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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: CONRAD, Eastern Virginia Medical School | Biosyn, Inc. You are currently viewing:
This License Agreement involves

CONRAD, Eastern Virginia Medical School | Biosyn, Inc.

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Title: LICENSE AGREEMENT
Governing Law: Virginia     Date: 4/2/2007
Industry: Biotechnology and Drugs    

LICENSE AGREEMENT, Parties: conrad  eastern virginia medical school , biosyn  inc.
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EXHIBIT 10.36

 

LICENSE AGREEMENT

between

CONRAD, Eastern Virginia Medical School

and

Biosyn, Inc., a subsidiary of Cellegy Pharmaceuticals, Inc.

 

THIS AGREEMENT (this “Agreement”), effective as of the 30th day of January, 2006 by and between Biosyn, Inc. (“Biosyn”), a corporation organized and existing under the laws of the Commonwealth of Pennsylvania and a wholly owned subsidiary of Cellegy Pharmaceuticals, Inc. (“Cellegy”), and having its principal place of business at1800 Byberry Road, Building 13, Huntingdon Valley, PA 19006, and CONRAD, Eastern Virginia Medical School, (“CONRAD”), organized and existing under the laws of the State of Virginia and having its principal place of business at the address set forth in Section 10.1.

 

WITNESSETH:

 

WHEREAS, Biosyn owns or controls certain United States patents and patent applications and corresponding foreign patents and patent applications and related technology relating to compounds and formulations having microbicidal properties for treating or preventing the contraction of sexually transmitted diseases and/or inactivating pathogenic microbes;

 

WHEREAS, Biosyn wishes to grant to CONRAD a non-exclusive license to its Technology related to such compounds and formulations (as specifically defined herein) in the Developing Countries to make, have made, use, research, develop, market and sell, but only for the Public Sector; and

 

WHEREAS, CONRAD wishes to conduct research and development activities with regard to Biosyn’s Technology and to make, have made, use, research, develop, market and sell, in and for the benefit of the Developing Countries and for the Public Sector, products that incorporate the Technology and to share the results of such research and development activities with Biosyn.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements of the parties contained herein, and intending to be legally bound, the parties agree as follows:

 

1.

Definitions

 

“C31G” means compounds, compositions and processes covered under the C31G Patents in Schedule II, along with associated trademarks and know-how, sometimes referred to as Savvy, and for use in the prevention of transmission of sexually transmitted diseases including HIV and for contraception.

 

“C31G Permitted Field of Use” means for the prevention of infection by HIV and other sexually transmitted pathogens and for contraception, by topical, but not systemic, administration.


 

“CV-N License” means the Patent License Agreements between Biosyn and the National Institutes of Health (“NIH”) by the Public Health Service (“PHS”) dated February 27, 2003 and February 28, 2003, a copy of which is appended hereto as Schedule V.

 

“CV-N Permitted Field of Use” means compositions, devices and methods for the prevention of infection by HIV and other sexually transmitted pathogens, by topical, but not systemic, administration, utilizing cyanovirin-N, anti-HIV mutants of cyanovirin-N, including glycosylation-resistant mutants of cyanovirin-N, and anti-HIV fragments of both, including conjugated forms of cyanovirin-N, mutants of cyanovirin-N, and anti-HIV fragments of both, to increase the in vivo half-life, but excluding pegylated cyanovirin-N, pegylated mutants of cyanovirin-N, and pegylated anti-HIV fragments of both. For the avoidance of doubt, such compositions shall include sustained release formulations; devices shall include all drug delivery systems, including but not limited to condoms, sponges, vaginal rings, suppositories, IUDs and other solid matrices; and topical administration shall include administration to mucosal membranes, including vaginal, anal and oral membranes.

 

“Cyanovirin-N” or “CV-N” means a naturally occurring protein originally isolated from the cyanobacterium Nostoc ellipsosporum .

 

“Developing Countries” means countries eligible for support from the Global Alliance for Vaccine Initiatives (GAVI) or successor organization, or which at the effective date of this Agreement are those countries with a Gross National Product of less than US $1,000 per capita per year, and at the effective date of this Agreement include those listed in Schedule I.

 

“Patents” means any and all patent applications (including provisional patent applications) and any and all patents issuing therefrom together with any foreign equivalents, patents of addition, divisions, continuations, continuations-in-part, substitutions, extensions or renewals therefore or re-issues, registrations and re-validations, international applications under the Patent Cooperation Treaty, and including supplementary protection certificates or other governmental-granted exclusivity in the nature of a patent.

 

“Products” means any product or product candidate that incorporates or is covered by the Technology.

 

“Public Sector” means the U.S. government and/or the government of a Developing Country, or any nonprofit entity empowered by the U.S. government and/or the government of a Developing Country to act for said government in matters applicable to this Agreement, organizations within the United Nations system including the World Health Organization and UNICEF, and other nonprofit organizations when they purchase drugs or vaccines for delivery, manufacture and/or sale in the U.S. and Developing Countries.

 

“Technology” means any technology, compounds, formulations, pharmaceutical compositions and methods and processes covered by a Valid Claim in Patents covering C31G, CV-N, or UC-781, including those patents and patent applications listed on Schedule II , Schedule III , and Schedule IV , respectively, a product incorporating C31G, CV-N, or UC-781 or the use or manufacture thereof, and/or other proprietary technology and know-how (including manufacturing process technology) related to C31G, CV-N, or UC-781 or any such Patents.


 

“UC-781” is a non-nucleoside reverse transcriptase inhibitor of the HIV-1 reverse transcriptase enzyme.

 

“UC-781 License” means the License Agreement between Biosyn, Inc., and Uniroyal Chemical Company, Inc., dated May 22, 2001, a copy of which is appended hereto as Schedule VI.

 

“UC-781 Permitted Field of Use” means use as a human topical microbicide, alone or in combination with other compounds, for application to the skin, mucosal and/or epithelial tissue as an active ingredient in formulations such as creams, foams, jellies, or other similar formulations, including contraceptive and other vaginal delivery devices such as sponges, intrauterine devices, diaphragms and condoms; but Permitted Field of Use does not include, and specifically excludes:

 

(a)   non-human uses;

 

(b)   human application for both systemic therapeutic uses and systemic post-exposure prophylactic uses; and

 

(c)   uses when applied to or incorporated into any surface (except for human surfaces consisting of skin, mucosal and/or epithelial tissue) or device (except contraceptive and other vaginal delivery devices as provided for above in this definition) including, but not limited to, gloves, aprons, tubing and filters.

 

“Valid Claim” means a claim of any issued, unexpired Patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, from which no further appeal can be taken or with respect to which an appeal is not taken within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

 

2.

License Grant

 

2.1   Biosyn hereby grants to CONRAD a non-exclusive license in the Developing Countries under the Technology to make, have made, use, conduct research, import, export, offer for sale, sell and have sold Products, solely for the Public Sector in the Developing Countries, and with respect to the Technology related to UC-781, only in the UC-781 Permitted Field of Use, with respect to the Technology related to CV-N, only in the CV-N Permitted Field of Use and with respect to the Technology related to C31G, only in the C31G Permitted Field of Use. CONRAD shall also have the right to make, have made and conduct research on Products anywhere in the world provided that CONRAD may only offer for sale, sell, and have sold such Products solely for the Public Sector in the Developing Countries. CONRAD shall have the right to grant sublicenses only with Biosyn’s written approval, which approval shall not be unreasonably withheld; except that CONRAD may, without Biosyn’s written approval, grant sublicenses to affiliated entities for the sole purpose of executing CONRAD’s charitable mission; provided, however, that any sublicense shall include all applicable restrictions and limitations of this Agreement.


 

2.2   Biosyn shall provide CONRAD access to its Investigational New Drug Applications for C31G and UC-781 and to such other data relating to C31G, UC-781 and CV-N in Biosyn’s possession as CONRAD shall reasonably request from time to time in order to facilitate research and development activities conducted by CONRAD. Any data or other information provided to CONRAD under this Agreement shall be subject to Section 8 and CONRAD shall only use the same for the sole purpose of conducting research and developing Products in the respective Permitted Fields of Use and for the purpose of providing the Products to the Public Sector in the Developing World (collectively, the “Purpose”). Disclosure of such data and other information can only be made to those representatives and agents who need to know in order to perform activities directed at the Purpose and to regulatory authorities for the purpose of seeking approval of such Products for the Purpose.

 

2.3   Notwithstanding the provisions of this Agreement to the contrary, to the extent that the rights held by Biosyn to the Technology are subject to or limited by (i) rights held by the Public Health Service, the National Institutes of Health and the U.S. Government under the CV-N License, (ii) rights held by Uniroyal Chemical Company, Inc. under the UC-781 License, (iii) rights held by a government agency, (iv) rights of Philanthropic Ventures Holding Corporation (“PVHC”) granted or to be granted under the Letter of Reaffirmation, dated October 7, 2004, between Cellegy and PVHC, (v) rights granted or to be granted to the International Partnership for Microbicides under the Sponsored Development and Collaboration Agreement, dated as of January 1, 2003, or (vi) the rights of third party philanthropic organizations such as The Global Microbicide Project (“GMP”), the World Health Organization, USAID and the International Partnership for Microbicides, the parties understand and agree that rights to such intellectual property licensed to CONRAD hereunder are subject to such limitations.

 

2.4   As consideration for the licenses and rights granted to CONRAD under this Agreement, CONRAD shall pay a license grant fee of one hundred dollars ($100.00). CONRAD shall pay the license grant fee within thirty (30) days from the date of execution of this Agreement by both Parties.

 

3.

Term and Termination

 

3.1   This Agreement shall commence effective as of the date first above set forth and, unless earlier terminated pursuant to the terms of this Agreement, shall remain in effect until the expiration of the last-to-expire Valid Claim of Patents included in the Technology.

 

3.2   CONRAD may terminate this Agreement at any time and for any reason or no reason upon sixty (60) days prior written notice. This Agreement may be terminated prior to expiration of the term hereof by either party in the event of any material breach of this Agreement by the other party that shall go uncorrected for a period of sixty (60) days after notice of such breach, setting forth the details thereof with reasonable particularity, has been given to the other party. In the event of any termination under this Section 3.2, the License shall immediately and automatically revert back to Biosyn.


 

4.

Representations, Warranties and Covenants

 

4.1   Biosyn represents and warrants to CONRAD that (a) Biosyn is a wholly owned subsidiary of Cellegy Pharmaceuticals, Inc., has been duly incorporated and is a validly subsisting under the laws of the Commonwealth of Pennsylvania; (b) Biosyn has taken all actions necessary to authorize it to enter into and perform its obligations under this Agreement and to consummate the transactions contemplated hereby; and (c) this Agreement is a legal, valid and binding obligation of Biosyn, enforceable in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to creditors’ rights and to general equitable principles.

 

4.2   CONRAD represents and warrants to Biosyn that (a) CONRAD has all requisite power and authority to enter into and perform all of its obligations under this Agreement and to carry out the transactions contemplated hereby in accordance with the terms and conditions set forth herein; and (b) this Agreement is a legal valid and binding obligation of CONRAD, enforceable in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to creditors’ rights and to general equitable principles.

 

4.3   CONRAD covenants as follows:

 

(a)   CONRAD shall use commercially reasonable efforts to conduct research and/or development activities on Products.

 

(b)   CONRAD shall own all results and data CONRAD creates, develops or collects in its research and development activities related to Products. CONRAD hereby grants to Biosyn an option to purchase some or all such results and data as Biosyn elects, on terms that are no less favorable to Biosyn than commercially reasonable terms for such results and data, and shall negotiate in good faith the terms of such purchase with Biosyn, its parent corporation, successor or permitted assignee, with such terms taking into consideration, among other factors, all of the benefits and burdens of CONRAD hereunder and relating to the results or data sought to be acquired and amounts expended by Biosyn before and after the date of this Agreement related to research and development activities concerning the Technology to which the results or data relate. In all events, the amount payable by Biosyn (or its parent, successor or permitted assignee) shall not exceed the amount of funds expended after the date of this Agreement by CONRAD (excluding overhead) that are directly related to the study or trial producing the results and data that Biosyn desires to acquire; and the foregoing is intended to represent a maximum limit on payment rather than an indicia of a commercially reasonable amount. Except for sale to Biosyn as provided above, CONRAD shall not sell, license or otherwise provide such results or data to a third party for use other than in the Public Sector in Developing Countries.

 

(c)   CONRAD hereby grants to Biosyn an option to purchase all such results and data and will discuss the terms of such purchase with Biosyn, its parent corporation, successor or permitted assignee in good faith, taking into consideration all of the benefits and burdens hereunder.


 

(d)   CONRAD shall keep Biosyn informed of (i) its research and/or development activities, (ii) efforts to obtain regulatory approvals with respect to any Products it develops and the status of such efforts, and (iii) plans and achievements relating to the sale or distribution of any such Products throughout the Developing Countries. The parties shall meet at times and places mutually agreeable or shall participate in telephone conferences from time to time to enable CONRAD to report to Biosyn on the foregoing matters. Such reporting, whether by telephone or in meetings, shall take place not less frequently than semiannually.

 

5.

Limitation of Liability

 

5.1   Biosyn makes no representations or warr


 
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