Exhibit 10.21
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION (THE "SEC") PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT WITH RESPECT TO THE OMITTED PORTIONS.
OMITTED PORTIONS ARE INDICATED BY [***]
A COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
Between
PharmAthene, Inc.
175 Admiral Cochrane Dr., Suite 400, Annapolis, MD 21401
(Cooperator)
and
U. S. Army Medical Research
Institute of Infectious Diseases
Fort Derrick, Maryland 21702-5011
(Laboratory)
Article 1. Background
1.00 This Agreement is entered into under the authority of the Federal Technology Transfer Act of 1986,15 U.S.C. 3710a, et seq., between the Cooperator and the Laboratory, the parties to this Agreement.
1.01 Laboratory, on behalf of the U.S. Government, and Cooperator desire to cooperate in research and development on Evaluation of Valortim(TM), an Anti-toxin Monoclonal Antibody, in the African green monkey model for Inhalational Anthrax according to the attached Scope of Work (SOW) described in Appendix A.
1.02 Cooperator has entered into a Collaboration Agreement dated November 29, 2004 (the "Collaboration Agreement") with Medarex, Inc. ("Medarex") regarding the research and development of fully human antibodies with respect to the anthrax protective factor antigen (the "Collaboration").
1.03 Valortim (the "Compound") is one of the compounds that is being developed through the Collaboration and is subject to the terms of the Collaboration Agreement.
1.04 On behalf of Cooperator and pursuant to the terms of a Cooperative Research and Development Agreement for Material Transfer dated August 29th, 2006 (the "CRADA-M"), between Laboratory and Medarex, Medarex is providing Laboratory with [***] mg of the Compound.
NOW, THEREFORE, the parties agree as follows:
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Article 2. Definitions
2.00 The following terms are defined for this Agreement as follows:
2.01 "Agreement" means this cooperative research and development agreement.
2.02 "Invention" and "Made" have the meanings set forth in Title 15 U.S.C. Section 3703(9) and (10).
2.03 "Proprietary Information" means information marked with a proprietary legend which embodies trade secrets developed at private expense or which is confidential business or financial information, provided that such information:
(i) is not generally known, or which becomes generally known or available during the period of this Agreement from other sources without obligations concerning their confidentiality;
(ii) has not been made available by the owners to others without obligation concerning its confidentiality; and
(iii) is not already available to the receiving party without obligation concerning its confidentiality.
(iv) is not independently developed by or on behalf of the receiving party, without reliance on the information received hereunder.
2.04 "Subject Data" means all recorded information first produced in the performance of this Agreement.
2.05 "Subject Invention" means any Invention Made as a consequence of, or in relation to, the performance of work under this Agreement.
Article 3. Research Scope and Administration
3.00 Scope of Work. Research performed under this Agreement shall be performed solely in accordance with the SOW incorporated as a part of this Agreement at Appendix A. It is agreed that any descriptions, statements, or specifications in the SOW shall be interpreted as goals and objectives of the services to be provided under this Agreement and not requirements or warranties. Laboratory and Cooperator will endeavor to achieve the goals and objectives of such services; however, each party acknowledges that such goals and objectives, or any anticipated schedule of performance, may not be achieved.
3.01 Review of Work. Periodic conferences shall be held between the parties for the purpose of reviewing the progress of work. It is understood that the nature of this research is such that completion within the period of performance specified, or within the limits of financial support allocated, cannot be guaranteed. Accordingly, all research will be performed in good faith.
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3.02 Principal Investigator. Any work required by the Laboratory under the SOW will be performed under the supervision of Elizabeth Leffel, PhD, M.P.H., elizabeth.leffel@us.army.mil, phone (301) 619-4459, fax (301)619-4625, who, as co-principal investigator has responsibility for the scientific and technical conduct of this project on behalf of the Laboratory. Any work required by the Cooperator under the SOW will be performed under the supervision of Valerie Riddle, MD, FACP, Vice President and Medical Director, PharmAthene, Inc., 175 Admiral Cochrane Dr., Suite 400, Annapolis, MD 21401,410-571-8923 (voice),410-571-8927 (fax), riddlev@pharmamene.com, who, as co-principal investigator has responsibility for the scientific and technical conduct of this project on behalf of the Cooperator.
3.03 Scope Change. If at any time the co-principal investigators determine that the research data dictates a substantial change in the direction of the work, the parties shall make a good faith effort to agree on any necessary change to the SOW and make the change by written notice to the addresses listed in section 13.04 Notices.
3.04 Final Report. The parties shall prepare a final report of the results of this project within six months after completing the SOW.
Article 4. Ownership and Use of Physical Property
4.01 Ownership of Materials or Equipment. All materials or equipment developed or acquired under this Agreement by the parties shall be the property of the party which developed or acquired the property, except that government equipment provided by Laboratory (1) which through mixed funding or mixed development must be integrated into a larger system, or (2) which through normal use at the termination of the Agreement has a salvage value that is less than the return shipping costs, shall become the property of Cooperator.
4.02 Use of Provided Materials. Both parties agree that any materials relating to them which were provided by one party to the other party will be used for research purposes only. The materials shall not be sold, offered for sale, used for commercial purposes, or be furnished to any other party without advance written approval from the Provider's official signing this Agreement or from another official to whom the authority has been delegated, and any use or furnishing of material shall be subject to the restrictions and obligations imposed by this Agreement.
Article 5. Financial Obligation
5.00 Advance Payment. The performance of research by Laboratory under this Agreement is conditioned on the advance payment by Cooperator of Laboratory's agreed upon costs for the performance of such research.
5.01 Deposit Account. Cooperator shall pay $[***] to Laboratory for the performance of the research specified by Article 3.00. $[***] of such funds shall be deposited in [Department of the Army, Special Collaborative Agreement Account No. __________________] upon execution of this agreement. The check should be made payable to:
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U.S. Treasury and sent to:
Ms. Elizabeth Dorsey
USAMRIID, Budget Office
1425 Porter Street
Fort Detrick, MD 21702-5011
Phone: 301-619-2148 Fax: 301-619-4619
Laboratory shall not be obligated to perform any of the research specified herein, or to take any other action required by this Agreement, if the agreed to funds are not deposited as required by this Article.
5.02 Insufficient and Excess Funds. Laboratory shall not be required to continue its research and development activities under this Agreement if the funds provided by Cooperator are insufficient to cover Laboratory's agreed upon costs for such continued activities. Funds not expended by Laboratory shall be returned to Cooperator upon Laboratory's submission of a final fiscal report to Cooperator.
5.03 Accounting Records. Laboratory shall maintain separate and distinct current accounts, records, and other evidence supporting all its expenditures under this Agreement. Laboratory shall provide Cooperator a semi-annual report accounting for the use of Cooperator's funds and a final fiscal report within four months after completing the SOW or ending its research activities under this Agreement. The accounts and records of Laboratory shall be available for reasonable inspection and copying by Cooperator and its authorized representative.
Article 6. Patent Rights
6.00 Reporting. The parties shall promptly report to each other all Subject Inventions reported to either party by its employees. All Subject Inventions Made during the performance of this Agreement shall be listed in the Final Report required by this Agr ...
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