Confidential
      material omitted and filed separately with the Securities and Exchange
      Commission. Asterisks denote such omissions.

    


    Exhibit
      10.3

    


    JOINT
      DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

    


    BY
      AND
      BETWEEN

     

    GTC
      

     

    BIOTHERAPEUTICS,
      INC.

    


    AND

    


    LFB-BIOTECHNOLOGIES
      S.A.S.U.

    


    September
      29, 2006

    

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

    

    


    TABLE
      OF CONTENTS

    


    
      	 	 	
              Page

            
	
               

            	 	 
	
               ARTICLE
                1

            	
              DEFINITIONS

            	
              2

            
	
               ARTICLE
                2

            	
              SCOPE
                OF COLLABORATION; JOINT OBLIGATIONS; DILIGENCE

            	
              14

            
	
              2.1

            	
              Scope
                of Collaboration

            	
              14

            
	
              2.2

            	
              Conduct
                of Parties

            	
              17

            
	
              2.3

            	
              Assistance

            	
              17

            
	
               ARTICLE
                3

            	
              GRANT
                OF RIGHTS

            	
              18

            
	
              3.1

            	
              License
                Grant to GTC

            	
              18

            
	
              3.2

            	
              License
                Grant to LFB Biotech

            	
              19

            
	
              3.3

            	
              Exercise
                of Commercialization Rights in Co-Exclusive Territory

            	
              20

            
	
              3.4

            	
              Trademark
                License

            	
              20

            
	
              3.5

            	
              Performance
                of Development and Commercialization Activities By Third
                Parties

            	
              21

            
	
              3.6

            	
              Reservation
                of Rights

            	
              21

            
	
              3.7

            	
              Competing
                Products

            	
              21

            
	
              3.8

            	
              Third
                Party Patent Rights

            	
              21

            
	
              3.9

            	
              Effect
                of Bankruptcy on License Grants

            	
              21

            
	
               ARTICLE
                4

            	
              COLLABORATION
                GOVERNANCE

            	
              22

            
	
              4.1

            	
              Team
                Leaders/Project Managers

            	
              22

            
	
              4.2

            	
              Joint
                Steering Committee; Minutes

            	
              22

            
	
              4.3

            	
              Subcommittees

            	
              22

            
	
              4.4

            	
              Meetings
                of the JSC

            	
              23

            
	
              4.5

            	
              Responsibilities
                of the JSC

            	
              23

            
	
              4.6

            	
              Decisions

            	
              23

            
	
              4.7

            	
              Legal
                Structure of the Collaboration

            	
              24
                

            
	
               ARTICLE
                5

            	
              DEVELOPMENT
                PHASE

            	
              24

            
	
              5.1

            	
              Development
                Plan

            	
              24

            
	
              5.2

            	
              Development
                Activities

            	
              25

            
	
              5.3

            	
              Diligence
                Requirements

            	
              26

            


    

     

    -
      i -

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

    

     

    TABLE
      OF CONTENTS

    (continued)

    


    
      	 	 	
              Page

            
	
               

            	 	 
	
              5.4

            	
              Development
                Costs

            	
              26

            
	
              5.5

            	
              Right
                of Reference to Data

            	
              26

            
	
              5.6

            	
              Transfer
                of Know-How

            	
              27

            
	
              5.7

            	
              Conduct
                of Clinical Trials

            	
              27

            
	
              5.8

            	
              Regulatory
                Filings and Approvals

            	
              28

            
	
              5.9

            	
              Ownership
                of Regulatory Approvals

            	
              29

            
	
               ARTICLE
                6

            	
              COMMERCIALIZATION
                PHASE

            	
              29

            
	
              6.1

            	
              Commercialization
                Plan

            	
              29

            
	
              6.2

            	
              Commercialization
                Activities

            	
              29

            
	
              6.3

            	
              Commercialization
                Costs

            	
              31

            
	
              6.4

            	
              Diligence
                Requirements

            	
              31

            
	
              6.5

            	
              Advertising
                and Promotional Materials

            	
              31

            
	
              6.6

            	
              Customer
                Complaints and Inquiries

            	
              32

            
	
              6.7

            	
              Drug
                Safety

            	
              32

            
	
              6.8

            	
              Product
                Withdrawals and Recalls

            	
              32

            
	
               ARTICLE
                7

            	
              PRODUCT
                SUPPLY

            	
              33

            
	
              7.1

            	
              Clinical
                Supply of Product

            	
              33

            
	
              7.2

            	
              Forecasts
                and Commercial Supply

            	
              33

            
	
              7.3

            	
              Disclaimer
                of Warranty

            	
              34

            
	
              7.4

            	
              Second
                Manufacturing Site

            	
              34

            
	
               ARTICLE
                8

            	
              PAYMENTS
                AND ACCOUNTING

            	
              34

            
	
              8.1

            	
              Equity
                Purchase

            	
              34

            
	
              8.2

            	
              Funding
                of Costs and Sharing of Profits

            	
              34

            
	
              8.3

            	
              Reports

            	
              38

            
	
              8.4

            	
              Records;
                Audit

            	
              39

            
	
              8.5

            	
              Currency
                of Account and Payment

            	
              40

            
	
              8.6

            	
              Blocked
                Currency

            	
              41

            
	
              8.7

            	
              Taxes

            	
              41

            


    

     

    -
      ii -

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

    

     

    TABLE
      OF CONTENTS

    (continued)

    


    
      	 	 	
              Page

            
	
               

            	 	 
	
               ARTICLE
                9

            	
              PATENTS
                AND INVENTIONS

            	
              41

            
	
              9.1

            	
              Ownership

            	
              41

            
	
              9.2

            	
              Patent
                Prosecution

            	
              42

            
	
              9.3

            	
              Enforcement
                of Patent Rights

            	
              43

            
	
              9.4

            	
              Claimed
                Infringement

            	
              44

            
	
              9.5

            	
              Declaratory
                Actions

            	
              44

            
	
              9.6

            	
              Costs
                of Patent Prosecution and Enforcement

            	
              44

            
	
               ARTICLE
                10

            	
              TRADEMARK
                USAGE AND MAINTENANCE

            	
              45

            
	
              10.1

            	
              Trademarks

            	
              45

            
	
               ARTICLE
                11

            	
              COVENANTS,
                REPRESENTATIONS, AND WARRANTIES

            	
              46

            
	
              11.1

            	
              Mutual
                Covenants

            	
              46

            
	
              11.2

            	
              Representations
                and Warranties of the Parties

            	
              47

            
	
              11.3

            	
              Additional
                Representations and Warranties of LFB Biotech

            	
              48

            
	
              11.4

            	
              Additional
                Representations and Warranties of GTC

            	
              48

            
	
              11.5

            	
              Performance
                by Affiliates

            	
              48

            
	
               ARTICLE
                12

            	
              CONFIDENTIALITY

            	
              49

            
	
              12.1

            	
              Treatment
                of Confidential Information

            	
              49

            
	
              12.2

            	
              Exceptions

            	
              49

            
	
              12.3

            	
              Authorized
                Disclosures

            	
              49

            
	
              12.4

            	
              Publicity

            	
              50

            
	
              12.5

            	
              Publication

            	
              50

            
	
              12.6

            	
              Termination
                of Prior Confidentiality Agreements

            	
              51

            
	
               ARTICLE
                13

            	
              INDEMNIFICATION

            	
              51

            
	
              13.1

            	
              Indemnification
                by LFB Biotech

            	
              51

            
	
              13.2

            	
              Indemnification
                by GTC

            	
              52

            
	
              13.3

            	
              Procedure

            	
              52

            
	
              13.4

            	
              Shared
                Liability Claims

            	
              53

            


    

     

    -
      iii -

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

    

     

    TABLE
      OF CONTENTS

    (continued)

    


    
      	 	 	
              Page

            
	
               

            	 	 
	
              13.5

            	
              Effect
                of Disclosures

            	
              53

            
	
              13.6

            	
              Insurance

            	
              54

            
	
               ARTICLE
                14

            	
              TERM
                AND TERMINATION

            	
              54

            
	
              14.1

            	
              Term

            	
              54

            
	
              14.2

            	
              Termination
                Rights

            	
              55

            
	
              14.3

            	
              Effects
                of Termination

            	
              57

            
	
              14.4

            	
              Survival;
                Accrued Rights

            	
              62

            
	
              14.5

            	
              Effect
                of Termination on Sublicenses

            	
              62

            
	
               ARTICLE
                15

            	
              DISPUTE
                RESOLUTION

            	
              62

            
	
              15.1

            	
              Disputes

            	
              62

            
	
              15.2

            	
              Arbitration

            	
              62

            
	
               ARTICLE
                16

            	
              MISCELLANEOUS

            	
              63

            
	
              16.1

            	
              Actions
                by Affiliates

            	
              63

            
	
              16.2

            	
              Assignment

            	
              63

            
	
              16.3

            	
              Governing
                Law

            	
              64

            
	
              16.4

            	
              Non-Waiver

            	
              64

            
	
              16.5

            	
              Disclaimer
                of Indirect Damages

            	
              64

            
	
              16.6

            	
              Severability

            	
              64

            
	
              16.7

            	
              Notice

            	
              64

            
	
              16.8

            	
              Headings

            	
              65

            
	
              16.9

            	
              Force
                Majeure

            	
              65

            
	
              16.10

            	
              Entire
                Agreement

            	
              65

            
	
              16.11

            	
              Amendments

            	
              66

            
	
              16.12

            	
              Independent
                Contractors and Relationship of the Parties

            	
              66

            
	
              16.13

            	
              Exhibits

            	
              66

            
	
              16.14

            	
              No
                Strict Construction

            	
              66

            
	
              16.15

            	
              Recording

            	
              66

            
	
              16.16

            	
              Counterparts

            	
              66

            


    

     

    -
      iv -

    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    JOINT
      DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

    


    This
      Joint Development and Commercialization Agreement (the “Agreement”)
      is
      entered into as of September 29, 2006 (the “Effective
      Date”),
      by
      and between GTC Biotherapeutics, Inc., a Massachusetts corporation, having
      offices at 175 Crossing Boulevard, Framingham, Massachusetts 01702, USA
      (“GTC”),
      and
      LFB Biotechnologies S.A.S.U., a société par actions simplifiée unipersonnelle,
      having offices at 3, avenue des Tropiques, Les Ulis, 91958 Courtaboeuf, France
      (“LFB
      Biotech”).
      GTC
      and LFB Biotech are sometimes referred to herein individually as a “Party”
and
      collectively as the “Parties.”

    


    INTRODUCTION

    


    A.   LFB
      Biotech and its
      Affiliates possess certain intellectual property, know-how and skills with
      respect to processes and purification, expertise in clinical and regulatory
      affairs, manufacturing, molecular biology and biosecurity, extensive marketing
      and sales experience in therapeutic products, commercial infrastructure and
      financial resources.

    


    B.   GTC
      possesses
      certain intellectual property with respect to the production of transgenic
      proteins in milk, purification and promoters, know-how and skills in the areas
      of regulatory affairs, quality systems animal husbandry, milking, biosecurity,
      molecular biology, embryology, product recovery and purification.

    


    C.   LFB
      Biotech and GTC
      wish to collaborate to leverage and maximize the strengths of each party to
      develop and commercialize, on a worldwide basis, mutually selected transgenic
      animal products based on, derived from or incorporating recombinant plasma
      proteins and monoclonal antibodies.

    


    D.   LFB
      Biotech and GTC
      have agreed that the first program to be undertaken pursuant to their
      collaboration will be the development and commercialization of an rFVIIa product
      in respect of which LFB Biotech and its Affiliates have developed certain
      intellectual property, know how and skills.

    


    E.   Concurrently
      with
      the execution of this Agreement, LFB Biotech and GTC are entering into a certain
      Stock and Note Purchase Agreement (as defined below), pursuant to which LFB
      Biotech will make an equity investment of up to an aggregate of $25 million
      in
      GTC preferred and common stock and a convertible note of GTC.

    


    F.   LFB
      Biotech is a
      wholly-owned subsidiary of Laboratoire Francais du
      Fractionnement et des Biotechnologies S.A.,
      a
      French société
      anonyme
      (“LFB
      SA”).

    


    G.   As
      a material
      inducement for GTC to enter into this Agreement, GTC and LFB SA are
      entering into a certain Keepwell Agreement concurrently with the execution
      of this Agreement, pursuant to which, among other matters,
      LFB SA agrees to (i) cause LFB Biotech and the Affiliates of LFB
      Biotech to perform and comply with any relevant obligations under this
      Agreement, (ii) be liable for any GTC damages caused by the failure of LFB
      Biotech or its Affiliates to perform and comply with such obligations, and
      (iii)
      indemnify and hold GTC harmless for any such
      failures.

     

    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

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

    


    ARTICLE
      1

    DEFINITIONS

    


    1.1   “Accounting
      Standards”
shall
      mean (a) with respect to GTC, United States Generally Accepted Accounting
      Principles, and (b) with respect to LFB Biotech, International Financial
      Reporting Standards.

     

    1.2   “Action”
means
      any claim, action, cause of action or suit (whether in contract or tort or
      otherwise), litigation (whether at law or in equity, whether civil or criminal),
      controversy, assessment, arbitration, investigation, hearing, charge, complaint,
      demand, notice or proceeding of, to, from, by or before any governmental
      authority.

     

    1.3   “Additional
      Plasma Product”
means
      a
      Transgenic version of any therapeutic recombinant blood plasma product other
      than the Initial Product.

     

    1.4   “Affiliate”
means
      any Person who directly or indirectly controls or is controlled by or is under
      common control with a Party to this Agreement. For purposes of this
      Section 1.4, “control”, “controls”, or “controlled by” means ownership
      directly or through one or more Affiliates, of more than fifty percent (50%)
      or
      more of the shares of stock entitled to vote for the election of directors,
      in
      the case of a corporation, or more than fifty percent (50%) of the equity
      interest in the case of any other type of legal entity, status as a general
      partner in any partnership, or any other arrangement whereby a Party controls
      or
      has the right to control the Board of Directors or equivalent governing body
      of
      a corporation or other entity, or the ability to direct the management or
      policies of a corporation or other entity.

     

    The
      Parties acknowledge that in the case of certain entities organized under the
      laws of certain countries outside of the United States, the maximum percentage
      ownership permitted by law for a foreign investor may be less than fifty percent
      (50%), and that in such case such lower percentage shall be substituted in
      the
      preceding sentence, provided that such foreign investor has the power to direct
      the management and policies of such entity. 

     

    1.5   “Agreement”
shall
      have the meaning set forth in the preamble to this Agreement.

     

    1.6   “Alliance
      Affecting Core Business”
means,
      with respect to a Party, a binding agreement between such Party or its Affiliate
      and a Third Party for the development and/or commercialization of a product
      which (a) if developed or commercialized by the other Party, would be within
      the
      Core Business of such other Party, and (b) Competes with a Core Business Product
      of the other Party as listed on Exhibit
      H.
      

     

    1.7   “Base
      Product Term”
shall
      have the meaning set forth in Section 14.1(b).

     

    1.8   “Change
      of Control”
with
      respect to a Party means (a) a sale of all or substantially all of such Party’s
      assets or business to which this Agreement relates; (b) a merger, reorganization
      or consolidation involving such Party in which the stockholders of such Party
      immediately prior to such transaction cease to own collectively a majority
      of
      the voting equity securities of the successor entity; or (c) a Person or group
      of Persons acting in concert acquires more than fifty percent (50%) of the
      voting equity securities of such Party. For purposes of this Agreement, a Party
      shall be deemed to have undergone a Change of Control in the event that any
      of
      the transactions listed in (a), (b) or (c) above take place with respect to:
      (1)
      an Affiliate of such Party that Controls such Party, or (2) an Affiliate of
      such
      Party whose performance or assets are material to such Party’s performance of
      its obligations under this Agreement, including without limitation those
      obligations under any Development Plan or Commercialization Plan
      hereunder.

     

    
      
        
          
          

        

        
          2

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.9   “Co-Exclusive
      Territory”
means
      the rest of the world outside the European Territory and the North American
      Territory.

     

    1.10   “Collaboration Term”
means
      the term of this Agreement, as set forth in Section 14.1.

     

    1.11   “Combination
      Product”
shall
      have the meaning set forth in Section 1.80.

     

    1.12   “Commercial
      License”
shall
      mean a commercial license agreement, substantially upon the terms set forth
      in
Exhibit
      G,
      that is
      executed by the Parties in the circumstances described in Section
      8.2(c)(ii).

     

    1.13   “Commercialization”
or
      “Commercialize”
      means
      the promotion, detailing, sale and distribution of a Product in the Territory,
      including, without limitation, all LFB Biotech Commercialization Activities
      and
      GTC Commercialization Activities.

     

    1.14   “Commercialization
      Activities”
means
      the LFB Biotech Commercialization Activities and/or the GTC Commercialization
      Activities, as the context suggests.

     

    1.15   “Commercialization
      Costs”
      means,
      with respect to a Product, all direct external costs and direct internal costs
      properly incurred or paid by each Party with respect to such Product plus,
      to
      the extent permitted under Appendix II to Exhibit
      D
      indirect
      costs properly allocated by such Party as Commercialization Costs, in each
      case
      during the Commercialization Phase for such Product, excluding the specific
      costs required to achieve the second Major Regulatory Approval and other costs
      properly allocated as Development Costs hereunder. Commercialization Costs
      shall
      include, without limitation, those costs described on Appendix II to Exhibit
      D,
      and which are related to marketing and selling of the Product, and the cost
      of
      producing and distributing Product for sale, sample and other uses approved
      in
      the Commercialization Plan. Subject to Joint Steering Committee approval, costs
      incurred for phase IV studies, distribution, sales force, and any related
      promotional costs are to be considered Commercialization Costs. For the
      avoidance of doubt, (a) any Development Costs, including without limitation
      significant costs of expanding a Product’s labeled indication or approved
      territory or other costs included in the determination of Product Participation
      shall not be included as Commercialization Costs in the calculation of Net
      Profits, and (b) Commercialization Costs shall not be included in the
      determination of the Product Participation of each Party, and shall be included
      in the determination of Net Profits as per Exhibit D.

    


    
      
        
          
          

        

        
          3

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.16   “Commercialization
      Phase”,
      with
      respect to a Product, shall mean the period commencing upon the first Major
      Regulatory Approval of such Product and continuing throughout the remaining
      Product Term with respect to such Product; provided
      that,
      notwithstanding commencement of the Commercialization Phase, (a) Development
      Activities shall continue in other countries or regions of the Territory until
      Regulatory Approval has been obtained in all countries or regions set forth
      in
      the applicable Development Plan and (b) certain costs incurred by the Parties
      during the Commercialization Phase shall be allocated as Development Costs
      as
      specified herein.

     

    1.17   “Commercialization
      Plan”
shall
      have the meaning set forth in Section 6.1.

     

    1.18   “Commercially
      Reasonable Efforts”
means,
      with respect to each Party, commercially reasonable efforts in accordance with
      such Party’s business, legal, ethical, medical and scientific judgment, and in
      accordance with the efforts and resources such Party would use for a product
      owned by it or to which it has rights, which is of similar market potential,
      at
      a similar stage in its product life, taking into account the competitiveness
      of
      the marketplace, the proprietary position of the product, the regulatory
      structure involved, the profitability of the product and other relevant
      factors.

     

    1.1    “Compete”,
      “Competes”
      or
“Competing”
      means,
      with respect to any two therapeutic products, whether or not one of such
      products is a Product, and whether or not one or both of such products is
      Transgenic, that (a) one such product which is a ************. 

     

    1.20   “Competing
      Product”
means
      any Transgenic or non-Transgenic therapeutic product, other than a Product,
      that
      Competes with a Product, provided
      that the
      term “Competing Product” shall not include any products that ************.


     

    1.21   “Confidential
      Information”
of
      a
      Party means any scientific, technical, trade or business information possessed,
      obtained by, developed for or given to a Party which is treated by such Party
      as
      confidential or proprietary, including, without limitation Research Materials
      (defined below), formulations, techniques, methodology, assay systems, formulae,
      protocols, SOPs, procedures, tests, equipment, data, reports, know-how, sources
      of supply, patent positioning, relationships with consultants and employees,
      pricing, business plans and business developments, information concerning the
      existence, scope or activities of any research, development, manufacturing
      or
      other projects of such Party (e.g., plans, rationale, competitive strategy
      or
      other information related to developing or marketing products or technology
      covered by such Party’s patents, patent applications or published patent
      applications), and any other confidential information about or belonging to
      such
      Party’s suppliers, licensors, licensees, partners, Affiliates, customers,
      potential customers or others and which is disclosed by such Party to the other
      Party during the Collaboration Term. “Research Materials” include, without
      limitation, genes, DNA sequences, plasmids, vectors, expression systems, cells,
      cell lines, organisms, antibodies, biological substances, and any constituents,
      progeny, mutants, derivatives or replications thereof or therefrom, together
      with all reagents, chemical compounds or other materials. It is understood
      and
      agreed by the Parties that (a) the GTC Know-How shall be deemed to be the
      Confidential Information of GTC for all purposes hereunder, (b) the LFB Biotech
      Know-How shall be deemed to be the Confidential Information of LFB Biotech
      for
      all purposes hereunder and (c) the terms of this Agreement shall constitute
      Confidential Information of each Party.

    


    
      
        
          
          

        

        
          4

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.22   “Control”
means,
      with respect to any information or intellectual property right, possession
      by a
      Party or its Affiliates of the ability (whether by ownership, license, or
      otherwise) to grant access, a license, or a sublicense to such information
      or
      intellectual property right without violating the terms of any agreement or
      other arrangement with, and without the payment of additional consideration
      (other than royalty payments, milestone payments and other amounts otherwise
      payable under the relevant agreement) to, any Third Party as of the time such
      Party would first be required hereunder to grant the other Party such access,
      license, or sublicense.

     

    1.2    “Core
      Business”
      means
      (a) with respect to LFB Biotech and its Affiliates, the development and
      commercialization of (i) protein obtained from human plasma fractionation and
      their recombinant counterparts and (ii) recombinant monoclonal antibodies with
      applications in oncology, auto immune diseases, infectious diseases and graft
      rejection; and, (b) with respect to GTC and its Affiliates, the development
      and
      commercialization of (i) therapeutic Transgenic protein products and (ii)
      recombinant monoclonal antibodies with applications in oncology, auto immune
      diseases, infectious diseases and asthma. The applications for monoclonal
      antibodies may be extended as provided in the definition of “Core Business
      Product”.

     

    1.24   “Core
      Business Competitor”
means,
      with respect to a Party at the relevant time, any Third Party that is developing
      or commercializing one or more products that (a) if developed or commercialized
      by such Party would be within the Core Business of such Party and its Affiliates
      and (b) Competes with a Core Business Product of such Party and its
      Affiliates.

     

    1.25   “Core
      Business Competitor Equity Acquisition”
means
      with respect to a Party (a) the acquisition by a Core Business Competitor of
      such Party of more than ************ of the voting equity securities of the
      other Party or (b) a Core Business Competitor of such Party obtaining the right
      to ************. For purposes of this Agreement, a Core Business Competitor
      Equity Acquisition shall be deemed to have occurred with respect to a Party
      in
      the event that any of the transactions listed in (a) or (b) above take place
      with respect to: (1) an Affiliate of the other Party that Controls such other
      Party, or (2) an Affiliate of such other Party whose performance or assets
      are
      material to such other Party’s performance of its obligations under this
      Agreement, including without limitation those obligations under any Development
      Plan or Commercialization Plan hereunder.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.26   “Core
      Business Product/Products”
means,
      with respect to a Party and its Affiliates, a specific product within the Core
      Business of such Party and its Affiliates as set forth on Exhibit
      H
      as the
      same shall be amended in accordance with the following. Each Party shall notify
      the other Party annually of any change in the Core Business Products of such
      Party and its Affiliates, together with adequate supporting documentation,
      and,
      absent a dispute, Exhibit
      H
      shall be
      amended to reflect such change subject to the following conditions: (i) neither
      Party shall be required to delete any product which is ************; (ii) any
      ************ product ************ may be added to or deleted from Exhibit
      H
      by
      either Party without restriction provided that in the case of an addition such
      product is under development or being commercialized by such Party or its
      Affiliates; (iii) a Party may add a ************ product to Exhibit H only
      if
      such product meets any one of the following criteria: (A) For products in the
      stage of research or development, (1) such Party and its Affiliates have spent
      in the preceding year at least ************ for research and/or development
      of
      such product, or (2) such Party or its Affiliates have developed a scalable
      manufacturing asset for such product, either through Transgenic process or
      a
      cell line, or (3) such product is in a pre-clinical research program at a stage
      that is reasonably expected to be within ************ of initiation of human
      clinical trials or (4) such product has been licensed from an outside
      institution, including a university or a company or partnership, provided that
      if after ************ of the license term such licensed product does not also
      satisfy either criteria, (2) or (3) above or the criteria set forth in the
      following clause (B) or such Party or its Affiliates have not spent at least
      ************ in total during such ************ period on research and/or
      development of such product (such amount not to include license fees payable
      to
      the relevant outside institution), then such product shall be deleted from
      Exhibit H; and (B) for products in the stage of commercialization a product
      which, on an annual basis accounts for more than ************ of such Party’s or
      its Affiliates’ revenues, whether from sales, product milestones, royalties or
      other product revenues; and (iv) a Party shall delete a recombinant monoclonal
      antibody product from Exhibit
      H
      if for
      the preceding year it has not met any of the criteria set forth in the foregoing
      clauses (iii)(A) or (B). If a ************ product of a Party or its Affiliates
      would be eligible for addition to Exhibit
      H
      but is
      for an application not covered in the definition of “Core Business” of such
      Party and its Affiliates, then such product may be added to Exhibit
      H
      and for
      so long as such product remains on Exhibit
      H
      the
      definition of “Core Business” of such Party and its Affiliates shall be deemed
      amended to include such application.

     

    1.27   “Damages”
shall
      have the meaning set forth in Section 13.1.

     

    1.28   “Development”
or
      “Develop”
means
      all activities performed by or on behalf of either Party pursuant to the
      Development Plan with respect to a Product during the Development Phase,
      including, without limitation, all activities related to preclinical testing,
      DNA construct discovery and development, animal development and maintenance,
      test method development and stability testing, toxicology, formulation, process
      development, manufacturing scale-up, qualification and validation, quality
      assurance/quality control, clinical studies (from Phase I Trials through Phase
      III Trials), regulatory affairs, statistical analysis and report writing, and
      all other pre-marketing activities, each to the extent performed pursuant to
      the
      Development Plan.

     

    1.29   “Development
      Activities”
means,
      collectively or individually, as the context suggests, the LFB Biotech
      Development Activities and the GTC Development Activities.

     

    1.30   “Development
      Costs”,
      for
      purposes of determining a Party’s Product Participation with respect to any
      Product under Section 8.2(b), shall mean all direct external costs and direct
      internal costs properly paid or incurred by such Party in connection with the
      Development of such Product, plus, to the extent permitted under Appendix I
      to
Exhibit
      D,
      indirect costs properly allocated by such Party to the Development of such
      Product, in each case during the Development Phase or thereafter as expressly
      provided herein. Development Costs shall include, without limitation, all
      Pre-Marketing Costs and the cost of producing and distributing Product for
      preclinical, clinical and other uses approved in the Development Plan in
      addition to those other costs set forth on Appendix I to Exhibit
      D,
      in each
      case that are incurred in the performance of Development activities under the
      Development Plan. 

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.31   “Development
      Phase”
shall
      mean, with respect to a Product, the period commencing upon the Product Start
      Date for such Product and continuing until the first Major Regulatory Approval
      for such Product; provided that certain costs incurred after the Development
      Phase shall be treated as Development Costs if specified herein or agreed to
      in
      writing in advance by the Joint Steering Committee.

     

    1.32   “Development
      Plan”
shall
      have the meaning set forth in Section 5.1.

    


    1.33   “Disclosing
      Party”
shall
      have the meaning set forth in Section 12.1.

     

    1.34   “Dispute”
shall
      have the meaning set forth in Section 15.1.

     

    1.35   “ECB”
means
      the European Central Bank.

     

    1.36   “Effective
      Date”
shall
      have the meaning set forth in the preamble to this Agreement.

     

    1.37   “EMEA”
means
      the European Agency for the Evaluation of Medicinal Products, or any successor
      organization.

     

    1.38   “European
      Territory”
means
      the member states (as of the Effective Date) of the European Union, as well
      as
      Switzerland, Norway, Lichtenstein, Iceland, Bulgaria, Romania, Croatia, Serbia,
      Montenegro, Slovenia, Bosnia, Macedonia, Albania, Turkey, Byelorussia, Ukraine
      and Moldavia and each of their respective territories and
      possessions.

     

    1.39   “FDA”
means
      the United States Food and Drug Administration, or any successor
      organization.

     

    1.40   “First
      Commercial Sale”
means
      the first commercial sale of a Product by or on behalf of a Party or its
      Affiliate in a country as part of a nationwide introduction after Regulatory
      Approval has been achieved for such Product in such country. Sales for test
      marketing, clinical trial purposes or compassionate or similar use shall not
      be
      considered to constitute a First Commercial Sale.

     

    1.41   “FTE”
shall
      have the meaning set forth in Section 5.2(b).

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.42   “Fully
      Absorbed Cost of Goods”
means,
      with respect to a Product and the Party responsible for manufacturing or
      supplying such Product, (a) the variable costs and fixed costs incurred by
      such
      Party associated with the manufacture (inclusive of finishing processes
      including filling, packaging, labeling and/or other preparation), quality
      assurance, quality control and other testing, storage and shipping of batches
      of
      such Product or (b) if such Product is not manufactured by such Party, the
      amounts paid to a Third Party manufacturer for the manufacture of such Product
      plus, to the extent not included in the amounts paid to such Third Party
      manufacturer, the actual costs associated with the acquisition of shipments
      of
      Product from such Third Party manufacturer. For purposes of this definition,
      “variable
      costs”
means
      the cost of labor, raw materials, scrap (being product losses normally recorded
      in the process of manufacturing and to the exclusion of abnormal waste,
      spillage, processing, handling or idle facility costs), supplies and other
      resources directly consumed in the manufacture, quality assurance, quality
      control and other testing, storage and shipping of batches of the applicable
      Product, and “fixed
      costs”
means
      the cost of facilities, utilities, insurance (including any product liability
      insurance or accrual for self-insurance), facility and equipment depreciation
      (unless the capital cost of such facility or equipment has been directly charged
      to the program), manufacturing overhead (cost accounting, personnel management,
      and information technology), and other fixed costs directly related to the
      manufacture, quality assurance, quality control and other testing, storage
      and
      shipping of batches of such Product, as well as amounts required to be paid
      to
      Third Parties in connection with the manufacture, use, sale, offer for sale
      or
      import of such Product to the extent not otherwise included as Development
      Costs
      or Commercialization Costs of such Party. Fixed costs shall be allocated to
      such
      Product based upon the proportion of such costs directly attributable to support
      of the manufacturing, quality assurance, quality control and other testing,
      storage and shipping processes for such Product. If a facility is used to
      manufacture Products and has the capacity to manufacture products for other
      programs of such Party, fixed costs shall be allocated in proportion to the
      actual use of such facility for the manufacture of Products and the capacity
      to
      manufacture products for such other programs. For the avoidance of doubt, no
      idle capacity of a manufacturing facility, or a proportionate use thereof,
      shall
      be included in Fully Absorbed Cost of Goods except, in the case of a facility
      dedicated solely to the manufacture of Products, it shall be included to the
      extent the JSC determines that such facility is appropriately sized. Fully
      Absorbed Cost of Goods shall exclude all costs otherwise covered under
      Development Costs or Commercialization Costs. Unless otherwise expressly
      provided in this Agreement, all cost determinations made in the calculation
      of
      Fully Absorbed Cost of Goods shall be in accordance with the Parties’ respective
      Accounting Standards, consistently applied.

     

    1.43   “GMP”
means
      the current Good Manufacturing Practices of the FDA or any similar practice
      standards promulgated by applicable Regulatory Authorities with jurisdiction
      over the manufacture, use, or sale of Product, as then in effect.

     

    1.44   “Greater
      Funding Party”
means,
      with respect to a Product, a Party that has funded more than ************ of
      the
      costs of Development of such Product hereunder as of or after the date the
      Product Participation percentages of the Parties are first set pursuant to
      Section 8.2(b), and prior to full reimbursement to such Party of any IPV
      Difference in accordance with Section 8.2(d).

     

    1.45   “GTC
      Assumed Liability”
shall
      have the meaning set forth in Section 13.2.

     

    1.46   “GTC
      Commercialization Activities”
means,
      with respect to a Product, the designated Commercialization activities of GTC
      as
      specified in the Commercialization Plan for such Product.

     

    1.47   “GTC
      Development Activities”
shall
      have the meaning set forth in Section 5.2(c).

     

    1.48   “GTC
      Indemnitee”
shall
      have the meaning set forth in Section 13.1.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.49   “GTC
      Know-How”
means
      all Know-How that is Controlled by GTC or its Affiliates as of the Effective
      Date or during the Collaboration Term that is necessary or reasonably useful
      for
      the Development and/or Commercialization of Products under this
      Agreement.

     

    1.50   “GTC
      Patent Rights”
means
      all Patent Rights Controlled by GTC or its Affiliates as of the Effective Date
      or during the Collaboration Term the practice of whose claims are necessary
      or
      useful to the Development and/or Commercialization of Products under this
      Agreement, excluding Joint Patent Rights.

     

    1.51   “GTC
      Technology”
means,
      collectively, GTC Know-How and GTC Patent Rights.

     

    1.52   “Indemnified
      Party”
shall
      have the meaning set forth in Section 13.3.

     

    1.53   “Indemnifying
      Party”
shall
      have the meaning set forth in Section 13.3.

     

    1.54   “Initial
      Collaboration Term”
shall
      have the meaning set forth in Section 14.1(a).

     

    1.55   “Initial
      Development Plan”
shall
      have the meaning set forth in Section 5.1

     

    1.56   “Initial
      Product”
means
      a
      Transgenic version of a therapeutic product incorporating, based on or derived
      from rFVIIa. 

     

    1.57   “Insolvency
      Event”
means,
      with respect to a Party, (a) such Party’s filing a petition in voluntary
      bankruptcy or making an assignment for the benefit of creditors or consenting
      to
      the appointment of a receiver of all or any substantial part of its property,
      or
      filing a petition to take advantage of any laws affecting debtors generally,
      in
      each of the foregoing cases only if it is directed to and will result in
      liquidation of such Party, or (b) the commencement against such Party of any
      case, proceeding or other action seeking the adjudication of such Party as
      bankrupt by a court of competent jurisdiction or the appointment by such a
      court
      of a trustee or receiver or receivers of such Party of all or any substantial
      part of the property of such Party upon the application of any creditor in
      any
      insolvency or bankruptcy proceeding or other creditors suit, which case,
      proceeding or other action is not dismissed within sixty (60) days after its
      commencement, in each of the foregoing cases only if it is directed to and
      will
      result in liquidation of such Party. 

     

    1.58   “Invention”
means
      any invention or discovery, whether or not patentable, made as a result of
      the
      activities of a Party or the Parties pursuant to this Agreement, which invention
      or discovery relates to a Product in any manner, including, but not limited
      to,
      any invention or discovery relating to the making, using or selling of a
      Product.

     

    1.59   “Investment
      Present Value”
or
      “IPV”
means,
      with respect to a Product, the net present value of the Parties’ Development
      Costs for such Product during the period commencing on the Product Start Date
      for such Product and ending on the date of the first Major Regulatory Approval
      for such Product, as calculated in accordance with the applicable Product
      Participation Model, and subject to adjustment pursuant to Section
      8.2(b)(iv).

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.60   “IPV
      Difference”
means,
      with respect to a Product, the difference between a Greater Funding Party’s IPV
      and the IPV if the Development Costs of such Product were shared ************,
      taking into consideration the weighting of Development Costs set forth in
      Section 8.2(b)(ii).

     

    1.61   “IPV
      Payment”
      has the
      meaning set forth in Section 14.3(a)(iv).

     

    1.62   “Joint
      Inventions”
shall
      have the meaning set forth in Section 9.1(b).

     

    1.63   “Joint
      Patent Rights”
shall
      have the meaning set forth in Section 9.1(b).

     

    1.64   “Joint
      Steering Committee”
or
      “JSC”
shall
      have the meaning set forth in Section 4.1.

     

    1.65   “Joint
      Technology”
means
      the Joint Patent Rights and any Joint Inventions.

     

    1.66   “Keepwell
      Agreement”
has
      the
      meaning set forth in the Preamble to this Agreement.

     

    1.67   “Know-How”
means
      any information or materials (whether or not proprietary or patentable and
      whether stored or transmitted in oral, documentary, electronic or other form),
      including, without limitation, ideas, concepts, formulas, methods, procedures,
      designs, compositions, plans, documents, data, inventions, discoveries,
      developments, works of authorship, biological materials, and any information
      relating to research and development plans, experiments, results, compounds,
      therapeutic leads, candidates and products, clinical and preclinical data,
      toxicological data, pharmacological data, formulations, trade secrets and
      manufacturing, marketing, financial, regulatory, personnel, customer sales
      and
      invoicing and other business information and plans, and any scientific,
      clinical, regulatory, marketing, financial and commercial information or data
      which relates to a Product in any manner.

     

    1.68   “LFB
      Biotech Assumed Liability”
shall
      have the meaning set forth in Section 13.1.

     

    1.69   “LFB
      Biotech Commercialization Activities”
means,
      with respect to a Product, the designated Commercialization activities of LFB
      Biotech as specified in the Commercialization Plan for such
      Product.

     

    1.70   “LFB
      Biotech Development Activities”
shall
      have the meaning set forth in Section 5.2(b).

     

    1.71   “LFB
      Biotech Indemnitees”
shall
      have the meaning set forth in Section 13.2.

     

    1.72   “LFB
      Biotech Know-How”
means
      all Know-How that is Controlled by LFB Biotech or its Affiliates as of the
      Effective Date or during the Collaboration Term that is necessary or reasonably
      useful for the Development and/or Commercialization of Products under this
      Agreement.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.73   “LFB
      Biotech Patent Rights”
means
      all Patent Rights Controlled by LFB Biotech or its Affiliates as of the
      Effective Date or during the Collaboration Term the practice of whose claims
      are
      necessary or useful to the Development and/or Commercialization of Products
      under this Agreement, excluding Joint Patent Rights.

     

    1.74   “LFB
      Biotech Technology”
means,
      collectively, LFB Biotech Know-How and LFB Biotech Patent Rights.

     

    1.75   “MAb
      Product”
means
      the Transgenic version of any therapeutic product based on, incorporating or
      derived from monoclonal antibodies.

     

    1.76   “Major
      Market EU Countries”
means,
      individually and collectively, France, Germany, Italy, Spain and the United
      Kingdom.

     

    1.77   “Major
      Regulatory Approval”
means
      a
      Regulatory Approval from the FDA or the EMEA.

     

    1.78   “Major
      Regulatory Filing”
means
      a
      Regulatory Filing with the FDA or the EMEA. 

     

    1.79   “Net
      Profits”
means,
      with respect to a Product for a particular reporting period, aggregate profits
      or losses resulting from the Commercialization of such Product worldwide and
      shall be equal to (a) worldwide Net Sales of and any other revenues relating
      to
      such Product for such period, including without limitation any royalties,
      sublicense income or other payments received from Third Parties, less (b)
      Commercialization Costs for such Product, before income taxes. Net Profits
      will
      be shared based on each party’s Product Participation as described in Section
      8.2.

     

    1.80   “Net
      Sales”
means,
      with respect to a Product, the net sales on behalf of a Party or any Affiliate,
      licensee or sublicensee of such Party, for the Product sold to Third Parties
      (other than licensees or sublicensees) in bona fide, arm’s-length transactions,
      as determined in accordance with applicable IFRS Accounting Standards, as
      consistently applied, and which shall include the following customary deductions
      from the invoiced sale price, as generally and consistently applied by a Party:
      

    ************

     

    1.81   “North
      American Territory”
means
      the United States and Canada, and their respective territories and
      possessions.

     

    1.82   “Originating
      Party”
means,
      with respect to a Product, the Party responsible for introducing such Product
      to
      the collaboration under this Agreement. The Parties acknowledge and agree that
      LFB Biotech is the Originating Party of the Initial Product and GTC is the
      Originating Party of any rhAAT Products.

     

    1.83   “Party”
and/or
      “Parties”
shall
      have the respective meanings set forth in the preamble to this
      Agreement.

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.84   “Patent
      Rights”
means
      any patent applications and any divisions, continuations, or
      continuations-in-part thereof, and any patents issuing thereon and all
      substitutions, reissues, reexaminations and extensions thereof and supplemental
      protection certificates relating thereto, and all counterparts of the foregoing
      in any country.

     

    1.85   “Person”
means
      any natural person, corporation, firm, business trust, joint venture,
      association, organization, company, partnership, or other business entity,
      or
      any government, or any agency or political subdivision thereof.

     

    1.86   “Phase
      I Trial”
means
      a
      clinical trial as defined in 21 C.F.R 312.21(a), as may be amended from time
      to
      time, or any non-US equivalent thereto, in each case that is designed to
      determine the metabolism and pharmacologic actions of the applicable Product
      in
      humans, the side effects associated with increasing doses, and, if possible,
      to
      gain early evidence on effectiveness. 

     

    1.87   “Phase
      II Trial”
means
      a
      clinical trial as defined in 21 C.F.R. 312.21(b), as may be amended from time
      to
      time, or any non-US equivalent thereto, in each case that is designed to assess
      the clinical efficacy of the applicable Product for a particular indication
      or
      indications and to determine the common side-effects and safety risks associated
      with the use of such Product.

     

    1.88   “Phase
      III Trial”
means
      a
      clinical trial as defined in 21 C.F.R. 312.21(c), as may be amended from time
      to
      time, or any non-US equivalent thereto, in each case that is designed to gather
      additional information about the efficacy, tolerability and safety of the
      applicable Product that is needed to evaluate the overall benefit-risk
      relationship of the Product and to provide an adequate basis for physician
      labeling.

     

    1.89   “Pivotal
      Trial”
      means,
      with respect to a Product, a Phase III Trial or other clinical trial, the
      results of which are identified by the JSC as the essential data from which
      a
      Regulatory Authority will determine whether to grant Regulatory Approval for
      such Product.

     

    1.90   “Pivotal
      Trial Completion Date”
means,
      with respect to a Product, the date of the JSC’s decision that the results of
      the Pivotal Trial are adequate to support a Regulatory Filing for purposes
      of
      obtaining the first Major Regulatory Approval for such Product.

     

    1.91   “Pre-Marketing
      Costs”
means
      all costs related to market research and development, strategic market plans,
      strategic product positioning, pricing studies, inventory build and all other
      pre-approval activities, each to the extent performed pursuant to the
      Development Plan. As part of Development Costs, Pre-Marketing Costs should
      be
      approved by the Joint Steering Committee and reflected in the Development Plan.
      For the avoidance of doubt, Pre-Marketing Costs approved and incurred are
      included as Development Costs for the calculation of Product
      Participation.

     

    1.92   “Product”
or
      “Products”
means
      one or more of the following, as the context suggests: (a) the Initial Product,
      (b)(i) any rhAAT Product, (ii) any Additional Plasma Products, and (iii) any
      MAb
      Products, and that are, with respect to (b)(i), (ii), and (iii), selected by
      the
      Parties for inclusion in the collaboration hereunder pursuant to Section
      2.1.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.93   “Product
      Participation”
shall
      have the meaning set forth in Section 8.2(a).

     

    1.94   “Product
      Participation Model”
means,
      with respect to a Product, the model agreed upon by the Parties, substantially
      in the form attached as Exhibit
      D
      hereto,
      for calculating the Parties’ respective contributions to the Development of such
      Product and, based upon such contributions, determining the percentage of each
      Party’s respective participation in the aggregate Net Profits that are derived
      from such Product, all as more fully described in Section 8.2.

     

    1.95   “Product
      Start Date”
means,
      (a) with respect to the Initial Product, the Effective Date, and (b) with
      respect to any other Products, the date the relevant Product becomes subject
      to
      this Agreement pursuant to Section 2.1.

     

    1.96   “Product
      Trademark”
shall
      have the meaning set forth in Section 10.1(a).

     

    1.97   “Product
      Term”
shall
      have the meaning set forth in Section 14.1(b)(iii).

     

    1.98   “Publishing
      Party”
shall
      have the meaning set forth in Section 12.5(a). 

     

    1.99   “rFVIIa”
means
      recombinant human blood factor VIIa.

     

    1.100   “rFVIIa
      Rabbit”
means
      a
      transgenically modified rabbit that produces rFVIIa in its milk.

     

    1.101   “Recall”
means
      the removal or correction of a marketed Product that the FDA, EMEA or an
      equivalent Regulatory Authority considers to be in violation of law and against
      which a Regulatory Authority would otherwise initiate legal action (e.g., a
      seizure). 

     

    1.102   “Receiving
      Party”
shall
      have the meaning set forth in Section 12.1.

     

    1.103   “Regulatory
      Approvals”
mean
      any approvals, licenses, registrations or authorizations (including pricing
      and
      reimbursement approvals) of any Regulatory Authority, whether or not
      conditional, that are necessary for the commercial sale of a Product in a
      regulatory jurisdiction in the Territory. 

     

    1.104   “Regulatory
      Authority”
means
      any and all national, supra-national, regional, state, or local regulatory
      agency, department, bureau, commission, council, or other governmental entity,
      whose approval or authorization is necessary for, or to whom notice must be
      given prior to, the manufacture, distribution, use, or sale of a Product in
      the
      Territory, including, without limitation, the FDA and the EMEA.

     

    1.105   “Regulatory
      Filings”
mean
      all applications, filings, dossiers and the like submitted to a Regulatory
      Authority in the Territory for the purpose of obtaining a Regulatory Approval
      from such Regulatory Authority in the Territory.

     

    1.106   “rhAAT”
      means
      recombinant blood protein alpha-1 antitrypsin.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.107   “rhAAT
      Product”
means
      the Transgenic version of any therapeutic product incorporating, based on or
      derived from rhAAT.

     

    1.108   “Senior
      Management”
means,
      for a Party, the Chief Executive Officer or a senior executive who is designated
      by the Chief Executive Officer of such Party.

     

    1.109   “Shared
      Liability Claims”
shall
      have the meaning set forth in Section 13.4(a).

     

    1.110   “Specifications”
shall
      have the meaning set forth in Section 7.3.

     

    1.111   “Stock
      and Note Purchase Agreement”
shall
      have the meaning set forth in Section 8.1.

     

    1.112   “Supply
      Agreement”
      means,
      with respect to a Product, a definitive agreement executed between the Parties
      to govern the terms and conditions of manufacture and supply of such Product
      hereunder.

     

    1.113   “Target
      Antigen”
      means
      ************.

     

    1.114   “Target
      Receptor”
      means
      ************.

     

    1.115   “Territory”
means,
      individually or collectively, as the context shall suggest, the European
      Territory, the North American Territory and the Co-Exclusive
      Territory.

     

    1.116   “Third
      Party”
means
      any person or entity (including, without limitation, any governmental authority)
      other than a Party or its Affiliates. 

     

    1.117   “Third
      Party Claims”
shall
      have the meaning set forth in Section 13.1.

     

    1.118   “Trademark
      Owner”
shall
      mean the Party owning a Product Trademark pursuant to Section 10.1.

     

    1.119   “Trademark
      User”
shall
      have the meaning set forth in Section 3.4.

     

    1.120   “Transgenic”
      means,
      with respect to any therapeutic product, including without limitation a Product,
      that such product was produced or derived from transgenically modified
      animals.

     

    1.12    “United
      States”, “US” or “USA”
      shall
      mean the United States of America and its territories and possessions, including
      without limitation the Commonwealth of Puerto Rico and the U.S. Virgin
      Islands.

     

    1.122   “Unsettled
      Shared Damages”
shall
      have the meaning set forth in Section 13.4.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    ARTICLE
      2

    SCOPE
      OF COLLABORATION; JOINT OBLIGATIONS; DILIGENCE

    


    2.1   Scope
      of Collaboration

    


    (a)   General.
      LFB
      Biotech and GTC wish to establish a collaborative alliance to Develop and
      Commercialize Products in the Territory, all as more specifically described
      herein and in the applicable Development Plan and Commercialization Plan.
      Without limiting the foregoing, the
      Parties agree to: (i) engage in Development of Products, with the goal of
      obtaining Regulatory Approval for each Product as soon as reasonably practicable
      in each market where it makes commercial sense to do so given the size of the
      potential market and the safety and efficacy profile of the relevant Product;
      and (ii) engage in Commercialization of Products, with the goal of optimizing
      the profit available to each Party. Each Party agrees to use Commercially
      Reasonable Efforts in performing its tasks and responsibilities and in
      conducting all activities ascribed or assigned to it from time to time under
      this Agreement, the then current Development Plan, and the then current
      Commercialization Plan with respect to each Product.

    


    (b)   Initial
      Product.
      The
      Parties shall initially collaborate to Develop and Commercialize the Initial
      Product in accordance with the terms and conditions of this Agreement, the
      Initial Development Plan and the Commercialization Plan for the Initial
      Product.

    


    (c)   rhAAT
      Product.

    


    (i)   In
      the
      event that GTC wishes to pursue a program for the development of an rhAAT
      Product, LFB Biotech shall have a first option to include such rhAAT Product
      within the collaboration hereunder and GTC shall not negotiate or enter into
      an
      agreement with a Third Party with respect to such rhAAT Product before first
      offering a proposal to LFB Biotech in accordance with this Section 2.1(c).
      

    


    (ii)   GTC
      shall
      propose any such rhAAT Product for inclusion in the collaboration by providing
      LFB Biotech with a written proposal for the Development of such rhAAT Product.
      LFB Biotech shall have ************ following the receipt of such proposal
      to
      notify GTC in writing whether or not LFB Biotech wishes to include such rhAAT
      Product as a Product under this Agreement.

    


    (iii)   If
      LFB
      Biotech notifies GTC within such ************ period that LFB Biotech wishes
      to
      include such rhAAT Product as a Product hereunder, the Parties, through the
      JSC,
      shall negotiate in good faith for a period not to exceed ************, or such
      longer time as the Parties may mutually agree, a preliminary Development Plan
      with respect to such rhAAT Product, which Development Plan shall include a
      preliminary Development budget. If the Parties reach agreement on a Development
      Plan for a rhAAT Product within such time period, or such longer time period
      as
      the Parties may mutually agree, such rhAAT Product shall become subject to
      this
      Agreement as a “Product” hereunder.

    


    (iv)   If
      (a)
      LFB Biotech (1) notifies GTC that LFB Biotech does not wish to pursue the
      Development or Commercialization of such rhAAT Product hereunder or (2) does
      not
      notify GTC in writing within such ************ of LFB Biotech’s intention
      whether or not to include such rhAAT Product hereunder, or (b) LFB Biotech
      timely notifies GTC that it wishes to pursue such rhAAT Product hereunder,
      but
      the Parties are unable to agree in good faith upon a Development Plan for the
      proposed rhAAT Product within the time frame provided in subsection (iii) above,
      GTC may pursue the development and commercialization of such rhAAT Product
      unilaterally or negotiate and enter into an agreement with any Third Party
      for
      the development and commercialization of such rhAAT Product with no further
      obligation to LFB Biotech with respect thereto, subject to the provisions of
      Section 3.7.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    


    (d)   Additional
      Plasma Products.

    


    (i)   Either
      Party may, from time to time during the Term, but is not obligated to, propose
      to the other Party for inclusion in the collaboration under this Agreement
      any
      Additional Plasma Products that such Party believes are reasonably likely to
      enhance the goals of the collaboration.

    


    (ii)   The
      Originating Party may propose such Additional Plasma Product for inclusion
      in
      the collaboration by providing the non-Originating Party with a written proposal
      for the Development of such Additional Plasma Product and the non-Originating
      Party shall have ************ following the receipt of such proposal to inform
      the Originating Party whether or not it wishes to include such Additional Plasma
      Product as a Product under this Agreement.

    


    (iii)   If
      the
      non-Originating Party notifies the Originating Party in writing within such
      ************ period that it wishes to include such Additional Plasma Product
      under this Agreement, the Parties, through the JSC, shall negotiate in good
      faith for a period not to exceed ************, or such longer time as the
      Parties may mutually agree, a preliminary Development Plan with respect to
      such
      Additional Plasma Product, which Development Plan shall include a preliminary
      Development budget. If the Parties reach agreement on a Development Plan for
      such Additional Plasma Product within such time period or such longer time
      period as the Parties may mutually agree, such Additional Plasma Product shall
      become subject to this Agreement as a “Product” hereunder.

    


    (iv)   If
      (a)
      the non-Originating Party (1) notifies the Originating Party that it does not
      wish to pursue the Development or Commercialization of such Additional Plasma
      Product hereunder, or (2) does not notify the Originating Party in writing
      within such ************ period of its intention whether or not to include
      such
      Additional Plasma Product hereunder, or (b) the non-Originating Party timely
      notifies the Originating Party that it wishes to pursue such Additional Plasma
      Product hereunder, but the Parties are unable to agree in good faith upon a
      Development Plan for the proposed Additional Plasma Product within the time
      frame provided in subsection (iii) above, the Originating Party may pursue
      the
      development and commercialization of such Additional Plasma Product unilaterally
      or negotiate and enter into an agreement with any Third Party for the
      development and commercialization of such Additional Plasma Product with no
      further obligation to the non-Originating Party with respect thereto, subject
      to
      the provisions of Section 3.7.

    


    (e)   MAb
      Products.

    


    (i)   Either
      Party may, from time to time during the Term, but is not obligated to, propose
      to the other Party for inclusion in the collaboration under this Agreement
      MAb
      Products that
      such
      Party believes are reasonably likely to enhance the goals of the
      collaboration.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (ii)   The
      Originating Party may propose a MAb Product for inclusion in the collaboration
      by providing the non-Originating Party with a written proposal for the
      Development of such MAb Product and the non-Originating Party shall have
      ************ following the receipt of such proposal to inform the Originating
      Party whether or not it wishes to include such MAb Product as a Product under
      this Agreement.

    


    (iii)   If
      the
      non-Originating Party notifies the Originating Party in writing within such
      ************ period that it wishes to include such MAb Product under this
      Agreement, the Parties, through the JSC, shall negotiate in good faith for
      a
      period not to exceed ************, or such longer time as the Parties may
      mutually agree, a preliminary Development Plan with respect to such MAb Product,
      which Development Plan shall include a preliminary Development budget. If the
      Parties reach agreement on a Development Plan for such MAb Product within such
      time period or such longer time period as the Parties may mutually agree, such
      MAb Product shall become subject to this Agreement as a “Product”
hereunder.

    


    (iv)   If
      (a)
      the non-Originating Party (1) notifies the Originating Party that it does not
      wish to pursue the Development or Commercialization of such MAb Product
      hereunder, or (2) does not notify the Originating Party in writing within such
      ************ period of its intention whether or not to include such MAb Product
      hereunder, or (b) the non-Originating Party timely notifies the Originating
      Party that it wishes to pursue such MAb Product hereunder, but the Parties
      are
      unable to agree in good faith upon a Development Plan for the proposed MAb
      Product within the time frame provided in subsection (iii) above, the
      Originating Party may pursue the development and commercialization of such
      MAb
      Product unilaterally or negotiate and enter into an agreement with any Third
      Party for the development and commercialization of such MAb Product with no
      further obligation to the non-Originating Party with respect thereto, subject
      to
      the provisions of Section 3.7.

     

    2.2   Conduct
      of Parties.
      Each
      Party understands and agrees that it is to its mutual benefit to maximize the
      clinical and commercial potential of the Products. Each Party shall conduct
      itself and its activities hereunder consistent with that understanding and
      with
      sound and ethical business and scientific practices, and in accordance with
      the
      applicable Development Plan and Commercialization Plan, provided that the
      foregoing shall not limit the activities of the Parties with respect to any
      product that is not a Product or a Competing Product and is not otherwise
      subject to Section 3.7.

     

    2.3   Assistance.
      Each
      Party agrees to provide to the other all reasonable assistance and take all
      actions reasonably requested by the other Party that are necessary to enable
      the
      requesting Party to comply with its obligations under this Agreement or
      otherwise meet the mutual objectives of the Parties set forth in
      Section 2.2 above, or with any applicable law or regulation.

     

    2.4   Product
      List.
      Exhibit
      A attached hereto sets forth the Products under this Agreement. As the Effective
      Date only the Initial Product is listed on Exhibit
      A.
      As
      other Products become subject to this Agreement as provided above, Exhibit
      A
      shall be
      updated by including such Products.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    ARTICLE
      3

    GRANT
      OF RIGHTS

    


    3.1   License
      Grant to GTC

    


    (a)   Research
      and Development License.
      Subject
      to the terms and conditions of this Agreement, LFB Biotech hereby grants to
      GTC
      a co-exclusive (together with LFB Biotech) right and license (with the right
      to
      sublicense with the JSC’s approval) during the Term in the Territory, under the
      LFB Biotech Technology and LFB Biotech’s interest in any and all Joint
      Technology, to: 

    


    (i)   with
      respect to the Initial Product, (A) create and breed one or more herds of rFVIIa
      Rabbits and use such rFVIIa Rabbits to produce rFVIIa for use in making the
      Initial Product, and (B) Develop, make and have made the Initial Product, all
      in
      accordance with applicable laws and regulations and the Initial Development
      Plan; and 

    


    (ii)   with
      respect to subsequent Product(s), (A) create and breed one or more herds of
      transgenic mammals, and use such transgenic mammals to produce material for
      use
      in making such Product(s), and (B) Develop, make and have made Product(s),
      all
      in accordance with applicable laws and regulations and the applicable
      Development Plan.

    


    (b)   Commercialization
      License.
      Subject
      to the terms and conditions of this Agreement, LFB Biotech hereby grants to
      GTC
      an exclusive or co-exclusive (as described below) right and license (with the
      right to sublicense with the JSC’s approval) during the Term, commencing upon
      the Commercialization Phase with respect to the applicable Product, under the
      LFB Biotech Technology and LFB Biotech’s interest in any and all Joint
      Technology, to:

    


    (i)   with
      respect to the Initial Product, (A) use the rFVIIa Rabbits to manufacture
      commercial quantities of rFVIIa, (B) make, have made, sell, offer for sale,
      and
      import the Initial Product in the North American Territory, (C) subject to
      Section 3.3, in cooperation with LFB Biotech, make, have made, sell, offer
      for
      sale, and import the Initial Product in the Co-Exclusive Territory, and (D)
      make, have made, and sell Initial Product to LFB Biotech for further
      distribution and sale by LFB Biotech in the European Territory, all in
      accordance with applicable laws and regulations and the applicable
      Commercialization Plan; and

    


    (ii)   with
      respect to subsequent Product(s), (A) use transgenic mammals created pursuant
      to
      the license under Section 3.1(a)(ii) to manufacture commercial quantities of
      material for use in the manufacture of Product(s), (B) make, have made, sell,
      offer for sale, and import Product(s) in the North American Territory, (C)
      subject to Section 3.3, in cooperation with LFB Biotech, make, have made, sell,
      offer for sale, and import Product(s) in the Co-Exclusive Territory, and (D)
      make, have made, and sell Product(s) to LFB Biotech for further distribution
      and
      sale by LFB Biotech in the European Territory, all in accordance with applicable
      laws and regulations and the applicable Commercialization Plan.

     

    For
      purposes of clarity, the foregoing license shall be exclusive to GTC for the
      North American Territory under Sections 3.1(b)(i)(B) and 3.1(b)(ii)(B) above
      and
      co-exclusive (together with LFB Biotech) in the Co-Exclusive Territory under
      Sections 3.1(b)(i)(C) and 3.1(b)(ii)(C) above.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    3.2   License
      Grant to LFB Biotech

    


    (a)   Research
      and Development License.
      Subject
      to the terms and conditions of this Agreement, GTC hereby grants to LFB Biotech
      a co-exclusive (together with GTC) right and license (with the right to
      sublicense with the JSC’s approval) during the Term in the Territory, under the
      GTC Technology and GTC’s interest in any and all Joint Technology,
      to:

    


    (i)   with
      respect to the Initial Product, (A) create and breed one or more herds of rFVIIa
      Rabbits and use such rFVIIa Rabbits to produce rFVIIa for use in making the
      Initial Product, and (B) Develop, make and have made the Initial Product, all
      in
      accordance with applicable laws and regulations and the Initial Development
      Plan; and 

    


    (ii)   with
      respect to subsequent Product(s), (X) create and breed one or more herds of
      transgenic mammals, and use such transgenic mammals to produce material for
      use
      in making such Product(s), and (Y) Develop, make and have made Product(s),
      all
      in accordance with applicable laws and regulations and the applicable
      Development Plan.

    


    (b)   Commercialization
      License.
      Subject
      to the terms and conditions of this Agreement, GTC hereby grants to LFB Biotech
      an exclusive or co-exclusive (as described below) right and license (with the
      right to sublicense with the JSC’s approval ) during the Term, commencing upon
      the Commercialization Phase with respect to the applicable Product, under the
      GTC Technology and GTC’s interest in any and all Joint Technology,
      to:

    


    (i)   with
      respect to the Initial Product, (A) sell, offer for sale, and import the Initial
      Product in the European Territory, and (B) subject to Section 3.3, in
      cooperation with GTC, sell, offer for sale, and import the Initial Product
      in
      the Co-Exclusive Territory, all in accordance with applicable laws and
      regulations and the applicable Commercialization Plan provided that if a
      Regulatory Authority requires a second site for the production of the Initial
      Product, such license shall be extended to the use of rFVIIa Rabbits to
      manufacture commercial quantities of rFVIIa and to the making of the Initial
      Product for distribution and sale in the Territory; and

    


    (ii)   with
      respect to subsequent Product(s), (A) use transgenic mammals created pursuant
      to
      the license under Section 3.2 (a)(ii) to manufacture commercial quantities
      of
      material for use in the manufacture of Product(s), (B) make, have made, sell,
      offer for sale, and import Product(s) in the European Territory, (C) subject
      to
      Section 3.3, in cooperation with GTC, make, have made, sell, offer for sale,
      and
      import Product(s) in the Co-Exclusive Territory, and (D) make, have made, and
      sell Product(s) to GTC for further distribution and sale by GTC in the North
      American Territory, all in accordance with applicable laws and regulations
      and
      the applicable Commercialization Plan; provided,
      that
      LFB Biotech may not exercise the license to make and have made Products granted
      pursuant to the foregoing unless and until the JSC determines to establish
      a
      second manufacturing site, or LFB Biotech notifies GTC of its decision to
      establish a second manufacturing site, in each case in accordance with the
      provisions of Section 7.4.

     

    For
      the
      purposes of clarity, the foregoing license shall be exclusive to LFB Biotech
      with respect to the European Territory under Sections 3.2(b)(i)(A) and
      3.2(b)(ii)(B) above and co-exclusive (together with GTC) in the Co-Exclusive
      Territory under Sections 3.2(b)(i)(B) and 3.2(b)(ii)(C) above.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    3.3   Exercise
      of Commercialization Rights in Co-Exclusive Territory.
      Each
      Party acknowledges and agrees that the Commercialization rights licensed to
      a
      Party under Sections 3.1(b)(i)(C), 3.1(b)(ii)(C), 3.2(b)(i)(B) and 3.2(b)(ii)(C)
      shall only be exercisable by such Party with respect to each country or region
      of the Co-Exclusive Territory that the JSC has designated to such Party as
      provided in Section 6.2(c), and neither Party shall exercise such rights in
      a
      country or region of the Co-Exclusive Territory that the JSC has exclusively
      designated to the other Party, its Affiliate or to a Third Party as provided
      in
      Section 6.2(c).

     

    3.4   Trademark
      License.
      Subject
      to the terms and conditions of this Agreement, each Trademark Owner hereby
      grants to the other Party (the “Trademark User”) during the Term (a) a fully
      paid up, royalty free, exclusive right and license to use the Product Trademarks
      of such Trademark Owner to Commercialize Products in the Territory which is
      exclusive to the Trademark User as provided in this Agreement, and (b) a fully
      paid up, royalty free, co-exclusive right and license to use the Product
      Trademarks to Commercialize Products in the Co-Exclusive Territory, all in
      accordance with applicable laws and regulations and the applicable
      Commercialization Plan, and subject to the following limitations:

    


    (i)   The
      Trademark User acknowledges that the Trademark Owner is and shall remain the
      owner of the Product Trademarks owned by such Trademark Owner and that all
      use
      of such Product Trademarks by the Trademark User shall inure to the benefit
      of
      the Trademark Owner.

    


    (ii)   The
      Trademark User agrees that it will use such Product Trademark in connection
      with
      the relevant Products manufactured by or for GTC or LFB Biotech, as the case
      may
      be, pursuant to, or as permitted by, this Agreement and for no other purpose,
      and shall agree to comply with such reasonable quality assurance provisions
      of
      the Trademark Owner as the Trademark Owner may reasonably specify in writing
      to
      ensure that the quality of any Product manufactured by or on behalf of GTC
      or
      LFB Biotech, as the case may be, remains, in all material respects, at least
      as
      high as that of Product manufactured by the Trademark Owner.

    


    (iii)   The
      Trademark User agrees to use the Product Trademarks of the Trademark Owner
      only
      in the form and manner, and with appropriate proprietary markings, reasonably
      prescribed in writing from time to time by the Trademark Owner. The Trademark
      Owner will deliver such initial requirements with respect to the form and manner
      of Product Trademarks use to the Trademark user prior to launch of the
      applicable Product. The Trademark User agrees not to use any other trademark
      in
      combination with the relevant Product Trademark or in connection with the
      relevant Product without prior written approval of the Trademark Owner, which
      approval will not be unreasonably withheld.

    


    (iv)   The
      Trademark User agrees, during the term of this Agreement and thereafter, not
      to
      seek to register the Product Trademarks of the Trademark Owner or any
      confusingly similar trademark in any country or region.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    The
      Trademark User may sublicense the rights granted under this Section 3.4 to
      a
      Third Party engaged by such Party to Commercialize Products with the approval
      of
      the JSC in accordance with Section 3.5 solely for purposes of such
      Commercialization.

    


    3.5   Performance
      of Development and Commercialization Activities By Third
      Parties.
      Neither
      Party may subcontract any significant element of its Development Activities
      and/or Commercialization Activities to one or more Third Parties without the
      prior approval of the JSC.

     

    3.6   Reservation
      of Rights.
      Each
      Party expressly reserves and retains all intellectual property rights not
      expressly granted herein, and no right or license under any Patent Rights,
      trademarks, Know How or other proprietary rights of either Party is granted
      or
      shall be granted by implication.

     

    3.7   Competing
      Products.

    


    (a)   During
      the Term, each Party agrees not to, and shall cause its Affiliates not to,
      alone
      or together with a Third Party, (i) develop or commercialize any Competing
      Product in the Territory, or (ii) acquire, directly or indirectly, any
      rights or interest in or to a Competing Product which is being detailed,
      promoted, marketed or sold in the Territory.
      In
      addition to any other remedies that may be available for a breach of the
      foregoing restrictions, in the event an Affiliate of a Party takes any of the
      actions described in subsections (i) or (ii) above, the other Party shall have
      the right to immediately terminate this subsection 3.7(a) with respect to itself
      and its Affiliates upon written notice and in the event of such termination
      shall no longer be subject to the restrictions set forth in this Section
      3.7(a).

    


    (b)   Each
      Party further undertakes that (i) it shall not, and shall cause its Affiliates
      not to, enter into any undertaking with a Third Party which would prohibit
      such
      Party from Developing and/or Commercializing any Product hereunder, and (ii)
      at
      the
      time a proposal is made for the inclusion of a Product for Development and
      Commercialization pursuant to this Agreement, each Party will disclose to the
      other Party ************.

    


    3.8   Third
      Party Patent Rights.
      In the
      event that a license under any Third Party patent or other intellectual property
      right is necessary for the use, Development, manufacture, sale, offer for sale
      or importation of a Product, the costs of obtaining and maintaining such license
      shall be ************.

     

    3.9   Effect
      of Bankruptcy on License Grants.
      All
      rights and licenses granted under or pursuant to this Agreement by either Party
      are, and will otherwise be deemed to be, for purposes of Section 365(n) of
      the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as
      defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree
      that each Party, as a licensee of such rights under this Agreement, will retain
      and may fully exercise all of such Party’s rights and elections under the U.S.
      Bankruptcy Code.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    ARTICLE
      4

    COLLABORATION
      GOVERNANCE

    


    4.1   Team
      Leaders/Project Managers.
      Within
      ************ after the Effective Date, each Party shall designate an individual
      (each, a “Team
      Leader”)
      to
      facilitate communication between the Parties and mutually manage the objectives
      and activities of the Parties, as specified by the JSC, with respect to the
      Development and Commercialization of Products under this Agreement and who
      will
      be the primary contact person within each Party’s organization for matters
      pertaining to the collaboration hereunder. Each Party may change its designated
      Team Leader from time to time upon notice to the other Party, it being
      acknowledged by both Parties that they should endeavor to maintain continuity
      to
      the maximum extent practicable. In addition, with respect to each Product to
      be
      Developed within the collaboration as decided by the JSC, the Originating Party
      shall designate an individual (each such individual a “Project
      Leader”)
      who
      will be responsible for the management of the Development of such Product and,
      if the JSC deems appropriate, for its Commercialization. The non-Originating
      Party will also designate an individual (a “Project
      Liaison”)
      to
      work closely with the Project Leader with respect to such Development and
      Commercialization and who will have overall responsibility within such other
      Party for oversight of such Product. The same individuals may be Team Leaders
      and Project Leaders/Project Liaisons. Neither the Team Leaders nor the Project
      Leaders shall have authority to make decisions with respect to the Development
      or Commercialization of Products, which authority shall be within the sole
      power
      of the JSC.

     

    4.2   Joint
      Steering Committee; Minutes.
      Within
      ************ after the Effective Date, LFB Biotech and GTC shall form a Joint
      Steering Committee (“JSC”)
      consisting of ************ representatives from each Party. Each Party may
      replace its representatives at any time upon prior written notice to the other
      Party, it being acknowledged by both Parties that they should endeavor to
      maintain continuity of their representatives to the maximum extent practicable.
      Each Party may invite a reasonable number of additional employees and/or
      advisors to attend part or all of the meetings of the JSC. The chairperson
      of
      the JSC shall alternate between a representative selected by GTC and a
      representative selected by LFB Biotech, with each chairperson to serve for
      a
      term of ************ following his or her designation as chairperson. GTC shall
      have the right to designate the initial chairperson of the JSC. The chairperson
      shall be responsible for providing an agenda for each meeting of the JSC
      ************ in advance of such meeting. Agenda items shall be added at the
      request of either Party provided that the chairperson receives such request
      no
      later than ************ in advance of such meeting. The Party chairing the
      JSC
      shall prepare written draft minutes of all meetings in reasonable detail and
      distribute such draft minutes to all members of the JSC for comment and review
      within ************ after the relevant meeting. The members of the JSC shall
      have ************ to provide comments. The Party preparing the minutes shall
      incorporate timely received comments and distribute finalized minutes to all
      members of the JSC within ************ following the relevant
      meeting.

     

    4.3   Subcommittees.
      The JSC
      shall have the right to establish subcommittees as determined by the JSC. Each
      Party shall have the right to have ************ serve on each
      subcommittee.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    4.4   Meetings
      of the JSC.
      During
      the Term, unless otherwise decided by the JSC, the JSC shall meet at least
      quarterly, with at least ************ such meetings per year to be attended
      by
      the members of the JSC in person and the remaining meetings to be held by audio
      or video conference, as agreed by the JSC. The chairman of the JSC shall have
      the right to convene any additional meetings of the JSC upon ************ prior
      written notice to all members of the JSC and shall be required to convene any
      such additional meeting upon request of a Party specifying the agenda items(s)
      to be discussed. In-person meetings shall be held on an alternating basis
      between the headquarters of each Party or otherwise as mutually agreed by the
      Parties. Each Party shall be responsible for its own expenses for participating
      in the JSC. Meetings of the JSC shall be effective only if ************ of
      each
      Party is present or participating.

     

    4.5   Responsibilities
      of the JSC.
      In
      addition to its other responsibilities and activities expressly described in
      this Agreement, the JSC shall have the responsibility and authority to:
      (a) monitor and oversee all aspects of the Development and
      Commercialization of Products under this Agreement; (b) agree upon, adopt
      and/or amend or modify the Development Plans, Commercialization Plans and
      Product Participation Models, and all updates or amendments thereto;
      (c) establish and approve budgets for the activities of the Parties under
      this Agreement to be included in the Development Plans and Commercialization
      Plans; (d) establish subcommittees pursuant to Section 4.3, and address
      disputes or disagreements arising in any subcommittee so established;
      (e) serve as the initial forum for discussion of and attempts to resolve
      any disputes or disagreements between the Parties relating to this Agreement;
      (e) approve the design of clinical trials for studies that form the basis of
      Regulatory Filings; (f) oversee the Regulatory Approval process for all Products
      and create mechanisms for interaction of the Parties with respect to submission
      of Regulatory Filings; (g) coordinate efforts of the Parties to assure
      proper reporting of all adverse events; (h) develop standard operating
      procedures for addressing customer inquiries and complaints; (i) make decisions
      in such other matters pertaining to the implementation of this Agreement as
      may
      be necessary; and (j) perform such other functions as the Parties may agree
      in
      writing.

     

    4.6   Decisions.
      The JSC
      shall attempt to decide all matters by consensus, with each Party having one
      collective vote. The members of the JSC shall act in good faith to cooperate
      with one another and to reach agreement with respect to issues to be decided
      by
      the JSC. In the event that the members of the JSC cannot achieve consensus
      within ************ with respect to any matter over which the JSC has authority
      and responsibility, the JSC shall refer the matter to Senior Management of
      GTC
      and LFB Biotech, who shall in good faith attempt to resolve such dispute. If
      Senior Management of GTC and LFB Biotech are unable to resolve such matter
      with
      ************ thereafter, then, at the request of either of the Parties, the
      matter shall be submitted to non-binding mediation by a mutually agreed
      independent third party knowledgeable as to the matter(s) in dispute who shall
      render his/her decision within ************. If both Parties do not accept
      the
      decision of such mediator within ************ after such decision having been
      rendered, or if the Parties have not agreed on a mediator within ************
      after a request for mediation, then, subject to the rights and obligations
      of
      the Parties under this Agreement, and, except for those matters expressly
      excluded from arbitration hereunder, the matter shall be referred to arbitration
      as described in Section 15.2. 

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    4.7   Legal
      Structure of the Collaboration.
      The JSC
      will periodically, starting no later than one year from the Effective Date,
      evaluate the legal status of the collaboration and make recommendations as
      to
      whether it would be in the best interests of the Parties and their collaboration
      to change its structure to ************ 

     

    ARTICLE
      5

    DEVELOPMENT
      PHASE

    


    5.1   Development
      Plan

    


    (a)   All
      Development with respect to any Product hereunder shall be conducted pursuant
      to
      a Development Plan prepared and approved by the JSC, which shall set forth
      the
      plan for the pre-clinical and clinical Development, and Regulatory Approval
      of
      such Product in each of the European Territory, the North American Territory
      and
      the Co-Exclusive Territories and the activities to be carried out related
      thereto by LFB Biotech and GTC, together with a proposed budget for such
      activities (each, a “Development
      Plan”).
      The
      Parties will mutually agree upon a preliminary Development Plan for the Initial
      Product (the “Initial
      Development Plan”)
      within
      ************ following the Effective Date, a copy of which shall be attached
      hereto as Exhibit
      B.
      Each
      Development Plan and updated Development Plan shall include a projection of
      (a)
      the plan of Development activities with respect to the relevant product and
      timelines for performing such activities, (b) the proposed budget for such
      Development activities, (c) expected Development funding by each Party, and
      (d)
      a non-binding forecast of clinical supply of Product to be supplied as provided
      under Article 7. The Development Plan for a Product shall also specify the
      jurisdictions (other than the US and EU) where Regulatory Approval will be
      sought for such Product and prospective indication extension after the First
      Major Regulatory Approval. Development Plans for subsequent Products shall
      also
      be attached to Exhibit
      B
      as such
      Development Plans are prepared, approved and amended by the JSC. For indicative
      purposes only a preliminary version of the business case prepared by the Parties
      for the Initial Product is attached hereto as Exhibit B-1. Such business case
      shall be reviewed and updated on a regular basis by the JSC.

    


    (b)   For
      so
      long as necessary to complete Development of any Product, the Parties, through
      the JSC, shall update the Development Plan with respect to such Product on
      an
      annual basis prior to the commencement of the next calendar year, or more often
      as determined by the JSC.

    


    (c)   The
      JSC
      will review performance against the Development Plan for each Product on a
      quarterly basis, and will report any variations to the Parties in writing.
      If,
      in any quarter, there is a variation of ************ or greater from the budget,
      the JSC will revise the Development Plan and budget for the applicable Product
      ************ prior to the commencement of the second quarter following the
      quarter in which the variation occurred. For example, if a ************
      variation is reported in quarter one, a revised Development Plan and budget
      must
      be prepared at least ************ prior to the commencement of quarter
      three.

    


    (d)   Until
      such time as a Development Plan is updated in accordance with this Section
      5.1,
      the preceding Development Plan (including, without limitation, all budget
      projections and minimum expenditures therein) shall remain in effect. The JSC
      shall not update any Development Plan in a manner that is inconsistent with
      or
      contradicts the terms of this Agreement.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    5.2   Development
      Activities.

    


    (a)   General.
      Each
      Party shall be responsible for carrying out its designated activities relating
      to Development of the relevant Product, as set forth in and in accordance with
      this Agreement and the applicable Development Plan. Each Party will commit
      those
      financial and human resources specified for such Party in the Development Plan
      for each Product, it being acknowledged that (i) neither Party is required
      to
      commit all its financial and human resources to the implementation of a
      Development Plan, and (ii) those capital and human resources utilized by a
      Party
      to the Development of Products hereunder are not required to be exclusively
      dedicated to the collaboration. 

    


    (b)   LFB
      Biotech Development Activities.
      The
      designated Development activities of LFB Biotech as specified in the applicable
      Development Plan shall be referred to as the “LFB
      Biotech Development Activities”.
      In its
      performance of the LFB Biotech Development Activities with respect to any
      Product, LFB Biotech shall devote no less than the minimum levels of effort
      (in
      terms of full-time equivalent personnel “FTEs”)
      and
      financial resources as set forth in the applicable Development Plan. Without
      limiting the foregoing, the LFB Biotech Development Activities with respect
      to
      the Initial Product shall include the following:

    


    (i)   Supply
      to
      GTC reasonable quantities of rFVIIa produced by ************ for use by GTC
      in
      the performance of its activities under this Agreement and the Initial
      Development Plan.

    


    (ii)   Provide
      Know-How and expertise in the areas of process development, purification and
      product characterization, design and management of clinical trials, regulatory
      affairs, sales and marketing, plasma proteins and monoclonal
      antibodies.

    


    (iii)   Under
      the
      direction and supervision of the JSC, and in accordance with the Initial
      Development Plan, assume primary responsibility for clinical trials in the
      Territory for the Initial Product pursuant to Section 5.7(b).

    


    (c)   GTC
      Development Activities.
      The
      designated Development activities of GTC as specified in the applicable
      Development Plan shall be referred to as the “GTC
      Development Activities”.
      In its
      performance of the GTC Development Activities with respect to any Product,
      GTC
      shall devote no less than the minimum levels of effort (in terms of FTEs) and
      financial resources as set forth in the applicable Development Plan. Without
      limiting the foregoing, the GTC Development Activities with respect to the
      Initial Product shall include the following:

    


    (i)   Generate
      rFVIIa Rabbits using GTC’s ************ to be used for production of rFVIIa
      pursuant to this Agreement.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (ii)   Provide
      all necessary GTC Technology for purposes of herd development, including for
      transgenic production of proteins in milk, purification technology and
      promoters.

    


    (iii)   Provide
      Know-How and expertise in the areas of regulatory affairs, quality systems,
      molecular biology, embryology, animal husbandry and milking, process development
      and product recovery and purification.

    


    (iv)   Manufacture
      and supply rFVIIa material to LFB Biotech ************ in sufficient quantities
      for Phase II Trials and Phase III Trials during the Development Phase, and
      to
      the Parties as specified below during the Commercialization Phase.

     

    5.3   Diligence
      Requirements.

    


    (a)   Development
      Milestones.
      The
      Parties shall agree on objective time-based Development milestones with respect
      to each Product for each of the European Territory, the North American Territory
      and the Co-Exclusive Territory, which shall be included in the Development
      Plan
      for each Product. Each Party will be responsible for meeting the milestones
      in
      its respective exclusive Territory and in each country or region in the
      Co-Exclusive Territory designated to such Party in the applicable Development
      Plan.

    


    (b)   Failure
      to Meet Development Milestones.
      The
      failure of a Party to achieve any Development milestone for a Product shall
      ************.

     

    5.4   Development
      Costs.

    


    (a)   Initial
      Product. Unless
      otherwise specified in the applicable Development Plan or this Agreement,
      subject to Section 5.7(b)(ii), each Party shall bear ************ costs and
      expenses incurred in connection with its respective Development Activities
      with
      respect to the Initial Product, as such costs are incurred. Notwithstanding
      the
      foregoing, LFB Biotech shall purchase from GTC quantities of the Initial Product
      for the conduct of the LFB Biotech Development Activities in the European
      Territory and the Co-Exclusive Territory pursuant to the applicable Development
      Plans, as set forth in Article 7.

    


    (b)   Other
      Products. Unless
      otherwise specified in the applicable Development Plan, subject to Section
      8.2(c), each Party shall bear fifty percent (50%) of the costs and expenses
      incurred in connection with the Development of each Product other than the
      Initial Product. 

     

    5.5   Right
      of Reference to Data.
      Subject
      to this Section 5.5, the Party conducting any clinical trial or other
      Development Activities under the relevant Development Plan shall own all data
      arising or resulting therefrom; provided that ownership of Regulatory Filings
      and Regulatory Approvals shall be determined in accordance with Sections 5.8
      and
      5.9, respectively. Each Party agrees to provide the other Party, in a timely
      manner, with access to all clinical, safety and other data arising from its
      respective Development Activities. The other Party shall have the right to
      cross-reference all such data and information in any Regulatory Filing for
      any
      Product under this Agreement.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    5.6   Transfer
      of Know-How.
      Promptly, but in no event more than ************ after the Effective Date,
      each
      Party shall disclose and transfer to the other Party all Know-How Controlled
      by
      such Party or its Affiliates that is necessary or useful to the other Party
      in
      the performance of its obligations under this Agreement with respect to the
      Initial Product. Within ************ of the preparation of the preliminary
      Development Plan with respect to any other Product hereunder, each Party shall
      disclose and transfer to the other Party all Know-How Controlled by such Party
      and its Affiliates not previously disclosed hereunder that is necessary or
      useful to the other Party in the performance of its obligations under this
      Agreement with respect to such Product. Throughout the Product Term with respect
      to each Product, each Party will disclose and supply to the other Party from
      time to time any
      material modifications or updates to
      the
      Know-How Controlled by such Party or its Affiliates that are necessary or useful
      to the other Party in the performance of its obligations under this Agreement
      with respect to such Product. The transfer of Know-How pursuant to this Section
      5.6 may occur by means of written documentation, personal consulting or other
      communications between the Parties, or by demonstration (show-how). All Know-How
      transferred hereunder shall be used by the Party receiving the same solely
      in
      accordance with this Agreement and shall be the Confidential Information of
      the
      Party providing the same.

     

    5.7   Conduct
      of Clinical Trials.

    


    (a)   General.
      The
      clinical Development and Regulatory Approval program with respect to each
      Product, and the respective activities and responsibilities of each Party with
      respect thereto, shall be included in the Development Plan for such Product.
      It
      is the intention of the Parties that all clinical studies for Products shall
      be
      conducted in a manner such that the results will be acceptable to Regulatory
      Authorities in the European Territory and the North American Territory, as
      well
      as the Co-Exclusive Territory to the extent reasonably possible. Unless
      otherwise specified in the applicable Development Plan, subject to Section
      8.2(c), each Party shall bear fifty percent (50%) of the costs and expenses
      incurred in connection with the clinical studies of each Product other than
      the
      Initial Product. 

    


    (b)   Initial
      Product.

    


    (i)    Conduct
      of Phase II Trials and Phase III Trials by LFB Biotech.
      Under
      the direction and supervision of the JSC, LFB Biotech shall have primary
      responsibility for the conduct of Phase II Trials and Phase III Trials for
      the
      Initial Product in the entire Territory in accordance with this Agreement and
      the applicable Development Plan. ************ data from such Phase II Trials
      and
      Phase III Trials shall be fully shared with GTC, and such data may be used
      by
      both Parties in applications for Regulatory Approval pursuant to Section
      5.8.

    


    (ii)   Funding
      of Clinical Development.
      LFB
      Biotech will bear all costs of clinical trials with respect to the Initial
      Product in the entire Territory, subject to GTC’s option to co-fund as provided
      below. GTC shall have the option, but not the obligation, to fund up to
      ************ of the costs of clinical trials with respect to the Initial Product
      in the Territory. GTC may exercise such option by providing LFB Biotech with
      written notice of its election to co-fund at any time prior to ************
      with
      respect to the Initial Product together with payment of the amount of funding
      GTC is willing to contribute. If GTC elects not to participate, or not to fully
      participate, in the funding of clinical trials with respect to the Initial
      Product, the Product Participation with respect to the Initial Product shall
      be
      adjusted in accordance with the Product Participation Model on Exhibit
      D
      to
      reflect LFB Biotech’s greater participation in the funding of clinical trials,
      subject to readjustment pursuant to Section 8.2(b)(iv). Notwithstanding the
      foregoing, provided that GTC’s participation in the funding of the Development
      of the Initial Product is at least ************ of the total IPV, GTC’s Product
      Participation with respect to the Initial Product shall be no less than
      ************.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    5.8   Regulatory
      Filings and Approvals.

    


    (a)   Preparation
      of Proposed Regulatory Filings.
      The
      Parties agree to seek Regulatory Approvals from the FDA, the EMEA, and the
      applicable Regulatory Authorities in each of the other countries listed in
      the
      applicable Development Plan, as may be amended by the Parties from time to
      time.
      LFB Biotech shall prepare all Regulatory Filings for Products in the European
      Territory. GTC shall prepare all Regulatory Filings for Products in the North
      American Territory. The JSC shall determine, on a country-by-country basis,
      which Party shall be responsible for preparing Regulatory Filings and Regulatory
      Approvals in the Co-Exclusive Territory. All such Regulatory Filings shall
      be
      prepared in accordance with the applicable Development Plan and all applicable
      laws and regulations. Each Party shall submit to the other Party each proposed
      Regulatory Filing for the other Party’s review and comment. The reviewing Party
      shall notify the Party responsible for such Regulatory Filing in writing of
      any
      proposed modifications to such Regulatory Filing as soon as reasonably
      practicable after receipt of such filing, and the Party preparing such
      Regulatory Filing shall consider, in good faith, whether to implement such
      proposed modifications; provided
      that the
      Party responsible for making such Regulatory Filing shall have the right to
      make
      the final determination, in its sole discretion, as to the form and substance
      of
      such Regulatory Filing.

    


    (b)   Submission
      to Regulatory Authorities.
      Each
      Party agrees to use Commercially Reasonable Efforts to file promptly, in its
      own
      name, all Regulatory Filings finalized in accordance with
      Section 5.8(a) with the proper Regulatory Authority.

    


    (c)   Copies
      of Regulatory Filings.
      Each
      Party shall provide to the other Party copies of all Regulatory Filings for
      Products submitted to Regulatory Authorities in the Territory within a
      reasonable time following the filing thereof. In addition, the Parties shall
      share all correspondence and communications, other than Regulatory Filings,
      with
      Regulatory Authorities relating to a Product in the Territory.

    


    (d)   Interactions
      with Regulatory Authorities.
      The
      Party responsible for making a Regulatory Filing pursuant to this Section 5.8
      shall also be responsible for and control all interactions with Regulatory
      Authorities with respect to such Regulatory Filing. To the extent practicable,
      each Party shall provide to the other Party reasonable advance written notice
      of
      meetings and conference telephone calls with any Regulatory Authority related
      to
      the Product in the Territory, and shall use Commercially Reasonable Efforts
      to
      invite one senior executive or regulatory counsel of the other Party to attend
      meetings with such Regulatory Authorities as a silent observer, if and to the
      extent permitted by the relevant Regulatory Authority.

     

    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    
      5.9   Ownership
        of Regulatory Approvals.
        Subject
        to Section 5.5, as between the Parties, (a) LFB Biotech shall own and maintain
        all Regulatory Filings and all Regulatory Approvals that relate to the Product
        in the European Territory, (b) GTC shall own and maintain all Regulatory
        Filings
        and all Regulatory Approvals that relate to the Product in the North American
        Territory, and (c) ownership and maintenance of Regulatory Filings and
        Regulatory Approvals in the Co-Exclusive Territory shall be determined by
        the
        JSC on a country-by-country basis.

       

    

    ARTICLE
      6

    COMMERCIALIZATION
      PHASE

    


    6.1   Commercialization
      Plan.
      All
      Commercialization with respect to a Product under this Agreement shall be
      conducted pursuant to a Commercialization Plan, which shall set forth the plan
      for the Commercialization of such Product and the activities to be carried
      out
      with respect thereto, together with a proposed budget for such activities (each,
      a “Commercialization
      Plan”).
      The
      Parties, through the JSC, shall agree upon a preliminary Commercialization
      Plan
      for each Product at least ************ prior to anticipated Regulatory Approval
      for such Product. A copy of each Commercialization Plan shall be attached hereto
      as part of Exhibit C.
      During
      the Commercialization Phase with respect to each Product, the Parties, through
      the JSC, shall update the Commercialization Plan with respect to such Product
      on
      an annual basis prior to the commencement of the next calendar year, or more
      often as determined by the JSC. Each updated Commercialization Plan shall
      include, for the subsequent ************, the projection of the plan for
      Commercialization Activities for the Product in each Territory and timelines
      for
      performing such activities, the projected Net Sales and other revenues from
      the
      sale of the Product, together with an updated Commercialization budget. The
      Commercialization Plan shall contain an estimation of the resources that each
      Party intends to employ in connection with the Commercialization of the relevant
      Product. In addition, the JSC will review performance against the
      Commercialization Plan for each Product on a quarterly basis, and will report
      any variations to the Parties in writing. If, in any quarter, there is a
      variation of ************ or greater from the budget or from projected Net
      Sales
      and other revenues, the JSC will revise the Commercialization Plan and budget
      for the applicable Product ************ prior to the commencement of the second
      quarter following the quarter in which the variation occurred. For example,
      if a
      ************ variation is reported in quarter one of a calendar year, a revised
      Commercialization Plan and budget must be prepared at least ************ prior
      to the commencement of quarter three of such calendar year. Until such time
      as
      an updated Commercialization Plan is approved in accordance with this Section
      6.1, the preceding Commercialization Plan (including, without limitation, all
      budget projections therein) shall remain in effect. The JSC shall not approve
      any Commercialization Plan that is inconsistent with or contradicts the terms
      of
      this Agreement.

     

    6.2   Commercialization
      Activities.

    


    (a)   European
      Territory.
      Subject
      to the terms and conditions of this Agreement, LFB Biotech shall have exclusive
      rights to Commercialize Products in the European Territory. LFB Biotech shall
      use Commercially Reasonable Efforts to maximize profits with respect to each
      Product in each country of the European Territory where Regulatory Approval
      has
      been obtained, including the performance of those activities with respect to
      the
      European Territory specified in the applicable Commercialization
      Plan.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (b)   North
      American Territory.
      Subject
      to the terms and conditions of this Agreement, GTC shall have exclusive rights
      to Commercialize Products in the North American Territory. GTC shall use
      Commercially Reasonable Efforts to maximize profits with respect to each Product
      in each country of the North American Territory where Regulatory Approval has
      been obtained, including the performance of those activities with respect to
      the
      North American Territory specified in the applicable Commercialization
      Plan.

    


    (c)   Co-Exclusive
      Territory.
      Subject
      to the terms and conditions of this Agreement, each Party shall have the
      exclusive right to Commercialize Products in each country or region of the
      Co-Exclusive Territory designated to such Party by the JSC in the applicable
      Commercialization Plan, and neither Party shall grant Commercialization rights
      to a Third Party in the Co-Exclusive Territory except as expressly set forth
      herein. The JSC will decide the appropriate party, whether one of the Parties
      and/or its Affiliate or a Third Party, to exclusively Commercialize Products
      in
      a given national or regional territory within the Co-Exclusive Territory on
      the
      basis of criteria determined by the JSC; provided that where one of the Parties
      has an Affiliate within such national or regional territory and the other Party
      does not, then such Affiliate shall have a first right to negotiate with the
      JSC
      for the distribution of such Product. If such Affiliate agrees in writing to
      meet the undertakings as to minimum sales commitments set by the JSC (which
      shall have first obtained such information as it may require in order to
      determine what minimum sales commitments would be reasonable in the
      circumstances) and demonstrates to the satisfaction of the JSC that it has
      the
      capability of performing such undertakings, such Affiliate shall be given the
      right to Commercialize the relevant Product, even if such Affiliate may be
      of
      lesser standing than a Third Party in terms of the criteria determined by the
      JSC. Where both Parties have an Affiliate in a given national or regional
      territory within the Co-Exclusive Territory, the JSC will determine the
      appropriate entity to Commercialize the relevant Product, which entity may
      be a
      Third Party, based on the criteria it has previously determined, but with a
      view
      to maximizing the profits for the collaboration while allowing each Party the
      opportunity to build its marketing and sales presence in the Co-Exclusive
      Territory taken as a whole and, on an overall basis, to share equally in
      Commercialization activities in the Co-Exclusive Territory taken as a whole.
      In
      any event, each Party or its Affiliate shall use Commercially Reasonable Efforts
      to maximize profits with respect to each Product in each country of the
      Co-Exclusive Territory where Regulatory Approval has been obtained, including
      the performance of those activities with respect to the Co-Exclusive Territory
      designated to such Party or its Affiliate specified in the applicable
      Commercialization Plan. Each Party shall be responsible for the performance
      of
      the Commercialization activities of its Affiliate hereunder.

    


    (d)   No
      Parallel Trade.
      Due to
      the territorial nature of Regulatory Approvals, each Party will undertake
      Commercially Reasonable Efforts within applicable legal constraints to limit
      trade of Products between and among the North American Territory, the European
      Territory, and the specific countries or regions within the Co-Exclusive
      Territory exclusively designated to a Party under the applicable
      Commercialization Plan.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    6.3   Commercialization
      Costs.
      Unless
      otherwise specified in the applicable Commercialization Plan, each Party shall
      bear all costs and expenses incurred in connection with its respective
      Commercialization Activities with respect to each Product. Notwithstanding
      the
      foregoing, except as otherwise determined by the JSC, LFB Biotech shall purchase
      from GTC its commercial supply of Initial Products in the European Territory
      and
      Co-Exclusive Territory pursuant to the initial Commercialization Plan, as set
      forth in Article 8. 

     

    6.4   Diligence
      Requirements.

    


    (a)   Commercialization
      Milestones.
      The
      Parties shall agree on objective time-based Commercialization milestones with
      respect to each Product for each Party’s respective exclusive Territory and each
      country or region in the Co-Exclusive Territory, which shall be included in
      the
      Commercialization Plan for the relevant Product. Each Party will be responsible
      for meeting the milestones in its respective exclusive Territory and in each
      country or region in the Co-Exclusive Territory designated to such Party in
      the
      applicable Commercialization Plan.

    


    (b)   Failure
      to Meet Commercialization Milestones.
      The
      failure of a Party to timely achieve any Commercialization milestone designated
      to such Party in the Commercialization Plan for a Product shall have the
      consequences set forth below with respect to the applicable country or region
      in
      the Territory; provided
      that
      such failure ************, unless such failure occurs within the ************
      period following a Change of Control of the Party failing to achieve such
      milestone as provided in subsection (ii) below.

    


    (i)   If
      such
      Party fails to achieve one or more applicable Commercialization milestones
      for a
      Product in either of the first two full calendar years following the First
      Commercial Sale of such Product, ************.

    


    (ii)   Commencing
      upon the beginning of third full calendar year following the First Commercial
      Sale of a Product, if such Party fails to achieve one or more applicable
      Commercialization milestones during any full calendar year during the
      Commercialization Phase for the Product, starting in the next full calendar
      year
      ************. 

     

    6.5   Advertising
      and Promotional Materials.

    


    (a)   Promotional
      Materials.
      The
      Parties, through the JSC, shall collaborate to develop all advertising and
      promotional materials related to the Products (collectively, “Promotional
      Materials”)
      in the
      Territory utilizing the Product Trademarks, in accordance with style and
      branding guidelines to be mutually agreed upon and with applicable laws and
      regulations. Neither Party shall use in the conduct of its respective
      Commercialization Activities any Promotional Materials that have not been
      finally approved by the JSC. Ownership of Promotional Materials shall be
      determined consistently with ownership of Regulatory Approvals under Section
      5.9.

    


    (b)   Filing
      of Promotional Materials with Regulatory Authorities.
      Each
      Party shall be responsible for filing with the relevant Regulatory Authority,
      in
      accordance with all applicable laws and regulations and industry standards,
      Promotional Materials with respect to use of the Product in the respective
      Territory, consistent with Section 5.8.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    6.6   Customer
      Complaints and Inquiries.
      LFB
      Biotech shall be responsible for receiving and addressing all customer
      complaints and inquiries regarding Products in the European Territory. GTC
      shall
      be responsible for receiving and addressing all customer complaints and
      inquiries regarding Products in the North American Territory. The JSC shall
      determine, on a country-by-country or region-by-region basis, which Party shall
      be responsible for receiving and addressing customer complaints and inquiries
      regarding Products in the Co-Exclusive Territory. Following receipt of any
      customer complaint or inquiry, the responsible Party shall log the complaint
      or
      inquiry and determine the appropriate response, in accordance with applicable
      laws and regulations and the procedures established by the JSC and set forth
      in
      the applicable Commercialization Plan; provided,
      that
      the Party responsible for addressing any complaint or inquiry shall promptly
      notify the other Party after receiving any material complaint or inquiry and
      shall consult with the other Party prior to taking any action in response
      thereto that would materially affect the other Party’s rights or obligations
      under this Agreement.

     

    6.7   Drug
      Safety.

    


    (a)   New
      Information.
      Each
      Party shall promptly inform the other Party of any adverse safety information
      or
      data affecting any Product in the Territory or either Party’s obligations with
      respect to the safety of Products under this Agreement.

    


    (b)   Adverse
      Event Reporting; Safety Database.
      Each
      Party shall be responsible for reporting, at its expense, to appropriate
      authorities, in accordance with local requirements, all adverse events related
      to use of a Product in its respective Territory (or its respective designated
      country or region in the Co-Exclusive Territory); provided,
      that
      each Party shall consult with the other Party before making any such report.
      The
      non-reporting Party shall provide to the reporting Party, upon the reporting
      Party’s request, reasonable assistance in connection with the reporting of all
      of adverse events, responding to safety queries and assessing safety issues,
      in
      each case, to the extent related to a Product in the Territory. Adverse events
      related to the use of a Product in the Territory shall be recorded in a single,
      centralized database for such Product. Such database shall be held, owned and
      maintained by the Originating Party of such Product at the Originating Party’s
      expense, which shall be a Development Cost of the Originating Party hereunder.
      Direct access to the safety database for each Product will be granted to both
      Parties. Details of safety reporting activities relating to the Product in
      the
      Territory will be addressed in a pharmacovigilance agreement, which the Parties
      shall enter into within ************ following the first Regulatory Approval
      of
      such Product.

     

    6.8   Product
      Withdrawals and Recalls.
      In the
      event that, within a Party’s Territory (or its designated country or region in
      the Co-Exclusive Territory), (a) a Party determines that an event, incident,
      or
      circumstance that may result in the need for a Recall or other removal of a
      Product or any lot or lots thereof from the market; (b) the applicable
      Regulatory Authority threatens to remove a Product from the market; or
      (c) the applicable Regulatory Authority requires distribution of a “Dear
      Doctor” letter or its equivalent regarding the use of a Product, the Party
      making such determination or receiving notice of such threat or requirement
      shall promptly advise the other Party in writing with respect thereto, and
      shall
      provide the other Party with copies of all relevant correspondence, notices
      and
      the like. The Parties shall reasonably cooperate through the JSC to determine
      what action is warranted and to take such action with respect to the conduct
      of
      any such Recall, market withdrawal or other corrective action with respect
      to a
      Product in the Territory.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    ARTICLE
      7

    PRODUCT
      SUPPLY

    


    7.1   Clinical
      Supply of Product.

    


    (a)   Initial
      Product.

    


    (i)   Requirements.
      Subject
      to the terms set forth in this Article 7, GTC shall supply to LFB Biotech its
      requirements for the Initial Product for the conduct of the LFB Biotech
      Development Activities and for Phase II Trials and Phase III Trials at a
      transfer price ************.

    


    (ii)   Ordering
      Process.
      The
      Parties shall agree upon and set forth in the Supply Agreement for the Initial
      Product: (A) the amount of Initial Product to be supplied by GTC to LFB
      Biotech during the Development Phase for such Product (subject to maximums
      to be
      agreed upon), and (B) the procedures for LFB Biotech to submit its
      requirements and GTC to supply such requirements. Such procedures shall include,
      without limitation, (1) forecasting procedures, including annual
      non-binding forecasts of LFB Biotech’s requirements, (2) firm purchase
      commitments no less than ************ prior to the time the order must be
      delivered to LFB Biotech by GTC, (iii) procedures for return and replacement
      of
      Initial Product that is in breach of the product warranty set forth in the
      relevant Supply Agreement, and (iv) payment terms. Any purchase orders, purchase
      order releases, confirmations, acceptances, invoices, and similar documents
      submitted by either Party shall be for administrative purposes only and shall
      not add to or modify the terms of this Agreement or the relevant Supply
      Agreement, except for the specification of quantities or requested delivery
      dates.

    


    (b)   Other
      Products.
      The
      Parties shall mutually agree in writing upon the availability and timing of
      delivery of clinical supplies of Products other than the Initial Product, which
      shall be set forth in the applicable Development Plan. All such Products shall
      be supplied at ************.

     

    7.2   Forecasts
      and Commercial Supply.

    


    (a)   Initial
      Product.

    


    (i)   Exclusive
      Supply; Forecasts.
      Subject
      to Section 7.4(c), and unless otherwise specified in the applicable
      Commercialization Plan, GTC or its designated Third Party subcontractor shall
      be
      the exclusive manufacturer and supplier of commercial quantities of the Initial
      Product throughout the Territory. The Supply Agreement for the Initial Product
      shall set forth the forecasting requirements of the Parties for the Initial
      Product in the Territory.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (ii)   Commercial
      Supply.
      Unless
      otherwise specified in the applicable Commercialization Plan, GTC shall use
      Commercially Reasonable Efforts to supply to LFB Biotech its commercial
      requirements for the Initial Product in the European Territory, and the
      commercial requirements of the collaboration for the Initial Product in the
      Co-Exclusive Territory, at a transfer price equal ************. GTC shall supply
      Initial Product to LFB Biotech and, if applicable, to any Third Party selected
      by the JSC to Commercialize or distribute the Initial Product in a country
      or
      region in the Co-Exclusive Territory, on a non-discriminatory basis. The Supply
      Agreement for the Initial Product shall set forth the other relevant terms
      and
      conditions of the manufacture and supply of Initial Product in the
      Territory.

    


    (b)   Other
      Products.
      The
      Parties shall mutually agree in writing upon the terms and conditions with
      respect to the manufacture and supply of commercial quantities of Product(s)
      other than the Initial Product, which shall be set forth in the relevant Supply
      Agreement. All such Products shall be supplied at ************.

     

    7.3   Disclaimer
      of Warranty.
      EXCEPT
      TO THE EXTENT EXPRESSLY PROVIDED IN THE APPLICABLE SUPPLY AGREEMENT,
EACH
      PARTY EXPRESSLY DISCLAIMS
      ANY
      WARRANTY WITH RESPECT TO THE PRODUCT(S) SUPPLIED HEREUNDER, WHETHER EXPRESS
      OR
      IMPLIED, WRITTEN OR ORAL (INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
      MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE).

     

    7.4   Second
      Manufacturing Site.
      ************ 

    


    (a)   ************
      

    


    (b)   ************

    


    (c)   ************
      

    


    (d)   ************

    


    (e)   ************

     

    ARTICLE
      8

    PAYMENTS
      AND ACCOUNTING

    


    8.1   Equity
      Purchase.
      In
      conjunction with the establishment of the collaboration hereunder between LFB
      Biotech and GTC, LFB Biotech shall make an equity and debt investment in GTC
      of
      up to an aggregate of $25 million pursuant to a definitive purchase agreement,
      substantially in the form of Exhibit
      E
      hereto,
      to be executed by and between the Parties on or about the Effective Date (the
      “Stock
      and Note Purchase Agreement”).

     

    8.2   Funding
      of Costs and Sharing of Profits.

    


    (a)   General.
      Subject
      to the terms and conditions of this Agreement, on a Product-by-Product basis,
      it
      is the Parties’ intention that each Party will share equally in the costs of
      Development and Commercialization and that in such case each Party will be
      entitled to fifty percent (50%) of the Net Profits of the collaboration with
      respect to such Product, as adjusted in accordance with the profit participation
      percentage for such Party under the applicable Product Participation Model
      as
      described below (the “Product
      Participation”).
      

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (b)   Product
      Participation Calculation.

    


    (i)   The
      Parties shall agree upon the final (subject to adjustment by the JSC as provided
      herein) Product Participation Model for each Product no later than ************
      following ************ for such Product, and shall attach a copy of such Product
      Participation Model as part of Exhibit
      D
      to this
      Agreement and such Product Participation Model shall be incorporated herein
      be
      reference. Product Participation calculations will be included upon their
      approval. A standard form of Product Participation Model is attached as part
      of
      Exhibit D to this Agreement.

    


    (ii)   The
      Product Participation of a Party with respect to a Product shall be based upon
      the IPV of such Party with respect to such Product in accordance with the
      applicable Product Participation Model. All Development Costs of a Party shall
      be included in the IPV calculation under the Product Participation Model. IPV
      will be calculated using a discount rate of ************. Development Costs
      of
      each Party will be factored into the Product Participation Model by calendar
      year based on the official statutory accounts of each Party, or properly
      allocated Development Costs reconciled to the relevant Party’s statutory
      accounts and approved by the JSC, in each case as reflected in the reports
      delivered pursuant to Sections 8.3(a) and (b). Any significant differences
      between the Parties’ statutory bases of accounting will be identified by the JSC
      during the annual budgeting process. A common basis will be selected or
      approximated, subject to approval of the JSC. Depreciation or amortization
      of
      expenditures will be excluded from the IPV calculation to the extent such costs
      have previously been incorporated elsewhere in the Product Participation Model.
      The Joint Steering Committee will evaluate ************ after the Effective
      Date
      the impacts of the discrepancies in such accounting methods and decide on
      relevant rules to be applied to account for and reconcile such discrepancies
      in
      the calculation of the respective Product Participations. 

    


    For
      purposes of calculating each Party’s IPV, to reflect the increased risk
      associated with earlier investment, Development Costs paid or incurred by a
      Party in earlier stages of a Product’s Development program will be weighted more
      highly than later-stage Development Costs, in accordance with the following
      schedule:

     

    
      
        	
                Timing
                  of Expenditure

              	
                Weight
                  Accorded

              
	
                From
                  Product Start Date through last day of month ending before decision
                  of JSC
                  to commence Phase III Trials

              	
                ************
                  of Development Cost

              
	
                From
                  the month when decision is made by JSC to commence Phase III Trials
                  through Pivotal Trial Completion Date

              	
                ************
                  of Development Cost

              
	
                Pivotal
                  Trial Completion Date to date of receipt of written confirmation
                  of Major
                  Regulatory Approval

              	
                ************
                  of Development Cost

              


      

    

     

    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (iii)   Notwithstanding
      the foregoing, after the first Major Regulatory Approval is obtained for a
      Product, only those Development Costs specifically allocable to obtaining the
      other Major Regulatory Approval as per the Development Plan previously approved
      by the JSC (including, without limitation, the costs of additional clinical
      trials, if any, required for purposes of obtaining such other Major Regulatory
      Approval) shall be subject to weighting in accordance with the above schedule,
      and all other Development Costs properly incurred or allocated by the Parties
      shall be weighted ************ of cost. Any costs with respect to a Product
      incurred by a Party prior to the decision by the JSC to proceed with the
      Development of such Product shall not be included as Development Costs. Subject
      to adjustment from time to time pursuant to Section 8.2(b)(iv), each Party’s
      relative IPV will also represent such Party’s Product Participation percentage
      for such Product; provided,
      that
      the Product Participation of the Parties shall be rounded to the closest full
      percentage point with no decimals. Notwithstanding any of the foregoing, if
      GTC’s relative participation in funding the Development of the Initial Product
      is ************, the minimum Product Participation of GTC with respect to the
      Initial Product shall be no ************.

    


    (iv)   The
      Product Participation of each Party with respect to a Product shall be fixed
      as
      of ************, and shall remain fixed for the remainder of the Product Term,
      subject to adjustment on ************ basis as follows:

    


    (A)   After
      the
      first Major Regulatory Approval is obtained for such Product, the Product
      Participation Model for such Product shall be adjusted by the JSC in accordance
      with Section 8.2(b)(iii) to account for Development Costs of the Parties
      specifically allocable to obtaining the other Major Regulatory Approval,
      provided they are previously approved by the Joint Steering Committee within
      the
      framework of the Development Plan.

    


    (B)   The
      Product Participation Model with respect to each Product shall be reviewed
      and
      adjusted by the JSC to reflect any additional significant costs properly
      allocated as Development Costs (such as capital costs and additional costs
      incurred by a Party to expand the indication or territory of the Product),
      approved by the JSC and incurred by the Parties in the previous year with
      respect to such Product, and the Parties’ respective Product Participation
      percentages shall be adjusted to reflect such additional Development Costs.
      Within ************ after the Effective Date, the Parties will agree upon a
      methodology for determining which costs shall be deemed “significant” for
      purposes of this Section 8.2(b) and costs not satisfying the agreed upon
      criteria shall be treated as Commercialization Costs and will be subject to
      reimbursement pursuant to Section 8.2(d).

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (C)   If
      a
      Party’s Product Participation for a Product is ************ but is ************,
      then once the Greater Funding Party has been fully reimbursed for any IPV
      Difference out of any distributed Net Profits in accordance with Section 8.2(d),
      the Product Participation of each Party with respect to the relevant Product
      shall be set at ************ for the remainder of the relevant Product Term,
      in
      each case (i) and (ii), subject to further adjustment in accordance with
      subsections (A) and (B) above. If a Party’s Product Participation for a Product
      (other than the Initial Product with respect to GTC) is ************ then the
      provisions of Section 8.2(c)(ii) shall apply.

    


    (c)   Funding
      of Development and Commercialization.

    


    (i)   Funding
      Obligations and Rights of the Parties.
      Subject
      to Sections 5.7(b) and 8.2(c)(ii), and except as set forth in the applicable
      Development Plan or Commercialization Plan, each Party will be responsible
      for
      paying those costs and expenses it incurs in the performance of its Development
      Activities and Commercialization Activities with respect to each Product, in
      each case as such costs are incurred.

    


    (ii)   Minimum
      Funding Commitment for Certain Products.
      Subject
      to the applicable Development Plan, it is the Parties’ present intention that
      each Party will ultimately ************ of the costs of Development for each
      Product other than the Initial Product. Notwithstanding the foregoing, if a
      Party is unable or unwilling to fund ************ of the Development Costs
      with
      respect to a Product other than the Initial Product, it shall notify the JSC
      in
      writing, within ************ prior to the completion of the annual budget under
      the applicable Development Plan, the amount of Development Costs such Party
      is
      able to fund during the relevant upcoming calendar year. Upon receipt of such
      notice, the JSC shall adjust the budget accordingly and such Party shall be
      obligated to fund that portion of Development Costs specified in the budget
      during the applicable calendar year. Subject to further adjustment in accordance
      with Section 8.2(b)(iv), the Profit Participation Model shall be revised to
      reflect such lesser participation. Notwithstanding the foregoing, in order
      to
      maintain its Profit Participation with respect to any Product other than the
      Initial Product, each Party must have funded ************ of the Development
      Costs (as weighted in accordance with the Product Development Model) of such
      Product in the aggregate during the period commencing on the relevant Product
      Start Date and ending on ************ for such Product. If a Party fails to
      fund
      ************ of such Development Costs of such Product during such period,
      then
      such Product shall cease to be subject to this Agreement, the licenses hereunder
      with respect to such Product shall terminate, and, without further action by
      the
      Parties, the rights and obligations of the Parties with respect to such Product
      after the time of such termination shall be governed by the terms of a
      definitive Commercial License to be executed between the Parties at such time,
      the material terms of which are set forth on Exhibit
      G.
      The
      Parties shall mutually agree upon the definitive terms of the Commercial License
      within ************ following the Product Start Date of each Product hereunder
      (other than the Initial Product).

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (d)   Reimbursement
      of Commercialization Costs.
      Each
      Party will be reimbursed for its Commercialization Costs with respect to a
      Product out of net revenues on Net Sales and other revenues derived from such
      Product prior to the distribution of Net Profits to the Parties in accordance
      with Section 8.3(c). After reimbursement of such costs, Net Profits shall be
      allocated between the Parties in accordance with their respective Product
      Participation and distributed in accordance with Section 8.3(c). In addition,
      if
      one Party’s Product Participation for a Product is ************ but is
      ************, the IPV Difference of the Greater Funding Party with respect
      to
      such Product shall be reimbursed to such Greater Funding Party out of its
      greater portion of Net Profits until such time as the IPV Difference is
      reimbursed in full, at which time the Product Participations of each Party
      shall
      be adjusted in accordance with Section 8.2(b)(iv)(C). If the aggregate
      Commercialization Costs of the Parties exceed the aggregate Net Sales and other
      revenues of the collaboration as a whole with respect to such Product in a
      calendar year, the amount of the net loss shall be treated as follows, depending
      on the calculated Product Participation for each Party:

    


    (i)   If
      each
      Party’s Product Participation for the relevant Product is ************, the
      amount of the loss incurred by each Party will be counted at ************
      of cost
      value in the IPV reimbursement calculation in the Product Participation Model
      in
      the calendar year in which the loss is recorded and will result in an adjustment
      to the amount of the IPV Difference that must be reimbursed to the Greater
      Funding Party pursuant to this Section 8.2(d).

    


    (ii)   If
      a
      Party’s Product Participation for a Product is ************
      but is
************,
      net
      losses incurred will be considered the responsibility of each Party in
      accordance with its Product Participation percentage. For example, if a Party
      has a Product Participation ************,
      such
      Party will be responsible for ************
      of the
      net losses with respect to such Product in the applicable calendar year. If
      at
      the end of any calendar year, a Party has funded less than its allocated
      percentage of aggregate net losses, such Party shall reimburse the other Party
      to the extent of such under funding. Such payment will be made in accordance
      with Section 8.3(c).

    


    (iii)   If
      a
      Party’s Product Participation for a Product is ************ net
      losses incurred will be considered the responsibility of each Party in
      accordance with its Product Participation percentage until such time as the
      Product is no longer subject to this Agreement. When such Party ************
      as
      described in Section 8.2(c)(ii), the foregoing provisions, including
      reimbursement on an annual basis, will apply to the extent applicable with
      respect to net losses incurred ************.
      Any
      reimbursement payment will be made in accordance with Section
      8.3(c).

     

    8.3   Reports.

    


    (a)   Quarterly
      Development and Commercialization Reports.
      Within
      ************ following the close of each calendar quarter during the Term,
      each
      Party will submit to the JSC a written report setting forth in reasonable
      detail, on a Product-by-Product basis, such Party’s Development Activities and
      Commercialization Activities for such Product and its actual costs (including
      Development Costs and Commercialization Costs) incurred in connection with
      the
      Development and/or Commercialization of Product(s) for such quarter, together
      with the aggregate amounts as at the end of such quarter past due and unpaid
      to
      Third Parties in respect of goods or services furnished by such Third Parties
      to
      the reporting Party in connection with its activities under this Agreement.
      The
      reports specified in this Section 8.3(a) shall be used in monitoring the
      Parties’ compliance with their respective Development and Commercialization
      obligations under this Agreement and by the JSC in updating the Development
      and
      Commercialization Plans in accordance with Sections 5.1 and 6.1 and the Product
      Participation Models in accordance with Section 8.2.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (b)   Quarterly
      Net Profits Reports.
      During
      the Term following First Commercial Sale with respect to a Product, each Party
      shall, within ************ following the end of each calendar quarter, furnish
      to the JSC a written quarterly report showing, in reasonable detail and on
      a
      Product-by-Product basis: (i) the gross sales of Product sold by such Party,
      its
      Affiliates, sublicensees and/or subcontractors; (ii) any other revenues relating
      to the Products, including without limitation royalties and any other payments
      from sublicensees or subcontractors; (iii) a calculation of Net Sales of the
      Party for such quarter; (iv) the Development Costs of such Party for such
      quarter, and (v) the Commercialization Costs of such Party for such
      quarter.

    


    (c)   Annual
      Reconciliation of Net Profit.
      On an
      annual basis during the Term, and upon the expiration or termination of this
      Agreement, the JSC (or a subcommittee thereof) shall submit to both Parties
      within ************ of the end of the applicable calendar year, or of the
      effective date of termination, as the case may be, a summary report setting
      forth, on a Product-by-Product basis for the previous calendar year (or portion
      thereof) and for the cumulative program to date for each Product from the
      Product Start Date through the period of the report: (i) the gross sales of
      Product sold by each Party, its Affiliates, sublicensees and/or subcontractors;
      (ii) any other revenues of each Party relating to the Products, including
      without limitation royalties and any other payments from sublicensees or
      subcontractors; (iii) a calculation of Net Sales of each Party; (iv) the
      Development Costs of each Party, and (v) the Commercialization Costs of each
      Party. Such report shall account for any differences between the Parties’
accounting methodologies in a manner to be reasonably agreed by the Parties.
      The
      report shall also indicate, on a Product-by-Product basis, the Product
      Participation of each Part and the amount of IPV (if prior to the First
      Commercial Sale) or of Net Profits due each Party (if after the First Commercial
      Sale) for the applicable reporting period based on the Product Participation
      Model, and shall reconcile such amount with the net profits and loss statements
      of such Party for the applicable reporting period. If the report indicates
      that
      the Net Profits received by a Party with respect to a Product in the reporting
      period exceed the amount due such Party for such reporting period, such Party
      shall pay the other Party the amount of the difference within ************
      following receipt of the report (each such payment, a “Profit
      Payment”).
      If
      the report indicates that there is an aggregate net loss, the provisions of
      Section 8.2 shall determine the treatment of the Parties’ respective losses and
      any reimbursement due from one Party to the other shall be made within
      ************ following receipt of the report.

     

    8.4   Records;
      Audit.

    


    (a)   Records.
      The
      Parties shall keep, and shall cause their respective Affiliates and
      subcontractors to keep, complete, true and accurate books and records with
      respect to all data related to sales of and costs incurred in connection with
      the Products, and specifically regarding sales figures, in accordance with
      the
      defined Accounting Standards and in sufficient detail to reflect all gross
      sales, Net Sales, Development Costs and Commercialization Costs, and to enable
      the amount of Net Profits due each Party hereunder to be determined. The Parties
      will keep, and shall cause their respective Affiliates and subcontractors to
      keep, such books and records for at least ************ following the end of
      the
      calendar quarter to which they pertain. Such books and records shall be kept
      by
      each Party, or the applicable Affiliate or subcontractor, at its principal
      place
      of business.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (b)   Audit
      of Records.

    


    (i)   During
      the Term and for ************ thereafter, each Party shall have the right,
      at
      its own expense, through an independent certified public accounting firm of
      nationally or internationally recognized standing (or such other independent
      Third Party on which the Parties may agree) acceptable to the other Party,
      to
      review financial and related records in the location(s) where such records
      are
      maintained by the other Party or such other Party’s Affiliates or
      subcontractors, upon reasonable notice, during regular business hours and under
      obligations of confidence, for the sole purpose of verifying such other Party’s
      compliance with its obligations under this Agreement; provided
      that
      such examination shall not take place more than once per calendar year and
      shall
      not cover records for more than the preceding ************; and provided
      further
      that
      such accounting firm or other Third Party auditor shall first have entered
      into
      a confidentiality agreement mutually agreeable to the Parties. The results
      of
      such review shall be made available to both Parties.

    


    (ii)   If
      the
      review reflects any significant misreporting of expenses or performance by
      the
      Party subject to the review, i.e. the amount of such misreporting is equal
      to or
      ************ of the expense or performance amount that should have properly
      been
      reported during the applicable reporting period or is in excess of ************,
      the Party subject to the review shall pay all of the costs of such
      review
      and, in
      the event of any underpayment shall pay any additional sum, including interest
      charges (at a rate ************
      percentage points above LIBOR), shown to be due to the other Party.

    


    (iii)   In
      the
      event that either Party in good faith disputes the results of the review, or
      any
      specific aspect thereof, then such Party shall inform the other Party by written
      notice within ************ after receiving the result of the review, specifying
      in detail the reasons for disputing the results thereof. The Parties shall
      promptly thereafter meet and negotiate in good faith a resolution to such
      dispute. In the event that the Parties are unable to resolve such dispute within
      ************ after such dispute notice is received, the matter shall be resolved
      in a manner consistent with the procedures set forth in Article 15.

     

    8.5   Currency
      of Account and Payment. 
      For
      purposes of Sections 8.2, 8.3 and 8.4, all amounts will be calculated in United
      States Dollars and all Profit Payments hereunder shall be calculated and paid
      in
      United States Dollars. Conversion into United States Dollars from other
      currencies for purposes of calculating Net Profits and of setting and adjusting
      the Product Participation Models shall be calculated using average rates
      published by the ECB for the calendar month in which the sale of the Product
      occurred or the relevant Development Cost or Commercialization Cost was
      incurred, as the case may be. Any rates not listed by the ECB, will be derived
      using the average Exchange Rates published in the Wall Street Journal for the
      applicable calendar month. All amounts invoiced by GTC for goods or services
      will be invoiced and paid in United States Dollars and all amounts invoiced
      by
      LFB Biotech for goods or services shall be invoiced and paid in Euros, in each
      case except as otherwise may be agreed. 

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    8.6   Blocked
      Currency.
      If by
      reason of exchange controls or other laws in a particular jurisdiction a Party
      is unable to convert to United States Dollars or Euros, as the case may be,
      in
      accordance with Section 8.5, and transfer any portion of the amount payable
      by
      such Party under this Agreement, then such Party shall promptly notify the
      other
      Party in writing and shall pay such amounts through such means or methods as
      are
      lawful in such jurisdiction as the other Party may reasonably designate. Failing
      the designation by the other Party of such lawful means or methods within
      ************ after such notice is given to such other Party, the Party
      responsible for making such payment shall deposit such payment in local currency
      to the credit of the other Party in a recognized banking institution designated
      by the Party entitled to such payment, or if none is designated within the
      ************ period described above, in a local banking institution selected
      by
      the Party responsible for making such payment and identified in a written notice
      to the Party entitled to such payment, and such deposit shall fulfill all
      obligations of the Party responsible for making such payment with respect
      thereto.

     

    8.7   Taxes.

    


    (a)   Cooperation
      and Coordination.
      The
      Parties acknowledge and agree that it is their mutual objective and intent
      to
      minimize, to the extent permitted under applicable laws and regulations, taxes
      payable with respect to their collaboration efforts under this Agreement and
      that they shall use their best efforts to cooperate and coordinate with each
      other to achieve such objective.

    


    (b)   Payment
      of Tax.
      A Party
      receiving a payment pursuant to this Article 8, or otherwise deemed to receive
      a
      payment under this Agreement, shall pay any and all taxes levied on such payment
      or deemed payment. If applicable laws or regulations require that taxes be
      deducted and withheld from a payment made pursuant to this Article 8, the
      remitting Party shall (i) deduct those taxes from the payment;
      (ii) pay the taxes to the proper taxing authority; and (iii) send
      evidence of the obligation together with proof of payment to the other Party
      within ************ following that payment.

    


    (c)   Tax
      Residence Certificate.
      A Party
      receiving a payment pursuant to this Article 8 shall provide the remitting
      Party
      a certification from the revenue authorities of any jurisdiction that it is
      a
      tax resident of that jurisdiction if such receiving Party wishes to claim the
      benefits of an income tax treaty to which that jurisdiction is a party. Upon
      the
      receipt thereof, any deduction and withholding of taxes shall be made at the
      appropriate treaty tax rate.

     

    (d)   Assessment.
      Either
      Party may, at its own expense, protest any assessment, proposed assessment,
      or
      other claim by any governmental authority for any additional amount of taxes,
      interest or penalties or seek a refund of such amounts paid if permitted to
      do
      so by law. The Parties shall cooperate with each other in any protest by
      providing records and such additional information as may reasonably be necessary
      for a Party to pursue such protest.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    ARTICLE
      9

    PATENTS
      AND INVENTIONS

    


    9.1   Ownership.

    


    (a)   Sole
      Inventions.
      Except
      as otherwise expressly provided in this Agreement, as between GTC and LFB
      Biotech, and subject to the express license grants under Articles 3, 7.4 and
      14
      hereof, each Party shall exclusively own all and retain all right, title and
      interest in and to all Inventions and Know-How made solely by the employees,
      contractors, consultants or agents of such Party, its Affiliates or
      sublicensees, as applicable (“Sole
      Inventions”).

    


    (b)   Joint
      Inventions.
      LFB
      Biotech and GTC shall ************ any Invention invented jointly by the
      employees or agents of LFB Biotech and GTC or their respective Affiliates,
      with
      or without Third Parties (the “Joint
      Inventions”),
      and
      any Patent Rights that claim such Joint Inventions (the “Joint
      Patent Rights”).
      Neither LFB Biotech nor GTC, ************. 

    


    (c)   Inventorship.
      Solely
      for the purpose of determining ownership of Inventions with respect to any
      US
      Patent Rights under this Section 9.1, inventorship shall be determined in
      accordance with United States patent laws.

    


    9.2   Patent
      Prosecution.

    


    (a)   LFB
      Biotech Patent Rights and Joint Patent Rights in LFB Biotech’s
      Territory.

    


    (i)   LFB
      Biotech shall retain sole and exclusive ownership of all LFB Biotech Patent
      Rights and, subject to Section 9.2(a)(ii), shall retain control over, and bear
      all expenses associated with, the filing, prosecution, and maintenance of any
      LFB Biotech Patent Rights in the entire Territory and any Joint Patent Rights
      in
      the European Territory and any country or region of the Co-Exclusive Territory
      as the JSC may designate. LFB Biotech shall confer in good faith with GTC
      regarding LFB Biotech’s patent strategy with respect to any LFB Biotech Patent
      Rights licensed to GTC hereunder and any Joint Patent Rights in LFB Biotech’s
      respective Territory or region and GTC shall have the right to comment upon
      LFB
      Biotech’s strategy.

    


    (ii)   In
      the
      event LFB Biotech decides, at its sole discretion, not to file, nationalize
      or
      validate a patent application covering an LFB Biotech Sole Invention or Joint
      Invention or LFB Biotech Know-How in any country in the Territory or LFB Biotech
      decides not to continue to prosecute or maintain a patent or patent application
      included in the LFB Biotech Patent Rights licensed to GTC hereunder, LFB Biotech
      shall promptly notify GTC of such decision and GTC shall have the right to
      file,
      prosecute, and maintain such patent or patent application at its sole expense
      and discretion. If GTC elects to file, prosecute, or maintain such patent or
      patent application (as applicable) at its own expense, LFB Biotech shall
      reasonably cooperate with GTC in connection with such filing, prosecution and/or
      maintenance.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (b)   GTC
      Patent Rights and Joint Patent Rights in GTC’s Territory.

    


    (i)   GTC
      shall
      retain sole and exclusive ownership of all GTC Patent Rights and, subject to
      Section 9.2(b)(ii), shall retain control over, and bear all expenses associated
      with, the filing, prosecution, and maintenance of any GTC Patent Rights in
      the
      entire Territory and any Joint Patent Rights in the North American Territory
      and
      any country or region of the Co-Exclusive Territory as the JSC may designate.
      GTC shall confer in good faith with LFB Biotech regarding GTC’s patent strategy
      with respect to any GTC Patent Rights licensed to LFB Biotech hereunder and
      any
      Joint Patent Rights in GTC’s respective Territory or region and LFB Biotech
      shall have the right to comment upon GTC’s strategy.

    


    (ii)   In
      the
      event GTC decides, at its sole discretion, not to file, nationalize or validate
      a patent application covering a GTC Sole Invention or Joint Invention or GTC
      Know-How in any country in the Territory or GTC decides not to continue to
      prosecute or maintain a patent or patent application included in the GTC Patent
      Rights licensed to LFB Biotech hereunder, GTC shall promptly notify LFB Biotech
      of such decision and LFB Biotech shall have the right to file, prosecute, and
      maintain such patent or patent application at its sole expense and discretion.
      If LFB Biotech elects to file, prosecute, or maintain such patent or patent
      application (as applicable) at its own expense, GTC shall reasonably cooperate
      with LFB Biotech in connection with such filing, prosecution and/or
      maintenance.

     

    9.3   Enforcement
      of Patent Rights.

    


    (a)   Notice.
      Each
      Party shall give prompt written notice to the other Party promptly after gaining
      knowledge of any Third Party activity that infringes any GTC Patent Right,
      LFB
      Biotech Patent Right, or Joint Patent Right, or if any declaratory judgment
      action is filed by a Third Party against such Party alleging noninfringement
      or
      invalidity of any GTC Patent Right, LFB Biotech Patent Right or Joint Patent
      Right. 

    


    (b)   Enforcement
      Rights.

    


    (i)   LFB
      Biotech Patent Rights.
      LFB
      Biotech shall have the primary right, but not the obligation, to institute,
      prosecute and control any action or proceeding with respect to any unauthorized
      Third Party activity under the LFB Biotech Patent Rights, including any LFB
      Biotech Patent Rights licensed to GTC hereunder. If LFB Biotech fails to bring
      an infringement action under such LFB Biotech Patent Rights or to notify GTC
      whether or not LFB Biotech intends to bring such action, in each case within
      a
      period of ************ after delivery of the notice set forth in
      Section 9.3(a), then GTC shall have the right, but not the obligation, to
      bring and control an action with respect to such Third Party activity, by
      counsel of its own choice.

    


    (ii)   GTC
      Patent Rights.
      GTC
      shall have the primary right, but not the obligation, to institute, prosecute
      and control any action or proceeding with respect to any unauthorized Third
      Party activity under the GTC Patent Rights, including any GTC Patent Rights
      licensed to LFB Biotech hereunder. If GTC fails to bring an infringement action
      under such GTC Patent Rights or to notify LFB Biotech whether or not it intends
      to bring such action, in each case within a period of ************ after
      delivery of the notice set forth in Section 9.3(a), then LFB Biotech shall
      have the right, but not the obligation, to bring and control an action with
      respect to such Third Party activity, by counsel of its own choice.

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (iii)   Joint
      Patent Rights.
      LFB
      Biotech shall have the primary right, but not the obligation, to institute,
      prosecute and control any action or proceeding with respect to any unauthorized
      Third Party activity under the Joint Patent Rights in the European Territory.
      GTC shall have the primary right, but not the obligation, to institute,
      prosecute and control any action or proceeding with respect to any unauthorized
      Third Party activity under the Joint Patent Rights in the North American
      Territory. The Parties shall mutually agree upon which Party shall have the
      primary right, but not the obligation, to institute, prosecute and control
      any
      action or proceeding with respect to any unauthorized Third Party activity
      under
      the Joint Patent Rights in the Co-Exclusive Territory. If the Party having
      the
      primary right to institute, prosecute and control any action or proceeding
      pursuant to this Section 9.3(b)(iii) fails to bring an infringement action
      under
      the Joint Patent Rights or to notify the other Party whether or not it intends
      to bring such action, in each case within a period of ************ after
      delivery of the notice set forth in Section 9.3(a), then the other Party
      shall have the right, but not the obligation, to bring and control an action
      with respect to such Third Party activity, by counsel of its own
      choice.

    


    (iv)   Notification;
      Cooperation.
      If a
      Party intends to initiate an infringement action under this Section 9.3(b),
      or
      decides not to initiate such action, it shall promptly provide written
      notice
      to the
      other Party of such intent. The Party controlling any action under this Section
      9.3(b) shall notify the other Party promptly upon commencement of such action
      and shall keep the other Party reasonably informed of the status of such action.
      In
      connection
      with any
      action under this Section 9.3(b), the Parties will cooperate fully and will
      provide each other with any information or assistance that the other may
      reasonably request, at the expense of the Party initially bringing the action.
      Notwithstanding a Party’s right to control an action under this Section 9.3(b),
      neither Party shall settle or compromise any claim or proceeding that would
      adversely affect the scope, validity or enforceability of any
      Patent
      Right
      granted
      by one Party to another hereunder or otherwise adversely affect the rights
      and
      licenses granted hereunder unless agreed to in writing by both Parties, which
      consent shall not be unreasonably withheld or delayed.

    


    (c)   Allocation
      of Recovery.
      Any
      damages or monetary awards recovered by the Party enforcing an action hereunder
      shall (i)(A) first be applied to reimburse such Party in an amount equal to
      the
      costs and expenses of such Party in connection with such litigation, and (B)
      then be applied to reimburse the non-enforcing Party in an amount equal to
      the
      costs and expenses of such Party in connection with such litigation, and
      (ii) any remaining balance shall be ************.

     

    9.4   Claimed
      Infringement.
      In the
      event that a Party becomes aware of any Third Party claim that the manufacture,
      use, sale, offer for sale, and/or importation of any Product in the Territory
      infringes the Patent Rights of any such Third Party, the terms and conditions
      of
      Article 13 shall apply.

     

    9.5   Declaratory
      Actions.
      The
      rights of the Parties to defend any declaratory judgment action alleging
      noninfringement or invalidity of any GTC Patent Right, LFB Biotech Patent Right
      or Joint Patent Right shall be consistent with the rights of the Parties to
      prosecute and control an action against a Third Party pursuant to Section
      9.3(b).

     

    9.6   Costs
      of Patent Prosecution and Enforcement.
      All
      costs incurred or paid by a Party in prosecuting and enforcing any Patent Rights
      in accordance with this Article 9, to the extent not otherwise reimbursed to
      or
      recovered by such Party, shall be treated as Development Costs of such Party
      to
      the extent incurred during the Development Phase, and as Commercialization
      Costs
      of such Party to the extent incurred during the Commercialization
      Phase.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    ARTICLE
      10

    TRADEMARK
      USAGE AND MAINTENANCE

    


    10.1   Trademarks.

    


    (a)   Selection
      of Product Marks.
      Promptly after the Effective Date, LFB Biotech and GTC agree to undertake a
      program to identify suitable trademarks for use with the Initial Product in
      the
      Territory under this Agreement, it being agreed that the Originating Party
      shall
      make a presentation to the other Party as to the trademarks it considers
      appropriate. The objective of the Parties is to develop a single trademark
      suitable for use throughout the Territory but the Parties recognize that it
      may
      be necessary or desirable to use additional or alternative trademarks in certain
      Territories or certain countries within the Territories. As additional Products
      are added to the Agreement pursuant to Section 2.1, the Parties shall undertake
      a similar program with respect to each Product to identify suitable trademarks
      for use in connection such Products hereunder, with the Originating Party making
      a presentation to the other Party as to the trademarks it considers appropriate.
      All trademarks which the Parties decide should be used for a Product (with
      respect to such Product the “Product
      Trademark”
or
      the
“Product
      Trademarks”)
      will
      be owned by the Originating Party of such Product (the “Trademark
      Owner”).
      Similarly, the Parties will cooperate in the selection and approval (i.e.,
      through USAN and WIPO) of a generic name for each Product and a domain name
      with
      respect to each Product, with the objective the each Product shall have the
      same
      approved generic name and the same domain name throughout the entire Territory.
      The provisions of this Agreement as to the ownership and licensing of Product
      Trademarks shall apply mutatis
      mutandis
      to the
      ownership and licensing of generic names and domain names.

    


    (b)   Product
      Trademark Prosecution.
      The
      Trademark Owner shall be responsible for filing and prosecuting applications
      to
      register its Product Trademarks in the entire Territory, and for maintenance
      of
      such registrations thereafter, and shall initially bear all costs associated
      therewith, provided that the Trademark User shall reimburse the Trademark Owner
      for all costs associated with filing, prosecuting and maintaining its Product
      Trademark in the Trademark User’s exclusive Territory and in each country or
      region in the Co-Exclusive Territory designated to such Trademark User in the
      Commercialization Plan for such Product. GTC shall consult with LFB Biotech
      with
      respect to the countries or regions (e.g. a Community Trade Mark) in which
      registration of Product Trademarks owned by GTC will be sought in the European
      Territory, and will register the Product Trademarks in all such countries or
      regions as reasonably requested by LFB Biotech in the European Territory. LFB
      Biotech will register Product Trademarks owned by LFB Biotech in the United
      States and Canada. The Trademark Owner will consult with the Trademark User
      with
      respect to the countries or regions within the Co-Exclusive Territory in which
      the Product Trademarks owned by the Trademark Owner will be registered and
      will
      register the Product Trademarks in all such countries or regions as reasonably
      requested by the Trademark User. 

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (c)   Product
      Trademark Enforcement.
      LFB
      Biotech shall be responsible for enforcing the Product Trademarks in the
      European Territory and shall bear all costs associated therewith and GTC shall
      be responsible for enforcing the Product Trademarks in the North American
      Territory and shall bear all costs associated therewith. The Parties shall
      mutually determine, through the JSC, on a Product- by- Product and
      country-by-country basis, which Party shall be responsible for enforcing the
      Product Trademarks in respect of the relevant Product in the Co-Exclusive
      Territory. Each Party shall promptly inform the other Party in writing of any
      alleged or threatened infringements of the Product Trademarks in the Territory,
      or of any challenge to the validity of the Product Trademarks of which they
      become aware, and the JSC shall consider the action to be taken. In the event
      that the Parties, through the JSC, elect to prosecute or defend the matter,
      they
      will determine which Party will do so using counsel approved by both Parties,
      and no settlement, consent judgment or other voluntary disposition of the matter
      may be entered into by either Party without the consent of the other
      Party.

    


    (d)   No
      Implied Licenses.
      Except
      for the license granted in Section 3.1(e), nothing herein shall create any
      rights of either Party in and to any Product Trademarks owned by the other
      Party
      as provided in this Agreement.

    


    (e)   Costs
      of Trademark Prosecution and Enforcement.
      All
      costs incurred or paid by a Party in prosecuting and enforcing Product
      Trademarks for a Product in accordance with this Article 10, to the extent
      not
      otherwise reimbursed to or recovered by such Party, shall be treated as
      Development Costs of such Party to the extent incurred during the Development
      Phase, and as Commercialization Costs of such Party to the extent incurred
      during the Commercialization Phase.

    


    ARTICLE
      11

    COVENANTS,
      REPRESENTATIONS, AND WARRANTIES

    


    11.1   Mutual
      Covenants.
      Each
      Party covenants the following:

    


    (a)   That
      it
      shall comply, and cause its Affiliates, employees, agents, sublicensees and
      subcontractors to comply, with all federal, state, provincial, territorial,
      governmental, and local laws, rules, and regulations applicable to the
      Development, manufacture, and Commercialization of Products in the Territory
      by
      such Party pursuant to the Development Plan, the Commercialization Plan, and
      this Agreement, including without limitation, with respect to the United States,
      the Prescription Drug Marketing Act, the Federal Food, Drug and Cosmetics Act
      of
      1938, as amended, the Health Insurance Portability and Accountability Act,
      the
      Federal Anti-Kickback Statute, and any applicable FDA regulations relating
      to
      sampling practices.

    


    (b)   That
      it
      shall disclose promptly, without delay, to the other Party all information
      in
      its Control, and as to which it becomes aware, concerning side effects, injury,
      toxicity, or sensitivity reaction and incidents or severity thereof with respect
      to the Products.

    


    (c)   That
      it
      shall not, and shall cause its Affiliates not to, during the Term, grant,
assign,
      transfer, convey or otherwise encumber its right, title and interest in its
      respective Patent Rights and Know-How in a manner that conflicts or is
      inconsistent with the rights and licenses granted to the other Party under
      this
      Agreement.

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (d)   To
      the
      extent that any of its obligations under this Agreement require performance
      or
      observance by one or more of its Affiliates, it has made, or shall have made
      prior to the time such performance or observance is required, arrangements
      with
      the relevant Affiliate(s) to cause such obligations to be performed or observed
      in accordance with the terms and conditions of this Agreement.

    


    (e)   At
      no
      time during the Term shall its past due and unpaid obligations to Third Parties
      in respect of goods or services furnished by such Third Parties to such Party
      in
      connection with its activities under this Agreement exceed ************ in
      the
      aggregate.

    


    11.2   Representations
      and Warranties of the Parties.

    


    (a)   GTC
      and
      LFB Biotech each represents and warrants to the other that, as of the Effective
      Date: 

    


    (i)   it
      is
      duly organized, validly existing, and in good standing under the laws of its
      jurisdiction of incorporation;

    


    (ii)   it
      has
      the authority and right to enter into this Agreement and to perform its
      obligations hereunder;

    


    (iii)   this
      Agreement is a legal and valid obligation binding upon it and is enforceable
      in
      accordance with its terms, subject to applicable limitations on such enforcement
      based on bankruptcy laws and other debtors’ rights;

    


    (iv)   its
      execution, delivery and performance of this Agreement will not conflict in
      any
      material fashion with the terms of any other agreement or instrument to which
      it
      is or becomes a party or by which it is or becomes bound, subject to the terms
      of any disclosure that either Party shall have made to the other Party on the
      date hereof nor violate any law or regulation of any court, governmental body
      or
      administrative or other agency having authority over it;

    


    (v)   to
      its
      knowledge, all necessary consents, approvals and authorizations of all
      government authorities and other persons required to be obtained as of the
      Effective Date in connection with the execution, delivery and performance of
      this Agreement have been obtained; and

    


    (vi)   neither
      its name nor the name of any of its Affiliates or their respective employees
      or
      consultants who will be undertaking any activities related to this Agreement
      or
      the Product are listed on the debarment list maintained by the FDA pursuant
      to
      21 U.S.C. § 335(a) and § 335(b) and published on the internet at the
      following address (or any successor address):
      http://www.fda.gov/ora/compliance_ref/debar/default.htm.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    11.3   Additional
      Representations and Warranties of LFB Biotech.
      LFB
      Biotech hereby represents and warrants to GTC that, as of the Effective
      Date:

    


    (a)   There
      are
      no claims or, to LFB Biotech’s knowledge, written threats of interference,
      nullity or similar invalidity proceedings (or the equivalent in countries
      outside the United States) pending with respect to the LFB Biotech Patent
      Rights;

    


    (b)   Neither
      LFB Biotech nor any of its Affiliates has previously
      granted, assigned, transferred, conveyed or otherwise encumbered its right,
      title and interest in the LFB Biotech Technology in a manner that conflicts
      or
      is inconsistent with the rights and licenses granted to GTC under this
      Agreement;

    


    (c)   To
      the
      best of LFB Biotech’s knowledge, LFB Biotech or its Affiliates Controls all
      right, title and interest in and to the LFB Biotech Technology, including any
      data, materials and animals provided to GTC hereunder, and LFB Biotech has
      the
      right to grant the rights and licenses granted to GTC hereunder;
      and

    


    (d)   There
      is
      no action, claim, demand, suit, proceeding, arbitration, grievance, citation,
      summons, subpoena, inquiry or investigation pending or relating to or, to LFB
      Biotech’s knowledge, threatened that the LFB Biotech Technology infringes upon
      the patent rights or other intellectual property rights of any Third
      Party.

     

    11.4   Additional
      Representations and Warranties of GTC.
      GTC
      hereby represents and warrants to LFB Biotech that, as of the Effective
      Date:

    


    (a)   There
      are
      no claims or, to GTC’s knowledge, written threats of interference, nullity or
      similar invalidity proceedings (or the equivalent in countries outside the
      United States) pending with respect to the GTC Patent Rights;

    


    (b)   Neither
      GTC nor any of its Affiliates has previously
      granted, assigned, transferred, conveyed or otherwise encumbered its right,
      title and interest in the GTC Technology
      in a
      manner that conflicts or is inconsistent with the rights and licenses granted
      to
      LFB Biotech under this Agreement;

    


    (c)   To
      the
      best of GTC’s knowledge, GTC or its Affiliates Controls all right, title and
      interest in and to the GTC Technology, including any materials provided to
      LFB
      Biotech hereunder, and GTC has the right to grant the rights and licenses
      granted to LFB Biotech hereunder; and

    


    (d)   There
      is
      no action, claim, demand, suit, proceeding, arbitration, grievance, citation,
      summons, subpoena, inquiry or investigation pending or relating to or, to GTC’s
      knowledge, threatened that the GTC Technology infringes upon the patent rights
      or other intellectual property rights of any Third Party.

     

    11.5   Performance
      by Affiliates.
      Either
      Party may perform some or all of its obligations under this Agreement through
      one or more of its Affiliates or sublicensees or subcontractors, provided,
      however,
      that
      such Party shall remain responsible for, and be guarantor of, the performance
      by
      its Affiliates, sublicensees and subcontractors.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    ARTICLE
      12

    CONFIDENTIALITY

    


    12.1   Treatment
      of Confidential Information.
      Except
      as provided below, the Parties agree that during the Term, and for a period
      of
      ************ thereafter, each Party (the “Receiving
      Party”)
      shall
      (a) maintain in confidence Confidential Information of the other Party (the
“Disclosing
      Party”)
      to at
      least the same extent and with the same degree of care as the Receiving Party
      maintains its own proprietary information of similar kind and value (but at
      a
      minimum each Party shall use Commercially Reasonable Efforts), including,
      without limitation, using Commercially Reasonable Efforts to protect the
      integrity and confidentiality of the Disclosing Party’s Confidential
      Information, (b) not disclose such Confidential Information to any Third
      Party without prior written consent of the Disclosing Party, except for
      disclosures made in confidence to any Third Party that are explicitly permitted
      by the Development Plan or Commercialization Plan or approved by the JSC, and
      (c) not use such Confidential Information for any purpose except those
      permitted by this Agreement.

     

    12.2   Exceptions.
      Notwithstanding the foregoing, the Receiving Party shall have no such
      confidentiality and non-use obligations with respect to any portion of the
      Confidential Information of the Disclosing Party that:

     

    (a)   at
      the
      time of disclosure by the Disclosing Party to the Receiving Party, was generally
      available to the public, or after such disclosure, becomes generally available
      to the public through no fault attributable to the Receiving Party;
      or

    


    (b)   was
      known
      to the Receiving Party, without obligation to keep it confidential, prior to
      when it was received from the Disclosing Party, as evidenced by the Receiving
      Party’s written records in existence at the time of disclosure; or

    


    (c)   is
      subsequently disclosed to the Receiving Party, without obligation to keep it
      confidential, by a Third Party lawfully in possession thereof and having the
      right to so disclose; or

    


    (d)   as
      demonstrated by the Receiving Party by competent written proof, has been
      independently developed by employees of the Receiving Party who do not have
      access to or knowledge of such Confidential Information.

    


    12.3   Authorized
      Disclosures.
      Nothing
      in this Agreement shall prohibit the Receiving Party from disclosing
      Confidential Information of the other Party, as well as the terms and conditions
      of this Agreement:

    


    (a)   to
      the
      Receiving Party’s Affiliates, employees, agents, consultants, sublicensees,
      clinical investigators, and contract manufacturers, if any, but only on a
      need-to-know basis for purposes provided for in this Agreement, provided
      that
      such disclosure occurs pursuant to a written confidentiality agreement
      containing provisions at least as protective as those of this Article
      12;

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (b)   to
      the
      Receiving Party’s professional advisors or investors who are bound by a duty of
      confidentiality with obligations at least as protective as the provisions of
      this Article 12;

    


    (c)   to
      the
      extent required by court order, law, or regulation, provided
      that the
      Receiving Party provides the other Party prior written notice of the required
      disclosure and takes reasonable steps to limit such disclosure to the minimum
      required amount and to obtain, or cooperate with the other Party in obtaining,
      a
      protective order or other similar order requiring that such Confidential
      Information be used only for the purposes required by such court order, law,
      or
      regulation.

    


    12.4   Publicity.
      All
      publicity, press releases, and other public announcements relating to this
      Agreement or the performance hereunder other than publications described in
      Section 12.5 shall be reviewed in advance by, and shall be subject to the
      written approval of, both Parties (which approval shall not be unreasonably
      withheld). Notwithstanding the foregoing, any disclosure which is required
      by
      law or any listing or securities trading agreement concerning a Party’s publicly
      traded securities, based upon advice of the disclosing Party’s counsel, may be
      made without the prior consent of the other Party, provided
      that
      (a) the other Party shall be given prompt notice of any such legally
      required disclosure and to the extent practicable the disclosing Party shall
      provide the other Party an opportunity to comment on the proposed disclosure
      and
      in the case of the legally required disclosure of the text of this Agreement,
      to
      request the redaction of such parts hereof as may be appropriate, which request
      shall be transmitted by the disclosing Party to the authority requiring such
      disclosure, and (b) such disclosure is limited only to the information that
      is required to be disclosed by the applicable foregoing exception. The Parties
      will agree upon a press release to announce the execution of this Agreement.
      The
      press release will be in the form set out in Exhibit
      F.
      Thereafter, GTC and LFB Biotech may each disclose to Third Parties the
      information contained in such press release without the need for further
      approval by the other Party. Notwithstanding any of the foregoing, the Parties
      acknowledge that GTC shall disclose on a Current Report on Form 8-K the
      existence of this Agreement and its material terms within ************ Business
      Days after the Effective Date provided such Form 8-K shall contain only the
      information set forth in the press release set out in Exhibit F unless LFB
      Biotech otherwise agrees in writing, such agreement not to be unreasonably
      withheld or delayed.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    12.5   Publication.

    


    (a)   Each
      Party agrees that it shall not, and shall cause its Affiliates not to, publish
      or present to the public the results of non-clinical studies or clinical trials
      or other information related to any Product in the Territory without the
      opportunity for prior review by the other Party. If a Party (the “Publishing
      Party”)
      wishes
      to publish or to present to the public such results, then it shall provide
      the
      other Party (the “Non-Publishing
      Party”)
      the
      opportunity to review any of the Publishing Party’s proposed abstracts,
      manuscripts or presentations (including verbal presentations) which relate
      to
      the Product at least ************ prior to its intended submission for
      publication and agrees, upon request, not to submit any such abstract or
      manuscript for publication until the other Party is given a reasonable period
      of
      time to secure patent protection for any material in such publication which
      it
      believes to be patentable. Both Parties understand that a reasonable commercial
      strategy may require delay of publication of information or filing of patent
      applications. The Parties agree to review and consider delay of publication
      and
      filing of patent applications under certain circumstances. Neither Party or
      its
      Affiliates shall have the right to publish or present to the public Confidential
      Information of the other Party, except as permitted under Sections 12.2 or
      12.3. Nothing contained in this Section 12.5 shall prohibit the inclusion
      of information necessary for a patent application, provided that the
      non-Publishing Party is given a reasonable opportunity to review the information
      to be included prior to submission of such patent application. Notwithstanding
      anything to the contrary herein, either Party may disclose information about
      the
      clinical trials performed or to be performed on Products hereunder, without
      the
      need to obtain the other Party’s approval (provided,
      however,
      that
      the Publishing Party will use reasonable efforts to inform the other Party
      and
      to allow the other Party to comment on the disclosure), to the extent that
      such
      disclosure is reasonably necessary to comply with applicable laws, regulations
      and guidelines of Regulatory Authorities.

    


    (b)   It
      is
      understood that a detail of the Product in the Territory shall not be considered
      to be publication or presentation to the public and shall therefore not be
      subject to the requirements of Section 12.5(a).

     

    12.6   Termination
      of Prior Confidentiality Agreements.
      This
      Agreement supersedes all nondisclosure agreements entered into by the Parties
      prior to the Effective Date. All information exchanged between the Parties
      that
      qualified as confidential or proprietary under such nondisclosure agreements
      prior to the Effective Date shall be deemed Confidential Information hereunder
      and shall be subject to the terms of this Article 12.

    


    ARTICLE
      13

    INDEMNIFICATION

    


    13.1   Indemnification
      by LFB Biotech.
      Unless
      otherwise provided herein, LFB Biotech agrees to indemnify, hold harmless and
      defend GTC, its Affiliates, and its and their respective directors, officers,
      employees and agents (the “GTC
      Indemnitees”)
      from
      any and all liabilities, costs, damages, fines, penalties, amounts paid in
      settlement, fees and expenses (including reasonable fees and expenses of legal
      counsel) (“Damages”)
      arising from an Action by a Third Party (collectively, “Third
      Party Claims”)
      resulting or alleged to result from, directly or indirectly, any of the
      following (each, an “LFB
      Biotech Assumed Liability”):

    


    (a)   a
      breach
      by LFB Biotech of a representation, warranty, or covenant made under this
      Agreement; 

    


    (b)   any
      negligence or willful misconduct of the LFB Biotech Indemnitees in connection
      with their performance of LFB Biotech’s obligations under this
      Agreement;

    


    (c)   the
      practice of the LFB Biotech Technology to manufacture, use, sale, offer for
      sale, and/or import Products under this Agreement infringing the Patent Rights
      of any Third Party;

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (d)   the
      infringement of any Third Party Patent Rights by LFB Biotech or its Affiliates
      or subcontractors in the manufacture, use, sale, offer for sale, and/or
      importation of Products under this Agreement; or

    


    (e)   the
      manufacture, use, sale, offer for sale and/or importation of the Products by
      LFB
      Biotech or its Affiliates or subcontractors causing, directly or indirectly,
      any
      Third Party personal injury or death, possibility of injury or death or economic
      loss.

    Such
      indemnity shall not apply to the extent it is shown that such Third Party Claim
      was the result of any GTC Assumed Liability (as defined below) or constitutes
      a
      Shared Liability Claim.

     

    13.2   Indemnification
      by GTC.
      Unless
      otherwise provided herein, GTC shall indemnify, hold harmless and defend LFB
      Biotech, its Affiliates, and its and their respective directors, officers,
      employees and agents (the “LFB
      Biotech Indemnitees”)
      from
      any and all Damages arising from any Third Party Claims resulting or alleged
      to
      result from, directly or indirectly, any of the following (each, a “GTC
      Assumed Liability”):

    


    (a)   a
      breach
      by GTC of a representation, warranty, or covenant made under this Agreement;
      or

    


    (b)   any
      negligence or willful misconduct of the GTC Indemnitees in connection with
      their
      performance of GTC’s obligations under this Agreement;

    


    (c)   the
      practice of the GTC Technology to manufacture, use, sale, offer for sale, and/or
      import Products under this Agreement infringing the Patent Rights of any Third
      Party;

    


    (d)   the
      infringement of any Third Party Patent Rights by GTC or its Affiliates or
      subcontractors in the manufacture, use, sale, offer for sale, and/or importation
      of Products under this Agreement; or

    


    (e)   the
      manufacture, use, sale, offer for sale and/or importation of the Products by
      GTC
      or its Affiliates or subcontractors causing, directly or indirectly, any Third
      Party personal injury or death, possibility of injury or death or economic
      loss.

    Such
      indemnity shall not apply to the extent it is shown that such Third Party Claim
      was the result of any LFB Biotech Assumed Liability or constitutes a Shared
      Liability Claim.

    


    13.3   Procedure.
      In the
      event of a Third Party Claim against a Party entitled to indemnification under
      Section 13.1 or 13.2 hereof (“Indemnified
      Party”),
      the
      Indemnified Party shall promptly notify the other Party (“Indemnifying
      Party”)
      in
      writing of the Third Party Claim and the Indemnifying Party shall undertake
      and
      solely manage and control, at its sole expense, the defense of the Third Party
      Claim and its settlement; provided
      that the
      omission of such notice shall not relieve either Party from its obligations
      under this Section 13.3, except to the extent the other Party can establish
      actual prejudice and direct damages as a result thereof. The Indemnified Party
      shall cooperate with the Indemnifying Party, including, as requested by the
      Indemnifying Party and at the Indemnifying Party’s cost, entering into a joint
      defense agreement. The Indemnified Party may, at its option and expense, be
      represented in any such action or proceeding by counsel of its choice. The
      Indemnifying Party shall not be liable for any litigation costs or expenses
      incurred by the Indemnified Party without the Indemnifying Party’s written
      consent. The Indemnifying Party shall not settle any such Third Party Claim
      unless such settlement fully and unconditionally releases the Indemnified Party
      from all liability relating thereto, unless the Indemnified Party otherwise
      agrees in writing.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    13.4   Shared
      Liability Claims.

    


    (a)   Allocation.
      If any
      Third Party Claim is made that (A) the manufacture, use, sale, offer for sale,
      and/or importation of Products under this Agreement infringes the Patent Rights
      of any Third Party, or (B) the use of the Products has caused, directly or
      indirectly, any Third Party personal injury or death, possibility of injury
      or
      death or economic loss and such Third Party Claim does not constitute an LFB
      Biotech Assumed Liability or a GTC Assumed Liability, then such Third Party
      Claim shall be considered a “Shared
      Liability Claim”.
      GTC
      and LFB Biotech shall each be liable for ************ of all Damages incurred
      by
      the Parties or their respective Affiliates or any of them arising from any
      Shared Liability Claim. All such claims, actions, suits, proceedings, hearings,
      investigations and demands shall be governed exclusively by this Section 13.4
      and, except as expressly set forth in this Section 13.4, neither Party shall
      seek from the other Party any indemnity or other recovery on account of any
      such
      claims.

    


    (b)   Procedure.
      Each
      Party shall give the other Party prompt written notice of any Shared Liability
      Claim, but the omission of such notice shall not relieve either Party from
      its
      obligations under this Section 13.4, except to the extent the other Party
      can establish actual prejudice and direct damages as a result thereof. The
      Parties shall collaborate in good faith to defend any Shared Liability Claim
      in
      accordance with this Section 13.4 and no settlement shall be entered into
      without the approval of both Parties, such approval not to be unreasonably
      withheld or delayed. Any costs incurred by a Party in defense of a Shared
      Liability Claim shall be treated as the Development Costs of such
      Party.

    


    (c)   Reconciliation.
      Within
      ************ following the end of each calendar quarter during which any Shared
      Liability Claim has been pending, each Party shall provide to the JSC a written
      statement of all Damages incurred by such Party or its Affiliates in connection
      with such claim (“Unsettled
      Shared Damages”).
      ************ of any Unsettled Shared Damages shall be allocated to each Party
      as
      the Development Costs of such Party.

    


    (d)   Exception.
      For
      purposes of clarity, the obligations of each Party to indemnify the other Party
      under a Commercial License executed in accordance with Section 8.2(c)(ii) shall
      be governed by the terms of the Commercial License and shall not be governed
      by
      this Article 13 unless otherwise specifically agreed.

     

    13.5   Effect
      of Disclosures.
      Notwithstanding any disclosure, whether in oral, written, electronic or other
      form, made by either Party under the representation and warranty in Section
      11.2(a)(iv) hereof, such Party’s indemnity obligations under this Agreement and
      the other Party’s remedies shall remain in full force and effect as if such
      representation and warranty were unqualified in any way.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    13.6   Insurance.
      Each
      Party shall procure and maintain insurance, including product liability
      insurance, naming the other Party as an additional insured, adequate to cover
      its obligations hereunder and which is consistent with normal business practices
      of prudent corporations similarly situated at all times during which the Product
      is being clinically tested with human subjects or commercially distributed
      or
      sold. The Parties acknowledge and agree that such insurance shall not be
      construed to create a limit of either Party’s liability with respect to its
      indemnification obligations under this Article 13. Each Party shall provide
      the
      other with written evidence of such insurance upon request. Each Party shall
      provide the other with written notice at least ************ prior to the
      cancellation, non-renewal or material change in such insurance.

    


    ARTICLE
      14

    TERM
      AND TERMINATION

    


    14.1   Term.

    


    (a    Collaboration
      Term.
      Unless
      earlier terminated in accordance with the terms of this Article 14, the term
      of
      this Agreement shall commence on the Effective Date and expire on the fifteenth
      (15th)
      anniversary thereof (the “Initial
      Collaboration Term”).
      At
      least ************ prior to the expiration of the Initial Collaboration Term,
      the Parties shall mutually determine whether to (i) extend the collaboration
      to
      continue adding new Products in accordance with Section 2.1, or (ii) if no
      Product Term is then in effect, allow the Agreement to expire by its terms.
      In
      any event, the collaboration under this Agreement shall be continued with
      respect to those Products, if any, for which the Product Term thereof is still
      in effect and shall continue for such purposes until the last to expire of
      such
      Product Terms. The Initial Collaboration Term, together with any extension
      or
      continuation thereof as provided in this Section 14.1, is referred to herein
      as
      the “Collaboration
      Term”.

    


    (b)   Product
      Term.

    


    (i)   Unless
      earlier terminated in accordance with this Agreement, the initial term of this
      Agreement with respect to each Product shall commence on the applicable Product
      Start Date and end on the later of (a) the ************ anniversary of the
      Effective Date, and (b) the date that is ************ years following the date
      of the last Regulatory Approval for such Product in any country in the
      Territory. The initial Product term for any Product as set forth in this Section
      14.1(b) is referred to herein as the “Base
      Product Term”.

    


    (ii)   The
      Parties shall begin discussing in good faith an extension of the Base Product
      Term for each Product on or about the date that is ************ prior to the
      end
      of such Base Product Term. Any extension of the Base Product Term must be agreed
      upon by the date that is ************ prior to the date upon which the Base
      Product Term of such Product shall expire, or this Agreement shall terminate
      with respect to such Product on such date. The Base Product Term with respect
      to
      any Product, together with any extension agreed by the Parties in accordance
      with this Section 14.1(b)(ii), is referred to herein as the “Product
      Term”.

    


    (c)   Upon
      expiration of the Product Term with respect to any Product, all rights and
      licenses granted hereunder with respect to such Product shall terminate and
      neither Party shall have any obligations to the other Party with respect to
      such
      Product, except to the extent such obligations were incurred prior to such
      expiration; provided,
      however,
      that in
      the case of a Product then in use for the treatment of human patients, the
      Parties shall, under the guidance of the JSC, which shall continue to exist
      for
      such purposes following such expiration, use Commercially Reasonable Efforts
      to
      continue to exercise such responsibilities as shall ensure the continued
      availability of the Product to patients, including continued licensing and
      supply arrangements, subject to commercially reasonable compensation as the
      JSC
      shall determine.

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    14.2   Termination
      Rights.

    


    (a)   Termination
      of a Product Term Without Fault.
      The
      Product Term with respect to a Product may be terminated without fault under
      the
      following circumstances: 

    


    (i)   at
      any
      time by the mutual consent of the Parties;

    


    (ii)   with
      no
      further action required on the part of either Party if the JSC determines that
      it is not commercially viable to proceed with Development or Commercialization
      of such Product; 

    


    (iii)   by
      either
      Party upon ************ written notice to the other Party if, after commencing
      Development of a Product, the JSC fails to agree on a subsequent Development
      Plan or Commercialization Plan for such Product in accordance with Section
      5.1
      or 6.1 after such matter has been submitted to Senior Management and to
      mediation for resolution in accordance with Section 4.6 (for the avoidance
      of
      doubt, such matters shall not be subject to arbitration pursuant to Section
      15.2); provided,
      that if
      any such failure to agree occurs within a ************ period following a Change
      of Control of a Party and is not resolved through mediation in accordance with
      Section 4.6 such failure to agree shall be deemed a material breach permitting
      the other Party to terminate the relevant Product Term immediately on written
      notice to the Party subject to the Change of Control unless the Party subject
      to
      the Change of Control can demonstrate that the failure to agree was caused
      by
      the other Party’s having negotiated in bad faith (for the avoidance of doubt,
      the Party subject to the Change of Control may submit the question of whether
      the other Party acted in bad faith to arbitration in accordance with Section
      15.2 and in such event such termination shall not be effective unless and until
      a final decision is rendered in the other Party’s favor in such arbitration
      proceeding); and  

    


    (iv)   In
      the
      event of a Force Majeure event as provided in Section 16.9.

    


    (b)   Termination
      of a Product Term for Material Breach.
      Either
      Party may terminate the Product Term with respect to a Product upon ************
      written notice for (i) the other Party’s material breach of any material
      obligation under this Agreement with respect to such Product, including without
      limitation, (A) any disclosure requirements with respect to Competing Products
      or with respect to an Alliance Affecting Core Business, (B) the failure to
      achieve any express Development and Commercialization milestone set forth in
      the
      applicable Development Plan and Commercialization Plan, which failure is
      ************, and (C) the obligation to make any undisputed Profit Payment
      required under Section 8.3, or (ii) a deemed material breach by the other Party
      following a Change of Control of such other Party pursuant to Section
      6.4(b)(ii), in each case (i) and (ii) which breach is not cured during such
      ************.

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (c)   Termination
      of Agreement Without Fault.
      This
      Agreement may be terminated in its entirety without the fault of either Party
      under the following circumstances:

    


    (i)   at
      any
      time by the mutual consent of the Parties; or

    


    (ii)   by
      either
      Party upon ************ written notice to the other Party at any time after
      the
      ************ of the Effective Date if at the time of delivery of such notice
      no
      Products (including the Initial Product) are then being Developed or
      Commercialized by the Parties under this Agreement and no Products are listed
      on
      the Product List attached as Exhibit
      A
      for
      Development or Commercialization hereunder.

    


    (d)   Termination
      of Agreement for Insolvency Event.
      A Party
      may terminate this Agreement in its entirety on ************ notice to the
      other
      Party upon the occurrence of an Insolvency Event with respect to such other
      Party.

    


    (e)   Termination
      of Agreement in case of Alliance Affecting Core Business, Change of Control
      or
      Core Business Competitor Equity Acquisition.

    


    (i)   If
      one
      Party or its Affiliate proposes to enter into an Alliance Affecting Core
      Business, it shall disclose such Alliance Affecting Core Business to the other
      Party and if the disclosing Party or its Affiliate does enter into such an
      Alliance Affecting Core Business the other Party shall have the rights to (A)
      terminate this Agreement upon ************ prior written notice to the Party
      which itself or whose Affiliate is entering into such Alliance Affecting Core
      Business, or (B) if the disclosing Party’s Affiliate enters into the Alliance
      Affecting Core Business, in lieu of terminating this Agreement, to immediately
      terminate this subsection 14.2(e)(i) with respect to itself and its Affiliates
      upon written notice and in the event of such termination shall no longer be
      subject to the restrictions set forth in this Section 14.2(e)(i);
      provided
      that the
      foregoing termination rights shall not apply if (A) such Party, before it or
      its
      Affiliate enters into such Alliance Affecting Core Business, shall have
      ************. The Party proposing to enter into an Alliance Affecting Core
      Business shall not be required to disclose to the other Party (x) the identity
      of the Third Party with whom it or its Affiliate proposes to enter into such
      Alliance Affecting Core Business or (y) the product(s) proposed to be developed
      or commercialized in such Alliance Affecting Core Business, other than in
      general terms sufficient to demonstrate that such product(s) are within the
      description of the other Party’s Core Business and Compete with the other
      Party’s Core Business Product(s). 

    


    (ii)   If
      a
      Change of Control occurs with respect to a Party or the relevant Affiliate
      and
      the Third Party obtaining control of such Party or the relevant Affiliate is
      not
      a Core Business Competitor of the other Party, and if after the Change of
      Control such Party does not propose any products for Development or
      Commercialization under this Agreement during the ************ period
      immediately following the effective date of such Change of Control, then the
      other Party shall have the right to terminate this Agreement in its entirety
      upon ************ prior written notice.

    


    (iii)   If
      a
      Change of Control occurs with respect to a Party or the relevant Affiliate
      and
      the Third Party obtaining control is a Core Business Competitor of the other
      Party or if a Core Business Competitor Equity Acquisition occurs with respect
      to
      a Party or the relevant Affiliate, then the other Party shall have the right
      to
      terminate this Agreement in its entirety upon ************ prior written
      notice.

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (f)   Termination
      of Agreement if Two Products Subject to Termination for Material
      Breach.
      If a
      Party has the right to terminate two or more Products for the other Party’s
      material breach pursuant to Section 14.2(b), then whether or not such Party
      has
      exercised such right (unless such Party has expressly waived in writing such
      right with respect to one or more Products), such Party shall have the right
      to
      terminate this Agreement in its entirety upon ************ prior written notice
      to the other Party, unless within such ************ period all material breaches
      which gave rise to the right of termination of such Products are
      cured.

    


    (g)   Termination
      of Agreement if LFB Biotech in Default of Stock and Note Purchase Agreement
      Obligations.
      GTC
      shall have the right to terminate this Agreement in its entirety upon
      ************ prior written notice upon any failure by LFB Biotech to meet any
      of
      its funding obligations under the Stock and Note Purchase
      Agreement.

    


    (h)   Termination
      for Default of Covenant Under Section 11.1(e).
      If a
      Party fails to perform its undertaking set forth in Section 11.1(e) (as reported
      pursuant to Section 8.3(a)) for ************, then the other Party shall have
      the right to terminate this Agreement in its entirety upon ************ prior
      written notice to the Party in default, unless within such ************ period
      such Party has reduced the amounts past due and unpaid referred to in Section
      11.1(e) to no more than ************; provided, that if the other Party does
      not
      provide written notice of such termination within ************ after receipt
      of
      the applicable report under Section 8.3(a), it shall be deemed to have
      irrevocably waived its termination right with respect to that particular failure
      but not with respect to any subsequent failure to perform under Section
      11.1(e).

     

    14.3   Effects
      of Termination.

    


    (a)   Termination
      of Product Term without Fault.
      If a
      Product Term is terminated pursuant to Section 14.2(a)(i) (mutual
      agreement),
      Section 14.2(a)(ii) (JSC
      decision),
      Section 14.2(a)(iii) (JSC
      unable to agree on Development Plan or Commercialization Plan)
      (but
      excluding a termination for any deemed material breach under the proviso
      thereof, the effect of which shall be determined in accordance with Section
      14.3(c)) or Section 14.2(a)(iv) (Force
      Majeure),
      such
      termination shall have the following effects: 

    


    (i)   Such
      Product shall be removed from the Product List attached as Exhibit
      A
      and
      shall no longer be subject to this Agreement.

    


    (ii)   If
      the
      Product is in the Commercialization Phase:

    


    (A)   all
      licenses
      granted to GTC hereunder with respect to such Product will become exclusive,
      irrevocable, perpetual licenses with respect to the North American Territory
      and
      such part of the Co-Exclusive Territory as to which GTC or any Affiliate of
      GTC
      had previously been granted an exclusive or co-exclusive license in respect
      of
      such Product, bearing an aggregate royalty as set forth in 14.3(a)(v) below;
      

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (B)   all
      licenses
      granted to LFB Biotech hereunder with respect to such Product will become will
      become exclusive, irrevocable, perpetual licenses with respect to the European
      Territory and such part of the Co-Exclusive Territory as to which LFB Biotech
      or
      any Affiliate of LFB Biotech had previously been granted an exclusive or
      co-exclusive license in respect of such Product, bearing an aggregate royalty
      as
      set forth in 14.3(a)(v) below; 

    


    (C)   with
      respect to
      such remaining part of the Co-Exclusive Territory as shall not be subject to
      an
      exclusive license in favor of GTC or LFB Biotech, the Originating Party of
      such
      Product shall be granted an exclusive license in respect of such remaining
      part
      of the Co-Exclusive Territory, bearing an aggregate royalty as set forth in
      14.3(a)(v) below, such license to be of the same scope as the exclusive licenses
      described in subsections (A) or (B) above, as applicable and

    


    (D)   if
      a Party was
      manufacturing and supplying or was required to manufacture and supply such
      Product to the other Party as of the date of termination, it shall continue
      to
      do so at ************ until the earlier of (x) ************ years following
      termination and (y) such time as the Continuing Party has established a
      satisfactory alternative supply of such Product.

    


    (iii)   If
      the
      Product is in the Development Phase and Phase II Trials have commenced with
      respect to such Product, then:

    


    (A)   the
      Originating Party shall be deemed the “Continuing
      Party”
with
      respect to such Product, provided
      that the
      Originating Party shall promptly notify the non-Originating Party in writing
      in
      the event that the Originating Party decides not to continue to pursue the
      development or commercialization of such Product. The non-Originating Party
      shall have the right, to be exercised within ************ after receiving such
      notice, to notify the Originating Party in writing whether the non-Originating
      Party wishes to pursue the development and commercialization of such Product.
      If
      the non-Originating Party timely notifies the Originating Party that the
      non-Originating Party desires to develop and commercialize the Product, the
      non-Originating Party shall become the Continuing Party with respect to such
      Product. If the non-Originating Party notifies the Originating Party that the
      non-Originating Party does not wish to develop and commercialize the Product,
      or
      does not timely provide notice, the Originating Party shall remain the
      Continuing Party with respect to such Product;

    


    (B)   all
      licenses from the Continuing Party to the non-Continuing Party with respect
      to
      such Product shall terminate;

    


    (C)   all
      licenses from the non-Continuing Party to the Continuing Party with respect
      to
      such Product shall continue in effect but shall become perpetual exclusive
      licenses (subject to subsection (A) above) with respect to the entire Territory,
      bearing an aggregate royalty as set forth in Section 14.3(a)(v) below;


    


    (D)   until
      the
      earlier of (x) ************ following termination and (y) such time as the
      Continuing Party has established an alternative supply of such Product, if
      the
      non-Continuing Party was manufacturing and supplying or was contemplated to
      manufacture and supply such Product, it shall continue to manufacture and supply
      such Product to the Continuing Party at ************;

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (E)   the
      non-Continuing Party shall grant the Continuing Party a perpetual (subject
      to
      subsection (A) above), non-exclusive, royalty-bearing license (such royalty
      to
      be included in the royalty set forth in Section 14.3(a)(v) below) under the
      non-Continuing Party’s technology and Know-How to the extent reasonably
      necessary to manufacture such Product, with the right to sublicense to Third
      Parties engaged by the Continuing Party to manufacture such Product for the
      Continuing Party; and

    


    (F)   the
      non-Continuing Party shall return to the Continuing Party all Know-How and
      Confidential Information of the Continuing Party then in the non-Continuing
      Party’s possession that is solely related to the terminated
      Product.

    


    (iv)   If
      the
      Product is in the Development Phase but Phase II Trials have not commenced
      with
      respect to such Product, then the non-Originating Party in respect of such
      Product shall have the right to elect in writing within either to (x) be treated
      in accordance with Section 14.3(a)(iii) above or (y) receive from the
      Originating Party a payment in cash (the “IPV
      Payment”)
      equal
      to ************ of such non-Originating Party’s IPV with respect to such Product
      as of the date of termination as calculated in accordance with the Product
      Participation Model. If the non-Originating Party elects to receive the IPV
      Payment:

    


    (A)   the
      Originating Party shall pay the non-Originating Party the IPV Payment within
      ************ of receipt of the non-Originating Party’s written notice of such
      election;

    


    (B)   all
      licenses from the non-Continuing Party to the Continuing Party with respect
      to
      such Product shall continue in effect but shall become perpetual exclusive
      licenses with respect to the entire Territory, bearing a commercially reasonable
      royalty to be determined by the Parties through good faith negotiations within
      ************ after such termination; provided,
      that if
      the Parties are unable to agree upon such royalties within such ************,
      then the matter shall be resolved through dispute resolution in accordance
      with
      Section 14.3(d);

     

    (C)   the
      non-Continuing Party shall grant the Continuing Party a perpetual,
      non-exclusive, royalty-bearing license (such royalty to be included in the
      royalty calculation under subsection (iv)(B) above) under the non-Continuing
      Party’s technology and Know-How to the extent reasonably necessary to
      manufacture such Product, with the right to sublicense to Third Parties engaged
      by the Continuing Party to manufacture such Product for the Continuing Party;
      and

    


    (D)   the
      provisions of Sections 14.3(a)(iii)(B), (D), and (F) shall apply with respect
      to
      such terminated Product.

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (v)   The
      royalty to be paid to a Party in respect of the licenses granted to such Party
      under Sections 14.3(a)(ii)(A),(B) and (C) or 14.3(a)(iii)(C) above shall be
      an
      ************ for all such licenses in respect of the relevant Product and shall
      be determined by the Parties through good faith negotiations within ************
      after such termination in such manner as the amount received by each Party
      through the payment of such royalties will be ************, it being agreed
      by
      the Parties that the then most recent Development and/or Commercialization
      Plans
      with respect to such Product shall be accepted as a reference in determining
      such royalty. If GTC and LFB Biotech are unable to agree on such royalties
      within such ************ period, then the matter shall be resolved through
      dispute resolution in accordance with Section 14.3(d).

    


    (b)   Termination
      of Agreement Without Fault or Insolvency Event.

    


    (i)   If
      this
      Agreement is terminated in its entirety pursuant to Section 14.2(c)(i)
      (mutual
      agreement),
      Section 14.2(d) (Termination
      of Agreement for Insolvency Event)
      or
      Section 14.2(e) (Termination
      of Agreement in case of Change of Control, Alliance Affecting Core Business
      or
      Core Business Competitor Equity Acquisition),
      then
      the provisions of Section 14.3(a) shall be applicable with respect to each
      of
      the Products then under Development or Commercialization.

    


    (ii)   If
      this
      Agreement is terminated in its entirety pursuant to Section 14.2(c)(ii)
      (no
      Products in Development or Commercialization after three years)
      then
      all licenses granted hereunder by either Party shall immediately terminate
      and
      each Party shall promptly return to the other Party all Know-How and
      Confidential Information of the other Party then in such Party’s
      possession.

    


    (c)   Termination
      for Fault.
      If the
      Product Term with respect to a Product is terminated under Section 14.2(b)
      (material
      breach)
      (including for the avoidance of doubt a deemed material breach in accordance
      with subsection (ii) thereof or in accordance with Section 14.2(a)(iii)), or
      this Agreement is terminated in its entirety under Section 14.2(f)
      (Termination of the Agreement if two Products subject to Termination for
      Breach),
      14.2(g)
      (Failure
      of LFB Biotech to Meet Funding Obligations under Stock and Note Purchase
      Agreement)
      or
      14.2(h) (Default
      of Covenant under Section 11.1(e))
      then:

    


    (i)   all
      rights and licenses granted by the terminating Party to the terminated Party
      hereunder, or with respect to the terminated Product, as the case may be, shall
      terminate (provided
      that,
      subject to the terms and conditions of this Agreement, the terminated Party
      may
      continue to sell off its existing inventory of Products on hand as of the
      effective date of termination, and may fill any orders for Products accepted
      prior to the effective date of termination, provided that such orders are filled
      within ************ after the effective date of termination);

    


    (ii)   all
      rights and licenses granted by the terminated Party to the terminating Party
      hereunder with respect to any Products then being Developed or Commercialized,
      or with respect to the terminated Product, as the case may be, shall remain
      in
      effect, but shall convert to exclusive (in the terminating Party’s exclusive
      Territory hereunder, including those countries or regions of the Co-Exclusive
      Territory that are exclusively designated to such Party or its Affiliates by
      the
      JSC) and non-exclusive (in the rest of the Territory), worldwide, irrevocable,
      perpetual and royalty-free licenses;

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (iii)   the
      terminated Party shall return to the terminating Party all Know-How and
      Confidential Information of the terminating Party then in the terminated Party’s
      possession that is solely related to the terminated Product(s);

    


    (iv)   to
      the
      extent legally permissible, the terminated Party shall transfer to the
      terminating Party ownership, possession and control of all Regulatory Filings
      prepared by and Regulatory Approvals held by the terminated Party or its
      Affiliates that solely relate to the terminated Product(s), together with copies
      of all correspondence and conversation logs with Regulatory Authorities relating
      thereto, and copies of all data, reports, records and materials in the
      terminated Party’s or its Affiliates’ possession that solely relate to the use,
      sale, offer for sale or importation of the terminated Product(s), including
      all
      non-clinical, pre-clinical and clinical data relating thereto;

    


    (v)   the
      terminated Party shall grant the terminating Party a fully paid, non-exclusive,
      royalty-free, worldwide, irrevocable, perpetual license to use in the
      manufacture of the terminated Product(s) any technology or Know-How Controlled
      by the terminated Party or its Affiliates that is reasonably necessary for
      the
      manufacture of such Product(s);

    


    (vi)   if
      the
      terminated Party is a Trademark Owner then the terminated Party shall assign
      the
      relevant Product Trademark(s) of which it is the Trademark Owner, together
      with
      all goodwill associated therewith, to the terminating Party;

    


    (vii)   to
      the
      extent the terminated Party was manufacturing and supplying the terminated
      Product(s) to the terminating Party, the terminated Party shall continue to
      manufacture and supply such Product(s) to the terminating Party at ************
      until the earlier of (x) ************ following termination and (y) such time
      as
      the Continuing Party has established a satisfactory alternative supply of such
      Product; provided,
      that
      the terminating Party shall use good faith reasonable efforts to establish
      a
      manufacturing site for such Product as soon as reasonably practicable following
      the date of termination;

    


    (viii)   the
      terminated Party agrees to use best efforts (subject to any legal and regulatory
      constraints) to transfer the manufacture of the terminated Product(s) (including
      any transgenic mammals it owns or controls and that are used in the production
      of the terminated Product(s)) to the terminating Party or a Third Party
      designated by the terminating Party as soon as possible following such
      termination; and

    


    (ix)   the
      terminated Party shall provide at cost to the terminating Party reasonable
      technical support with respect to the manufacture of the terminated Product(s)
      as reasonably requested by the terminating Party for a period not to exceed
      ************ from the effective date of termination.

    


    (d)   Disputes
      Regarding the Calculation of Royalties.
      If GTC
      and LFB Biotech are unable to agree on the royalties to be paid under
      subsections (a)(iv)(B), (a)(v) or (c)(ii) of this Section 14.3 within the
      negotiation period provided therein, then, at the request of either of the
      Parties, the matter shall be submitted to non-binding mediation by a mutually
      agreed independent third party knowledgeable as to the matter(s) in dispute
      who
      shall render his/her decision within ************. If both Parties do not accept
      the decision of such mediator within ************ after such decision having
      been rendered, or if the Parties have not agreed on a mediator within
      ************ after a request for mediation, then, subject to the rights and
      obligations of the Parties under this Agreement, the matter shall be referred
      to
      arbitration as described in Section 15.2.

    


    
      
        
          
          

        

        
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            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    14.4   Survival;
      Accrued Rights.
      The
      rights and obligations of the Parties under the following provisions of this
      Agreement shall survive any expiration or any termination of this Agreement
      in
      its entirety or with respect to any Product: Sections 1, 7.3, 7.4(e), 8.3(c)
      (with respect to final reports and Profit Payments), 8.4, 8.5, 8.6 and 8.7
      (in
      each case 8.5, 8.6 and 8.7, with respect to post-expiration or post-termination
      payment and accounting obligations), 12.1, 12.2, 12.3, 12.5, 13.1, 13.2, 13.3,
      13.4, 13.5, 14.3, 14.4, 14.5, 15.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.10,
      16.11, 16.12, 16.13 and 16.14. In any event, expiration or termination of this
      Agreement shall not relieve the Parties of any liability which accrued hereunder
      prior to the effective date of such expiration or termination nor preclude
      either Party from pursuing all rights and remedies it may have hereunder or
      at
      law or in equity with respect to any breach of this Agreement.

     

    14.5   Effect
      of Termination on Sublicenses.
      If this
      Agreement is terminated in the entirety or with respect to a particular Product,
      as the case may be, and a given sublicense granted by the terminated Party
      is in
      force and effect on the date of such termination, then any Patent Rights and/or
      Know-How of the terminating Party sublicensed by the terminated Party to the
      sublicensee shall automatically become directly licensed from the terminating
      Party to such sublicensee under the terms and conditions of this Agreement
      with
      respect to the applicable Product(s), which license shall be of the same scope
      licensed to the sublicensee, provided
      that the
      sublicensee (a) agrees in writing to be bound to the terminating Party under
      the
      terms and conditions of this Agreement, (b) is not in breach of the relevant
      sublicense and (c) agrees to thereafter make all reports and payments due under
      this Agreement with respect to the applicable Product(s) directly to the
      terminating Party or its designee; provided,
      that
      the terminating Party will not be required to assume any obligations broader
      in
      scope than it has under this Agreement.

    


    ARTICLE
      15

    DISPUTE
      RESOLUTION

    


    15.1   Disputes.
      Except
      as otherwise set forth in this Agreement, in the event of any dispute,
      controversy or claim arising out of or relating to this Agreement, or the
      breach, termination or invalidity thereof (a “Dispute”),
      either Party may promptly, upon written notice to the other Party, refer such
      Dispute to the respective Senior Management, and such Senior Management shall
      attempt in good faith to resolve such Dispute. If the Parties are unable to
      resolve a given Dispute pursuant to this Section 15.1 within ************ after
      referring such Dispute to the Senior Management, either Party may elect to
      resolve such Dispute in accordance with Section 15.2, to the exclusion of other
      remedies. 

    


    
      
        
          
          

        

        
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            Commission. Asterisks denote such
            omissions.

        

      

    

     

    15.2   Arbitration.
      

    


    (a)   Subject
      to Section 15.1 and except as otherwise expressly provided in this Agreement,
      any dispute, claim or controversy relating to, arising out of, or in connection
      with this Agreement, including any question regarding its formation, existence,
      validity, enforceability, performance, interpretation, breach, or termination,
      shall be finally resolved under the rules of the London Court of International
      Arbitration by a panel of three arbitrators appointed in accordance with such
      rules and having relevant legal or business experience. Each Party shall
      nominate one such arbitrator, and the two arbitrators so nominated shall
      nominate the third. The place of arbitration shall be London, England. The
      language of the arbitration shall be English. The arbitrators shall be empowered
      to order production of all documents reasonably calculated to lead to
      information or other documents relevant to such proceeding. Each Party shall
      bear the fees and expenses of its legal representation in the arbitration.
      Judgment upon the arbitrators’ award may be entered in any court of competent
      jurisdiction. The award of the arbitrators may include compensatory damages
      but
      under no circumstances will the arbitrators be authorized to, nor shall they,
      award punitive damages or multiple damages against either Party, except to
      the
      extent consistent with Section 16.5, and the Parties expressly waive the right
      to assert claims for punitive damages or multiple damages.

    


    (b)   Nothing
      in this Article shall prevent any Party, whether before or during the pendancy
      of an arbitration under this Article, from seeking conservatory and interim
      measures, including, but not limited to temporary restraining orders or
      preliminary injunctions, or their equivalent, from any court of competent
      jurisdiction. Further, notwithstanding anything to the contrary in this Article
      15, without resort to arbitration in the first instance, either Party shall
      have
      the right to bring suit in a court of competent jurisdiction against the other
      Party for (i) any breach of such other Party’s duties of confidentiality
      pursuant to Article 12 of this Agreement, or (ii) any infringement of its own
      Patent Rights or other proprietary rights by such other Party.

    


    ARTICLE
      16

    MISCELLANEOUS

    


    16.1   Actions
      by Affiliates.
      In the
      event an Affiliate of a Party fails to perform any obligation or comply with
      any
      provision hereunder that requires performance or compliance by such Affiliate
      and such failure to perform or comply would constitute or be deemed a breach
      of
      the relevant obligation or provision of this Agreement if such Affiliate were
      the relevant Party, such failure to perform or comply shall be deemed a breach
      of such obligation or provision by the relevant Party. In the event of any
      failure of an Affiliate of a Party to perform or comply with an applicable
      obligation hereunder, the other Party shall provide notice of such failure
      to
      the Party whose Affiliate failed to perform, in accordance with Section
      16.7.

     

    16.2   Assignment.
      Neither
      Party may assign this Agreement or any rights or obligations hereunder without
      the prior written consent of the other Party, such consent not to be
      unreasonably withheld, and any attempted assignment without such consent shall
      be null and void. Notwithstanding the foregoing, either Party may assign this
      Agreement or all of its rights and obligations hereunder in connection with
      (a)
      a merger or acquisition or a sale of substantially all of such Party’s assets to
      which this Agreement relates, or (b) to an Affiliate that Controls such Party
      in
      connection with a transfer to such Controlling Affiliate of substantially all
      of
      such Party’s assets to which this Agreement relates. This Agreement shall be
      binding upon and, subject to the other terms of this Section 16.2, inure to
      the
      benefit of the Parties’ successors and permitted assigns and each Party shall
      cause any successor or permitted assign to agree in writing to be bound by
      the
      terms and conditions hereof.

    


    
      
        
          
          

        

        
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          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    16.3   Governing
      Law.
      This
      Agreement shall be construed and interpreted in accordance with the laws of
      the
      State of New York, USA, without regard to any conflicts of law principles that
      would provide for the application of the laws of another jurisdiction and
      excluding (a) the United Nations Convention on Contracts for the International
      Sale of Goods, (b) the 1974 Convention on the Limitation Period in the
      International Sale of Goods; and (c) the Protocol amending the 1974 Convention,
      done at Vienna April 11, 1980. The foregoing notwithstanding, the Parties
      acknowledge and agree that any arbitration proceeding pursuant to Article 15
      shall be subject to the procedural laws of England and Wales.

     

    16.4   Non-Waiver.
      The
      waiver by either of the Parties of any breach of any provision hereof by the
      other Party shall not be construed to be a waiver of any succeeding breach
      of
      such provision or a waiver of the provision itself.

     

    16.5   Disclaimer
      of Indirect Damages.
      NEITHER
      PARTY WILL BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY
      (PUNITIVE), MULTIPLE DAMAGES OR OTHER INDIRECT DAMAGES (INCLUDING, WITHOUT
      LIMITATION, LOST PROFITS) ARISING FROM OR RELATING TO THIS AGREEMENT OR ANY
      BREACH HEREOF, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTWITHSTANDING THE
      FOREGOING, NOTHING IN THIS SECTION 16.5 IS INTENDED TO LIMIT OR RESTRICT
      (a) ANY RIGHTS OR REMEDIES OF EITHER PARTY WITH RESPECT TO A BREACH OF
      ARTICLE 12 BY THE OTHER PARTY, OR (b) THE INDEMNIFICATION RIGHTS OR
      OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD PARTY CLAIMS UNDER SECTIONS
      14.1, 14.2 AND 14.3.

     

    16.6   Severability.
      If and
      to the extent that any court or tribunal of competent jurisdiction holds any
      of
      the terms or provisions of this Agreement, or the application thereof to any
      circumstances, to be invalid or unenforceable in a final nonappealable order,
      the Parties shall use their best efforts to reform the portions of this
      Agreement declared invalid to realize the intent of the Parties as fully as
      practical, and the remainder of this Agreement and the application of such
      invalid term or provision to circumstances other than those as to which it
      is
      held invalid or unenforceable shall not be affected thereby, and each of the
      remaining terms and provisions of this Agreement shall remain valid and
      enforceable to the fullest extent of the law.

    


    
      
        
          
          

        

        
          64

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    16.7   Notice.
      Any
      notice or other communication required or permitted hereunder shall be in
      writing and shall be deemed given (a) when delivered personally, (b) on the
      next
      business day after timely delivery to an overnight courier (postage prepaid),
      or
      (c) on the third business day after deposit in the United States mail (certified
      or registered mail return receipt requested, postage prepaid), as
      follows:

    


    
      	
              To
                LFB Biotech:

            	
              To
                GTC:

            
	 	 
	
              LFB-Biotechnologies

            	
              GTC
                Biotherapeutics, Inc.

            
	
              3,
                avenue des Tropiques

            	
              175
                Crossing Boulevard

            
	
              91958
                Courtaboeuf Cedex - France

            	
              Framingham,
                MA 01702

            
	 	 
	
              Attention:
                Président

            	
              Attention:
                CEO and General Counsel

            
	
              Facsimile:
                +33 (0) 1 69 82 72 67

            	
              Facsimile:
                1 (508) 370-3797

            
	 	 
	
              with
                a copy to:

            	 
	 	 
	
              Laboratoire
                Francais du Fractionnement

            	 
	
              et
                des Biotechnologies 

            	 
	
              3,
                avenue des Tropiques

            	 
	
              91958
                Courtaboeuf Cedex - France

            	 
	 	 
	
              Attention:
                Président Directeur Général 

            	 
	
              Facsimile:
                +33 (0) 1 69 82 72 67

            	 


    

    


    or
      to
      such other address as to which the Party has given written notice thereof.
      For
      the avoidance of doubt, GTC shall send a copy of any notice with respect to
      a
      default by LFB Biotech of its obligations hereunder (including without
      limitation any failure of an Affiliate of LFB to perform or comply with an
      applicable obligation hereunder) to LFB SA at the time such notice is sent
      to
      LFB Biotech; provided,
      that
      the failure of GTC to send such copy to LFB SA shall not relieve LFB Biotech
      from its obligations and liabilities hereunder or LFB SA from its obligations
      and liabilities under the Keepwell Agreement or diminish in any way the remedies
      available to GTC under this Agreement, the Keepwell Agreement or otherwise,
      with
      respect to the applicable default.

     

    16.8   Headings.
      The
      headings appearing herein have been inserted solely for the convenience of
      the
      Parties and shall not affect the construction, meaning or interpretation of
      this
      Agreement or any of its terms and conditions.

     

    16.9   Force
      Majeure.
      No
      failure or omission by the Parties in the performance of any obligation of
      this
      Agreement shall be deemed a breach of this Agreement nor shall it create any
      liability if the same shall arise from any cause or causes beyond the reasonable
      control of the affected Party, including, but not limited to, the following,
      which for purposes of this Agreement shall be regarded as beyond the control
      of
      the Party in question: acts of nature; acts or omissions of any government;
      any
      rules, regulations, or orders issued by any governmental authority or by any
      officer, department, agency or instrumentality thereof; fire; storm; flood;
      earthquake; accident; war; rebellion; insurrection; riot; invasion; terrorism;
      strikes; and lockouts or the like; provided
      that the
      Party so affected shall use its best efforts to avoid or remove such causes
      of
      nonperformance and shall continue performance hereunder with the utmost dispatch
      whenever such causes are removed. The
      obligations of each Party hereunder shall be deemed to be suspended until the
      effects of the Force Majeure are relieved.
      If
      however, such cause or causes are not removed or discontinued within
************
      of the
      commencement thereof, and
      the
      failure to remove them affects the performance of a material obligation of
      a
      Party hereunder with respect to a Product, the other Party
      may
      terminate the Product Term with
      respect to the applicable Product upon written notice to the affected
      Party.

    


    
      
        
          
          

        

        
          65

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    16.10   Entire
      Agreement.
      This
      Agreement, including the Exhibits hereto, constitutes the entire
      understanding between the Parties with respect to the subject matter contained
      herein and supersedes any and all prior agreements, understandings and
      arrangements whether oral or written between the Parties relating to the subject
      matter hereof. This Agreement will control in the event of any conflict between
      this Agreement and any Development Plan or between this Agreement and any
      Commercialization Plan.

     

    16.11   Amendments.
      No
      amendment, change, modification or alteration of the terms and conditions of
      this Agreement shall be binding upon either Party unless in writing and signed
      by the Party to be charged.

     

    16.12   Independent
      Contractors and Relationship of the Parties.
      It is
      understood that both Parties are independent contractors and engage in the
      operation of their own respective businesses, and neither Party is to be
      considered the agent or partner of the other Party for any purpose whatsoever,
      except as otherwise expressly provided in this Agreement. Neither Party has
      any
      authority to enter into any contracts or assume any obligations for the other
      Party or make any warranties or representations on behalf of the other Party.
      Without limiting the generality of the foregoing, neither Party shall be liable
      for any obligations of the other Party to such other Party’s subcontractors,
      sublicensees or other third parties with whom such other Party has contracted
      in
      connection with the performance of its obligations hereunder. Furthermore,
      nothing in this Agreement or the transactions contemplated hereby shall be
      construed as creating a partnership among the Parties, including without
      limitation for tax purposes.

     

    16.1    Exhibits.
      All
      Exhibits to this Agreement are part of this Agreement.

     

    16.14   No
      Strict Construction.
      This
      Agreement has been prepared jointly and shall not be strictly construed against
      either Party.

     

    16.15   Recording.
      Each
      Party shall have the right, at any time, to record, register or otherwise notify
      this Agreement in appropriate governmental or regulatory offices anywhere in
      the
      Territory, and GTC or LFB Biotech, as the case may be, shall provide reasonable
      assistance to the other in effecting such recordal, registration or
      notification.

     

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

     

    [Signature
      page follows.]

    


    
      
        
          
          

        

        
          66

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    IN
      WITNESS WHEREOF,
      the
      parties hereto have caused this Joint Development and Commercialization
      Agreement to be executed by their duly authorized officers as of the date first
      above written.

    


    
      	 	
              GTC
                BIOTHERAPEUTICS, INC.

            
	 	 
	 	 
	
               By:
 

            	
              /s/
                Geoffrey F. Cox

            
	 	
              Geoffrey
                F. Cox

            
	 	
              Chairman,
                Chief Executive Officer and
                President

            


    

    


     

    
      	 	
              LFB-BIOTECHNOLOGIES
                S.A.S.U.

            
	 	 
	 	 
	
               By: 


            	
              /s/
                Christian Bechon

            
	 	
              Christian
                Bechon

            
	 	
              President

            


    

     

    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    LIST
      OF EXHIBITS AND ANNEXES

    


    
      	
              EXHIBIT
                A:

            	
              PRODUCT
                LIST

            
	 	 
	
              EXHIBIT
                B:

            	
              DEVELOPMENT
                PLAN

            
	 	 
	
              EXHIBIT
                B-1

            	
              PRELIMINARY
                BUSINESS PLAN FOR INITIAL PRODUCT

            
	 	 
	
              EXHIBIT
                C:

            	
              COMMERCIALIZATION
                PLAN

            
	 	 
	
              EXHIBIT
                D:

            	
              PRODUCT
                PARTICIPATION MODEL

            
	 	 
	 	
              APPENDIX
                I TO EXHIBIT D:
                DEVELOPMENT COSTS

            
	 	 
	 	
              APPENDIX
                II TO EXHIBIT D:
                COMMERCIALIZATION COSTS

            
	 	 
	
              EXHIBIT
                E:

            	
              STOCK
                AND NOTE PURCHASE AGREEMENT

            
	 	 
	
              EXHIBIT
                F:

            	
              FORM
                OF PRESS RELEASE

            
	 	 
	
              EXHIBIT
                G:

            	
              TERMS
                OF COMMERCIAL LICENSE

            
	 	 
	
              EXHIBIT
                H:

            	
              CORE
                BUSINESS PRODUCTS 

            
	 	 
	 	 
	
              ANNEX
                1:

            	
              LIST
                OF CURRENT PRODUCTS EXCLUDED FROM “COMPETING PRODUCTS”
                DEFINITION

            


    

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    EXHIBIT
      A

    


    Product
      List

    


    
      	
              ¡

            	
              Transgenic
                version of rFVIIa (Initial Product)

            


    

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    EXHIBIT
      B

    


    Development
      Plan

    


    [Initial
      Development Plan to be completed by GTC/LFB Biotech within 180 days of Effective
      Date.]

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    EXHIBIT
      B-1

    


    Preliminary
      Business Plan for Initial Product

    


    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    EXHIBIT
      C

    


    Commercialization
      Plan

    


    [Preliminary
      Commercialization Plan for each Product to be agreed
      upon

    at
      least one year prior to anticipated Regulatory Approval for such
      Product.]

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    EXHIBIT
      D

    


    Product
      Participation Model

    


    ************

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    Appendix
      I to Exhibit D

    


    Development
      Costs

    


    Development
      Costs of a Party with respect to a Product may include the following costs
      to
      the extent they are paid or incurred during the Development Phase for such
      Product, as approved in advance by the JSC or, to the extent expressly provided
      in the Agreement, thereafter, and are ordinary and necessary for the Development
      of such Product:

    


    
      	 	
              —

            	
              Direct
                salary and wages. 

            


    

    
      	 	
              —

            	
              Payroll
                taxes and fringe benefitsrelated to direct salary and
                wages.

            


    

    
      	 	
              —

            	
              Travel,
                training, staff licenses and
                certifications.

            


    

    
      	 	
              —

            	
              Direct
                materials and direct supplies, including specialized
                software.

            


    

    
      	 	
              —

            	
              Direct
                costs for production of such Product including, but not limited to,
                construct discovery and development, animal development, animal
                maintenance, process development, validation, pre-clinical, clinical
                work
                and regulatory filings.

            


    

    
      	 	
              —

            	
              Direct
                external costs for consultants, temporary help and special
                studies.

            


    

    
      	 	
              —

            	
              Direct
                costs for research and development and pre-commercialization sales
                and
                marketing efforts, including without limitation the development and
                documentation of process methods and procedures for the manufacture
                and
                the Fully Absorbed Cost of Goods for batches manufactured and supplied
                for
                use in preclinical and clinical trial and pre-Commercialization
                activities.

            


    

    
      	 	
              —

            	
              Direct
                costs for outside services contracted with Third Parties related
                to
                performance of clinical trials, process development, pre-clinical
                studies,
                or other activities, including without
                limitation:

            


    

    
      
        	 	
                o

              	
                direct,
                  out-of-pocket external costs, including clinical grants, clinical
                  laboratory fees, positive controls and the cost of studies conducted
                  and
                  services provided by contract research organizations and individuals,
                  consultants, toxicology contractors, and manufacturers necessary
                  or useful
                  for the purpose of obtaining Regulatory
                  Approvals;

              


      

      
        	 	
                o

              	
                costs
                  related to data management, statistical designs and studies, document
                  preparation and other expenses associated with the clinical testing
                  program; and

              


      

      
        	 	
                o

              	
                costs
                  for preparing, submitting, reviewing or developing data or information
                  for
                  the purpose of submission of applications to obtain Regulatory
                  Approvals
                  (including user fees).

              


      

    

    
      	 	
              —

            	
              Direct
                costs for license fees and other amounts paid to a Third Party in
                connection with the Development of such
                Product.

            


    

    
      	 	
              —

            	
              Direct
                costs relating to the investigation, filing, prosecution and maintenance
                of Patent Rights that cover the development, manufacture, use or
                sale of
                such Product. that are incurred during the Development
                Phase.

            


    

    
      	 	
              —

            	
              Direct
                costs of filing and maintaining Product Trademark registrations that
                are
                incurred during the Development
                Phase.

            


    

    
      	 	
              —

            	
              Other
                direct Development Costs to the extent mutually agreed by the Parties
                through the JSC. 

            


    

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    
      	 	
              —

            	
              Costs
                of building inventory necessary for Product launch to the extent
                incurred
                during the Development Phase. The JSC shall agree on an inventory
                plan for
                build-up of commercial supplies of Product in advance of launch on
                a
                country by country basis. The cash impact of this build up will be
                included in the Product Participation calculation to the extent incurred
                during the Development Phase.

            


    

    


    
      	 	
              —

            	
              Indirect
                Costs should be allocated considering a reasonable and appropriate
                share
                of

            


    

    


    
      	 	
              -

            	
              Indirect
                materials and supplies for the Development Activities of the relevant
                Party, properly allocated.

            


    

    
      	 	
              -

            	
              Indirect
                equipment rental, maintenance, and calibration, properly
                allocated.

            


    

    
      	 	
              -

            	
              administration,
                facilities costs, information resources, cost accounting and forecasting,
                human resources, insurance, and incentive compensation performance
                bonus
                (whether paid in cash or stock), but excluding non-cash expense resulting
                from Accounting Standard SFAS123R or any equivalent accounting standard,
                share-based compensation accounting for stock options, stock appreciation
                rights and the like.

            


    

    


    
      	 	
              —

            	
              Cash
                costs for direct capital expenditures, or other significant investments,
                licenses, or assets used for the Development of such Product, in
                each case
                to be reviewed and approved by the JSC. If the asset is used for
                more than
                one program, its costs will be attributed to each program based on
                the
                program’s use of the asset’s available
                capacity.

            


    

    
      
        	 	
                o

              	
                Prior
                  investments used in a program will be included based on their depreciation
                  in accordance with the relevant Accounting
                  Standard.

              


      

       

    

    Depreciation
      or amortization resulting from investments that have been allowed on a cash
      basis will be excluded.

    


    
      	 	
              —

            	
              For
                clarity, the costs of issuing or repaying debt or equity financing,
                including interest or dividends shall not be included as Development
                Costs
                of a Party. 

            


    

    


    Development
      Costs will include only overhead costs that are ordinary and necessary for
      the
      Development of the Products. Overhead costs will be allocated by each Party
      to
      Development Costs based on allowable cost items and an allocation method to
      be
      approved by the JSC. 

    


    The
      Parties will use their respective best efforts to specify within ************
      of
      the Effective Date the project accounting allocation methods of each Party
      which
      will be used to attribute Development Costs to the Development program for
      each
      Product.

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    Appendix
      II to Exhibit D

    


    Commercialization
      Costs

    


    Commercialization
      Costs of a Party with respect to a Product may include the following costs
      to
      the extent they are paid or incurred during the Commercialization Phase for
      such
      Product, except to the extent such costs are properly allocated as Development
      Costs under the Agreement, and are ordinary and necessary for the Development
      of
      such Product:

    


    
      	 	
              —

            	
              Direct
                salary and wages. 

            


    

    
      	 	
              —

            	
              Payroll
                taxes and fringe benefits related to direct salary and
                wages

            


    

    
      	 	
              —

            	
              Ttravel,
                training, staff licenses and
                certifications.

            


    

    
      	 	
              —

            	
              Direct
                materials and direct supplies, including specialized
                software.

            


    

    
      	 	
              —

            	
              Direct
                costs for production of such Product, including Fully Absorbed Cost
                of
                Goods for the manufacture and supply of
                Product.

            


    

    
      	 	
              —

            	
              Direct
                external costs for consultants, temporary help and special
                studies.

            


    

    
      	 	
              —

            	
              Costs
                of sales and marketing efforts, including without
                limitation:

            


    

    
      
        	 	
                o

              	
                Finished
                  Product distribution expense, including all distribution expenses
                  such as
                  transportation, customs duties, insurance, fees paid to warehouses,
                  packaging and labeling expenses;

              


      

      
        	 	
                o

              	
                Field
                  selling expenses, meaning the actual costs of staff, expenses,
                  and
                  external costs, incurred in the active detail or selling of a Product.
                  In
                  the event that more than one Product is being actively detailed
                  or
                  marketed, these costs will be allocated to each Product based on
                  a
                  reasonable method considering time incurred, details performed,
                  etc. The
                  method will be approved by the JSC during the annual budget
                  process;

              


      

      
        	 	
                o

              	
                Direct
                  promotion expense, including all Product-specific promotion expenses
                  incurred in the promotion of the Product including, but not limited
                  to,
                  journal or direct to consumer advertising, agency fees, samples,
                  speaker
                  programs and other costs incurred in the promoting and marketing
                  of
                  Products. 

              


      

      
        	 	
                o

              	
                Marketing
                  overhead, will include only overhead costs that are ordinary and
                  necessary
                  for the marketing of the Products. Overhead costs will be allocated
                  by
                  each Party to marketing costs based on allowable cost items and
                  an
                  allocation method to be approved by the JSC.


              


      

    

    
      	 	
              —

            	
              Direct
                costs for outside services contracted with Third Parties related
                to
                performance of post-registration studies, including payments for
                contract
                research, clinical grant costs, bulk drug, contract manufacturing
                costs,
                user fees, etc.

            


    

    
      	 	
              —

            	
              Direct
                costs for license fees and other amounts paid to a Third Party in
                connection with the making, use or selling of such Product.
                

            


    

    
      	 	
              —

            	
              Direct
                costs relating to the investigation, filing, prosecution and maintenance
                of Patent Rights that cover the Development, manufacture, use or
                sale of
                such Product that are incurred during the Commercialization
                Phase.

            


    

    
      	 	
              —

            	
              Costs
                of filing and maintaining Product Trademark registration that are
                incurred
                during the Commercialization Phase.

            


    

    
      	 	
              —

            	
              The
                direct cost of all the external and internal regulatory support necessary
                to maintain the worldwide product registration for the Product including
                stability testing, preparation of annual reports, answering questions
                of
                Regulatory Authorities, preparing expert reports as required by Regulatory
                Authorities, etc.

            


    

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    
      	 	
              —

            	
              Costs
                of building inventory necessary for Product launch to the extent
                incurred
                during the Commercialization Phase. The JSC shall agree on an inventory
                plan for build-up of commercial supplies of Product in advance of
                launch
                on a country by country basis. Costs incurred during Commercialization
                will be reimbursed from net Sales.

            


    

    
      	 	
              —

            	
              Cash
                impact of Direct Working Capital changes, for example significant
                increases in accounts receivable from
                customers.

            


    

    
      	 	
              —

            	
              Direct
                costs of support necessary for adverse experience documentation and
                reporting, response to health professional and consumer inquiries
                about
                the Product including the preparation and maintenance of the Product
                database, administration of Phase IV study grants and supplies, the
                monitoring and review of medical literature concerning the Product,
                evaluation of the need for labeling changes, coordination with marketing
                to manage promotional material review, and medical review and oversight
                of
                such activities.

            


    

    
      	 	
              —

            	
              Cash
                costs for direct capital expenditures, or other significant investments,
                licenses, or assets used in the Development or Commercialization
                of such
                Product. If the asset is used for more than one program, its costs
                will be
                attributed to each program based on the program’s use of the asset’s
                available capacity.

            


    

    
      
        	 	
                o

              	
                Prior
                  investments used in a program will be included based on their depreciation
                  in accordance with the relevant Accounting
                  Standard.

              


      

      
        	 	
                o

              	
                Depreciation
                  or amortization resulting from investments that have been allowed
                  on a
                  cash basis will be excluded.

              


      

    

    
      	 	
              —

            	
              Indirect
                costs should be allocated considering a reasonable and appropriate
                share
                of:

            


    

    
       

      
        	 	
                o

              	
                Indirect
                  materials and supplies for the Commercialization Activities of
                  the
                  relevant Party, properly allocated.

              


      

      
        	 	
                o

              	
                indirect
                  equipment rental, maintenance, and calibration, properly
                  allocated.

              


      

      
        	 	
                o

              	
                To
                  the extent specifically allocable to Commercialization of the Product,
                  an
                  appropriate share of administration, facilities costs, information
                  resources, cost accounting and forecasting, human resources, insurance,
                  and incentive compensation performance bonus (whether paid in cash
                  or
                  stock), but excluding non-cash expense resulting from Accounting
                  Standard
                  SFAS123R or any equivalent accounting standard, share-based compensation
                  accounting for stock options, stock appreciation rights and the
                  like.

              


      

    

    
      	 	
              —

            	
              For
                clarity, the costs of issuing or repaying debt or equity financing,
                including interest or dividends shall not be included as Commercialization
                Costs of a Party. 

            


    

    


    Commercialization
      Costs will include only overhead costs that are ordinary and necessary for
      the
      Commercialization of Products. Overhead costs will be allocated by each Party
      to
      Commercialization Costs based on allowable cost items and an allocation method
      to be approved by the JSC. 

     

    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    EXHIBIT
      E

    


    Stock
      and Note Purchase Agreement

    


    [To
      be attached at signing.]

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    EXHIBIT
      F

    


    Form
      of Press Release

    


    [To
      be attached at signing.]

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    EXHIBIT
      G

    


    HEADS
      OF AGREEMENT

    


    COMMERCIAL
      PRODUCT LICENSE

    


    by
      and between

    


    GTC
      BIOTHERAPEUTICS, INC. (“GTC”)

    


    And

    


    LFB-BIOTECHNOLOGIES
      S.A.S.U. (“LFB”)

    


     

    RECITALS

     

    A.   GTC
      and
      LFB are parties to that certain Joint Development and Commercialization
      Agreement dated September 29, 2006 (hereinafter, the “Collaboration
      Agreement”)
      (capitalized terms used herein and not defined shall have the meaning ascribed
      to them in the Collaboration Agreement);

    


    B.   Pursuant
      to Section 8.2(c)(ii) of the Collaboration Agreement, if a Party fails to fund
      ************ of the Development Costs of a Product (other than the Initial
      Product) (hereinafter, an “Affected
      Product”)
      during
      the period commencing on the relevant Product Start Date and ending on
      ************ for such Product (hereinafter, the “Funding
      Commitment Period”),
      then
      such Affected Product shall no longer be included within the Collaboration
      Agreement and the rights and obligations of the Parties with respect to such
      Affected Product after the expiration of such period shall be governed by the
      terms of a definitive commercial license agreement (hereinafter, the
“Commercial
      License”)
      to be
      executed between the Parties at such time; and

    


    C.   This
      Heads of Agreement sets forth the basic material terms of the Commercial License
      and the Parties shall negotiate in good faith a definitive agreement based
      on
      such terms within ************ from the Product Start Date with respect to
      any
      Product other than the Initial Product.

    


    
      	
              1.

            	
              SELECTED
                DEFINITIONS

            


    

     

    1.1   “Commercial
      Party”
means,
      for purposes hereof, the Party that has failed to fund ************ of the
      Development Costs of a Product during the Funding Commitment
      Period.

     

    1.2   “Continuing
      Party”
means,
      for purposes hereof, the Party other than the Commercial Party.

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    1.3   “Exclusive
      Collaboration Territory”
means,
      for purposes hereof, the European Territory with respect to LFB, and the North
      American Territory with respect to GTC. For purposes hereof, a Party’s Exclusive
      Collaboration Territory shall not include any portion of the Co-Exclusive
      Territory that was designated to such Party or its Affiliates or its Third
      Party
      subcontractors by the JSC under the Collaboration Agreement.

     

    1.4   “ROW”
or
      “Rest
      of World”
means,
      for purposes hereof, the rest of the Territory outside the Commercial Party’s
      Exclusive Collaboration Territory.

     

    
      	
              2.

            	
              RIGHTS
                OF THE PARTIES WITH RESPECT TO AFFECTED
                PRODUCTS

            


    

     

    2.1   Termination
      of Product from Collaboration Agreement. The
      Affected Product shall be excluded from the Collaboration Agreement and except
      to the extent described herein, the terms and conditions of the Collaboration
      Agreement shall no longer apply to such Affected Product. 

     

    
      	 	
              2.2

            	
              License
                to Continuing Party.

            


    

    


    (a)   The
      Commercial Party shall grant the Continuing Party an exclusive license under
      the
      Commercial Party’s Patent Rights and Know How to develop and commercialize the
      Affected Product in ROW, which license shall otherwise be of the same scope
      as
      its license from the Commercial Party under the Collaboration Agreement with
      respect to the Affected Product. 

    


    (b)   Such
      license shall bear an aggregate ************ royalty on Net Sales of the
      Affected Product in ROW (the “Product
      Royalty”).
      The
      precise Product Royalty will be negotiated in good faith by the Parties on
      an
      Affected Product-by-Affected Product basis, taking into consideration the IPV
      of
      the Commercial Party at the end of the Funding Commitment Period. Any dispute
      regarding the amount of the Product Royalty to be paid with respect to Net
      Sales
      of an Affected Product shall be subject to dispute resolution in accordance
      with
      the terms set forth in Article 15 of the Collaboration Agreement.

    


    
      	 	
              2.3

            	
              License
                to Commercial Party.

            


    

    


    (a)   The
      Commercial Party shall have no rights to develop and commercialize the Affected
      Product in ROW and all rights and licensed granted by the Continuing Party
      to
      the Commercial Party with respect to the Affected Product in ROW shall
      terminate.

    


    (b)   The
      Commercial Party shall retain exclusive rights under the Continuing Party’s
      Patent Rights and Know-How to develop and commercialize the Affected Product
      in
      the Commercial Party’s Exclusive Collaboration Territory.

    


    (c)   Subject
      to Section 2.4 below, the relevant terms and conditions of the Collaboration
      Agreement, including without limitation all performance obligations of the
      Commercial Party thereunder, shall be incorporated into the Commercial License
      and shall continue to apply to the Affected Product solely with respect to
      the
      Commercial Party’s Exclusive Collaboration Territory.

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    
      	 	
              2.4

            	
              Further
                Economic Terms.

            


    

    


    (a)   The
      Continuing Party shall retain ************ all profits on Net Sales of the
      Affected Product in ROW, subject to its obligation to pay to the Commercial
      Party the Product Royalty and, if applicable, a reasonable transfer price in
      connection with the manufacture and supply of the Affected Product for ROW
      as
      set forth in 2.5 below.

    


    (b)   The
      Product Participation Model for the Affected Product and profit-sharing
      mechanism under the Collaboration Agreement shall be incorporated into the
      Commercial License and shall apply solely to Net Sales of Affected Products
      in
      the Commercial Party’s Exclusive Collaboration Territory. Thus, for example, if
      at the end of the Funding Commitment Period the Continuing Party’s Product
      Participation percentage is ************ and the Commercial Party’s Product
      participation percentage is ************, the Continuing Party shall be entitled
      to ************ of Net Profits in the Commercial Party’s Exclusive Collaboration
      Territory and the Commercial Party shall be entitled to ************ of such
      Net
      Profits, subject to subsequent adjustment under the same terms provided in
      the
      Collaboration Agreement.

    


    (c)   The
      Commercial Party shall continue to bear Development Costs and Commercialization
      Costs in its Exclusive Collaboration Territory and such costs shall be factored
      into the Product Participation Model under the same terms provided in the
      Collaboration Agreement to adjust the Parties’ relative IPV solely with respect
      to the Commercial Party’s Exclusive Collaboration Territory. Thus, the
      Commercial Party may increase its Product Participation percentage solely in
      its
      Exclusive Collaboration Territory by contributing a larger share of Development
      Costs in its Exclusive Collaboration Territory; provided
      that the
      Commercial Party shall not regain any rights in ROW by reason of such additional
      funding.

     

    
      	 	
              2.5

            	
              Manufacture
                and Supply of Product.

            


    

    


    (a)   If
      the
      Commercial Party was supplying the Affected Product to the Continuing Party
      or a
      Third Party Commercialization partner under a Supply Agreement, it shall
      continue to do so and the terms of the relevant Supply Agreement, other than
      its
      economic terms, shall remain in effect. The Commercial Party shall continue
      to
      supply the Affected Product for those territories in ROW which it was previously
      supplying at a transfer price equal to ************.

    


    (b)   If
      the
      Continuing Party desires the Commercial Party to supply Affected Product to
      the
      Continuing Party for additional regions of ROW, and the Commercial Party is
      willing and has the capacity to supply Affected Product for such additional
      regions, it shall supply such Affected Product at a transfer price equal to
      ************ under the terms of a definitive Supply Agreement to be negotiated
      for such purposes.

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

     

    (c)   If
      the
      Commercial Party is unable to supply, through itself or third parties, all
      or
      part of the Continuing Party’s requirements for the Affected Product, it shall
      grant the Continuing Party a perpetual, non-exclusive, royalty bearing (such
      royalty to be included in the Product Royalty described above) license under
      the
      Commercial Party’s Patent Rights and Know-How to the extent reasonably necessary
      to enable the Continuing Party to manufacture the Affected Product, with the
      right to sublicense to Third Parties engaged by the Continuing Party to
      manufacture such Product, under the terms of the Commercial
      License.

    


    (d)   If
      the
      Continuing Party was supplying the Affected Product to the Commercial Party
      under a Supply Agreement, it shall continue to do so with respect to the
      Commercial Party’s Exclusive Collaboration Territory at a transfer price equal
      to ************.

     

    2.6   Other
      Material Terms and Conditions.
      The
      Parties shall negotiate in good faith the other terms and conditions of the
      Commercial License, which shall be commercially reasonable and shall include,
      without limitation, customary representations, warranties, covenants and
      indemnities, reasonable performance obligations and appropriate remedies for
      default thereof, provisions regarding intellectual property rights,
      confidentiality, payments and reporting and other customary provisions for
      a
      commercial product license of this type.

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    EXHIBIT
      H

     

    Core
      Business Products

    


    
      	
            	
              ¡

            	
              GTC
                Core Business Products:

            


    

    ************

    


    LFB
      Biotech Core Business Products 

    


    MARKETED
      PRODUCTS

    ************

    


    R
      & D PRODUCTS

    ************

    


    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

          Confidential
            material omitted and filed separately with the Securities and Exchange
            Commission. Asterisks denote such
            omissions.

        

      

    

    


    ANNEX
      1

    


    Products
      Excluded from Competing Product Definition

    


    


    GTC
      Excluded Products as of the Effective Date:

    


    
      	
            	
              ¡

            	
              GTC
                Products:

            


    

    ************

    


    


    
      	
            	
              ¡

            	
              Transgenic
                Products developed by GTC as part of pre-existing contracts or agreements
                with external partners: 

            


    

    ************

    


    


    LFB
      Biotech Excluded Products as of the Effective Date:

    


    


    MARKETED
      PRODUCTS

    ************