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.
000 Xxxxxxx Xxxxxxxx Xx., Xxxxx 000, Xxxxxxxxx, XX 00000
(Cooperator)
and
U. S. Army Medical Research
Institute of Infectious Diseases
Xxxx Xxxxxxx, Xxxxxxxx 00000-0000
(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 Xxxxxxxxx Xxxxxx, PhD, M.P.H.,
xxxxxxxxx.xxxxxx@xx.xxxx.xxx, phone (000) 000-0000, fax (000)000-0000, 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 Xxxxxxx
Xxxxxx, MD, FACP, Vice President and Medical Director, PharmAthene, Inc., 000
Xxxxxxx Xxxxxxxx Xx., Xxxxx 000, Xxxxxxxxx, XX 21401,000-000-0000
(voice),000-000-0000 (fax), xxxxxxx@xxxxxxxxxx.xxx, 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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Confidential Treatment filed separately with the SEC.
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U.S. Treasury and sent to:
Xx. Xxxxxxxxx Xxxxxx
USAMRIID, Budget Xxxxxx
0000 Xxxxxx Xxxxxx
Xxxx Xxxxxxx, XX 00000-0000
Phone: 000-000-0000 Fax: 000-000-0000
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 Agreement.
6.01 Cooperator Employee Inventions. Laboratory waives any ownership
rights the U.S. Government may have in Subject Inventions Made by Cooperator
employees and agrees that Cooperator shall have the option to retain title in
Subject Inventions Made by Cooperator employees. Cooperator shall notify
Laboratory promptly upon making this election and agrees to timely file patent
applications on Cooperator's Subject Invention at its own expense.
6.02 Laboratory Employee Inventions. Laboratory shall have the initial
option to retain title to, and file patent application on, each Subject
Invention Made by its employees ("Laboratory Inventions"). The Laboratory agrees
to grant an exclusive license to any invention arising under this Agreement to
which it has ownership to the Cooperator in accordance with Title 15 U.S. Code
Section 3710a, on terms negotiated in good faith. Any invention arising under
this Agreement is subject to the retention by the U.S. Government of
nonexclusive, nontransferable, irrevocable, paid- up license to practice, or
have practiced, the invention throughout the world by or on behalf of the U.S.
Government. At the written request of Cooperator, Laboratory will grant to
Cooperator a non exclusive, fully paid-up, royalty-free, worldwide license, with
the right to sublicense, to use and practice such Laboratory Invention under
Laboratory's rights in such Laboratory Invention and any and all patent
applications, patents and other rights claiming or covering such Laboratory
Invention.
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6.03 Joint Inventions. Any Subject Invention patentable under U.S. patent
law which is Made jointly by Laboratory employees and Cooperator employees under
the Scope of Work of this Agreement shall be jointly owned by the parties. The
parties shall discuss together a filing strategy and filing expenses related to
the filing of the patent covering the Subject Invention. If a party decides not
to retain its ownership rights to a jointly owned Subject Invention, it shall
offer to assign such rights to the other party, pursuant to Paragraph 6.05,
below.
6.04 Government Contractor Inventions. Laboratory represents that as of
the date of this Agreement the only investigators for the Research Project shall
be Laboratory's employees. Laboratory shall notify Cooperator, in advance, if
Laboratory intends to use its contractors to perform services on the Research
Project either (i) as investigators, or (ii) in any other capacity under which
such contractors will conduct any substantive research, analysis, or evaluation
of the Materials (collectively, "Key Personnel"). If any of Laboratory's
contractors are to be Key Personnel for the Research Project, Laboratory shall
suspend work on the Research Project until Cooperator provides its prior written
consent to the use of the contractor as a Key Personnel. If Cooperator does not
provide its written consent thereto, Laboratory shall cease all work on the
Research Project and shall be entitled to terminate this Agreement immediately.
Cooperator, nevertheless, acknowledges that Laboratory will use contractors to
perform work on the Research Project other than as Key Personnel. In accordance
with 37 Code of Federal Regulations 401.14, if one of Laboratory's contractors
conceives of an invention while performing services at Laboratory's facilities
to fulfill Laboratory's obligations under this Agreement, Laboratory may require
the contractor to negotiate a separate agreement with Cooperator regarding
allocation of rights to any Subject Invention the contractor makes, solely or
jointly, under this Agreement.
6.05 Filing of Patent Applications. The party having the right to retain
title to, and file patent applications on, a specific Subject Invention may
elect not to file patent applications, provided it so advises the other party
within 90 days from the date it reports the Subject Invention to the other
party. Thereafter, the other party may elect to file patent applications on the
Subject Invention and the party initially reporting the Subject Invention agrees
to assign its ownership interest in the Subject Invention to the other party
subject to the retention by the party assigning ownership of a nonexclusive,
irrevocable, paid-up license to practice, or have practiced, the Subject
Invention throughout the world.
6.06 Patent Expenses. The expenses attendant to the filing of patent
applications shall be borne by the party filing the patent application. Each
party shall provide the other party with copies of the patent applications it
files on any Subject Invention, along with the power to inspect and make copies
of all documents retained in the official patent application files by the
applicable patent office. The parties agree to reasonably cooperate with each
other in the preparation and filing of patent applications resulting from this
Agreement.
6.07 Exception for Certain Subject Inventions. The parties hereto
acknowledge and agree that the terms of Section 2 of that certain CRADA-M
between Laboratory and Medarex, Inc., dated as of August 29th, 2006, pursuant to
which Medarex will provide Laboratory with certain materials and information for
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the performance of work hereunder, will supersede any conflicting term set forth
in this Article 6 with respect to any inventions or discoveries made as a result
of Laboratory's use of such materials or information in the performance of work
hereunder.
Article 7. Exclusive License
7.00 Grant. The Laboratory agrees to grant to the Cooperator an exclusive
license in each U.S. patent application, and patents issued thereon, covering a
Subject Invention, which is filed by the Laboratory subject to the reservation
of a nonexclusive, nontransferable, irrevocable, paid-up license to practice and
have practiced the Subject Invention on behalf of the United States.
7.01 Exclusive License Terms. The Cooperator shall elect or decline to
exercise its right to acquire an exclusive license to any Subject Invention
within six months of being informed by the Laboratory of the Subject Invention.
The specific royalty rate and other terms of license shall be negotiated
promptly in good faith and in conformance with the laws of the United States.
Article 8. Background Patent(s)
8.00 Laboratory Background Patent(s): Laboratory has filed patent
application(s), or is the assignee of issued patent(s), listed below which
contain(s) claims that are related to research contemplated under this
Agreement. No license(s) to this/these patent applications or issue patents
is/are granted under this Agreement, and this/these application(s) and any
continuations to it/them are specifically excluded front the definitions of
"Subject Invention" contained in this Agreement:
8.01 Cooperator Background Patent(s): Cooperator has filed patent
application(s), or is the assignee of issued patent(s), listed below which
contain(s) claims that are related to research contemplated under this
Agreement. No license(s) to this/these patent applications or issue patents
is/are granted under this Agreement, and this/these application(s) and any
continuations to it/them are specifically excluded from the definitions of
"Subject Invention" contained in this Agreement:
[***]
Article 9. Subject Data and Proprietary Information
9.00 Subject Data Ownership. Subject Data shall be jointly owned by the
parties. Either party shall have the right to review all Subject Data that has
not been delivered to the other party, except to the extent that such Subject
Data are subject to a claim of confidentiality or privilege by a third party.
Subject Data shall not be disclosed by Laboratory except as set forth in Section
9.04 below.
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9.01 Proprietary Information/Confidential Information. Each party shall
place a proprietary notice on all information it delivers to the other party
under this Agreement that it asserts is proprietary. The parties agree that any
Proprietary Information or Confidential Information furnished by one party to
the other party under this Agreement, or in contemplation of this Agreement,
shall be used, reproduced and disclosed by the receiving party only for the
purpose of carrying out this Agreement, and shall not be released by the
receiving party to third parties unless consent to such release is obtained from
the providing party.
9.02 Army limited-access database. Notwithstanding anything to the
contrary in this Article, the existence of established CRADAs specifying areas
of research and their total dollar amounts may be documented on limited access,
password-protected websites of the U.S. Army Medical Research and Materiel
Command (the parent organization of Laboratory), to provide the Command's
leadership with a complete picture of military research efforts.
9.03 Laboratory Contractors. Cooperator acknowledges and agrees to allow
Laboratory's disclosure of Cooperator's proprietary information to Laboratory's
Contractors for the purposes of carrying out this Agreement. Laboratory agrees
that it has or will ensure that its Contractors are under written obligation not
to disclose Cooperator's proprietary information, except as required by law or
court order, before Contractor employees have access to Cooperator's proprietary
information under this Agreement.
9.04 Release Restrictions. Laboratory shall have the right to use all
Subject Data for any Governmental purpose, but shall not release Subject Data
publicly except: (i) subject to the last sentence of this Section 9.04,
Laboratory in reporting on the results of research may publish Subject Data in
technical articles and other documents to the extent it determines to be
appropriate; and (ii) Laboratory may release Subject Data where release is
required by law or court order. For the purpose of restricting any disclosure of
Cooperator's confidential information, Laboratory will send proposed
publications or presentations, whether oral, electronic, or written, to
Cooperator for review at least sixty (60) calendar days prior to any such
proposed publications or presentation. Cooperator will return comments or
suggested revisions to the proposed publications to Laboratory within thirty
(30) calendar days of their receipt by Laboratory. In the event a proposed
publication or presentation contains patentable subject matter or Confidential
Information of Cooperator, Laboratory agrees to delay such publication or
presentation for an additional thirty (30) calendar days to allow Cooperator the
opportunity to seek appropriate patent protection for such inventions or
information or to request Recipient to delete any Confidential Information of
Laboratory, which Information shall be deleted upon such request and prior to
publication or presentation.
9.05 FDA Documents. If this Agreement involves a product regulated by the
U.S. Food and Drug Administration (FDA), then the Cooperator or the U.S. Army
Medical Research and Materiel Command, as appropriate, may file any required
documentation with the FDA. In addition, the parties authorize and consent to
allow each other or their contractors or agents access to, or to
cross-reference, any documents filed with the FDA related to the product.
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Article 10. Termination
10.00 Termination by Mutual Consent. Cooperator and Laboratory may elect
to terminate this Agreement, or portions thereof, at any time by mutual consent.
10.01 Termination by Unilateral Action. Either party may unilaterally
terminate this entire Agreement at any time by giving the other party written
notice, not less than 30 days prior to the desired termination date.
10.02 Termination Procedures. In the event of termination, the parties
shall specify the disposition of all property, patents and other results of work
accomplished or in progress, arising from or performed under this Agreement by
written notice. Upon receipt of a written termination notice, the parties shall
not make any new commitments and shall, to the extent feasible, cancel all
outstanding commitments that relate to this Agreement. Notwithstanding any other
provision of this Agreement, any exclusive license entered into by the parties
relating to this Agreement shall be simultaneously terminated unless the parties
agree to retain such exclusive license.
Article 11. Disputes
11.00 Settlement. Any dispute arising under this Agreement which is not
disposed of by agreement of the principal investigators shall be submitted
jointly to the signatories of this Agreement. A joint decision of the
signatories or their designees shall be the disposition of such dispute.
However, nothing in this section shall prevent any party from pursuing any and
all administrative and/or judicial remedies which may be allowable.
Article 12. Liability
12.00 Property. Neither party shall be responsible for damages to any
property provided to, or acquired by, the other party pursuant to this
Agreement.
12.01 Cooperator's Employees. Cooperator agrees to indemnify and hold
harmless the U.S. Government for liability of any kind involving an employee of
Cooperator arising in connection with this Agreement, and for all liabilities
arising out of the use by Cooperator of Laboratory's research and technical
developments, or out of any use, sale or other disposition by Cooperator of
products made based on Laboratory's technical developments, except to the extent
the liability is due to the negligence of Laboratory under the provisions of the
Federal Torts Claims Act. This provision shall survive termination or expiration
of this Agreement.
12.02 No Warranty. The parties make no express or implied warranty as to
any matter whatsoever, including the conditions of the research or any Invention
or product, whether tangible or intangible, Made, or developed under this
agreement, or the ownership, merchantability, or fitness for a particular
purpose of the research or any Invention or product.
Article 13. Miscellaneous
13.00 Governing Law. This Agreement shall be governed by the laws of the
United States Government.
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13.01 Export Control and Biological Select Agents and Toxins. The
obligations of the parties to transfer technology to one or more other parties,
provide technical information and reports to one or more other parties, and
otherwise perform under this Agreement are contingent upon compliance with
applicable United States export control laws and regulations. The transfer of
certain technical data and commodities may require a license from a cognizant
agency of the United States Government or written assurances by the Parties that
the Parties shall not export technical data, computer software, or certain
commodities to specified foreign countries without prior approval of an
appropriate agency of the United States Government. The Parties do not, alone or
collectively, represent that a license shall not be required, nor that, if
required, it shall be issued. In addition, where applicable, the parties agree
to fully comply with all laws, regulations, and guidelines governing biological
select agents and toxins.
13.01 Independent Contractors. The relationship of the parties to this
Agreement is that of independent contractors and not as agents of each other or
as joint venturers or partners.
13.02 Use of Name or Endorsements. (a) The parties shall not use the name
of the other party on any product or service which is directly or indirectly
related to either this Agreement or any patent license or assignment agreement
which implements this Agreement without the prior approval of the other party.
(b) By entering into this Agreement, Laboratory does not directly or indirectly
endorse any product or service provided, or to be provided, by Cooperator, its
successors, assignees, or licensees. Cooperator shall not in any way imply that
this Agreement is an endorsement of any such product or service. Press releases
or other public releases of information shall be coordinated between the parties
prior to release, except that the Laboratory may release the name of the
Cooperator and the title of the research without prior approval from the
Cooperator.
13.03 Survival of Specified Provisions. The rights specified in provisions
of this Agreement covering Patent Rights, Subject Data and Proprietary
Information, and Liability shall survive the termination or expiration of this
Agreement.
13.04 Notices. All notices pertaining to or required by this Agreement
shall be in writing and shall be signed by an authorized representative
addressed as follows:
If to Cooperator: Xxxxxxx Xxxxxx, MD, FACP
Vice President and Medical Director
PharmAthene, Inc.
000 Xxxxxxx Xxxxxxxx Xx., Xxxxx 000
Xxxxxxxxx, XX 00000
000-000-0000 (voice), 000-000-0000 (fax)
With a copy to: Xxxxxx Xxxxxx
Vice President and Chief Financial Officer
PharmAthene, Inc.
000 Xxxxxxx Xxxxxxxx Xx., Xxxxx 000
000-000-0000 (voice), 000-000-0000 (fax)
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If to Laboratory: USAMRIID
Business Plans and Programs Xxxxxx
0000 Xxxxxx Xxxxxx
Xxxx Xxxxxxx, XX 00000-0000
Phone: 000-000-0000 Fax: 000-000-0000
Any party may change such address by notice given to the other in the manner set
forth above.
Article 14. Article 14. Duration of Agreement and Effective Date
14.01 Effective Date. This Agreement shall enter into force as of the date
it is signed by the last authorized representative of the parties.
14.02 Expiration Date. This Agreement will automatically expire l year
from effective date unless it is revised by written notice and mutual agreement.
[remainder of page remains blank; signatures follow]
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IN WITNESS WHEREOF, the Parties have caused this agreement to be executed
by their duly authorized representatives as follows:
For the Cooperator: PharmAthene Inc.
/s/ Xxxxxxx Xxxxxx, MD
---------------------------------------
(Signature)
Xxxxxxx Xxxxxx, MD
DATE 8/29/06 Vice-President & Medical Director
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For the U.S. Government: U.S. Army Medical Research Institute of
Infectious Diseases
/s/ Xxxxxx X. Xxxxx, Xx.
---------------------------------------
(Signature)
Xxxxxx X. Xxxxx, Xx.
Colonel, U.S. Army
DATE 12 Sep 06 Commanding
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For the USAMRIID Principal Investigator:
I hereby acknowledge the terms and conditions of this Agreement:
DATE 6 Sept 06 /s/ Xxxxxxxxx Xxxxxx, Ph.D
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(Signature)
Xxxxxxxxx Xxxxxx, Ph.D
