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 4301 Jones Bridge Road, Bethesda, Maryland 20814-4799;

     

    (2) The
      Henry
      M. Jackson 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 1401 Rockville Pike, Suite 600, Rockville, Maryland 20852;
      and the following two “Collaborators”:

     

    (3) The
      Cleveland Clinic Foundation (which includes the Lernerer Research Institute),
      hereinafter referred to as “CCF”,
      with
      offices at 9500 Euclid Avenue, Cleveland, Ohio 44195; and

     

    (4) Cleveland
      BioLabs, Inc., hereinafter referred to as “CBL”,
      located at 10265 Carnegie Avenue, Cleveland, Ohio 44106.

     

    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.

     

     

    


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    SIGNATURE
      PAGE TO FOLLOW

     

     

     

    
      
        
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    Signature
      page for CRADA between USU, Foundation and Collaborator:

     

    FOR
      USU:

     

    
      	/s/ James A. Zimble, M.D.	 	Date: September 10, 2004
	
              James
                A. Zimble, M.D.

              President

            	 	 
	
            	 	 
	 	 	 
	
              Mailing Address for Notices:

               

            	 	 
	
              Uniformed
                Services University of the Health Sciences

              ATTN:
                General Counsel

              4301
                Jones Bridge Road

              Bethesda,
                MD 20814

            	 
	 	 	 
	 	 	 
	FOR THE
              FOUNDATION:	 	 
	 	 	 
	
              /s/
                John W. Lowe

            	 	Date: August 18, 2004
	
              John
                W. Lowe

              President

            	 	
            
	 	 	
            
	Mailing Address for Notices:	 	
            
	
            	 	
            
	
              The
                Henry M. Jackson Foundation for the Advancement of Military Medicine,
                Inc.

              ATTN:
                General Counsel

              1401
                Rockville Pike

              Suite
                600

              Rockville,
                MD 20852

            	
            
	 	 	
            
	 	 	
            
	FOR COLLABORATOR
              CCF:	 	
            
	 	 	
            
	/s/ Paul E. DiCorleto, Ph.D.	 	Date: September 15, 2004
	
              Paul
                E. DiCorleto, Ph.D.

              Chairman
                of the Lerner Research Institute

            	 	 
	 	 	 
	 	 	 
	Mailing Address for Notices of a Scientific
              Nature:	 	 
	 	 	 
	
              Andrei
                Gudkov, Ph.D.

              The
                Cleveland Clinic Foundation

              Lerner
                Research Institute / Mailcode NC2O

              9500
                Euclid Avenue

              Cleveland,
                OH 44195

            	 	 


    

     

    
      
        
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	Mailing Address for other Notices:	 	 
	 	 	 
	
              Commercialization
                Counsel

              CCF
                Innovations/Mailcode ND2O

              9500
                Euclid Avenue

              Cleveland,
                OH 44195

            	 	 
	 	 	 
	 	 	 
	FOR COLLABORATOR
              CBL:	 	 
	 	 	 
	/s/ Michael Fonstein, Ph.D.	 	Date: September
              21, 2004
	
              Michael
                Fonstein, Ph.D.

              Chief
                Executive Officer

            	 	 
	
            	 	 
	Mailing Address for Notices:	 	 
	 	 	 
	
              Cleveland
                BioLabs, Inc.

              10265
                Carnegie Avenue

              Cleveland,
                OH 44106

              Attn:
                Michael Fonstein, Ph.D.

            	 	 
	 	 	 
	 	 	 
	ACKNOWLEDGED:	 	 
	 	 	 
	/s/
              COL David G. Jarrett, MC, USA  	 	 Date:
              August 18, 2004
	
              COL
                David G. Jarrett, MC, USA

              Director

              USU/AFRRI

            	 	 
	 	 	 
	 	 	 
	/s/ Mark H. Whitnall, Ph.D.	 	Date: August
              18, 2004
	
              Mark
                H. Whitnall, Ph.D.

              USU/AFRRI
                Principal Investigator

              Team
                Leader

              USU/AFRRI
                Radiation Casualty Management Team

            	 	 
	 	 	 


    

     

    
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