COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
This
Cooperative Research and Development Agreement, hereinafter referred to as
the
“CRADA,”
consists of this Cover Page, an attached agreement, and various Appendices
referenced in the agreement. This Cover Page serves to identify the parties
to
this CRADA:
This
CRADA is made and entered into by and among:
(1) The
Uniformed Services University of the Health Sciences (which includes the Armed
Forces Radiobiology Research Institute (“AFRRI”)),
an
institution of higher learning within the Department of Defense, an agency
of
the United States Government, hereinafter referred to as “USU,”
located at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇;
(2) The
▇▇▇▇▇
▇. ▇▇▇▇▇▇▇ Foundation for the Advancement of Military Medicine, Inc., a tax-
exempt corporation organized and existing under the laws of the State of
Maryland, hereinafter referred to as the “Foundation,”
with
offices located at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇;
and the following two “Collaborators”:
(3) The
Cleveland Clinic Foundation (which includes the Lernerer Research Institute),
hereinafter referred to as “CCF”,
with
offices at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇; and
(4) Cleveland
BioLabs, Inc., hereinafter referred to as “CBL”,
located at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇.
WHEREAS,
The
Federal Technology Transfer Act of 1986, as amended, 15 U.S.C. § 3710a
et seq.,
provides for making Federal laboratories’ developments accessible to private
industry and to state and local governments, and for the improvement of the
economic, environmental, and social well-being of the United States by
stimulating the civil utilization of Federally-funded technology
developments;
WHEREAS,
USU/AFFRI has extensive expertise, capabilities, and information in the areas
of
radioprotectants and radiation casualty management;
WHEREAS,
the
Foundation has an agreement with USU to support the development and
commercialization of scientific and medical technologies, and pursuant to such
agreement the Foundation acts as patent management organization for USU and
has
the authority, on behalf of USU, to enter into research and licensing agreements
and receive and distribute funds in connection therewith;
WHEREAS,
it is
the intent of USU and the Foundation to promote the goals of the Federal
Technology Transfer Act and collaborate with private parties to promote the
development, manufacture, and marketing of products and services that utilize
transferred technology for the benefit of mankind; and
WHEREAS,
the
Collaborators have the interest, resources, capabilities, and technical
expertise to transition the results of USU/AFFRI research and development for
public use.
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NOW,
THEREFORE,
in
consideration of the mutual covenants contained herein, and for other good
and
valuable consideration, the receipt and sufficiency of which are hereby
expressly acknowledged, the Parties agree as follows:
ARTICLE
1
INTRODUCTION
1.1. This
CRADA shall be effective as of August 01, 2004 (the “Effective
Date”).
The
research and development activities that will be undertaken by each of the
Parties in the course of this CRADA are summarized in the Research Plan
(“RP”)
attached as Appendix
A.
The
funding and staffing commitments of the Parties are set forth in Appendix
B.
This
CRADA is made under the authority of the Federal Technology Transfer Act, 15
U.S.C. §3710a, and is governed by its terms.
ARTICLE
2
DEFINITIONS
As
used
in this CRADA, the following terms shall have the indicated
meanings:
2.1. “Cooperative
Research and Development Agreement”
or
“CR.ADA”
means
this agreement, with its Appendices, entered into by the USU pursuant to the
Federal Technology Transfer Act of 1986, as amended, 15 U.S.C. § 3710a
et
seq.,
and
Executive Order 12591 of April 10, 1987.
2.2. “Government”
means
the government of the United States of America as represented through the USU,
which is a Party to this CRADA.
2.3. “IP”
means
intellectual property.
2.4. “Principal
Investigator(s)”
or
“PI(s)”
means
the person(s) designated respectively by the Parties to this CRADA who will
be
responsible for the scientific and technical conduct of the RP.
2.5. “Proprietary/Confidential
Information”
means
confidential scientific, business, or financial information that is treated
as
proprietary or confidential by the disclosing Party provided that such
information does not include:
2.5.1. information
that is publicly known or available from other sources who are not under a
confidentiality obligation to the source of the information;
2.5.2. information
that has been made available by its owners to others without a confidentiality
obligation;
2.5.3. information
that is already known by or available to the receiving Party without a
confidentiality obligation; or
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2.5.4. information
that has been independently developed by the receiving Party, without any
reference to or use of the information received by it under this CRADA as
evidenced by written records of the receiving Party.
2.6. “Research
Materials”
means
all tangible materials other than Subject Data first produced in the performance
of this CRADA.
2.7. “Research
Plan”
or
“RP”
means
the statement in Appendix
A
of the
respective research and development commitments of the Parties to this
CRADA.
2.8. “Subject
Invention”
means
any invention of a Party or Parties conceived or first actually reduced to
practice in the performance of the Research Plan of this CRADA that is or may
be
patentable or otherwise protected under title 35, United States Code, or any
novel variety of plant that is or may be protectable under the Plant Variety
Protection Act (7 U.S.C. § 2321 et seq.).
2.9. “Subject
Data”
means
all recorded information first produced by any of the Parties in the performance
of this CRADA.
ARTICLE
3
COOPERATIVE
RESEARCH
3.1. Principal
Investigators.
The USU
laboratory identified in the RP will perform USU research work under this CRADA,
and the USU and the USU PI designated in the RP will be responsible for the
scientific and technical conduct of this project on behalf of USU. The
Collaborator PI designated in the RP who will be responsible for the scientific
and technical conduct of this project on behalf of the
Collaborator.
3.2. Research
Plan Changes.
The RP
may be modified only by express written agreement of the Parties.
3.3. Compliance
With Laws.
In
conducting the research activities under this CRADA, each Party and its
employees and agents shall comply with all federal, state, and local laws,
ordinances, rules, and regulations applicable to such activities. The use and
dissemination of information, materials, and Subject Data exchanged under this
CRADA will be in accordance with all federal laws and regulations, including
but
not limited to the Federal Food, Drug and Cosmetic Act, the Biological Products
Section of the Public Health Service Act, and the regulations issued thereunder,
the International Traffic in Arms Regulations (22 CFR Part 120 et seq.),
and
the Department of Commerce Export Regulations (15 CFR Part 730 et seq.)
Nothing in this CRADA shall be construed as a license to export such
information, materials, or Subject Data or to permit any disclosure in violation
of law, regulation, or Department of Defense policy. Each exporting Party is
responsible for obtaining any export licenses that may be required by federal
law.
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ARTICLE
4
REPORTS
4.1. Interim
Reports.
USU and
the Collaborators shall exchange formal written interim progress reports on
a
schedule agreed to by the PIs, but at least within twelve- (12) months after
this CRADA becomes effective and at least once within every twelve- (12) month
period thereafter.
4.2. Final
Reports.
USU and
the Collaborators shall exchange final reports of their results within four-
(4)
months after completing the projects described in the RP or after the expiration
or termination of this CRADA, whichever first occurs. Interim and final reports
shall (i) set forth the technical progress made, identifying such problems
as
may have been encountered, (ii) identify Subject Inventions pursuant to Section
6.1, and (iii) in the case of interim reports, establish goals and objectives
requiring further effort, and describe any proposed modifications to the
Research Plan pursuant to Section 3.2.
ARTICLE
5
FINANCIAL
AND STAFFING OBLIGATIONS
5.1. Contributions
of the Parties.
The
required contributions of the Parties, including payment schedules, if
applicable, are set forth in Appendix
B.
Neither
USU nor the Foundation shall be obligated to perform any of the research
specified herein or to take any other action required by this CRADA if any
funding as set forth in Appendix
B
is not
provided.
5.2. Authority
of the Parties.
None of
the Parties hereto shall have the authority, express or implied, to bind or
commit any of the other Parties to perform or provide in any manner, or to
pay
money for, services or material with respect to any third party unless
authorized in writing by such other Party’s designated representative. Nothing
contained herein shall render any Party liable for any debts or obligations
of
the other Parties, except as otherwise specifically provided in this
CRADA.
5.3. Accounting
Records.
USU
shall maintain separate and distinct current accounts, records, and other
evidence supporting all its obligations under this CRADA, and shall provide
the
Collaborators a final fiscal report pursuant to Section 4.2. USU shall return
unused funds, if any, to the Collaborators when USU sends the final fiscal
report.
5.4. Capital
Equipment.
Equipment purchased by USU with funds provided by the Collaborators shall be
the
property of USU. All capital equipment provided under this CRADA by one Party
for the use of another Party remains the property of the providing Party unless
other disposition is mutually agreed in writing by the Parties. If title to
this
equipment remains with the providing Party, that Party is responsible for
maintenance of the equipment and the costs of its transportation to and from
the
site where it will be used.
ARTICLE
6
IP
INTERESTS
6.1. Reporting
of Subject Inventions.
Each
Party shall promptly report to the other Parties in writing each Subject
Invention and any patent applications filed thereon. Each Party shall report
all
Subject Inventions to the other Parties in sufficient detail to determine
inventorship. Such reports shall be treated as Proprietary/Confidential
Information in accordance with Section 8.4.
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6.2. Title
to and Ownership of Subject Inventions.
Inventorship shall be determined in accordance with the patent laws of the
United States of America. All Subject Inventions conceived or first actually
reduced to practice solely by an employee of a Party shall belong to the
employee (or to the employee’s employer if the employee and the employer have so
agreed). Two or more Parties shall jointly own a Subject Invention if each
of
such Parties employed at least one inventor thereof at the time of its
conception or first actual reduction to practice, provided that each Party
has
acquired the interest of its respective employee(s) in the Subject Invention.
Each Party shall cooperate with the other Party(ies) to obtain inventor
signatures on patent applications, assignments, and other documents required
to
secure IP protection.
6.3. Filing
of Patent Applications.
Each
Party shall have the primary responsibility for filing patent or other IP
applications on the Subject Inventions of its own employee(s) in a timely
manner, at its own expense, and after consultation with the other Parties.
Notwithstanding the foregoing, by mutual agreement, the Parties may identify
which Party shall file a patent application on any Subject Invention. The
Parties will consult and mutually determine a filing strategy for jointly owned
Subject Inventions.
6.4. Prosecution
of Intellectual Property Applications.
Within
one- (1) month of receipt or filing, each Party shall provide the other Parties
with copies of the applications and all documents received from or filed with
the relevant patent or other IP office in connection with the prosecution of
such applications. Each Party shall also provide the other Parties with the
power to inspect and make copies of all documents retained in the patent or
other IP application files by the applicable patent or other IP office. Where
licensing is contemplated by the Collaborators, the Parties agree to consult
with one another with respect to the prosecution of applications for USU and
Foundation Subject Inventions and jointly owned Subject Inventions described
in
Section 6.2.
6.5. Copyright
License to the Government.
The
Collaborators hereby grant to the Government and its agents a nonexclusive,
nontransferable, irrevocable, world-wide, royalty-free license to all of the
Collaborators’ rights set forth in 17 U.S.C. § 106 and § 905 in and to any and
all works of authorship and mask works, respectively, prepared pursuant to
this
CRADA.
6.6. Copyright
Statement.
The
Collaborators shall include the following statement on any work of authorship
or
mask work created in the performance of this CRADA:
“The
U.S.
Government has a copyright license in this work pursuant to a CRADA with The
Cleveland Clinic Foundation and Cleveland BioLabs, Inc.”
ARTICLE
7
LICENSING
7.1. No
License in Government or Foundation Subject Inventions.
Collaborators understand and agree that they acquire under this Agreement no
property interest in any Government or Foundation [rights to any Subject
Invention. USU and Foundation, in their discretion, respectively may offer
a
license or an option for a license to Government or Foundation IP rights in
Subject Invention(s), but no such offer or commitment is made
herein.
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7.2. License
in Collaborator Subject Inventions.
Pursuant to 15 U.S.C. § 3710a(b)(2), for Subject Inventions that, pursuant to
Section 6.2, are either solely owned by one of the Collaborators or jointly
owned by the two Collaborators, the Collaborator(s) grant(s) to the Government
a
nonexclusive, nontransferable, irrevocable, paid-up license to practice the
Subject Invention or have the Subject Invention practiced throughout the world
by or on behalf of the Government for research or other Government
purposes.
7.3. Joint
Subject Inventions.
Each
Party shall have the right to use any Subject Invention that is jointly owned
pursuant to Section 6.2 and to license its use to others in all
fields.
ARTICLE
8
PROPRIETARY
RIGHTS AND PUBLICATION
8.1. Right
of Access and Use.
The
Parties agree to exchange all Subject Data produced in the course of research
under this CRADA. The Parties agree to share Research Materials equally unless
other disposition is mutually agreed. Each of the Parties to this CRADA shall
have the right to use all Subject Data and Research Materials for their own
purposes, consistent with their obligations under this CRADA.
8.2. Ownership
of Subject Data and Research Materials.
Subject
to the sharing requirements of Paragraph 8.1 and the regulatory filing
requirements of Paragraph 8.3, the producing Party will retain ownership of
and
title to all Subject Data and all Research Materials produced solely by the
producing Party’s investigator(s). Jointly developed Subject Data and Research
Materials will be jointly owned.
8.3. Dissemination
of Subject Data and Research Materials.
To the
extent allowed under law, the Collaborators, Foundation, and USU agree to use
reasonable efforts to keep Subject Data and Research Materials confidential
until published or until corresponding patent applications are filed. Any
information that would identify human subjects of research or patients will
be
maintained confidentially and in compliance with all applicable laws and
regulations, including without limitation the Health Insurance Portability
and
Accountability Act of 1996 (HIPAA), as amended, and its implementing
regulations. To the extent permitted by law, the Collaborators shall have the
exclusive right to use any and all Subject Data in and for any regulatory filing
by or on behalf of the Collaborators, except that Foundation and USU shall
have
the exclusive right to use Subject Data for that purpose, and authorize others
to do so, if the CRADA is terminated or if the Collaborators abandon their
commercialization efforts.
8.4. Proprietary/Confidential
Information.
Each
Party agrees to limit its disclosure of Proprietary/Confidential Information
to
the amount necessary to carry out the Research Plan of this CRADA, and shall
place a confidentiality notice on all such information. Confidential oral
communications shall be identified as such at time of disclosure and shall
be
reduced to writing within thirty- (30) days by the disclosing Party. Each Party
receiving Proprietary/Confidential Information agrees that any information
so
designated shall be used by it only for the purposes described in the attached
Research Plan. Any Party may object to the designation of information as
Proprietary/Confidential Information by another Party. Subject Data and Research
Materials developed solely by a Collaborator may be designated as
Proprietary/Confidential Information when they are wholly separable from the
Subject Data and Research Materials developed jointly with USU investigators
and
advance designation of such data and material categories is set forth in the
RP.
The exchange of other confidential information, e.g., patient-identifying data,
should be similarly limited and treated.
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8.5. Protection
of Proprietary/Confidential Information.
Proprietary/Confidential Information shall not be disclosed, copied, reproduced,
or otherwise made available to any other person or entity without the consent
of
the disclosing Party except as required under court order or the Freedom of
Information Act (5 U.S.C. §552). Each Party shall protect the
Proprietary/Confidential Information of each and all of the other Parties with
at least the same degree of care used in the protection of its own
Proprietary/Confidential Information of similar character (but no less a degree
of care than a normally prudent business would exercise); none of the Parties
may disclose the Proprietary/Confidential Information of any other Party without
the prior written consent of that other Party except as specified below; each
Party shall limit disclosure thereof to employees having a need to know in
effectuating the purposes of this CRADA and who have been informed of the
confidential nature thereof and the provisions of this Article; and upon
termination of this CRADA (except to the extent otherwise provided in this
CRADA
or by written agreement of the Parties) each Party shall upon request deliver
such Proprietary/Confidential Information preserved in physical form to the
Party owning such information or, upon written consent of the owning Party,
certify in writing its destruction. Each Party agrees that the other Parties
are
not liable for the disclosure of Proprietary/Confidential Information which,
after notice to and consultation with the concerned Party, the other Party(ies)
in possession of the Proprietary/Confidential Information determine may not
be
lawfully withheld, provided the concerned Party has been given an opportunity
to
seek a court order to enjoin disclosure.
8.6. Duration
of Confidentiality Obligation.
The
obligation to maintain the confidentiality of Proprietary/Confidential
Information shall expire at the earlier of the date when the information is
no
longer Proprietary/Confidential Information as defined in Section 2.5 or five-
(5) years after the expiration or termination date of this CRADA. Any Party
may
request an extension to this term when necessary to protect
Proprietary/Confidential Information relating to products not yet
commercialized.
8.7. Publication.
The
Parties are encouraged to make publicly available the results of their research.
In order to protect rights in Subject Inventions or Proprietary/Confidential
Information, the Parties agree, during the term of this CRADA and for one-
(1)
year thereafter or such greater period as is required, to confer and consult
prior to any publication or public disclosure of information about a Subject
Invention, Subject Data, or Research Materials to ensure that no
Proprietary/Confidential Information is released and that patent rights are
not
compromised. Before any Party submits a paper or abstract for publication or
otherwise intends to publicly disclose information about a Subject Invention,
Subject Data, or Research Materials, the other Parties shall be provided thirty-
(30) days to review the proposed abstract, publication, presentation, or other
document and object to any proposed release of information. For the purposes
of
this Section, the term “disclosure” shall include submission of any manuscripts
for peer review prior to publication, as well as any oral, poster, or online
presentation. It is the responsibility of the Party intending to make public
disclosure to notify the other Parties of such intent.
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If
a
Party objects to a proposed public disclosure, that Party must so notify the
other Parties within thirty- (30) days of receiving notice of intent to disclose
publicly. If no timely objection is received by the Party intending to make
public disclosure, concurrence is assumed. If a Party objects on the grounds
that patent or other IP rights may be compromised, the publication or other
disclosure shall be delayed for up to sixty- (60) additional days upon written
request by any Party as necessary to preserve U.S. or foreign patent or other
IP
rights. A patent application must be filed by the responsible Party as
determined by Section 6.3, at the expense of the objecting Party, within ninety-
(90) days of the date of notification of intent to make public disclosure,
or by
another date mutually agreed to by the Parties.
ARTICLE
9
REPRESENTATIONS
AND WARRANTIES
9.1. Representations
and Warranties of USU.
USU
hereby represents and warrants that the official signing this CRADA has
authority to do so.
9.2. Representations
and Warranties of Foundation.
Foundation hereby represents and warrants that the official signing this CRADA
has authority to do so.
9.3. Representations
and Warranties of the Collaborators.
Each
Collaborator hereby represents and warrants that it has the requisite power
and
authority to enter into this CRADA and to perform according to its terms, and
that the Collaborator’s official signing this CRADA has authority to do so. Each
Collaborator further represents that it is financially able to satisfy all
of
its funding commitments made in Appendix
B.
ARTICLE
10
TERMINATION
10.1. Termination
By Mutual Consent.
The
Parties may terminate this CRADA, or portions thereof, at any time by mutual
written consent. In such event the Parties shall specify the disposition of
all
property, Subject Inventions, patent or other IP applications, and other results
of work accomplished or in progress, arising from or performed under this CRADA,
all in accordance with the rights granted to the Parties under the terms of
this
CRADA.
10.2. Unilateral
Termination.
Any one
of the Parties hereto may unilaterally terminate this entire CRADA at any time
by giving written notice to the other Parties at least thirty- (30) days prior
to the desired termination date, and any rights accrued in property, patents
or
other IP rights shall be disposed of as provided in paragraph 10.1, except
that
in the event of unilateral termination by a Collaborator, USU may, at its
option, retain funds previously transferred by either or both of the
Collaborators to USU for use in completing the Research Plan solely or with
another partner.
10.3. New
Commitments.
No
Party shall make new commitments related to this CRADA after a mutual
termination or notice of a unilateral termination and shall, to the extent
feasible, cancel all outstanding commitments and contracts by the termination
date. Notwithstanding the foregoing, the Foundation and USU may, at their sole
option and discretion, waive this requirement for any Parties they so choose
if
both Foundation and USU agree that such waiver is warranted.
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10.4. Termination
Costs.
Concurrently with the exchange of final reports pursuant to Sections 4.2 and
5.3, USU shall submit to the Collaborators for payment a statement of all costs
incurred prior to the date of termination and for all reasonable termination
costs including the cost of returning Collaborators property or removal of
abandoned property, for which the Collaborators shall be
responsible.
ARTICLE
11
DISPUTES
11.1. Settlement.
Any
dispute arising under this CRADA that is not disposed of by agreement of the
Principal Investigators shall be submitted jointly to the signatories of this
CRADA. If the signatories are unable to jointly resolve the dispute within
thirty- (30) days after notification thereof, the designated USU official (or
his/her designee or successor) shall propose a resolution. Nothing in this
Article shall prevent any Party from pursuing any additional administrative
remedies that may be available and, after exhaustion of such administrative
remedies and after fifteen- (15) days have passed following the proposal of
the
designated USU official, pursuing all available judicial remedies.
11.2. Continuation
of Work.
Pending
the resolution of any dispute or claim pursuant to this Article, the Parties
agree that performance of all obligations shall be pursued diligently in
accordance with the direction of the USU signatory.
ARTICLE
12
LIABILITY
12.1. Property.
The
Government shall not be responsible for damages to any Collaborator property
provided to USU, where the Collaborator retains title to the property, or any
property acquired by any Collaborator for its own use pursuant to this
CRADA.
12.2. NO
WARRANTY.
EXCEPT
AS SPECIFICALLY STATED IN ARTICLE 9, 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 CRADA, OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR
PURPOSE OF THE RESEARCH OR ANY INVENTION OR PRODUCT.
12.3. Liability
and Indemnification.
In
general, each Party shall be responsible for its own losses, obligations,
liabilities, costs, and expenses of every kind incurred by that Party or any
of
its officers, directors, employees, or agents. Each Party shall secure its
own
workers’ compensation, unemployment compensation, or like insurance for its
employees as required by law. Each Collaborator agrees to hold the Government
(including USU/AFRRI) and the Foundation harmless and to indemnify the
Government and the Foundation for all liabilities, demands, damages, expenses,
and losses arising out of the use by that Collaborator for any purpose of the
Subject Data, Research Materials, and/or Subject Inventions produced in whole
or
part by USU or Foundation employees under this CRADA, unless due to the
negligence or willful misconduct of USU, the Foundation, or the employees or
agents of either. Each Collaborator shall be liable for any claims or damages
it
incurs in connection with this CRADA. USU has no authority or obligation to
indemnify the Collaborators. To the extent authorized under the provisions
of
the Federal Tort Claims Act, including 28 U.S.C. § 2671-2680, the Government
will be liable for any loss, claim, damage, or expense caused by the negligent
or wrongful act or omission of any employee of the Department of Defense or
any
member of the United States Armed Forces while acting within the scope of his
or
her office or employment.
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12.4. Force
Majeure.
No
Party shall be liable for any unforeseeable event beyond its reasonable control
not caused by the fault or negligence of such Party, which causes such Party
to
be unable to perform its obligations under this CRADA, and which it has been
unable to overcome by the exercise of due diligence. In the event of the
occurrence of such a force
majeure
event,
the Party unable to perform shall promptly notify the other Parties. It shall
further use its best efforts to resume performance as quickly as possible and
shall suspend performance only for such period of time as is necessary as a
result of the force
majeure
event.
ARTICLE
13
MISCELLANEOUS
13.1. Governing
Law.
The
construction, validity, performance, and effect of this CRADA shall be governed
by and interpreted in accordance with U.S. federal law. To the extent that
federal law does not address an issue or that state law otherwise applies to
any
issue in any judicial or administrative proceeding, the Parties agree that
Maryland law shall apply. Federal law and regulations will preempt any
conflicting or inconsistent provisions in this CRADA.
13.2. Entire
Agreement.
This
CRADA constitutes the entire agreement between the Parties concerning the
subject matter of this CRADA and supersedes any prior understanding or written
or oral agreement.
13.3. Headings.
Titles
and headings of the articles and sections of this CRADA are for convenient
reference only, do not form a part of this CRADA, and shall in no way affect
its
interpretation.
13.4. Waivers.
None of
the provisions of this CRADA shall be considered waived by any Party unless
such
waiver is given in writing to the other Party. The failure of a Party to insist
upon strict performance of any of the terms and conditions hereof, or failure
or
delay to exercise, any rights provided herein or by law, shall not be deemed
a
waiver of any rights of any Party.
13.5. Severability.
The
illegality or invalidity of any provisions of this CRADA shall not impair,
affect, or invalidate the other provisions of this CRADA.
13.6. Amendments.
If any
Party desires a modification or extension to this CRADA, the Parties shall,
upon
reasonable notice of the proposed modification or extension by the Party
desiring the change, confer in good faith to determine the desirability of
such
modification or extension. Such modification or extension shall not be effective
until and unless a written amendment is signed by the signatories to this CRADA
or by their representatives duly authorized to execute such
amendment.
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13.7. Assignment.
Neither
this CRADA nor any rights or obligations of any Party hereunder shall be
assigned or otherwise transferred by any Party without the prior written consent
of the other Parties.
13.8. Notices.
All
notices pertaining to or required by this CRADA 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, to the addresses
indicated on the signature page for each Party. Any Party may change such
address by notice given to the other Party in the manner set forth
above.
13.9. Independent
Contractors.
The
relationship of the Parties to this CRADA is that of independent contractors
and
not agents of each other or joint venturers or partners. Each Party shall
maintain sole and exclusive control over its personnel and operations. [
employees who will be working at USU facilities may be asked to sign a Guest
Researcher or Special Volunteer Agreement appropriately modified in view of
the
terms of this CRADA.]
13.10. Use
of Name or Endorsements.
The
Collaborators shall not use the name of USU or the Foundation in any
advertising, press release, or promotional or sales literature, without their
prior written consent. By entering into this CRADA, USU and the Foundation
do
not directly or indirectly endorse any product or service provided, or to be
provided, whether directly or indirectly related either to this CRADA or to
any
patent or other IP license or agreement that implements this CRADA, by the
Collaborators, their successors, assignees, or licensees. The Collaborators
shall not in any way state or imply that this CRADA is an endorsement of any
such product or service by the Government or any of its organizational units
or
employees. Collaborator-issued press releases that reference or rely upon the
work of USU or the Foundation under this CRADA shall be made available to USU
and the Foundation at least ten- (10) business days prior to publication for
review and comment.
ARTICLE
14
DURATION
OF AGREEMENT
14.1. Duration.
This
CRADA expires five- (5) years after its Effective Date, unless otherwise
extended in writing according to the provisions of Section 13.6. It is mutually
recognized that the duration of this project cannot be rigidly defined in
advance and that the contemplated time periods for various phases of the RP
are
only good faith guidelines subject to adjustment by mutual agreement to fit
circumstances as the RP proceeds.
14.2. Survival.
The
provisions of Articles 2, 5 through 8 inclusive, and 12, as well as Sections
4.2, 10.3, 10.4, 11.1, 13.1 through 13.5 inclusive, 13.7 through 13.10
inclusive, and 14.2, shall survive the termination or expiration of this
CRADA.
REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK
SIGNATURE
PAGE TO FOLLOW
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Signature
page for CRADA between USU, Foundation and Collaborator:
FOR
USU:
| /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇, M.D. | Date: September 10, 2004 | |
|
▇▇▇▇▇
▇. ▇▇▇▇▇▇, M.D.
President
|
||
|
Mailing Address for Notices:
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||
|
Uniformed
Services University of the Health Sciences
ATTN:
General Counsel
▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
||
| FOR THE FOUNDATION: | ||
|
/s/
▇▇▇▇ ▇. ▇▇▇▇
|
Date: August 18, 2004 | |
|
▇▇▇▇
▇. ▇▇▇▇
President
|
||
| Mailing Address for Notices: | ||
|
The
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Foundation for the Advancement of Military Medicine,
Inc.
ATTN:
General Counsel
▇▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇
▇▇▇
▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
||
| FOR COLLABORATOR CCF: | ||
| /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Ph.D. | Date: September 15, 2004 | |
|
▇▇▇▇
▇. ▇▇▇▇▇▇▇▇▇, Ph.D.
Chairman
of the ▇▇▇▇▇▇ Research Institute
|
||
| Mailing Address for Notices of a Scientific Nature: | ||
|
▇▇▇▇▇▇
▇▇▇▇▇▇, Ph.D.
The
Cleveland Clinic Foundation
▇▇▇▇▇▇
Research Institute / Mailcode NC2O
▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
||
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| Mailing Address for other Notices: | ||
|
Commercialization
Counsel
CCF
Innovations/Mailcode ND2O
▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
||
| FOR COLLABORATOR CBL: | ||
| /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Ph.D. | Date: September 21, 2004 | |
|
▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, Ph.D.
Chief
Executive Officer
|
||
| Mailing Address for Notices: | ||
|
Cleveland
BioLabs, Inc.
▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Attn:
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Ph.D.
|
||
| ACKNOWLEDGED: | ||
| /s/ COL ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, MC, USA | Date: August 18, 2004 | |
|
COL
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, MC, USA
Director
USU/AFRRI
|
||
| /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, Ph.D. | Date: August 18, 2004 | |
|
▇▇▇▇
▇. ▇▇▇▇▇▇▇▇, Ph.D.
USU/AFRRI
Principal Investigator
Team
Leader
USU/AFRRI
Radiation Casualty Management Team
|
||
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