Unassociated Document


    
      	 	
              *Certain
                confidential information contained in this document, marked by brackets,
                has been omitted and filed with the Securities and Exchange Commission
                pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
                amended.

            


    

    


     

    COLLABORATION
      AND LICENSE AGREEMENT

     

    BY
      AND AMONG

     

    INTERNATIONAL
      AIDS VACCINE INITIATIVE,

     

    CHILDREN’S
      RESEARCH INSTITUTE,

     

    THE
      CHILDREN’S HOSPITAL OF PHILADELPHIA

     

    AND

     

    TARGETED
      GENETICS CORPORATION

     

    DATED
      AS OF JANUARY 1,
      2005

     

    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    Table
      of Contents

     

    
      	 	 	Page
	
              ARTICLE
                1

            	
              DEFINITIONS

            	
              2

            
	 	 	 
	
              ARTICLE
                2

            	
              SCOPE
                OF COLLABORATION

            	
              13

            
	
              2.1

            	
              Scope
                of Collaboration

            	
              13

            
	
              2.2

            	
              Operation
                of Collaboration

            	
              14

            
	
              2.3

            	
              Diligence
                and Compliance with Law

            	
              14

            
	
              2.4

            	
              Personnel
                and Resources

            	
              14

            
	
              2.5

            	
              Further
                Assurances

            	
              14

            
	 	 	 
	
              ARTICLE
                3

            	
              RESEARCH
                AND DEVELOPMENT PROGRAM

            	
              14

            
	
              3.1

            	
              Work
                Plan and Budget

            	
              14

            
	
              3.2

            	
              Program
                Management Committee

            	
              15

            
	
              3.3

            	
              Operational
                Committee

            	
              16

            
	
              3.4

            	
              Development
                Responsibilities of the Parties

            	
              17

            
	
              3.5

            	
              Development
                Program Funding.

            	
              19

            
	
              3.6

            	
              Reports;
                Inspection

            	
              21

            
	
              3.7

            	
              Subcontracting
                of Development Work

            	
              22

            
	
              3.8

            	
              Approval
                Applications and Regulatory Approvals For Manufacturing and Clinical
                Trials

            	
              23

            
	
              3.9

            	
              Records
                and IAVI Audit Rights

            	
              25

            
	
              3.10

            	
              Commercialization
                of IAVI Vaccine

            	
              25

            
	 	 	 
	
              ARTICLE
                4

            	
              CONSIDERATION

            	
              25

            
	
              4.1

            	
              Consideration
                from IAVI to CRI and CHOP

            	
              25

            
	
              4.2

            	
              Consideration
                from IAVI to TGC

            	
              25

            
	
              4.3

            	
              Consideration
                from TGC to IAVI

            	
              26

            
	
              4.4

            	
              Taxes
                and Withholding

            	
              29

            
	
              4.5

            	
              Currency

            	
              29

            
	
              4.6

            	
              Payments;
                Late Payments

            	
              29

            
	
              4.7

            	
              Royalty
                Payment Terms

            	
              30

            
	 	 	 
	
              ARTICLE
                5

            	
              EXCLUSIVITY,
                GRANT OF RIGHTS AND RELATED COVENANTS

            	
              30

            
	
              5.1

            	
              Exclusivity

            	
              30

            
	
              5.2

            	
              Grant
                of License by TGC of TGC Controlled Intellectual Property to
                IAVI

            	
              33

            
	
              5.3

            	
              Grant
                of License by CRI of CRI Patent Rights and Know How to
                IAVI

            	
              36

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    
       

      Table
        of Contents

      (continued)

    

     

    
      	 	 	Page
	
              5.4

            	
              Grant
                of License by CHOP of CHOP Patent Rights and Know How to
                IAVI

            	
              36

            
	
              5.5

            	
              Grant
                of License by IAVI of IAVI Know How and IAVI Patent Rights to
                TGC

            	
              37

            
	
              5.6

            	
              Grant
                of Licenses of Joint Know How and Joint Patent Rights

            	
              38

            
	
              5.7

            	
              Covenant
                Not to Sue Under Certain Intellectual Property

            	
              38

            
	
              5.8

            	
              Covenants
                by TGC With Respect to Rights Under TGC Intellectual
                Property

            	
              39

            
	
              5.9

            	
              Covenant
                by CRI With Respect to Rights Under CRI Intellectual
                Property

            	
              40

            
	
              5.10

            	
              Covenant
                by CHOP With Respect to Rights Under CHOP Intellectual
                Property

            	
              40

            
	
              5.11

            	
              Covenant
                by IAVI With Respect to Rights Under IAVI Intellectual
                Property

            	
              40

            
	
              5.12

            	
              Covenant
                by IAVI With Respect to Rights Under [*]

            	
              41

            
	
              5.13

            	
              Covenant
                by IAVI With Respect to Rights Under [*]

            	
              41

            
	
              5.14

            	
              Grant
                of Option to License by CRI to TGC

            	
              41

            
	
              5.15

            	
              Grant
                of Option to License by CHOP to TGC

            	
              42

            
	
              5.16

            	
              No
                Other Rights

            	
              42

            
	
              5.17

            	
              Subject
                to the rights of the Government

            	
              42

            
	 	 	 
	
              ARTICLE
                6

            	
              REPRESENTATIONS,
                WARRANTIES AND COVENANTS

            	
              42

            
	
              6.1

            	
              Representations
                and Warranties of the Parties Concerning Corporate
                Authorizations

            	
              42

            
	
              6.2

            	
              Representations,
                Warranties of TGC

            	
              43

            
	
              6.3

            	
              Disclaimer

            	
              43

            
	
              6.4

            	
              Representations,
                Warranties of IAVI With Respect to Rights Under IAVI Know How and
                IAVI
                Patent Rights

            	
              43

            
	 	 	 
	
              ARTICLE
                7

            	
              INTELLECTUAL
                PROPERTY MATTERS

            	
              44

            
	
              7.1

            	
              Ownership
                and Inventorship of Intellectual Property

            	
              44

            
	
              7.2

            	
              Prosecution
                and Maintenance of TGC, CHOP or CRI Controlled Patents;
                Abandonment

            	
              44

            
	
              7.3

            	
              Prosecution
                and Maintenance of Joint Patents; Abandonment.

            	
              45

            
	
              7.4

            	
              Enforcement
                of Patent Rights

            	
              46

            
	
              7.5

            	
              Settlement
                with a Third Party

            	
              47

            
	
              7.6

            	
              Infringement
                of Third Party Rights

            	
              47

            
	 	 	 
	
              ARTICLE
                8

            	
              CONFIDENTIALITY

            	
              48

            
	
              8.1

            	
              Confidentiality;
                Exceptions

            	
              48

            


    

    
      
         

        *Confidential
          Treatment Requested.

      

    

     

    
      
        
        

      

      
        ii

        
          

        

      

      
        
        

      

    

     

    
      Table
        of Contents

      (continued)

       

      
        	 	 	Page


      

    

    
      	
              8.2

            	
              Authorized
                Disclosure

            	
              49

            
	
              8.3

            	
              Return
                of Confidential Information

            	
              49

            
	
              8.4

            	
              Publications
                and Announcements

            	
              50

            
	 	 	 
	
              ARTICLE
                9

            	
              TERM
                AND TERMINATION

            	
              51

            
	
              9.1

            	
              Term.

            	
              51

            
	
              9.2

            	
              Termination
                for Technical Non-Viability

            	
              51

            
	
              9.3

            	
              Termination
                at Will

            	
              51

            
	
              9.4

            	
              Termination
                for Cause

            	
              52

            
	
              9.5

            	
              Termination
                for Insolvency

            	
              52

            
	
              9.6

            	
              Rights
                on and Effect of Termination.

            	
              53

            
	
              9.7

            	
              Accrued
                Rights

            	
              56

            
	
              9.8

            	
              Survival;
                Expiration of Development Program

            	
              56

            
	 	 	 
	
              ARTICLE
                10

            	
              INDEMNIFICATION;
                INSURANCE; LIMITATION OF LIABILITY

            	
              56

            
	
              10.1

            	
              Indemnification
                by IAVI

            	
              56

            
	
              10.2

            	
              Indemnification
                by TGC

            	
              57

            
	
              10.3

            	
              Indemnification
                by CHOP

            	
              57

            
	
              10.4

            	
              Indemnification
                by CRI

            	
              57

            
	
              10.5

            	
              Indemnification
                Procedure.

            	
              57

            
	
              10.6

            	
              Insurance.

            	
              59

            
	
              10.7

            	
              Limitation
                of Liability; Remedies Cumulative

            	
              59

            
	 	 	 
	
              ARTICLE
                11

            	
              GOVERNING
                LAW; DISPUTE RESOLUTION

            	
              60

            
	
              11.1

            	
              Governing
                Law

            	
              60

            
	
              11.2

            	
              Dispute
                Resolution

            	
              60

            
	 	 	 
	
              ARTICLE
                12

            	
              MISCELLANEOUS

            	
              60

            
	
              12.1

            	
              Assignment.

            	
              60

            
	
              12.2

            	
              Force
                Majeure

            	
              61

            
	
              12.3

            	
              Further
                Actions

            	
              61

            
	
              12.4

            	
              Governmental
                Approvals and Filing of Agreement

            	
              61

            
	
              12.5

            	
              Notices

            	
              61

            
	
              12.6

            	
              Waiver

            	
              62

            
	
              12.7

            	
              Disclaimer
                of Agency

            	
              62

            
	
              12.8

            	
              Severability

            	
              62

            
	
              12.9

            	
              Entire
                Agreement; Amendment

            	
              63

            
	
              12.10

            	
              Counterparts

            	
              63

            


    

     

    
      
        
        

      

      
        iii

        
          

        

      

      
        
        

      

    


    Table
      of Contents

    (continued)

    


    
      	 	
              Page

            
	
              ATTACHMENT
                A: DEVELOPING WORLD COUNTRIES

            	 
	 	 
	
              ATTACHMENT
                B: WORK PLAN

            	 
	 	 
	
              ATTACHMENT
                C: CLINICAL SUPPLY AGREEMENT

            	 
	 	 
	
              ATTACHMENT
                D: TGC ACCOUNTING DETAILS

            	 
	 	 
	
              ATTACHMENT
                E: TGC CONTROLLED PATENTS, CRI
                PATENTS AND CHOP PATENTS
                -
                RELEVANT TO PROGRAMS

            	 
	 	 
	
              ATTACHMENT
                F: USAID STANDARD PROVISIONS

            	 


    

     

    
      
        
        

      

      
        iv

        
          

        

      

      
        
        

      

    

     

    COLLABORATION
      AND LICENSE AGREEMENT

     

    This
      COLLABORATION AND LICENSE AGREEMENT (this “Agreement”),
      effective as of January 1, 2005 (the “Effective
      Date”),
      is
      entered into by and among INTERNATIONAL AIDS VACCINE INITIATIVE, a
      not-for-profit corporation with its principal offices at 110 Williams Street,
      27th Floor, New York, New York 10038 (hereinafter referred to as “IAVI”),
      CHILDREN’S RESEARCH INSTITUTE, a not-for-profit corporation with its principal
      offices at 700 Children’s Drive, Columbus, Ohio 43205 (hereinafter referred to
      as “CRI”),
      THE
      CHILDREN’S HOSPITAL OF PHILADELPHIA, a not-for-profit corporation with its
      principal offices at 34th
      Street
      & Civic Center Boulevard, Philadelphia, PA 19104 (hereinafter referred to as
      “CHOP”),
      and
      TARGETED GENETICS CORPORATION, a Washington corporation with its principal
      offices at 1100 Olive Way, Suite 100, Seattle, Washington 98101 (hereinafter
      referred to as “TGC”).
      IAVI,
      CRI, CHOP and TGC are sometimes referred to herein individually as a
“Party”
and
      collectively as the “Parties.”

     

    Recitals

     

    1.
      IAVI
      has,
      as one of its principal objectives, the acceleration of development of vaccines
      against HIV for use and distribution in the Developing World (as defined
      below).

     

    2.
      CRI
      and
      its personnel possess certain skills and own or have rights to certain patents,
      patent applications, other valuable technology and know how relating to AAV
      (as
      defined below) vector vaccine design, and may develop or acquire additional
      such
      rights.

     

    3.
      CHOP
      and its personnel possess certain skills and own or have rights to certain
      patents, patent applications, other valuable technology and know how relating
      to
      AAV vector vaccine design developed by the Vaccine Designer (as defined below),
      and may develop or acquire additional such rights.

     

    4.
      TGC
      possesses certain skills and owns or has rights to certain patents, patent
      applications, other valuable technology and know how relating to vector design,
      production, and purification of AAV vectors which can aid IAVI in its
      objectives, and may develop or acquire additional such rights.

     

    5.
      IAVI,
      CRI
      and TGC had previously entered into the Initial Agreement (as defined below).
      

     

    6.
      Since
      the Effective Date, the Vaccine Designer (who was previously employed by CRI)
      has been an employee of CHOP.

     

    7.
      With
      effect from the Effective Date, CRI, IAVI and TGC seek to restate and replace
      the understandings and agreements of the Initial Agreement (as defined below)
      with this Agreement and CHOP wishes to join as a Party to this
      Agreement.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    8.
      As
      set
      forth in this Agreement, CRI, CHOP, IAVI and TGC shall attempt to design and
      develop IAVI Vaccines (as defined below) for use in the Developing World that
      will be: (i) further designed by CHOP (with the involvement of IAVI, CRI and
      TGC); (ii) developed by TGC and IAVI; (iii) at least through Phase II clinical
      trials, manufactured and supplied by TGC exclusively to IAVI (or as directed
      by
      IAVI) subject to the terms of this Agreement; and (iv) marketed, sold and
      otherwise distributed in the Developing World exclusively by IAVI (and its
      sublicensees).

     

    9.
      The
      Development Program (as defined below) and the other transactions contemplated
      by this Agreement are of mutual interest and benefit to the Parties, and will
      further the objectives of IAVI in a manner consistent with its status as a
      not-for-profit, tax-exempt, institution.

     

    In
      consideration of the premises and of the mutual covenants and obligations set
      forth herein, the Parties hereby agree as set out below.

     

    ARTICLE
      1

     

    DEFINITIONS

     

    For
      purposes hereof, the following terms shall have the meanings specified
      below:

    


    1.1 “AAV”
means
      an adeno-associated virus composed of a viral capsid comprising three proteins
      known as VP1, VP2, and VP3, wherein the genome is a single strand DNA molecule
      of approximately 4.5kb in size, flanked by inverted terminal repeats
      (“ITRs”) of
      approximately 145bp designated ITRs. 

    


    1.2 “AAV
      Vector”
      means a
      recombinant AAV where the approximately 4.5kb genome has been replaced by HIV
      sequences of interest under the control of appropriate regulatory
      sequences.

    


    1.3 “Additional
      Patent Rights”
means
      all rights in, to or under any patent application or patent not under the
      Control of CRI, CHOP, TGC, or IAVI which are [*]
      for the
      Development, Manufacture and/or Commercialization of any IAVI Vaccine or TGC
      Vaccine as the case may be, by the applicable Party or Parties.

    


    1.4 “Act”
has
      the
      meaning set forth in Section 4.3.2(a).

    


    1.5 “Affiliate”
of
      a
      Party means (a) a Parent or (b) any entity at least fifty percent (50%) of
      the
      voting capital interests (or equivalent control) of which are, directly or
      indirectly, owned, or the voting of which is controlled, by such Party or a
      Parent of such Party.

    


    1.6 “Applicable
      Laws”
means
      all laws, statutes, ordinances, codes, rules and regulations which have been
      enacted by a Government Authority and are in force as of the Initial Agreement
      Date or come into force during the term of the Initial Agreement or this
      Agreement, in each case to the extent that the same are applicable to the
      performance by the Parties of their respective obligations or to the exercise
      of
      their respective rights under this Agreement. For purposes of this Agreement,
      GLP, GCP and GMP shall be deemed to be within the term “Applicable
      Laws.”

     

    
      *Confidential
        Treatment Requested.

       

    

    
      
        
        

      

      
        -2-

        
          

        

      

      
        
        

      

    


    1.7 “Bankruptcy
      Code”
shall
      mean the US Bankruptcy Code and any similar or equivalent laws, statutes,
      ordinances, codes, rules and regulations in any other country.

    


    1.8 “CRI”
has
      the
      meaning set forth in the first paragraph of this Agreement. 

    


    1.9 “CRI
      Know How”
means
      all unpatented Know How, developed by or
      under
      the supervision of the
      Vaccine Designer, which is: (a) Controlled by CRI as of the Initial Agreement
      Date or during the Development Period; (b) conceived or first reduced to
      practice in the course of work under, or provided by CRI under,
      the
      Development Program or the Research and Development Program; and (c) which
      is
      reasonably necessary or useful for the Development, Manufacture and/or
      Commercialization of any IAVI Vaccine;
      provided,
      however,
      that,
      in any event, CRI Know How shall exclude any Joint Know How and Patent
      Rights.

     

    1.10 “CRI
      Patent Rights”
means
      Patent Rights, conceived by or
      conceived
      under
      the supervision of the
      Vaccine Designer, which
      claim AAV Vector compositions, methods of making AAV Vector compositions, or
      use
      of AAV Vector compositions, which Patent Rights are reasonably necessary or
      useful for the
      Development, Manufacture and/or Commercialization of
      any IAVI
      Vaccine, solely to the extent of the subject matter of such Patent Rights that:
      (a) are Controlled by CRI as of the Initial Agreement Date or during the
      Development Period; and (b) claim: (i) priority to any such Patent Rights;
      (ii)
      any invention conceived during the Development Period; in each case only to
      the
      extent of subject matter conceived, at least in part, from activities funded
      by
      IAVI under the Initial Agreement or this Agreement; or
      (iii)
      any invention disclosed to CRI, by Vaccine Designer in an invention disclosure
      during the Development Period, which resulted in subject matter provided by
      CRI
      under the Development Program or
      the
      Research and Development Program
      to the
      Parties that is disclosed in a patent application currently pending and not
      later abandoned; provided,
      however,
      that,
      in any event, CRI Patent Rights shall exclude any Joint Patent
      Rights.

     

    1.11 “CHOP
      Know How”
means
      all unpatented Know How, developed by or
      under
      the supervision of the
      Vaccine Designer, which is: (a) Controlled by CHOP as of the Effective Date
      or
      during the Development Period after the Effective Date; (b) conceived or first
      reduced to practice in the course of work under, or provided by CHOP under,
      the
      Development Program; and (c) which is reasonably necessary or useful for the
      Development, Manufacture and/or Commercialization of any IAVI
      Vaccine;
      provided,
      however,
      that,
      in any event, CHOP Know How shall exclude any Joint Know How and Patent
      Rights.

     

    1.12 “CHOP
      Patent Rights”
means
      Patent Rights, conceived by or
      conceived
      under
      the supervision of the
      Vaccine Designer, which
      claim AAV Vector compositions, methods of making AAV Vector compositions, or
      use
      of AAV Vector compositions, which Patent Rights are reasonably necessary or
      useful for the
      Development, Manufacture and/or Commercialization of
      any IAVI
      Vaccine, solely to the extent of the subject matter of such Patent Rights that:
      (a) are Controlled by CHOP as of the Effective Date or during the Development
      Period after the Effective Date; and (b) claim: (i) priority to any such Patent
      Rights; or (ii) any invention conceived during the Development Program; in
      each
      case only to the extent of subject matter conceived, at least in part, from
      activities funded by IAVI under this Agreement; provided,
      however,
      that,
      in any event, CHOP Patent Rights shall exclude any Joint Patent
      Rights.

     

    
      
        
        

      

      
        -3-

        
          

        

      

      
        
        

      

    

     

    1.13 “Clinical
      Supply Agreement”
means
      the Clinical Supply Agreement dated as of December 24, 2003, by and between
      IAVI
      and TGC, a copy of which is attached as Exhibit
      C.

     

    1.14 “Collaboration
      Payments”
means
      the cash payments to be made by IAVI to CRI, CHOP or TGC under this Agreement,
      pursuant to Section 3.5.2.

     

    1.15 “Commercial
      Supply Agreement”
means
      any future agreement to supply any IAVI Vaccine (i) to be used in Phase III
      clinical trials or equivalent designed clinical trials if named differently
      outside the United States, or (ii) which has received Regulatory Approval for
      sale.

     

    1.16 “Commercialize”
means
      to distribute, sell, offer for sale, lease, license, promote, market, import,
      export, and with respect to TGC only to use for commercial purposes, and,
      subject to the terms of this Agreement, to have any of those things
      done.

     

    1.17 “Confidential
      Information”
has
      the
      meaning set forth in Section 8.1.

     

    1.18 “Control”
means,
      with respect to Intellectual Property, that the Party named as having control
      possesses the ability and right to grant a license or sublicense under such
      Intellectual Property to the other Party or Parties hereunder in accordance
      with
      the terms of this Agreement without violating the terms of any agreement or
      other arrangement with a Third Party, either due to ownership of such
      Intellectual Property, or otherwise.

     

    1.19 “Develop”
      means
      to
      research, develop and, subject to the terms of this Agreement, to have either
      of
      those things done. For the avoidance of doubt, “Develop” does not include
      manufacturing development activities, but with respect to IAVI and TGC (and
      their sublicensees) only, “Develop” does include pre-clinical and clinical
      development activities.

     

    1.20 “Developed
      World”
means
      all countries in the world
      other
      than countries in the Developing World.

     

    1.21 “Developing
      World”
means
      those countries defined from time to time during the term of this Agreement
      by
      the World Bank as having “low-income economies” or “middle-income economies”
(whether lower-middle or upper-middle) (or an equivalent list of countries
      mutually acceptable to CRI, CHOP, IAVI and TGC, if such World Bank country
      lists
      are discontinued). A list of all such countries in
      the
      Developing World as
      of the
      date of execution of this Agreement is set forth in Attachment A annexed
      hereto.

     

    1.22 “Development
      Period”
means
      the period beginning on the Initial Agreement Date and ending upon the last
      day
      in which funded activities are performed under the Development
      Program.

     

    1.23 “Development
      Program”
means
      the program and activities described in the Work Plan and Budget, including
      the
      activities of the Vaccine Designer and the Vaccine Developer thereunder, as
      conducted during the term of this Agreement and with the IAVI funding provided
      under this Agreement. Each year of the Development Program will be divided
      into
      Program Quarters.

     

    
      
        
        

      

      
        -4-

        
          

        

      

      
        
        

      

    


    1.24 “Development
      Work”
has
      the
      meaning set forth in Section 3.1.

     

    1.25  “Effective
      Date”
has
      the
      meaning set forth in the first paragraph of this Agreement.

     

    1.26 “FDA”
means
      the United States Food and Drug Administration, and any successor
      thereto.

     

    1.27 “FFDCA”
      means
      the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 et seq., as amended
      from time to time, and any successor thereto.

     

    1.28 “FTE”
means
      the full time equivalent-billing rate for a Party’s employees that is agreed
      upon in the Work Plan and Budget for a Project Year.

     

    1.29  “GAAP”
means
      generally accepted accounting principles as adopted and practiced in the United
      States.

     

    1.30 “GCP”
means,
      to the extent applicable, the good clinical practices applicable in the United
      States (under the regulations set forth in 21 C.F.R. Subchapter A and the
      requirements imposed thereunder by the FDA) and in effect from time to time
      during the term of this Agreement, together with the equivalent or corresponding
      regulations and requirements in jurisdictions outside the United
      States.
      

     

    1.31 “GLP”
means,
      to the extent applicable, the good laboratory practices applicable in the United
      States (under the regulations set forth in 21 C.F.R. Subchapter A and the
      requirements imposed thereunder by the FDA) and in effect from time to time
      during the term of this Agreement, together with the equivalent or corresponding
      regulations and requirements in jurisdictions outside the United
      States.

     

    1.32 “GMP”
      means,
      to the extent applicable, the good manufacturing practices applicable in the
      United States (under the regulations set forth in 21 C.F.R. Subchapter C and
      the
      requirements imposed thereunder by the FDA) and in effect from time to time
      during the term of this Agreement, together with the equivalent or corresponding
      regulations and requirements in jurisdictions outside the United States
      (including applicable ICH rules and guidelines, such as the International
      Conference on Harmonization Guidelines and Good Manufacturing Practice Guidance
      for Active Pharmaceutical Ingredients).

     

    1.33 “Government
      Authority”
means
      any supranational, national, regional, state or local government, court,
      governmental agency, authority, board, bureau, instrumentality or regulatory
      body.

     

    1.34 “IAVI”
has
      the
      meaning set forth in the first paragraph of this Agreement.

     

    1.35 “IAVI
      Know How”
means
      all unpatented Know How which is Controlled
      by IAVI
      and has been developed, solely or with a Third Party, by IAVI either
      (a) under
      the
      Development Program or
      (b) outside
      of the Development Program but during the Development Period through
      the use of
      Program
      Materials; and
      which, in
      each
      case,
      is
      reasonably necessary or useful for the Development, Manufacture and/or
      Commercialization of an AAV product;
      provided,
      however,
      that,
      in any event, IAVI Know How shall exclude any Joint Know How
      and
      Patent Rights.

     

    
      
        
        

      

      
        -5-

        
          

        

      

      
        
        

      

       

    

    1.36 “IAVI
      Patent Rights”
means
      Patent Rights Controlled by IAVI to the extent of the subject matter of such
      rights that claim any invention which:
      (a) was conceived
      of during the Development Period which conception arose, at least in part,
      from
      activities conducted as part of the Development Program or through
      the use of Program
      Materials;
      and
      (b)
      which is
      reasonably necessary or useful for the Development, Manufacture and/or
      Commercialization of an
      AAV
      product; provided,
      however,
      that,
      in any event, IAVI Patent Rights shall exclude any Joint Patent
      Rights. 

     

    1.37 “IAVI
      Vaccine”
means
      a
      prophylactic or therapeutic composition(s) for inducing an [*]
      to
      HIV in
      a person which composition(s): (a) [*]
      and
      encapsidated within an AAV capsid, (b) is developed under the Development
      Program or constitutes an improvement
      or
      modification thereof, including, but not limited to, [*],
      and (c)
      has been further Developed for Manufacture and Commercialization solely for
      the
      Developing World by or on behalf of IAVI
      (or its
      sublicensees). 

     

    1.38 “Indemnitee”
has
      the
      meaning set forth in Section 10.5.1 of this Agreement.

     

    1.39 “Indemnitor”
has
      the
      meaning set forth in Section 10.5.1 of this Agreement.

     

    1.40 “Intellectual
      Property”
means
      any Patent Rights, Know How, and other proprietary rights of
      a
      Person in
      technology.

     

    1.41 “Initial
      Agreement”
means
      the Industrial Collaboration Agreement, dated February 1, 2000, as amended,
      by
      and among IAVI, CRI and TGC.

     

    1.42 “Initial
      Agreement Date”
means
      February 1, 2000.

     

    1.43 “Insolvency
      Event”
shall
      mean the occurrence of any of the following: (i) the appointment of a
      trustee, receiver or custodian for all or substantially all of the property
      of a
      Party, (or for any lesser portion of such property, if the result of such
      appointment materially and adversely affects the ability of such Party to
      fulfill its obligations hereunder or thereunder) which appointment is not
      dismissed within sixty (60) days; (ii) the determination by a court or
      tribunal of competent jurisdiction that a Party is insolvent; (iii) the
      filing of a petition for relief in bankruptcy by a Party on its own behalf,
      or
      the filing of any such petition against a Party if the proceeding is not
      dismissed or withdrawn within sixty (60) days thereafter; (iv) an
      assignment by a Party for the benefit of creditors; or (v) the dissolution
      or liquidation of a Party. 

     

    1.44 “Joint
      Inventions”
means
      any invention(s) Controlled by a Party, whether patentable or not,
      conceived
      by
      inventors from more than one Party (or
      its
      employees, agents or consultants) during
      the term
      of
      this Agreement in the course of the performance by such Parties of activities
      under the Development Program.

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
        -6-

        
          

        

      

      
        
        

      

    


    1.45 “Joint
      Know How”
means
      all unpatented Know How Controlled by a Party which is developed, created or
      invented by inventors from more than one Party (or
      its
      employees, agents or consultants)
      during
      the term of this Agreement in the course of the performance by such Parties
      of
      activities under the Development Program. For the purpose of clarity, no Know
      How developed, created or invented during the term of the Initial Agreement
      is
      Joint Know How. 

     

    1.46 “Joint
      Patent Rights”
means
      Patent Rights Controlled by a Party filed on Joint Inventions; provided,
      however,
      no
      Patent Rights filed, conceived of or claiming priority to any invention filed
      during the term of the Initial Agreement is a Joint Patent Right. 

     

    1.47 “Know
      How”
means
      information, data and proprietary rights of any type whatsoever (other than
      the
      Patent Rights) in any tangible or intangible form whatsoever, including, without
      limitation, inventions, practices, methods, techniques, specifications,
      formulations, formulae, knowledge, know how, skill, experience, test data,
      analytical and quality control data, stability data, results of studies,
      technical drawings and related copyrights, trade secrets and any other similar
      information.

     

    1.48 “Lead
      Party”
shall
      have the meaning set forth therefore in Section 7.3.1.
      

     

    1.49 “Losses”
mean,
      collectively, any and all losses, damages, liabilities, costs and expenses
      resulting from a Third Party claim, action suit or proceeding brought against
      an
      Indemnitee, including reasonable attorneys’ fees and expenses incurred by or
      required of any Indemnitee that arise in connection therewith.

     

    1.50 “Manufacture”
means
      to make, to create large scale processes for making and, subject to the terms
      of
      this Agreement, to have either of those things done.

     

    1.51 “Marketing
      Approval Application”
means
      an application to the relevant Government Authority in a country seeking
      required approval for the marketing and sale of a product for use in humans
      for
      prophylactic and/or therapeutic purposes. As an example, the current term for
      a
      Marketing Approval Application made to the FDA for a product such as any IAVI
      Vaccine is “BLA” (Biological License Application), and the term shall be applied
      to comparable types of applications in other nations. An initial application
      required for conducting clinical testing in humans (called an Investigative
      New
      Drug application “IND” in the US) would not be a Marketing Approval Application
      as the term is used herein. 

     

    1.52 “Net
      Sales”
means
      the gross sales amount (i.e., gross invoice prices) invoiced or otherwise
      charged by a Party or its respective Affiliates and sublicensees for the sale
      or
      other disposition of a product to Third Parties less the following to the extent
      attributable to such sale or disposition of such product: (a) actual
      credited allowances for spoiled, damaged, outdated and returned product and
      for
      retroactive price reductions; (b) the amounts of actual trade and cash
      discounts and rebates (including rebates to Third Party payors), including
      Medicaid (and equivalent federal, state or local programs located within or
      outside the United Stated of America) rebates, given that were not already
      credited to such customers in the invoice; (c) all transportation,
      shipping, insurance and Third Party handling charges invoiced in accordance
      with
      industry norms, as well as sales taxes, excise taxes and import/export duties
      actually paid, all of the foregoing to the extent included in the gross invoiced
      amount; and (d) other reasonable and customary allowances and adjustments
      actually credited to customers, whether during a specific royalty period or
      not.
      Sales among any combination of TGC, IAVI, their respective Affiliates, and
      any
      of their respective sublicensees for resale will not be part of the Net Sales
      hereunder. Sales to Affiliates or sublicensees for end use will be treated
      for
      purposes of the calculation of Net Sales as if sold at the average price in
      the
      month of sale by the Party to unrelated Third Parties.

     

    
      
        
        

      

      
        -7-

        
          

        

      

      
        
        

      

    


    1.53 “Operational
      Committee”
has
      the
      meaning set forth in Section 3.3.

     

    1.54 “Outside
      Contractor”
means
      any Person contracted by a Party to provide products or services, including,
      without limitation, clinical trials, regulatory services and manufacturing
      services, which are material to the performance of the Party’s responsibilities
      under the Agreement or which result in any work product or other information
      that a Party would include or might reasonably be expected to include in any
      document or report to be provided hereunder, including, without limitation,
      a
      Marketing Approval Application or filing for Regulatory Approval with respect
      to
      any IAVI Vaccine submitted to a Government Authority or be subject to review
      by
      a Government Authority, including, without limitation, the FDA. Without limiting
      the foregoing, the term “Outside Contractor” shall include any Person contracted
      by a Party whose acts or omissions in connection with its assumption of any
      obligation of a Party under this Agreement, would be imputed to, and would
      therefore be considered the acts or omissions of such Party pursuant to the
      FFDCA or by a Government Authority, including, without limitation, the
      FDA.

     

    1.55 “Outside
      Contractor Agreement”
has
      the
      meaning set forth in Section 3.7.

     

    1.56 “Parent”
of
      a
      Party means any entity that, directly or indirectly, owns or controls the voting
      of at least fifty percent (50%) of the voting capital interests (or equivalent
      control) of such Party.

     

    1.57 “Patent
      Rights”
means
      all rights in, to or under any patents or patent applications, including any
      continuation, continuation-in-part, division, provisional or any substitute
      applications, any reissue, re-examination, renewal or extension (including
      any
      supplemental protection certificate) of any such patent, and any confirmation
      patent or registration patent or patent of addition based on any such patent,
      and all foreign counterparts of any of the foregoing.
      

     

    1.58 “Person”
means
      any person, individual, sole proprietorship, partnership, joint venture,
      corporation, limited liability company or other legal entity.

     

    1.59 “Program
      Management Committee”
shall
      mean the committee established as the “Program Management Committee” pursuant to
      the Initial Agreement. 

     

    1.60 “Program
      Materials”
means
      all product specific reagents, vectors, vaccines and other materials Controlled
      by a Party and developed in the course of the performance of activities under
      the Development Program or the Research and Development Program.
      

     

    1.61 “Program
      Quarters”
means
      four calendar quarters of three months each.

     

    
      
        
        

      

      
        -8-

        
          

        

      

      
        
        

      

    


    1.62 “Project
      Year”
means
      the applicable twelve (12) month period or such other period agreed upon in
      the
      corresponding Work Plan and Budget, beginning on the first day of the calendar
      year in which this Agreement is executed, or on any anniversary
      thereof.

     

    1.63 “Public
      Sector”
means
      governmental health agencies of the Developing World and shall also include
      IAVI, the World Health Organization, UNICEF and other non-profit agencies,
      to
      the extent, as to each of the foregoing, that it purchases, uses, imports or
      manufactures any IAVI Vaccine for delivery and/or sale on a non-profit basis
      solely for use within the Developing World.

     

    1.64 “Qualified
      Terminating Party”
shall
      mean: (i) with respect to a breach by IAVI or the occurrence of an Insolvency
      Event with respect to IAVI, only TGC; (ii) with respect to a breach by TGC
      or
      the occurrence of an Insolvency Event with respect to TGC, only IAVI; and (iii)
      with respect to a breach by CRI or CHOP or the occurrence of an Insolvency
      Event
      with respect to CHOP, either TGC or IAVI. 

     

    1.65 “Reasonable
      Efforts”
means,
      with respect to the efforts to be expended by any Person with respect to any
      objective or obligation, such reasonable, diligent, good faith efforts to
      accomplish such objective or obligation as would normally be used in the
      biopharmaceutical industry or by a non-profit research institution, as the
      case
      may be, to accomplish a similar objective or meet a similar obligation under
      similar circumstances. With respect to any objective or obligation relating
      to
      the Commercialization, or relating to obtaining Regulatory Approval, of a
      product by any Person, “Reasonable Efforts” means such efforts and resources as
      would normally be used by a Person in the biopharmaceutical industry or a
      non-profit research institution, as the case may be, similarly situated to
      the
      applicable Party, and with respect to a similarly situated product which is
      of
      similar market potential at a similar stage in the development or life of such
      product, taking into account issues of target indications, safety, efficacy,
      product profile, the competitiveness of the marketplace, the proprietary
      position of the product, the regulatory structure involved, profitability of
      the
      product and other relevant commercial factors. IAVI shall be considered a
      non-profit research institution for purposes of this definition.

     

    1.66 “Regulatory
      Approval”
means,
      with respect to a nation or, where applicable, a multinational jurisdiction,
      any
      approvals, licenses, registrations or authorizations necessary for the
      manufacture, clinical trials, marketing and/or sale (as applicable in a given
      case) of any IAVI Vaccine or
      TGC
      Vaccine (to the extent TGC has either control over or rights to use a regulatory
      filing for such TGC Vaccine) in
      such
      nation or such jurisdiction, and for the avoidance of doubt, shall include
      any
      such approval, license, registration or authorization granted pursuant to a
      Marketing Approval Application. 

     

    1.67 “Research
      and Development Program”
has
      the
      meaning given to it in the Initial Agreement.

     

    1.68 “Responsible
      Executives”
has
      the
      meaning set forth in Section 11.2.

     

    1.69 “Shares”
has
      the
      meaning set forth in Section 4.3.2.

     

    1.70  “TGC”
has
      the
      meaning set forth in the first paragraph of this Agreement.

     

    
      
        
        

      

      
        -9-

        
          

        

      

      
        
        

      

    

     

    1.71 “TGC
      Accounting Method”
      shall
      mean
      the
accounting
      method set forth in Attachment D and further described in Section 3.5.5, which
      method shall not be modified without the prior written consent of TGC and
      IAVI. 

     

    1.72 “TGC
      anti-HIV Vaccine”
means
      a
      prophylactic or therapeutic composition(s) for [*]
      to
      HIV in
      a person which composition(s): (a) [*]
      and
      encapsidated within an AAV capsid, (b) is the
      [*]
      or
      constitutes a modification of the [*],
      including, but not limited to, any [*]
      and
      (c)
      is licensed, offered for sale, lease, distribution, import or use by or for
      TGC
      (or TGC’s sublicensees or collaborators) in the Developed World. [*].
      

     

    1.73 “TGC
      Controlled anti-HIV Vaccine” means
      a
      prophylactic or therapeutic composition(s) for inducing an [*]
      to HIV
      in a person, which comprises an [*]
      and
      encapsidated within an AAV capsid, which was developed by TGC alone or in
      collaboration with a Third Party and with respect to which TGC [*]
      for the
      Development and Manufacture, and the [*]
      for the
      Commercialization, of such composition(s).

     

    1.74 “TGC
      HIV Royalty”
shall
      mean an amount equal to:

     

    (i)
       [*]
      percent
      ([*]%)
      of (a)
      TGC Non-Royalty Revenue with respect to any TGC anti-HIV Vaccine minus (b)
      any
      payments to Third Parties incurred by TGC for [*]for
      the
      Development, Manufacture and/or Commercialization of such TGC anti-HIV Vaccine;
      plus 

     

    (ii)
       [*]
      percent
      ([*]%)
      of TGC
      Royalty Revenue with respect to any TGC anti-HIV Vaccine. 

     

    For
      example, the TGC HIV Royalty under (ii) above for any
      TGC
      anti-HIV Vaccine would
      be
      calculated as follows for the following hypothetical scenario: 

     

    
      	 	
              ·

            	
              TGC
                receives [*]
                percent
                ([*]%)
                (non-manufacturing royalty) of partner net
                sales of
                TGC anti-HIV Vaccine and has to pay [*]
                percent ([*]%)
                of
                net sales in
                licensing costs for required [*].
                This
                example assumes that the
                partner markets the product and pays all sales and marketing costs
                and
                that TGC manufactures the product and is reimbursed for such cost
                by
                partner. 

            


    

     

    
      	 	
              ·

            	
              net
                sales
                by
                the partner are $[*]
                million. 

            


    

     

    
      	 	
              ·

            	
              $[*]
                million multiplied by [*]
                equals $[*]
                million to TGC. 

            


    

     

    
      	 	
              ·

            	
              $[*]
                million minus $[*]
                million ([*]
                percent ([*]%)[*])
                equals $[*]
                million to TGC. 

            


    

     

    
      	 	
              ·

            	
              IAVI
                would receive [*]
                percent ([*]%)
                of $[*]
                million or $[*]
                million from TGC. 

            


    

     

    1.75 “TGC
      Know How”
means
      all unpatented Know How which is owned solely or partly by TGC as of the Initial
      Agreement Date or during the Development Period and which is [*]
      for the
      Development, Manufacture and/or Commercialization of any IAVI
      Vaccine;
      provided,
      however,
      that,
      in any event, TGC Know How shall exclude any Joint Know How and Patent
      Rights.

     

    *Confidential
      Treatment Requested.

    


    
      
        
        

      

      
        -10-

        
          

        

      

      
        
        

      

       

    

    1.76 “TGC
      Licensed Know How”
means
      all unpatented Know How which is Controlled (but not owned) by TGC as of the
      Initial Agreement Date or
      during
      the Development Period
      as a
      result of being licensed to TGC by a Third Party and which is [*]
      for the
      Development, Manufacture and/or Commercialization of any IAVI
      Vaccine;
      provided,
      however,
      that,
      in any event, TGC Licensed Know How shall exclude any Joint Know How and Patent
      Rights.

     

    1.77 “TGC
      Licensed Patent Rights”
means
      all Patent Rights to the extent of the subject matter of such rights which
      claim
      AAV Vector compositions, methods of making AAV Vector compositions, or use
      of
      AAV Vector compositions, to the extent Controlled (but not owned) by TGC as
      a
      result of being licensed to TGC by a Third Party Licensor under one or more
      Third Party Agreements, and all improvements to any of the foregoing;
      provided,
      however,
      that,
      in any event, TGC Licensed Patent Rights shall exclude any Joint Patent
      Rights.

     

    1.78 “TGC
      Non-Royalty Revenue”
means
      all licensing fees and milestones actually received by TGC from any
      licensee or sublicensee or a
      collaborative, funding or marketing partner for the Development, Manufacture
      and/or Commercialization of one or more TGC anti-HIV Vaccines (regardless of
      how
      such licensing fees or milestones may be characterized). TGC Non-Royalty Revenue
      does not include (i) revenue received from a collaborative, funding or marketing
      partner by way of reimbursement of actual development costs in the course of
      such collaboration or marketing agreement; (ii) reimbursements for
      out-of-pocket costs or expenses; (iii) amounts received for the manufacture
      or
      supply of products or materials by TGC; (iv) reimbursement of expenses
      associated with commercial sale of the product; (v) market value of equity
      or
      debt (i.e.,
      excluding any premium paid on equity or discount received on debt) purchased
      by such collaborative, funding or marketing partner or other amounts received
      for loans or financing; (vi) amounts received with respect to products other
      than [*];
      or
      (vii) TGC Royalty Revenue. 

     

    1.79 “TGC
      Other Royalty”
shall
      mean an amount equal to [*]
      percent
      ([*]%)
      of (a)
      TGC Royalty Revenue received by TGC minus (b) any payments to Third Parties
      incurred by TGC for [*]
      required
      for the Development, Manufacture and/or Commercialization of such TGC Other
      Vaccine.

     

    1.80 “TGC
      Other Vaccine”
means
      any TGC Vaccine other than a TGC anti-HIV Vaccine, including, but not limited
      to, any TGC Controlled anti-HIV Vaccine and any TGC Partnered anti-HIV
      Vaccine. 

     

    1.81 “TGC
      Partnered anti-HIV Vaccines” means
      a
      prophylactic or therapeutic composition(s) for [*]
      to HIV
      in a person, which [*]and
      encapsidated within an AAV capsid, which was developed by TGC alone or in
      collaboration with a Third Party and with respect to which TGC does not Control,
      the Intellectual Property necessary for the Development and Manufacture, and
      the
      rights necessary for the Commercialization of such composition(s).

     

    1.82 “TGC
      Patent Rights”
means
      all Patent Rights Controlled
      by
      TGC to
      the extent of the subject matter of such rights which claim AAV Vector
      compositions, methods of making AAV Vector compositions, or use of AAV Vector
      compositions solely to the extent that such rights are owned, but not
      in-licensed, solely or jointly by TGC as of the Initial Agreement Date, or
      claim
      priority to any such Patent Rights, or claim any invention conceived during
      the
      Development Period which conception arose, at least in part, from activities
      funded by IAVI under the Initial Agreement or this Agreement, and all
      improvements to any of the foregoing;
      provided,
      however,
      that,
      in any event, TGC Patent Rights shall exclude any Joint Patent
      Rights. 

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
        -11-

        
          

        

      

      
        
        

      

    


    1.83 “TGC
      Regulatory Documents”
means
      the Biologics Master File and all other documents filed or required to be filed
      or otherwise submitted by TGC, by TGC on IAVI’s behalf or by IAVI upon receipt
      from TGC, to the FDA or other similar governmental agency or authority in
      connection with obtaining Regulatory Approval of any IAVI Vaccine
      by
      TGC.

     

    1.84 “TGC
      Royalty Revenue”
means
      revenue received by TGC
      or any
      of its Affiliates from
      the
      sale of TGC anti-HIV Vaccine or TGC Other Vaccine (as applicable) whether such
      revenue is received in the form of a royalty or
      profit
      share from
      a
      sublicensee and/or Development, Manufacture and/or Commercialization partner
      or
      from Net
      Sales
      of TGC
      anti-HIV Vaccine or TGC Other Vaccine (as applicable) by TGC and its
Affiliates,
      minus:
      (i) all cost of goods incurred by TGC, and not reimbursed by partner, associated
      with manufacturing for commercial sale such product; (ii) Third
      Party
      payments
      incurred by TGC, and not reimbursed by partner, for licensing of Third Party
      Intellectual Property required for the Development, Manufacture and/or
      Commercialization of such product; (iii) all sales, marketing and administrative
      costs incurred by TGC, and not reimbursed by a partner, associated with selling
      such product; and (iv) research and development costs incurred
      by
      TGC,
      and not
      reimbursed, by partner, to develop such product.  

     

    1.85 “TGC
      Vaccine”
means
      a
      prophylactic or therapeutic composition(s) for inducing an immune response
      to a
      pathogen in a person, which
      composition(s) is
      intended
      for use to
      prevent or delay progression of disease where
      such
      composition(s) is covered by or utilizes any Joint Know How, Joint Patent
      Rights, or utilizes any TGC Know How or TGC Patent Right developed solely by
      TGC
      as a result of its activities under this Agreement or the Initial Agreement
      and
      is comprised of an antigen or antigens of the pathogen flanked by AAV ITRs
      and
      encapsidated within an AAV capsid.
      [*].
      

     

    1.86 “Third
      Party”
means
      any Person other than a Party or any Affiliate of a Party.

     

    1.87 “Third
      Party Licensor”
means
      the licensor of the TGC Licensed Patent Rights to TGC. 

     

    1.88 “Third
      Party Agreements”
means
      any agreement between TGC and a Third Party Licensor for the license to TGC
      of
      the TGC Licensed Patent Rights.

     

    1.89 “USAID”
means
      the United States Agency for International Development, or any successor federal
      agency.

     

    1.90 “Vaccine
      Designer”
means
      Dr. Philip R. Johnson or a replacement mutually acceptable to the
      Parties.

     

    1.91 “Vaccine
      Developer”
means
      the Party or Parties (a) performing activities under this Agreement for the
      construction and composition of the AAV Vectors comprising the HIV antigens
      and
      the methods of making and purifying the vectors, (b) conducting or managing
      clinical trials of any IAVI Vaccine, or (c) contributing relevant experience
      in
      preclinical testing and evaluation of, and obtaining Regulatory Approvals for,
      any IAVI Vaccine and for the manufacture of any IAVI Vaccine.

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
        -12-

        
          

        

      

      
        
        

      

    


    1.92 “Work
      Plan and Budget”
means
      the set of tasks, procedures, protocols, standards, budgets, and target time
      frames regarding development of any IAVI Vaccine set forth in Attachment B
      hereto, and any additional work plans and budgets for development of any IAVI
      Vaccine hereunder for subsequent Project Years agreed to in writing by CRI,
      CHOP, IAVI and TGC from time to time during the term of, and in accordance
      with,
      this Agreement.

     

    ARTICLE
      2

     

    SCOPE
      OF
      COLLABORATION

     

    2.1 Scope
      of Collaboration.
      The
      Parties agree to continue to cooperate in good faith under this Agreement in
      an
      attempt to continue to effectively and efficiently develop safe, effective,
      cost
      effective and accessible IAVI Vaccine(s) to prevent or slow the progression
      of
      AIDS. To achieve this goal, CRI, IAVI and TGC wish to restate and replace the
      Initial Agreement as set forth herein, CHOP wishes to become a Party to this
      Agreement and the Parties wish to provide for the following as set forth in
      the
      terms of this Agreement: 

     

    (a) the
      joint
      development of one or more IAVI Vaccines; 

     

    (b) the
      manufacture of such IAVI Vaccines by TGC for use in preclinical, Phase I and
      Phase II clinical trials; 

     

    (c) the
      sale,
      lease, distribution, import or use of IAVI Vaccines by IAVI in the Developing
      World; 

     

    (d) the
      granting of licenses to all four (4) Parties as set forth herein;
      and

     

    (e) the
      sale,
      lease, distribution, import or use of TGC anti-HIV Vaccines by TGC in the
      Developed World.

     

    2.2 Operation
      of Collaboration.
      For
      purposes thereof, certain Parties have established and/or shall establish
      various committees as set forth in Article 3 of this Agreement to oversee the
      development of one or more IAVI Vaccines, and each Party shall, subject to
      the
      terms and conditions set forth in Article 8, provide (or cause its Affiliates
      to
      provide) to any relevant Committee any reasonably necessary Confidential
      Information Controlled by such Party and such other information, that such
      Party
      is able to provide, as may be reasonably required for the Parties to operate
      effectively and efficiently under this Agreement. 

     

    2.3 Diligence
      and Compliance with Law.
      Subject
      to the terms of this Agreement, each Party shall use Reasonable Efforts to
      fulfill all responsibilities assigned to it under this Agreement and the
      then-applicable Work Plan and Budget. In fulfilling
      its obligations under this Agreement each Party agrees to comply in all material
      respects with all Applicable Laws as applicable. No Party shall, or shall be
      required to, undertake any activity under or in connection with this Agreement
      which violates, or which it believes, in good faith, may violate, any Applicable
      Law. Without limiting the foregoing, no Party shall be obligated to export
      any
      IAVI Vaccine or any other technology or Intellectual Property licensed hereunder
      to any country which is at the relevant time under a trade embargo imposed
      by
      U.S. law or regulation if such export would constitute or facilitate any
      violation of such embargo or restriction; provided,
      however,
      that
      IAVI may, at its own risk and expense, apply for (for itself and for TGC, to
      the
      extent applicable to the transactions under this Agreement) an exemption, export
      license, or other governmental authorization removing all such embargoes and
      restrictions as to any one or more countries in the Developing World with
      respect to such export of one or more IAVI Vaccines or any other technology
      or
      Intellectual Property licensed hereunder. If IAVI so requests, CRI, CHOP and
      TGC
      will make available reasonable assistance to IAVI, at IAVI’s cost, in support of
      its application for any such exemption, license or authorization.

     

    
      
        
        

      

      
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    2.4 Personnel
      and Resources.
      Each
      Party agrees to use
      Reasonable Efforts to
      commit
      the personnel, facilities, expertise and other resources necessary
      to
      perform its obligations under this Agreement, and to
      perform its obligations under this Agreement in accordance with its terms;
      provided,
      however,
      that no
      Party warrants that the collaboration hereunder will achieve any of the research
      or commercial objectives contemplated by the Parties. 

     

    2.5 Further
      Assurances.
      Upon
      the terms and subject to the conditions hereof, each of the Parties will use
      all
      Reasonable Efforts to take, or cause to be taken, all actions necessary, proper
      or advisable under Applicable Laws or otherwise to consummate and make effective
      the transactions contemplated by this Agreement.

     

    ARTICLE
      3

     

    RESEARCH
      AND DEVELOPMENT PROGRAM

     

    3.1 Work
      Plan and Budget.
      In
      accordance with the terms and conditions set forth below, the Research and
      Development Program has been and the Development Program will be conducted
      by or
      on behalf of CRI, CHOP, IAVI and TGC pursuant to a Work Plan and Budget (the
      activities described thereunder being the “Development
      Work”),
      with
      the Work Plan and Budget in effect as of the Effective Date being attached
      hereto as Attachment B. 

     

    3.2 Program
      Management Committee.

     

    3.2.1 CRI,
      IAVI
      and TGC have previously established a Program Management Committee pursuant
      to
      the Initial Agreement. That Program Management Committee will continue to
      operate and be maintained throughout the period of the Development Program
      as
      set forth in this Agreement, except that, the Program Management Committee
      under
      this Agreement shall consist of three (3) members, one (1) appointed by each
      of
      CHOP, IAVI and TGC, and shall be chaired by the member appointed by IAVI. Each
      of those Parties shall have the right to change its members on the Program
      Management Committee upon written notice to those other Parties. The Program
      Management Committee shall:

     

    (a) Approve
      the Development Program, including, without limitation, go/no-go criteria,
      timelines and responsibilities;

     

    
      
        
        

      

      
        -14-

        
          

        

      

      
        
        

      

    


    (b) Approve
      a
      Work Plan and Budget for each Project Year; 

     

    (c) Monitor
      and make recommendations regarding the performance of the Parties under the
      Development Program and the conduct of the Development Program;

     

    (d) Be
      responsible for regular coordination and monitoring of activities
      hereunder;

     

    (e) Comment
      and advise on each Party’s regulatory strategies relating to the IAVI Vaccines;
      and

     

    (f) Approve
      any modifications, including increases or decreases in the size, scope or costs
      of the Work Plan and Budget during the Project Year that should be incorporated
      into the Development Program.

     

    3.2.2 Subject
      to Section 3.2.3 and 3.2.6, the Program Management Committee shall only act
      through the unanimous consent of its members. Meetings of the Program Management
      Committee will be held at the reasonable call of any member or CRI, upon at
      least five days prior notice to the others. Members of the Program Management
      Committee may attend a meeting of the Program Management Committee either in
      person or by telephone conference call, but not by proxy. The Program Management
      Committee may take action at meetings in which all members are in attendance
      or
      by a signed unanimous written consent in lieu of a meeting. In the event of
      a
      deadlock vote regarding a matter before the Program Management Committee, the
      Responsible Executives of each of CHOP, IAVI and TGC shall meet to resolve
      the
      matter in accordance with the procedures set out in Section 11.2.


     

    3.2.3 CRI
      shall
      have the right to participate as a non-voting member in discussions of the
      Program
      Management Committee or the Operational Committee regarding
      reviewing the content of the Work Plan and Budget for the following Project
      Year. If any decision of the Program
      Management Committee or the Operational Committee directly relates to the rights
      or obligations of CRI under this Agreement, CRI shall be included as a voting
      member and the Program Management Committee or the Operational Committee shall
      only act through the unanimous consent of its members
      and
an
      appointed representative of CRI. The
      Program
      Management Committee or the Operational Committee will give CRI’s representative
      at least five days prior notice of the meeting at which such decision will
      be
      discussed. CRI’s representative may attend that meeting either in person or by
      telephone conference call, but not by proxy. The Program Management Committee
      or
      the Operational Committee may take action with respect to any such decision
      at
      meetings in which all members and the CRI representative are in attendance
      or by
      a signed unanimous written consent in lieu of a meeting. In the event of a
      deadlock vote regarding any such decision, the Responsible Executives of each
      of
      CRI, CHOP, IAVI and TGC shall meet to resolve the matter in accordance with
      the
      procedures set out in Section 11.2. CRI shall have the right to change its
      representative upon written notice to the other Parties.

     

    3.2.4 Notwithstanding
      the foregoing and to the extent not materially and adversely affecting CRI
      or
      CHOP, only IAVI and TGC members of the Program Management Committee shall vote
      on matters related to the methods of making and purifying IAVI Vaccines,
      clinical trials, Regulatory Approvals and Marketing Approval Applications for
      IAVI Vaccines, any Manufacture and/or Commercialization of any IAVI Vaccine
      and
      any other responsibilities designated in an applicable Work Plan and Budget
      as
      the responsibility of the Vaccine Developer. Accordingly, with respect to any
      of
      the foregoing matters, the Program Management Committee shall be entitled to
      act, and may only act, through the consent of both the IAVI member and the
      TGC
      member.

     

    
      
        
        

      

      
        -15-

        
          

        

      

      
        
        

      

    


    3.2.5 The
      Program Management Committee shall approve the Work Plan and Budget for each
      year and such approval shall be documented by written approval of the Program
      Management Committee member from each of CHOP, IAVI and TGC.
      Written
      approval
from
      each
      of CHOP,
      IAVI and TGC
      (either
      from the Program Committee Member or a designee) shall
      be
      required from time to time throughout each year to
      approve any changes to the Work Plan or Budget. If a change to the Work Plan
      or
      Budget is (a) an
      increase
      to any item (other than capital equipment) that does not exceed the greater
      of
      US$[*]
      and
[*]%
      of the
      budgeted cost of that item, or (b) a new activity or item (other than capital
      equipment), the cost of which does not exceed US$[*],
      then in
      each case, the necessary approvals can be given by email
      from the
      Program Committee Member or a designee.
      

     

    3.2.6 Notwithstanding
      anything to the contrary, any part, or any change to a part, of a Work Plan
      and
      Budget that assigns any Development Work to CRI must be discussed with and
      approved in a timely manner in writing by CRI’s representative.

     

    3.2.7 The
      Program Management Committee may appoint individuals to serve as representatives
      on subcommittees to assist the Program Management Committee with respect to
      any
      particular area required for any IAVI Vaccine development under the Development
      Program, including, for example, product manufacturing, quality control and
      assurance, preclinical studies design, implementation and evaluation, clinical
      protocols design, implementation and evaluation, and regulatory
      affairs.

     

    3.3 Operational
      Committee.
      IAVI,
      CHOP and TGC will each appoint representatives to an operational committee
      (the
“Operational
      Committee”),
      which
      will oversee the operational, research and development aspects of the design,
      production and distribution of any IAVI Vaccine and will be subject to oversight
      by the Program Management Committee. The Operational Committee will meet
      quarterly, or more frequently if mutually agreed, and will report to the Program
      Management Committee. The Project Management Committee shall determine the
      number and required qualifications of representatives to the Operational
      Committee and each of IAVI, CHOP and TGC will appoint their respective initial
      representatives to the Operational Committee promptly thereafter. Subject to
      Section 3.2.3 and 3.2.6, all actions taken and decisions made by the Operational
      Committee shall require a vote by members of the Operational Committee, which
      vote will constitute a recommendation to, and must be approved by, the Program
      Management Committee in order to be effective. Notwithstanding the foregoing,
      only IAVI and TGC members of the Operational Committee shall be permitted to
      vote on matters related to the methods of making and purifying IAVI Vaccines,
      clinical trials, Regulatory Approvals and Marketing Approval Applications for
      any IAVI Vaccine, any Manufacture and/or Commercialization of any IAVI Vaccine
      and any other responsibilities designated in an applicable Work Plan and Budget
      as the responsibility of the Vaccine Developer, to the extent not materially
      and
      adversely affecting CRI or CHOP. Accordingly, with respect to any of the
      foregoing matters, the Operational Committee shall be entitled to act, and
      may
      only act, through the consent of both the IAVI members and the TGC members.
      Members of the Operational Committee may attend a meeting of the Operational
      Committee either in person or by telephone conference call, but not by proxy.
      Each of IAVI, CHOP and TGC may change any of its appointments to the Operational
      Committee at any time upon giving written notice to the other relevant
      Parties.

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
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    3.4 Development
      Responsibilities of the Parties.
      

     

    3.4.1 TGC
      shall:

     

    (i) Perform
      the Development Work assigned to TGC in the Work Plan and Budget in accordance
      with the Work Plan and Budget and all Applicable Laws, and shall use Reasonable
      Efforts to perform such Development Work within the applicable time frames
      designated therein;

     

    (ii) Consult
      with and provide IAVI with quarterly reports concerning the progress of the
      research and development conducted by TGC as part of the Development
      Program;

     

    (iii) Provide
      IAVI with such samples of Program Materials as may be requested by IAVI from
      time to time, however, such Program Materials provided by TGC shall not be
      disclosed or utilized in any experiments by IAVI or sent to any Third Party
      without the prior written permission of TGC
      (not to
      be unreasonably withheld) unless disclosed or utilized in accordance with
      Sections 5.2.5 or 5.2.6;

     

    (iv) Upon
      IAVI’s or an Outside Contractor’s written request for additional documentation
      containing any Joint Know How or TGC Know How to answer a request made by a
      regulatory authority in connection with a Regulatory Approval, provide such
      documentation subject to the conditions of Article 8; 

     

    (v) Upon
      IAVI’s reasonable request, consult with IAVI and its authorized representatives
      concerning TGC progress and developments in connection with the Development
      Program; 

     

    (vi) Make
      available to IAVI such supplies of any IAVI Vaccine, as contemplated in the
      Work
      Plan, as may be reasonably required to meet research and pre-clinical objectives
      under the Development Program to develop any IAVI Vaccine; and

     

    (vii) Pursuant
      to and in accordance with the terms of the Clinical Supply Agreement,
      manufacture or have manufactured under GMP conditions all IAVI Vaccines required
      by IAVI for use in clinical trials up through Phase II, and provide such IAVI
      Vaccines to IAVI in a form as reasonably requested by IAVI for use in such
      clinical trials. 

     

    3.4.2 CRI
      and
      CHOP shall:

     

    
      
        
        

      

      
        -17-

        
          

        

      

      
        
        

      

    


    (i) Have
      all
      research conducted by CHOP or CRI in connection with the Development Program
      be
      supervised by Dr. Philip R. Johnson who, by his signature below,
      agrees to perform such services;

     

    (ii) Perform
      the Development Work assigned to CRI or CHOP respectively in the Work Plan
      and
      Budget in accordance with the Work Plan and Budget and all Applicable Laws,
      and
      shall use Reasonable Efforts to perform such Development Work within the
      applicable time frames designated therein; 

     

    (iii) Consult
      with and provide IAVI and TGC and their authorized representatives with
      quarterly reports concerning the progress of the research and development
      conducted by CRI or CHOP respectively as part of the Development Program, and
      such samples of Program Materials paid for by IAVI, as may be requested by
      IAVI
      from time to time, however, such Program Materials provided by CRI or CHOP
      shall
      not be disclosed or utilized in any experiments by IAVI or sent to any Third
      Party without the prior written permission of TGC, and CRI or CHOP (as
      applicable), (in
      each
      case, not to be unreasonably withheld) unless disclosed or utilized in
      accordance with Sections 5.2.5 or 5.2.6; and

     

    (iv) Upon
      IAVI’s or an Outside Contractor’s written request for additional documentation
      containing any Joint Know How, CRI Know How or CHOP Know How to answer a request
      made by a regulatory authority in connection with a Regulatory Approval, provide
      such documentation subject to the conditions of Article 8.

     

    3.4.3 IAVI
      shall:

     

    (i) Fund
      the
      Development Work described in the Work Plan and Budget;

     

    (ii) Perform
      the Development Work assigned to IAVI in the Work Plan and Budget in accordance
      with the Work Plan and Budget and all Applicable Laws, and shall use Reasonable
      Efforts to perform such Development Work within the applicable time frames
      designated therein; 

     

    (iii) 
      Use
      Reasonable Efforts to conduct such clinical trials as may be reasonably
      necessary to obtain Regulatory Approvals and Marketing Approval Applications
      required to market and sell, in bulk or finished pharmaceutical form, as
      appropriate, any IAVI Vaccine in those countries of the Developing World
(as
      may
      be determined by IAVI); and to cooperate with TGC,
      at
      TGC’s cost, to assist TGC in its efforts to find a collaborative partner for the
      development, marketing and distribution of a TGC anti-HIV Vaccine; and

     

    (iv) Comply
      with all Applicable Laws in the performance of its obligations under the
      Development Program, including applicable legal and contractual requirements
      and
      restrictions relating to any of its funding sources for monies used to fund
      the
      Development Program.

     

    3.4.4 Each
      of
      CRI, CHOP, IAVI and TGC may appoint one or more advisory committees with respect
      to this Agreement and the conduct of the Development Program, including outside
      experts. Each of those Parties will take into reasonable account the views
      of
      the other of those Parties concerning the members of such committee(s), and,
      where reasonably so instructed by one of those Parties, each of CRI, CHOP,
      IAVI
      and TGC agrees to prevent the disclosure of any Confidential Information of
      the
      instructing Party to specific members of such committee(s).

     

    
      
        
        

      

      
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    3.4.5 CHOP
      agrees to notify TGC, CRI and IAVI promptly in the event that, for any reason,
      Dr. Johnson is unable or unwilling to continue to supervise CHOP’s
      activities under the Development Program. In such event, CHOP will within
      fourteen (14) days nominate a successor at CHOP, subject to the approval of
      TGC
      and IAVI, which approval shall not be unreasonably withheld or delayed. If
      CHOP,
      IAVI and TGC are unable to agree upon a successor at CHOP acceptable to TGC
      and
      IAVI within thirty (30) days from the date Dr. Johnson ceases to supervise
      CHOP’s activities under the Development Program, IAVI may terminate CHOP’s
      participation in the Development Program under this Agreement immediately upon
      written notice to CHOP (without affecting TGC’s continued participation
      hereunder). In the event that CHOP’s participation in the Development Program is
      terminated as set forth in the previous sentence, Section 9.6.5 shall apply
      and
      TGC and IAVI shall determine a replacement Vaccine Designer. The foregoing
      provisions shall apply to any replacement or successor to Dr. Johnson
      selected by IAVI, CHOP and TGC in accordance with the terms of this
      Agreement.
      

     

    3.5 Development
      Program Funding. 

     

    3.5.1 The
      Work
      Plan and Budget as of the Effective Date is attached hereto as Attachment B
      and
      describes CRI’s, CHOP’s and TGC’s respective work for the current Project Year
      of the Development Program. On or before the end of the ninth month of each
      Project Year, CRI, CHOP and TGC will jointly prepare and provide in draft form
      to IAVI a proposed Work Plan and Budget for the next Project Year, containing
      a
      statement of CRI’s, CHOP’s and TGC’s work for next Project Year and of the
      amounts of budgeted Collaboration Payments to be made with respect to that
      Project Year. CHOP, IAVI and TGC (and CRI with respect to any part of the Work
      Plan and Budget that assigns any Development Work to CRI) will work in good
      faith to agree on the final, written Work Plan and Budget for the next Project
      Year on or before the end of the eleventh month of each Project Year. All Work
      Plan and Budgets will take into account the progress made to that time in the
      course of the Development Program, and none of CHOP, IAVI or TGC (nor CRI with
      respect to any part of the Work Plan and Budget that assigns any Development
      Work to CRI) will unreasonably withhold or delay its agreement to any such
      Work
      Plan and Budget. 

     

    3.5.2 IAVI
      agrees to pay CRI, CHOP and/or TGC the quarterly Collaboration Payments set
      forth in the applicable Work Plan and Budget. [*]
      of
      the
      Collaboration Payments due and payable for a Program Quarter, estimated based
      on
      the applicable Work Plan and Budget, will be paid by IAVI to CRI, CHOP and
      TGC
      on or before the first day of such Program Quarter. The remainder of the
      Collaboration Payments for such Program Quarter will be due and payable within
      thirty (30) days of receipt of each respective invoice from CRI, CHOP and TGC
      for the actual services rendered or any costs incurred by each of CRI, CHOP
      and
      TGC (net of the Collaboration Payments already made for such Program Quarter)
      with respect to the concluded Program Quarter, which invoice must be accompanied
      by an activity-based expenditure report in such form as may be reasonably
      acceptable to IAVI. Each such invoice will be paid by IAVI to CRI, CHOP and
      TGC
      respectively (and each invoice shall be separately payable regardless of whether
      or not any other invoice has been properly submitted). If, during any Project
      Year, the Program Management Committee (and CRI, if Sections 3.2.3 or 3.2.6
      apply) recommends and IAVI agrees to modify or otherwise change the activities
      to be conducted by CRI, CHOP or TGC, or the amount budgeted for activities
      previously approved, the budget for funding to CRI, CHOP or TGC for that Project
      Year (and corresponding Collaboration Payments due) will be revised to reflect
      any adjustment in the estimated expenses for such Project Year as a result
      of
      the modified or otherwise changed activities or budget. IAVI
      shall not be responsible for paying any amounts incurred resulting from changes
      that were not approved as provided for in the foregoing sentence.

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
        -19-

        
          

        

      

      
        
        

      

    


    3.5.3 In
      the
      event that the Work Plan and Budget for any Project Year has not been agreed
      upon by one month before the start of such Project Year, the Responsible
      Executives of each of CHOP, IAVI and TGC (and
      CRI
      if Sections 3.2.3 or 3.2.6 apply) shall
      meet to resolve the matter. In the interim, subject to the limitations set
      forth
      in Section 3.5.2, pending agreement on the applicable Work Plan and Budget,
      IAVI will provide funding payments for such Project Year quarterly at the times
      provided in Section 3.5.2 in amounts sufficient to fund the activities
      ongoing from the just-ended Project Year, as approved by the Program Management
      Committee under an interim, short-term Work Plan and Budget for the Development
      Program. Absent an approved final, interim or short-term Work Plan and Budget,
      no Party shall have any obligation to perform or fund any Development Program
      activities during a Project Year for which a Work Plan and Budget has not been
      agreed.

     

    3.5.4 Subject
      to the provisions contained in this Section 3.5.4, IAVI may terminate the
      Development Program with respect to any reasonably separable portions of the
      Work Plan and Budget by giving at least ninety (90) days written notice to
      CRI,
      CHOP and TGC. In such event, any decreases in CRI’s, CHOP’s or TGC’s activities
      and obligations to perform Development Work shall be matched by a corresponding
      decrease in funding amounts under the Work Plan and Budget; provided,
      however,
      that,
      unless otherwise agreed, any such decrease in a Work Plan and Budget shall
      not
      take effect any earlier than ninety (90) days after notification of the decrease
      to CRI, CHOP and TGC and provided,
      further
      that
      IAVI will be required to pay CRI, CHOP and/or TGC the budgeted FTE and actual
      non-labor costs and any non-cancelable obligations incurred in good faith,
      in
      each case only to the extent actually incurred by CRI, CHOP and/or TGC in
      accordance with the Work Plan and Budget and not transferred to another
      comparable revenue generating project under the Work Plan and Budget during
      the
      ninety (90) day period. 

     

    3.5.5 TGC
      Accounting Method.
      The
      amount of Collaboration Payments required to be paid to TGC with respect to
      a
      Project Year will be prepared and agreed in accordance with the provision of
      this Agreement for the determination of the Work Plan and Budget
      for
      a
      Project Year, on the basis of the “TGC Accounting Method”, which includes a
      negotiated fixed FTE and manufacturing rate.

     

    3.5.6 USAID
      Requirements.
      CRI,
      CHOP and TGC acknowledge and agree that IAVI will utilize monies originating
      from the USAID to fund, in whole or in part, any Work Plan and Budget, where
      such Work Plan and Budget provides for such funding through IAVI in writing.
      If
      utilized such USAID monies shall fund, on a best efforts basis, efforts at
      TGC,
      as described in the appropriate Work Plan and Budget. Such
      budget related to the TGC efforts in a Work Plan and Budget shall be calculated
      based on arms length negotiated FTE and manufacturing fixed unit
      rates.
      Any
      funding required under a Work Plan and Budget which exceeds the funding
      allowable under IAVI’s USAID grant or co-operative agreement shall be provided
      by IAVI from funding sources other than the U.S. government. If IAVI
      utilizes monies originating from USAID
      to
      fund any
      activities or expenses under a Work
      Plan
      and Budget
      the
      USAID Standard Provisions included in Attachment F to this Agreement will be
      incorporated into that Work
      Plan
      and Budget
      by
      reference.
      IAVI
      represents and warrants that, as of the date of execution of this Agreement,
      aside from the USAID Standard Provisions, there are, and have been, no other
      rules,
      regulations or grant requirements that the other Parties must comply with as
      a
      result of IAVI funding
      any
      activities or expenses under this Agreement or the Initial Agreement with monies
      from any external funding source. IAVI shall disclose in writing all rules,
      regulations or grant requirements (“Requirements”) that the other Parties must
      comply with as a result of IAVI funding any activities or expenses under this
      Agreement with monies from any other external funding source. The
      Parties shall have no obligation to comply with such Requirements until they
      receive such notice and agree in writing to receive such funds. 

     

    
      
        
        

      

      
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    3.5.7 IAVI
      shall comply with the terms of any grant or co-operative agreement (from USAID
      or any other external funding source) used by IAVI to fund any activities or
      expenses under this Agreement. 

     

    3.5.8 IAVI
      will
      bear all costs and expenses incurred by IAVI in performance of IAVI’s
      responsibilities under the Development Program.

     

    3.6 Reports;
      Inspection.
      Each
      Party shall maintain, and shall use Reasonable Efforts to cause its Outside
      Contractors to maintain, accurate and complete records of all Development Work
      and all results of any trials, studies and other investigations conducted under
      this Agreement by or on behalf of such Party, its Affiliates and Outside
      Contractors, as applicable. A Party, or such Party’s authorized representatives,
      may visit those portions of the facilities of the other Parties or their Outside
      Contractors (and the contracting Party shall use Reasonable Efforts to ensure
      that such visits are permitted under the agreement with Outside Contractor)
      where Development Work is being performed during normal business hours upon
      reasonable prior notice without undue interruption to normal business
      operations, and provided that
      such
      requests for visits are not otherwise unreasonable and are conducted on a
      confidential basis. 

     

    3.7 Subcontracting
      of Development Work.
      Each of
      CHOP, IAVI and TGC may contract with one or more Outside Contractors to perform
      any or all of its obligations under the Development Program, provided
      that (i)
      except as otherwise agreed to by the Program Management Committee, each Outside
      Contractor shall be subject to the approval of each of CHOP, IAVI and TGC for
      the proposed work, such approval not to be unreasonably withheld or delayed,
      (ii) the contracting Party permits those other Parties upon their request to
      review and comment on, and uses Reasonable Efforts to incorporate the reasonable
      comments of those other Parties in, the drafts of the respective agreements
      engaging the Outside Contractors (each an “Outside
      Contractor Agreement”)
      and
      (iii) the contracting Party provides those other Parties upon their request
      with a true and accurate copy of each such Outside Contractor Agreement promptly
      after execution thereof. TGC and CHOP agree that IAVI may seek to enforce TGC
      or
      CHOP’s remedies under any such Outside Contractor Agreement directly against
      such Outside Contractor without first exhausting its remedies against TGC or
      CHOP if the Outside Contractor breaches such Outside Contractor Agreement so
      as
      to cause TGC or CHOP to breach this Agreement and IAVI shall have the right,
      but
      not the obligation to cure any default of TGC or CHOP under the applicable
      Outside Contractor Agreement even if TGC or CHOP terminates or rejects such
      agreement; provided,
      however,
      that if
      IAVI shall seek to exercise such remedies, TGC or CHOP shall remain primarily
      liable and obligated to IAVI under all provisions of this Agreement. CHOP,
      IAVI
      and TGC agree to use Reasonable Efforts to include in each Outside Contractor
      Agreement the following provisions: (a) a prohibition against sublicensing
      by
      such Outside Contractor of any Intellectual Property licensed to the contracting
      Party under this Agreement which is licensed to such Outside Contractor by
      TGC,
      CHOP or IAVI (which license shall be for the sole purpose of allowing the
      Outside Contractor to perform its obligations under the Outside Contractor
      Agreement); (b) if TGC is required to provide such Outside Contractor any IAVI
      Vaccine, a prohibition against the sale or distribution by such Outside
      Contractor of such IAVI Vaccine to any Third Party; (c) unless prohibited
      by law, an assignment to the appropriate Party of the rights to all Intellectual
      Property, including all patents and patent applications, developed by such
      Outside Contractor in the course of performing the Outside Contractor
      Agreement
      and if
      such an assignment is prohibited by law, an exclusive license transferable
      for
      the benefit of the appropriate Parties as required herein;
      (d) an
      express
      disclaimer that other than as required to perform the Outside Contractor
      Agreement, no right, title or license is provided to the Outside Contractor,
      including for
      manufacturing, having manufactured, supplying, using or selling any product
      which uses [*]
      proteins
      for a therapeutic or prophylactic effect and which is derived from or embodies,
      in whole or in part, any Intellectual Property of a Party; (e) in the event
      IAVI
      is named as a third party beneficiary or executes such contract, an
      acknowledgement that IAVI may enforce TGC’s and CHOP’s rights and remedies under
      such Outside Contractor Agreement, as set forth in the previous sentence of
      this
      Section 3.7; and (f) a right for any such Party to terminate such Outside
      Contractor Agreement in the event of a breach of the terms set forth in any
      of
      (a)-(e) above. 

     

    
      
        
        

      

      
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    3.8 Approval
      Applications and Regulatory Approvals For Manufacturing and Clinical
      Trials.

     

    3.8.1 TGC
      Regulatory Approvals.
      TGC
      shall consult in good faith with IAVI with respect to all Regulatory Approval
      filings and
      TGC
      shall
      use Reasonable Efforts to obtain and
      with
      appropriate assistance from IAVI
      maintain
      all clinical trial and manufacturing-related Regulatory Approval filings
      necessary for any IAVI Vaccine to be supplied to IAVI under this Agreement
      or
      the Clinical Supply Agreement, in the form agreed by CHOP, IAVI and TGC (and
      CRI
      if Sections 3.2.3 or 3.2.6 apply, or in the case of any Regulatory Approval
      filing
      a
      section of which has been generated by CRI or which is based on CRI preclinical
      data).
      Without
      limiting the foregoing, as part of the Development Program, TGC will assemble,
      or assist IAVI in assembling, all Regulatory Approval filings concerning the
      manufacture by TGC or clinical use by IAVI of any IAVI Vaccine. The expenses
      incurred by TGC in assembling such Regulatory Approval filings shall be paid
      or
      reimbursed as and to the extent provided under the applicable Work Plan and
      Budget and under Section 3.5, as may be modified pursuant to the terms of
      such Section 3.5. To the extent permitted by Applicable Laws, all TGC
      Regulatory Documents shall be owned by TGC. In the event this Agreement is
      terminated by IAVI pursuant to Section 9.5, at IAVI’s expense TGC will promptly
      send to IAVI complete copies of all Regulatory Approval filings concerning
      the
      manufacture or clinical use of any IAVI Vaccine (including English translations
      thereof, if applicable) and of any other correspondence with any Government
      Authority relating to the manufacture or clinical use of such IAVI Vaccine.
       

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
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    3.8.2 IAVI
      Regulatory Approvals.
      IAVI,
      with appropriate assistance from TGC, will use Reasonable Efforts to assemble,
      obtain and maintain all Marketing Approval Applications and Regulatory Approval
      filings, including but not limited to, those related to any clinical trials,
      as
      are reasonably required to develop, market, sell or distribute, in bulk or
      finished pharmaceutical form, as appropriate, any IAVI Vaccine in those
      countries of the Developing World in which IAVI, in its sole discretion, elects
      to market, sell or distribute the IAVI Vaccine. To
      the
      extent permitted by Applicable Laws, all
      such
      Marketing Approval Applications and Regulatory Approval filings and resulting
      approvals shall be owned by IAVI and IAVI shall retain full rights to utilize
      such filings and approvals for other products or services not inconsistent
      with
      any terms of this Agreement. The expenses incurred by IAVI in assembling such
      Marketing Approval Applications and Regulatory Approvals shall be paid in
      accordance with Section 3.5.8. TGC will cooperate with IAVI, at IAVI’s expense
      as provided in Section 3.5.8, in such manner as IAVI may reasonably request
      in
      obtaining such Regulatory Approvals. If TGC raises objections to any
      proposed
      filing by
      IAVI
      because
      such
      filing compromises the Development, Manufacture and/or Commercialization of
      any
      product by a party with Intellectual Property rights from TGC that are not
      conveyed to IAVI by TGC in this Agreement, IAVI
      and
      TGC will consult with each other and try to reach mutual agreement
      on the
      proposed filing. If no agreement is reached, IAVI and TGC shall meet to resolve
      the matter in accordance with the procedures set out in Section
      11.2.

     

    3.8.3 Rights
      of Reference.
      (a) Subject
      to the payment of royalties in accordance with Section 4.3, TGC shall have
      all
      necessary rights, to reference and utilize any relevant regulatory documents
      filed by IAVI with respect to any IAVI Vaccine (and resulting approvals),
      including Marketing Approval Applications and Regulatory Approvals and including
      any data or information contained therein for
      the
      purpose of the development of a TGC Vaccine.
      From
      time to time, IAVI shall provide TGC with such reasonable assistance and execute
      such documents as are necessary to effectuate such rights of reference and
      use;
      (b) Subject to the payment of royalties in accordance with Section 4.2, IAVI
      shall have all necessary rights, pursuant to the rights granted to IAVI by
      TGC
      in Sections 5.2 and 5.6 and/or in connection with any filings made by IAVI
      pursuant to Section 3.8.2, to reference and utilize any relevant TGC Controlled
      regulatory documents filed by TGC with respect to any IAVI Vaccine or TGC
      Vaccine (and resulting approvals), including TGC Regulatory Documents, Marketing
      Approval Applications and Regulatory Approvals and including any data or
      information contained therein
      in
      connection with the Development, Manufacture and/or Commercialization of an
      IAVI
      Vaccine and TGC shall use it Reasonable Efforts to gain access for IAVI to
      such
      regulatory documents filed but not Controlled by TGC .
      From
      time to time, TGC shall provide IAVI with such reasonable assistance and execute
      such documents as are necessary to effectuate such rights of reference and
      use;
      and
      (c)
      the
      foregoing rights of reference and use in (a) and (b) shall survive any
      expiration or termination of this Agreement. 

     

    3.8.4 In
      the
      event that TGC terminates this Agreement under Sections 9.4 or 9.5 due to
      IAVI’s breach or the occurrence of an Insolvency Event with respect to IAVI, or
      IAVI terminates this Agreement under Sections 9.2 or 9.3, and for the purpose
      of
      assisting TGC in developing products other than IAVI Vaccines, IAVI, at the
      request and expense of TGC and for a period of six (6) months after the
      effective date of such termination, shall cooperate reasonably with TGC or
      its
      designee, if applicable, in the issuance (or reissuance, transfer, or right
      to
      use, as appropriate) in the name of TGC or its designee of all Regulatory
      Approvals theretofore obtained or held by IAVI with respect to any IAVI
      Vaccines. 

     

    
      
        
        

      

      
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    3.8.5 In
      the
      event that IAVI terminates this Agreement under Sections 9.4 or 9.5 due to
      TGC’s
      breach or the occurrence of an Insolvency Event with respect to TGC, TGC, at
      the
      request and expense of IAVI and for a period of six (6) months after the
      effective date of such termination, shall cooperate reasonably with IAVI or
      its
      designee, if applicable, in the issuance (or reissuance, transfer, or right
      to
      use, as appropriate) in the name of IAVI or its designee of all Regulatory
      Approvals theretofore obtained or held by TGC with respect to any IAVI Vaccines.
      

     

    3.8.6 IAVI
      shall be responsible for filing all reports required to be filed under
      Applicable Laws in order to maintain any Regulatory Approvals granted to IAVI
      or
      its Affiliates or licensees for marketing and sale of any and all IAVI Vaccines
      in the Developing World, including, without limitation, adverse drug event
      reports. TGC shall reasonably cooperate with IAVI in preparing and filing all
      such reports and, upon IAVI’s request, provide IAVI with any information in
      TGC’s possession and Control which is relevant to any such reports.
      Notwithstanding the foregoing, to the extent TGC or IAVI has or receives any
      information regarding any adverse drug experience which may be related to the
      use of any IAVI Vaccines or
      the
      TGC anti-HIV Vaccine,
      TGC and
      IAVI, as the case may be, shall promptly provide the other Party with all such
      information in accordance with TGC’s or IAVI’s, as the case may be, obligations
      under Applicable Laws. The Parties shall determine the procedures to be followed
      as between themselves with respect to reporting adverse drug event and such
      procedures to be consistent with each of the Parties’ obligations under
      Applicable Laws. 

     

    3.9 Records
      and IAVI Audit Rights.
      TGC,
      CHOP and CRI shall keep and maintain complete and accurate records and books
      of
      account in sufficient detail and form so as to enable verification of the costs
      and expenses incurred by TGC, CHOP and CRI in conducting the Development Work.
      TGC, CHOP and CRI shall maintain such records and books of account for a period
      of not less than five (5) years following the year to which the records pertain.
      TGC, CHOP and CRI shall permit such records and books of account to be examined
      at TGC’s, CHOP or CRI’s premises, respectively, by IAVI’s internal auditor
      and/or by an independent certified public accountant selected by IAVI and
      acceptable to TGC, CHOP or CRI, respectively, such acceptance not to be
      unreasonably withheld. The selected accountant/auditor shall agree to be bound
      by obligations of confidentiality with respect to the examined records and
      books
      at least as protective as those provided in Article 8 herein. IAVI shall not
      have the right to examine records and books of account for the purpose of an
      audit by it of a Project Year that ended more than two (2) years prior to the
      initial date of the examination and no more than one such examination may be
      conducted by or on behalf of IAVI in any calendar year (and the records and
      books for a given Project Year shall not be examined more than once). Each
      and
      any such examination shall be conducted during normal business hours and only
      after ten (10) days prior written notice to such Party. The cost of such
      examination shall be borne by IAVI, unless such examination reveals a
      discrepancy of greater than ten percent (10%) per audit in the other Party’s
      favor, in which case such Party shall bear such cost. 

     

    
      
        
        

      

      
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    3.10 Commercialization
      of IAVI Vaccine.
      IAVI
      shall use its Reasonable Efforts to launch, promote, market and sell or
      distribute the IAVI Vaccine, in bulk or finished pharmaceutical form, and shall
      do so in compliance with Applicable Laws. The Parties acknowledge and agree
      that
      any IAVI Vaccine is to be used, distributed and sold by or on behalf of IAVI
      solely in the Developing World and not outside the Developing World. IAVI shall
      use Reasonable
      Efforts and
      shall
      cause its Third
      Party
      contractors to use Reasonable Efforts to prevent any IAVI Vaccine from being
      used, distributed or sold outside the Developing World. Subject to Applicable
      Laws, in the event that IAVI or TGC has knowledge that any IAVI Vaccines are
      being used, distributed or sold outside the Developing World (by importation
      or
      otherwise), such Party shall notify the other and IAVI and TGC shall cooperate
      and assist each other in securing the cessation of such unauthorized use,
      distribution and/or sale at IAVI’s sole expense.

     

    ARTICLE
      4

     

    CONSIDERATION

     

    4.1 Consideration
      from IAVI to CRI and CHOP.
      In
      consideration of obligations of and rights granted by CRI and CHOP respectively
      hereunder, IAVI shall pay to CRI and CHOP respectively such Collaboration
      Payments as are provided for in Section 3.5.

     

    4.2 Consideration
      from IAVI to TGC.

     

    4.2.1 Funding.
      In
      consideration of obligations of and rights granted by TGC hereunder, IAVI shall
      pay to TGC such Collaboration Payments as are provided for in Section
      3.5.

     

    4.2.2 Royalty
      Payments.
      In
      further consideration of obligations of and rights granted by TGC hereunder,
      IAVI shall pay to TGC a royalty in the amount of [*] percent
      ([*]%)
      of the
      Net Sales of any [*]
      to
      Persons in the [*]
      who are
[*] until
      the
      earlier of (i) [*]
      or
      (ii)
[*]. If
      TGC
      Know How, TGC Licensed Know How or Joint Know How owned by TGC but not IAVI
      is
      used by IAVI or its sublicensees in the Development, Manufacture or
      Commercialization of an IAVI Vaccine after
      that date, TGC will agree to a [*]
      reduction in that royalty after consultation with the other Parties, which
      will be paid by IAVI to TGC
      on a
      country by country basis,
      until
[*]
      years
      from the initial receipt of such Net Sales. 

     

    4.2.3 Manufacturing
      Revenue.
      In
      consideration of the obligations of TGC and rights granted by TGC, in the event
      that TGC and IAVI agree that
      TGC
      will manufacture and sell any IAVI Vaccine to IAVI following Regulatory Approval
      of such IAVI Vaccine for marketing, sale or distribution, TGC shall sell such
      IAVI Vaccine to IAVI (and IAVI shall purchase same from TCG) at prices to be
      agreed by IAVI and TGC.

     

    4.3 Consideration
      from TGC to IAVI.
      In
      consideration of the obligations, commitments, rights and representations made
      by IAVI herein, including, but not limited to IAVI’s funding of the Development
      Program and IAVI’s agreement to provide access to certain IAVI Know How and IAVI
      Patent Rights that may be necessary or useful in the development of TGC Vaccines
      pursuant to Section 5.5, TGC shall issue IAVI shares of TGC’s common stock and
      pay IAVI royalties pursuant to Sections 4.3.2 and 4.3.1.

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
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    4.3.1 Royalty
      Payments.
      

     

    (a) TGC
      HIV Royalty.
      TGC
      will
      pay IAVI the TGC HIV Royalty with respect to all TGC Royalty Revenues and all
      TGC Non-Royalty Revenues arising from the Commercialization of any TGC anti-HIV
      Vaccine anywhere in the Developed
      World until the earlier of (i) the expiration of the term of the last patent
      within the Patent Rights Controlled by TGC and utilized in the TGC anti-HIV
      Vaccine or (ii) a determination by a court or administrative agency of competent
      jurisdiction that the last claim of the last patent within the Patent Rights
      Controlled by TGC and utilized in the TGC anti-HIV Vaccine is invalid or
      unenforceable. If,
      after
      that date,
      IAVI
      Know How, Joint Know How owned by IAVI but not TGC or TGC Know How funded by
      IAVI during the Development Period is used by TGC or its sublicensees in the
      Development, Manufacture or Commercialization of an TGC
      anti-HIV Vaccine, IAVI will agree to a reasonable reduction in the TGC HIV
      Royalty after consultation with the other Parties, which
      will be paid by TGC to IAVI on
      a
      country by country basis,
      until
      twelve (12) years from the initial receipt of TGC Royalty Revenue. TGC’s
      agreement to pay the TGC HIV Royalty is based on the value TGC places on the
      body of information compiled by IAVI as it moves IAVI Vaccines through the
      clinic, toward Commercialization and through regulatory approval processes.
      Therefore, (1) with respect to any
      TGC
      HIV Royalty payment due to IAVI with respect to TGC Non-Royalty Revenue, that
      TGC HIV Royalty payment will be reduced: (a) by [*]%,
      if due
      prior to the [*]
      by IAVI
      of [*]
      with a
[*]
      which
[*]
      of the
      lead IAVI Vaccine; (b) by [*]%,
      if due
      prior to the [*]
      by IAVI
      of a [*]
      with a
[*]
      which
[*]
      of the
      lead IAVI Vaccine; and (c) by [*]%,
      if due
      prior to the [*]
      by IAVI
      of [*]
      of the
      lead IAVI Vaccine; and (2) with
      respect to any
      [*]
      due to
      IAVI with respect to [*],
      that
[*]
      will be
      reduced: (a) by [*]%,
      if the
      first such payment is due prior to the [*]
      by IAVI
      of a [*]
      with a
[*]
      which
[*]
      of the
      lead IAVI Vaccine; (b) by [*]%,
      if the
      first such payment is due prior to the [*]
      by IAVI
      of a [*]
      with a
[*]
      which
[*]
      of the
      lead IAVI Vaccine; and (c) by [*]%,
      if the
      first such payment is due prior to the [*]
      by
      IAVI
      of [*]
      of the
      lead IAVI Vaccine.
      

    


    (b) TGC
      Other Royalty.
      TGC
      will pay IAVI the TGC Other Royalty with respect to all TGC Royalty Revenues
      arising from the license, sale, lease, distribution, import or use of any TGC
      Other Vaccine anywhere in the Developing
      World and the Developed World
      until
      the earlier
      of (i)
      the expiration of the term of the last patent within the Patent Rights
      Controlled by TGC and utilized in the TGC Other Vaccine or (ii) a determination
      by a court or administrative agency of competent jurisdiction that the last
      claim of the last patent within the Patent Rights Controlled by TGC and utilized
      in the TGC anti-HIV Vaccine is invalid or unenforceable. If,
      after
      that date,
      IAVI
      Know How, Joint Know How owned by IAVI but not TGC or TGC Know How funded by
      IAVI during the Development Period is used by TGC or its sublicensees in the
      Development, Manufacture or Commercialization of a TGC Other Vaccine,
      IAVI
      will
      agree to a reasonable reduction in the TGC Other Royalty after consultation
      with
      the other Parties, which
      will be paid by TGC to IAVI on
      a
      country by country basis,
      until
      twelve (12) years from the initial receipt of TGC Royalty Revenue.

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
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    4.3.2 Stock
      Issuance.
      Within
      six business days of the date of execution of this Agreement, TGC shall issue
      to
      IAVI twenty five thousand (25,000) shares of TGC common stock, $0.01 par value
      (the “Shares”).

     

    (a) In
      connection with the acquisition of the Shares, and without derogating in any
      way
      from the representations and warranties of TGC, IAVI represents as
      follows:

     

    (i) IAVI
      has
      been advised that the Shares have not been, and will not be, registered under
      the Securities Act of 1933, as amended (the “Act”),
      nor
      qualified under any state securities laws on the ground, among other things,
      that no distribution or public offering of the Shares is to be effected and
      that
      in this connection TGC is relying in part on the representations of IAVI set
      forth herein.

     

    (ii) IAVI
      is
      acquiring the Shares for its own account as principal, for investment purposes
      only, and not with a view to, or for, resale or distribution of all or any
      part
      of the Shares, and no other person has a direct or indirect beneficial interest
      in such shares. IAVI has determined that the Shares are a suitable investment
      for it and that it can bear a complete loss of value of the Shares. IAVI has
      the
      financial ability to bear the economic risk of its investment, has adequate
      means for providing for its current needs and has no need for liquidity with
      respect to its investment in the Shares. IAVI has such knowledge and experience
      in financial and business matters that it is capable of evaluating the merits
      and risks of its investment in the Shares. IAVI is authorized and qualified
      to
      become a holder of Shares.

     

    (iii) IAVI
      is
      an “accredited investor” for the purposes of Regulation D promulgated by the
      Securities and Exchange Commission under the Act.

     

    (iv) IAVI
      has
      not purchased the Shares as a result of any general solicitation or general
      advertising.

     

    (v) IAVI
      (a)
      acknowledges that: (i) no federal or state agency has passed upon the Shares
      or
      made any finding or determination as to the fairness of this investment; (ii)
      the Shares may not be transferred, sold or otherwise disposed of, except as
      may
      be permitted under the Act and applicable state securities laws pursuant to
      registration or exemption therefrom; and accordingly, IAVI may be required
      to
      bear the financial risks of an investment in the Shares for an indefinite period
      of time; and (b) consents to (i) the placing of a legend substantially in the
      form set forth below on the certificate representing the Shares stating that
      the
      Shares have not been registered and setting forth the restriction on transfer
      contemplated hereby and (ii) the placing of a stop transfer order on the books
      of TGC and with any transfer agents against the Shares; provided
      that,
      notwithstanding the foregoing, the shares may be transferred and such legend
      removed upon receipt by TGC of an opinion of reputable counsel in form
      reasonably acceptable to TGC that such transfer is exempt from or not subject
      to
      registration under the Act.

     

    
      
        
        

      

      
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    A
      legend
      shall be placed on certificates representing the Shares substantially in the
      form set forth below:

     

    THE
      SECURITIES EVIDENCED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT
      OF
      1933, AS AMENDED, NOR ANY STATE SECURITIES LAWS. NEITHER THIS SECURITY NOR
      ANY
      INTEREST OR PARTICIPATION HEREIN MAY BE OFFERED FOR SALE, SOLD OR OTHERWISE
      ASSIGNED OR TRANSFERRED, DIRECTLY OR INDIRECTLY, NOR MAY THE SECURITIES BE
      TRANSFERRED ON THE BOOKS OF THE CORPORATION, IN THE ABSENCE OF SUCH REGISTRATION
      WITHOUT AN OPINION OF STOCKHOLDER’S COUNSEL, IN FORM REASONABLY ACCEPTABLE TO
      THE CORPORATION, THAT SUCH TRANSACTION IS EXEMPT FROM OR NOT SUBJECT TO
      REGISTRATION.

     

    The
      foregoing representations shall survive the time when the Shares are
      issued.

     

    (b) In
      connection with the acquisition of the Shares, TGC represents that, assuming
      the
      accuracy of the representations of IAVI contained in Section 4.3.2(a), the
      offer, issuance and sale of the Shares are and will be exempt from the
      registration requirements of the Act, and have been registered or qualified
      (or
      are exempt from registration and qualification) under the registration, permit
      or qualification requirements of all applicable state securities
      laws.

     

    (c) With
      a
      view to making available to IAVI the benefits of Rule 144 promulgated under
      the
      Securities Act (“Rule
      144”)
      and
      any other rule or regulation of the SEC that may at any time permit IAVI to
      sell
      the Shares to the public without registration, TGC agrees to: (i) make and
      keep
      public information available, as those terms are understood and defined in
      Rule
      144, (ii) file with the SEC in a timely manner all reports and other documents
      required of TGC under the Securities Act and the Exchange Act of 1934, as
      amended; and (iii) furnish to IAVI, so long as IAVI owns any Shares, forthwith
      upon request (x) a written statement by TGC that it has complied with the
      reporting requirements of Rule 144, the Securities Act and the Exchange Act,
      and
      (y) such other information as may be reasonably requested in availing IAVI
      of
      any rule or regulation of the SEC which permits the selling of any of the Shares
      without registration.

     

    (d) Each
      of
      IAVI and TGC (the “Indemnifying
      Party”)
      agrees
      to indemnify and hold harmless the other, its agents, officers, directors,
      representatives and affiliates (collectively, the “Indemnified
      Parties”)
      against any and all loss, liability, claim, damage and expense, including
      reasonable attorneys’ fees, arising out of or based upon any false
      representation or warranty or breach or failure by the Indemnifying Party to
      comply with any covenant or agreement made by the Indemnifying Party in this
      Section 4.3.2 or in any other document furnished by the Indemnifying Party
      to
      any of the Indemnified Parties in connection with the offer or sale of the
      Shares. Notwithstanding the foregoing, neither IAVI nor TGC shall be liable
      for
      any lost profits or special, incidental or consequential damages.

     

    4.4 Taxes
      and Withholding.
      All
      payments under this Agreement will be made without any deduction or withholding
      for or on account of any tax unless such deduction or withholding is required
      by
      Applicable Laws. If the paying Party is so required to deduct or withhold,
      such
      Party will (i) promptly notify the other Party of such requirement,
      (ii) pay to the relevant authorities the full amount required to be
      deducted or withheld promptly upon the earlier of determining that such
      deduction or withholding is required or receiving notice that such amount has
      been assessed against the other Party, and (iii) promptly forward to the
      other Party an official receipt (or certified copy) or other documentation
      reasonably acceptable to the other Party evidencing such payment to such
      authorities. The Parties shall reasonably cooperate to obtain exemption from
      or
      reduction of any required withholdings or deductions in accordance with
      Applicable Laws.

     

    
      
        
        

      

      
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    4.5 Currency.
      All
      amounts payable and calculations hereunder shall be in United States dollars.
      As
      applicable, Net Sales of any Person and any expenses incurred by any Party
      shall
      be translated into United States dollars in accordance with customary and usual
      translation procedures, consistently applied. If, due to restrictions or
      prohibitions imposed by national or international authority, payments cannot
      be
      made as provided in this Article 4, the Parties shall consult with each
      other with a view to finding a prompt and acceptable solution.

     

    4.6 Payments;
      Late Payments.
      Each
      Party shall make all payments due any other Party under this Agreement by wire
      transfer of immediately available funds to such account notified by the
      receiving Party from time to time to the paying Party in writing in accordance
      with the provisions of Section 12.5. If any sum due and payable under this
      Agreement shall not have been paid on or before the applicable due date, simple
      interest shall accrue on the unpaid amount at a rate equal
      to
      the London Interbank Offered Rate (LIBOR) plus two
      percent
      (2%)
      per
      annum or, if less, the maximum rate permitted under Applicable Law from the
      payment due date until the actual date of payment without prejudice to any
      other
      claim or remedy available to the non-paying Party; provided,
      however,
      that no
      interest shall accrue on any portion of an unpaid amount which is the subject
      of
      a good faith, legitimate dispute. If any such dispute is resolved against the
      paying Party, the date of resolution shall be deemed the date that payment
      to
      the other Party originally was due. 

     

    4.7 Royalty
      Payment Terms.
      Royalties payable by either TGC or IAVI to the other under this Article 4 shall
      be payable on a calendar quarterly basis within sixty (60) days after the end
      of
      each calendar quarter, or if royalties are paid by IAVI or TGC to the other
      from
      revenue received by IAVI or TGC from a licensee or other partner, then Royalties
      payable by either TGC or IAVI to the other under this Article 4 shall be payable
      on a calendar quarterly basis within thirty (30) days after receipt of revenue
      from the licensee or partner. Each such royalty payment shall be accompanied
      by
      a written notice setting forth the royalty amount owed and describing in
      reasonable detail the calculation thereof. 

     

    ARTICLE
      5

     

    EXCLUSIVITY,
      GRANT OF RIGHTS AND RELATED COVENANTS

     

    5.1 Exclusivity.
      It is
      the intent of the Parties that, during the term of this Agreement and the
      Clinical Supply Agreement, as applicable, CHOP, IAVI and TGC shall design and
      develop one or more IAVI Vaccines for use in the Developing World that will
      be:
      (i) designed by CHOP (with the involvement of IAVI, CRI and TGC); (ii) developed
      by TGC and IAVI; and (iii) at least through [*]
      manufactured exclusively by TGC and supplied exclusively to IAVI (or as directed
      by IAVI). TGC and IAVI acknowledge that they will negotiate in good faith and
      agree to the Commercial Supply Agreement for Phase III clinical supply and
      commercial manufacture if both IAVI and TGC agree (in their respective sole
      discretion) that TGC will continue as exclusive supplier of IAVI Vaccine to
      IAVI
      for use in the Developing World. The exclusivity provided for in this Article
      5
      is in all cases limited to IAVI Vaccines and shall not limit or restrict any
      Party from the Development, Manufacture and/or Commercialization of any other
      product candidate or product. Notwithstanding the foregoing, and subject to
      Sections 4.3, 5.1.3, 5.2.9, 5.2.10, 5.3 and 5.4, nothing in this Article 5
      is
      intended to limit or restrict the Development, Manufacture and/or
      Commercialization of a TGC anti-HIV Vaccine for the Developed
      World.

     

    
      
        
        

      

      
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    5.1.1 Exclusive
      Commercialization and Supply.
      In
      order
      to provide IAVI with certain assurances, during the term of this Agreement
      and
      the Clinical Supply Agreement, that IAVI will have the exclusive right to
      Commercialize any IAVI Vaccine which is funded and developed under the
      Development Program for the Developing World, TGC undertakes and agrees that
      (1)
      it shall not supply
      any IAVI Vaccine which
      is
      funded and developed under the Development Program
      to any
      other Person for Commercialization and/or use in or for the Developing World,
      and (2)
      neither
      it nor any of its Affiliates shall, directly or indirectly (including, without
      limitation, in the capacity of licensor) Commercialize and/or use any IAVI
      Vaccine which is funded and developed under the Development Program or any
      composition(s) for inducing [*]
      to HIV
      in a person, which [*]
      and
      encapsidated within an AAV capsid, which was developed [*],
      for the
      prophylactic or therapeutic treatment of AIDS in or for the Developing World.
      

     

    5.1.2 Alternate
      Supply.
      In
      order to provide IAVI with certain assurances that IAVI will be able to
      Manufacture and/or Commercialize any IAVI Vaccine for the Developing World,
      in
      the event (i) this Agreement is terminated by IAVI under Sections 9.4 or 9.5;
      or
      (ii) TGC is unable to fulfill its manufacturing obligations under this Agreement
      or the Clinical Supply Agreement ([*]);
      or
      (iii) TGC chooses not to or IAVI does not request TGC to supply any IAVI Vaccine
      for Phase III development or for marketing, sale or distribution, TGC agrees
      that, subject to the terms and conditions of this Agreement, IAVI and its
      sublicensees shall be free to exercise the exclusive [*]
      to
      Manufacture and/or Commercialize any IAVI Vaccine solely for the Developing
      World as set forth in Sections 5.2 and 5.6. 

     

    5.1.3 Commercialization
      Rights.
      The
      Parties acknowledge and agree that except
      as
      expressly provided herein, the Parties each retain their respective rights,
      title and interests in and to all Intellectual Property, including, with
      respect to TGC its right to practice, exploit and/or offer to license to a
      Third
      Party any Intellectual Property Controlled by TCG for the Development,
      Manufacture and/or Commercialization of any TGC Vaccine or any other products
      that are not an IAVI Vaccine. 

     

    5.1.4 Intellectual
      Property.
      The
      Parties acknowledge that the [*]
      any IAVI
      Vaccine intended for distribution
      in the
      Developing World by IAVI has not been fixed as of the Effective Date and it
      is
      the purpose of this Agreement and the Clinical Supply Agreement to define the
      [*]
      the IAVI
      Vaccines. Therefore it is acknowledged and agreed by the Parties that the grant
      of any rights and licenses under this Agreement to the Intellectual Property
      Controlled by TGC, the CRI Patent Rights, the CRI Know How, the CHOP Patent
      Rights and the CHOP Know How will be limited to such Intellectual
      Property as
      is [*]
      for the
      Development, Manufacture and/or Commercialization of any IAVI Vaccine
for
      the
      Developing World which is funded or developed under the Development Program
      Subject to the provisions in this Agreement, CHOP, CRI and TGC agree to use
      Reasonable Efforts to assess and determine, based on the then current
      Development Program, the TGC Controlled Patent Rights, the CHOP Patent Rights
      and the CRI Patent Rights necessary or useful for IAVI to Manufacture and
      Commercialize any IAVI Vaccine and to attach such list of Patent Rights to
      this
      Agreement as Attachment E. The Parties further acknowledge and agree that such
      Attachment E shall be modified yearly, based on the then current Development
      Program, and that, from year to year, the Patent Rights included on Attachment
      E
      may be removed and/or additional rights may be included .
      If
      the
      circumstances described in Sections 5.1.2(ii) or 5.1.2(iii) occur, the Parties
      agree to
      use
      Reasonable Efforts to assess and determine, based on the then current
      Development Program and consistent with the licenses granted in Article 5,
      the
      TGC Controlled Patent Rights, the CHOP Patent Rights and the CRI Patent Rights
      necessary for IAVI to Manufacture and Commercialize any IAVI Vaccine funded
      and
      developed under the Development Program at that time and to attach such list
      of
      Patent Rights to this Agreement as Attachment E.

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    5.1.5 Intellectual
      Property Generated from Use of Program Materials.
      At
      IAVI’s request, the Parties may agree to utilize Program Materials to support
      additional Third Party studies not conducted as part of the approved Development
      Program. Prior to any such use, the Parties will negotiate in good faith the
      Third Party contracts governing the use of such Program Materials, including,
      without limitation, ownership and other Intellectual Property rights.


     

    5.1.6 Additional
      Patent Rights.
      During
      the Term of this Agreement, Additional Patent Rights may be identified as
      necessary for the Development, Manufacture and/or Commercialization of any
      IAVI
      Vaccine for the Developing World. CRI, CHOP, IAVI and TGC agree to consult
      with,
      inform, and collaborate on identifying such Additional Patent Rights during
      the
      term of this Agreement. Upon identification of any Additional Patent Rights,
      CRI, CHOP, IAVI and TGC will mutually agree to a licensing strategy to obtain
      such rights subject to the following conditions:

     

    (a) In
      the
      event IAVI determines it requires Additional Patent Rights for the Development,
      Manufacture and/or Commercialization of any IAVI Vaccine for the Developing
      World and [*]
      determines that [*]
      are not
      necessary for the [*]
      of any
      TGC Vaccine, or any AAV product [*],
      IAVI
      shall be responsible, [*],
      for
      obtaining licenses or such other rights as it deems appropriate to such
      Additional Patent Rights, provided,
      however,
      IAVI
      will not in any agreement involving such Additional Patent Rights obligate
      or
      create an apparent obligation for any other Party to license, or acquire any
      obligations with respect to, such Additional Patent Rights. IAVI will involve
      the other Parties in the process of obtaining the Additional Patent Rights
      to
      the extent necessary or useful for them to ensure no such obligations are
      created, which involvement shall not discharge TGC’s obligations to the Parties
      hereunder. [*].
      

     

    (b) In
      the
      event IAVI determines it requires Additional Patent Rights for the Development,
      Manufacture and/or Commercialization of any IAVI Vaccine for the Developing
      World and [*]
      also
      determines that [*]
      are
      necessary for such other Party to [*]
      any AAV
      based product [*],
      IAVI
      and such Party will jointly cooperate to obtain such license for IAVI and such
      Party;
      provided,
      however,
      that no
      Party will obligate or create an apparent obligation for any other Party to
      license, or acquire any obligations with respect to such Additional Patent
      Rights.
      The
      Parties being licensed will involve the other Parties in the process of
      obtaining the additional Patent Rights to the extent necessary or useful for
      them to ensure no such obligations are created, which involvement shall not
      discharge the Parties’ obligations hereunder. [*].
      

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
          -31-

          
            

          

        

        
          
          

        

      

    


    (c) In
      the
      event TGC determines it requires Additional Patent Rights for the Development,
      Manufacture and/or Commercialization of a [*],
      or
[*]
      product
      and [*]
      determines it does not [*]
      for the
[*]
      of any
[*],
      TGC
      shall be responsible, [*],
      for
      obtaining licenses or such other rights as it deems appropriate to such
      Additional Patent Rights, provided,
      however,
      TGC will
      not in any agreement involving such Additional Patent Rights obligate or create
      an apparent obligation for any other Party to license, or acquire any
      obligations with respect to, such Additional Patent Rights. TGC will involve
      the
      other Parties in the process of obtaining any Additional Patent Rights to the
      extent they are related to the HIV component of the IAVI Vaccine, and to the
      extent necessary or useful for them to ensure no such obligations are created,
      which involvement shall not discharge TGC’s obligations to the Parties
      hereunder. [*].
      

     

    (d) Subject
      to (a), (b) and (c) above, IAVI shall be solely responsible for obtaining all
      Intellectual Property necessary for the Development, Manufacture and/or
      Commercialization of any IAVI Vaccine for the Developing World (at IAVI’s sole
      cost and expense) which is not otherwise expressly licensed to IAVI under this
      Article 5. 

     

    (e) For
      Additional Patent Rights that do not fall within (a), (b), (c) or (d) above,
      no
      Party shall have any obligation hereunder with respect to such Additional Patent
      Rights and any Party choosing to license such Additional Patent Rights shall
      be
      solely responsible for all costs, fees and payments due with respect
      thereto.
      No
      Party
      will obligate or create an apparent obligation for any other Party to license,
      or acquire any obligations with respect to such Additional Patent
      Rights.

     

    5.2 Grant
      of License by TGC of TGC Controlled Intellectual Property to
      IAVI.

     

    5.2.1 Right
      to TGC Controlled Intellectual Property.
      Subject
      to the terms and conditions of this Agreement and the Clinical Supply Agreement,
      TGC hereby grants to IAVI an [*]
      and
      license under the Intellectual Property Controlled by TGC which is [*]
      to make,
      have made, use, sell, offer for sale and import any IAVI Vaccine funded and
      developed under the Development Program for the Developing World. For the
      avoidance of doubt, the foregoing license shall permit IAVI to Manufacture
      IAVI
      Vaccine outside the Developing World but solely to the extent such IAVI Vaccine
      is used, distributed and sold within the Developing World. IAVI
      agrees not to exercise such right and license unless the circumstances described
      in Section 5.1.2 (i), 5.1.2 (ii) or 5.1.2 (iii) occur.  

     

    5.2.2 Right
      to TGC Controlled Intellectual Property.
      Subject
      to the terms and conditions of this Agreement and the Clinical Supply Agreement,
      TGC hereby grants to IAVI a [*]
      and
      license under the Intellectual Property Controlled by TGC which is [*]
      to make,
      have made, use, sell, offer for sale and import any IAVI Vaccine not funded
      and
      developed under the Development Program for the Developing World. For the
      avoidance of doubt, the foregoing license shall permit IAVI to Manufacture
      IAVI
      Vaccine outside the Developing World but solely to the extent such IAVI Vaccine
      is used, distributed and sold within the Developing World. IAVI agrees not
      to
      exercise such right and license unless the circumstances described in
[*].

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    5.2.3 Term
      of License.
      The
      term of the rights and licenses granted in Sections 5.2.1 and 5.2.2 shall
      commence on the Effective Date and shall expire on the later of: (a) the
      expiration of the term of the last patent within the Patent Rights Controlled by
      TGC or
      (b) a determination by a court or administrative agency of competent
      jurisdiction that the last claim in the last patent within the Patent Rights
      Controlled by TGC is invalid or unenforceable, unless
      the term
      of such right and license is earlier terminated pursuant to the provisions
      of
      Article 9 (and provided further
      that the
      license to [*]
      granted
      above shall survive the expiration of such term to the extent provided for
      in
      Section 9.6.9). 

     

    5.2.4 TGC
      Licensed Patent Rights or TGC Licensed Know How.
      No
      grant
      of the right or sublicense granted in Section 5.2.1 or 5.2.2 shall be effective
      or remain in effect with
      respect to any TGC Licensed Patent Rights or TGC Licensed Know How unless
      and until IAVI [*]
      for
[*]
      or
[*]
      (including [*]
      or other
      charges) due or payable [*]
      to the
      applicable Third Party Licensors under the applicable Third Party Agreements
      (or
      otherwise) to the extent that such monies are payable on account of (i)
[*];
      (ii)
[*]
      to IAVI
      under or to any TGC Licensed Patent Rights and/or TGC Licensed Know How; or
      (iii) the exercise by IAVI of such sublicensed rights. TGC shall provide to
      IAVI, in advance of any such monies being due, redacted copies of the applicable
      Third Party Agreement which set forth an explanation of any such amounts due.
      Unless disputed, IAVI shall pay all such amounts to TGC within thirty (30)
      days
      of an invoice therefore, except to the extent an alternative arrangement is
      otherwise agreed to by IAVI and TGC. All licenses granted under this Section
      5.2
with
      respect to any TGC Licensed Patent Rights or TGC Licensed Know How are
      subject to and limited by, and IAVI agrees to comply with, the applicable terms
      and conditions of the applicable Third Party Agreements, [*].
      

     

    5.2.5 Technology
      Transfer.
      If
      (i)
      TGC is unable to fulfill its manufacturing obligations under this Agreement
      or
      the Clinical Supply Agreement (following written notice and a reasonable
      opportunity to cure such inability); or (ii) TGC chooses not to or IAVI does
      not
      request TGC to supply any IAVI Vaccine, which has been funded and developed
      under the Development Program, for Phase III development or for marketing,
      sale
      or distribution, TGC and IAVI shall agree upon and implement a reasonable
      technology transfer plan, [*]
      or a
      mutually agreed upon chosen contract manufacturer to manufacture the
[*]
      which is
      the [*]
      in
      effect at the time of such technology transfer implementation.

     

    5.2.6 Technology
      Transfer on TGC Breach or Insolvency Event.
      If the
      Agreement is terminated by IAVI under Section 9.4 or 9.5 because of TGC’s breach
      or the occurrence of an Insolvency Event with respect to TGC, TGC
      and
      IAVI shall agree upon and implement a reasonable technology transfer plan,
      [*]
      to
      manufacture any [*]
      which is
      the [*]
      in
      effect at the time of termination, which will include, but not be limited to,
      a
[*]
      of
      requisite [*],
      documentation, and materials, related to any such IAVI Vaccine. Without
      limitation of the generality of the foregoing, the Parties shall use Reasonable
      Efforts to complete the transition of the [*]
      of any
      IAVI Vaccine to IAVI [*]
      as soon
      as is reasonably possible. Once such transfer to IAVI, [*],
      has
      occurred, TGC shall provide to IAVI [*],
      such
      manufacturing process [*] as
      specifically relate to the manufacturing process transferred to IAVI under
      this
      Section 5.2.6. IAVI may [*]
      to
      manufacture IAVI Vaccine provided that [*]
      (such
      approval not to be unreasonably withheld or delayed) that the [*]
      with the
      capability and resources to provide [*]
      for the
      production of [*],
      and has
      adequate security safeguards to [*]
      in any
      Intellectual Property Controlled by [*]
      used by
[*]
      to make
      any IAVI Vaccine. IAVI’s agreement with such manufacturer shall include
      appropriate restrictions on the use of any Intellectual Property Controlled
      by
      TGC by such manufacturer, including, but not limited to (i) [*]
      consistent with the terms and conditions stated herein, (ii) a commitment to
      use
      Commercially Reasonable
      Efforts to
      ensure
      that the [*]
      pursuant
      to this Section 5.2.6 is utilized [*]
      for the
      Developing World and
      (iii)
      an [*]
      a
      license to any improvements on the [*].
      TGC
      shall have the right to review and approve the restrictions detailed in the
      previous sentence (such approval shall not be unreasonably withheld or delayed).
      

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    5.2.7 Third
      Party Agreements.
      Upon
      written request from IAVI, TGC shall provide to IAVI copies of all Third Party
      Agreements that are reasonably necessary or
      useful
for
      IAVI
      to make, use or sell an IAVI Vaccine. TGC may [*]
      which
      does not pertain to the obligations or rights of IAVI as a sublicensee under
      any
Third
      Party Agreement. 

     

    5.2.8 TGC’s
      Retained Right.
      All
      rights and licenses granted by TGC under this Section 5.2 are subject to TGC’s
      retained right to perform its obligations under this Agreement and the Clinical
      Supply Agreement (and under any subsequent supply agreement for the IAVI
      Vaccine, if any). 

     

    5.2.
      9 Right
      to TGC Controlled anti-HIV Vaccines.
      TGC
      hereby grants to IAVI a [*]
      license
      under any TGC Controlled Intellectual Property or product rights to any TGC
      Controlled anti-HIV Vaccine to Develop, Manufacture and/or Commercialize any
      TGC
      Controlled anti-HIV Vaccine [*]
      for the
      Developing World. The term of such [*]
      shall
      commence on the Effective Date and shall expire on the earlier of: (a) the
      expiration of the term of the last patent within the Patent Rights Controlled by
      TGC or
      (b) a determination by a court or administrative agency of competent
      jurisdiction that the last claim in the last patent within the Patent Rights
      Controlled by TGC is invalid or unenforceable. 

     

    5.2.10 Right
      to TGC Partnered anti-HIV Vaccines.
      If TGC
      can secure for IAVI the grant of a [*]
      and
      license under any TGC Partnered anti-HIV Vaccine or product rights to any TGC
      Partnered anti-HIV Vaccine to Develop, Manufacture and/or Commercialize any
      TGC
      Partnered anti-HIV Vaccine [*]
      for the
      Developing World, the TGC HIV Royalty shall be [*]
      per
      cent.

     

    5.3 Grant
      of License by CRI of CRI Patent Rights and Know How to IAVI. 

     

    5.3.1 Right
      to CRI Patent Rights.
      Subject
      to the terms and conditions of this Agreement, including Sections 5.1.3 and
      5.7,
      CRI hereby grants to IAVI an [*],[*]
      license
      under the CRI Patent Rights to make, have made, use, sell, offer for sale and
      import any IAVI Vaccine for the Developing World. For the avoidance of doubt,
      the foregoing [*]
      shall
      permit IAVI to Manufacture IAVI Vaccine outside the Developing World but solely
      to the extent such IAVI Vaccine is used, distributed and sold within the
      Developing World. 

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    5.3.2 Right
      to CRI Know-How. Subject
      to the terms and conditions of this Agreement, including Sections 5.1.3 and
      5.7,
      CRI hereby grants to IAVI a [*],[*]
      license
      under the CRI Know-How to make, have made, use, sell, offer for sale and import
      the IAVI Vaccine for the Developing World. For the avoidance of doubt, the
      foregoing [*]
      shall
      permit IAVI to Manufacture IAVI Vaccine outside the Developing World but solely
      to the extent such IAVI Vaccine is used, distributed and sold within the
      Developing World. CRI shall have no obligation to provide CRI Know How or Joint
      Know How other than pursuant to Sections 3.4.2(iv) or 9.6.1.

     

    5.3.3 Term
      of License. The
      term
      of the right and license granted in Sections 5.3.1 and 5.3.2 shall commence
      on
      the Effective Date and shall expire on the later of (a) the expiration of the
      term of the last patent within the CRI Patent Rights; or (b) a determination
      by
      a court or administrative agency of competent jurisdiction that the last claim
      in the last patent within the CRI Patent Rights is invalid or unenforceable,
      unless
      the term
      of such right and license is earlier terminated pursuant to the provisions
      of
      Section 9 (and provided further
      that the
      license to any CRI Know How granted above shall survive the expiration of such
      term to the extent provided for in Section 9.6.9).

     

    5.3.4 CRI
      Retained Right. All
      rights and licenses granted by CRI under Articles 5 and 9 are subject to CRI’s
      retained
      right to
      practice and have practiced all such Intellectual Property for research and
      educational efforts other than clinical trials on the [*].

    


    5.4 Grant
      of License by CHOP of CHOP Patent Rights and Know How to
      IAVI.

     

    5.4.1 Right
      to CHOP Patent Rights and Know How.
      Subject
      to the terms and conditions of this Agreement, including Sections 5.1.3 and
      5.7,
      CHOP hereby grants to IAVI an [*]
      license
      under the CHOP Patent Rights to make, have made, use, sell, offer for sale
      and
      import any IAVI Vaccine for the Developing World. For the avoidance of doubt,
      the foregoing [*]
      shall
      permit IAVI to Manufacture IAVI Vaccine outside the Developing World but solely
      to the extent such IAVI Vaccine is used, distributed and sold within the
      Developing World. 

     

    5.4.2 Right
      to CHOP Know-How. Subject
      to the terms and conditions of this Agreement, including Sections 5.1.3 and
      5.7,
      CHOP hereby grants to IAVI a [*],[*]
      license
      under the CHOP Know-How to make, have made, use, sell, offer for sale and import
      the IAVI Vaccine for the Developing World. For the avoidance of doubt, the
      foregoing [*]
      shall
      permit IAVI to Manufacture IAVI Vaccine outside the Developing World but solely
      to the extent such IAVI Vaccine is used, distributed and sold within the
      Developing World. CHOP shall have no obligation to provide CHOP Know-How or
      Joint Know-How. CHOP shall have no obligation to provide CHOP Know How or Joint
      Know How other than pursuant to Sections 3.4.2(iv), 9.6.1 and
      9.6.5.

     

    5.4.3 Term
      of License.
      The
      term of the [*]
      license
      granted in Sections 5.4.1 and 5.4.2 shall commence on the Effective Date and
      shall expire on the later of (a) the expiration of the term of the last patent
      within the CHOP Patent Rights; or (b) a determination by a court or
      administrative agency of competent jurisdiction that the last claim in the
      last
      patent within the CHOP Patent Rights is invalid or unenforceable, unless
      the term
      of such [*]
      license
      is earlier terminated pursuant to the provisions of Section 9 (and provided further
      that the
      license to any CHOP Know How granted above shall survive the expiration of
      such
      term to the extent provided for in Section 9.6.9). 

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    5.4.4 CHOP
      Retained Right. All
      rights and licenses granted by CHOP under Articles 5 and 9 are subject to CHOP’s
      retained
      right to
      practice and have practiced all such Intellectual Property for research and
      educational efforts other than clinical trials on the [*].

    


    5.5 Grant
      of License by IAVI of IAVI Know How and IAVI Patent Rights to
      TGC.

     

    5.5.1 Right
      to IAVI Know How and IAVI Patent Rights.
      Subject
      to the terms and conditions of this Agreement and the Clinical Supply Agreement,
      IAVI hereby grants to TGC a
      [*]
      license
      under the IAVI Know How and IAVI Patent Rights which are [*]
      to
      make,
      have made, use, sell, offer for sale and import any AAV product, including
      without limitation [*];
      provided,
      however,
      IAVI
      retains an [*]
      license
      to Develop, Manufacture and Commercialize any IAVI Vaccine for the Developing
      World. 

     

    5.5.2 Term
      of License.
      The
      term of the right and license granted in Section 5.5.1 shall commence on the
      Effective Date and shall expire on the later of (a) the expiration of the term
      of the last patent within the IAVI Patent Rights; or (b) a determination by
      a
      court or administrative agency of competent jurisdiction that the last claim
      in
      the last patent within the IAVI Patent Rights is invalid or unenforceable,
      unless
      the term
      of such right and license is earlier terminated pursuant to the provisions
      of
      Article 9 (and provided,
      further
      that the
      license to any IAVI Know How granted above shall survive the expiration of
      such
      term to the extent provided for in Section 9.6.9). 

     

    5.5.3 IAVI
      Retained Right.
      All
      rights and licenses granted by IAVI to TGC under this Section 5.5 are subject
      to
      IAVI’s retained right to exercise
      its rights and perform
      its obligations under this Agreement and the Clinical Supply Agreement (and
      under any subsequent supply agreement for the IAVI Vaccine, if any). Subject
      to
      this Section 5.5, IAVI retains all rights and licenses to all IAVI Intellectual
      Property for any purpose other than an [*].
      

     

    5.6 Grant
      of Licenses of Joint Know How and Joint Patent Rights.

     

    5.6.1 IAVI
      Right to Joint Patent Rights for any IAVI Vaccine.
      Subject
      to the terms and conditions of this Agreement including Sections 5.1.3, 5.7,
      each of CRI, CHOP and TGC hereby grant to IAVI an [*]
      license
      under the Joint Patent Rights Controlled by CRI, CHOP and TGC respectively
      to
      make, have made, use, sell, offer for sale and import any IAVI Vaccine for
      the
      Developing World. For the avoidance of doubt, the foregoing [*]
      shall
      permit IAVI to Manufacture IAVI Vaccine outside the Developing World but solely
      to the extent such IAVI Vaccine is used, distributed and sold within the
      Developing World.

     

    5.6.2  IAVI
      Right to Joint Know How for any IAVI Vaccine. Subject
      to the terms and conditions of this Agreement including Sections 5.1.3, 5.7,
      each of CRI, CHOP and TGC hereby grant to IAVI a [*]
      license
      under the Joint Know How Controlled by CRI, CHOP and TGC respectively to make,
      have made, use, sell, offer for sale and import any IAVI Vaccine for the
      Developing World. For the avoidance of doubt, the foregoing [*]
      shall
      permit IAVI to Manufacture IAVI Vaccine outside the Developing World but solely
      to the extent such IAVI Vaccine is used, distributed and sold within the
      Developing World.

    
       

      *Confidential
        Treatment
        Requested.


    

    
      
        
        

      

      
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    5.6.3 TGC
      Right to Joint Know How and Joint Patent Rights for any AAV Product Other Than
      An IAVI Vaccine.
      Subject
      to the terms and conditions of this Agreement, IAVI hereby grants to TGC an
      [*]
      license
      under the Joint Know How and Joint Patent Rights Controlled by IAVI which are
      [*]
      to make,
      have made, use, sell, offer for sale and import any AAV product other than
      an
      IAVI Vaccine for use and sale worldwide.

     

    5.6.4 TGC
      Right to Joint Know How and Joint Patent Rights for any Non-AAV
      Product.
      Subject
      to the terms and conditions of this Agreement, IAVI hereby grants to TGC a
      non-exclusive, sublicenseable right and license under the Joint Know How and
      Joint Patent Rights Controlled by IAVI which are [*]
      for TGC
      to make, have made, use, sell, offer for sale and import any non-AAV product
      worldwide.

     

    5.6.5 Term
      of Licenses.
      The
      term of the rights and licenses granted in Sections 5.6.1 to 5.6.4 shall
      commence on the Effective Date and shall expire on the later of (a) the
      expiration of the term of the last patent within the Joint Patent Rights; or
      (b)
      a determination by a court or administrative agency of competent jurisdiction
      that the last claim in the last patent within the Joint Patent Rights is invalid
      or unenforceable, unless
      the term
      of such right and license is earlier terminated pursuant to the provisions
      of
      Section 9 (and provided further
      that the
      license to any Joint Know How granted above shall survive the expiration of
      such
      term to the extent provided for in Section 9.6.9). 

     

    5.7 Covenant
      Not to Sue
      under Certain Intellectual Property.
      Notwithstanding
      the grant of exclusive rights and licenses under Sections 5.2, 5.3, 5.4, 5.6.1
      and 5.6.3 and subject to the terms and conditions of this Agreement, each Party
      covenants not to sue the other Parties under the Joint Know How, Joint Patent
      Rights, CRI Know How, CRI Patent Rights, CHOP Know How, CHOP Patent Rights,
      IAVI
      Know How, IAVI Patent Rights and any Intellectual Property Controlled by TGC
      (as
      applicable) solely to the extent necessary and solely for the purpose of a
      Party
      or an Outside Contractor performing its obligations under this Agreement or
      an
      Outside Contractor Agreement (as applicable). 

     

    5.8 Covenants
      by TGC With Respect to Rights Under TGC Intellectual
      Property.

     

    5.8.1 
      During
      the term of this Agreement, TGC shall not exercise, license or sublicense any
      rights granted to TGC under any TGC Licensed Patent Rights, any TGC Patent
      Right, any Joint Patent Right, any TGC Licensed Know How, any TGC Know How,
      or
      any Joint Know How that would be inconsistent with the rights and licenses
      granted under this Agreement other than, and only to the extent necessary,
      to
      assist TGC to fulfill TGC’s obligations under the terms and conditions of this
      Agreement and the Clinical Supply Agreement (and any subsequent supply
      agreement). 

     

    5.8.2 During
      the term of this Agreement, if TGC elects at its sole discretion, not to
      maintain any Third Party Agreements for the TGC Licensed Patent Rights that
      are
[*]
      for the
      Development, Manufacture and/or Commercialization of an IAVI Vaccine; TGC shall
      notify IAVI not less than [*]
      before
      any relevant deadline. Thereafter, (i) IAVI shall have the right to request
      TGC
      to maintain such Third Party Agreements on behalf of IAVI in which case
[*]
      with
      maintenance of the Third Party Agreements; or (ii) TGC shall assist IAVI in
      pursuing a license for such TGC Licensed Patent Rights with the Third Party
      Licensor.

    
       

      *Confidential
        Treatment
        Requested.


      
        
          
          

        

        
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    5.8.3 TGC
      and
      IAVI acknowledge and agree that it is their mutual intention and agreement
      that
      should TGC become a debtor in case under title 11 of the United States Code
      (the
“Bankruptcy Code”), then IAVI, its affiliates and any permitted sub-licensees of
      IAVI shall be entitled to all the benefits accorded a licensee under Bankruptcy
      Code Section 365(n). Furthermore, it is hereby acknowledged and agreed that
      this
      Agreement shall be “such contract” as that phrase is used in Section 365(n) and
      that:

     

    (i)
       Any
      escrow agreement (the “Escrow Agreement”) which may be entered into by IAVI and
      TGC establishing an escrow into which all relevant documentation and materials
      related to any IAVI Vaccine (the “Escrow Materials”) are deposited, any
      Commercial Supply Agreement and any other agreement executed pursuant to this
      Agreement or in order to allow IAVI to exploit any Intellectual Property
      Controlled by TGC, any Joint Know How or any Joint Patent Rights and
      improvements thereon, in each case, which
      is
[*]
      for IAVI
      to Develop, Manufacture and Commercialize any IAVI Vaccine (collectively,
      the “Subject Intellectual Property”) shall each be considered an “agreement
      supplementary to such contract” as that phrase is used in said Section
      365(n);

    


    (ii) All
      Program Materials of TGC, IAVI Vaccine and any and all Escrow Materials shall
      be
      included within the definition of “any embodiment of such intellectual property”
as such phrase is used in said Section 365(n), along with any other embodiment
      of the Subject Intellectual Property (Including improvements), and IAVI shall
      have all rights with respect thereto as are set forth in Section 365(n), as
      well
      as the rights set forth in the Escrow Agreement, as supplements to one another
      and not in lieu of one another;

    


    (iii) Unless
      and until TGC as debtor in possession or TGC’s trustee (if any) rejects this
      agreement or any agreement supplementary to this Agreement, then upon the
      written request of IAVI, and pursuant to Bankruptcy Code Section 365(n)(4),
      TGC
      as debtor in possession or TGC’s trustee (if any) shall: (A) at IAVI’s option
      either (I) perform this Agreement, or (II) provide and deliver to IAVI all
      the
      Subject Intellectual Property, all the Escrow Materials, and all embodiments
      of
      the Subject Intellectual Property, held by either TGC as debtor in possession
      or
      TGC’s trustee (if any); and (B) not interfere with the rights of IAVI, its
      affiliates, and/or any sub-licensee under this Agreement, the Escrow Agreement,
      any supply agreement, or any other agreement supplementary to this Agreement,
      including any right to obtain the Subject Intellectual Property, improvements,
      all deliverables described in this Agreement, the Escrow Materials, or any
      embodiment of the Subject Intellectual Property from another entity (such as
      the
      Escrow Agent).

    


    (iv) Upon
      rejection of this Agreement, IAVI shall be deemed to have requested of TGC
      as
      debtor in possession (or of TGC’s trustee, if any) that TGC as debtor in
      possession or such trustee (A) immediately provide and deliver to IAVI or any
      affiliate or sub-licensee as IAVI may subsequently designate in writing, all
      Subject Intellectual Property, all of the Escrow Materials, and all other
      embodiments of the Subject Intellectual Property without further notice or
      seeking relief from the automatic stay or other leave from any court; and (B)
      not interfere with the rights of IAVI, its affiliates, and/or any sub-licensee
      under this Agreement, the Escrow Agreement, any supply agreement, or any other
      agreement supplementary to this Agreement, including any right to obtain the
      Subject Intellectual Property, the Escrow Materials, or any embodiment of the
      Subject Intellectual Property from another entity (such as the Escrow Agent);
      

    
       

      *Confidential
        Treatment
        Requested.



      
        
          
          

        

        
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    5.9 Covenant
      by CRI With Respect to Rights Under CRI Intellectual
      Property.
      During
      the term of this Agreement, CRI shall not exercise, license or sublicense any
      rights of CRI in or under any Joint Patent Right, any CRI Patent Right, any
      Joint Know How, or any CRI Know How that would be inconsistent with the rights
      and licenses granted under this Agreement other than, and only to the extent
      necessary, to assist CRI to fulfill CRI’s obligations under the terms and
      conditions of this Agreement. 

     

    5.10 Covenant
      by CHOP With Respect to Rights Under CHOP Intellectual
      Property.
      During
      the term of this Agreement, CHOP shall not exercise, license or sublicense
      any
      rights of CHOP in or under any Joint Patent Right, any CHOP Patent
      Right,
      any
      Joint Know How, or any CHOP Know How
      that
      would be inconsistent with the rights and licenses granted under this Agreement
      other than, and only to the extent necessary, to assist CHOP to fulfill CHOP’s
      obligations under the terms and conditions of this Agreement. 

     

    5.11 Covenant
      by IAVI With Respect to Rights Under IAVI Intellectual
      Property.
      During
      the term of this Agreement, IAVI shall not exercise, license or sublicense
      any
      rights of IAVI in or under any Joint Patent Right, any IAVI Patent Right, any
      Joint Know How, or any IAVI Know How that would be inconsistent with the rights
      and licenses granted under this Agreement other than, and only to the extent
      necessary, to assist IAVI to fulfill its obligations under the terms and
      conditions of this Agreement.
      

     

    5.12 Covenant
      by IAVI With Respect to Rights Under [*].
      During
      the term of this Agreement, and
      for
      so long as the licenses granted to TGC pursuant to Section 5.5 survive, IAVI
      shall [*]
      in or
      under [*]
      concerning manufacturing processes for
      the
      Development, Manufacture and/or Commercialization of any [*].

     

    5.13 Covenant
      by IAVI With Respect to Rights Under [*].
      During
      the term of this Agreement, and
      for
      so long as the licenses granted to TGC pursuant to Section 5.6.3 survive, IAVI
      shall [*]
      in or
      under any [*] for
      the
      Development, Manufacture and/or Commercialization (including manufacture) of
      any
[*]
      or the
      transfer, use, offer for sale, lease, market, sale, importation or making of
      any
[*].
      

     

    5.14 Grant
      of Option to License by CRI to TGC.
      

     

    (a)    
      CRI hereby grants to TGC an [*],
      for
[*]
      from
      disclosure by CRI to TGC of CRI Patent Rights and CRI Know How, to acquire
      at
[*]
      terms a
[*]
      right
      and license under the CRI Patent Rights and CRI Know How (and, if available,
      an
      exclusive right and license under the CRI Patent Rights) to make, have made,
      use, sell, offer for sale and import a TGC anti-HIV Vaccine.

     

    *Confidential
      Treatment
      Requested.


    
      
        
        

      

      
        -39-

        
          

        

      

      
        
        

      

    

     

    (b)    
      CRI hereby grants to TGC an [*]
      option,
      for [*]from
      disclosure by CRI to TGC that: (i)  CRI has received a Notice of Allowance
      of Joint Patent Rights, or (ii) CRI has received an invention disclosure on
      Joint Know-How that it does not intend to file a patent application on,
      whichever is applicable; to acquire at [*]
      terms a
[*]
      and
      license under the Joint Patent Rights and Joint Know How to make, have made,
      use, sell, offer for sale and import a TGC Vaccine (collectively (a) and (b)
      the
“TGC
      CRI Option”).
      

     

    (c)    
      CRI shall not grant any license (or option or similar right) to the foregoing
      without first affording TGC the benefits of the TGC CRI Option provided;
      however, if the Parties do not enter into a license for the foregoing within
      [*]
      of TGC
      exercising the TGC CRI Option and CRI and TGC have negotiated in good faith,
      CRI
      shall have no further obligation to TGC regarding such rights or any Patent
      Rights therefrom.

     

    (d)    
      TGC agrees that if executed, such licenses shall all contain a right of CRI
      to
      terminate such licenses if TGC is not meeting its [*]
      requirements, which shall include at minimum, making [*].

     

    5.15 Grant
      of Option to License by CHOP to TGC.
      

     

    (a)    
      CHOP hereby grants to TGC an [*]
      option,
      for [*]
      days
      from disclosure by CHOP to TGC of CHOP Patent Rights and CHOP Know How, to
      acquire at [*]
      terms a
[*]
      right
      and license under the CHOP Patent Rights and CHOP Know How (and, if available,
      an exclusive right and license under the CHOP Patent Rights) to make, have
      made,
      use, sell, offer for sale and import a TGC anti-HIV Vaccine.

     

    (b)    
      CHOP hereby grants to TGC an [*]
      option,
      for [*]
      days
      from disclosure by CHOP to TGC that: (i)  CHOP has received a Notice of
      Allowance of Joint Patent Rights, or (ii) CHOP has received an invention
      disclosure on Joint Know-How that it does not intend to file a patent
      application on, whichever is applicable; to acquire at [*]
      terms a
[*]
      right
      and license under the Joint Patent Rights and Joint Know How to make, have
      made,
      use, sell, offer for sale and import a TGC Vaccine (collectively (a) and (b)
      the
“TGC
      CHOP Option”).
      

     

    (c)    
      CHOP shall not grant any license (or option or similar right) to the foregoing
      without first affording TGC the benefits of the TGC CHOP Option provided;
      however, if the Parties do not enter into a license for the foregoing within
      six
[*]
      of TGC
      exercising the TGC CHOP Option and CHOP and TGC have negotiated in good faith,
      CHOP shall have no further obligation to TGC regarding such rights or any Patent
      Rights therefrom.

     

    (d)    
      TGC agrees that if executed, such licenses shall all contain a right of CHOP
      to
      terminate such licenses if TGC is not meeting its [*]
      requirements, which shall include at minimum, making [*].

     

    5.16 No
      Other Rights.
      This
      Agreement confers no right, license or interest by implication, estoppel, or
      otherwise under any patents, patent applications, Know
      How
      or other
      Intellectual Property rights of any Party except as expressly set forth in
      this
      Agreement. 

     

    5.17 Subject
      to the Rights of the Government. All
      licenses are expressly subject to the rights of the federal government. IAVI
      agrees to comply with all laws and regulations related to funded research
      including 35 USC §
      200
et
      seq.
      and to
      provide information reasonably requested to enable any Party to comply
      therewith.

    
       

      *Confidential
        Treatment
        Requested.

      
 

      
        
          
          

        

        
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    ARTICLE
      6

     

    REPRESENTATIONS
      AND WARRANTIES

     

    6.1 Representations
      and Warranties of the Parties Concerning Corporate
      Authorizations.
      Each
      Party represents and warrants to the other Parties that:

     

    (a) Such
      Party is duly organized and validly existing and in good standing under the
      laws
      of the jurisdiction of its organization.

     

    (b) Such
      Party has the full corporate power and is duly authorized to enter into, execute
      and deliver this Agreement, and to carry out and otherwise perform its
      obligations thereunder.

     

    (c) This
      Agreement has been duly executed and delivered by, and is the legal and valid
      obligation binding upon, such Party and the entry into, the execution and
      delivery of, and the carrying out and other performance of its obligations
      under
      this Agreement by such Party (i) does not conflict with, or contravene or
      constitute any default under, any agreement, instrument or understanding, to
      which it is a party, including, without limitation its certificate of
      incorporation or by-laws, and (ii) to such Party’s knowledge as of the
      Effective Date from the Effective Date forward, does not violate Applicable
      Law
      or any judgment, injunction, order or decree of any Government Authority having
      jurisdiction over it.

     

    6.2 Representations,
      Warranties of TGC.
      TGC
      represents and warrants to the other Parties that:

     

    (a) As
      of the
      Effective Date, the TGC Patent Rights and the TGC Know How necessary for TGC
      to
      comply with its obligations under this Agreement are in all cases free and
      clear
      of any lien, claim, charge, encumbrance or right of any Third Party; and


     

    (b) As
      of the
      Effective Date, to the extent necessary for TGC to comply with its obligations
      under this Agreement, all rights granted to TGC in, to and under the TGC
      Licensed Patent Rights, the TGC Licensed Know How, the Joint Patent Rights
      and
      the Joint Know How are in all cases free and clear of any lien, claim, charge,
      encumbrance or right of any Third Party (except to the extent expressly provided
      for in the applicable Third Party Agreement, in the case of the TGC Licensed
      Patent Rights and the TGC Licensed Know How).

     

    6.3 Disclaimer.
      EXCEPT
      AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE PARTIES MAKE NO, AND EXPRESSLY
      DISCLAIM ALL, REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EITHER
      EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING, WITHOUT LIMITATION ANY WARRANTY
      OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY
      OF
      NON-INFRINGEMENT.

     

    
      
        
        

      

      
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    6.4 Representations,
      Warranties of IAVI With Respect to Rights Under IAVI Know How and IAVI Patent
      Rights.
      As of
      the Effective Date, IAVI has not utilized,
      or granted a right or license to any Third Party of any Joint
      Patent Right or Joint Know How for any other purpose other than the Development,
      Manufacture or Commercialization of an IAVI Vaccine, and IAVI has not utilized,
      or granted a right or license to any Third Party of any IAVI Know How or IAVI
      Patent Rights, for any AAV product other than the IAVI Vaccine.

     

    ARTICLE
      7

     

    INTELLECTUAL
      PROPERTY MATTERS

     

    7.1 Ownership
      and Inventorship of Intellectual Property.

     

    7.1.1 Inventorship
      of all inventions shall be determined in accordance with rules and guidelines
      regarding inventorship as established under United States patent
      law.

     

    7.1.2 Nothing
      herein shall be construed as a transfer of a Party’s ownership in its
      Intellectual Property. Subject
      to Sections 7.1.3 and 7.1.4, ownership of an invention shall follow inventorship
      of that invention provided that, in the event such ownership conflicts with
      Applicable Laws the Parties shall comply with such Applicable Laws. IAVI shall
      provide any
      owner
      of affected Intellectual Property with copies of all relevant agreement
      provisions that affect ownership of such Intellectual Property in order to
      assure compliance with Applicable Laws.

     

    7.1.3 Know
      How
      invented under the Research and Development Program with IAVI funding by
      employees from more than one Party
      during
      the term of the Initial Agreement is jointly owned by TGC and CRI.
      Any
      Patent Rights conceived jointly by employees of more
      than
      one Party
      under
      the Research and Development Program with IAVI funding or claiming priority
      thereto,
      including
      the
      patent application filed as US provisional [*]” and
      any
      patent issuing therefrom,
      are
      jointly owned by CRI and TGC.

     

    7.2 Prosecution
      and Maintenance of TGC, CHOP or CRI Controlled Patents;
      Abandonment. Unless
      otherwise provided for between the Parties:

     

    7.2.1 TGC
      shall
      have the sole right to file, prosecute, maintain and defend [*]
      and
      shall bear [*]
      associated therewith.

     

    7.2.2 CHOP
      shall have the sole right to file, prosecute, maintain and defend [*],
      and
      shall bear [*]
      associated therewith unless the Parties agree otherwise. 

     

    7.2.3 CRI
      shall
      have the sole right to file, prosecute, maintain and [*]
      and
[*],
      and
      shall bear [*]
      associated therewith unless the Parties agree otherwise. 

     

    7.2.4 IAVI
      shall have the sole right to file, prosecute, maintain and defend [*]
      and
      shall bear [*]
      associated therewith.

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    7.2.5 In
      the
      event TGC, CHOP or CRI elects, in any country, not to file or continue to
      prosecute and thereby abandon an application for a patent, or not to maintain
      and thereby abandon a patent, or
      not
      defend a challenge thereto, including an opposition, interference or declaratory
      judgment action,
      where
      the applicable patent or patent application is exclusively licensed to IAVI
      hereunder (and in the case of a TGC Licensed Patent Right, where TGC has the
      right to prosecute, maintain or defend a challenge thereto); TGC, CHOP or CRI,
      as applicable, shall notify IAVI not less than [*]
      or such
      lesser period where required before any relevant deadline and shall, if
      requested to do so, provide IAVI with copies of all necessary papers and
      prosecution documents. IAVI, thereafter, shall have the right but not the
      obligation to pursue, [*],
      prosecution of such patent application or maintenance of such issued patent
      so
      long as the inventors are given the right for prior review and comment, which
      comments shall not be unreasonably disregarded if provided timely (provided,
      however,
      that
      with respect to any patent application or patent licensed to TGC by a Third
      Party Licensor, IAVI shall only have a right to pursue prosecution or
      maintenance to the extent permitted in the applicable Third Party
      Agreement).

     

    7.2.6 IAVI,
      in
      accordance with Article 8, is solely responsible for notifying any agency
      providing funding to IAVI for the Development Program of all patent related
      matters regarding subject inventions (as that term is defined in 35 U.S.C.
      §
      201)
      (including any Joint Patent Rights), including any planned failure to file,
      abandonment of prosecution (including, failure to defend any opposition or
      re-examination) and failure to maintain such rights in the subject
      inventions.

     

    7.3  Prosecution
      and Maintenance of Joint Patents; Abandonment. 

     

    7.3.1 IAVI,
      TGC, CHOP and CRI agree to discuss in good faith and implement a mutually
      agreeable patent strategy and, unless specifically provided for between the
      Parties, to designate [*]
      responsible for the preparation, filing, prosecution, maintenance and defense
      of
      Joint Patent Rights with respect to all Joint Inventions that may be patentable
      (the “Lead
      Party”).
      [*]
      associated with filing, prosecution and maintenance of the Joint Patent Rights.
      

     

    7.3.2 The
      Lead
      Party and the Parties having a named inventor on the Joint Invention shall
      discuss and agree on the content and form of relevant Joint Patent Rights
      applications and any other relevant matters before such Joint Patent Rights
      applications are made. The Lead Party and the Parties having a named inventor
      on
      the Joint Patent Rights application shall consider in good faith any comments
      from the other. Notwithstanding Section 7.3.1, the Parties having a named
      inventor on the Joint Invention shall [*]
      for
      their right to review and comment on the relevant Joint Patent Rights
      applications.

     

    7.3.3 The
      Lead
      Party with respect to a given Joint Patent Right shall have the first right
      to
      file, prosecute and maintain such Joint Patent Rights worldwide, and
[*].
      The
      Lead Party shall seek the prior advice and comment, not to be unreasonably
      disregarded, relating to such Joint Patent Rights from the Parties having a
      named inventor on the Joint Patent Rights. In the event that the Lead Party
      elects not to (i) file or prosecute a patent application on a particular Joint
      Invention, (ii) maintain any Joint Patent Right or (iii) at any time, continue
      to pay any such patent prosecution and maintenance costs; in each case in any
      country, the Parties having a named inventor on the Joint Patent Rights shall
      have the right but not the obligation to do so [*]
      and
      TGC
      unless IAVI and/or TGC no longer have rights in or to such Joint Patent Rights
      hereunder in which case the Parties having a named inventor on the Joint Patent
      Rights shall [*]
      if they
      elect to so file, prosecute or maintain such Joint Patent Rights.
      Thereafter, if any Party declines to act, any combination or all of the other
      Parties may elect to so act for such Party at its or their sole discretion
      and
      expense and the relevant Parties will promptly provide that Party with copies
      of
      necessary papers and prosecution documents. 

    
       

      *Confidential
        Treatment
        Requested.


    

    
      
        
        

      

      
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    7.4 Enforcement
      of Patent Rights.

     

    7.4.1 If
      any
      Patent Right Controlled by TGC, CHOP Patent Right, CRI Patent Right or Joint
      Patent Right Controlled by CHOP or CRI which is licensed exclusively hereunder
      is or might reasonably be infringed by a Third Party (an “Infringement”),
      the
      Party first having knowledge of such Infringement shall promptly notify the
      other Parties in writing of such Infringement in reasonable detail.

     

    7.4.2 TGC
      shall
      have [*],
      to
      institute, prosecute and control, using counsel of [*]
      choice,
      any action or proceeding with respect to an Infringement, opposition, or
      declaratory action of a Patent Right within the TGC Patent Rights, TGC Licensed
      Patent Rights, or Joint Patent Rights but only where TGC is one of the joint
      owners and the owners have waived their right of defense in such Joint Patent
      Rights in writing. TGC, represented by counsel [*],
      shall
      bear [*]
      in
      connection with any such action or proceeding. Furthermore, for so long as
      (i)
      the TGC CRI Option as provided for in Section 5.14 or the TGC CHOP Option as
      provided for in Section 5.15 survives and (ii) TGC pays all costs and expenses
      in connection with any such action or proceeding, TGC shall have [*],
      to
      institute, prosecute and control, using mutually agreeable counsel, any action
      or proceeding with respect to an Infringement, opposition, or declaratory action
      of a CRI Patent Right or CHOP Patent Right where CRI or CHOP (as applicable)
      has
      waived its right of defense in such Patent Right in writing. Upon TGC’s request
      and [*],
      IAVI,
      CHOP and CRI shall provide TGC with reasonable cooperation and assistance with
      respect to any such action or proceeding and each of CRI, CHOP and IAVI
      shall
      have the
      right to be represented by counsel of its choice at [*].

     

    7.4.3 IAVI
      shall have [*],
      to
      institute, prosecute and control, using counsel of [*]
      choice,
      any action or proceeding with respect to an Infringement, opposition, or
      declaratory action of a Patent Right within IAVI’s Patent Rights. IAVI,
      represented by counsel [*],
      shall
      bear [*]
      in
      connection with any such action or proceeding. Upon IAVI’s request and
[*],
      TGC,
      CHOP and CRI shall provide IAVI with reasonable cooperation and assistance
      with
      respect to any such action or proceeding and each of CRI, CHOP and TGC
      shall
      have the
      right to be represented by counsel of its choice [*].

     

    7.4.4 To
      the
      extent that the Infringement in IAVI’s reasonable judgment, if continued, would
      materially and adversely [*]
      in or
      for the Developing World and TGC, CHOP or CRI, as applicable, has elected
[*]
      with
      respect to such Infringement, IAVI shall have the right (to the extent permitted
      pursuant to any applicable agreement with a Third Party Licensor of the
      applicable Patent Rights or any other prohibition of applicable patent right),
      but not the obligation, to institute and/or prosecute and control an action
      or
      proceeding with respect to such an Infringement, by counsel [*].
      In the
      event that IAVI institutes any such action or proceeding, TGC, CHOP and CRI
      will
      each in their sole discretion provide assistance if necessary for IAVI to
      institute and prosecute such action or proceeding and, upon IAVI’s request and
      at IAVI’s [*]
      including
      upon IAVI’s request, to give IAVI reasonable assistance and authority to
      institute and prosecute such action or proceeding. Each Party shall have the
      right to be represented by counsel of its choice at [*].
      In
      addition, if the patent alleged to be infringed is owned by a Third Party
      Licensor and TGC does not have authority to require such Third Party Licensor
      to
      join as a party plaintiff, TGC agrees to use Reasonable Efforts to cause such
      Third Party Licensor to agree to be joined as a party plaintiff if helpful
      or
      necessary for IAVI to prosecute an action or proceeding, and to give IAVI
      reasonable assistance and authority to institute and prosecute such action
      or
      proceeding. IAVI, represented by counsel of its choice, shall bear [*]
      in
      connection with any such action or proceeding. 

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    7.4.5 Unless
      otherwise required as a result of prior written agreement, any damages or other
      monetary awards recovered in an action or proceeding described in Section 7.4.2,
      7.4.3, 7.4.4, 7.4.5 or 7.4.6 shall be applied first to [*]
      incurred
      in connection with the action or proceeding with respect to such Infringement,
      opposition or declaratory judgment action including,
      in each case, reasonable attorneys’ fees and expenses (and,
      in
      the circumstance where the Patent Right infringed is owned by a Third Party
      Licensor and an agreement between TGC and such Third Party Licensor requires
      reimbursement of such Third Party Licensor, such Third Party Licensor’s
      out-of-pocket costs and expenses incurred in connection with such Infringement
      action or proceeding), on a [*]
      based
      upon the Parties’ respective out-of-pocket expenses, until all such
      out-of-pocket expenses have been recovered. Any remaining amount of such damages
      or other monetary awards shall then be retained by [*].
      

     

    7.5 Settlement
      with a Third Party.
      No
      Party may settle any action or proceeding under Section 7.4 above with respect
      to an Infringement, opposition, or declaratory action in
      a
      manner that creates a material obligation or admits fault on behalf of any
      other
      Party
      without
      the written consent of such other
      Party,
      such
      consent shall not be unreasonably withheld or delayed.

     

    7.6 Infringement
      of Third Party Rights.
      The
      following shall apply in the event that a Third Party alleges that Intellectual
      Property owned, held or otherwise controlled by such Third Party are being
      infringed or have been infringed by the Parties in performing their obligations
      or exercising their rights with respect to any IAVI Vaccine under this
      Agreement:

     

    7.6.1As
      between IAVI and TGC, subject to TGC’s obligations, if any, pursuant to an
      agreement with a Third Party in effect prior to the Effective Date, TGC shall
      ([*])
      defend
      any claim in any legal action or proceeding brought against TGC and/or IAVI
      arising from an allegation by a Third Party that the [*]
      by
[*]
      in
      connection with an IAVI Vaccine under this Agreement or the Clinical Supply
      Agreement infringes a patent owned, held or otherwise controlled by such Third
      Party [*].
      In
      addition, TGC shall have the right to take any appropriate step to initiate
      and
      pursue to final resolution any challenge, opposition or other similar action
      or
      proceeding, including, without limitation interference proceedings, relating
      to
      a patent application or patent owned, held or otherwise controlled by a Third
      Party solely with respect to the [*].
      TGC and
      IAVI shall consult with each other concerning strategy, approaches and the
      consequences of approaches that may be taken under this Section 7.6.1. IAVI
      shall provide all reasonable assistance requested by TGC in connection with
      any
      such action or proceeding, provided, however
      that TGC
      shall [*]
      by IAVI
      in providing such assistance. TGC may not settle an action or proceeding under
      this Section 7.6.1 without requesting the written consent of IAVI and such
      consent shall not be unreasonably withheld or delayed. If TGC does not consent
      [*]
      of
      receipt of IAVI’s request for consent, IAVI may settle but not in a manner that
      creates a material obligation or admits fault on behalf of TGC.

    
       

      *Confidential
        Treatment
        Requested.


    

    
      
        
        

      

      
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ARTICLE
      8

     

    CONFIDENTIALITY

     

    8.1 Confidentiality;
      Exceptions.
      Except
      to the extent otherwise expressly provided in this Agreement, the Clinical
      Supply Agreement, or the Commercial Supply Agreement
      (if
      any),
      the
      Parties agree that, for the term of this Agreement and for [*]
      years
      thereafter, all non-public or proprietary know how, data, and technical,
      financial and other information of any nature whatsoever, including, without
      limitation “confidential”-marked invention disclosures and discussions about
      nonpublic or proprietary matters between or among the Parties (“Confidential
      Information”),
      in
      all such cases which are exchanged, disclosed or submitted, either orally or
      in
      writing (including, without limitation by electronic means) or through
      observation, by one Party (the “Disclosing
      Party”)
      to
      another Party (the “Receiving
      Party”)
      hereunder shall be received and maintained by the Receiving Party in strict
      confidence, shall not be used for any purpose other than for the purposes of
      exercising such Receiving Party’s rights or performing such Receiving Party’s
      obligations hereunder, and shall not be disclosed to any Third Party (including,
      without limitation in connection with any publications, presentations or other
      disclosures). Notwithstanding the foregoing, the Receiving Party may, subject
      to
      the other provisions of this Agreement and the Clinical Supply Agreement,
      disclose the Disclosing Party’s Confidential Information to those of its, and
      its Affiliates’, Outside Contractors’ or its sublicensees’ (or potential
      sublicensees’), directors, officers, employees, agents, consultants,
      representatives and clinical investigators that have a need to know such
      Confidential Information to achieve the purposes of this Agreement and the
      Clinical Supply Agreement (the “Other
      Receiving Parties”);
      provided,
      however,
      that
      such Receiving Party shall ensure that the Other Receiving Parties to whom
      disclosure is to be made are bound by, and take reasonable efforts to ensure
      compliance with, the confidentiality, and prohibition of use, terms hereof.
      Each
      Receiving Party will promptly notify the Disclosing Party upon discovery of
      any
      unauthorized use or disclosure of any Confidential Information of the Disclosing
      Party. Confidential Information belongs to and shall remain the property of
      the
      Disclosing Party. The provisions of this Article 8 shall not apply to any
      information which can be shown by the Receiving Party:

     

    8.1.1 To
      have
      been known to or in the possession of the Receiving Party prior to the date
      of
      its actual receipt from the Disclosing Party,
      as
      demonstrated by competent written records;

     

    8.1.2 To
      be or
      to have become part of the public domain other than through any act or omission
      of the Receiving Party in breach of this Agreement or the Clinical Supply
      Agreement or any other agreement between the Parties;

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    8.1.3 To
      have
      been disclosed to the Receiving Party, other than under an obligation of
      confidentiality, by a Third Party which had no obligation to the Disclosing
      Party not to disclose such information to others; or

     

    8.1.4 To
      have
      been subsequently independently developed by the Receiving Party without use
      of
      or access to the Confidential Information as demonstrated by competent written
      records.

     

    8.2 Authorized
      Disclosure.
      Each
      Party may disclose Confidential Information of the Disclosing Party hereunder
      solely to the extent such disclosure is reasonably necessary or useful in
      connection with submissions to any Government Authority for the purposes of
      this
      Agreement or the Clinical Supply Agreement or in filing or prosecuting patent
      applications contemplated under this Agreement or the Clinical Supply Agreement,
      prosecuting or defending litigation, complying with Applicable Laws or
      conducting Development Work for the purposes expressly permitted by this
      Agreement or the Clinical Supply Agreement; provided
      that in
      the event of any such disclosure of the Disclosing Party’s Confidential
      Information by the Receiving Party, the Receiving Party will, except where
      impracticable, give reasonable advance notice to and fully cooperate with the
      Disclosing Party regarding such disclosure requirement (so that the Disclosing
      Party may seek a protective order and or other appropriate remedy or waive
      compliance with the confidentiality provisions of this Article 8) and will
      use
      its reasonable efforts to secure confidential treatment of such Confidential
      Information required to be disclosed. IAVI
      shall designate all disclosures of Confidential Information to any funding
      agency “CONFIDENTIAL.” 

     

    8.3 Return
      of Confidential Information.
      The
      Receiving Party shall keep Confidential Information belonging to the Disclosing
      Party in appropriately secure locations using at least the same degree of care
      that it uses to prevent the unauthorized disclosure or use of its own
      confidential information. Upon the expiration or termination of this Agreement,
      any Confidential Information possessed in tangible form by a Receiving Party
      or
      an Other Receiving Party and belonging to the Disclosing Party, shall, upon
      written request from the Disclosing Party, be immediately returned to the
      Disclosing Party (or destroyed if so requested) and not retained by the
      Receiving Party or the Other Receiving Party; provided,
      however
      that (a)
      the Receiving Party may retain, and is not required to return, (i) Confidential
      Information of the Disclosing Party which is used in connection with such
      Receiving Party’s exercise of any license granted to it hereunder which license
      survives the expiration or termination of this Agreement and (ii) one (1) copy
      of Confidential Information of the Disclosing Party to reflect its compliance
      with this Agreement, and (b) the Receiving Party may retain one (1) copy of
      any
      Confidential Information of a Disclosing Party for so long as any Applicable
      Laws require such retention but thereafter shall dispose of such retained
      Confidential Information in accordance with Applicable Laws or this
      Section 8.3. In the case of either (a) or (b) above, the Receiving Party
      shall continue to comply with the other provisions of this Article 8 with
      respect to the applicable Confidential Information.

     

    8.4 Publications
      and Announcements.

     

    8.4.1 Except
      as
      otherwise permitted under this Agreement or the Clinical Supply Agreement or
      as
      required by law, regulation, or court order, each Party agrees not to publish
      any Confidential Information received from a Disclosing Party. It is understood
      further that Confidential Information may be disclosed by TGC to Third Parties
      bound by non-disclosure agreements to the extent such Confidential Information
      both (1) [*]
      and
      (2) is disclosed in relation to matters [*].

     

    
      
        
        

      

      
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    8.4.2 If
      any
      Receiving Party (the “Publishing
      Party”)
      desires to disclose any Confidential Information received from a Disclosing
      Party which relates to the Research and Development Program or the Research
      Program in scientific journals, publications or scientific presentations or
      otherwise, the Publishing Party shall provide the Disclosing Party an advance
      copy of any proposed publication or summary of a proposed oral presentation
      relating to such Confidential Information prior to submission for publication
      or
      disclosure. The Disclosing Party shall have a reasonable opportunity to
      recommend any changes it reasonably believes are necessary to preserve such
      Confidential Information and the Publishing Party shall either incorporate
      such
      recommended changes or remove such Confidential Information. If the Disclosing
      Party informs the Publishing Party, within thirty (30) days of receipt of an
      advance copy of a proposed publication or summary of a proposed oral
      presentation, that such publication in its reasonable judgment could be expected
      to have a material adverse effect on the commercial value of such Confidential
      Information, the Publishing Party shall either delay or prevent such disclosure
      or publication as proposed by the Disclosing Party or remove such Confidential
      Information. In the case of potentially patentable inventions, the delay shall
      be sufficiently long to permit the timely preparation and filing of a patent
      application(s) or application(s) for a certificate of invention on the
      information involved, provided,
      however,
      that
      the Disclosing Party owning such information shall be entitled to require the
      removal of such Confidential Information to prevent such disclosure or
      publication if in its commercially reasonable judgment such patent application
      will not reasonably protect the commercial value of such Confidential
      Information or if in its commercially reasonable judgment such disclosure or
      publication would otherwise have a material adverse effect on the commercial
      value of any such Confidential Information. 

     

    8.4.3 None
      of
      the Parties shall issue any press releases or public announcements concerning
      this Agreement without the prior written consent of the other Parties to the
      form, timing and content of any such release of announcement, except as required
      by Applicable Law; provided,
      however,
      that
      any Party may issue press releases or public announcements which incorporate
      information concerning this Agreement which information was included in a press
      release or public announcement which was approved by the other Parties in any
      prior press release concerning this Agreement. No Party shall unreasonably
      withhold or delay its consent to any such press release or announcement. It
      is
      understood that general comments made by a Party relating to the relationship
      between the Parties established by this Agreement or the Clinical Supply
      Agreement, including, for example, general comments made in response to
      inquiries at professional meetings and other similar circumstances, are not
      intended to be restricted by the provisions of this Article 8.
      Notwithstanding
      any of the foregoing, the existence, general subject matter and scope of this
      Agreement is not Confidential Information of any Party. No Party shall use
      the
      names or trademarks of another Party, or any adaptation thereof, including
      referring to any employee therefrom, without prior written consent in each
      instance. 

    
       

      *Confidential
        Treatment
        Requested.


    

    
      
        
        

      

      
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    ARTICLE
      9

     

    TERM
      AND
      TERMINATION

     

    9.1 Term.

     

    9.1.1 This
      Agreement shall commence as of the Effective Date and shall continue in full
      force and effect until the term of the last remaining license granted pursuant
      to Article 5 has expired. 

     

    9.1.2 Notwithstanding
      the provisions of Section 9.1.1, this Agreement in its entirety may be
      terminated prior to expiration in accordance with the terms and conditions
      of
      this Article 9 (and any termination of this Agreement shall automatically
      terminate the Development Program as of the effective date of such
      termination).

     

    9.2 Termination
      for Technical Non-Viability.
      During
      the Development Period, IAVI may terminate this Agreement upon not less than
      [*]
      prior
      written notice to TGC, CHOP and CRI, if, in [*],
      based
      on the failure of any IAVI Vaccine to meet safety or technical criteria set
      out
      in the Development Program, IAVI reasonably determines that further development
      of any IAVI Vaccine is not technically or commercially viable. The [*]
      day
      notice period may be shortened upon lump sum payment of the Collaboration
      Payments budgeted to fund the [*]
      charges,
[*]
      (to the
      extent that any manufacturing capacity [*]
      for the
[*]
      in such
[*]
      day
      period cannot reasonably be [*]
      product
[*]
      from a
      Third Party [*]))
      and
      [*]
      costs of
[*]
      where
      such costs are costs specified in the [*].
      [*]
      shall
      use good faith efforts to [*]
      by TGC
      following notification by [*]
      (including, but not limited to, [*]
      revenue
      generating projects or [*]
      manufacturing suite time [*]).
      

     

    9.3 Termination
      at Will.
      IAVI
      may terminate this Agreement at any time in IAVI’s sole discretion, at any time
      from and after the first anniversary of the Effective Date, upon not less than
      [*]
      prior
      written notice to TGC, CHOP and CRI. The [*]
      notice
      period may be shortened upon lump sum payment of the Collaboration Payments
      budgeted to fund the [*],
      the
[*] (to
      the
      extent that any [*]
      reasonably [*]
      for the
[*]
      in such
[*]
      cannot
      reasonably be [*]
      product
      ([*]
      from a
      Third Party [*])),
      and
[*]
      costs of
[*] where
      such costs are costs specified in the [*].
      TGC
      shall use good faith efforts to minimize the costs incurred by TGC following
      notification by IAVI of termination of the Agreement (including,
      but not limited to, [*]
      revenue
      generating projects or [*]
      manufacturing suite time [*]).
      

     

    9.4  Termination
      for Cause.
      Subject
      to Sections 9.4.1, 9.4.2, 11.2 and 12.2 below, if any Party commits a
      material breach of this Agreement or the Clinical Supply Agreement at any time,
      any of the non-breaching Parties may provide written notice thereof to the
      breaching Party specifying the breach in reasonable detail. If the breach
      specified in such written notice is not cured within [*]
      of
      receipt of such notice in the case of a breach consisting of an undisputed
      nonpayment of money, or within [*]
      of
      receipt of such notice in the case of any other material breach, the Qualified
      Terminating Party shall have the right to terminate this Agreement and the
      Clinical Supply Agreement with respect to the breaching Party by and effective
      upon written notice (except where the breach, in IAVI’s reasonably exercised
      judgment, is based on the failure of any IAVI Vaccine to meet safety or
      technical criteria set out in the Development Program, in which case Section
      9.2
      shall apply). Although neither CRI nor CHOP is a Qualified Terminating Party,
      CRI may terminate its participation in the Development Program in the event
      of a
      material breach by any other Party and CHOP may terminate its participation
      in
      the Development Program in the event of a material breach by any other Party
      which, in each case has not been cured after proper written notice thereof
      within the time periods specified above in accordance with the foregoing
      provisions of this Section 9.4. Furthermore, in the event CRI or CHOP is the
      breaching Party, IAVI may terminate CRI’s or CHOP’s (as applicable) involvement
      in the Development Program (rather than terminating this Agreement which, in
      such case, shall remain in effect). The Parties acknowledge and agree that
      failure to exercise any right or option, or to take any action expressly within
      the discretion of a Party shall not be deemed to be a material breach
      hereunder.

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    9.4.1 If
      the
      breach specified in a notice to CRI pursuant to Section 9.4 could be cured
      if
      CRI were permitted to enter into a Outside Contractor Agreement: (1) no
      Qualified Terminating Party shall have the right to terminate this Agreement;
      (2) CHOP shall not have the right to terminate its participation in the
      Development Program; and (3) CRI shall have no liability under this Agreement
      for such breach and the other Parties’ sole recourse against CRI for such breach
      shall be to terminate CRI’s participation in the Development Program and all of
      its rights under Sections 3.1 through 3.4 above immediately upon written notice
      from a Qualified Terminating Party following the expiration of the cure period
      specified in Section 9.4.

    


    9.4.2 If
      any
      Party is in breach of any provision of this Agreement, during the period from
      the Effective Date until the date on which this Agreement is executed, and
      such
      breach relates to an obligation of such Party which was not included in the
      Initial Agreement, each Party agrees that such breach is automatically waived.
      However if such breach relates to an obligation of such Party which was included
      in the Initial Agreement, CRI, IAVI and TGC may enforce that obligation in
      accordance with the terms of this Agreement.

    


    9.5 Termination
      for Insolvency.
      To the
      extent permitted by Applicable Laws, on or after the occurrence of an Insolvency
      Event with respect to a Party, any Qualified Terminating Party may terminate
      this Agreement and/or the Clinical Supply Agreement by and effective upon
      written notice to the other Parties. Although neither CRI nor CHOP is a
      Qualified Terminating Party, each of CRI and CHOP may terminate its
      participation in the Development Program in the event of the occurrence of
      an
      Insolvency Event with respect to IAVI or TGC. All rights and licenses granted
      under or pursuant to this Agreement by one Party to any other Party are, and
      shall otherwise be deemed to be, for the purposes of Section 365(n) of the
      Bankruptcy Code, licenses of rights to “intellectual property” as defined under
      Section 101(35A) of the Bankruptcy Code. The Parties agree that all
      Parties, as licensees of such rights and licenses, shall retain and may fully
      exercise all of their rights and elections under the Bankruptcy
      Code.

     

    9.6 Rights
      on and Effect of Termination. 

     

    9.6.1 IAVI
      Termination for Technical or Commercial Non-Viability or at Will.
      In the
      event that IAVI terminates this Agreement under Sections 9.2 or 9.3, all
      rights and licenses granted to IAVI under Sections 5.2.5, 5.2.6, 5.2.9 and
      5.2.10, and all rights granted to IAVI under the Clinical Supply Agreement,
      shall terminate and revert to TGC, CHOP or CRI (as applicable) and
      all
      rights and licenses granted to IAVI under Sections 5.2.1, 5.2.2, 5.3.1, 5.3.2,
      5.4.1, 5.4.2, 5.6.1 and 5.6.2 which relate to [*]
      related
      Intellectual Property shall terminate and revert to TGC, CHOP or CRI (as
      applicable) in respect of that [*]
      related
      Intellectual Property only and
      as of
      the date of termination all of the licenses granted to IAVI under Sections
      5.2.1, 5.2.2, 5.3.1, 5.3.2, 5.4.1, 5.4.2, 5.6.1 and 5.6.2 will be converted
      to
[*]
      licenses
      to [*]
      under
      Intellectual Property Controlled by TGC, CCRI Patent Rights, CCRI Know How,
      CHOP
      Patent Rights, CHOP Know How, Joint Patent Rights and Joint Know How to
Develop
      (which in this case will not include conducting Phase II or Phase III clinical
      trials)
      any IAVI
      Vaccines [*]
      for the
      Developing World. IAVI agrees it has no license to [*]
      hereunder. CRI,
      CHOP
      and TGC shall (1) use
      their
      Reasonable Efforts, in consultation with IAVI, to assess and determine,
      consistent with this
      continuing [*],
      the
[*]
      TGC
      Controlled Patent Rights, CRI Patent Rights and CHOP Patent Rights that are
      available to IAVI and to attach such list of Patent Rights to this Agreement
      as
      Attachment E;
      (2)
provide
      to IAVI reasonable assistance, [*],
      by
      providing IAVI with the TGC Know How, TGC Licensed Know How, CRI Know How,
      CHOP
      Know How and Joint Know How embodied in written documents consisting of raw
      data, study reports and other similar materials which exist at the time of
      termination and are specifically identified and requested by IAVI in order
      to
      exercise such licenses;
      and (3)
      provide to IAVI any Program Materials existing at the time of termination which
      have been [*],
      subject
      to TGC’s obligations under Applicable Law or with respect to any Regulatory
      Approval (however, such Program Materials shall not be utilized in any
      experiments by IAVI or sent to any Third Party without the prior written
      permission of CRI, CHOP or TGC
      (as
      applicable) which
      approval shall not
      be
      unreasonably withheld) and
      IAVI
      is not licensed under any [*]
      regarding such Program Material for [*].
      For the
      avoidance of doubt CRI, CHOP and TGC are under no obligation to maintain,
      prosecute, enforce or defend any Intellectual Property as a direct result of
      the
      continuing [*]
      license
      unless
      (and then only with respect to prosecution, maintenance and defense) IAVI
      provides prior written notice that it agrees to pay all costs, including product
      development milestone costs, associated with such maintenance, prosecution
      or
      defense of such Intellectual Property.
      IAVI
      agrees that it shall pay all costs associated with TGC Licensed Patent Rights
      and TGC Licensed Know How incurred by TGC as a result of the continuing
[*]
      license
following
      termination.
      Prior
      to
      the use of Program Materials in human clinical trials, IAVI shall obtain
[*]
      of
[*]
      that
      covers the necessary requirements, including but [*]
      to the
[*]
      suitable
      for use in clinical trials. TGC is under no obligation to agree to such
[*].

     

    
      
        
        

      

      
        -50-

        
          

        

      

      
        
        

      

    


    9.6.2 IAVI
      Covenants on Termination for Technical or Commercial Non-Viability or at
      Will.
      In the
      event that IAVI terminates this Agreement under Sections 9.2 or 9.3,
IAVI
      shall for
      so
      long as the licenses granted to TGC pursuant to Section 5.5 survive
      (1)
      provide TGC with reasonable prior notice of [*]
      of any
      rights of IAVI in or under, any IAVI
      Know How
      or Joint Know How [*];
      and
      (2)
      not
[*]
      in or
      under any
      IAVI
      Patent Right, IAVI Know How, Joint Patent Right or Joint Know How for
      the
[*].

     

    9.6.3 TGC
      Termination for IAVI Cause or IAVI Insolvency.
      In the
      event that TGC terminates this Agreement with respect to IAVI only under
      Section 9.4, or entirely under Section 9.5, all rights and licenses granted
      to IAVI by TGC under Sections 5.2.1, 5.2.2, 5.6.1 and 5.6.2, and all rights
      granted to IAVI under the Clinical Supply Agreement, shall terminate and revert
      to TGC. Thereafter, IAVI shall have no further right or interest in, to or
      under
      any Intellectual Property of TGC pursuant to this Agreement or the Clinical
      Supply Agreement. In such event, (1) TGC shall provide to IAVI any Program
      Materials existing at the time of termination which have been [*]
      (however, such Program Materials shall not be utilized in any experiments by
      IAVI or sent to any Third Party without the prior written permission of CRI,
      CHOP or TGC
      (as
      applicable) (not to be unreasonably withheld), and (2)
      IAVI
      shall grant to TGC (i) an
      [*]
      and
      license under the IAVI Know How and IAVI Patent Rights which are [*]
      for the
      Development, Manufacture and/or Commercialization of any AAV product, including
      without limitation TGC Vaccines, and to transfer, use, have used, offer for
      sale, lease, market, sell, have sold and import such products worldwide;
provided,
      however,
      IAVI
      retains [*]
      and
      license under the IAVI Know How and IAVI Patent Rights for the Development,
      Manufacture and/or Commercialization of any IAVI Vaccine in the Developing
      World; and (ii) [*]
      and
      license under the IAVI Know How and IAVI Patent Rights which are [*]
      for the
      Development, Manufacture and/or Commercialization of any non-AAV product, and
      to
      transfer, use, have used, offer for sale, lease, market, sell, have sold and
      import such products worldwide. IAVI
      shall provide
      to TGC such documents recording or describing any IAVI Know How needed to
      exercise the licenses in (i) and (ii) above.

    
       

      *Confidential
        Treatment
        Requested.


      
        
          
          

        

        
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    9.6.4 CRI/CHOP
      Participation Termination for IAVI Cause or IAVI Insolvency. In
      the
      event that either CRI or CHOP terminates its participation in the Development
      Program under Section 9.4 because of a material breach by IAVI or under
      Section 9.5 because of the occurrence of an Insolvency Event with respect to
      IAVI, all rights and licenses granted to IAVI by CRI or CHOP (as applicable)
      under Sections 5.3.1, 5.3.2, 5.4.1, 5.4.2, 5.6.1 and 5.6.2 (as applicable),
      shall terminate and revert to CRI or CHOP (as applicable). Thereafter, IAVI
      shall have no further right or interest in, to or under any Intellectual
      Property of CRI or CHOP (as applicable) pursuant to this Agreement. In such
      event, CRI or CHOP (as applicable) shall provide to IAVI any Program Materials
      existing at the time of termination which have been [*]
      such
      Program Materials shall not be utilized in any experiments by IAVI or sent
      to
      any Third Party without the prior written permission of CRI, CHOP or
      TGC
      (as
      applicable) (not to be unreasonably withheld) and IAVI is not licensed under
      any
      Intellectual Property regarding such Program Material for Manufacture or
      Commercialization.

     

    9.6.5 IAVI
      Termination for Vaccine Designer Withdrawal.
      In the
      event that IAVI terminates CHOP’s participation in the Development Program under
      this Agreement under Section 3.4.5, the rights and licenses granted to the
      Parties by CHOP under Sections 5.4.1, 5.4.2, 5.6.1, 5.6.2 and 5.7 shall survive
      such termination and remain in effect. In such event, CHOP shall (1) provide
      to
      IAVI such documents recording or describing any Know How licensed under Sections
      5.4.2 and 5.6.2; and (2) provide to IAVI any Program Materials existing at
      the
      time of termination which have been [*].

     

    9.6.6 IAVI
      Termination for TGC Cause or TGC Insolvency.
      In the
      event that IAVI terminates this Agreement, with respect to TGC only under
      Section 9.4, or entirely under Section 9.5, the licenses granted to IAVI under
      Sections 5.2.1, 5.2.2, 5.3.1, 5.3.2, 5.4.1, 5.4.2, 5.6.1 and 5.6.2 shall survive
      such termination and remain in effect, subject to the continuing obligation
      to
      pay Third Party payments as required under Section 5.2.4, as well as royalties
      under Section 4.2.2. In such event, TGC shall (1) use its Reasonable Efforts,
      in
      consultation with IAVI, to assess and determine, based on the then current
      Development Program and consistent with the licenses granted in Section 5,
      the
      TGC Controlled Patent Rights [*]
      IAVI to
      Manufacture and Commercialize any IAVI Vaccine [*]
      at the
      time of termination and to attach such list of Patent Rights to this Agreement
      as Attachment E; (2) provide to IAVI such documents recording or describing
      any
      Know How licensed under Sections 5.2.1, 5.2.2 and 5.6.2 in accordance with
      section 5.2.6; (3) provide to IAVI any Program Materials existing at the time
      of
      termination which have been [*],
      subject
      to TGC’s obligations under Applicable Law or with respect to any Regulatory
      Approval; and (4) discuss with IAVI which other materials existing at the time
      of termination which have been [*]
      should
      be transferred to IAVI. 

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
          -52-

          
            

          

        

        
          
          

        

      

    


    9.6.7 CRI/CHOP
      Participation Termination for TGC Cause or TGC Insolvency.
      In the
      event that either CRI or CHOP terminates its participation in the Development
      Program under Section 9.4 because of a material breach by TGC or under
      Section 9.5 because of the occurrence of an Insolvency Event with respect to
      TGC, all rights and licenses granted to TGC by CRI or CHOP shall terminate
      and
      revert to CRI or CHOP (as applicable). Thereafter, TGC shall have no further
      right or interest in, to or under any Intellectual Property of CRI or CHOP
      (as
      applicable) pursuant to this Agreement. 

     

    9.6.8 CRI/CHOP
      Participation Termination.
      In
      the
      event CRI’s or CHOP’s participation in the Development Program is terminated,
      (1) Articles 3, 4 and 6 shall no longer apply with respect to CRI or CHOP (as
      applicable) and (2) the licenses granted to CRI or CHOP (as applicable) under
      Article 5 shall terminate (without limiting the licenses and rights granted
      by
      CRI or CHOP (as applicable) under Article 5, which unless otherwise expressly
      stated in this Section 9.6 shall survive.

     

    9.6.9 Know
      How.
      Pursuant to the other express provisions of this Article 9 regarding termination
      and/or survival of licenses, any licenses to Know How granted by a Party under
      Article 5 shall survive the expiration of the term of such license specified
      in
      Article 5 to the extent and so long as the licensed Party continues to utilize
      such Know How in accordance with the license to such Know How. 

     

    9.6.10 Except
      for a termination by IAVI pursuant to Section 9.4 (Termination for
      Cause) or
      Section 9.5 (Termination for Insolvency),
      the
      grant of licenses to TGC under Section 5 shall survive any such termination,
      subject to the payment of royalties as set forth in Section 4.3.1.

     

    9.7 Accrued
      Rights.
      Termination, relinquishment or expiration of this Agreement for any reason
      shall
      be without prejudice to any right which may have accrued to the benefit of
      any
      Party prior to such termination, relinquishment or expiration, including damages
      arising from any breach under this Agreement or the Clinical Supply Agreement.
      Such termination, relinquishment or expiration shall not relieve any Party
      from
      obligations which are expressly indicated to survive termination or expiration
      of this Agreement or the Clinical Supply Agreement.

     

    9.8 Survival;
      Expiration of Development Program.
      Without
      limiting the express provisions of Sections 9.6 (Rights on and Effect of
      Termination) and 9.7 (Accrued Rights), the following articles and sections
      of
      this Agreement shall survive expiration or termination of this Agreement for
      any
      reason: Sections 3.8.3, 3.8.4 and 3.8.5, 7.1 (Ownership and Inventorship of
      Intellectual Property), 7.2 (Prosecution and Maintenance of TGC, CHOP or CRI
      Controlled Patents; Abandonment), 7.3 (Prosecution and Maintenance of Joint
      Patents; Abandonment), Article 8 (Confidentiality), Sections 9.5 (Termination
      for Insolvency), 9.6 (Rights on and Effect of Termination), 9.7 (Accrued Rights)
      and this Section 9.8, Articles 10 (Indemnification; Insurance; Limitation of
      Liability; excluding Section 10.5 Insurance), 11 (Governing Law; Dispute
      Resolution), and 12 (Miscellaneous). 

    
       

      *Confidential
        Treatment
        Requested.


    

    
      
        
        

      

      
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    ARTICLE
      10

     

    INDEMNIFICATION;
      INSURANCE; LIMITATION OF LIABILITY

     

    10.1 Indemnification
      by IAVI.
      IAVI
      hereby agrees to save, defend, and hold the other Parties, their respective
      Affiliates, sublicensees, officers, directors, employees, consultants,
      representatives and agents (“IAVI Indemnitees”)
      harmless from and against any and all Losses caused by (i) the negligence or
      willful misconduct of, or failure to comply with Applicable Laws by, IAVI or
      any
      of its Affiliates, Outside Contractors, Contract Manufacturers (other than
      TGC,
      CHOP, CRI, or their respective Affiliates), or its directors, officers, agents,
      employees, representatives or consultants; (ii) the material breach by IAVI
      or
      any of its Affiliates of any provision of this Agreement; or (iii) the
      manufacture, use, sale, offer for sale or import of any product related
      to
      this
      Agreement;
      except
      to the extent such Losses are subject to an obligation by such IAVI Indemnitee
      under this Article 10.

     

    10.2 Indemnification
      by TGC.
      TGC
      hereby agrees to save, defend, and hold the other Parties, their respective
      Affiliates, sublicensees, officers, directors, employees, consultants,
      representatives and agents (“TGC Indemnitees”)
      harmless from and against any and all Losses (i) the negligence or willful
      misconduct of, or failure to comply with Applicable Laws by, TGC or any of
      its
      Affiliates, Outside Contractors, Contract Manufacturers (other than IAVI, CHOP,
      CRI, or their respective Affiliates), or its directors, officers, agents,
      employees, representatives or consultants; (ii) the material breach by TGC
      or
      any of its Affiliates of any provision of this Agreement; or (iii) the
      manufacture, use, sale, offer for sale or import of any product related to
      this
      Agreement; except to the extent such Losses are subject to an obligation by
      such
      TGC Indemnitee under this Article 10.

     

    10.3 Indemnification
      by CHOP.
      CHOP
      hereby agrees to save, defend, and hold the other Parties, their respective
      Affiliates, sublicensees, officers, directors, employees, consultants,
      representatives and agents (“CHOP Indemnitees”)
      harmless from and against any and all Losses caused by (i) the negligence or
      willful misconduct of, or failure to comply with Applicable Laws by, CHOP or
      any
      of its Affiliates, Outside Contractors, Contract Manufacturers (other than
      IAVI,
      TGC, CRI, or their respective Affiliates), or its directors, officers, agents,
      employees, representatives or consultants; or (ii) the material breach by CHOP
      or any of its Affiliates of any provision of this Agreement;
      except
      to the extent such Losses are subject to an obligation by such CHOP Indemnitee
      under this Article 10.

     

    10.4 Indemnification
      by CRI.
      CRI
      hereby agrees to save, defend, and hold the other Parties, their respective
      Affiliates, sublicensees, officers, directors, employees, consultants,
      representatives and agents (“CRI Indemnitees”)
      harmless from and against any and all Losses caused by (i) the negligence or
      willful misconduct of, or failure to comply with Applicable Laws by, CRI or
      any
      of its Affiliates, Outside Contractors, Contract Manufacturers (other than
      IAVI,
      TGC, CHOP or their respective Affiliates), or its directors, officers, agents,
      employees, representatives or consultants; or (ii) the material breach by CRI
      or
      any of its Affiliates of any provision of this Agreement;
      except
      to the extent such Losses are subject to an obligation by such CRI Indemnitee
      under this Article 10.

     

    
      
        
        

      

      
        -54-

        
          

        

      

      
        
        

      

    

     

    10.5 Indemnification
      Procedure.

     

    10.5.1 Each
      indemnified Party specified above in this Article 10 (the “Indemnitee”)
      agrees
      to give the indemnifying Party (the “Indemnitor”)
      prompt
      written notice of any Losses or discovery of fact upon which the Indemnitee
      intends to base a request for indemnification hereunder. Notwithstanding the
      foregoing, the failure to give timely notice to the Indemnitor shall not release
      the Indemnitor from any liability to the Indemnitee to the extent the Indemnitor
      is not prejudiced thereby.

     

    10.5.2 The
      Indemnitee shall furnish promptly to the Indemnitor copies of all papers and
      official documents in the Indemnitee’s possession or control which relate to any
      Losses; provided,
      however,
      that if
      the Indemnitee defends or participates in the defense of any Losses, then the
      Indemnitor shall also provide such papers and documents to the Indemnitee.
      The
      Indemnitee shall cooperate with the Indemnitor in providing witnesses and
      records and other reasonable assistance necessary in the defense against any
      Losses at Indemnitor’s sole expense.

     

    10.5.3 The
      Indemnitor shall have the right, by prompt notice to the Indemnitee, to assume
      direction and control of the defense of any Third Party claim forming the basis
      of such Losses, with counsel reasonably acceptable to the Indemnitee and at
      the
      sole cost of the Indemnitor, so long as (i) the Indemnitor shall promptly
      notify the Indemnitee in writing (but in no event more than thirty (30) days
      after the Indemnitor’s receipt of notice of the Third Party claim giving rise to
      indemnification hereunder), absent the development of facts that give the
      Indemnitor the right to claim indemnification from the Indemnitee and
      (ii) the Indemnitor diligently pursues the defense of the
      claim.

     

    10.5.4 If
      the
      Indemnitor assumes the defense of the claim as provided in Section 10.5.3
      above, the Indemnitee may participate in such defense with the Indemnitee’s own
      counsel who shall be retained at the Indemnitee’s sole cost and expense;
provided,
      however,
      that
      neither the Indemnitee nor the Indemnitor shall consent to the entry of any
      judgment or enter into any settlement with respect to the claim without the
      prior written consent of the other, which consent shall not be unreasonably
      withheld or delayed. If the Indemnitee withholds consent in respect of a
      judgment or settlement involving only the payment of money by the Indemnitor
      and
      which would not involve any stipulation or admission of liability or result
      in
      the Indemnitee becoming subject to any material obligation, including injunctive
      relief or other relief (or loss of rights hereunder), the Indemnitor shall
      have
      the right, upon notice to the Indemnitee within five (5) days of receipt of
      the
      Indemnitee’s written denial of consent, to pay to the Indemnitee, or to a trust
      for its or the Third Party’s benefit, as shall be established at trial or by
      settlement, the full amount of the Indemnitor’s obligation under
      Section 10.1, 10.2, 10.3 or 10.4, as applicable, with respect to such
      proposed judgment or settlement, including all interest, costs or other charges
      relating thereto, together with all attorneys’ fees and expenses incurred to
      such date for which the Indemnitor is obligated under this Agreement, if any,
      at
      which time the Indemnitor’s rights and obligations with respect to the claim
      shall cease.

     

    
      
        
        

      

      
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    10.5.5 If
      the
      Indemnitor does not so assume the defense of such claim, the Indemnitee may
      conduct such defense with counsel of the Indemnitee’s choice but may not settle
      such case without the written consent of the Indemnitor, such consent not to
      be
      unreasonably withheld or delayed. 

     

    10.5.6 Except
      to
      the extent expressly provided for in Section 10.5.5 above, the Indemnitor
      shall not be liable for any settlement or other disposition of a Loss by the
      Indemnitee which is reached without the written consent of the Indemnitor,
      such
      consent not to be unreasonably withheld or delayed.

     

    10.5.7 Except
      as
      otherwise provided in this Section 10.5, the portion of costs and expenses,
      including reasonable fees and expenses of counsel, incurred by any Indemnitee
      under Section 10.5.5 in connection with any claim corresponding to the
      Indemnitor’s obligation under Section 10.1, 10.2, 10.3 or 10.4, as
      applicable, shall be reimbursed on a calendar quarter basis by the Indemnitor,
      for so long as the Indemnitee controls the defense of the claim, without
      prejudice to the Indemnitor’s right to contest the Indemnitee’s right to
      indemnification and subject to refund in the event the Indemnitor is ultimately
      held not to be obligated to indemnify the Indemnitee.

     

    10.6 Insurance.
      

     

    10.6.1 TGC
      shall
      maintain general liability or similar insurance concerning TGC’s activities in
      connection with the Development Program with general aggregate limits of at
      least $[*],
      such
      limits of liability may be met by utilizing umbrella or excess liability limits,
      during the Development Program (prior to any commercial launch of an IAVI
      Vaccine as to which royalties would be payable to IAVI hereunder) and of at
      least $[*]
      following any commercial launch of such an IAVI Vaccine, and during the period
      IAVI Vaccine remains on the market and subject to a royalty obligation
      hereunder. TGC shall maintain product liability insurance with coverage of
      at
      least $[*]
      per
      occurrence and $[*]
      annual
      aggregate limit and TGC shall maintain at least the statutory minimum levels
      of
      product liability insurance for international trials with IAVI Vaccine,
      including satisfaction of specific in-country insurance where required by law.
      TGC shall name IAVI and CHOP, and CRI so long as it is party to this Agreement,
      as additional insured parties with respect to product liability insurance for
      IAVI clinical trials of any IAVI Vaccine. TGC shall provide CRI, CHOP and IAVI
      with a certificate of insurance evidencing such coverage.

     

    10.6.2 IAVI
      shall maintain product liability insurance with coverage of at least
      $[*]
      for each
      occurrence and $[*]
      annual
      aggregate limit for domestic trials. IAVI shall name TGC and CHOP,
      and CRI
      so long as it is party to this Agreement,
      as
      additional insured parties with respect to product liability insurance for
      IAVI
      clinical trials of any IAVI Vaccine. IAVI shall provide CRI, CHOP and TGC with
      a
      certificate of insurance evidencing such coverage.

     

    10.7 Limitation
      of Liability; Remedies Cumulative.

     

    10.7.1 EXCEPT
      FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS HEREUNDER, UNDER NO CIRCUMSTANCES
      SHALL ANY PARTY BE LIABLE TO ANY OTHER PARTY FOR CONSEQUENTIAL, INCIDENTAL,
      PUNITIVE OR SPECIAL DAMAGES, REGARDLESS OF WHETHER OR NOT AWARE OF THE
      POSSIBILITY OF SUCH DAMAGES.

    
       

      *Confidential
        Treatment
        Requested.

       

      
        
          
          

        

        
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    10.7.2 THE
      REMEDIES PROVIDED IN THIS AGREEMENT ARE CUMULATIVE AND NOT EXCLUSIVE OR IN
      LIMITATION OF ANY OTHER REMEDY AVAILABLE UNDER THIS AGREEMENT OR AT LAW OR
      IN
      EQUITY. ACCORDINGLY, UNLESS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT,
      A
      REMEDY PROVIDED IN THIS AGREEMENT AS AVAILABLE TO TGC, CRI, CHOP OR IAVI IS
      NOT
      INTENDED AS AN EXCLUSIVE REMEDY.

     

    ARTICLE
      11

     

    GOVERNING
      LAW; DISPUTE RESOLUTION

     

    11.1 Governing
      Law.
      This
      Agreement shall be governed by and construed under the laws of the State of
      New
      York, without reference to or giving effect to its conflicts of laws rules
      or
      principles.

     

    11.2 Dispute
      Resolution.
      If the
      Parties are unable to resolve a dispute among them informally, any Party, by
      written notice to the other Parties, may have such dispute referred to their
      respective executive officers designated for attempted resolution by good faith
      negotiations (each, a “Responsible
      Executive”).

     

    For
      IAVI:    General
      Counsel

     

    For
      CRI:     General
      Counsel

     

    For
      CHOP: General
      Counsel

     

    For
      TGC:    Chief
      Executive Officer of TGC

     

    Any
      such
      dispute shall be submitted to the Responsible Executives no later than thirty
      (30) days following such request by a Party. In the event the Responsible
      Executives are not able to resolve any such dispute within thirty (30) days
      after submission of the dispute to such Responsible Executives, a Party may
      pursue whatever measures legally available to resolve such dispute. All
      negotiations pursuant to this Section 11.2 shall be treated as compromise
      and settlement negotiations. Nothing said or disclosed, nor any document
      produced, in the course of such negotiations which is not otherwise
      independently discoverable shall be offered or received as evidence or used
      for
      impeachment or for any other purpose in any current or future arbitration or
      litigation. 

     

    
      
        
        

      

      
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    ARTICLE
      12

     

    MISCELLANEOUS

     

    12.1 Assignment.

     

    12.1.1 A
      Party
      may not assign or otherwise transfer its rights or obligations under this
      Agreement without the prior written consent of the other Parties, such consent
      not to be unreasonably withheld or delayed, except that a Party may assign
      or
      otherwise transfer its rights or obligations in whole or in part without such
      consent (i) to an Affiliate of such Party, provided
      that no
      such assignment shall relieve any Party as the primary obligor hereunder, or
      (ii) to a Third Party in connection with the merger, consolidation, or sale
      of such Party or substantially all of the assets of the assigning Party, or
      reorganization affecting substantially all of the assets or voting control
      of
      the assigning Party.

     

    12.1.2 This
      Agreement shall be binding upon and inure to the benefit of the successors
      and
      permitted assigns of the Parties. Any assignment not in accordance with this
      Agreement shall be void.

     

    12.2 Force
      Majeure.
      No
      Party shall lose any rights hereunder or be liable to the other Parties for
      damages or losses on account of failure of performance by the defaulting Party
      if the failure is occasioned by government action, war, fire, explosion, flood,
      strike, lockout, embargo, act of God, raw material shortage, terrorism or any
      other similar cause beyond the control of the defaulting Party, provided
      that the
      Party claiming force majeure shall promptly notify the other Parties in writing
      setting forth the nature of such force majeure, shall use Reasonable Efforts
      to
      eliminate, remedy or overcome such force majeure and shall resume performance
      of
      its obligations hereunder as soon as reasonably practicable after such force
      majeure ceases. 

     

    12.3 Further
      Actions.
      Each
      Party agrees to execute, acknowledge and deliver such further instruments,
      and
      to do all such other acts, as may be necessary or appropriate in order to carry
      out the purposes and intent of this Agreement.

     

    12.4 Governmental
      Approvals and Filing of Agreement.
      To the
      extent, if any, that a Party concludes in good faith that it is required to
      file
      or register this Agreement or a notification thereof with any Governmental
      Authority in accordance with Applicable Laws, such Party may do so. In such
      situation, the Party making such filing or registration will request
      confidential treatment of sensitive provisions of this Agreement. Each Party
      shall provide to the others a draft of any copy of this Agreement or any excerpt
      hereof or thereof proposed to be filed with any Governmental Authority to the
      other Parties and their counsel as far as possible in advance of release thereof
      and in sufficient time for review of such documents by the other Parties and
      their counsel. In the event any Party objects to any such draft, the applicable
      document will be modified to such Party’s reasonable satisfaction to the extent
      permitted by Applicable Laws. 

     

    12.5 Notices.
      All
      notices required or permitted to be given under this Agreement or the Clinical
      Supply Agreement, including, without limitation all invoices provided by CRI,
      CHOP or TGC to IAVI, shall be in writing and shall be deemed given if delivered
      personally or by facsimile transmission receipt verified, mailed by registered
      or certified mail return receipt requested, postage prepaid, or sent by express
      courier service, to the Parties at the following addresses, or at such other
      address for a Party as shall be specified by like notice, provided
      that
      notices of a change of address shall be effective only upon receipt
      thereof.

     

    
      
        
        

      

      
        -58-

        
          

        

      

      
        
        

      

    

    


    
      	
              TARGETED
                GENETICS CORPORATION

            	 	
              with
                a copy (other than for invoices) to:

            
	
              1100
                Olive Way, Suite 100

            	 	
              Morrison
                Forester LLP

            
	
              Seattle,
                WA 98101

            	 	
              425
                Market Street

            
	
              Attention:
                Chief Executive Officer

            	 	
              San
                Francisco, California 94105

            
	
              FAX:
                206-623-7064

            	 	
              Attention:
                Jonathan Dickstein

            
	 	 	
              FAX:
                415-268-7522

            
	 	 	 
	
              INTERNATIONAL
                AIDS VACCINE 

            	 	
              with
                a copy (other than for invoices) to: 

            
	
              INITIATIVE,
                INC.

            	 	
              General
                Counsel

            
	
              110
                William Street, 27th Floor

            	 	
              110
                William Street, 27th Floor 

            
	
              New
                York, New York 10038

            	 	
              New
                York, New York 10038

            
	
              Attention:
                President

            	 	
              FAX:
                212-847-1112

            
	
              FAX:
                212-847-1112

            	 	 
	 	 	 
	
              CHILDREN’S
                RESEARCH INSTITUTE

            	 	
              with
                a copy to:

            
	
              700
                CRI Drive

            	 	
              General
                Counsel

            
	
              Columbus,
                Ohio 43205 

            	 	
              CRI
                Hospital

            
	
              Attention: 
                Dan Mann

            	 	
              700
                CRI Drive

            
	
              Vice
                President, Children’s Research

            	 	
              Columbus,
                Ohio 43205

            
	
              Institute

            	 	
              Attention:
                Rhonda Comer

            
	
              FAX:
                614-722-2716

            	 	
              FAX:
                614-722-3945

            
	 	 	 
	
              THE
                CHILDREN’S HOSPITAL OF PHILADELPHIA

            	 	
              with
                a copy to:

            
	
              34th
                Street
                & Civic Center Blvd.

            	 	
              Office
                of the General Counsel

            
	
              Philadelphia,
                PA 19104

            	 	
              The
                Children’s Hospital of Philadelphia

            
	
              Attention:
                Phillip R. Johnson, MD

            	 	
              34th
                Street
                & Civic Center Blvd

            
	
              Fax:
                267-426-0363

            	 	
              Abramson
                Bldg.

            
	 	 	
              Philadelphia,
                PA 19104

            
	 	 	
              Attention:
                Richard Dashefsky, Esq.

            
	 	 	
              Fax:
                267-426-6128

            


    

    


    The
      date
      of receipt of any notice given under this Agreement, including, without
      limitation any invoice provided by CRI, CHOP or TGC to IAVI, shall be deemed
      to
      be the date given if delivered personally or by facsimile transmission receipt
      verified, seven (7) days after the date mailed if mailed by registered or
      certified mail return receipt requested, postage prepaid, and two (2) days
      after
      the date sent if sent by express courier service.

     

    12.6 Waiver.
      No
      failure of any Party to exercise and no delay in exercising any right, power
      or
      remedy in connection with this Agreement (each a “Right”)
      will
      operate as a waiver thereof, nor will any single or partial exercise of any
      Right preclude any other or further exercise of such Right or the exercise
      of
      any other Right. A valid waiver must be in writing and signed by the waiving
      Party.

     

    
      
        
        

      

      
        -59-

        
          

        

      

      
        
        

      

       

    

    12.7 Disclaimer
      of Agency.
      The
      relationship between the Parties established by this Agreement is that of
      independent contractors, and nothing contained herein shall be construed to
      (i) give any Party the power to direct or control any activities of the
      other not expressly specified in this Agreement, (ii) constitute the Parties
      as
      the legal representative or agent of the other Parties or as partners, joint
      venturers, co-owners or otherwise as participants in a joint or common
      undertaking, or (iii) allow any Party to create or assume any liability or
      obligation of any kind, express or implied, against or in the name of or on
      behalf of any other Party for any purpose whatsoever, except as expressly set
      forth in this Agreement.

     

    12.8 Severability.
      If any
      term, covenant or condition of this Agreement or the application thereof to
      any
      Party or circumstance shall, to any extent, be held to be invalid or
      unenforceable by a court or administrative agency of competent jurisdiction,
      then (i) the remainder of such documents, or the application of such term,
      covenant or condition to Parties or circumstances other than those as to which
      it is held invalid or unenforceable, shall not be affected thereby and each
      term, covenant or condition of such documents shall be valid and be enforced
      to
      the fullest extent permitted by law; and (ii) the Parties covenant and
      agree to renegotiate any such term, covenant or application thereof in good
      faith in order to provide a reasonably acceptable alternative to the term,
      covenant or condition of such documents or the application thereof that is
      invalid or unenforceable, it being the intent of the Parties that the basic
      purposes of this Agreement are to be effectuated.

     

    12.9 Entire
      Agreement; Amendment.
      This
      Agreement and the Clinical Supply Agreement, including all schedules and
      exhibits attached hereto and thereto, which are hereby incorporated herein
      or
      therein by reference, set forth all covenants, promises, agreements, warranties,
      representations, conditions and understandings between all of the Parties with
      respect to the subject matter hereof and supersedes and terminates all prior
      and
      contemporaneous agreements and understandings between all of the Parties with
      respect to the subject matter hereof, including the Initial Agreement which
      is
      hereby superseded and replaced in its entirety with effect from the Effective
      Date. There are no covenants, promises, agreements, warranties, representations,
      conditions or understandings, either oral or written, between all of the Parties
      with respect to the subject matter hereof other than as set forth herein or
      therein. No alteration, modification, amendment, change or addition to this
      Agreement shall be binding upon the Parties unless reduced to writing and signed
      by the respective authorized officers of all the Parties.

     

    12.10 Counterparts.
      This
      Agreement may be executed in counterparts, each of which shall be deemed an
      original, but all of which together shall constitute one and the same
      instrument.

     

    
      
        
        

      

      
        -60-

        
          

        

      

      
        
        

      

    


    IN
      WITNESS WHEREOF,
      the
      Parties have executed this Agreement by their proper officers as of the date
      and
      year first above written.

     

    
      
        	
                CHILDREN’S
                  RESEARCH INSTITUTE

                 

              	 	 
	
                By:

              	
                /s/
                  Daniel R. Mann                                                         

              	
                 

              	
                Date:
                  June 20, 2006          

              
	
                Name:
                  Daniel R. Mann

              	 	 
	
                Title:
                  Vice President

              	 	 


      

    

     

    
      	
              THE
                CHILDREN’S HOSPITAL OF PHILADELPHIA 

               

            	 	 
	
              By:

            	
              /s/ Philip
                R. Johnson, M.D.                                          

            	
               

            	
              Date:
                June 20, 2006          

            
	
              Name:
                Philip R. Johnson, M.D.

            	 	 
	
              Title:
                Chief Scientific Officer

            	 	 


    

    


    
      	
              INTERNATIONAL
                AIDS VACCINE INITIATIVE

               

            	 	 
	
              By:

            	
              /s/ Seth
                F. Berkley, M.D.                                              

            	
               

            	
              Date:
                June 22, 2006          

            
	
              Name:
                Seth F. Berkley, M.D.

            	 	 
	
              Title:
                President and Chief Executive Officer

            	 	 


    

     

    
      	
              TARGETED
                GENETICS CORPORATION

               

            	 	 
	
              By:

            	
              /s/ H.
                Stewart Parker                                                   

            	
               

            	
              Date:
                June 20, 2006          

            
	
              Name:
                H. Stewart Parker

            	 	 
	
              Title:
                President and CEO

            	 	 


    

     

    Acknowledged
      with respect to Section 3.4.2(i)

     

     

    
      	
              /s/ Philip
                R. Johnson, M.D.                                                       

            	
               

            
	
              Dr. Philip
                R. Johnson

            	 	 
	
               

              Date:
June
                20, 2006            

            	 	 


    

     

    
      
        
        

      

      
        -61-

        
          

        

      

      
        
        

      

    

      

    ATTACHMENT
      A


    


    DEVELOPING
      WORLD 

     

    Countries
      with Low-income economies:

     

    
      	
              Afghanistan

            	 	
              Guinea

            	 	
              Nicaragua

            
	
              Bangladesh

            	 	
              Guinea-Bissau

            	 	
              Niger

            
	
              Benin

            	 	
              Haiti

            	 	
              Nigeria

            
	
              Bhutan

            	 	
              India

            	 	
              Pakistan

            
	
              Burkina
                Faso

            	 	 	 	
              Rwanda

            
	
              Burundi

            	 	
              Kenya

            	 	
              São
                Tomé
                and Principe

            
	
              Cambodia

            	 	
              Korea,
                Dem Rep.

            	 	
              Senegal

            
	
              Cameroon

            	 	
              Kyrgyz
                Republic

            	 	
              Sierra
                Leone

            
	
              Central
                African Republic

            	 	
              Lao
                PDR

            	 	
              Solomon
                Islands

            
	
              Chad

            	 	
              Lesotho

            	 	
              Somalia

            
	 	 	
              Liberia

            	 	
              Sudan

            
	 	 	
              Madagascar

            	 	
              Tajikistan

            
	 	 	
              Malawi

            	 	
              Tanzania

            
	
              Comoros

            	 	
              Mali

            	 	
              Timor-Leste

            
	
              Congo,
                Dem. Rep.

            	 	
              Mauritania

            	 	
              Togo

            
	
              Congo,
                Rep.

            	 	
              Moldova

            	 	
              Uganda

            
	
              Côte
                d’Ivoire

            	 	
              Mongolia

            	 	
              Uzbekistan

            
	
              Eritrea

            	 	
              Mozambique

            	 	
              Vietnam

            
	
              Ethiopia

            	 	
              Myanmar

            	 	
              Yemen,
                Rep.

            
	
              Gambia,
                The

            	 	 	 	
              Zambia

            
	
              Ghana
                

            	 	
              Nepal
                

            	 	
              Zimbabwe

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    Countries
      with Lower-middle-income economies

     

    
      	
              Albania

            	 	
              El
                Salvador

            	 	
              Peru

            
	
              Algeria

            	 	
              Fiji

            	 	
              Philippines

            
	
              Angola

            	 	
              Georgia

            	 	
              Romania

            
	
              Armenia

            	 	
              Guatemala

            	 	
              Samoa

            
	
              Azerbaijan

            	 	
              Guyana

            	 	
              Serbia
                & Montenegro

            
	
              Belarus

            	 	
              Iran,
                Islamic Rep.

            	 	
              Sri
                Lanka

            
	
              Bolivia

            	 	
              Iraq

            	 	
              Suriname

            
	
              Bosnia
                and Herzegovina

            	 	
              Jamaica

            	 	
              Swaziland

            
	
              Brazil

            	 	
              Jordon
                

            	 	
              Syrian
                Arab Republic

            
	
              Bulgaria

            	 	
              Kazakhstan

            	 	
              Thailand

            
	
              Cape
                Verde

            	 	
              Kiribati

            	 	
              Tonga

            
	
              China

            	 	
              Macedonia,
                FYR

            	 	
              Tunisia

            
	
              Colombia

            	 	
              Maldives

            	 	
              Turkmenistan

            
	
              Cuba

            	 	
              Marshall
                Islands

            	 	
              Ukraine

            
	
              Djibouti

            	 	
              Micronesia,
                fed. Sts.

            	 	
              Vanuatu

            
	
              Dominican
                Republic

            	 	
              Morocco

            	 	
              West
                Bank and Gaza

            
	
              Ecuador

            	 	
              Namibia

            	 	 
	
              Egypt,
                Arab Rep.

            	 	
              Paraguay

            	 	 
	 	 	 	 	
              Turkmenistan

            
	 	 	 	 	
              Ukraine
                

            
	 	 	 	 	
              Vanuatu
                

            
	 	 	 	 	
              West
                Bank and Gaza 

            


    

    


    
      
        
        

      

      
        -2-

        
          

        

      

      
        
        

      

    

     

    Countries
      with Upper-middle-income economies

     

    
      	
              American
                Samoa

            	 	
              Grenada

            	 	
              Poland

            
	
              Antigua
                and Barbuda

            	 	
              Hungary
                

            	 	
              Russian
                Federation

            
	
              Argentina

            	 	
              Latvia

            	 	
              Seychelles

            
	
              Barbados

            	 	
              Lebanon

            	 	
              Slovak
                Republic

            
	
              Belize

            	 	
              Libya

            	 	
              South
                Africa

            
	
              Botswana

            	 	
              Lithuania

            	 	 
	
              Chile

            	 	
              Malaysia

            	 	
              St.
                Kitts and Nevis

            
	
              Costa
                Rica

            	 	
              Mauritius

            	 	
              St.
                Lucia

            
	
              Croatia

            	 	
              Mayotte

            	 	
              St.
                Vincent & the Grenadines

            
	
              Czech
                Republic

            	 	
              Mexico

            	 	
              Trinidad
                and Tobago

            
	
              Dominica

            	 	
              Northern
                Mariana Islands

            	 	
              Turkey

            
	
              Equitorial
                Guinea

            	 	
              Oman

            	 	
              Uruguay

            
	
              Estonia
                

            	 	
              Palau

            	 	
              Venezuela,
                RB

            
	
              Gabon

            	 	
              Panama

            	 	 


    

     

    
      
        
        

      

      
        -3-

        
          

        

      

      
        
        

      

    


    ATTACHMENT
      B

    


    WORK
      PLAN AND BUDGET

    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

       

      

        CONFIDENTIAL

        


        [*]

        


        Work
          Plan 2006: Activities, Development Overview, Budget

        


        Author(s): [*]

        IAVI

        Targeted
          Genetics

        CHOP

         

        Written:
          

        


        
          	
                  Version
                    #

                	 	
                  Reason
                    for change

                	 	
                  Date
                    (dd/mmm/yy)

                
	
                  1

                	 	 	 	
                  [*]

                
	
                  2

                	 	
                  [*]

                	 	
                  [*]

                
	
                  3

                	 	
                  [*]

                	 	
                  [*]

                
	
                  4

                	 	
                  [*]

                	 	
                  [*]

                


        

         

        Approval:


        


        
          	
                  Approved
                    by

                	 	
                  Date
                    (dd/mmm/yy)

                	 	
                  Signature

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	 	 	 
	
                  [*]

                	 	 	 	
                  See
                    Contract 

                


        

         

        
          *Confidential
            Treatment Requested.

        


        
          
            
            

          

          
            p1
              of
              10

            
              

            

          

          
            
            

          

        

         

        CONFIDENTIAL


        OBJECTIVES

        


        Goal

        The
          goal
          of this project is the development of [*]through
          the conduct of the [*]

        


        Objectives
          of 2006

        
          	·  	
                  Complete
                    [*].

                


        

        
          	·  	
                  Complete
                    [*].

                


        

        
          	·  	
                  Complete
                    [*].

                


        

        
          	·  	
                  [*].

                


        

        
          	·  	
                  [*]

                


        

        
          	·  	
                  Complete
                    [*]

                


        

        
          	·  	
                  Complete
                    [*]

                


        

        
          	·  	
                  Complete
                    [*]

                


        

        
          	·  	
                  Support
                    [*]

                


        

        
          	·  	
                  Preparation
                    of [*]

                


        

        
          	·  	
                  [*]

                


        

        
          	·  	
                  [*]

                


        

        
          	·  	
                  Prepare
                    [*]

                


        

         

        ACTIVITIES

        


        
          	
                	A.	
                  [*]

                


        

        


        
          	1.  	
                  [*]

                


        

         

        
          	2.  	
                  [*]

                


        

        


        
          	3.  	
                  [*]

                


        

        
           

          *Confidential
            Treatment Requested.

        


        
          
            
            

          

          
            p2
              of
              10

            
              

            

          

          
            
            

          

        


        CONFIDENTIAL

         

        
          	
                  Process
                    Development  

                
	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  1

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  Complete
                    [*]

                	 	
                  TGC:

                  -  Support
                    in conducting [*]

                  -  [*]

                  -  [*]

                
	
                  2

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  TGC:
                    

                  Assess
                    [*]

                


        

        


        
          *Confidential
            Treatment Requested.

        


        
          
            
            

          

          
            p3
              of
              10

            
              

            

          

          
            
            

          

        

         

        CONFIDENTIAL


        
          	4.  	
                  [*],
                    including [*] 

                


        

          
          Description of Activities

         

        
          	
                  Quality  

                
	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  3

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  TGC:
                    

                  -  Complete
                    [*]

                  -  Development
                    of [*]
                    assays.

                
	
                  4

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  TGC:
                    

                  -  Maintain
                    [*]

                  -  Maintain
                    [*]

                
	
                  5

                	 	
                  [*]

                	 	
                  [*]

                	 	 	 	
                  IAVI

                


        

        


        
          	5.  	
                  Produce
                    and release [*]

                


        

        


        
          	
                  Quality  

                
	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  6

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  Manufacture
                    [*].
                    

                	 	
                  TGC:
                    

                  -  [*]

                
	
                  7

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  Release
                    of [*]

                	 	
                  TGC:

                  -  [*]and
                    [*]

                  -  Contract
                    testing costs. 

                  -  [*]

                
	
                  8

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  Product
                    fill and release.

                	 	
                  TGC:

                  -  Manage
                    [*]
                    and [*]at
                    a [*]

                  -  Test
                    [*]

                
	
                  9

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  10

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                


        

        
          	 	 


          	B.  	
                       
                    [*]

                


        

        


        
          	1.  
                  	
                       
                    [*]

                


          	 	 


        

        
          	
                  Preclinical

                
	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  11

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  Complete
                    [*]

                	 	
                  TGC:
                    

                  -  [*]

                  -  [*]

                  -  [*]

                
	
                  
                    12

                  

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  Test
                    [*]

                	 	
                  CHOP
                    - [*]

                
	
                  13

                	 	
                  [*]

                	 	
                  [*]

                	 	 	 	
                  IAVI
                    - [*]

                
	
                  14

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  Develop
                    in [*]

                	 	
                  IAVI
                    - [*]

                


        

         

        *Confidential
          Treatment
          Requested.

         

        
          
            
            

          

          
            p4
              of
              10

            
              

            

          

          
            
            

          

           

          CONFIDENTIAL

           

        

        
          	2.  	
                       
                    CHOP/CCRI personnel charges

                


        

         

        
          	
                  Science
                    /NHP charges  

                
	 	 	 	 	 	 	 	 	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  15

                	 	
                  [*]

                	 	
                  [*]

                	 	 	 	
                  -  CHOP/CCRI

                  [*]

                


        

         

        
          	C.  	
                       
                    [*]

                


        

        
          	1.  	
                       
                    [*]

                


        

        
          	2.  	
                       
                    [*]

                


        

        
          	 
	
                  Regulatory  

                
	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  16

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  IAVI
                    [*]

                
	
                  17

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  TGC:

                  -  [*]

                  -  Meet
                    with [*]
                    in
                    [*]

                  -  Travel
                    and expenses for [*]

                


        

         

        
          	D.  
                  	
                       
                    [*]

                


        

        


        
          	1.  	
                       
                    [*]

                


        

         
          a.  [*]

        
          	 
	
                  Clinic  

                
	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  18

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  TGC:

                  -  [*]

                  -  [*]

                  -  [*]

                  -  [*]

                
	
                  19

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  TGC

                
	
                  
                    20

                  

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  IAVI

                
	
                  21

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  IAVI:
                    [*]

                
	
                  22

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  IAVI
                    [*]

                


        

         

        *Confidential
          Treatment
          Requested.

         

        
          
            
            

          

          
            p5
              of
              10

            
              

            

          

          
            
            

          

        

         

        CONFIDENTIAL

         

        
          	2.  	
                       
                    [*]

                


        

        [*]

        


        
          	
                  Clinical
                    Immunology  

                
	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  23

                	 	
                  [*]

                	 	
                  Q4

                	 	
                  [*]

                	 	
                  IAVI:

                  -   [*]

                


        

        


        
          *Confidential
            Treatment Requested.

        


        
          
            
            

          

          
            p6
              of
              10

            
              

            

          

          
            
            

          

        

         

        CONFIDENTIAL

        


        
          	E.  	
                       
                    [*]

                


        

        [*]

        


        
          	
                  Project
                    Management

                
	 
	
                  Activity
                    Number

                	 	
                  Activity

                	 	
                  Start-
                    Finish

                	 	
                  Goal

                	 	
                  By
                    Whom / Deliverables

                
	
                  24

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  IAVI:

                  [*]

                
	
                  25

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  TGC:

                  [*]

                


        

         

        
          *Confidential
            Treatment Requested.

        

        


        
          
            
            

          

          
            p7
              of
              10

            
              

            

          

          
            
            

          

        

         

        CONFIDENTIAL

         

        BUDGET

        


        
          	
                  Targeted
                    Genetics Corporation

                	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	
                  [*]

                	 	
                  The
                    project has received funds for the first two
                    quarters.

                	 	 	 	 
	
                  [*]

                	 	 	 	 	 	 	 	 	 	 
	
                  [*]

                	 	 	 	 	 	 	 	 	 	 
	 	 	
                  Actual
                    data

                	 	
                  projected
                    budget

                	 	
                  projected
                    budget

                	 	
                  projected
                    budget

                	 	 
	 	 	 	 	 	 	 	 	 	 	 
	
                  [*]

                	 	
                  Quarter
                    1

                	 	
                  Quarter
                    2

                	 	
                  Quarter
                    3

                	 	
                  Quarter
                    4

                	 	
                  Total

                
	
                  [*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                
	
                   

                	 	 	 	 	 	 	 	 	 	 
	
                  [*]

                	 	
                  Quarter
                    1

                	 	
                  Quarter
                    2

                	 	
                  Quarter
                    3

                	 	
                  Quarter
                    4

                	 	
                  Total

                
	
                  [*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  [*]

                	 	
                  $[*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  
                    [*]

                  

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                	 	
                  [*]

                
	
                  [*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                
	 	 	 	 	 	 	 	 	 	 	 
	
                  [*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                	 	
                  $[*]

                


        

         

          *Confidential
            Treatment
            Requested.

           

        

        
          
            
            

          

          
            p8 of 10

            
              

            

          

          
            
            

          

        

         

        
          	 	 	 	 	 	 	 	 	 	 	 
	
                  -To
                    be confirmed by regulatory agencies is whether [*]
                    is required for [*]

                	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	
                  *Note:
                    [*]
                    associated with [*]
                    are [*]
                    until approval is received from [*]

                	 	 	 	 


        

         

        [*]
          activity
          line items (budget in BOLD)

        


        [*]

        


        This
          Work
          Plan is funded with monies from the [*]
          International [*].
          The
          provisions in Attachment F to the Agreement, entitled "[*]
          Standard
[*]",
          shall
          apply to this Work Plan with the same force and effect as if they were
          attached
          herein.

         

        [*]

         

        *Confidential
          Treatment
          Requested.

         

      

      
        
          
          

        

        
          p9
            of
            10

          
            

          

        

        
          
          

        

      

    

    
       

      CONFIDENTIAL

       

      [*]

    

     

    *Confidential
      Treatment
      Requested.

     

    
      
        
        

      

      
        p10 of 10

        
          

        

      

      
        
        

      

    

    

      CONFIDENTIAL

       

      [*]

      


      Work
        Plan 2006: Activities, Development Overview, Budget

      


      Author(s): [*]

      [*]

       

      Written:
        

      


      
        	
                Version
                  #

              	 	
                Reason
                  for change

              	 	
                Date
                  (dd/mmm/yy)

              
	
                1

              	 	 	 	
                [*]

              
	
                2

              	 	
                [*]

              	 	
                [*]

              
	
                3

              	 	
                [*]

              	 	
                [*]

              
	
                4

              	 	
                [*]

              	 	
                [*]

              


      

       

      Approval:


      


      
        	
                Approved
                  by

              	 	
                Date
                  (dd/mmm/yy)

              	 	
                Signature

              
	
                [*]

              	 	
                [*]

              	 	
                [*]

              
	
                [*]

              	 	 	 	 
	
                [*]

              	 	 	 	
                [*]

              


      

       

      
        *Confidential
          Treatment Requested.

      

       

      
        
          
          

        

        
          p1
            of
            8

          
            

          

        

        
          
          

        

      

      
         

        CONFIDENTIAL

OBJECTIVES

      


      Goal

      The
        goal
        of this project is the development of [*]

      


      Objectives
        of 2006

      
        	·  	
                Complete
                  [*]

              


      

      
        	·  	
                Continue
                  [*]

              


      

      
        	·  	
                Support
                  [*]

              


      

       

      ACTIVITIES

      


      
        	A.  	
                [*]

              


      

       

      The
        design of the [*]
        will be
        undertaken for this vaccine candidate

      


      
        	1.  	
                [*]

              


      

      


      
        	2.  	
                [*]

              


      

      


      
        	3.  	
                [*]

              


      

      


      
        	4.  	
                [*]

              


      

      


      
        	
                Quality  

              
	 
	
                Activity
                  Number

              	 	
                Activity

              	 	
                Start-
                  Finish

              	 	
                Goal

              	 	
                By
                  Whom / Deliverables

              
	
                1

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                TGC:
                  

                -  [*]

                -  [*] 

              
	
                2

              	 	
                QA

              	 	
                Q1-Q4

              	 	 	 	
                IAVI

              


      

       

      
        	5.  	
                [*]

              


      

      


      
        	
                Quality  

              
	 
	
                Activity
                  Number

              	 	
                Activity

              	 	
                Start-
                  Finish

              	 	
                Goal

              	 	
                By
                  Whom / Deliverables

              
	
                3

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI

                -  [*]

              
	
                4

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI
                  [*]

              
	
                5

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI

                [*]

              
	
                
                  6

                

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI
                  - [*]

              


      

       

      *Confidential
        Treatment
        Requested.


      
        
          
          

        

        
          p2
            of
            8

          
            

          

        

        
          
          

        

      

       

      
        CONFIDENTIAL

         

      

      
        	B.  	
                [*]

              


      

      


      
        	1.  	
                [*]

              


      

      


      
        	
                NHP
                    

              
	 
	
                Activity
                  Number

              	 	
                Activity

              	 	
                Start-
                  Finish

              	 	
                Goal

              	 	
                By
                  Whom / Deliverables

              
	
                7

              	 	
                [*]

              	 	 	 	
                [*]

              	 	
                -  CCRI

                [*]

              
	
                8

              	 	
                [*]

              	 	 	 	
                [*]

              	 	
                -  CCRI

                [*]

              
	
                9

              	 	
                [*]

              	 	 	 	
                [*]

              	 	
                -  [*]

              
	
                10

              	 	
                [*]

              	 	 	 	 	 	
                -  CCRI/CHOP

                [*]

              


      

       

      
        	C.  	
                [*]

              


      

      


      [*]

      


      
        	1.  	
                 [*]

              


      

      


      
        	
                Regulatory  

              
	 
	
                Activity
                  Number

              	 	
                Activity

              	 	
                Start-
                  Finish

              	 	
                Goal

              	 	
                By
                  Whom / Deliverables

              
	
                11

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI
                  

                [*]

              
	
                12

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI

                [*]

              


      

       

      Note:
        [*]

      


      
        *Confidential
          Treatment Requested.

      

       

      
        
          
          

        

        
          p3
            of
            8

          
            

          

        

        
          
          

        

      

       

      
        CONFIDENTIAL

         

      

      
        	D.  	
                [*]

              


      

      


      
        	1.  	
                Conduct
                  [*]

              


      

      
        	a.  	
                Complete
                  [*]

              


      

      


      
        	
                Clinic

              
	 
	
                Activity
                  Number

              	 	
                Activity

              	 	
                Start-
                  Finish

              	 	
                Goal

              	 	
                By
                  Whom / Deliverables

              
	
                13

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                TGC:
                  

                -  [*]

                -  [*]

              
	
                14

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                15

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                16

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                17

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                18

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                19

              	 	
                [*]

              	 	 	 	 	 	
                IAVI:
                  [*]

              
	
                20

              	 	
                [*]

              	 	 	 	 	 	
                IAVI:
                  [*]

              
	
                21

              	 	
                [*]

              	 	
                [*]

              	 	 	 	 


      

       

      
        *Confidential
          Treatment Requested.

      

       

      
        
          
          

        

        
          p4
            of
            8

          
            

          

        

        
          
          

        

      

       

      
        CONFIDENTIAL

         

      

      
        	b.  	
                [*]

              


      

      


      
        	
                Clinic  

              
	 
	
                Activity
                  Number

              	 	
                Activity

              	 	
                Start-
                  Finish

              	 	
                Goal

              	 	
                By
                  Whom / Deliverables

              
	
                22

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                TGC:
                  

                -  [*]

                -  [*]

                -  [*]

              
	
                23

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                24

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                25

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                26

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                27

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                28

              	 	
                [*]

              	 	 	 	 	 	 
	
                29

              	 	
                [*]

              	 	
                [*]

              	 	 	 	
                IAVI
                  ([*])

              


      

       

      
        *Confidential
          Treatment Requested.

      

       

      
        
          
          

        

        
          p5
            of
            8

          
            

          

        

        
          
          

        

      

       

      
        CONFIDENTIAL

         

      

      
        	2.  	
                [*]

              


      

       

      [*]

      


      
        	
                Clinical
                  Immunology  

              
	 
	
                Activity
                  Number

              	 	
                Activity

              	 	
                Start-
                  Finish

              	 	
                Goal

              	 	
                By
                  Whom / Deliverables

              
	
                30

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                31

              	 	
                [*]

              	 	
                [*]

              	 	 	 	
                IAVI
                  - [*]

              
	
                32

              	 	
                [*]

              	 	
                [*]

              	 	 	 	
                IAVI
                  - [*]

              


      

       

      
        *Confidential
          Treatment Requested.

      

       

      
        
          
          

        

        
          p6
            of
            8

          
            

          

        

        
          
          

        

      

       

      CONFIDENTIAL

      


      
        	E.  	
                [*]

              


      

      


      Provide
        [*]

      


      
        	1.  	
                [*]

              


      

      
        	 	 


      

      
        	
                Project
                  Management

              
	 
	
                Activity
                  Number

              	 	
                Activity

              	 	
                Start-
                  Finish

              	 	
                Goal

              	 	
                By
                  Whom / Deliverables

              
	
                33

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                IAVI:

                -  [*]

              
	
                34

              	 	
                [*]

              	 	
                [*]

              	 	
                [*]

              	 	
                TGC:

                -  [*]

              
	
                35

              	 	
                [*]

              	 	
                [*]

              	 	 	 	
                CHOP
                  

                Estimated
                  Cost: $[*]

              


      

       

      BUDGET

      


      TGC
        -
[*]

      CHOP/CCRI
        - [*]

      


      [*]
        Funding

      


      This
        Work
        Plan is [*].
        The
        provisions in Attachment F to the Agreement, entitled "[*]",
        shall
        apply to this Work Plan with the same force and effect as if they were attached
        herein.

      
         

        *Confidential
          Treatment Requested.

      

       

      
        
          
          

        

        
          p7
            of
            8

          
            

          

        

        
          
          

        

      

       

      
        CONFIDENTIAL

         

      

      [*]

      [*]

      


      
         

        *Confidential
          Treatment Requested.

      

    

     

    
      
        
        

      

      
        p8
          of
          8

        
          

        

      

      
        
        

      

    

    ATTACHMENT
      C

    


    CLINICAL
      SUPPLY AGREEMENT, DATED DECEMBER 24, 2003, BY AND 

    AMONG
      IAVI AND THE COMPANY

     

    [Previously
      filed (with confidential treatment granted with respect to certain portions)
      with the Securities and Exchange Commission as Attachment E to Exhibit 10.2
      to
      the Company’s
      Current
      Report on Form 8-K, filed on January 12, 2004].

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    


    ATTACHMENT
      D

    


    TGC
      ACCOUNTING DETAILS

     

    All
      TGC
      accounting and budgeting under this agreement as reflected in annual budgets,
      quarterly expenditure reports and all other financial tools and instruments
      will
      be done based on work activity, using Generally Accepted Accounting Principles,
      following [*].
      TGC
      will invoice IAVI for [*],
      as
      performed in accordance with the approved Work Plan, [*].
      Additionally, IAVI will reimburse TGC for those [*]
      as
      set
      forth in the Work Plan and Budget on an [*].
      The
[*]
      (FTE
      Rate) shall be calculated at the beginning of each project year based on
[*].
      The
[*]
      shall be
      reviewed and approved by IAVI prior to the commencement of each new project
      year. The Work Plan may be amended by mutual written consent of the parties
      in
      accordance with Section 3.5.4.

    


    All
      quarterly expenditure reports will be presented in a format substantially
      consistent with the format set forth in the Work Plan and Budget. For both
      budgeting and billing purposes, the [*],
      agreed
      to in advance, shall be used for each FTE budgeted and expended. If IAVI
      requests [*])[*]
      agrees
      to [*]
      TGC and
      IAVI agree that the fixed FTE Rate shall be [*]
      and
      agree that the [*]
      shall be
      at a [*]
      for each
      manufacturing room IAVI uses within the TGC manufacturing facility. IAVI shall
      be responsible for coordinating all work activities it subcontracts to third
      parties. If IAVI requests TGC to coordinate subcontracted activities, TGC shall
      invoice IAVI a [*]
      on such
      subcontracted costs as a [*].

    
      
         

        *Confidential
          Treatment
          Requested.


      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    ATTACHMENT
      E

    TGC
      CONTROLLED PATENTS, CRI PATENTS AND CHOP PATENTS - 

    RELEVANT
      TO PROGRAM

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    ATTACHMENT
      F

    USAID
      STANDARD PROVISIONS

    


    Supplementary
      Provisions: 

    Standard
      U.S. Government Requirements

    


    Contractor
      shall comply with the standard U.S. Government requirements specified in this
      Appendix.

    


    1.
      Applicability of 22 CFR Part 226 

    2.
      Reimbursable Costs   

    3.
      Indirect Costs    

    4.
      Accounting Systems and Records 

    5.
      Payment Advances and Refunds 

    6.
      Debarment     

    7.
      Probity      

    8.
      Disclaimers and Approvals  

    9.
      Procurement of Goods and Services

    10.
      Equipment     

    11.
      Travel and Transportation  

    12.
      Human
      Subjects Research 

    
      13.
        Animal Welfare 

    

    14.
      Worker’s Compensation Insurance

    15.
      Nondiscrimination

    16.
      Real
      Property

    17.
      Clean/Air Water 

    18.
      Communication Products

    19.
      Investment Promotion

    20.
      Organizations Eligible for Assistance

    21.
      Condoms

    22.
      Prohibition on the Promotion or Advocacy of the Legalization or 
      Practice
      of Prostitution or Sex Trafficking

    


    The
      following are the principal standard federal requirements applicable to the
      performance of both parties’ responsibilities under this Agreement (in addition
      and without prejudice to the other provisions of this Agreement):

    


    
      	
              (1)

            	
              Applicability
                of 22 CFR Part 226. This
                provision is only applicable to agreements awarded to U.S.
                organizations.

            


    

    


    
      	 	
              All
                provisions of 22 CFR Part 226 are applicable to this
                agreement.

            


    

    


    
      	
              (2)

            	
              Reimbursable
                Costs.  This
                Provision is only applicable to cost reimbursement
                contracts.
                

            


    

    


    To
      be
      reimbursable under this Agreement, costs must comply with the applicable cost
      principles. For educational institutions, use OMB Circular A-21; for all other
      non-profit organizations, use OMB Circular A-122; and for profit making firms,
      use Federal Acquisition Regulation 31.2 (see below). Requirements include the
      following, without limitation: direct costs must be necessary and incurred
      specifically for the Services; verifiable from the books and records of
      Contractor, as applicable, and supported by source documentation; allocable
      to
      this Agreement; reasonable in nature and amount; and allowable. To facilitate
      monitoring of charges under this Agreement, once each year, IAVI may provide
      Contractor with a USAID compliance form which Contractor agrees to fill out
      completely and accurately and return promptly to IAVI for review and
      consultation as appropriate.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    


    
      	
              (3)

            	
              Indirect
                Costs.  This
                Provision is only applicable to cost reimbursement
                contracts.
                

            


    

    


    Unless
      predetermined indirect cost rates are included in the approved budget for this
      Agreement (or each Task Order, when applicable), funding from USAID will only
      be
      used for reimbursable direct costs. 

    


    
      	
              (4)

            	
              Accounting
                Systems, Records and Audits. This
                Provision is only applicable to cost reimbursement
                contracts.
                

            


    

    


    Contractor
      shall maintain books, records, documents and other evidence in accordance with
      generally accepted and recognized accounting procedures. Contractor shall
      preserve and make available its accounting records and documents for examination
      and audit by IAVI, USAID and the Comptroller General of the United States,
      or
      any of their duly authorized representatives: (a) until the expiration of three
      years from the termination of this Agreement; (b) for such longer period, if
      any, as is required to complete an audit to resolve all questions concerning
      expenditures unless written approval has been obtained from USAID to dispose
      of
      the records; and (c) if any litigation, claim, or audit is started before the
      expiration of the three year period, the records shall be retained until all
      litigation, claims, or audit findings involving the records have been resolved.
      Contractor agrees to make available any further information requested by either
      IAVI or USAID with respect to any questions arising as a result of the
      aforementioned audit. U.S. organizations are also subject to the audit
      requirements of 22 CFR 226.26 (Non-Federal Audits).

    


    
      	
              (5)

            	
              Payment
                Advances and Refunds. If
                Contractor receives advance payments under this Agreement, Contractor
                shall maintain advances in interest bearing accounts unless: 1) Contractor
                receives less than $120,000 in U.S. Government awards per year; or
                2) the
                best interest bearing account would not be expected to earn more
                than $250
                in interest each year; or 3) the bank would require an unreasonable
                average or minimum balance so as to make it impractical to do so.
                Interest
                earned in excess of $250 per year must be refunded to IAVI. In addition,
                funds advanced to Contractor but not expended by the end of the Agreement
                or not expended in accordance with the terms of this Agreement must
                be
                refunded to IAVI. 

            


    

    


    
      	
              (6)

            	
              Debarment.
                Contractor
                certifies that neither it nor its principals is presently excluded
                or
                disqualified or proposed for exclusion or disqualification from
                participation in this Agreement by any U.S. Federal department or
                agency
                (see the U.S. Government’s Excluded Parties List at
                http://epls.arnet.gov). Furthermore, Contractor agrees that it will
                not
                enter into a subcontract or subaward with a disqualified or excluded
                party
                on this list.

            


    

    


    
      	
              (7)

            	
              Probity. 

            


    

    


    
      	 	
              (a)
                Contractor represents and warrants that (i) to the best of its knowledge
                and belief, no IAVI employee, officer, or agent, or member of his/her
                immediate family, his or her partner, or an organization which is
                about to
                employ any of the foregoing, has a financial interest in Contractor;
                and
                (ii) no officer, employee or agent of IAVI has solicited or accepted
                gratuities, favors, or anything of monetary value from
                Contractor.

            


    

    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    
      	 	
              (b)
                U.S. Executive Orders and U.S. law prohibit transactions with, and
                the
                provision of resources and support to, individuals and organizations
                associated with terrorism. It is the legal responsibility of Contractor
                to
                ensure compliance with these Executive Orders and laws in the conduct
                of
                its own activities. Contractor is required to obtain the updated
                lists at
                the time of procurement of goods or services. The updated lists are
                available at:
                http://treasury.gov/offices/enforcement/ofac/sanctions/terrorism.htm
                and
                http://www.un.org/Docs/sc/committees/1267. This provision must be
                included
                in all contracts, subcontracts or subawards awarded
                hereunder.

            


    

    


    
      	
              (8)

            	
              Disclaimers
                and Approvals. Contractor
                agrees that USAID will not assume liability for third party claims
                for
                damages arising out of this Agreement and that Contractor will have
                no
                relationship with USAID solely because of this
                Agreement.

            


    

    


    
      	
              (9)

            	
              Procurement
                of Goods and Services.  

            


    

    


    
      	 	
              (a)
                Procurements of goods and services pursuant to this Agreement shall
                be
                conducted in accordance with sound commercial practices and the USAID
                Standard Provisions “USAID Eligibility Rules for Goods and Services (April
                1998)” and shall be supported by original invoices or other appropriate
                supporting documentation. The text of this policy is available on
                USAID’s
                website (see below).

            


    

    


    (b)
      Goods
      on USAID’s list of ineligible items (military equipment, surveillance equipment,
      equipment to support police or law enforcement activities, abortion equipment,
      luxury goods, gambling equipment, and weather modification equipment) may not
      be
      financed. Goods on USAID’s list of restricted items (agricultural equipment,
      pesticides, fertilizers, U.S. government-owned excess property, used equipment,
      pharmaceuticals, including HIV Test kits, motor vehicles) may only be financed
      with IAVI’s written approval.

    


    (c)
      Other
      Goods and services may be procured from any country except the following Foreign
      Policy Restricted Countries: Cuba, Iran, Laos, North Korea, or Syria. Goods
      may
      not be procured from firms on the U.S. government’s Excluded Parties List (see
“http://epls.arnet.gov”). For purposes of the preceding sentence, “procured
      from” includes supplier nationality (for goods and services) and goods’ source
      and origin.

    


    
      	
              (10)

            	
              Equipment.
                This
                provision is applicable when the purchase of equipment is authorized
                under
                this Agreement. Unless
                indicated otherwise in the schedule of this Agreement, title to all
                equipment purchased with funds provided hereunder shall belong to
                IAVI.

            


    

    


    
      	
              (11)

            	
              Travel
                and Transportation. This
                provision is applicable when international travel is authorized under
                this
                Agreement. Unless
                included in the approved budget for this Agreement, no funds may
                be
                expended for international travel without IAVI’s written approval.
                Expenditures of funds provided under this Agreement (i) for transportation
                of goods or travel of personnel overseas shall be subject to the
                USAID
                Standard Provision, “International Air Travel and Transportation (JUNE
                1999),” and (ii) for shipments of goods by sea shall be subject to the
                USAID Standard Provision, “Ocean Shipment of Goods (JUNE 1999).” The text
                of these provisions is available on USAID’s website (see
                below).

            


    

    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    
      	
              (12)

            	
              Human
                Subjects Research.  This
                provision is applicable when human subjects research is conducted
                pursuant
                to this Agreement. Contractor
                agrees to comply with USAID policies, to the extent applicable, including
                without limitation the Common Federal Policy for the Protection of
                Human
                Subjects (implemented by USAID at 22 CFR Part 225); the “Procedures for
                Protection of Human Subjects in Research Supported by USAID”; and the
                USAID Standard Provision entitled “Protection of the Individual as a
                Research Subject (APRIL 1998).” The texts of these policies are available
                on USAID’s website (see below.)

            


    

    


    
      	
              (13)

            	
              Animal
                Welfare. This
                provision is applicable when research involving laboratory animals
                is
                conducted pursuant to this Agreement.
                Contractor agrees to work with IAVI to ensure compliance with USAID
                policies to the extent applicable, as referenced in the USAID Standard
                Provision entitled “Care of Laboratory Animals (NOVEMBER 1985)”. The text
                of this policy is available on USAID’s website (see
                below).

            


    

    


    
      	
              (14)

            	
              Worker’s
                Compensation Insurance. The
                provision is applicable to U.S. based contractors who will perform
                work
                hereunder outside the United States. Pursuant
                to 22 CFR Part 226, Appendix A, Contractor agrees to provide worker’s
                compensation insurance to all persons employed outside the U.S. who
                are
                U.S. citizens or residents. Contractor agrees to provide insurance
                required by applicable law to all persons employed outside the U.S.
                who
                are not U.S. citizens or residents

            


    

    


    
      	
              (15)

            	
              Nondiscrimination.
                This
                provision is applicable when work under this Agreement will be performed
                in the United States or when employees are recruited in the United
                States.
                No
                U.S. citizen or legal resident will be excluded from participation
                in, be
                denied the benefits of, or be otherwise subjected to discrimination
                under
                any activity funded under this Agreement on the basis of race, color,
                national origin, age, handicap or
                sex.

            


    

    


    
      	
              (16)

            	
              Real
                Property. Funding
                may not be used under this Agreement to construct, alter, repair
                or
                improve real property without IAVI’s advance written approval, which
                [approval] may be subject to additional USAID
                requirements.

            


    

    


    
      	
              (17)

            	
              Clean
                Air/Water. This
                provision is applicable to contracts in excess of $100,000 to be
                performed
                in the United States. Contractor
                agrees to comply with all applicable standards, orders or regulations
                pursuant to the Clean Air Act (42 U.S.C. 7401 et seq.) and the Federal
                Water Pollution Control Act as amended (33 U.S.C. 1251 et seq.) Violations
                are to be reported to IAVI.

            


    

    


    
      	
              (18)

            	
              Communications
                Products. This
                provision is applicable if publications or videos are produced with
                funds
                provided under this Agreement.

            


    

    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    (a)
      Any
      materials publicizing or resulting from this Agreement must include
      acknowledgement of U.S. Government funding provided through IAVI using the
      following language: “This (publication, video, or other information/media
      product (specify)) was made possible through support by the U.S. Agency for
      International Development.” In addition, the following text must be added,
      unless, exempted, in writing by IAVI: “The opinions, findings, and conclusions
      or recommendations expressed herein are those of the author(s) and do not
      necessarily reflect the view of the U.S. Agency for International
      Development.”

    


    (b)
      Advance approval must be obtained from IAVI when funds are used under this
      Agreement to produce publications or videos that (i) will cost over $25,000
      to
      prepare and execute; or (ii) will be sent to or likely be seen by members of
      the
      U.S. Congress; or (iii) will have more than 50% of its copies distributed in
      the
      United States.

    


    
      	
              (19)

            	
              Investment
                Promotion. No
                funds or other support provided under this Agreement may be used
                by
                Contractor for an activity which: (a) will involve the relocation
                or
                expansion outside the United States of any of Contractor’s U.S.-based
                activities, if such relocation or expansion will replace some or
                all of
                the U.S. production and reduces the number of employees at that U.S.
                location; (b) would establish an export processing zone or designated
                area
                in a foreign country where the labor, environmental, tax, tariff,
                and
                safety laws of the country would not apply; or (3) contributes to
                the
                violation of internationally recognized rights of workers in the
                recipient
                country. The
                Contractor shall include this provision in any subcontracts or subawards
                under this Agreement.

            


    

    


    
      	
              (20)

            	
              Organizations
                Eligible for Assistance. If
                Contractor is otherwise eligible to receive funds under this Agreement
                to
                prevent, treat, or monitor HIV/AIDS, Contractor shall not be required
                to
                endorse or utilize a multisectoral approach to combating HIV/AIDS
                or to
                endorse, utilize, or participate in a prevention method or treatment
                program to which Contractor has a religious or moral objection. The
                Contractor shall include this provision in any subcontracts or subawards
                under this Agreement.

            


    

    


    
      	
              (21)
                

            	
              Condoms.
                If
                information is provided under this Agreement about the use of condoms,
                the
                information shall be medically accurate and shall include the public
                health benefits and failure rates of such use and shall be consistent
                with
                USAID’s fact sheet entitled “USAID: HIV/STI Prevention and Condoms”. This
                fact sheet may be accessed at: http://www.usaid.gov/our_work/global_health/aids/TechAreas/prevention/condomfactsheet.html.”

            


    

    


    
      	
              (22)
                

            	
              Prohibition
                on the Promotion or Advocacy of the Legalization or Practice of
                Prostitution or Sex Trafficking. None
                of the funds made available under this Agreement may be used by Contractor
                to promote or advocate the legalization or practice of prostitution
                or sex
                trafficking. The funds made available under this Agreement may be
                used by
                Contractor to provide palliative care, treatment, or post-exposure
                pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities,
                including test kits, condoms, and, when proven effective, microbicides,
                if
                applicable under this Agreement. For the purposes of this provision,
“sex
                trafficking” means the recruitment, harboring, transportation, provision,
                or obtaining of a person for the purpose of a commercial sex act.
                The
                Contractor shall include this provision in any subcontracts or subawards
                under this Agreement.

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    


    The
      text
      of the Standard Provisions and other regulations that are referenced above
      is
      available at the following websites. IAVI will provide a copy upon
      request.

    


    22
      CFR
      Part 226 - http://www.access.gpo.gov/nara/cfr/waisidx_02/22cfr226_02.html

    OMB
      Circular A-122 http://www.whitehouse.gov/omb/circulars/a122/a122_2004.html

    OMB
      Circular A-21 http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html

    FAR
      Part
      31.2 http://www.arnet.gov/far/current/html/Subpart%2031_2.html#wp1095552

    USAID
      Standard Provisions for US Organizations http://www.usaid.gov/policy/ads/300/303maa.pdf

    USAID
      Standard Provisions for non-US Organizations http://www.usaid.gov/policy/ads/300/303mab.pdf