A COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
Between
APOLLON, INC.
▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
("APOLLON")
and
▇▇▇▇▇▇ ▇▇▇▇ ARMY INSTITUTE OF RESEARCH
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
("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 and 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 APOLLON desire to collaborate in Development and
Evaluation of DNA Vaccines for Prevention of HIV-1 Infections.
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.
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 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 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 first produced in the
performance of this Agreement according to the Statement of Work described in
Appendices A and B.
1.6 "Subject Invention" means any invention Made in the performance of
work within the Statement of Work, Appendix A 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 in Appendix A. The parties acknowledge that each
party is conducting independent research in the field of DNA vaccination,
including research on vaccines for treatment and/or prophylaxis of HIV-1
infection, that is outside the Statement of Work and not subject to the terms of
this Agreement. This includes research by APOLLON relating to vaccine vector
backbone constructs; the "backbone" refers to all components of the vaccine
invented or developed by APOLLON except those gene elements which are provided
by WRAIR. WRAIR acknowledges that the use of any such APOLLON backbone in the
codevelopment of an HIV vaccine within the SOW would not result in WRAIR
acquiring and rights to make, use or sell the backbone.
2.2 Review of Work. Periodic conferences shall be held between WRAIR and
APOLLON personnel for the purpose of reviewing the progress of the work. 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
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agreed that all sponsored research is to be performed 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 ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇, Division of
Retrovirology, ▇▇▇▇▇▇ ▇▇▇▇ Army Institute of Research, ▇▇▇▇▇▇▇▇▇▇, ▇▇
▇▇▇▇▇-▇▇▇▇, who, as co-principal investigator, has responsibility for the
scientific and technical conduct of this project on behalf of WRAIR. Any work
required by APOLLON under the SOW will be performed under the direction of ▇▇.
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇, Ph.D., Vice President of Research and Development,
Apollon, Inc., ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, who,
as co-principal investigator, has responsibility for the scientific and
technical conduct of this project on behalf of APOLLON.
2.4 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(s) to the SOW and make the change(s) by written notice.
2.5 Final Report. The parties shall prepare a final report of the results
and achievements of this research collaboration within six months after
completing the SOW.
Article 3. Financial Obligation
3.1 Funding. The parties shall each be individually responsible for
funding its own respective researchers throughout this Agreement, including
laboratory facilities, salaries, overhead and indirect costs, etc. Each party
may determine at its own discretion, the amount of resources, personnel,
materials or funds it will devote to the work under this Agreement.
3.2 Expenses. The parties shall each be individually responsible for
expenses incurred by their respective researchers. Neither party shall be
liable or obligated to any third party contractual agreement undertaken by the
other party.
Article 4. Title to 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.
Article 5. Patent Rights
5.1 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
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this Agreement shall be listed in the Final Report required by this Agreement.
52. APOLLON Employee Inventions. WRAIR, on behalf of the U.S. Government,
waives any ownership rights the U.S. Government may have in Subject Inventions
Made by APOLLON employees and agrees that APOLLON shall have the option to
retain title in Subject Inventions made by APOLLON employees. APOLLON shall
notify WRAIR promptly upon making this election and agrees to timely file patent
applications on APOLLON's Subject Inventions at its own expense. APOLLON agrees
to grant to the U.S. Government on APOLLON's Subject Inventions a nonexclusive,
irrevocable, paid-up, non-transferable, non-commercial license in the patents
covering a Subject Invention, to practice or have practiced, throughout the
world by, or on behalf of the U.S. Government. The nonexclusive license shall
be evidenced by a confirmatory license agreement prepared by APOLLON in a form
satisfactory to WRAIR.
5.3 WRAIR Employee and Joint Inventions. WRAIR, on behalf of the U.S.
Government, shall have the initial option to retain title to, and file patents
at WRAIR's expense on, each Subject Invention Made solely by its employees under
this Agreement. Subject Invention(s) Made jointly by APOLLON and WRAIR
employees shall be jointly owned by the parties.
5.4. Filing of Patent Applications. The party having the right to retain
title 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 right, title and interest in the Subject Invention to
the other party. The assignment of the entire right, title and interest to
the other party pursuant to this paragraph shall be subject to the retention
by the party assigning title of a nonexclusive, irrevocable, paid-up license
to practice, or have practiced, the Subject Invention throughout the world.
5.5 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. The parties shall cooperate in filing, prosecuting and maintaining
patent applications on joint inventions and shall share expenses equally.
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5.6 Exclusive License.
5.6.1 Grant. WRAIR, on behalf of the U.S. Government, agrees to
grant to APOLLON an exclusive commercial license in each U.S. patent
application, and patents issued thereon, covering a Subject Invention, which is
filed by WRAIR on behalf of the U.S. Government or jointly by the parties
subject to the reservation of a nonexclusive, irrevocable, paid-up,
non-transferable, non-commercial worldwide license to practice and have
practiced the Subject Invention on behalf of the U.S. Government.
5.6.2 Exclusive License Terms. APOLLON shall elect or decline to
exercise its right to acquire a commercial license, either exclusive or
non-exclusive, at APOLLON's option, to any Subject Invention within six (6)
months of being informed by WRAIR 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. WRAIR agrees to
grant to APOLLON on WRAIR Subject Inventions a non-exclusive, irrevocable,
non-transferable, non-commercial, paid-up license in the patents covering a
Subject Invention, to practice or have practiced, throughout the world by, or
on behalf of APOLLON.
5.7 Background Patents and Other Preexisting Intellectual Property. Each
party owns or otherwise has rights to certain preexisting intellectual property,
including, without limitation, patents, patent applications, trade secrets,
know-how, DNA constructs and vectors, formulations, manufacturing, fermentation
and quality control methodology, which is related to research contemplated under
this Agreement. No license to any such invention or other intellectual property
which a party can demonstrate by probative evidence was in its possession,
whether actually or constructively reduced to practice, prior to the Effective
Date hereof is granted under this Agreement, including, without limitation,
intellectual property taught in patents, patent applications, or any
continuations, reissues, reexaminations, or foreign counterparts thereof,
including the patents, patent applications, and other intellectual property of
APOLLON listed in Appendix C of this Agreement, which are specifically excluded
from the definition of Subject Invention contained in this Agreement.
Article 6. Data and Publication
6.1 Rights. Subject Data shall be jointly owned by the parties. Either
party shall, upon request, have the right to review all Subject Data first
produced under this Agreement which has not been delivered to the other party,
except to the extent
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that such Subject Data is subject to a claim of confidence or privilege by a
third party.
6.2 Proprietary Information. WRAIR agrees that any Proprietary
Information furnished by APOLLON 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
released by WRAIR to third parties unless consent to the release is obtained
from APOLLON. APOLLON shall place a proprietary notice on all information it
delivers to WRAIR under this Agreement which it asserts is proprietary.
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) 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 APOLLON agree to confer prior to the
publication of Subject Data to assure that no Proprietary Information is
released and that patent rights are not jeopardized. Prior to submitting a
manuscript for review which contains the results of the research under this
Agreement, or prior to publication if no such review is made, each party
shall be offered an ample opportunity to review such proposed manuscript and
to file patent applications in a timely manner.
6.5 FDA Documents. If this Agreement involves a product developed
pursuant to an Invention Made under this CRADA regulated by the U.S. Food and
Drug Administration (FDA), then the APOLLON or the U.S. Army Medical Research
and Material Command, as appropriate, may file any required documentation with
the FDA. In addition, the parties authorize and consent to allow each other or
its contractor or agent limited access supervised by APOLLON designed to permit
the Army 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 APOLLON as follows:
7.1.1 Organization. WRAIR is a Federal laboratory of the U.S. Army
Medial Research and Material Command and is wholly owned by the Government of
the United States and whose substantial purpose is the performance of research,
development or engineering;
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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 required by
regulations or law have been obtained by WRAIR prior to the execution of this
Agreement. The WRAIR official executing this Agreement 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.
7.2 Representations and Warranties of APOLLON. APOLLON hereby represents
and warrants to WRAIR as follows:
7.2.1 Corporate Organization. APOLLON, as of the date hereof, is a
corporation duly organized, validly existing and in good standing under the laws
of the Commonwealth of Pennsylvania;
7.2.2 Power and Authority. APOLLON 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 and stockholders of
APOLLON have taken all actions required to be taken by law, APOLLON'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. 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 APOLLON or any valid order of
any court, or any regulatory agency or other body having authority to which
APOLLON is subject.
Article 8. Termination
8.1 Termination by Mutual Consent. APOLLON and WRAIR may elect to
terminate this Agreement, or portions thereof, at any time by mutual consent.
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8.2 Termination by Unilateral Action. Either party may unilaterally
terminate at any time this entire Agreement, or any part(s) of it thereof, 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 of termination, the parties
shall specify by written notice the disposition of all property, patents, and
other results of work accomplished or in progress, arising from or performed
under this Agreement. Upon the receipt of written termination notice, the
parties shall not make any new commitments that relate to this Agreement.
Article 9. Settlement of Disputes: 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 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 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 APOLLON's Employees. APOLLON agrees to indemnify and hold harmless
the U.S. Government for any loss, claim, damage, expense or liability of any
kind involving an employee of APOLLON arising in connection with this Agreement,
except to the extent that such loss, claim, damage, expense or liability is due
to the negligence of WRAIR under the provisions of the Federal Torts Claims
Act. This provision shall survive termination or expiration of this Agreement.
10.3 No Warranty. Except as specifically stated elsewhere in this
Agreement, neither party makes any 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.
10.4 Indemnification. APOLLON holds the U.S. Government harmless and
indemnifies the U.S. Government for any loss, claim, damage, expense or
liability of any kind arising out of use by APOLLON of WRAIR's research and
technical development or out of any use, sale or other disposition by APOLLON of
products made by the use of WRAIR's technical developments, except to the extent
that such loss, claim, damage, expense or liability is due to the
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negligence or willful misconduct of WRAIR under the provisions of the Federal
Torts Claims Act. 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.
11.3 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 APOLLON: President and CEO
Apollon, Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
If to WRAIR: Director
▇▇▇▇▇▇ ▇▇▇▇ Army Institute of Research
ATTN: Office of Research and
Technology Applications
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Any party may change such address by notice given to the other party in the
manner set forth above.
11.4 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.
11.5 Use of Name or Endorsements. (i) APOLLON 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
APOLLON, its successors, assignees, or licensees. APOLLON shall not in any way
imply that this Agreement is an endorsement of such products or service.
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11.6 The rights specified in 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 31, 2001, unless it is revised by written notice and mutual consent.
12.2 Effective Date. This Agreement shall enter into force as of the date
it is signed by the last authorized representative of the parties.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their duly authorized representatives as follows:
For APOLLON, INC.
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇.
______________________________
[Signature]
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇.
______________________________
[Typed or Printed Name]
Date: 13 Oct. 97 President and CEO
______________ ______________________________
[Typed or Printed Position Title]
For the UNITED STATES GOVERNMENT:
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Colonel, U.S. Army
Date: Director, ▇▇▇▇▇▇ ▇▇▇▇ Army Institute of
______________ Research
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Z