ex10-12.htm


    
      

    

    EXHIBIT
      10.12

     

     

    
      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 ””
[***]”.

      
 

       

       

       

    

    
      


      


      TISSUE
        PROCUREMENT, PROCESSING AND SUPPLY AGREEMENT

      


      


      


      Entered
        into this 1st day of October, 2007

      


      


      Between

      


      


      AlloSource

      6278
        S. Troy Circle

      Centennial,
        Colorado 80111

      


      


      


      


      And

      


      


      Tutogen
        Medical (US), Inc.

       13709
        Progress Blvd.

       Alachua,
        Florida 32615

      


      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      


      TISSUE
        PROCUREMENT, PROCESSING AND SUPPLY AGREEMENT

      


       

      This
        TISSUE PROCUREMENT, PROCESSING AND SUPPLY AGREEMENT (the
“Agreement”) is made and entered into by and between AlloSource, (“AlloSource”),
        an Illinois not-for-profit corporation, with offices located at 6278 S. Troy
        Circle, Centennial, CO 80111, and Tutogen Medical (US), Inc. (“Tutogen”), a
        Florida corporation, with offices located at 13709 Progress Blvd. Box 19,
        Alachua, FL  32615, (collectively, the “Parties” and each
        individually, a “Party”) as of this 1st day of October 2007 (the “Effective
        Date”).

      


      WHEREAS,
        Tutogen and AlloSource have entered into that certain Amended and Restated
        Tissue Recovery Agreement dated October 10, 2005 (the “Recovery Agreement”),
        whereby AlloSource supplies human tissue to Tutogen for further processing
        and
        distribution for the treatment of human patients, and

      


      WHEREAS,
        the Parties desire to supersede the Recovery Agreement with this Agreement
        to
        amend and restate the rights and obligations of the Parties.

      


      WHEREAS,
        AlloSource provides services related to the screening, recovery, serological
        testing, and processing of human tissues for transplantation; and

      


      WHEREAS,
        AlloSource and Tutogen, in recognition of the need for and benefits that
        result
        from the availability of tissue for transplantation, desire to cooperate
        with
        each other in the provision of tissue and allografts for transplantation;
        and

      


      NOW
        THEREFORE, in consideration of the mutual covenants and agreements
        contained herein, the receipt and sufficiency of which is hereby acknowledged,
        the Parties hereto agree as follows:

      


      


      
        	
                1.

              	
                Definitions:

              


      

      


      Unless
        otherwise stated in this Agreement:

      


      
        	
              	
                1.1.

              	
                “Allografts”
                  shall mean those grafts described on Exhibit B, collectively or
                  individually as the case may be. The term “Allografts” shall not include
                  any allografts that are developed by AlloSource, solely or jointly
                  with a
                  third-party or those allografts processed, marketed or distributed
                  by
                  AlloSource in accordance with Section 4.3
                  hereof.

              


      

      


      
        	
              	
                1.2.

              	
                "Donor"
                  shall mean a human, cadaveric Tissue donor that is the source of
                  Tissue
                  for transplantation, in accordance with agreed upon and established
                  medical criteria and procedures and the Donor Acceptance Criteria
                  described in Exhibit E.

              


      

      


      
        	
              	
                1.3.

              	
                “Processed
                  Tissue” shall mean human musculoskeletal tissues (soft tissue and bone),
                  after debridement, sectioning, and medical and serological clearance,
                  provided by AlloSource for further processing and distribution
                  by Tutogen,
                  as further described in Exhibit
                  C.

              


      

      


      
        	
              	
                1.4.

              	
                “Products”
                  shall mean Tissue, Processed Tissue and
                  Allografts.

              


      

      


      
        	
              	
                1.5.

              	
                "Tissue"
                  shall mean human musculoskeletal tissues (soft tissue and bone)
                  recovered
                  by AlloSource for Tutogen which meet the Acceptance Criteria described
                  in
                  Exhibit C.

              


      

      


      


      
        	
                2.

              	
                Term
                  and Termination:

              


      

      


      
        	
              	
                2.1.

              	
                Term.
                  This Agreement shall commence on the Effective Date and continue
                  in full
                  force and effect for five (5) years (“Initial
                  Term”).

              


      

       

      
        
          
          

        

        
          -2-

          
            

          

        

        
          
          

        

      

       

      
        	
              	
                2.2.

              	
                Renewal.
                  At least sixty (60) days prior to the twenty-seven (27) month anniversary
                  of the Effective Date (the “Negotiation Deadline”), the Parties shall meet
                  and negotiate in good faith the renewal terms and conditions of
                  this
                  Agreement.

              


      

      


      
        	
              	
                2.3.

              	
                Partial
                  Termination. AlloSource may suspend the performance of its obligations
                  under this Agreement for a period of sixty (60) days if it reasonably
                  determines that the performance of its obligations under this Agreement
                  could (i) jeopardize its status as a tax-exempt organization under
                  Section
                  501 of the Internal Revenue Code of 1986, as amended (the “Code”), (ii)
                  result in “unrelated business taxable income,” as defined in Section 512
                  of the Code, (iii) result in a default under AlloSource’s tax-exempt bonds
                  (the “Bonds”) or (iv) result in a violation of the National Organ
                  Transplant Act (42 U.S.C., Section 274(e)).  During such 60-day
                  suspension period, the Parties will negotiate in good faith in
                  an attempt
                  to amend this Agreement such that AlloSource’s performance will not (i)
                  jeopardize its tax-exempt status, (ii) result in unrelated business
                  taxable income, (iii) result in a default under the Bonds or (iv)
                  result
                  in a violation of the National Organ Transplant Act.  If, after
                  not less than sixty (60) days, AlloSource reasonably determines
                  that
                  AlloSource’s performance hereunder could jeopardize its status as a
                  tax-exempt organization under Section 501 of the Code, result in
                  unrelated
                  business taxable income, result in a default under the Bonds, or
                  result in
                  a violation of the National Organ Transplant Act, AlloSource may
                  immediately terminate this Agreement without
                  penalty.

              


      

      


      
        	
              	
                2.4.

              	
                AlloSource
                  Termination.  AlloSource may immediately terminate this
                  Agreement by written notice if payments due AlloSource, in accordance
                  with
                  Section 6 of this Agreement, are past due for more than thirty
                  (30)
                  days.

              


      

      


      
        	
              	
                2.5.

              	
                Termination.  This
                  Agreement may further be terminated as
                  follows:

              


      

      


      
        	
              	
                2.5.1.

              	
                At
                  any time, by either party, in the event the other Party files any
                  petition
                  for bankruptcy or similar proceeding or, if the other Party has
                  a petition
                  for bankruptcy or similar proceeding filed against it and such
                  proceeding
                  continues unstayed for sixty (60) days after the filing
                  thereof;

              


      

      


      
        	
              	
                2.5.2.

              	
                At
                  any time, by either Party, in the event a Force Majeure circumstance,
                  as
                  defined in Section 18 hereof, prevents the other Party from performing
                  for
                  a period of more than ninety (90) consecutive
                  days;

              


      

      


      
        	
              	
                2.5.3.

              	
                Upon
                  thirty (30) days written notice by either Party, in the event the
                  other
                  Party receives notification from an applicable regulatory body
                  or court of
                  competent jurisdiction, that it is not in compliance with any applicable
                  federal, state, or local law or regulation and fails to cure such
                  noncompliance, to the satisfaction of the applicable regulatory
                  body
                  within ninety (90) days of such notification;
                  or

              


      

      


      
        	
              	
                2.5.4.

              	
                Upon
                  thirty (30) days written notice by either Party, in the event the
                  other
                  Party materially breaches any representation, warranty, covenant
                  or
                  obligation under this Agreement and fails to cure such breach to
                  the
                  satisfaction of the other Party within ninety (90) days following
                  receipt
                  of written notice of such breach from the other
                  Party.

              


      

      


      
        	
              	
                2.6.

              	
                Effect
                  of Termination.  After either Party provides written notice
                  of its intent to terminate this Agreement to the other Party, the
                  Parties
                  shall continue to perform their respective obligations hereunder
                  until the
                  effective date of such termination.  Upon termination of this
                  Agreement, AlloSource shall supply Products to Tutogen, pursuant
                  to this
                  Agreement, in accordance with pending orders submitted to AlloSource
                  prior
                  to the effective date of termination and Tutogen shall pay the
                  applicable
                  fees in accordance with the terms and conditions of this
                  Agreement.

              


      

      


      
        	
                3.

              	
                Responsibilities
                  and Obligations:

              


      

      


      
        	
              	
                3.1.

              	
                Supply
                  of Tissue and Processed Tissue

              


      

       

      
        
          
          

        

        
          -3-

          
            

          

        

        
          
          

        

      

       

      
        	
              	
                3.1.1.

              	
                Tutogen
                  shall order and AlloSource shall make commercially reasonable efforts
                  to
                  procure for and supply to Tutogen Tissue and Processed Tissue as
                  defined
                  in the Tissue Acceptance Criteria (Exhibit C) and as specified in
                  the Tissue and Allograft Requirements (Exhibit A), pursuant to
                  Tutogen’s orders in accordance with Section 3.3
                  below.

              


      

      


      
        	
              	
                3.1.2.

              	
                Tutogen
                  agrees to accept Tissue and Processed Tissue from AlloSource that
                  have
                  been recovered in accordance with the applicable criteria set forth
                  in
                  section 3.1.1 above.

              


      

      


      
        	
              	
                3.1.3.

              	
                AlloSource
                  reserves the right to procure, process and supply Tissue, Processed
                  Tissue
                  and similar products to third parties.  AlloSource will consider
                  the fulfillment of Tutogen requirements on an equal priority basis
                  with
                  all other AlloSource customers which did not have an agreement
                  with
                  AlloSource prior to October 10,
                  2005.

              


      

      


      
        	
              	
                3.2.

              	
                Supply
                  of Allografts

              


      

      


      
        	
              	
                3.2.1.

              	
                Tutogen
                  has supplied AlloSource with Allograft designs, which AlloSource
                  shall
                  treat as confidential, in accordance with the provisions of Section
                  7.

              


      

      


      
        	
              	
                3.2.2.

              	
                In
                  accordance with Tutogen’s Allograft designs, AlloSource has developed
                  Allograft Specifications, which have been approved by Tutogen and
                  which
                  are set forth in Exhibit B.

              


      

      


      
        	
              	
                3.2.3.

              	
                AlloSource
                  shall use commercially reasonable efforts to commence production
                  of the
                  Allografts within thirty (30) days of the Effective Date of this
                  Agreement. AlloSource shall promptly notify Tutogen if AlloSource
                  determines that, despite its commercially reasonable efforts, it
                  is unable
                  to timely fabricate, process and package the Allografts in conformance
                  with the Allograft Specifications.

              


      

      


      
        	
              	
                3.2.4.

              	
                AlloSource
                  shall use commercially reasonable efforts to process, package and
                  supply
                  Allografts in accordance with the requirements shown in Exhibit B
                  and with the orders of Tutogen that have been accepted by
                  AlloSource.

              


      

      


      
        	
              	
                3.3.

              	
                Forecasts
                  and Orders

              


      

      


      
        	
              	
                3.3.1

              	
                In
                  accordance with the requirements set forth in Exhibit A, at least
                  ten (10) days prior to the first day of each calendar quarter during
                  the
                  Initial Term and any renewal term, Tutogen shall provide AlloSource
                  with a
                  written non-binding forecast as to Tutogen’s estimated requirements of
                  Products for each of the following twelve (12) calendar months,
                  the first
                  three (3) months of which shall be binding.  On or before the
                  first day of each month, Tutogen shall issue binding orders for
                  such month
                  for the quantities of Products set forth in such
                  forecast.  AlloSource shall have five (5) business days to
                  notify Tutogen of rejection of such binding order and reason for
                  such
                  rejection.  If no notice of rejection is given within such five
                  (5) business day period, the binding order shall be considered
                  accepted by
                  AlloSource.  AlloSource shall make reasonable business efforts
                  to fill such binding orders within thirty (30) days, but no later
                  than
                  ninety (90) days of such binding orders.  If AlloSource fails to
                  fill a binding order that was accepted by AlloSource within ninety
                  (90)
                  days of the date of such binding order, then Tutogen may cancel
                  such
                  binding order and may fill such order from another
                  source.

              


      

      


      
        	
              	
                3.3.2

              	
                In
                  the event that Tutogen does not place and accept orders for Products
                  in
                  accordance with the minimum monthly requirements specified in Exhibit
                  A,
                  Tutogen shall be required to pay AlloSource the reimbursement fees,
                  in
                  accordance with Section 6 below, for the minimum monthly requirements
                  less
                  the number of Products which are ordered and accepted by
                  Tutogen.

              


      

      


      
        	
              	
                3.3.3

              	
                AlloSource
                  may supply and Tutogen shall accept from AlloSource Tissues, Processed
                  Tissues and Allografts in an amount equal to or up to ten percent
                  (10%)
                  greater than the quantities set forth in Exhibit A hereto and set
                  forth in
                  each binding order (or such higher quantity if mutually agreed
                  in
                  writing).

              


      

       

      
        
          
          

        

        
          -4-

          
            

          

        

        
          
          

        

      

       

      
        	
              	
                3.3.4

              	
                AlloSource
                  shall ship Products to Tutogen at the following
                  address:

              


      

       

      Tutogen
        Medical, Inc.

      13709
        Progress Blvd., Box 19

      South
        Wing

      Alachua,
        FL 32615

      


      
        	
                 

              	
                3.3.5

              	
                Tutogen
                  shall be responsible for expenses associated with the shipment
                  of Products
                  from AlloSource to Tutogen.  Risk of loss and title to such
                  Products shall pass to Tutogen upon
                  shipment.

              


      

      


      
        	
                 

              	
                3.3.6

              	
                EXCEPT
                  AS SET FORTH HEREIN, ALLOSOURCE MAKES NO WARRANTIES, EXPRESS OR
                  IMPLIED,
                  WITH RESPECT TO THE PRODUCTS INCLUDING, WITHOUT LIMITATION, ANY
                  WARRANTY
                  OF MERCHANTABILITY OR WARRANTY OF FITNESS FOR A PARTICULAR
                  PURPOSE.

              


      

      


      


      
        	
                4.

              	
                Distribution:

              


      

      


      
        	
              	
                4.1

              	
                Tutogen
                  shall have the right to process all Tissue and Processed Tissue
                  for
                  distribution and to further process and distribute all Allografts
                  supplied
                  by AlloSource under this Agreement.

              


      

      


      
        	
              	
                4.2

              	
                Products
                  supplied to Tutogen shall be packaged and labeled by AlloSource
                  in
                  accordance with all applicable laws and regulations.  Tutogen
                  shall be solely responsible for the content of all final product
                  labeling.  No identifying information of AlloSource, including,
                  without limitation, the name AlloSource or any proprietary mark
                  of
                  AlloSource, shall appear on the label or documentation of the Products
                  unless required by law.

              


      

      


      
        	
              	
                4.3

              	
                Tutogen
                  acknowledges and agrees that AlloSource has in the past and shall
                  be
                  permitted currently and in the future to distribute tissue and
                  allografts
                  that are similar to or substantially the same as the Products in
                  the same
                  and different territories as Tutogen.  Notwithstanding anything
                  to the contrary in this Agreement, Tutogen agrees that AlloSource
                  has the
                  right to directly or indirectly recover, process, market, distribute
                  and
                  perform research utilizing any and all tissue and allografts
                  worldwide.  The Parties acknowledge and agree that AlloSource
                  may continue to process human bone and tissue to produce tissue
                  and
                  allografts under any other agreements or arrangements AlloSource
                  has now
                  or in the future and that the provision of such tissue, bone and
                  allografts may adversely affect AlloSource’s ability to meet its
                  requirements under this Agreement.  AlloSource will use
                  reasonable business efforts to mitigate such a situation and supply
                  as
                  much of the ordered Tissue and Processed Tissue as
                  possible.

              


      

      


      


      
        	
                5.

              	
                Regulatory
                  Compliance:

              


      

      


      
        	
              	
                5.1.

              	
                AlloSource
                  shall maintain Donor specific information (including information
                  supplied
                  to Tutogen) in accordance with AlloSource specifications and all
                  applicable laws and regulations.  This responsibility shall
                  survive the expiration or termination of this Agreement for a period
                  of
                  ten (10) years beyond the date of distribution, date of transplantation
                  (if known), date of disposition, or date of expiration of the Products
                  (whichever is longer) or longer if required by applicable federal,
                  state
                  and local laws or regulations.  Information shall include such
                  records as may be appropriate and necessary to assure that the
                  identification and notification of recipients of Products provided
                  under
                  this Agreement may occur, in the event that it becomes necessary
                  and
                  appropriate to make such identification and
                  notification.

              


      

      


      
        	
              	
                5.2.

              	
                Both
                  Parties agree to comply with all applicable federal, state and
                  local
                  standards, laws and regulations, such as the AATB Standards for
                  Tissue
                  Banking and FDA regulatory
                  requirements.

              


      

       

      
        
          
          

        

        
          -5-

          
            

          

        

        
          
          

        

      

       

      
        	
              	
                5.3.

              	
                Tutogen
                  shall obtain at its expense all regulatory approval of the FDA
                  or other
                  authority necessary or required for the manufacture and distribution
                  of
                  Products.  Tutogen shall be the sole and exclusive owner of all
                  regulatory approvals in the United States necessary or required
                  for the
                  manufacture and distribution of
                  Products.

              


      

      


      
        	
              	
                5.4.

              	
                Each
                  Party is obligated to notify the other Party, within ten (10) calendar
                  days, of receipt of any written notification from the AATB, U.S.
                  FDA or
                  other applicable regulatory body of a failure to comply with any
                  applicable standards or requirements.  Failure to provide such
                  notification may result in termination of this Agreement as indicated
                  in
                  Section 2.5.3.

              


      

      


      
        	
              	
                5.5.

              	
                Tutogen
                  shall be responsible for maintaining traceability for all Products
                  provided by AlloSource and distributed by Tutogen. Tracking records
                  shall
                  be maintained by Tutogen in accordance with applicable AATB and
                  U.S. FDA
                  standards and regulations.  Tutogen shall promptly notify
                  AlloSource of any product complaint or adverse event alleging serious
                  patient injury or risk that is associated with Products provided
                  to
                  Tutogen by AlloSource.  Such notification shall include
                  necessary tracking data, on a per Donor basis, for all implicated
                  Products
                  recovered by AlloSource and shipped to
                  Tutogen.

              


      

      


      
        	
              	
                5.6.

              	
                Both
                  Parties reserve the right to conduct reasonable, periodic audits
                  of the
                  other Party’s operations to assess compliance with AATB, FDA, or other
                  regulatory agency requirements. Such audits shall be scheduled
                  in advance
                  and shall be performed at a date and time convenient to the audited
                  Party.  Results of all audits will be provided to the audited
                  Party within thirty (30) days following completion of the audit
                  and may
                  include recommendations for improvement.  Results of such audits
                  will be considered confidential in nature and will not be released
                  to any
                  third party without the prior written consent of the other
                  Party.

              


      

      


      
        	
              	
                5.6.1.

              	
                In
                  connection with an audit, without limitation, AlloSource shall
                  permit
                  Tutogen, or any authorized agent of Tutogen, to review recovery
                  data
                  maintained by AlloSource.  The audited data shall be limited to
                  those records and standard operating procedures pertaining to the
                  Tissue
                  recovered for Tutogen.

              


      

      


      
        	
              	
                5.6.2.

              	
                In
                  connection with an audit, without limitation, Tutogen shall permit
                  AlloSource, or any authorized agent of AlloSource, to review product
                  traceability data for Products provided by AlloSource. The audited
                  data
                  shall be limited to those records and standard operating procedures
                  pertaining to the Products provided by AlloSource to Tutogen or
                  needed for
                  an Allograft.

              


      

      


      
        	
              	
                5.7.

              	
                Policies
                  and Procedures.  Each Party shall have coordinated policies
                  and procedures for handling Products covered by this Agreement,
                  including,
                  but not limited to: (i) customer complaints; (ii) the reporting
                  and
                  investigation of errors or adverse events that may affect the safety,
                  purity, or potency of a Product; (iii) implementation of corrective
                  and
                  preventive action; (iv) Product process investigations; and (v)
                  Product
                  recalls. These procedures shall outline notification timelines
                  that are
                  consistent with all applicable laws and regulations.  Upon
                  written request a Party shall make such policies and procedures
                  available
                  to the other Party for review and comment. In accordance with Section
                  7 of
                  this agreement, the receiving Party shall treat all such policies
                  and
                  procedures as confidential.

              


      

       

      
        	
              	
                5.8.

              	
                Complaints.  Tutogen
                  and AlloSource shall each provide the other with written notification
                  of
                  any formal complaint or adverse event alleging serious patient
                  injury or
                  risk related to Products supplied by AlloSource to Tutogen, or
                  any product
                  incorporating such Products, within five (5) working days of the
                  Party’s
                  receipt of notification of such complaint or adverse
                  event.  Each Party agrees to provide reasonable assistance and
                  cooperation to the other Party in the investigation and resolution
                  of any
                  such complaint or adverse event; provided that, Tutogen shall have
                  final
                  authority over all decisions concerning products that it manufactured
                  from
                  the Tissue, Processed Tissue or Allografts in question and responsibility
                  for all communication with any third party related to such
                  products.

              


      

       

      
        
          
          

        

        
          -6-

          
            

          

        

        
          
          

        

      

       

      
        	
              	
                5.9.

              	
                Product
                  Recalls. In the event either Party believes it
                  may be necessary to conduct a recall, field correction, market
                  withdrawal,
                  stock recovery, or other similar action with respect to any Products,
                  or
                  any product incorporating such Tissue or Processed Tissue  (a
                  “Recall”), Tutogen and AlloSource shall consult with each other as to how
                  best to proceed.  It is understood and agreed that the final
                  decision relative to any Recall of product(s) manufactured by Tutogen
                  shall be made by Tutogen and the final decision as to any Recall
                  of
                  Products provided by AlloSource shall be made by AlloSource; provided,
                  however, that either Party shall not be prohibited hereunder from
                  taking
                  any action that it feels may be necessary in order to comply with
                  applicable laws or regulations, or, in its opinion, to maintain
                  its
                  reputation in the industry.  In the event of a product or
                  Product recall, the following shall
                  apply:

              


      

       

      


      
        	
              	
                5.9.1.

              	
                If
                  a recall is due solely to negligence, error, omission or action
                  on the
                  part of Tutogen, then Tutogen shall bear the entire cost associated
                  with
                  such recall, including the costs incurred by AlloSource. Such AlloSource
                  expenses shall be itemized and provided to Tutogen for payment
                  or credit
                  issuance.

              


      

      


      
        	
              	
                5.9.2.

              	
                If
                  a recall is due solely to negligence, error, omission or action
                  on the
                  part of AlloSource, then AlloSource shall bear the entire cost
                  associated
                  with such recall, including the costs incurred by Tutogen.  Such
                  Tutogen expenses shall be itemized and provided to AlloSource for
                  payment
                  or credit issuance.

              


      

      


      
        	
              	
                5.9.3.

              	
                In
                  all other cases, the cost associated with a recall shall be borne
                  in
                  proportion to the negligence, error, omission or action of each
                  Party that
                  resulted in the Recall.

              


      

      


      
        	
                6.

              	
                Fees
                  and Payments:

              


      

      


      Tutogen
        shall reimburse AlloSource for Products ordered by Tutogen as indicated in
        Exhibit D (Reimbursement Fee Schedule).  The reimbursement fee
        is limited to costs associated with obtaining, handling and providing such
        Products; there is no charge associated with the Tissue itself, which is
        donated.  The Reimbursement Fee is due and payable to AlloSource
        within thirty (30) days following receipt of invoice.  Tutogen may
        withhold payment of any amounts that it has notified AlloSource in writing
        are
        in dispute, pending resolution by both Parties. Any amounts past due (other
        than
        amounts subject to a bona fide dispute) shall accrue interest at a rate of
        the
        lesser of one and one-half percent (1.5%) per month or the maximum rate allowed
        by law.

      


      
        	
                7.

              	
                Confidentiality:

              


      

      


      Each
        Party shall ensure the confidentiality of the other Party’s Confidential
        Information it receives by taking substantially the same precautions as it
        does
        with its own Confidential Information, but not less than a reasonable standard
        of care.  Neither Party shall, during the period of this Agreement and
        for three (3) years thereafter, use the other Party’s Confidential Information
        for any purpose other than to carry out its obligations
        hereunder.  The obligations of confidentiality shall not apply to
        information that the receiving Party is required by applicable laws to disclose;
        provided, however, that the receiving Party shall so notify the disclosing
        Party
        of its intent to disclose and cooperate with the non-disclosing Party at
        the
        non-disclosing Party’s expense on reasonable measures to protect the
        confidentiality of the non-disclosing Party’s Confidential
        Information.  Each Party may disclose Confidential Information
        received pursuant to this Agreement to its directors, officers, employees,
        consultants, attorneys and accountants provided that such persons and entities
        are obligated to hold the Confidential Information in confidence in accordance
        with restrictions and procedures no less stringent than provided for
        herein.  The Parties hereto understand and agree that this Section 7
        is reasonable and necessary to protect AlloSource’s and Tutogen’s respective
        business interests.  The Parties further agree that the other may
        suffer irreparable harm from a breach of this Section 7.  Thus, in
        addition to any other rights or remedies, all of which shall be deemed
        cumulative, a Party shall be entitled to pursue injunctive relief to enforce
        the
        terms of this Section 7.  For purposes of this Section, “Confidential
        Information” means information, which is disclosed by a Party to the other Party
        in whatever media, and is marked, identified or otherwise acknowledged to
        be
        confidential at the time of disclosure; provided that information shall not
        be
        deemed “Confidential Information” which is (a) publicly known, through no fault
        of the other party, (b) received by the other party from a source having
        the
        right to disclose such information, (c) known by the other party prior to
        disclosure of such information, or (d) independently developed by the other
        party without use of the disclosing party’s information.

       

      
        
          
          

        

        
          -7-

          
            

          

        

        
          
          

        

      

       

      
        	
                8.

              	
                Notices:

              


      

      


      Required
        notices to be given under this Agreement shall be deemed duly administered
        upon
        personal delivery or receipt by certified mail, return receipt requested
        and
        addressed as follows:

      


      Tutogen:                          
        CLAUDE
        PERING

                                                                
        TUTOGEN
        MEDICAL (US), INC.

                                                                
        13709
        PROGRESS BOULEVARD

                 SOUTH
        WING

                 ALACHUA,
        FLORIDA 32615

      


      AlloSource:

      


                 KEVIN
        CMUNT

                                                                
        ALLOSOURCE

                                                                
        6278 S. TROY CIRCLE

                                                                
        CENTENNIAL, CO 80111

      


      Or
        such other person or address as
        either Party may designate in writing.

       

      
        
          
          

        

        
          -8-

          
            

          

        

        
          
          

        

      

       

      
        	
                9.

              	
                Entire
                  Agreement:

              


      

      


      This
        Agreement sets forth the entire agreement between the Parties.  Any
        prior agreements, promises, negotiations, or representations, either oral
        or
        written, relating to the subject matter of this Agreement and not expressly
        set
        forth in this Agreement are of no force or effect.  This Agreement
        specifically supersedes the Recovery Agreement, which is hereby terminated
        as of
        the Effective Date of this Agreement.

      


      
        	
                10.

              	
                Modification:

              


      

       

      This
        Agreement, or any part or section of it, may not be amended or modified except
        by the mutual written consent of both Parties.

      


      
        	
                11.

              	
                Applicable
                  Law:

              


      

      


      This
        Agreement shall be governed by and construed in accordance with the laws
        of the
        State of Colorado.

      


      
        	
                12.

              	
                Waiver:

              


      

      


      Waiver
        of
        a breach of any provision of this Agreement shall not be deemed a waiver
        of any
        other breach of the same or a different provision of this
        Agreement.

      


      
        	
                13.

              	
                Severability:

              


      

      


      The
        individual provisions of this Agreement shall be severable and, if a court
        of
        competent jurisdiction holds any provision(s) of this Agreement to be in
        violation of any applicable law, the remaining provisions shall remain in
        full
        force and effect.

      


      
        	
                14.

              	
                Assignability:

              


      

      


      This
        Agreement shall be binding upon and inure to the benefit of the Parties and
        their successors and assigns.  This Agreement and all rights under it
        shall not be assignable by either Party without the prior written consent
        of the
        other, provided that AlloSource may assign this Agreement in whole or in
        part to
        a subsidiary or affiliate of AlloSource without the prior written consent
        of
        Tutogen.

      


      
        	
                15.

              	
                Indemnification:

              


      

      


      Tutogen
        agrees to indemnify, defend and hold harmless, AlloSource, its officers,
        directors, employees, subsidiaries, agents and affiliates from and against
        any
        and all claims, liability and expenses, including reasonable attorneys’ and
        experts’ fees and costs, which arise as a result of (i) Tutogen’s negligence or
        willful misconduct, (ii) Tutogen’s processing, labeling, packaging or
        distribution of allografts produced from Tissue or Processed Tissue shipped
        to
        Tutogen by AlloSource under this Agreement, (iii) any breach of this Agreement
        by Tutogen, (iv) the distribution of Allografts by Tutogen, (v) the Allograft
        Specifications attached hereto as Exhibit B, or (vi) any actual or alleged
        infringement of any patent or other property right relating to any actual
        or
        apparent intellectual property of Tutogen, including, without limitation,
        the
        methods of processing the Tissues or producing the
        Allografts.  AlloSource agrees to indemnify, defend and hold harmless,
        Tutogen, its officers, directors, employees, subsidiaries, agents and affiliates
        from and against any and all claims, liability and expenses, including
        reasonable attorneys’ and experts’ fees and costs, which arise as a result of
        (i) AlloSource’s negligence or willful misconduct, (ii) any breach of this
        Agreement by AlloSource (iii) non-compliance with the Allograft Specifications
        set forth in Exhibit B or (iv) any actual or alleged infringement of any
        patent or other property right relating to any actual or apparent intellectual
        property of AlloSource, including, without limitation, the methods of processing
        the Tissues or producing the Allografts.

       

      
        
          
          

        

        
          -9-

          
            

          

        

        
          
          

        

      

       

      
        	
                16.

              	
                Insurance:

              


      

      


      Each
        Party agrees to procure and maintain in full force and effect during the
        term of
        this Agreement, at its sole cost and expense, general and professional liability
        and product liability insurance in amounts of not less than $5,000,000 per
        incident and $5,000,000 annual aggregate, which insurance shall be written
        on a
“occurrence” basis policy form, with a reputable insurance carrier and name the
        other Party as an additional insured.  Each Party shall, on request,
        provide to the other Party a copy of a certificate of coverage or other written
        evidence reasonably satisfactory to such requesting Party of such insurance
        coverage.

      


      
        	
                17.

              	
                Limitation
                  of Liability:

              


      

      


      In
        no
        event shall either Party be liable, whether as a result of contractual breach,
        tort or otherwise, to the other Party for any consequential, special, or
        incidental damages incurred by such other Party, including but not limited
        to
        injury to goodwill, or indirect or speculative lost profits unless such
        liability results from the gross negligence or willful misconduct of the
        other
        Party.  The foregoing Limitation of Liability shall not apply to the
        Parties’ respective confidentiality obligations hereunder or to the Parties’
indemnification obligations regarding infringement of third party intellectual
        property rights.

      


      
        	
                18.

              	
                Force
                  Majeure:

              


      

      


      In
        the
        event that one Party fails to perform any obligation under this Agreement
        as a
        result of a strike, lockout or other labor difficulty, fire, explosion, flood,
        earthquake, embargo, act of war, terrorism, Act of God, regulation or
        restriction of Government or law, failure of suppliers, public utilities
        or
        common carrier or any other occurrence or circumstances beyond the reasonable
        control of such Party (“Force Majeure”), that Party shall not be liable in
        damages or otherwise for failure to perform its obligations hereunder and,
        in
        addition, such failure shall constitute grounds for the other Party to terminate
        this Agreement only if such Force Majeure event prevents the other Party
        from
        performing its obligations under this Agreement for more than ninety (90)
        consecutive days.  In the event of a protracted strike, lockout or
        other labor difficulty, lasting for six (6) months or longer, AlloSource
        or
        Tutogen may elect to terminate this Agreement immediately by providing written
        notice to the other Party.  Both Parties hereby agree that each will
        use reasonable business efforts to remedy a Force Majeure event.

      


      
        	
                19.

              	
                Intellectual
                  Property:

              


      

      


      Tutogen
        is the sole and exclusive owner of all right, title and interest in and to
        its
        products and in all of Tutogen’s patents, trademarks, inventions, copyrights,
        know-how, and trade secrets.  Tutogen does not grant AlloSource any
        right to use such patents, trademarks, inventions, copyrights, know-how and
        trade secrets except as set forth herein.  To the best of its
        knowledge, Tutogen represents and warrants that its patents, trademarks,
        inventions, copyrights, know-how, and trade secrets do not infringe any property
        right of any third party.  AlloSource is the sole and exclusive owner
        of all right, title and interest in and to its products and in all of
        AlloSource’s patents, trademarks, inventions, copyrights, know-how and trade
        secrets.  AlloSource does not grant Tutogen any right to use such
        patents, trademarks, inventions, copyrights, know-how and trade
        secrets.  To the best of its knowledge, AlloSource represents and
        warrants that its patents, trademarks, inventions, copyrights, know-how,
        and
        trade secrets do not infringe any property right of any third
        party.  Tutogen and AlloSource each shall have the right, in its sole
        discretion and at its own expense, to control the preparation, prosecution,
        and
        maintenance of patent applications and patents covering only its own
        intellectual property, and to select all patent counsel or other professionals
        to advise, represent or act for it in all matters relating to such patent
        applications and patent prosecution.

      


      
        	
                20.

              	
                Independent
                  Contractors:

              


      

      


      The
        relationship between AlloSource and Tutogen, established by this Agreement,
        is
        that of independent contractors.  Neither Party shall have authority
        to conclude contracts or otherwise to act for or bind the other Party in
        any
        manner, whatsoever, as agent or otherwise.

       

      
        
          
          

        

        
          -10-

          
            

          

        

        
          
          

        

      

       

      
        	
                21.

              	
                Representations
                  and Warranties:

              


      

      


      Each
        of
        the Parties represents and warrants that (i) it is fully authorized to enter
        into this Agreement; (ii) its entering into and performance under this Agreement
        does not violate or breach its Certificate of Incorporation or corporate
        bylaws
        or any agreement or contract to which it is a party; (iii) there is no claim,
        demand, action, suit, proceeding or investigation pending or currently
        threatened against it or any of its affiliates involving or relating to any
        tissues or products of Tutogen incorporating tissues, or which, if adversely
        determined, would restrict it from entering into this Agreement and carrying
        out
        its obligations under this Agreement; and (iv) it has no legal obligations
        which
        would prevent this Agreement from being fully implemented in accordance with
        its
        terms.

      


      
        	
                22.

              	
                Disposal
                  of Tissues:

              


      

       

      If
        Products provided under this Agreement are deemed by Tutogen as not acceptable
        for transplantation, Tutogen shall provide written notice to AlloSource of
        the
        reason for unacceptability. AlloSource shall either require return of Tissue
        to
        AlloSource or authorize Tutogen to dispose of the Tissue in accordance with
        applicable laws and regulations. Tutogen shall provide to AlloSource a
        disposition record for each such Tissue that is discarded and, at Tutogen’s
        request, AlloSource will issue credit memos, where
        appropriate.  Notwithstanding the foregoing, Tutogen shall pay for all
        Products delivered by AlloSource pursuant to this Agreement unless such Product
        fails to substantially comply with the Allograft Specifications attached
        as
        Exhibit B or the Tissue Acceptance Criteria attached as Exhibit C.

       

      
        	
                23.

              	
                Signatures
                  and Counterparts:

              


      

       

      Signatures
        of the Parties may be transmitted via facsimile and this Agreement may be
        executed in one or more counterparts, each of which shall be deemed an original
        and all of which shall constitute together the same document.

      


      
        	
                24.

              	
                Survival:

              


      

      


      The
        covenants contained in Sections 2.6, 4, 5.1, 5.4, 5.5, 5.7, 5.8, 5.9 7, 8,
        11,
        15, 17, 19 and 22 shall survive any termination or expiration of this
        Agreement.

      


      


      


      


      IN
        WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
        their
        duly authorized officers as of the date first written
        above.

      


      


      ATTEST:                                                                                                                         TUTOGEN
        MEDICAL (US), INC.

      


      


      ______________________________                                                                     By:
        ______________________________________

      Date                                                                        
        CLAUDE
        PERING                                                DATE

                                        
         CHIEF OPERATING OFFICER

      


      


      


      ATTEST:                                                                                                                         
        ALLOSOURCE:

      


      


      ______________________________                                                                     By:_______________________________________

                                                                Date                      
                                                         
J. KEVIN
        CMUNT                                                DATE

                                         
        EXECUTIVE VICE PRESIDENT

       

      
        
          
          

        

        
          -11-

          
            

          

        

        
          
          

        

      

      


      TUTOGEN
        MEDICAL (US), INC. – ALLOSOURCE

      EXHIBITS

      


      


      


      


      
        	
                 

              	
                A.

              	
                Tissue
                  and Allograft Requirements

              


      

      


      
        	
                 

              	
                B.

              	
                Allograft
                  Specifications

              


      

      


      
        	
                 

              	
                C.

              	
                Tissue
                  Acceptance Criteria

              


      

      


      
        	
                 

              	
                D.

              	
                Reimbursement
                  Fee Schedule

              


      

       

      
        
          	
                   

                	
                  E.

                	
                  
                    Donor
                      Acceptance
                      Criteria

                  

                


        

         

      

      
        
          
          

        

        
          -12-

          
            

          

        

        
          
          

        

         

      

      EXHIBIT
        A

      


      TISSUE
        AND ALLOGRAFT REQUIREMENTS

      [***]

      


      
        
          
          

        

        
          -13-

          
            

          

        

        
          
          

        

         

      

      .
        EXHIBIT B

      


      ALLOGRAFT
        SPECIFICATIONS

      [***]

      


      
        
          
          

        

        
          -14-

          
            

          

        

        
          
          

        

      

       

      EXHIBIT
        C

      


      TISSUE
        ACCEPTANCE CRITERIA

      [***]

      


      
        
          
          

        

        
          -15-

          
            

          

        

        
          
          

        

         

      

      EXHIBIT
        D

      


      REIMBURSEMENT
        FEE SCHEDULE

      [***]

       

      
        
          
          

        

        
          -16-

          
            

          

        

        
          
          

        

      

       

      EXHIBIT
        E

      


      DONOR
        ACCEPTANCE CRITERIA

      


      


      (See
        attached document)

      [***]

       

       

      -17-