ex10-11.htm


    
      

    

    EXHIBIT
      10.11

     

     

    
      CERTAIN
        PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO RULE 406 PROMULGATED
        UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND ARE SUBJECT TO A CONFIDENTIAL
        TREATMENT REQUEST.  COPIES OF THE EXHIBITS CONTAINING THE OMITTED
        INFORMATION HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
        COMMISSION.  THE OMITTED PORTIONS OF THIS DOCUMENT ARE MARKED WITH ””
[***]”.

    

     

    
      DISTRIBUTION
        AGREEMENT

       

      This
        Distribution Agreement (this "Agreement") is made and entered into as of
        August
        17, 2007 (the "Effective Date"), by and between Zimmer Dental, Inc., a Delaware
        corporation ("Zimmer"), and Tutogen Medical, Inc., a Florida corporation
        ("Tutogen").

       

      Recitals

       

      A.           Tutogen
        develops, manufactures and markets bio-implants and medical devices for tissue
        and bone repair and other surgical solutions, including the Products (as
        defined
        below).

       

      B.           Zimmer
        distributes a variety of dental products manufactured by itself and
        others.

       

      C.           Zimmer
        and Tutogen are currently parties to the following agreements (in each case,
        as
        amended) (i) the U.S. Service Agreement dated September 29, 2000 (the "U.S.
        Agreement"), (ii) the Xenograft Distribution Agreement dated September 29,
        2000
        (the "Xenograft Agreement"), (iii) the Canadian Distribution Agreement dated
        August 1, 2004 (the "Canada Agreement"), and (iv) the Agreement to Distribute
        Tutogen Products dated January 1, 2006 (the "Latin America
        Agreement").

       

      D.           Tutogen
        desires to appoint Zimmer as the exclusive distributor of the Products
        throughout the Exclusive Territory (as defined below) and as a non-exclusive
        distributor of the Products throughout the Non-Exclusive Territory (as defined
        below) for all uses and applications in the Field (as defined below), and
        Zimmer
        desires to accept such appointment, all in accordance with the terms and
        conditions of this Agreement.

       

      Agreement

       

      In
        consideration of the mutual covenants contained in this Agreement, Zimmer
        and
        Tutogen agree as follows:

       

       

      ARTICLE
        I

      DEFINITIONS
        AND RULES OF CONSTRUCTION

       

      1.1.          Definitions.

       

      (a)           Terms
        Defined in this Article.  For purposes of this Agreement, the
        following terms shall have the following meanings:

       

      "Affiliate"
        means, with respect to an entity, a Person that directly, or indirectly through
        one or more intermediaries, controls, is controlled by, or is under common
        control with, the entity.  For this purpose, "control" of an entity
        means the possession, direct or indirect, of the power to direct or cause
        the
        direction of the management and policies of the entity, whether through the
        ownership of voting securities, by contract or otherwise.

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      "Applicable
        Laws" means all applicable common law, statutes, ordinances, rules,
        regulations or orders of any Governmental Authority, including Regulatory
        Laws.

       

      "Business
        Day" means any day other than a Saturday, a Sunday or a day on which
        banks in New York are authorized or obligated by law or executive order to
        remain closed.

       

      "Change
        of Control" means, with respect to an entity, a transaction or series
        of related transactions as a result of which a Person or group of Persons
        acting
        in concert directly or indirectly acquires control of the entity or acquires
        ownership of all or substantially all of its assets.  The
        transaction(s) may be in any form or combination of forms, including an issuance
        of voting securities, a grant of one or more proxies, a merger (whether or
        not
        the entity survives), a consolidation, a share exchange, a reorganization
        or an
        asset sale.  For this purpose, "control" of an entity means the
        possession, direct or indirect, of the power to direct or cause the direction
        of
        the management and policies of the entity, whether through the ownership
        of
        voting securities, by contract or otherwise.

       

      "Exclusive
        Territory" means the countries and jurisdictions listed on Exhibit
        A attached hereto, including those countries and jurisdictions added
        pursuant to Section 2.2 hereof.

       

      "Field"
        means any and all dental and oral maxillofacial applications.

       

      "Field
        Action" means any correction or removal action by Zimmer or Tutogen due
        to safety, efficacy, quality or regulatory compliance concerns, including
        actions to recover title to or possession of, or to halt distribution of,
        Products that previously have been shipped to customers.

       

      "Governmental
        Authority" means any country in which the Product is manufactured,
        sterilized, marketed, sold, tested, investigated or otherwise regulated,
        and all
        states or other political subdivisions thereof and supranational bodies
        applicable thereto, including the European Union, and all agencies, commissions,
        officials, courts or other instrumentalities of the foregoing.

       

      "Insolvency
        Event" means that the Party (a) has commenced a voluntary
        proceeding under any insolvency law, (b) had an involuntary proceeding
        commenced against it under any insolvency law which has continued undismissed
        or
        unstayed for sixty (60) consecutive days, (c) had a receiver, trustee
        or similar official appointed for it or for any substantial part of its
        property, (d) made an assignment for the benefit of creditors or
        (e) had an order for relief entered with respect to it by a court of
        competent jurisdiction under any insolvency law.  For purposes hereof,
        the term "insolvency law" means any applicable bankruptcy, insolvency or
        other
        similar law now or hereafter in effect.

       

      "Intellectual
        Property" means (a) discoveries, inventions, improvements,
        concepts and ideas, whether or not patentable, (b) works of authorship
        fixed in a tangible medium of expression, (c) Trademarks, (d) trade
        secrets and know-how and (e) all proprietary rights relating thereto,
        including all applications, registrations and renewals in connection
        therewith.

       

      
        
          
          

        

        
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      "Marketing
        Approval" means, with respect to any country or jurisdiction, the act
        of the applicable Regulatory Authority that is necessary under applicable
        Regulatory Laws for the manufacture, marketing, distribution and sale of
        the
        Product in that country or jurisdiction, and satisfaction of all applicable
        regulatory and notification requirements and, to the extent applicable, the
        grant of Pricing Approval.

       

      "Non-Exclusive
        Territory" means [***].

       

      "Party"
        means Zimmer or Tutogen, as the context requires.

       

      "Person"
        means any individual, group or entity, including Governmental
        Authorities.

       

      "Point
        of Destination" means the location to which a Product is to be shipped,
        as designated by Zimmer in the applicable firm order.

       

      "Pricing
        Approval" means, with respect to any country or jurisdiction in which
        Governmental Authorities determine the pricing at which products will be
        reimbursed, the approval, agreement, determination or decision by the applicable
        authorities establishing that pricing.

       

      "Products"
        means the Tutogen grafts set forth on Exhibit B hereto.

       

      "Product
        Complaint" means any expression by a Third Party of
        dissatisfaction relating to the identity, durability, reliability, safety,
        efficacy or performance of any Product, including actual or suspected product
        tampering, contamination, mislabeling or misformulation.

       

      "Regulatory
        Authority" means, with respect to any country or jurisdiction, any
        Governmental Authority involved in granting Marketing Approval or Pricing
        Approval or in administering Regulatory Laws in that country or
        jurisdiction.

       

      "Regulatory
        Laws" means all Applicable Laws governing (a) the import, export,
        testing, sterilization, investigation, manufacture, marketing or sale of
        the
        Product, (b) establishing recordkeeping or reporting obligations,
        (c) Field Actions or (d) similar regulatory matters.

       

      "Specifications"
        means, with respect to each Product, (a) Tutogen's design and functionality
        specifications relating to the Product, (b) any design and functionality
        specifications provided by Tutogen in its sales literature or other product
        documentation and (c) any specifications for manufacturing, testing,
        sterilization, storing, packaging, shipping or labeling the Product set forth
        in
        any approved application for Marketing Approval and any supplements and
        amendments thereto.

       

      "Territory"
        means the Exclusive Territory and the Non-Exclusive Territory.

       

      
        
          
          

        

        
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      "Third Party"
        means any Person other than the Parties and their Affiliates.

       

      "Trademarks"
        means all trademarks, service marks, trade dress, logos and trade
        names, together with all translations, adaptations, derivations and combinations
        thereof (including all goodwill associated therewith), and all applications,
        registrations and renewals in connection therewith.

       

      "Tutogen
        IP" means all Intellectual Property that is subject as of the Effective
        Date, or becomes subject during the Term, to Tutogen's control and that is
        necessary or useful for the manufacture, testing, use, promotion, marketing,
        sale or distribution of the Product.

       

      "United States"
        means the United States of America, including its territories,
        commonwealths and possessions.

       

      (b)           Terms
        Defined Elsewhere.  Capitalized terms not defined in
        Section 1.1(a) shall have the meanings specified elsewhere in the text of
        this Agreement.  Those terms include the following:

       

      
        	
                Term

              	
                Section

              
	
                Agreement

              	
                Opening
                  paragraph

              
	
                Binding
                  Forecast

              	
                3.1

              
	
                Canada
                  Agreement

              	
                Recitals

              
	
                Claim

              	
                7.1(c)

              
	
                Commercialization
                  License

              	
                7.3

              
	
                Confidential
                  Information

              	
                6.1(a)

              
	
                Distribute

              	
                2.1(a)

              
	
                Effective
                  Date

              	
                Opening
                  paragraph

              
	
                Forecast

              	
                3.1

              
	
                Initial
                  Term

              	
                10.1

              
	
                Latin
                  America Agreement

              	
                Recitals

              
	
                Marketing
                  Partners

              	
                2.1(a)

              
	
                Tutogen

              	
                Opening
                  paragraph

              
	
                Product
                  Liability Claim

              	
                9.1(a)

              
	
                QA/RA
                  Agreement

              	
                5.3

              
	
                Renewal
                  Term

              	
                10.1

              
	
                Term

              	
                10.1

              
	
                U.S.
                  Agreement

              	
                Recitals

              
	
                Xenograft
                  Agreement

              	
                Recitals

              
	
                Zimmer

              	
                Opening
                  paragraph

              


      

      


      1.2.          Rules
        of Construction.

       

      (a)           When
        a reference is made in this Agreement to a Recital, an Article, a Section
        or an
        Exhibit, such reference is to a Recital, Article or Section of, or an Exhibit
        to, this Agreement, unless otherwise indicated.

       

      
        
          
          

        

        
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      (b)           Whenever
        the words "include," "includes" or "including" are used in this Agreement,
        they
        shall be understood to be followed by the words "without
        limitation."

       

      (c)           Pronouns,
        including "he," "she" and "it," when used in reference to any Person, shall
        be
        deemed applicable to entities or individuals, male or female, as appropriate
        in
        any given case.

       

      (d)           Article,
        Section and other headings contained in this Agreement are for reference
        purposes only and are not intended to describe, interpret, define or limit
        the
        scope, extent or intent of any provision of this Agreement.

       

      (e)           Standard
        variations on defined terms (such as the plural form of a term defined in
        the
        singular form, and the past tense of a term defined in the present tense)
        shall
        be deemed to have meanings that correlate to the meanings of the defined
        terms.

       

       

      ARTICLE
        II

      DISTRIBUTION

       

      2.1.          Distribution
        Rights.

       

      (a)           Tutogen
        hereby grants to Zimmer, and Zimmer hereby accepts, the exclusive right to
        promote, market, sell and distribute (collectively, "Distribute") the Products
        throughout the Exclusive Territory for all uses and applications in the
        Field.  Zimmer shall have the right to appoint Third Parties
        ("Marketing Partners") to participate in the Distribution of the Products
        in the
        Exclusive Territory.  Tutogen shall not, directly or indirectly,
        Distribute, or permit Distribution of, any allograft or xenograft products
        anywhere in the Exclusive Territory for any uses or applications in the Field,
        either on its own behalf or through any Affiliate or Third Party for as
        long as this Agreement is in effect.

       

      (b)           Tutogen
        hereby grants to Zimmer, and Zimmer hereby accepts, a non-exclusive right
        to
        Distribute the Products (except for the Tutodent Product which will be branded
        under a separate name) throughout the Non-Exclusive Territory for all uses
        and
        applications in the Field.  Zimmer shall have the right to appoint
        Marketing Partners to participate in the Distribution of such Products in
        the
        Non-Exclusive Territory.

       

      2.2.          Additional
        Countries for the Territory.

       

      (a)           Upon
        the Effective Date, Zimmer shall have the exclusive right to Distribute human
        Products in [***] for use in the Field, and
[***] shall be included within the Exclusive
        Territory solely
        for such purpose.  Zimmer shall have the exclusive right to Distribute
        all Products in [***] for use in the Field no later than
[***].

       

      (b)           Prior
        to Distributing, or permitting Distribution of, any Product for use in the
        Field
        in any country outside of the Territory, Tutogen first shall offer Zimmer
        the
        right to Distribute the Product in such country.  Tutogen shall
        provide written notice to Zimmer regarding the proposed Distribution arrangement
        for the Product in such country and Zimmer shall have thirty (30) days from
        its
        receipt of Tutogen's written notice to notify Tutogen whether it is interested
        in the Distribution arrangement.  If Zimmer notifies Tutogen within
        such 30-day period that it desires to Distribute the Product in such country,
        then the country shall be added to the Exclusive Territory.  If Zimmer
        fails to respond to Tutogen within such 30-day period or if Zimmer notifies
        Tutogen that it is not interested in pursuing the Distribution arrangement,
        then
        Tutogen shall be free to Distribute, or permit Distribution of, the Product
        in
        such country.  Notwithstanding the foregoing, after the Effective
        Date, Tutogen shall not enter into any agreements or other commitments that
        would limit or restrict Tutogen's ability to grant Zimmer exclusive Distribution
        rights for the Products in the Field in any country.

       

      
        
          
          

        

        
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      (c)           It
        shall be Tutogen's responsibility to ensure that it has the unrestricted
        right
        to expand the Exclusive Territory (and thereby expand the geographic scope
        of
        Zimmer's exclusive Distribution rights) pursuant this Section 2.2 without
        violating, conflicting with, resulting in the breach of, or constituting
        a
        default under any contract or agreement to which Tutogen is a party or by
        which
        any of its properties or businesses are bound.  Exhibit A to
        this Agreement shall be updated to reflect any countries added to the Exclusive
        Territory under this Section 2.2.

       

      2.3.          Competitive
        Products.[***] Nothing in this Agreement shall
        preclude Zimmer's third-party Marketing Partners from distributing and promoting
        any products that compete directly or indirectly with the Products, provided
        that such Marketing Partners are not distributing or promoting such products
        on
        behalf of Zimmer.

       

      2.4.          Marketing
        and Sales Activities.  Zimmer shall have control and
        authority over its marketing activities for the Products in the
        Field.  Zimmer's marketing and sales efforts may include development
        of collateral marketing materials, surgical training, attendance at professional
        tradeshows, and pre-clinical and clinical studies, at Zimmer's
        cost.  Zimmer shall provide Tutogen with a reasonable opportunity to
        review and approve all marketing and collateral materials relating to the
        Products solely for purposes of compliance with Regulatory Laws, which approval
        shall not be unreasonably withheld or delayed.

       

      2.5.          Branding.  The
        Products shall be branded as directed by Zimmer.  Tutogen shall adapt
        packaging and labeling for the Products as instructed by Zimmer to meet Zimmer's
        branding standards.  The costs for any change in branding will be
        borne by Zimmer.

       

      2.6.          Training
        Support.  Tutogen shall provide, at no charge to Zimmer, a
        reasonable number of technical sales training sessions for sales personnel
        of
        Zimmer and its Marketing Partners, at times and locations mutually agreed
        by the
        Parties.  Zimmer shall be primarily responsible for training end users
        in the field.

       

      2.7.          Sample
        Products.  At Zimmer's request, Tutogen shall provide a
        reasonable amount of sample Products for use with Zimmer's sales force, trade
        shows, promotional activities, training classes and the
        like.  Transfer pricing for the sample Products is set forth in
Exhibit C.

       

      2.8.          Acceptance
        of Products.  Zimmer, its Marketing Partners and/or the end
        users of the Products shall have a reasonable right of inspection to verify
        that
        the Products conform to the applicable firm order and the terms of this
        Agreement.  Any non-conforming Product shall be returned to
        Tutogen.  Tutogen shall bear all costs of return (including freight
        and insurance) and shall either replace the defective or nonconforming Product
        without charge (including payment of freight and insurance for delivery of
        the
        replacement product) or, at Zimmer's request, refund to Zimmer the entire
        amount
        paid in connection with the rejected Product.  Nothing in this
        Section, including the exercise of rights hereunder, shall be construed as
        a
        waiver of Zimmer's indemnification rights, its warranty rights or any other
        common law or statutory remedies.

       

      
        
          
          

        

        
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      ARTICLE
        III

      PURCHASING

       

      3.1.          Forecasts
        and Firm Orders.  On a monthly basis Zimmer shall provide to
        Tutogen a twelve (12) month rolling forecast of the anticipated quantities
        of the Products that Zimmer expects to order on a country-by-country basis
        (each, a "Forecast").  The first four (4) months of each Forecast
        shall be binding (each, a "Binding Forecast") and Zimmer agrees to place
        firm
        orders for at least that number Products set forth in each Binding Forecast
        (on
        an aggregate basis and not on a country-by-country basis, unless there are
        special packaging requirements for a particular country in which case Zimmer
        shall place firm orders for at least that number of Products set forth in
        the
        Binding Forecast for such country).  The remaining eight (8)
        months of each Forecast shall be non-binding and for planning purposes
        only.  The first Forecast will be delivered to Tutogen upon execution
        of this Agreement.

       

      3.2.          Fulfillment
        of Firm Orders.  Tutogen shall use commercially reasonable
        efforts to fulfill all firm orders for the Product submitted by Zimmer pursuant
        to this Section 3.2 and to deliver Products by the delivery date requested
        in the applicable purchase order.  Zimmer shall place firm orders for
        the Product no less than one hundred and twenty (120) days prior to the
        requested delivery date.  Firm orders shall be in Zimmer's standard
        form as modified from time to time.  Firm orders may be submitted via
        e-mail.  Each firm order shall be deemed accepted, once confirmed by
        Tutogen.  If any term in any firm order or confirmation conflicts with
        any term in this Agreement, the term in this Agreement shall govern and
        control.

       

      3.3.          Transfer
        Pricing.

       

      (a)           The
        processing fees (referred to herein as "transfer pricing") for the Products
        purchased during the Initial Term is set forth in Exhibit B attached
        hereto.  After the expiration of the Initial Term, Tutogen shall be
        entitled to increase the transfer pricing for any Product [***]
        per Renewal Term, provided that Tutogen notifies Zimmer in writing regarding
        the
        pricing increase at least one hundred twenty-five (125) days prior to the
        commencement of the applicable Renewal Term.

       

      (b)           A
        surcharge shall be applied for any firm order with aggregate transfer pricing
        less than €5,000 for purchases made in euros and $6,500 for purchases made in
        U.S. dollars, which surcharge shall be the greater of 10% of the transfer
        pricing in the firm order or €100 for purchases made in euros and $100 for
        purchases made in U.S. dollars.

       

      (c)           The
        transfer pricing is for processing finished Products (i.e. packaged, labeled
        and
        sterilized).  Subject to Section 3.5(c) below, Zimmer shall be
        responsible for all freight and delivery charges and any other costs for
        shipment of the Products from Tutogen's facilities in Neunkirchen, Germany
        or
        Alachua, Florida to the Point of Destination specified in the applicable
        firm
        order.

       

      
        
          
          

        

        
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      (d)           In
        the event of an unforeseen, extraordinary event that causes a significant
        increase in Tutogen's costs to provide the Product to Zimmer (e.g. adverse
        regulatory actions), appropriate representatives from Zimmer and Tutogen
        will
        discuss potential adjustments to the pricing set forth in Exhibit B;
        provided, however, that nothing in this Section 3.3 shall be construed to
        require Zimmer to agree to any such adjustment or to relieve Tutogen of its
        obligations to provide the Products to Zimmer at the transfer pricing provided
        herein.

       

      3.4.          Payment
        Terms.  Tutogen shall deliver to Zimmer an invoice for each
        firm order, which invoice shall contain customary information, including
        the
        quantity of Products delivered.  Payment terms for undisputed amounts
        due shall be [***] from the date of
        shipment.  Payments hereunder will be made in U.S. dollars or euros as
        indicated in Exhibit B hereto.  A discount of one percent
        (1%) calculated on the invoice total shall be applied in the case of payment
        within ten (10) days after Zimmer's receipt of the applicable
        invoice.

       

      3.5.          Shipping.

       

      (a)           All
        shipments shall be to the Point of Destination by a carrier selected by
        Zimmer.  Tutogen shall use commercially reasonable efforts to deliver
        the Products to the carrier designated by Zimmer no later than the delivery
        date
        set forth in the applicable firm order.  In the event that Tutogen is
        not able to timely deliver an entire firm order, Tutogen shall (i) deliver
        as
        much of the firm order as possible, and (ii) provide immediate notice to
        Zimmer
        of the anticipated shortfall, which notice shall specify the cause for the
        delay
        and the estimated delivery date for the remaining Products.

       

      (b)           Tutogen
        shall package, label, store and ship all Products in compliance with Applicable
        Laws and in accordance with good commercial and industry
        practice.  The Products shall be delivered to the Point of Destination
        sterile and ready for resale.  Tutogen shall package the Products
        suitably for export and appropriately to prevent damage during
        shipment.  The packing slip/delivery note shall have the part number,
        purchase order number and delivery quantity.

       

      (c)           The
        Products shall be shipped F.O.B. Tutogen's facilities in either Neunkirchen,
        Germany or Alachua, Florida.  At Zimmer's expense, Tutogen shall ship
        the Products to the Point of Destination designated by Zimmer in the applicable
        firm order.  Notwithstanding the foregoing, in the event that Tutogen
        is unable to fulfill an entire firm order in one shipment or Tutogen makes
        multiple shipments for a single firm order for any other reason (unless
        requested by Zimmer), then Tutogen shall bear the shipping costs and expenses
        for all such additional shipments.

       

      (d)           With
        respect to Products to be distributed in Germany, Tutogen shall deliver the
        Products directly to customers and end users as requested by Zimmer, until
        such
        time that Zimmer obtains (i) ISO certification for the Products and (ii)
        any
        wholesale license required by Regulatory Authorities in Germany.

       

      
        
          
          

        

        
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      3.6.          Tutogen
        Inventory.  Upon execution of this Agreement, Zimmer agrees
        to purchase Tutogen's inventory of Products as specified in Exhibit D
        hereto, in the quantities and at the transfer prices and other terms detailed
        in
        such exhibit.  Title to such inventory shall transfer to Zimmer
        effective as of the Effective Date.  Payment for such inventory shall
        be made to Tutogen within 15 Business Days of the Effective
        Date.  Products in such Inventory shall be stored by Tutogen at its
        facilities at no additional charge to Zimmer until Zimmer provides delivery
        instructions for such Products.  Tutogen shall store the inventory in
        compliance with Applicable Laws and in accordance with good commercial and
        industry practice.

       

      3.7.          Local
        Tissue Banks.  For any countries that require distribution of
        an allograft Product through a local tissue bank, both Zimmer and Tutogen
        will
        negotiate in good faith a change in the process and costs for orders, shipments
        and payments.

       

       

      ARTICLE
        IV

      MANUFACTURING

       

      4.1.          Inventory.  Tutogen
        shall maintain sufficient manufacturing capacity (including appropriate
        manufacturing, storage and distribution facilities and qualified personnel)
        to
        meet Zimmer's forecasted demand for the Products.

       

      4.2.          Manufacturing.  The
        Products shall be manufactured and sterilized in accordance with the
        Specifications and with all Applicable Laws.  Tutogen shall maintain
        throughout the Term and for the specified shelf life of the Product (or for
        such
        longer period as may be required by Applicable Laws) accurate and complete
        records relating to its manufacture, sterilization and testing of the Products,
        including all records required under Applicable Laws.

       

      4.3.          Product
        Modifications.  Tutogen shall not alter or modify the
        Products or their labeling without the prior written consent of
        Zimmer.

       

      4.4.          Product
        Warranty.  Tutogen warrants to Zimmer, its Marketing Partners
        and the end users of each Product, that the Product, when delivered in
        accordance with the applicable firm order, will (i) conform to the
        Specifications, (ii) have been manufactured, tested, stored, packaged,
        labeled, sterilized and shipped in compliance with Applicable Laws and
        (iii) be free of defects in design, material, engineering, fabrication and
        workmanship.  The foregoing warranty shall be in effect with respect
        to each Product for the labeled shelf life of the
        Product.  Tutogen further warrants to Zimmer that the Product, when
        delivered, shall be free and clear of any liens, security interests or
        encumbrances of any nature whatsoever.  TUTOGEN DISCLAIMS ALL IMPLIED
        WARRANTIES, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
        PARTICULAR PURPOSE.

       

      4.5.          Subcontracting.  Tutogen
        shall comply with all Applicable Laws related to suppliers, subcontractors
        and
        vendors and Tutogen shall require that all of its suppliers, subcontractors
        and
        vendors providing services or products in relation to the Products are in
        compliance with all Applicable Laws with regard to such services and
        products.  Tutogen shall remain primarily responsible for performance
        of its obligations hereunder, including obligations relating to Product quality
        assurance, compliance with Applicable Laws and confidential information,
        regardless of whether any of Tutogen's obligations are undertaken by a
        subcontractor.

       

      
        
          
          

        

        
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      ARTICLE
        V

      REGULATORY
        MATTERS

       

      5.1.          Compliance
        with Laws.  Each Party shall comply in all material respects
        with all Applicable Laws that pertain to its activities under this Agreement
        and, except as otherwise provided for herein, shall bear the entire cost
        and
        expense of such compliance.

       

      5.2.          Marketing
        Approvals.  Tutogen represents and warrants to Zimmer that it
        has applied for and received Marketing Approval for the Products in the
        countries specified in Exhibit E hereto, and that such approvals are in
        good standing.  The Parties acknowledge that existing Marketing Approvals
        may need to be modified or supplemented in certain countries in order to
        permit
        the rebranding and Distribution of the Products by Zimmer.  At
        Zimmer's request, to the extent that Marketing Approval has not been obtained
        for a Product in any country or jurisdiction within the Territory, Tutogen
        shall
        use commercially reasonable efforts to obtain Marketing Approval for such
        Product in such country or jurisdiction.  Tutogen shall have primary
        responsibility for all communications, submissions and interactions with
        the
        Regulatory Authorities for the purpose of obtaining and maintaining Marketing
        Approvals. Tutogen shall be responsible for the cost of original registrations
        and maintenance of the product registration. Zimmer shall be responsible
        for all
        costs and expenses incurred during the Term relating to modification of the
        original registration in an effort to rebrand the products and registration
        of
        facilities.  To the extent permitted under Applicable Laws, Tutogen
        hereby grants to Zimmer the fully paid up right to use any and all regulatory
        approvals and clearances related to the Products, for use in the Field of
        Use,
        owned by or licensed to Tutogen and existing as of the Effective Date or
        obtained during the Term.

       

      5.3.          Quality
        Assurance / Regulatory Affairs Document.  Concurrently with
        the execution of this Agreement, the Parties shall enter into a QA/RA agreement
        setting forth procedures and protocols for quality assurance and regulatory
        affairs relating to the Product (the "QA/RA Agreement").  To the
        extent that any term in the QA/RA Agreement conflicts with any term of this
        Agreement, this Agreement shall govern and control.

       

      5.4.          Actions
        by Regulatory Authorities.  Tutogen shall be responsible to
        Regulatory Authorities throughout the Territory as the manufacturer of the
        Products.  If either Party receives notice of an inspection,
        investigation, inquiry, import or export ban, product seizure, enforcement
        proceeding or similar action by a Regulatory Authority with respect to the
        Product or a Party's activities in connection with the Product, it will notify
        the other Party within forty-eight (48) hours after its receipt of notice
        of the action and will promptly deliver to the other Party copies of all
        relevant documents received from the Regulatory Authority.  The
        Parties shall cooperate in response to the action, including providing
        information and documentation as requested by the Regulatory
        Authority.  If the action primarily concerns Zimmer's activities, then
        Zimmer shall have primary responsibility to respond to the Regulatory Authority;
        otherwise, Tutogen shall have primary responsibility to respond.  In
        either case, upon request of the responding Party, the other Party shall
        provide
        consulting advice and assistance with the response.

       

      
        
          
          

        

        
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      5.5.          Inspections.  Zimmer
        shall have the right, upon reasonable prior notice to Tutogen and not more
        frequently than once a year and during regular business hours, to inspect
        and
        audit Tutogen's facilities and operations for the purpose of verifying Tutogen's
        compliance with its obligations under Regulatory Laws and applicable quality
        system requirements, including the right to (a) inspect and take samples of
        the Product, (b) observe manufacturing and related operations, processes
        and methods, (c) review documentation and (d) conduct quality
        assurance, quality system and regulatory compliance audits.

       

      5.6.          Product
        Labels.  Tutogen shall have sole responsibility for obtaining
        all necessary Product labels and for negotiating the language of the Product
        labels with the applicable Regulatory Authorities in the Territory; however,
        Tutogen shall not propose or agree to specific content without Zimmer's prior
        approval.

       

      5.7.          Product
        Complaints and Reports.  The Parties each shall collect and
        record Product Complaints (and any other events required to be recorded under
        Applicable Laws) in accordance with Applicable Laws and their standard
        procedures and policies in effect from time to time.  Each Party shall
        provide to the other Party reports of such complaints or events within
        seventy-two (72) hours after receipt.  Tutogen shall be
        responsible for investigating all Product Complaints.  Tutogen shall
        be responsible for submitting to the Regulatory Authorities all required
        reports
        and other materials, including annual reports, distribution reports and safety
        reports.  Each Party shall immediately notify the other Party of any
        material information it learns concerning the safety or efficacy of the Product,
        regardless of whether formal reporting to any Regulatory Authority is
        required.

       

      5.8.          Traceability.  Tutogen
        shall maintain manufacturing and traceability records with respect to the
        Products, including TUR forms and records by lot number.  Zimmer shall
        maintain records of distribution in the Territory, on a lot number basis,
        and
        make this information available to Tutogen as required for compliance with
        Applicable Laws.  Zimmer shall use reasonable efforts to encourage its
        customers to return completed TUR forms to Tutogen.

       

      5.9.          Field
        Actions.  If either Party in good faith determines that a
        removal, correction, recall or other Field Action involving a Product or
        its
        labeling is warranted (whether or not required by a Regulatory Authority),
        such
        Party shall immediately notify the other Party in writing and shall advise
        such
        other Party of the reasons underlying its determination that a removal,
        correction, recall or other Field Action is warranted.  The Parties
        shall consult with each other as to any action to be taken in regard to such
        removal, correction, recall or other Field Action.  If, after
        consultations, either Party in good faith believes that such a removal,
        correction, recall or Field Action should be undertaken with respect the
        Product
        or its labeling, the Parties shall cooperate in carrying out the
        same.  Tutogen shall be responsible for all of Zimmer's reasonable
        out-of-pocket costs and expenses, including the replacement cost of the
        Products, in the event of removals, corrections, recalls or other Field Actions
        with respect to any Product unless such removal, correction, recall or other
        Field Action was due to an act or omission of Zimmer, in which case Zimmer
        shall
        be responsible for Tutogen's reasonable out-of-pocket costs and expenses
        in
        connection therewith.   Tutogen shall be responsible for any
        required reporting to Regulatory Authorities with respect to any removal,
        correction, recall or other Field Action involving the Product or its
        labeling.

       

      
        
          
          

        

        
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      ARTICLE
        VI

      CONFIDENTIALITY

       

      6.1.          Confidentiality.  In
        the course of their activities pursuant to this Agreement, the Parties
        anticipate that they may disclose Confidential Information to one another
        and
        that either Party may, from time to time, be either the disclosing Party
        or the
        recipient of Confidential Information.  The Parties wish to protect
        such Confidential Information in accordance with this
        Section 6.1.  The provisions of this Section shall apply to
        disclosures furnished to or received by a Party and its agents and
        representatives (which may include agents and representatives of its Affiliates
        and Marketing Partners).  Each Party shall advise its agents and
        representatives of the requirements of this Section and shall be responsible
        to
        ensure their compliance with such provisions.

       

      (a)           For
        purposes hereof, "Confidential Information" with respect to a disclosing
        Party
        means all information, in any form or media that the disclosing Party furnishes
        to the recipient, whether furnished before or after the Effective Date, and
        all
        notes, analyses, compilations, studies and other materials, whether prepared
        by
        the recipient or others, that contain or reflect such information; provided,
        however, that Confidential Information does not include information that
        (i) is or hereafter becomes generally available to the public other than as
        a result of a disclosure by the recipient, (ii) was already known to the
        recipient prior to receipt from the disclosing Party as evidenced by prior
        written documents in its possession not subject to an existing confidentiality
        obligation to the disclosing Party, (iii) is disclosed to the recipient on
        a non-confidential basis by a person who is not in default of any
        confidentiality obligation to the disclosing Party or (iv) is developed by
        or on behalf of the recipient without reliance on confidential information
        received hereunder.  The contents of this Agreement shall be deemed to
        be Confidential Information of each Party.

       

      (b)           The
        recipient of Confidential Information shall (i) maintain its
        confidentiality using efforts and precautions at least as great as those
        it uses
        and takes to protect its own confidential information and trade secrets;
        (ii) use such Confidential Information solely in connection with the
        discharge of its obligations under this Agreement and (iii) not disclose
        such Confidential Information to any person other than those of its agents
        and
        representatives who need to know such Confidential Information in order to
        accomplish the objectives for which it was disclosed.  Notwithstanding
        the foregoing, the recipient of Confidential Information may disclose it
        to the
        extent necessary to comply with applicable laws or regulations or with an
        order
        issued by a court or regulatory body with competent jurisdiction; provided
        that,
        in connection with such disclosure, the recipient uses commercially reasonable
        efforts to obtain confidential treatment or an appropriate protective order,
        to
        the extent available, with respect to such Confidential
        Information.

       

      
        
          
          

        

        
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      (c)           Upon
        request of the disclosing Party, the recipient of Confidential Information
        shall
        promptly redeliver to the disclosing Party all Confidential Information provided
        to the recipient in tangible form, and the recipient shall not retain any
        copies, extracts or other reproductions, in whole or in part, of such
        Confidential Information.  All notes or other work product prepared by
        the recipient based upon or incorporating Confidential Information of the
        disclosing Party shall be destroyed, and such destruction shall be certified
        in
        writing to the disclosing Party by an authorized representative of the recipient
        who supervised such destruction.  Notwithstanding the foregoing,
        in-house legal counsel to the recipient shall be permitted to retain in its
        files one copy of all Confidential Information to evidence the scope of the
        Party's obligation of confidentiality.

       

      (d)           The
        obligations under this Section shall remain in effect from the Effective
        Date
        through the third anniversary of the expiration or termination of this
        Agreement.

       

      (e)           In
        addition to any other remedies available in law or equity, the disclosing
        Party
        shall be entitled to temporary and permanent injunctive relief in the event
        of a
        breach (or threatened breach) under this Section.

       

      (f)           The
        provisions of this Section shall supersede and replace any prior agreements
        between the Parties relating to Confidential Information covered
        hereby.

       

      6.2.          Publicity.  Neither
        Tutogen nor Zimmer shall issue any press release or otherwise publicize the
        subject matter of this Agreement without the prior written approval of the
        other
        Party, except to the extent that such press release or other public announcement
        is required by law in the opinion of legal counsel to the releasing Party
        or
        that the substance thereof has been previously reviewed and released by the
        other Party or is in the public domain through no fault of the releasing
        Party.  In the event of a required press release or other public
        announcement, the releasing Party shall provide the other Party with a copy
        of
        the proposed text prior to such announcement.  The Parties agree that
        if either Party is required to file this Agreement with any Governmental
        Authority, the releasing Party shall redact the financial terms of this
        Agreement to the extent possible in order to keep the financial terms of
        this
        Agreement confidential.

       

       

      ARTICLE
        VII

      INTELLECTUAL
        PROPERTY RIGHTS

       

      7.1.          IP
        Representations.  Tutogen hereby represents and warrants to,
        and covenants with, Zimmer as follows:

       

      (a)           Tutogen
        owns or holds valid and enforceable rights to use and license (to the extent
        a
        license is required), without infringing, misappropriating or violating the
        rights of any Person, any Intellectual Property that is necessary for
        (i) Tutogen to manufacture and sell the Product, (ii) Zimmer to
        Distribute the Product as contemplated by this Agreement and (iii) Tutogen
        to grant to Zimmer and its Marketing Partners the Distribution rights under
        this
        Agreement.

       

      (b)           Tutogen
        has not previously granted any license, covenant not to sue or other right
        that
        would be inconsistent with or conflict with the grant of the Distribution
        rights
        under this Agreement.

       

      
        
          
          

        

        
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      (c)           No
        Person has asserted a claim, suit, proceeding, action or demand (a "Claim")
        with
        respect to any of the Tutogen IP, which Claim (i) challenges the validity
        of Tutogen's interest in the Tutogen IP, (ii) alleges that Tutogen's use or
        practice of the Tutogen IP infringes, misappropriates or violates the rights
        of
        any Person or (iii) seeks to enjoin or restrain Tutogen's use or practice
        of the Tutogen IP in any manner that would interfere with the transactions
        contemplated by this Agreement.  Tutogen has no knowledge that any
        Person intends to assert such a Claim.

       

      7.2.          Trademarks.  Zimmer
        and its Marketing Partners shall have the right to use Tutogen's Trademarks
        associated with the Product (including, without limitation, Tutoplast® and Tutodent®)  for
        Product marketing purposes and as may be necessary in order to comply with
        applicable Regulatory Laws.  Zimmer and its Marketing Partners shall
        comply with the reasonable quality control instructions of Tutogen as to
        the
        form and manner in which such Trademarks shall be used.  Any
        Trademarks developed by Zimmer for the Product shall be owned exclusively
        by
        Zimmer.  Other than as expressly provided herein, no Party shall
        acquire or have any right to use the name or Trademarks of the other Party
        without its prior written consent.

       

      7.3.          Commercialization
        License.  Tutogen hereby grants to Zimmer a royalty-free
        license and right, with the right to sublicense, under the Tutogen IP and
        all
        improvements and future developments with respect thereto, to use, sell,
        offer
        to sell, have sold, and import/export the Products in the Field throughout
        the
        Territory (the "Commercialization License").  The Commercialization
        License shall be exclusive for the Exclusive Territory and non-exclusive
        for the
        Non-Exclusive Territory.  The Commercialization License shall be
        deemed to be, for purposes of Section 365(n) of the United States
        Bankruptcy Code, a license to rights to "intellectual property" as defined
        therein.  Zimmer, as licensee of such rights, shall have the rights
        and elections with respect thereto as specified in the United States
        Bankruptcy Code.  This Agreement shall be deemed to be an "agreement
        supplemental to" the Commercialization License for purposes of
        Section 365(n) of the United States Bankruptcy Code.

       

       

      ARTICLE
        VIII

      REPRESENTATIONS
        AND WARRANTIES

       

      Each
        Party hereby represents and warrants to, and covenants with, the other Party
        that:

       

      (a)           It
        is a corporation duly organized, validly existing and, if relevant in its
        jurisdiction of organization, in good standing under the laws of its
        jurisdiction of organization and has the power and authority to own, lease
        and
        operate its assets and to conduct the business now being conducted by
        it.  It has all requisite power and authority to enter into this
        Agreement and to perform its obligations hereunder.

       

      (b)           The
        execution, delivery and performance by it of this Agreement and the consummation
        by it of the transactions contemplated hereby have been duly authorized and
        approved by all necessary corporate or equivalent action on its
        part.  This Agreement has been duly executed and delivered by it and
        constitutes its legal, valid and binding obligation, enforceable against
        it in
        accordance with its terms, except as the same may be limited by applicable
        bankruptcy, insolvency, reorganization, moratorium or other laws relating
        to or
        affecting creditors' rights generally and by general equity
        principles.

       

      
        
          
          

        

        
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      (c)           The
        execution, delivery and performance by it of this Agreement and the consummation
        by it of the transactions contemplated hereby do not and will
        not:  (i) violate any Applicable Laws; (ii) conflict with,
        or result in the breach of any provision of, its certificate of incorporation,
        bylaws or equivalent organizational documents; (iii) result in the creation
        of any lien or encumbrance of any nature upon any property being transferred
        or
        licensed by it pursuant to this Agreement or (iv) violate, conflict with,
        result in the breach or termination of, or constitute a default under (or
        event
        which, with notice, lapse of time or both, would constitute a default under),
        any permit, contract or agreement to which it is a party or by which any
        of its
        properties or businesses are bound.

       

      (d)           No
        authorization, consent or approval of, or notice to or filing with, any
        Governmental Authority is required for the execution, delivery and performance
        by it of this Agreement, other than Marketing Approvals that have not been
        obtained prior to the Effective Date.

       

       

      ARTICLE
        IX

      INDEMNIFICATION
        AND INSURANCE

       

      9.1.          Indemnification
        by Tutogen.

       

      (a)           Tutogen
        shall indemnify and hold harmless Zimmer and its Affiliates and Marketing
        Partners and their respective shareholders, directors, officers, employees
        and
        agents from and against any and all liabilities, damages, losses, penalties,
        fines, costs and expenses, including reasonable attorneys' fees, paid or
        incurred by them in connection with any Claim based upon or arising
        from:  (i) any bodily injury, death or property damage resulting
        from any defect in the design, engineering, fabrication, manufacture or label
        (including the label warnings) of any Product or from the failure of any
        Product
        to conform to the applicable Specifications therefor (a "Product Liability
        Claim"); (ii) any infringement or violation of a Third-Party's Intellectual
        Property as a result of the use, manufacture, sale or distribution of the
        Product; (iii) any facts or circumstances that would constitute a breach by
        Tutogen of any of its representations, warranties or obligations under this
        Agreement; (iv) any violation by Tutogen of Applicable Laws or (v) any
        negligent or more culpable act or omission of Tutogen or its Affiliates or
        subcontractors or any of their respective employees or agents relating to
        the
        activities subject to this Agreement.

       

      (b)           Zimmer
        shall give Tutogen prompt written notice of any Claim with respect to which
        Tutogen's indemnification obligations may apply, but any delay or failure
        of
        such notice shall not excuse Tutogen's indemnification obligations except
        to the
        extent that Tutogen's legal position is prejudiced thereby.  Tutogen
        shall have the right to assume and control the defense and settlement of
        any
        such Claim; except that Zimmer shall have the right to assume and control,
        at
        Tutogen's expense, the defense and settlement of any such Claim
        if:  (i) Zimmer reasonably determines that there is a conflict of
        interest between Zimmer and Tutogen with respect to such Claim;
        (ii) Tutogen fails to employ counsel reasonably satisfactory to Zimmer to
        represent Zimmer within a reasonable time after Tutogen's receipt of notice
        of
        the Claim or (iii) in the reasonable opinion of counsel to Zimmer, the
        Claim could result in Zimmer becoming subject to injunctive or other
        non-monetary relief that could have a material adverse effect on Zimmer's
        ongoing business.  The Party not controlling the defense shall have
        the right to participate in the Claim at its own expense, but in any event
        shall
        cooperate with the controlling Party in the investigation and defense of
        the
        Claim.

       

      
        
          
          

        

        
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      (c)           If
        Tutogen is entitled to, and does, assume and control the defense and settlement
        of any Claim with respect to which its indemnification obligations apply,
        then
        Tutogen shall not settle such Claim without Zimmer's prior written consent
        (which consent shall not be unreasonably withheld or delayed), unless
        (i) the sole relief provided in such settlement is monetary in nature and
        shall be paid in full by Tutogen and (ii) such settlement does not include
        any finding or admission of a violation by Zimmer of any Applicable Laws
        or
        Third Party's rights.  Whenever Zimmer assumes and controls the
        defense and settlement of a Claim with respect to which Tutogen's
        indemnification obligations apply, Tutogen shall not be liable for any
        settlement thereof effected by Zimmer unless Zimmer shall have obtained
        Tutogen's prior written consent to the proposed settlement (which consent
        shall
        not be unreasonably withheld or delayed).

       

      (d)           Tutogen
        shall maintain, from the Effective Date through the first anniversary of
        the
        expiration date of the Term, a policy of insurance for Product Liability
        Claims.  Such policy shall (i) have a per occurrence limit of at
        least $1,000,000 and an annual aggregate limit of at least $5,000,000,
        (ii) name Zimmer as an additional insured and (iii) provide for at
        least thirty (30) days' advance written notice to Zimmer of
        cancellation or material change in coverage.  Tutogen shall provide
        evidence of such coverage to Zimmer promptly following execution of this
        Agreement and annually thereafter.  If Tutogen breaches its obligation
        to maintain insurance, (x) Zimmer shall have the right to obtain coverage
        as required on Tutogen's behalf and at Tutogen's expense, (y) Zimmer shall
        have the right to set-off the cost of such coverage against any payment owed
        to
        Tutogen for Product purchases and (z) Tutogen shall indemnify Zimmer from
        and against all costs and expenses associated with obtaining such
        coverage.

       

      9.2.          Indemnification
        by Zimmer.

       

      (a)           Zimmer
        shall indemnify and hold harmless Tutogen and its Affiliates and their
        respective shareholders, directors, officers, employees and agents from and
        against any and all liabilities, damages, losses, penalties, fines, costs
        and
        expenses, including reasonable attorneys' fees, paid or incurred by them
        in
        connection with any Claim based upon or arising from:  (i) any
        facts or circumstances that would constitute a breach by Zimmer of any of
        its
        representations, warranties or obligations under this Agreement; (ii) any
        violation by Zimmer of Applicable Laws or (iii) any negligent or more
        culpable act or omission of Zimmer or its Affiliates or Marketing Partners
        or
        any of their respective employees or agents relating to the activities subject
        to this Agreement.

       

      
        
          
          

        

        
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      (b)           Tutogen
        shall give Zimmer prompt written notice of any Claim with respect to which
        Zimmer's indemnification obligations may apply, but any delay or failure
        of such
        notice shall not excuse Zimmer's indemnification obligations except to the
        extent that Zimmer's legal position is prejudiced thereby.  Zimmer
        shall have the right to assume and control the defense and settlement of
        any
        such Claim; except that Tutogen shall have the right to assume and control,
        at
        Zimmer's expense, the defense and settlement of any such Claim
        if:  (i) Tutogen reasonably determines that there is a conflict
        of interest between Zimmer and Tutogen with respect to such Claim;
        (ii) Zimmer fails to employ counsel reasonably satisfactory to Tutogen to
        represent Tutogen within a reasonable time after Zimmer's receipt of notice
        of
        the Claim or (iii) in the reasonable opinion of counsel to Tutogen, the
        Claim could result in Tutogen becoming subject to injunctive or other
        non-monetary relief that could have a material adverse effect on Tutogen's
        ongoing business.  The Party not controlling the defense shall have
        the right to participate in the Claim at its own expense, but in any event
        shall
        cooperate with the controlling Party in the investigation and defense of
        the
        Claim.

       

      (c)           If
        Zimmer is entitled to, and does, assume and control the defense and settlement
        of any Claim with respect to which its indemnification obligations apply,
        then
        Zimmer shall not settle such Claim without Tutogen's prior written consent
        (which consent shall not be unreasonably withheld or delayed), unless
        (i) the sole relief provided in such settlement is monetary in nature and
        shall be paid in full by Zimmer and (ii) such settlement does not include
        any finding or admission of a violation by Tutogen of any Applicable Laws
        or
        Third Party's rights.  Whenever Tutogen assumes and controls the
        defense and settlement of a Claim with respect to which Zimmer's indemnification
        obligations apply, Zimmer shall not be liable for any settlement thereof
        effected by Tutogen unless Tutogen shall have obtained Zimmer's prior written
        consent to the proposed settlement (which consent shall not be unreasonably
        withheld or delayed).

       

      9.3.          Combined
        Obligations.  To the extent that Zimmer and Tutogen have
        indemnification obligations to one another in connection with a single Claim,
        Zimmer and Tutogen shall contribute to the aggregate damages arising from
        such
        Claim in such proportion as is appropriate to reflect their relative
        responsibilities for such damages, as well as any other relevant equitable
        considerations.  The amount paid or payable by Zimmer or Tutogen for
        purposes of apportioning the aggregate damages shall be deemed to include
        all
        reasonable legal fees and expenses incurred by such Party in connection with
        investigating, preparing for or defending against such Claim.

       

       

      ARTICLE
        X

      TERM
        AND TERMINATION

       

      10.1.        Term.  Unless
        earlier terminated in accordance with Section 10.2, the initial term of
        this Agreement (the "Initial Term") shall begin on the Effective Date and
        shall
        continue in effect until September 29, 2010.  The Initial Term shall
        be automatically extended for one year renewal terms (each, a "Renewal Term"),
        unless at least one hundred twenty (120) days prior to the expiration
        of the Initial Term or the applicable Renewal Term either Party notifies
        the
        other Party in writing that it desires not to renew the Initial Term or Renewal
        Term, as applicable.  The period from the Effective Date through the
        date of expiration or termination of this Agreement shall be referred to
        as the
        "Term."

       

      
        
          
          

        

        
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      10.2.        Termination.  This
        Agreement may be terminated prior to the expiration of the Initial Term or
        any
        Renewal Term as follows:

       

      (a)           If
        a Party is dissolved under applicable corporate law or becomes subject to
        an
        Insolvency Event, the other Party may terminate this Agreement by delivering
        written notice of its decision to do so within sixty (60) days after actual
        knowledge of the dissolution or the Insolvency Event.

       

      (b)           If
        either Party believes the other is in material default of this Agreement,
        it may
        give notice of such default to the other Party, and the defaulting Party
        shall
        have thirty (30) days in which to remedy the default.  If
        the default is not remedied within such thirty (30) day period, the
        non-defaulting Party may terminate this Agreement immediately upon delivery
        to
        the defaulting Party of a written notice of termination.  The
        non-defaulting Party's right to terminate this Agreement shall not be construed
        as an exclusive remedy.

       

      (c)           If
        a Party is subject to a Change of Control and the acquiring Person is, in
        the
        other Party's reasonable judgment, a direct competitor to the other Party,
        then
        the Party that is not subject to the Change of Control may terminate this
        Agreement effective immediately upon delivery of written notice of termination,
        provided that such notice must be delivered within sixty (60) days after
        consummation of the Change of Control.  For purposes hereof, a direct
        competitor of Zimmer shall include any direct competitor of Zimmer, Inc.,
        a
        Delaware corporation, or any direct or indirect subsidiary of Zimmer,
        Inc.  For purposes hereof, a direct competitor of Tutogen shall
        include any Person that process or distributes allograft or xenograft
        products.

       

      (d)           Either
        Party may terminate this Agreement in accordance with the terms of
        Section 11.2.

       

      10.3.        Order
        Fulfillment; Depletion of Inventory.  Upon the expiration or
        termination of this Agreement, (a) at Zimmer's request, Tutogen shall
        continue to manufacture and deliver all Products that are the subject of
        a firm
        order from Zimmer as of the date of expiration or termination and
        (b) Zimmer shall be permitted to sell to depletion any remaining inventory
        of the Products, including any Products delivered pursuant to clause (a)
        above.  Zimmer shall use commercially reasonable efforts to sell the
        remaining inventory of the Products within six (6) months of the date of
        expiration or termination.  After the expiration of such six-month
        period, Zimmer shall continue to have the right to sell to depletion any
        remaining inventory of the Products, provided that Tutogen shall have the
        option
        to repurchase any such remaining inventory at the transfer price paid by
        Zimmer
        for such Products.

       

      10.4.        Survival.  Termination
        or expiration of this Agreement for any reason shall be without prejudice
        to any
        rights that shall have accrued to the benefit of any Party prior to such
        termination or expiration.  The following Articles and Sections shall
        survive the expiration or termination of this
        Agreement:  Articles VI, IX and X and Sections 2.8, 4.2,
        4.4, 5.4, 5.7, 5.8, 5.9, 11.4 and 11.9.

       

      
        
          
          

        

        
          -
            18
            -

          
            

          

        

        
          
          

        

      

       

      ARTICLE
        XI

      MISCELLANEOUS

       

      11.1.       
        Agency.  Neither Party is, nor shall be deemed to be,
        an employee, agent, partner or legal representative of the other Party for
        any
        purpose.  Neither Party shall have the right, power or authority to
        enter into any contracts in the name of, or on behalf of, the other Party,
        nor
        shall either Party have the right, power or authority to pledge the credit
        of
        the other Party in any way or hold itself out as having the authority to
        do
        so.

       

      11.2.        Force
        Majeure.  If the performance of any obligation under this
        Agreement is prevented, restricted or interfered with by reason of war,
        revolution, civil commotion, acts of terrorism, blockade, embargo, strikes,
        government acts or similar event which is beyond the reasonable control of
        the
        Party affected, then the Party so affected shall, upon giving prior written
        notice to the other Party, be excused from such performance to the extent
        of
        such prevention, restriction, or interference, provided that the Party so
        affected shall use commercially reasonable efforts to avoid or remove such
        causes of nonperformance, and shall continue performance hereunder with
        reasonable dispatch whenever such causes are removed.  If such
        conditions inhibiting complete performance shall continue in excess of
        ninety (90) days, then the Party that is not affected by the force majeure
        event shall have the option, by delivery of written notice of termination
        to the
        affected Party, to terminate this Agreement.  The Parties agree that
        issues or problems with tissue supply (except as a result of changes in
        applicable Regulatory Laws) will not constitute a force majeure
        event.

       

      11.3.        Entire
        Agreement; Amendments.  This Agreement, together with the
        QA/RA Agreement, constitutes the entire agreement between the Parties hereto
        concerning its subject matter and supersedes all previous negotiations,
        agreements and commitments with respect thereto.  This Agreement
        specifically supersedes the Latin America Agreement, and the Latin America
        Agreement is hereby terminated.  This Agreement specifically
        supersedes the Xenograft Agreement with respect to all countries covered
        under
        such agreement except the United States, and the Xenograft Agreement shall
        remain in effect solely with respect to the United States.  This
        Agreement does not supersede the U.S. Agreement or the Canada Agreement,
        and
        such agreements shall remain in effect in accordance with their respective
        terms.  This Agreement shall not be released, discharged, amended or
        modified in any manner except by a written instrument signed by duly authorized
        officers or representatives of each of the Parties hereto.

       

      11.4.        Governing
        Law.  This Agreement shall be governed by and interpreted in
        accordance with the substantive laws of the State of Indiana, without regard
        to
        its choice of law rules.

       

      11.5.        Partial
        Illegality.  If any provision of this Agreement, or the
        application thereof to any Party or circumstances, shall be declared void,
        illegal or unenforceable, the remainder of this Agreement shall be valid
        and
        enforceable to the extent permitted by Applicable Laws.  In such
        event, the Parties shall use their best efforts to replace the invalid or
        unenforceable provision by a provision that, to the extent permitted by
        Applicable Laws, achieves the purposes intended under the invalid or
        unenforceable provision.  Any deviation by either Party from the terms
        and provisions of this Agreement in order to comply with Applicable Laws
        shall
        not be considered a breach of this Agreement.

       

      
        
          
          

        

        
          -
            19
            -

          
            

          

        

        
          
          

        

      

       

      11.6.        Waiver
        of Compliance.  No provision of this Agreement shall be
        waived by any act, omission or knowledge of a Party or its agents or employees,
        except by an instrument in writing expressly waiving such provision and signed
        by a duly authorized officer of the waiving Party, which waiver shall be
        effective only with respect to the specific obligation and instance described
        therein.

       

      11.7.        Notices.  All
        notices and other communications in connection with this Agreement, other
        than
        firm orders which are governed by Section 3.2, shall be in writing and
        shall be sent to the respective Parties at the following addresses, or to
        such
        other addresses as may be designated by the Parties in writing from time
        to time
        in accordance with this Section, by registered or certified mail, postage
        prepaid, or by express courier service, service fee prepaid, or by facsimile
        in
        accordance with this Section.

       

      To
        Tutogen:                          Tutogen
        Medical, Inc.

      13709
        Progress Blvd, Box 19

      Alachua,
        FL 32615

      Attn:  President

      Fax
        No.
        (386) 462-1421

      


      To
        Zimmer:                            Zimmer
        Dental, Inc.

      1900
        Aston Avenue

      Carlsbad,
        California  92008

      Attn:  President

      Fax
        No.  (760) 431-9753

      


      With
        a
        copy
        to:                    Zimmer
        Legal Department

      345
        East
        Main Street

      Warsaw,
        IN  46580

      Attn:  Assistant
        General Counsel

      Fax
        No.
        (574) 371-8591

      


      All
        notices shall be deemed given and received (i) if delivered by hand,
        immediately, (ii) if sent by mail, three (3) Business Days after
        posting, (iii) if delivered by express courier service, the next Business
        Day in the jurisdiction of the recipient or (iv) if sent by fax, at the time
        shown in the confirmed electronic receipt, or on the first Business day
        thereafter if the notice is not sent on a Business Day.

       

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

       

      11.9.        Limitation
        on Liability.  Except with respect to the Parties'
        indemnification obligations, neither Party shall be liable to the other for
        indirect, incidental, consequential, punitive or special damages, including
        but
        not limited to lost profits, arising from or relating to any breach of this
        Agreement, regardless of any notice of the possibility of such
        damages.

       

      
        
          
          

        

        
          -
            20
            -

          
            

          

        

        
          
          

        

      

       

      11.10.      Further
        Actions.  Each Party agrees, subsequent to the execution and
        delivery of this Agreement and without any additional consideration, to execute,
        acknowledge and deliver such further documents and instruments, and to do
        all
        such other acts, as may be necessary or appropriate in order to carry out
        the
        purposes and intent of this Agreement.

       

      11.11.      Assignment. 
        Except as otherwise provided herein, neither Party shall have the
        right
        to assign any of its rights or obligations under this Agreement without the
        prior written consent of the other Party.  Without limiting the
        termination rights set forth in Section 10.2(C), either Party, without any
        need
        for consent from the other Party, may assign this Agreement or any of its
        rights
        and/or obligations hereunder to an Affiliate or in connection with a merger
        or
        other business combination or the sale of substantially all of the assets
        of
        such assigning Party; provided, however, that no such assignment shall relieve
        the assigning Party of its obligations hereunder.  If and to the
        extent that a Party assigns any of its rights and/or obligations hereunder
        in
        accordance with this Section 11.11, then this Agreement shall be binding
        upon the assignee to the same extent as if it were a Party hereto, and each
        reference herein to the name of the assigning Party shall be deemed to include
        the assignee.  Any assignment not in accordance with this
        Section 11.11 shall be void.

       

      11.12.      Jointly
        Prepared.  This Agreement has been prepared jointly and shall
        not be strictly construed against either Party.

       

      11.13.      Third
        Party Rights.  Except as otherwise expressly provided herein,
        this Agreement is not intended to confer any benefits upon, or create any
        rights
        in favor of any Person other than the Parties.

       

      11.14.      Expenses.  Except
        as otherwise expressly provided in this Agreement, each Party shall be
        responsible for its own expenses incurred in connection with this Agreement
        and
        the transactions contemplated hereby.

       

      
        
          
          

        

        
          -
            21
            -

          
            

          

        

        
          
          

        

      

      


      IN
        WITNESS WHEREOF, each Party has caused this Agreement to be executed by its
        respective duly authorized representative as of the Effective Date.

       

      


      


      TUTOGEN
        MEDICAL, INC.

      


      


      By:                                    
                                                   

      


      Name:                                                                           

      


      Title:                                                                        
            

      


      


      


      ZIMMER
        DENTAL, INC.

      


      


      By:                                                                    
                   

      


      Name:                                                                           

      


      Title:                                                               
                     

      


      


      


      Solely
        for the purpose of Section 11.3,

      acknowledged
        and agreed by:

      


      TUTOGEN
        MEDICAL GMBH

      


      


      By:                                      
                                      

      


      Name:                                                                

      


      Title:                                                                  

       

       

      
        
          
          

        

        
          -
            22
            -

          
            

          

        

        
          
          

        

      

       

      EXHIBIT
        A

       

      Exclusive
        Territory

       

      [***]

      


       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

         

      

      EXHIBIT
        B

       

      Products
        and Transfer Pricing

       

      [***]

       

      EXHIBIT
        C

       

      Price
        for Sample Products

       

      [***]

       

      


      
        
          
          

        

        
          -
            2
            -

          
            

          

        

        
          
          

        

      

       

      Exhibit
        D

       

      German
        Dental Inventory

       

      [***]

       

      


      
        
          
          

        

        
          - 3
            -

          
            

          

        

        
          
          

        

      

       

      EXHIBIT
        E

       

      Territory

       

      Distribution
        Approval Status

      [***]

       

       

      - 4
        -