases, diabetes, neuropsychiatric disorders, cancer, and osteoarticular diseases. More information is available at: http://www.servier.com/
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 Alzheimers disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brains neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Additionally, recent studies have shown that the AMPAKINE compounds also impact areas in the brain stem that control breathing. Recent work has focused on the potential treatment of sleep apnea disorders which can have a deleterious impact on numerous disease states including congestive heart failure. Also, respiratory depression caused by opioid analgesics, anesthetic agents and benzodiazepines can be reduced by AMPAKINE compounds. For additional information regarding Cortex, please visit the Companys website at http://www.cortexpharm.com
Forward-Looking Statement
Note This press release contains forward-looking statements concerning the Companys 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 Companys current beliefs and expectations. The success of such activities depends on a number of factors, including the risks that the Companys 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 Companys patent applications; that competitors may challenge or design around the Companys 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 Companys Securities and Exchange Commission filings, the Companys 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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