EXHIBIT 10.9
DAMD17-94-0773
A COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
BETWEEN
JENNER TECHNOLOGIES, INC.
XXXXXXX, XXXXXXXXXX 00000
("JENNER:)
AND
XXXXXX XXXX ARMY INSTITUTE OF RESEARCH
XXXXXXXXXX, XX 00000-0000
("WRAIR")
A. WHEREAS the Federal Technology Transfer Act of 1986, 15 USC 3710a,
provides each Federal agency with the authority to permit the Directors of
Government-operated Federal Laboratories to enter into cooperative research and
development agreements (CRDAs) with Federal non-Federal entities, including
private firms and organizations. This authority allows Federal laboratories to
accept, retain, and use funds, personnel, services, and property from
collaborating parties and to provide personnel, services, and property to
collaborating parties. This authority also includes the disposition of patent
rights in any inventions which may result from such collaboration, or by
delegation of the Assistant Secretary of the Army for Research, Development and
Acquisition, other patent rights which are owned by the Government.
B. WHEREAS WRAIR and JENNER desire to collaborate in research and
development on formulation of liposome-encapsulated vaccines.
C. WHEREAS Title 41 Code of Federal Regulations 304 governs the
acceptance of payment from non-federal sources for travel expenses and is the
authority for receipt of in-kind travel expenses contemplated under this
Agreement.
NOW, THEREFORE, the parties agree as follows:
ARTICLE 1. DEFINITIONS
As used in this Agreement, the following terms shall have the following
meanings and such meanings should be equally applicable to both the singular and
the plural forms of the terms defined:
1.1 "Agreement" means this Cooperative Research and Development
Agreement.
1.2 "Invention" means any invention or discovery which is or may be
patentable or otherwise protected under Title 35 of the United States Code.
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1.3 "Made" in relation to any Invention means the conception or first
actual reduction to practice of such Invention.
1.4 "Proprietary Information" means JENNER information marked with a
proprietary legend or orally disclosed by JENNER which embodies proprietary
technical information or trade secrets which is confidential business or
financial information provided that such information:
(i) is not generally known or available 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 Government without
obligation concerning its confidentiality.
1.5 "Subject Data" means all recorded information, including without
limitation, protocols, procedures, data and results, in any form, first produced
in the performance of this Agreement.
1.6 "Subject Invention" means any invention Made in the performance of
work under this Agreement.
Article 2. Sponsored Research
2.1 Scope of Work. Sponsored research performed under this Agreement
shall be performed in accordance with the Statement of Work (SOW), incorporated
as a part of this Agreement at Appendix A. WRAIR agrees to provide WRAIR
resources, facilities and equipment required for the performance of the SOW.
2.2 Review of Work. Quarterly conferences shall be held between WRAIR
and JENNER personnel for the purpose of reviewing the progress of the work under
this Agreement. It is understood that the nature of this sponsored research is
such that completion within the period of performance specified, or within the
limits of financial support allocated, cannot be guaranteed. Accordingly, it is
agreed that all sponsored research will be performed by WRAIR on a best efforts
basis.
2.3 Principal Investigator(s). Any work required by WRAIR under the SOW
will be performed under the direction of [*], who as co-principal investigator
has responsibility for the scientific and technical conduct of this project on
behalf of WRAIR. Any work required by JENNER under the SOW will be performed
under the direction of [*], who as co-principal investigator has responsibility
for the scientific and technical conduct of this project on behalf of JENNER.
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2.4 [*] agrees to [*] and be [*] to the performance of work under this
Agreement. The parties will mutually agree upon the [*] pursuant to this
section. [*] will be solely [*] and, in performing the work under this
Agreement, [*] but only those entitlements and benefits provided pursuant to an
employment contract between [*] will be a [*] who will be assigned [*]. It is
understood by [*] that this is a commitment of [*] and that such employee is
required for the performance of the work. [*] agrees to assign [*] to the [*]
and to provide the [*] access to those [*] and resources necessary for the
accomplishment of the SOW, consistent with the [*] internal management policies.
[*] agrees to continue the [*], even if this Agreement is terminated earlier.
2.5 Scope Change. If at any time either co-principal investigator
determines 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(s) to the SOW.
2.6 Final Report. The parties shall prepare a final written report
detailing the Subject Data and the results and achievements of this research
collaboration, including, without limitation, any Subject Inventions, within
three months after completing the SOW.
Article 3. Financial Obligation
3.1 Performance Condition. The performance of research by WRAIR under
this Agreement is conditioned on the advance payment by JENNER of WRAIR's
partial cost for the performance of the research as provided in Section 3.2.
WRAIR 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.
3.2 Deposit Account. JENNER shall pay a total of [*] to WRAIR upon the
execution of this Agreement for the performance of the research specified by
Article 2. Such funds shall be deposited in Department of the Army Special
Collaborative Agreement Account No. ______.
3.3 Accounting Records. WRAIR shall maintain separate and distinct
current accounts, records, and other evidence supporting all its expenditures
under this Agreement. WRAIR shall provide JENNER a semiannual report accounting
for the use of JENNER's funds and a final fiscal report within six months after
completing the SOW or ending its research and development activities under this
Agreement. The accounts and records of WRAIR which are relevant to the conduct
of this project shall be available for reasonable inspection and copying by
JENNER or its authorized representative at least once per year.
Article 4. Title to Physical Property
4.1 Physical Property. 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.
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ARTICLE 5. PATENT RIGHTS
5.1 Reporting. Each party shall promptly notify each other of all
Subject Inventions reported to either party by its employees and provide a
detailed written description of each Subject Invention within 30 days of when
any Subject Invention is Made. All Subject Inventions Made during the
performance of this Agreement shall be listed in the Final Report required by
this Agreement.
5.2 JENNER Subject Inventions. WRAIR, on behalf of the U.S. Government,
waives any ownership rights the U.S. Government may have in Subject Inventions
Made by JENNER employees and agrees that JENNER shall retain ownership of and
title to any Subject Inventions made solely by JENNER employees. JENNER shall
file patent applications on JENNER's Subject Inventions at its own expense.
JENNER agrees to grant the U.S. Government a nonexclusive, irrevocable, paid-up
license under its interest in any patents covering a JENNER Subject Invention,
to practice or have practiced, such patents throughout the world by, or on
behalf of the U.S. Government. Such nonexclusive license shall be evidenced by a
confirmatory license agreement prepared by JENNER in a form satisfactory to
WRAIR.
5.3 WRAIR Subject Inventions. WRAIR, on behalf of the U.S. Government,
shall retain ownership of and title to, and file patents on, each Subject
Invention Made solely by WRAIR employees. WRAIR agrees to xxxxx Xxxxxx an
exclusive license to such Subject Inventions, pursuant to Section 5.7 herein.
5.4 Joint Subject Inventions. In the event that Subject Inventions are
made jointly by WRAIR and JENNER employees, each party shall have an undivided
interest in such Subject Inventions. WRAIR shall have the initial option to file
patents on each Subject Invention Made jointly by JENNER and WRAIR employees.
WRAIR agrees to license to Jenner its entire right, title and interest in each
such joint Subject Invention, pursuant to Section 5.7 herein. JENNER agrees to
grant the U.S. Government a nonexclusive, irrevocable, paid-up license under its
interest in any patents covering a joint Subject Invention, to practice or have
practiced, such patents throughout the world by, or on behalf of the U.S.
Government. Such nonexclusive license shall be evidenced by a confirmatory
license agreement prepared by JENNER in a form satisfactory to WRAIR.
5.5 Filing of Patent Applications. The party having the right to retain
title and/or 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 at its own expense.
5.6 Patent Expenses. The expenses attendant to the filing of patent
applications shall be [*] shall provide [*] documents retained in the official
patent application files by the applicable patent office. The parties [*] patent
applications resulting from this Agreement.
5.7 Exclusive License.
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5.7.1 Grant. WRAIR, on behalf of the U.S. Government, hereby
agrees to grant to JENNER an exclusive irrevocable license, with right to grant
and authorize sublicenses, to each U.S. and foreign patent application, and any
division, substitution, continuation, continuations-in-part of such
applications, and any patents issued thereon, and any renewal, extension,
re-issue, or re-examination thereof, covering a Subject Invention, which is
owned in whole or part by WRAIR on behalf of the U.S. Government, to develop,
make, have made, use, sell, and have sold products and processes covered by such
patents and patent applications, subject to the reservation of a nonexclusive,
irrevocable, paid-up license to practice and have practiced the Subject
Invention(s) on behalf of the U.S. Government.
5.7.2 Exclusive License Terms. JENNER shall elect or decline
to exercise its right to acquire an exclusive license to any Subject Invention
within [*] of being informed by WRAIR of the Subject Invention. The terms of the
license provided for in Section 5.7.1 shall be negotiated promptly in good faith
and in conformance with the laws of the United States but shall include at least
the following terms: (i) a royalty rate of [*] within the scope of a valid claim
of an issued patent claiming a Subject Invention jointly owned by WRAIR and
JENNER; (ii) a royalty rate of [*] within the scope of a valid claim of an
issued patent claiming a Subject Invention owned solely by WRAIR. In addition,
such license shall provide for the payment of milestone payments by JENNER to
WRAIR, on a product-by-product basis, of: (i) [*], and (ii) [*]; provided,
however, no milestone payments shall be required with respect to [*]. Such
license shall terminate, on a country-by country basis, upon the expiration of
any patents licensed to Jenner pursuant to this Section 5.7, unless terminated
earlier pursuant to the terms of such Agreement.
ARTICLE 6. DATA AND PUBLICATION
6.1 Rights. Subject Data shall be jointly owned by the parties and may
be used by either party, subject to this Article 6. Either party shall, upon
request, have the right to review and receive copies of all Subject Data which
has not been delivered to the other party.
6.2 Proprietary Information. WRAIR agrees that any Proprietary
Information furnished by JENNER to WRAIR under this Agreement, or in
contemplation of this Agreement, shall be used, reproduced and disclosed by
WRAIR only for the purpose of carrying out this Agreement, and shall not be
disclosed by WRAIR to third parties unless prior written consent to the release
is obtained from JENNER.
6.3 Release Restrictions. WRAIR shall have the right to use all Subject
Data for any U.S. Governmental purpose, but shall not release Subject Data
publicly except: (i) subject to Section 6.4, WRAIR, in reporting results of
sponsored research, may publish Subject Data in technical articles and other
documents to the extent it determines to be appropriate; and (ii) WRAIR may
release such Subject Data where such release is required by law or court order.
6.4 Publication. WRAIR and JENNER agree to confer prior to the
publication of any Subject Data to assure that no Proprietary Information is
released and that patent rights are not
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jeopardized. Prior to submitting an abstract or manuscript for review which
contains any Subject Data or results of the research under this Agreement, each
party shall have [*] to review each such proposed abstract or manuscript. Nor
shall WRAIR make any oral disclosure of Subject Data to third parties without
providing JENNER a written description of the topic and contents of any such
proposed disclosure at least [*] in advance of any oral disclosure.
6.5 FDA Documents. If this Agreement involves a product regulated by
the U.S. Food and Drug Administration (FDA), then the JENNER or the U.S. Army
Medical Research and Development Command, as appropriate, may file Subject Data
or any required documentation relating to the SOW with the FDA; provided,
however, each party shall request that any such filings be treated confidential
to the maximum extent allowed by law. In addition, the parties authorize and
consent to allow each other or its contractor or agent access to, or to
cross-reference, any documents filed with the FDA related to the product.
ARTICLE 7. REPRESENTATIONS AND WARRANTIES.
7.1 Representations and Warranties of WRAIR. WRAIR hereby represents
and warrants to JENNER as follows:
7.1.1 Organization. WRAIR is a Federal laboratory of the U.S.
Army Medical Research and Development Command and is wholly owned by the
Government of the United States and whose substantial purpose is the performance
of research, development or engineering;
7.1.2 Mission. The performance of the activities specified by
this Agreement are consistent with the mission of the WRAIR;
7.1.3 Authority. All prior reviews and approvals of this
Agreement required by regulations or law have been obtained by WRAIR prior to
the execution of this Agreement. The WRAIR official executing this Agreement on
behalf of WRAIR has the requisite authority to do so. Notwithstanding the
delegation of authority to execute this Agreement to the individual designated,
the Secretary of the Army has reserved to the Assistant Secretary of the Army
(Research, Development and Acquisition) the opportunity provided by 15 USC Sect.
3710a(c)(5)(A), to disapprove or require the modification of this Agreement
within 30 days of the date it is presented to him or her by WRAIR;
7.1.4 Statutory Compliance. WRAIR's Commander prior to
entering into this Agreement has given special consideration to entering into
CRDAs with small business firms and consortia involving small business firms.
7.1.5 No Conflicting Agreements. WRAIR has not previously
entered and during the term of this Agreement will not enter any agreement with
any third party granting rights inconsistent with those granted to JENNER
herein.
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7.2 Representations and Warranties of JENNER. JENNER hereby represents
and warrants to WRAIR as follows:
7.2.1 Corporate Organization. JENNER, as of the date hereof,
is a corporation duly organized, validly existing and in good standing under the
laws of the State of California;
7.2.2 Power and Authority. JENNER has the requisite power and
authority to enter into this Agreement and to perform according to the terms
thereof;
7.2.3 Due Authorization. The Board of Directors of JENNER have
taken all actions required to be taken by law, JENNER's Charter, Certificate or
Articles of Incorporation, its bylaws or otherwise, to authorize the execution
and delivery of this Agreement;
7.2.4 No Violation. To the best of JENNER's knowledge, the
execution and delivery of this Agreement does not contravene any material
provision of, or constitute a material default under any material agreement
binding on JENNER, or any valid order of any court, or any regulatory agency or
other body having authority to which JENNER is subject.
ARTICLE 8. TERMINATION.
8.1 Termination by Mutual Consent. JENNER and WRAIR may elect to
terminate this Agreement, at any time by mutual consent.
8.2 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.
8.3 Termination Procedures. In the event this Agreement terminates
before the SOW is completed, the parties shall return to the other all property
or information, including Proprietary Information, owned solely by the other.
Each party shall have the right to retain any joint property in its possession;
provided, however, that any party in the sole possession of joint property shall
promptly provide the other party with a copy or sample of such joint property on
the request of the other party. Upon the receipt of a written termination
notice, the parties shall not make any new commitments that relate to this
Agreement.
8.4 Termination Costs. Within 90 days following termination of this
Agreement, WRAIR shall submit a statement of all costs incurred prior to the
date of termination and for all termination costs. Any unspent funds provided to
WRAIR by JENNER shall be used to fund reasonable termination costs and any
remainder returned to Jenner. In the event funds are insufficient to cover all
of the termination costs, JENNER agrees to promptly meet with WRAIR to negotiate
a settlement agreement regarding the payment of any remaining reasonable
termination costs.
ARTICLE 9. DISPUTES.
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9.1 Settlement. Any dispute arising under this Agreement which is not
disposed of by agreement of the co-principal investigators shall be submitted
jointly to the signatories of this Agree ment. A joint decision of the
signatories or their designees shall be the disposition of such dispute.
Notwithstanding the above, nothing in this section shall prevent any party from
pursuing any and all administrative and/or judicial remedies which may be
allowable.
ARTICLE 10. LIABILITY.
10.1 Property. Neither party shall be responsible for damages to any
property provided to, or acquired by, the other party pursuant to this
Agreement.
10.2 JENNER's Employees. JENNER agrees to indemnify and hold harmless
the U.S. Government for any loss, claim, damage or liability of any kind
involving an employee of JENNER arising in connection with this Agreement under
the provisions of the Federal Tort Claims Act, except to the extent that such
loss, claim, damage or liability is due in whole or part to the negligence or
wilful misconduct of WRAIR.
10.3 No Warranty. Except as specifically stated elsewhere in this
Agreement, WRAIR makes no express or implied warranty as to any matter
whatsoever, including the conditions of the research or any Subject 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 Subject Invention.
10.4 Indemnification. JENNER holds the U.S. Government harmless and
indemnifies the U.S. Government for all liabilities, demands, damages, expenses
and losses arising out of use by JENNER of research and technical developments
solely owned by WRAIR developed pursuant to this Agreement, or out of any use,
sale or other disposition by JENNER of products made by the use of technical
developments solely owned by WRAIR developed pursuant to this Agreement;
provided, however, in no case shall JENNER be obligated to indemnify WRAIR or
the U.S. Government for any amount in excess of the research funds provided by
JENNER to WRAIR pursuant to this Agreement. This provision shall survive
termination or expiration of this Agreement.
ARTICLE 11. MISCELLANEOUS.
11.1 No Benefits. No member of, or delegate to the United States
Congress, or resident commissioner, shall be admitted to any share or part of
this Agreement, nor to any benefit that may arise therefrom; but this provision
shall not be construed to extend to this Agreement if made with a corporation
for its general benefit.
11.2 Governing Law. This Agreement shall be governed by the laws of the
United States Government.
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11.3 Further Assurances. From time to time, either party shall at the
request of the other: (i) deliver to the other party such records, data or other
documents consistent with the provisions of this Agreement; (ii) execute and
deliver or cause to be delivered, all such consents, assignments, licenses, or
further instruments of transfer as provided by the Agreement to allow the
parties to obtain the benefits provided for herein.
11.4 Notices. All notices pertaining to or required by this Agreement
shall be in writing and shall be signed by an authorized representative and
shall be delivered by hand or sent by certified mail, return receipt requested,
with postage prepaid, addressed as follows:
If to JENNER: Xxxxxxx X. Xxxxx, III
Chief Executive Officer
JENNER Technologies, Inc.
0000 Xxxxxxxx Xxxx Xxxxx
Xxxxxxx, Xxxxxxxxxx 00000
If to WRAIR: Director
Xxxxxx Xxxx Army Institute of Research
ATTN: Office of Research Management
Washington, D.C. 20307-5100
Any party may change such address by notice given to the other party in the
manner set forth above.
11.5 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.
11.6 Use of Name or Endorsements. (i) JENNER shall not use the name of
WRAIR or the Department of the Army 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 WRAIR. (ii) By entering into this Agreement WRAIR does not directly or
indirectly endorse any product or service provided, or to be provided, by
JENNER, its successors, assignees, or licensees. JENNER shall not in any way
imply that this Agreement is an endorsement of such products or service.
11.7 The rights specified in the provisions of this Agreement covering
"Patent Rights," "Data and Publication," and "Liability" shall survive the
termination or expiration of this Agreement.
ARTICLE 12. DURATION OF AGREEMENT AND EFFECTIVE DATE
12.1 Expiration of Agreement. This Agreement will automatically expire
on December 15, 1994, unless terminated earlier as provided by the terms of this
Agreement.
12.2 Effective Date. This Agreement shall enter into force as of
December 15, 1993.
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their duly authorized representatives as follows:
For JENNER TECHNOLOGIES, INC.:
10/20/93 /s/ XXXXXXX X. XXXXX
------------------------------- ---------------------------------------
Date Xxxxxxx X. Xxxxx, III
Chief Executive Officer
JENNER Technologies, Inc.
For the U.S. GOVERNMENT:
30 September '93 /s/ AUGUST X. XXXXXXX
------------------------------- ---------------------------------------
Date August X. Xxxxxxx
Colonel, Medical Corps
Director, Xxxxxx Xxxx Army Institute of
Research
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Cooperative Research and Development Agreement Between WRAIR and JENNER
Technologies, Inc.
APPENDIX A
STATEMENT OF WORK
[*]
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DAMD17-94-0773
NOTICE OF MODIFICATION
of
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
between
XXXXXX XXXX ARMY INSTITUTE OF RESEARCH
and
JENNER TECHNOLOGIES, INC.
WHEREAS, the Xxxxxx Xxxx Army Institute of Research ("WRAIR"),
Washington, DC and Jenner Technologies, Inc. ("JENNER"), 000 Xxxxxxxxx Xxxxx,
Xxxxxxxx, Xxxxxxxxxx 00000-0000, entered into a Cooperative Research and
Development Agreement ("Agreement") (Department of the Army Control Number
9311-M-C318, U.S. Army Medical Research and Materiel Command Control Number
DAMD17-94-0773) on December 15, 1993 for research and development on
"Formulation of Liposome-Encapsulated Vaccines," and inasmuch the parties desire
to modify the expiration date and the financial reimbursement provisions of the
Agreement,
NOW, THEREFORE, the parties agree as follows:
1. In Article 12.1 of the Agreement, the expiration date "December 15,
1994" is changed to read "December 15, 1997";
2. Article 3.2 of the Agreement is changed to read as follows:
"3.2 Deposit Account: JENNER shall reimburse WRAIR a total of
[*] for the performance of the research specified by Article 2. Such funds shall
be deposited in Department of the Army Special Collaborative Agreement Account
No. [to be named] as follows:
[*]
IN WITNESS WHEREOF, the parties have caused these modifications to be
executed by their duly authorized representatives as follows:
For JENNER TECHNOLOGIES, INC.:
/s/ XXXXXXX X. XXXXX, III
----------------------------------------
Xxxxxxx X. Xxxxx, III
Chief Executive Officer
Date: March 9, 1995
----------------------------------
For the UNITED STATES GOVERNMENT:
/s/ AUGUST X. XXXXXXX
----------------------------------------
August X. Xxxxxxx
Colonel, Medical Corps
Director, Xxxxxx Xxxx Army Institute of
Research
Date: 17 March '95
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