Document:

Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    AGREEMENT

    

    This
      AGREEMENT
      (“Agreement”)
      effective as of November 28, 2006
      (the
“Effective Date”) by mutual consent of Competitive Technologies, Inc.
      (hereinafter referred to as “CTT”), a Delaware corporation having a place of
      business at:

    

    Competitive
      Technologies, Inc.

    777
      Commerce Drive, Suite 100

    Fairfield,
      CT 06825

    

    and
      Michael Kiley (hereinafter referred to as “CONSULTANT”), an individual having a
      residential address at: 

    

    Michael
      Kiley

    1732
      Susquehannock Drive

    McLean,
      VA 22101

    

    CTT
      and
      CONSULTANT being sometimes hereinafter referred to singularly as a “Party” and
      collectively as “Parties”.

    

    Witnesseth

    

    WHEREAS,
      CTT
      wishes to engage CONSULTANT to provide consulting services, and CONSULTANT
      desires to provide such consulting services to CTT.

    

    NOW
      THEREFORE,
      in
      consideration of the mutual promises and covenants set forth herein, the Parties
      agree as follows: 

    

    
      	
              1.0

            	
              NATURE
                AND PLACE(S) OF SERVICE

            

    

    

    1.1 CONSULTANT
      shall provide to CTT consulting services for Business Development, New Business
      Initiatives, Strategic Planning, Technology Assessment and Valuation and
 and
      on
      such other matters as CONSULTANT and CTT may agree in writing from time to
      time
      (hereinafter called “Services”). 

    

    1.2 CONSULTANT
      shall perform Services from time to time as requested by officers of CTT. In
      performing Services, CONSULTANT shall report to such officers of
      CTT.

    

    1.3 The
      performance of the consultancy may take place at a location of the CONSULTANT’s
      choosing. However, when CONSULTANT performs Services at CTT’s offices in
      Fairfield, Connecticut, CTT shall provide CONSULTANT with the use of an office
      and shall arrange for secretarial and other necessary resources to assist
      CONSULTANT in the performance of his Services.

    

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    1.4 CONSULTANT
      will perform Services with the understanding that CONSULTANT is an independent
      contractor under the laws and rules of the United States Internal Revenue
      Service, and the laws and procedural holdings of the State of Connecticut.
      CONSULTANT is not an employee of CTT. As an independent contractor, CONSULTANT
      will not be entitled to receive, and CTT will not provide CONSULTANT with,
      life,
      medical, dental, disability or workman’s comprehensive insurance. In addition,
      CONSULTANT will not be eligible to participate in any of CTT’s incentive
      compensation plans. CONSULTANT will be responsible for the payment of all social
      security taxes, as well as all income taxes, including those payable to any
      municipal, state or federal agency. CONSULTANT will not be eligible to receive
      payment for any holidays or vacation, and CTT shall have no right to control
      CONSULTANT in the conduct of CONSULTANT’s activities under this Agreement so
      long as this Agreement is performed and fulfilled.

    

    1.5 CONSULTANT
      agrees that he shall defend, indemnify and hold harmless CTT in the event of
      any
      claim and/or any subsequent finding by any court or governmental agency that
      the
      relationship created by this Agreement is not an independent contractor
      relationship.

    

    1.6 CONSULTANT
      shall provide a monthly summary to CTT of activities performed under this
      consultancy.

    

    
      	
              2.0

            	
              NONDISCLOSURE
                AND RELEASE AGREEMENT BETWEEN THE
                PARTIES

            

    

    

    2.1 In
      order
      to allow CONSULTANT to perform Services hereunder, CONSULTANT will execute
      a
      Confidential Disclosure Agreement (“CDA”) with execution of this Agreement.
      Except as otherwise described in Section
      6.4,
      the
      terms of such CDA shall govern the handling of Confidential Information (as
      defined therein) pertaining to or resulting from this Agreement. A copy of
      said
      CDA is attached hereto as Exhibit
      A.

    

    2.2 Consultant
      shall also execute the Release Agreement attached hereto as Exhibit B
      contemporaneously with execution of this Agreement.

    

    
      	
              3.0

            	
              NOTICE
                OF TERMINATION OF
                AGREEMENT

            

    

    

    3.1 This
      Agreement shall have an initial six (6) month term commencing on November 28,
      2006 and shall thereafter renew for additional six (6) month terms by mutual
      written agreement unless sooner terminated by either Party under Section 3.2.
      

    

    3.2 Either
      CONSULTANT or CTT may terminate this Agreement at any time without providing
      thirty (30) days written notice, if the other Party shall breach its obligations
      hereunder; provided, however, that the non-breaching Party shall give the
      breaching Party written notice of such breach, and the breaching Party shall
      have fifteen (15) calendar days after receipt of such notice to cure such
      breach.

    

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    
      	
              4.0

            	
              COMPENSATION

            

    

    

    
      
        4.1
          Details.

      

    

    

    
      	 	
              4.1.1

            	
              Time.
                

            

    

    

    CTT
      agrees to retain CONSULTANT, and CONSULTANT agrees to devote sufficient time
      during the term of this Agreement to achieve the objectives of this Agreement;
      including CONSULTANT’S identifying of opportunities for CTT (including, but not
      limited to, contacts, leads and referrals) that will lead to new revenue for
      CTT. CONSULTANT
      and the CEO of CTT shall agree on the number of days that CONSULTANT will devote
      on a monthly basis under this Agreement. During the initial six month period,
      CTT shall not require less than 20 days of work per month. 

     

    4.1.2 Rate.
      

    

    CONSULTANT
      shall invoice CTT for Services at the agreed upon fee of one
      thousand dollars ($1,000.00 USD) per day for each full day that CONSULTANT
      provides Services to CTT. CONSULTANT shall invoice CTT for Services at the
      agreed upon fee of five
      hundred dollars
      ($500.00 USD) per day for each half day that CONSULTANT provides Services to
      CTT. 

    

    4.1.3 Expenses.
      

    

    
      	 	 	
              CTT
                agrees to reimburse CONSULTANT for reasonable and customary travel
                and
                accommodations incurred by CONSULTANT in performing Services,. In
                addition, CTT shall reimburse CONSULTANT for actual out-of-pocket
                expenses
                reasonably incurred in performing Services; provided that CONSULTANT
                agrees that he will not incur any expense (other than for travel
                and/or
                accommodation) in excess of two hundred and fifty dollars ($250.00
                USD)
                without prior written approval of an officer of CTT. Otherwise, CTT
                shall
                not reimburse CONSULTANT for expenses incurred in performing Services.
                

            

    

    

    
      	 	 	
              Notwithstanding
                the foregoing, all expenses referred to in this subparagraph
                4.1.5
                must be evidenced by CTT’s receipt of appropriate documentation for such
                expenses from CONSULTANT in order to be reimbursed by
                CTT.

            

    

     

    4.2 Payment.
      Payment
      for Services and the expenses referred to above will be made upon
      receipt from CONSULTANT of: (a)
      with
      respect to the initial payment hereunder, a completed Internal Revenue Service
      form W-9 and (b)
      with
      respect to the initial payment and all subsequent payments hereunder, all other
      documentation required to be delivered hereunder during the applicable payment
      period. All such payments will be made
      either
      monthly or biweekly, at CTT’s preference. Payments shall be made upon submission
      to CTT of an invoice by CONSULTANT indicating the number of days worked by
      CONSULTANT, the written report referred to in subparagraph
      1.5
      and a
      brief description of the work performed. No payments shall be made in advance
      of
      work performed. 

     

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    
      	
              5.0

            	
              ASSIGNMENT
                OR SUBCONTRACTING

            

    

    

    This
      is a
      personal services consultancy and CONSULTANT may not assign or transfer this
      Agreement, or any interest therein or claim hereunder, or subcontract any
      portion of the work hereunder, without the prior written approval of CTT. If
      CTT
      consents to such assignment or transfer, the terms and conditions of this
      Agreement shall be binding upon any assignee or transferee.

    

    

    
      	
              6.0

            	
              CONFLICT
                OF INTEREST

            

    

    

    6.1 CONSULTANT
      shall not hire any officer or employee of CTT to perform any service covered
      by
      this Agreement. 

    

    6.2 CONSULTANT
      affirms that to the best of his knowledge there exists no actual or potential
      conflict between CONSULTANT’s family, business, or financial interests and the
      Services to be provided under this Agreement, and in the event of a change
      in
      either private interests or services required under this Agreement, any question
      regarding possible conflict of interest which may arise as a result of such
      change shall be raised with CTT’s General Counsel. The Parties hereto further
      agree that no disclosure of this Agreement, either verbal or in writing, or
      of
      the relationship between the Parties shall be made without the express written
      consent of the non-disclosing Party.

    

    6.3 CONSULTANT
      affirms that for the term of this Agreement, he shall not enter into a business
      relationship with a third party that may be considered to be a conflict of
      interest with the terms and obligations CONSULTANT has with CTT as a result
      of
      this Agreement or with any agreement CONSULTANT has with said third party.
      CONSULTANT also affirms that he will not compete with CTT for a period of one
      (1) year after the termination of this Agreement, such competition to include
      the solicitation of CTT’s active clients or employees.

    

    6.4 Notwithstanding
      the terms of Article
      2.0
      herein,
      all the knowledge and information that CONSULTANT shall acquire during the
      term
      of this Agreement respecting the business of CTT shall be held by CONSULTANT
      in
      trust and in a fiduciary capacity for the sole benefit of CTT, its successors
      and assigns, and CONSULTANT agrees not to divulge or publish, or authorize
      anyone else to divulge or publish, during the term of this Agreement and for
      a
      period of three (3) years subsequent thereto, knowledge or information that
      CONSULTANT acquired in the course of his service under this Agreement, including
      any information concerning CTT’s business models and procedures that may be
      acquired.

    

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    
      	
              7.0

            	
              STANDARD
                FOR PERFORMANCE

            

    

    

    7.1 The
      Parties acknowledge that CTT, in selecting CONSULTANT to perform the Services
      hereunder, is relying upon CONSULTANT’s reputation for excellence in the
      performance of Services required hereunder. CONSULTANT shall perform Services
      in
      the manner of one who is a recognized specialist in the types of services to
      be
      performed. 

    

    7.2 CONSULTANT
      agrees to read and abide by the Competitive Technologies, Inc. Corporate Code
      of
      Conduct (“Code of Conduct”), and to complete the Corporate Code of Conduct
      Acknowledgment of Receipt and return the completed copy to CTT. A copy of the
      Code of Conduct, in which the Acknowledgment of Receipt is the last page, is
      attached hereto as Exhibit
      C.

    

    
      	
              8.0

            	
              MISCELLANEOUS

            

    

    

    8.1 Amendment
      and Waiver.
      Any
      provision of this Agreement may be amended or waived only with the written
      and
      signed consent of both Parties. Any waiver of any provision in this Agreement
      must be explicit and in a writing signed by the Party with the authority to
      waive the provision, and shall not be deemed a waiver of any other provision.
      Failure
      by a Party to enforce any provision of this Agreement or to assert a claim
      on
      account of breach of this Agreement shall not be deemed a waiver of its right
      to
      enforce the same or any other provision of this Agreement on the occasion of
      a
      subsequent breach.

    

    8.2 Severability.
      In the
      event that any court or arbitrator declares any part of this Agreement to be
      unenforceable, such unenforceability shall not invalidate any other part of
      this
      Agreement.

    

    8.3 Entire
      Agreement.
      This
      Agreement contains the entire agreement between the Parties and supersedes
      all
      prior written or oral agreements with respect to the subject matter herein.
      

    

    8.4 Applicable
      Law.
      This
      Agreement shall be governed by the laws of the State of Connecticut, but without
      recourse to that state’s conflict of laws provisions.

    

    8.5 Notice.
      Any
      payment, notice, or other communication required or permitted to be made to
      either Party hereunder shall be sufficiently made or given on the date of
      mailing if sent to such Party by certified, registered, or express mail or
      by
      known courier, by facsimile, or by hand delivery, at its address given below,
      or
      such other address as it shall hereafter designate to the other Party in
      writing:

    
      	 	 
	
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                Independent
                  Consulting Agreement between

              	
                Exhibit
                  10.1

              
	 	
                Michael
                  Kiley and Competitive Technologies, Inc.

              	 

      

    In
      the case of Competitive Technologies, Inc.:

    

    D.
      J.
      Freed, Ph.D.

    President
      and CEO

    Competitive
      Technologies, Inc.

    777
      Commerce Drive, Suite 100

    Fairfield,
      CT 06825

    

    

    with
      a copy to:

    

    Ms.
      Kristin Ann Kreuder, Esq.

    Associate
      General Counsel

    Competitive
      Technologies, Inc.

    777
      Commerce Drive, Suite 100

    Fairfield,
      CT 06825

    

    In
      the case of CONSULTANT:

    

    Michael
      Kiley

    1732
      Susquehannock Drive

    McLean,
      VA 22101

    

    8.5 Severability.
      If any
      provision of this Agreement is found by a court of competent jurisdiction to
      be
      invalid or void, such provision, to the extent possible, shall be severed from
      this Agreement, and all of the other provisions shall remain in
      effect.

    

    8.6 Integration.
      Other
      than as set forth in subparagraph
      2.0 herein,
      this Agreement expresses the full contract between the Parties, and all other
      prior or contemporaneous oral or written representations with regard to the
      subject matter hereof shall be of no effect. 

    

    8.7 Headings,
      Number and Gender.
      The
      headings of the several sections are inserted for convenience of reference
      only,
      and are not intended to be part of or to affect the meaning or interpretation
      of
      this Agreement. In this Agreement, where the context so permits, the singular
      shall include the plural, and vice versa, and references to a particular gender
      shall include the other genders.

    

    8.8 No
      Waiver.
      Failure
      by any Party to enforce any provision of this Agreement or assert a claim on
      account of breach hereof shall not be deemed a waiver of its right to enforce
      the same or any other provision hereof on the occasion of a subsequent
      breach.

    

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    8.9 Remedies.
      The
      remedies provided in this Agreement are not and shall not be deemed to be
      exclusive and shall be in addition to any other remedies that any Party may
      have
      at law or in equity.

    

    8.10 Force
      Majeure.
      No Party
      hereto shall be liable in damages or have the right to cancel this Agreement
      for
      any delay or default in performing hereunder if such delay or default is caused
      by conditions beyond its control, including but not limited to acts of God,
      government restrictions, wars, or insurrections.

    

    8.11 Execution. 
      This Agreement will not be binding upon the Parties until it has been duly
      executed by or on behalf of each Party, in which event it shall be effective
      on
      the Effective Date. No waiver, amendment or other modification hereof shall
      be
      valid or binding upon the Parties unless made in writing and duly executed
      by an
      authorized representative of both Parties.

    

    8.12 Counterparts.
      This
      Agreement may be executed in two (2) or more counterparts, each of which shall
      be deemed an original, but all of which together shall constitute one and the
      same instrument. Delivery of an executed counterpart of this Agreement by
      facsimile shall be equally effective as delivery of an original executed
      counterpart of this Agreement.

    

    8.13 Authorized
      Signatories.
      The
      undersigned individuals each represent and warrant that they have the authority
      to execute this Agreement on behalf of their respective companies or in their
      individual capacities, as the case may be. 

    

    *****

    

    

    IN
      WITNESS WHEREOF,
      the
      Parties hereto have executed this Agreement as of the dates shown below. The
      undersigned individuals each represent and warrant that they have the authority
      to execute this Agreement on behalf of their company or in their individual
      capacity, as applicable.

    

    

    
      	
              for
                Competitive Technologies, Inc.

            	 	
              CONSULTANT,
                Michael Kiley, in
                his individual capacity

            
	 	 	 	 	 
	
              By:

            	
              /s/
                Donald J. Freed

            	 	
              
                /s/
                  Michael Kiley

              

            
	 	 	 	 	 
	
              Name:

            	
              D.J.
                Freed, Ph.D.

            	 	
              Name:

            	
              Michael
                Kiley

            
	 	 	 	 	 
	
              Title:

            	
              President
                and CEO

            	 	
              Title:

            	
              Consultant

            
	 	 	 	 	 
	
              Date:

            	
              November
                28, 2006

            	 	
              Date:

            	
              November
                28, 2006

            

    

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    Soc.
      Sec. No: xxxxxxxxxx*            

     

     

    *(Your
      Social Security Number must be shown. Pursuant to Federal Privacy Act of 1974,
      you are hereby notified that disclosure of your Social Security number is
      required pursuant to Sections 6011 and 6051 of Subtitle F of the Internal
      Revenue Code and Regulation 4, Section 404, 1256, CFR, under Section 218, Title
      II of the Social Security Act, as amended. The Social Security Number is to
      verify your identity. The principal use of the number shall be to report
      payments you have received to Federal and State governments.)

    

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    EXHIBIT
      A

    

    Confidential
      Disclosure Agreement

    

    

    

    (Please
      see the attached )

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    EXHIBIT
      B

    Release
      Agreement

    

     

    

    (Please
      see the attached )

    
      	 	 
	
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              Independent
                Consulting Agreement between

            	
              Exhibit
                10.1

            
	 	
              Michael
                Kiley and Competitive Technologies, Inc.

            	 

    

    EXHIBIT
      C

    

    CTT
      Corporate Code of Conduct

    

    

     

    (Please
      see the attached)

    

      
        	 	 
	
                Rev.112206

              	
                Page
                  11 of 11Exhibit
      10.1

     

    PUBLIC
      HEALTH SERVICE

     

    COOPERATIVE
      RESEARCH AND DEVELOPMENT AGREEMENT

     

    This
      Agreement is based on the model Cooperative Research and Development Agreement
      (“CRADA “) adopted by the U.S. Public Health Service (“PHS”) Technology Transfer
      Policy Board for use by components of the National Institutes of Health (“NIH”),
      the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug
      Administration (“FDA “), which are agencies of the PHS within the Department of
      Health and Human Services (“HHS”). 

     

    This
      Cover Page identifies the Parties to this CRADA: 

     

    The
      U.S.
      Department of Health and Human Services, as represented by

    National
      Institute of Neurological Disorders and Stroke

    an
      Institute, Center, or Division (hereinafter referred to as the “ICD”)
      of
      the

    the
      National Institutes of Health

     

    and
      

     

    Lixte,
      Inc.

    hereinafter
      referred to as the “Collaborator”,

    having
      offices at 6 Tinker Lane, East Setatuket, New York 11733

    created
      and operating under the laws of Delaware. 

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

    COOPERATIVE
      RESEARCH AND DEVELOPMENT AGREEMENT

     

    Article
      1.   Introduction
      

     

    This
      CRADA between ICD and Collaborator will be effective when signed by the Parties,
      which are identified on both the Cover Page and the Signature Page (page 16).
      The official contacts for the Parties are identified on the Contacts Information
      Page (page 17). Publicly available information regarding this CRADA appears
      on
      the Summary Page (page 18). The research and development activities that will
      be
      undertaken by ICD and Collaborator in the course of this CRADA are detailed
      in
      the Research Plan, attached as Appendix A. The staffing, funding, and materials
      contributions of the Parties are set forth in Appendix B. Any changes to the
      model CRADA are set forth in Appendix C. 

     

    Article
      2.   Definitions
      

     

    The
      terms
      listed in this Article will carry the meanings indicated throughout the CRADA.
      To the extent a definition of a term as provided in this Article is inconsistent
      with a corresponding definition in the applicable sections of either the United
      States Code (U.S.C.) or the Code of Federal Regulations (C.F.R.), the definition
      in the U.S.C. or C.F.R. will control. 

     

    
      	2.1       
                	
              “Affiliate”
                means any corporation or other business entity controlled by, controlling,
                or under common control with Collaborator at any time during the
                term of
                the CRADA. For this purpose, “control” means direct or indirect beneficial
                ownership of at least fifty percent (50%) of the voting stock or
                at least
                fifty percent (50%) interest in the income of the corporation or
                other
                business entity. 

            

    

     

    
      	2.2          	
              “Background
                Invention”
                means an Invention conceived and first actually reduced to practice
                before
                the Effective Date. 

            

    

     

    
      	2.3        
               	
              “Collaborator
                Materials”
                means all tangible materials not first produced in the performance
                of this
                CRADA that are owned or controlled by Collaborator and used in the
                performance of the Research Plan. 

            

    

     

    
      	2.4        
               	
              “Confidential
                Information”
                means confidential scientific, business, or financial information
                provided
                that the information does not include:

            

    

     

    
      	(a)  	
              information
                that is publicly known or that is available from public sources;
                

            

    

     

    
      	(b)  	
              information
                that has been made available by its owner to others without a
                confidentiality obligation;

            

    

     

    
      	(c)  	
              information
                that is already known by the receiving Party, or information that
                is
                independently created or compiled by the receiving Party without
                reference
                to or use of the provided information; or

            

    

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

       

    

    
      	(d)  	
              information
                that relates to potential hazards or cautionary warnings associated
                with
                the production, handling, or use of the subject matter of the Research
                Plan.

            

    

     

    
      	2.5    
                   	
              “Cooperative
                Research and Development Agreement”
                or “CRADA”
                means this Agreement, entered into pursuant to the Federal Technology
                Transfer Act of I 986. as amended (§ 15 U.S.C. §§ 3710a et
                seq.),
                and Executive Order 12591 of April 10, 1987.

            

    

     

    
      	2.6    
                   	
              “CRADA
                Data”
                means all recorded information first produced in the performance
                of the
                Research Plan. 

            

    

     

    
      	2.7        
               	
              “CRADA
                Materials”
                means all tangible materials first produced in the performance of
                the
                Research Plan other than CRADA Data.

            

    

     

    
      	2.8       
                	
              “CRADA
                Subject Invention”
                means any Invention of either or both Parties, conceived or first
                actually
                reduced to practice in the performance of the Research Plan.
                

            

    

     

    
      	2.9       
                	
              “Effective
                Date”
                means the date of the last signature of the Parties executing this
                Agreement. 

            

    

     

    
      	2.10     
                	
              “Government”
                means the Government of the United States of America.
                

            

    

     

    
      	2.11     
                	
              “ICD
                Materials”
                means all tangible materials not first produced in the performance
                of this
                CRADA that are owned or controlled by ICD and used in the performance
                of
                the Research Plan. 

            

    

     

    
      	2.12     
                	
              “Invention”
                means any invention or discovery that is or may be patentable or
                otherwise
                protected under Title 35 of the United States Code, or any novel
                variety
                of plant which is or may be protectable under the Plant Variety Protection
                Act, 7 U.S.C. §§ 2321 et
                seq.
                

            

    

     

    
      	2.13     
                	
              “Patent
                Application”
                means an application for patent protection for a CRADA Subject Invention
                with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the
                corresponding patent-issuing authority of another nation.
                

            

    

     

    
      	2.14     
                	
              “Patent”
                means any issued United States patent, any international counterpart(s),
                and any corresponding grant(s) by a non-U.S. government in place
                of a
                patent. 

            

    

     

    
      	2.15     
                	
              “Principal
                Investigator(s)”
                or “PI(s)”
                means the person(s) designated by the Parties who will be responsible
                for
                the scientific and technical conduct of the Research Plan. .
                

            

    

     

    
      	2.16     
                	
              “Research
                Plan”
                means the statement in Appendix A of the respective research and
                development commitments of the Parties.

            

    

     

    Article
      3.   Cooperative
      Research and Development 

     

    
      	3.1       
                	
              Performance
                of Research and Development.
                The research and development activities to be carried out under this
                CRADA
                will be performed solely by the Parties identified on the Cover Page
                unless specifically stated elsewhere in this Agreement. The PIs will
                be
                responsible for the scientific and technical conduct of this project
                on
                behalf of their employers. Any Collaborator employees who will work
                at ICD
                facilities will be required to sign a Guest Researcher or Special
                Volunteer Agreement appropriately modified in view of the terms of
                this
                CRADA. 

            

    

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

     

    
      	3.2       
                	
              Research
                Plan.
                The Parties recognize that the Research Plan describes the collaborative
                research and development activities they will undertake and that
                interim
                research goals set forth in the Research Plan are good faith guidelines.
                Should events occur that require modification of these goals, then
                by
                mutual agreement the Parties can modify them through an amendment,
                according to Paragraph 13.6. 

            

    

     

    
      	3.3       
                	
              Use
                and Disposition of Collaborator Materials and ICD
                Materials.
                The Parties agree to use Collaborator Materials and ICD Materials
                only in
                accordance with the Research Plan, not to transfer these materials
                to
                third parties except in accordance with the Research Plan or as approved
                by the owning or providing Party, and, upon expiration or termination
                of
                the CRADA, to dispose of these materials as directed by the owning
                or
                providing Party. 

            

    

     

    
      	3.4       
                	
              Third-Party
                Rights in Collaborator’s CRADA Subject Inventions.
                If Collaborator has received (or will receive) support of any kind
                from a
                third party in exchange for rights in any of Collaborator’s CRADA Subject
                Inventions, Collaborator agrees to ensure that its obligations to
                the
                third party are both consistent with Articles 6 through 8 and subordinate
                to Article 7 of this CRADA. 

            

    

     

    
      	3.5       
                	
              Disclosures
                to ICD.
                Prior to execution of this CRADA, Collaborator agrees to disclose
                to ICD
                all instances in which outstanding royalties are due under a PHS
                license
                agreement, and in which Collaborator had a PHS license terminated
                in
                accordance with 37 C.F .R. § 404.10. These disclosures will be treated as
                Confidential Information upon request by Collaborator in accordance
                with
                Paragraphs 2.4, 8.3, and 8.4. 

            

    

     

    Article
      4.   Reports
      

     

    
      	4.1       
                	
              Interim
                Research and Development Reports.
                The PIs should exchange information regularly, in writing. This exchange
                may be accomplished through meeting minutes, annual reports, detailed
                correspondence, and circulation of draft manuscripts.
                

            

    

     

    
      	4.2       
                	
              Final
                Research and Development Reports.
                The Parties will exchange final reports of their results within four
                (4)
                months after the expiration or termination of this CRADA. These reports
                will set forth the technical progress made; any publications arising
                from
                the research; and the existence of invention disclosures of potential
                CRADA Subject Inventions and/or any corresponding Patent Applications.
                

            

    

     

    
      	4.3       
                	
              Fiscal
                Reports.
                If Collaborator has agreed to provide funding to ICD under this CRADA
                and
                upon the request of Collaborator, then concurrent with the exchange
                of
                final research and development reports according to Paragraph 4.2,
                ICD
                will submit to Collaborator a statement of all costs incurred by
                ICD for
                the CRADA. If the CRADA has been terminated, ICD will specify any
                costs
                incurred before the date of termination for which ICD has not received
                funds from Collaborator, as well as for all reasonable termination
                costs
                including the cost of returning Collaborator property or removal
                of
                abandoned Collaborator property, for which Collaborator will be
                responsible. 

            

    

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    

     

    Article
      5.   Staffing,
      Financial, and Materials Obligations 

     

    
      	5.1        
               	
              ICD
                and Collaborator Contributions.
                The contributions of any staff, funds, materials, and equipment by
                the
                Parties are set forth in Appendix B. The Federal Technology Transfer
                Act
                of 1986, l5 U.S.C. § 37l0a(d)(1) prohibits ICD from providing funds to
                Collaborator for any research and development activities under this
                CRADA.
                

            

    

     

    
      	5.2       
                	
              ICD
                Staffing.
                No ICD employees will devote 100% of their effort or time to the
                research
                and development activities under this CRADA. ICD will not use funds
                provided by Collaborator under this CRADA for ICD personnel to pay
                the
                salary of, any permanent ICD employee. Although personnel hired by
                ICD
                using CRADA funds will focus principally on CRADA research and development
                activities, Collaborator acknowledges that these personnel may nonetheless
                make contributions to other research and development activities,
                and the
                activities will be outside the scope of this CRADA.
                

            

    

     

    
      	5.3       
                	
              Collaborator
                Funding.
                Collaborator acknowledges that Government funds received by Collaborator
                from an agency of the Department of Health and Human Services may
                not be
                used to fund ICD under this CRADA. If Collaborator has agreed to
                provide
                funds to ICD then the payment schedule appears in Appendix B and
                Collaborator will make payments according to that schedule. If
                Collaborator fails to make any scheduled payment, ICD will not be
                obligated to perform any of the research and development activities
                specified herein or to take any other action required by this CRADA
                until
                the funds are received. ICD will use these funds exclusively for
                the
                purposes of this CRADA. Each Party will maintain separate and distinct
                current accounts, records, and other evidence supporting its financial
                obligations under this CRADA and, upon written request, will provide
                the
                other Party a Fiscal Report according to Paragraph 4.3, which delineates
                all payments made and all obligated expenses, along with the Final
                Research Report described in Paragraph 4.2.

            

    

     

    
      	5.4     
                     	
              Capital
                Equipment.
                Collaborator’s commitment, if any, to provide ICD with capital equipment
                to enable the research and development activities under the Research
                Plan
                appears in Appendix B. If Collaborator transfers to ICD the capital
                equipment or provides funds for ICD to purchase it, then ICD will
                own the
                equipment. If Collaborator loans capital equipment to ICD for use
                during
                the CRADA, Collaborator will be responsible for paying all costs
                and fees
                associated with the transport, installation, maintenance, repair,
                removal,
                or disposal of the equipment, and ICD will not be liable for any
                damage to
                the equipment. 

            

    

     

    Article
      6.   Intellectual
      Property 

     

    
      	6.1       
                	
              Ownership
                of CRADA Subject Inventions, CRADA Data, and CRADA
                Materials.
                Subject to the Government license described in Paragraph 7.5, the
                sharing
                requirements of Paragraph 8.1, and the regulatory filing requirements
                of
                Paragraph 8.2, the producing Party will retain sole ownership of
                and title
                to all CRADA Subject Inventions, all copies of CRADA Data, and all
                CRADA
                Materials produced solely by its employee(s). The Parties will own
                jointly
                all CRADA Subject Inventions invented jointly and all copies of CRADA
                Data
                and all CRADA Materials developed jointly.

            

    

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    

     

    
      	6.2       
                	
              Reporting.
                The Parties will promptly report to each other in writing each CRADA
                Subject Invention reported by their respective personnel, and any
                Patent
                Applications filed thereon, resulting from the research and development
                activities conducted under this CRADA. Each Party will report all
                CRADA
                Subject Inventions to the other Party in sufficient detail to determine
                inventorship, which will be determined in accordance with U.S. patent
                law.
                These reports will be treated as Confidential Information in accordance
                with Article 8. Formal reports will be made by and to the Patenting
                and
                Licensing Offices identified on the Contacts Information Page herein.
                

            

    

     

    
      	6.3       
                	
              Filing
                of Patent Applications.
                Each Party will make timely decisions regarding the filing of Patent
                Applications on the CRADA Subject Inventions made solely by its
                employee(s), and will notify the other Party in advance of filing.
                Collaborator will have the first opportunity to file a Patent Application
                on joint CRADA Subject Inventions and will notify PHS of its decision
                within sixty (60) days of an Invention being reported or at least
                thirty
                (30) days before any patent filing deadline, whichever occurs sooner.
                If
                Collaborator fails to notify PHS of its decision within that time
                period
                or notifies PHS of its decision not to file a Patent Application,
                then PHS
                has the right to file a Patent Application on the joint CRADA Subject
                Invention. Neither Party will be obligated to file a Patent Application.
                Collaborator will place the following statement in any Patent Application
                it files on a CRADA Subject Invention: “This invention was created in the
                performance of a Cooperative Research and Development Agreement with
                the
                National Institutes of Health, an Agency of the Department of Health
                and
                Human Services. The Government of the United States has certain rights
                in
                this invention.” If either Party files a Patent Application on a joint
                CRADA Subject Invention, then the filing Party will include a statement
                within the Patent Application that clearly identifies the Parties
                and
                states that the joint CRADA Subject Invention was made under this
                CRADA.
                

            

    

     

    
      	6.4       
                	
              Patent
                Expenses.
                Unless agreed otherwise, the Party filing a Patent Application will
                pay
                all preparation and filing expenses, prosecution fees, issuance fees,
                post
                issuance fees, patent maintenance fees, annuities, interference expenses,
                and attorneys’ fees for that Patent Application and any resulting
                Patent(s). If a license to any CRADA Subject Invention is granted
                to
                Collaborator, then Collaborator will be responsible for all expenses
                and
                fees, past and future, in connection with the preparation, filing,
                prosecution, and maintenance of any Patent Applications and Patents
                claiming exclusively-licensed CRADA Subject Inventions and will be
                responsible for a pro-rated share, divided equally among
                all licensees, of those expenses and fees for non-exclusively licensed
                CRADA Subject Inventions. Collaborator may waive its exclusive option
                rights at any time, and incur no subsequent financial obligation
                for those
                Patent Application(s) or Patent(s) 

            

    

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

       

    

    
      	6.5        
               	
              Prosecution
                of Patent Applications.
                The Party filing a Patent Application will provide the non-filing
                Party
                with a copy of any official communication relating to prosecution
                of the
                Patent Application within thirty (30) days of transmission of the
                communication. Each Party will also provide the other Party with
                the power
                to inspect and make copies of all documents retained in the applicable
                Patent Application or Patent file. The Parties agree to consult with
                each
                other regarding the prosecution of Patent Applications directed to
                joint
                CRADA Subject Inventions. If Collaborator elects to file and prosecute
                Patent Applications on joint CRADA Subject Inventions, then Collaborator
                agrees to use the U.S.P.T.O. Customer Number Practice and/or grant
                PHS a
                power(s) of attorney (or equivalent) necessary to assure PHS access
                to its
                intellectual property rights in these Patent Applications. PHS and
                Collaborator will cooperate with each other to obtain necessary signatures
                on Patent Applications, assignments, or other documents.
                

            

    

     

    Article
      7.   Licensing
      

     

    
      	7.1       
                	
              Background
                Inventions.
                Other than as specifically stated in this Article 7, nothing in this
                CRADA
                will be construed to grant any rights in one Party’s Background
                Invention(s) to the other Party, except to the extent necessary for
                the
                Parties to conduct the research and development activities described
                in
                the Research Plan. 

            

    

     

    
      	7.2       
                	
              Collaborator’s
                License Option to CRADA Subject Inventions.
                With respect to Government rights to any CRADA Subject Invention
                made
                solely by an ICD employee(s) or made jointly by an ICD employee(s)
                and a
                Collaborator employee(s) for which a Patent Application was filed,
                PHS
                hereby grants to Collaborator an exclusive option to elect an exclusive
                or
                nonexclusive commercialization license. The license will be substantially
                in the form of the appropriate model PHS license agreement and will
                fairly
                reflect the nature of the CRADA Subject Invention, the relative
                contributions of the Parties to the CRADA Subject Invention and the
                CRADA,
                a plan for the development and marketing of the CRADA Subject Invention,
                the risks incurred by Collaborator, and the costs of subsequent research
                and development needed to bring the CRADA Subject Invention to the
                marketplace. The field of use of the license will not exceed the
                scope of
                the Research Plan. 

            

    

     

    
      	7.3       
                	
              Exercise
                of Collaborator’s License Option.
                To exercise the option of Paragraph 7.2 Collaborator must submit
                a written
                notice to the PHS Patenting and Licensing Contact identified on the
                Contacts Information Page (and provide a copy to the ICD Contact
                for CRADA
                Notices) within three (3) months after either (i) Collaborator receives
                written notice from PHS that the Patent Application has been filed
                or (ii)
                the date on which Collaborator files the Patent Application. The
                written
                notice exercising this option will include a completed “Application for
                License to Public Health Service Inventions” and will initiate a
                negotiation period that expires nine (9) months after the exercise
                of the
                option. If PHS has not responded in writing to the last proposal
                by
                Collaborator within this nine (9) month period, the negotiation period
                will be extended to expire one (1) month after PHS so responds, during
                which month Collaborator may accept in writing the final license
                proposal
                of PHS. In the absence of Collaborator’s exercise of the option, or upon
                election of a nonexclusive license, PHS will be free to license the
                CRADA
                Subject Invention to others. These time periods may be extended at
                the
                sole discretion of PHS upon good cause shown in writing by Collaborator.
                

            

    

     

    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

       

    

    
      	7.4       
                	
              Government
                License in ICD Sole CRADA Subject Inventions and Joint CRADA Subject
                Inventions.
                Pursuant to 15 U.S.C. § 3710a(b)(1)(A), for CRADA Subject Inventions owned
                solely by ICD or jointly by ICD and Collaborator, and licensed pursuant
                to
                the option of Paragraph 7.2, Collaborator grants to the Government
                a
                nonexclusive, nontransferable, irrevocable, paid-up license to practice
                the CRADA Subject Invention or have the CRADA Subject Invention practiced
                throughout the world by or on behalf of the Government. In the exercise
                of
                this license, the Government will not publicly disclose trade secrets
                or
                commercial or financial information that is privileged or confidential
                within the meaning of 5 U.S.C. § 552(b)(4) or which would be considered
                privileged or confidential if it had been obtained from a non-federal
                party. 

            

    

     

    
      	7.5  
                       	
              Government
                License in Collaborator Sole CRADA Subject Inventions.
                Pursuant to 15 U.S.C. § 3710a(b)(2), for CRADA Subject Inventions made
                solely by an employee of Collaborator, Collaborator grants to the
                Government a nonexclusive, nontransferable, irrevocable, paid-up
                license
                to practice the CRADA Subject Invention or have the CRADA Subject
                Invention practiced throughout the world by or on behalf of the Government
                for research or other Government purposes.

            

    

     

    
      	7.6       
                	
              Third
                Party License.
                Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants an exclusive license
                to a CRADA Subject Invention made solely by an ICD employee or jointly
                with a Collaborator employee, the Government will retain the right
                to
                require Collaborator to grant to a responsible applicant a nonexclusive,
                partially exclusive, or exclusive sublicense to use the CRADA Subject
                Invention in Collaborator’s licensed field of use on terms that are
                reasonable under the circumstances; or, if Collaborator fails to
                grant a
                license, to grant the license itself. The exercise of these rights
                by the
                Government will only be in exceptional circumstances and only if
                the
                Government determines (i) the action is necessary to meet health
                or safety
                needs that are not reasonably satisfied by Collaborator, (ii) the
                action
                is necessary to meet requirements for public use specified by federal
                regulations, and such requirements are not reasonably satisfied by
                Collaborator; or (iii) Collaborator has failed to comply with an
                agreement
                containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The
                determination made by the Government under this Paragraph is subject
                to
                administrative appeal and judicial review under 35 U.S.C. § 203(2).
                

            

    

     

    
      	7.7       
                	
              Third-Party
                Rights In ICD Sole CRADA Subject Inventions.
                For a CRADA Subject Invention conceived prior to the Effective Date
                solely
                by an ICD employee that is first actually reduced to practice after
                the
                Effective Date in the performance of the Research Plan, the option
                offered
                to Collaborator in Paragraph 7.2 may be restricted if, before the
                Effective Date, PHS had filed a Patent Application and has either
                offered
                or granted a license or has executed a license in the CRADA Subject
                Invention to a third party. Collaborator nonetheless retains the
                right to
                apply for a license to any such CRADA Subject Invention in accordance
                with
                the terms and procedures of 35 U.S.C. § 209 and 37 C.F.R. Part 404.
                

            

    

     

    
      
        
        

      

      
        8

        
          

        

      

      
        
        

      

    

     

    
      	7.8       
                	
              Joint
                CRADA Subject Inventions Not Exclusively Licensed by
                Collaborator.
                If Collaborator does not acquire an exclusive commercialization license
                in
                a joint CRADA Subject Invention in all fields of use then, for those
                fields of use not exclusively licensed to Collaborator, each Party
                will
                have the right to use the joint CRADA Subject Invention and to license
                its
                use to others, and each Party will cooperate with the other, as necessary,
                to fulfill international licensing requirements. The Parties may
                agree to
                a joint licensing approach for any remaining fields of use.
                

            

    

     

    Article
      8.   Rights
      of Access and Publication 

     

    
      	8.1       
                	
              Right
                of Access to CRADA Data and CRADA Materials.
                ICD and Collaborator agree to exchange all CRADA Data and to share
                all
                CRADA Materials. If the CRADA is terminated, both Parties agree to
                provide
                CRADA Materials in quantities needed to complete the Research Plan.
                Such
                provision will occur before the termination date of the CRADA or
                sooner,
                if required by the Research Plan. 

            

    

     

    
      	8.2       
                	
              Use
                of CRADA Data and CRADA Materials.
                The Parties will be free to utilize CRADA Data and CRADA Materials
                internally for their own purposes, consistent with their obligations
                under
                this CRADA. The Parties may share CRADA Data or CRADA Materials with
                their
                Affiliates, agents or contractors provided the obligations of this
                Article
                8.2 are simultaneously conveyed. 

            

    

     

    
      	(a)  	
              CRADA
                Data. 

            

    

    
      	 	 

    

    
      	 	Collaborator and ICD will use reasonable efforts
              to keep
              CRADA Data confidential until published or until corresponding Patent
              Applications are filed. To the extent permitted by law, each Party
              will
              have the right to use any and all CRADA Data in and for any regulatory
              filing by or on behalf of the Party.

    

     

     

    
      	(b)  	
              CRADA
                Materials. 

            

    

     

    Collaborator
      and ICD will use reasonable efforts to keep descriptions of CRADA Materials
      confidential until published or until corresponding Patent Applications are
      filed. Collaborator acknowledges that the basic research mission of PHS includes
      sharing with third parties for further research those research resources made
      in
      whole or in part with NIH funding. Consistent with this mission and the tenets
      articulated in “Sharing of Biomedical Research Resources: Principles and
      Guidelines for Recipients of NIH Research Grants and Contracts”, December 1999,
      available at http://ott.od.nih.gov/NewPages/RTguide_final.html, following
      publication either Party may make available to third parties for further
      research those CRADA Materials made jointly by both PHS and Collaborator.
      Notwithstanding the above, if those joint CRADA Materials are the subject of
      a
      pending Patent Application or a Patent, the Parties may agree to restrict
      distribution or freely distribute them. Either Party may distribute those CRADA
      Materials made solely by the other Party only upon written consent from that
      other Party or that other Party’s designee. 

     

    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    

     

    
      	8.3  
                     	
              Confidential
                Information.
                Each Party agrees to limit its disclosure of Confidential Information
                to
                the amount necessary to carry out the Research Plan, and will place
                a
                confidentiality notice on all such information. A Party orally disclosing
                Confidential Information to the other Party will summarize the disclosure
                in writing and provide it to the other Party within fifteen (15)
                days of
                the disclosure. Each Party receiving Confidential Information agrees
                to
                use it only for the purposes described in the Research Plan. Either
                Party
                may object to the designation of information as Confidential Information
                by the other Party. 

            

    

     

    
      	8.4       
                	
              Protection
                of Confidential Information.
                Confidential Information will not be disclosed, copied, reproduced
                or
                otherwise made available to any other person or entity without the
                consent
                of the owning or providing Party except as required by a court or
                administrative body of competent jurisdiction, or federal law or
                regulation. Each Party agrees to use reasonable efforts to maintain
                the
                confidentiality of Confidential Information, which will in no instance
                be
                less effort than the Party uses to protect its own Confidential
                Information. Each Party agrees that a Party receiving Confidential
                Information will not be liable for the disclosure of that portion
                of the
                Confidential Information which, after notice to and consultation
                with the
                disclosing Party, the receiving Party determines may not be lawfully
                withheld, provided the disclosing Party has been given a reasonable
                opportunity to seek a court order to enjoin disclosure.
                

            

    

     

    
      	8.5       
                	
              Protection
                of Human Subjects’ Information.
                The research and development activities to be conducted under this
                CRADA
                are not intended to involve human subjects or human tissues within
                the
                meaning of 45 C.F .R. Part 46 and 21 C.F.R. Part 50. Should it become
                necessary to utilize human subjects or human tissues, or to provide
                a
                Party with access to information about identifiable human subjects,
                the
                Parties agree to amend this CRADA in accordance with Paragraph 13.6
                to
                ensure that the research and development activities conducted hereunder
                will conform to the appropriate federal laws and regulations, including
                but not limited to all applicable FDA regulations and HHS regulations
                relating to the protection of human subjects.

            

    

     

    
      	8.6       
                	
              Duration
                of Confidentiality Obligation.
                The obligation to maintain the confidentiality of Confidential Information
                will expire at the earlier of the date when the information is no
                longer
                Confidential Information as defined in Paragraph 2.4 or three (3)
                years
                after the expiration or termination date of this CRADA. Collaborator
                may
                request an extension to this term when necessary to protect Confidential
                Information relating to products not yet commercialized.
                

            

    

     

    
      	8.7       
                	
              Publication.
                The Parties are encouraged to make publicly available the results
                of their
                research and development activities. Before either Party submits
                a paper
                or abstract for publication or otherwise intends to publicly disclose
                information about a CRADA Subject Invention, CRADA Data or CRADA
                Materials, the other Party will have thirty (30) days to review the
                proposed publication or disclosure to assure that Confidential Information
                is protected. Either Party may request in writing that the proposed
                publication or other disclosure be delayed for up to thirty (30)
                additional days as necessary to file a Patent Application.
                

            

    

     

    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

     

    Article
      9.   Representations
      and Warranties 

     

    
      	9.1       
                	
              Representations
                of ICD.
                ICD hereby represents to Collaborator that:

            

    

     

    
      	(a)  	
              ICD
                has the requisite power and authority to enter into this CRADA and
                to
                perform according to its terms, and that ICD’s official signing this CRADA
                has authority to do so. 

            

    

     

    
      	(b)  	
              To
                the best of its knowledge and belief, neither ICD nor any of its
                personnel
                involved in this CRADA is presently subject to debarment or suspension
                by
                any agency of the Government which would directly affect its performance
                of the CRADA. Should ICD or any of its personnel involved in this
                CRADA be
                debarred or suspended during the term of this CRADA, ICD will notify
                Collaborator within thirty (30) days of receipt of final notice.
                

            

    

     

    
      	9.2       
                	
              Representations
                and Warranties of Collaborator.
                Collaborator hereby represents and warrants to ICD that:
                

            

    

     

    
      	(a)  	
              Collaborator
                has the requisite power and authority to enter into this CRADA and
                to
                perform according to its terms, and that Collaborator’s official signing
                this CRADA has authority to do so. 

            

    

     

    
      	(b)  	
              Neither
                Collaborator nor any of its personnel involved in this CRADA, including
                Affiliates, agents, and contractors are presently subject to debarment
                or
                suspension by any agency of the Government. Should Collaborator or
                any of
                its personnel involved in this CRADA be debarred or suspended during
                the
                term of this CRADA, Collaborator will notify ICD within thirty (30)
                days
                of receipt of final notice. 

            

    

     

    
      	(c)  	
              Subject
                to Paragraph 12.3, and if and to the extent Collaborator has agreed
                to
                provide funding under Appendix B, Collaborator is financially able
                to
                satisfy these obligations in a timely manner.

            

    

     

    Article
      10.   Expiration
      and Termination 

     

    
      	10.1     
                   	
              Expiration.
                This CRADA will expire on the last date of the term set forth on
                the
                Summary Page. In no case will the term of this CRADA extend beyond
                the
                term indicated on the Summary Page unless it is extended in writing
                in
                accordance with Paragraph 13.6. 

            

    

     

    
      	10.2     
                	
              Termination
                by Mutual Consent.
                ICD and Collaborator may terminate this CRADA at any time by mutual
                written consent. 

            

    

     

    
      	10.3     
                	
              Unilateral
                Termination.
                Either ICD or Collaborator may unilaterally terminate this CRADA
                at any
                time by providing written notice at least sixty (60) days before
                the
                desired termination date. ICD may, at its option, retain funds transferred
                to ICD before unilateral termination by Collaborator for use in completing
                the Research Plan. 

            

    

     

    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    

     

    
      	10.4      
               	
              Funding
                for ICD Personnel.
                If Collaborator has agreed to provide funding for ICD personnel and
                this
                CRADA is mutually or unilaterally terminated by Collaborator before
                its
                expiration, then Collaborator agrees that funds for that purpose
                will be
                available to ICD for a period of six (6) months after the termination
                date
                or until the expiration date of the CRADA, whichever occurs sooner.
                If
                there are insufficient funds to cover this expense, Collaborator
                agrees to
                pay the difference. 

            

    

     

    
      	10.5     
                	
              New
                Commitments.
                Neither Party will incur new expenses related to this CRADA after
                expiration, mutual termination, or a notice of a unilateral termination
                and will, to the extent feasible, cancel all outstanding commitments
                and
                contracts by the termination date. Collaborator acknowledges that
                ICD will
                have the authority to retain and expend any funds for up to one (1)
                year
                subsequent to the expiration or termination date to cover any unpaid
                costs
                obligated during the term of the CRADA in undertaking the research
                and
                development activities set forth in the Research Plan.
                

            

    

     

    Article
      11.   Disputes
      

     

    
      	11.1        
                	
              Settlement.
                Any dispute arising under this CRADA which is not disposed of by
                agreement
                of the Principal Investigators will be submitted jointly to the
                signatories of this CRADA. If the signatories, or their designees,
                are
                unable to jointly resolve the dispute within thirty (30) days after
                notification thereof, the Assistant Secretary for Health (or his/her
                designee or successor) will propose a resolution. Nothing in this
                Paragraph will prevent any Party from pursuing any additional
                administrative remedies that may be available and, after exhaustion
                of
                such administrative remedies, pursuing all available judicial remedies.
                

            

    

     

    
      	11.2     
                	
              Continuation
                of Work.
                Pending the resolution of any dispute or claim pursuant to this Article
                11, the Parties agree that performance of all obligations will be
                pursued
                diligently. 

            

    

     

    Article
      12.   Liability
      

     

    
      	12.1     
                	
              NO
                WARRANTIES.
                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 MATERIAL, WHETHER TANGIBLE OR INTANGIBLE,
                MADE OR DEVELOPED UNDER OR OUTSIDE THE SCOPE OF THIS CRADA, OR THE
                OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF
                THE
                RESEARCH OR ANY INVENTION OR MATERIAL, OR THAT A TECHNOLOGY UTILIZED
                BY A
                PARTY IN THE PERFORMANCE OF THE RESEARCH PLAN DOES NOT INFRINGE ANY
                THIRD-PARTY PATENT RIGHTS.

            

    

     

    
      	12.2     
                	
              Indemnification
                and Liability.
                Collaborator agrees to hold the Government harmless and to indemnify
                the
                Government for all liabilities, demands, damages, expenses and losses
                arising out of the use by Collaborator for any purpose of the CRADA
                Data,
                CRADA Materials or CRADA Subject Inventions produced in whole or
                part by
                ICD employees under this CRADA, unless due to the negligence or willful
                misconduct of ICD, its employees, or agents. The Government has no
                statutory authority to indemnify Collaborator. Each Party otherwise
                will
                be liable for any claims or damages it incurs in connection with
                this
                CRADA, except that ICD, as an agency of the Government, assumes liability
                only to the extent provided under the Federal Tort Claims Act, 28
                U.S.C.
                Chapter 171.

            

    

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

       

    

    
      	12.3     
                	
              Force
                Majeure.
                Neither Party will be liable for any unforeseeable event beyond its
                reasonable control and not caused by its own fault or negligence.
                which
                causes the 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.
                If a force
                majeure
                event occurs, the Party unable to perform will promptly notify the
                other
                Party. It will use its best efforts to resume performance as quickly
                as
                possible and will 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
                will be
                governed by U.S. federal law, as applied by the federal courts in
                the
                District of Columbia. If any provision in this CRADA conflicts with
                or is
                inconsistent with any U.S. federal law or regulation, then the U.S.
                federal law or regulation will preempt that provision.
                

            

    

     

    
      	13.2     
                	
              Compliance
                with Law.
                ICD and Collaborator agree that they will comply with, and advise
                their
                contractors and agents to comply with, all applicable statutes, Executive
                Orders, HHS regulations, and all FDA, CDC, and NIH policies relating
                to
                research on human subjects (45 C.F.R. Part 46, 21 C.F.R. Parts 50
                and 56)
                and relating to the appropriate care and use of laboratory animals
                (7
                U.S.C. §§ 2131 et
                seq.;
                9 C.F.R. Part 1, Subchapter A). Additional information on these subjects
                is available from the HHS Office for Human Research Protections or
                from
                the NIH Office of Laboratory Animal Welfare. Collaborator agrees
                to ensure
                that employees, contractors, and agents of Collaborator who might
                have
                access to a “select agent or toxin” (as that term is defined in 42 C.F .R.
                §§ 73.4-73.5) transferred from ICD is properly licensed to receive the
                “select agent or toxin”. 

            

    

     

    
      	13.3        
                	
              Waivers.
                None of the provisions of this CRADA will be considered waived by
                any
                Party unless a 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, will not be deemed a waiver of any rights of any
                Party.
                

            

    

     

    
      	13.4     
                	
              Headings.
                Titles and headings of the articles and paragraphs of this CRADA
                are for
                convenient reference only, do not form a part of this CRADA, and
                will in
                no way affect its interpretation. 

            

    

     

    
      	13.5     
                	
              Severability.
                The illegality or invalidity of any provisions of this CRADA will
                not
                impair, affect, or invalidate the other provisions of this CRADA.
                

            

    

     

    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

       

    

    
      	13.6     
                	
              Amendments.
                Minor modifications to the Research Plan may be made by the mutual
                written
                consent of the Principal Investigators. Substantial changes to the
                CRADA,
                extensions of the term, or any changes to Appendix C will become
                effective
                only upon a written amendment signed by the signatories to this CRADA
                or
                by their representatives duly authorized to execute an amendment.
                A change
                will be considered substantial if it directly expands the range of
                the
                potential CRADA Subject Inventions, alters the scope or field of
                any
                license option governed by Article 7, or requires a significant increase
                in the contribution of resources by either Party.
                

            

    

     

    
      	13.7     
                	
              Assignment.
                Neither this CRADA nor any rights or obligations of any Party hereunder
                will be assigned or otherwise transferred by either Party without
                the
                prior written consent of the other Party.

            

    

     

    
      	13.8     
                	
              Notices.
                All notices pertaining to or required by this CRADA will be in writing,
                signed by an authorized representative of the notifying Party, and
                delivered by first class, registered, or certified mail, or by an
                express/overnight commercial delivery service, prepaid and properly
                addressed to the other Party at the address designated on the Contacts
                Information Page, or to any other address designated in writing by
                the
                other Party. Notices will be considered timely if received on or
                before
                the established deadline date or sent on or before the deadline date
                as
                verifiable by U.S. Postal Service postmark or dated receipt from
                a
                commercial carrier. Notices regarding the exercise of license options
                will
                be made pursuant to Paragraph 7.3. Either Party may change its 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 will maintain sole and exclusive control over its personnel
                and
                operations. 

            

    

     

    
      	13.10   
                	
              Use
                of Name; Press Releases.
                By entering into this CRADA, the Government does not directly or
                indirectly endorse any product or service that is or will be provided,
                whether directly or indirectly related to either this CRADA or to
                any
                patent or other intellectual-property license or agreement that implements
                this CRADA by Collaborator, its successors, assignees, or licensees.
                Collaborator will not in any way state or imply that the Government
                or any
                of its organizational units or employees endorses any product or
                service.
                Each Party agrees to provide proposed press releases that reference
                or
                rely upon the work under this CRADA to the other Party for review
                and
                comment at least seven (7) days prior to publication. Either Party
                may
                disclose the Summary Page to the public without the approval of the
                other
                Party. 

            

    

     

    
      	13.11   
                	
              Reasonable
                Consent.
                Whenever a Party’s consent or permission is required under this CRADA, its
                consent or permission will not be unreasonably withheld.
                

            

    

     

    
      	13.12    
               	
              Export
                Controls.
                Collaborator agrees to comply with U.S. export law and regulations.
                If
                Collaborator has a need to transfer any CRADA Materials made in whole
                or
                in part by ICD, or ICD Materials, or ICD’s Confidential Information, to a
                person located in a country other than the United States, to an Affiliate
                organized under the laws of a country other than the United States,
                or to
                an employee of Collaborator in the United States who is not a citizen
                or
                permanent resident of the United States, Collaborator will acquire
                any and
                all necessary export licenses and other appropriate authorizations.
                

            

    

     

    
      
        
        

      

      
        14

        
          

        

      

      
        
        

      

       

    

    
      	13.13   
                	
              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.

            

    

     

    
      	13.14   
                	
              Survivability.
                The provisions of Paragraphs 3.3, 3.4, 4.2, 4.3, 5.3, 5.4, 6.l-9.2,
                l0.3,
                10.5, 11.1, 12.1-12.3, 13.1-13.3, 13.10 and 13.14 will survive the
                expiration or early termination of this CRADA.

            

    

     

    

     

    SIGNATURES
      BEGIN ON THE NEXT PAGE

     

    
      
        
        

      

      
        15

        
          

        

      

      
        
        

      

    

    SIGNATUREPAGE
      

     

    ACCEPTED
      AND AGREED 

     

    BY
      EXECUTING THIS AGREEMENT, EACH PARTY REPRESENTS THAT ALL STATEMENTS MADE HEREIN
      ARE TRUE, COMPLETE, AND ACCURATE TO THE BEST OF ITS KNOWLEDGE. COLLABORATOR
      ACKNOWLEDGES THAT IT MAY BE SUBJECT TO CRIMINAL, CIVIL, OR ADMINISTRATIVE
      PENALTIES FOR KNOWINGLY MAKING A FALSE, FICTITIOUS, OR FRAUDULENT STATEMENT
      OR
      CLAIM. 

     

    
      	FOR
              NINDS:	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	/s/ Story
              Landis 	 	 	
              3/20/06 

            	 
	
              

              Story
                Landis, Ph.D.

            	 	 	
              Date

            	 
	
              Director,
                National Institute of Neurological Disorders and Stroke

            	 	 	 	 

    

     

    

    
      	FOR
              COLLABORATOR:	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	/s/ John
              S. Kovach 	 	 	
              3/22/06 

            	 
	
              

              Dr.
                John S. Kovach

            	 	 	
              Date

            	 
	
              President,
                Lixte, Inc.

            	 	 	 	 

    

     

    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    

     

    CONTACTS
      INFORMATION PAGE 

     

    

    
      	
              CRADA
                Notices

            
	 	 	 
	
              For
                ICD: 

            	 	
              For
                Collaborator:

            
	
              Dr.
                Martha Lubet

            	 	
              Dr.
                John S. Kovach

            
	
              6120
                Executive Blvd 

            	 	
              6
                Tinker Lane

            
	
              Suite
                450

            	 	
              East
                Setatuket, NY 11733

            
	
              Rockville,
                MD 20892 

            	 	 

    

    

    

    
      	
              Patenting
                and Licensing

            
	 	 	 
	
              For
                ICD:

            	 	
              For
                Collaborator (if separate from above):

            
	
              Division
                Director, Division of Technology

            	 	
              Same
                as above 

            
	
              Development
                and Transfer

            	 	              
              
	
              NIH
                Office of Technology Transfer

            	 	           
              
	
              6011
                Executive Boulevard, Suite 325

            	 	          
              
	
              Rockville,
                Maryland 20852-3804

            	 	           
              
	
              Tel:
                301-496-7057

            	 	 
	
              Fax:
                301-402-0220

            	 	 

    

    

    

    
      	
              Delivery
                of Materials Identified In Appendix B (if any)

            
	 	 	 
	
              For
                ICD:

            	 	
              For
                Collaborator:

            
	
              Dr.
                Zhengping Zhuang 

            	 	
              N.A.

            
	
              Bldg
                10 Room 4N244

            	 	 
	
              10
                Center Drive

            	 	 
	
              Bethesda,
                MD 20892

            	 	 

    

    

    
      
        
        

      

      
        17

        
          

        

      

      
        
        

      

    

    SUMMARY
      PAGE 

     

    

    EITHER
      PARTY MAY, WITHOUT FURTHER CONSULTATION OR PERMISSION.

     

    RELEASE
      THIS SUMMARY PAGE TO THE PUBLIC.

     

    TITLE
      OF
      CRADA: Identification of agents regulating Nuclear Receptor Corepressor (N-CoR)
      pathway for glioma tumor cell differentiation 

     

    

    
      	
              PHS[ICD]
                Component:

            	 	
              National
                Institute of Neurological Disorders and Stroke 

            
	
              ICD
                Principal Investigator: 

            	 	
              Dr.
                Edward Oldfield 

            
	
              ICD
                Co-Principal Investigator: 

            	 	
              Dr.
                Zhengping Zhuang 

            
	
              Collaborator:
                

            	 	
              Lixte,
                Inc. 

            
	 	 	 
	
              Collaborator
                Principal Investigator: 

            	 	
              Dr.
                John S.Kovach 

            
	 	 	 
	
              TERM
                OF CRADA: 

            	 	
              2
                (Two) years from the Effective Date 

            

    

     

    
      
        
        

      

      
        18

        
          

        

      

      
        
        

      

    

     

    SIGNATURE
      PAGE 

     

    ACCEPTED
      AND AGREED TO 

     

    
       

      
        
          	FOR
                  NINDS:	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	/s/ Story
                  Landis 	 	 	
                  
                    10/19/06 

                  

                	 
	
                  

                  Story
                    Landis, Ph.D.

                	 	 	
                  Date

                	 
	
                  
                    Director,
                      National Institute of Neurological Disorders and
                      Stroke

                  

                	 	 	 	 

        

        	FOR
                COLLABORATOR:	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	/s/ John
                S. Kovach 	 	 	
                
                  10/26/06 

                

              	 
	
                

                Dr.
                  John S. Kovach

              	 	 	
                Date

              	 
	
                
                  President,
                    Lixte Biotechnology, Inc.

                

              	 	 	 	 

      

       

      
        
          
          

        

        
          A
            - 1

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