WWW.EXFILE.COM -- 15204 --MATRITECH, INC. -- EXHIBIT 10.1 TO FORM 8-K


    EXHIBIT
      10.1

     

    

      CONTRACT
        AMENDMENT NO. 1

      


      This
        Contract Amendment No. 1
        (“Amendment”) dated June 1, 2007 (“Amendment Date”) by and between Inverness
        Medical Innovations, Inc. with offices at 51 Sawyer Road, Suite 200, Waltham,
        MA
        02453 on behalf of itself and its subsidiaries (“Inverness”) and Matritech,
        Inc., a Delaware corporation with its principal place of business at 330
        Nevada
        Street, Newton, MA 02460 (“Matritech”).

      


      WHEREAS
        Inverness and Matritech are
        parties to a Supply Agreement dated as of November 3, 2006 (the “Agreement”),
        and wish to amend such agreement on the terms and conditions set forth in
        this
        Amendment;

      


      NOW
        THEREFORE the parties agree as
        follows:

      


      1.           Section
        3.2 of the Agreement is amended by adding the sentence: “Each such monthly
        forecast shall be provided to Inverness by the fifth business day of the
        month
        in which such forecast is due to be provided.”

      


      2.           Section
        4.4 of the Agreement is amended and restated as follows:  “Inverness
        shall submit to Matritech for approval a minimum of [ ** ] samples of Product
        from each trial production run.  For the avoidance of doubt, Matritech
        shall pay for such samples in accordance with Section 3
        above.  Approval shall not be unreasonably withheld or delayed by
        Matritech.  Once Matritech has advised Inverness in Writing of its
        approval of the trial production run samples or if Matritech fails to provide
        the Written approval or rejection of the same within 10 Business Days, Inverness
        shall cause the full production run of the Product to be manufactured and
        delivered to Matritech.”

      


      3.           Section
        4.6 of the Agreement is amended by deleting the words “thirty (30) calendar
        months” in the last sentence, and replacing them with the words “[ **
        ], or such longer period as is equal to the shelf life of
        the Product which may be extended in accordance with Section 4.7
        hereof”.

      


      4.           Section
        4.7 of the Agreement is amended and restated as follows:

      


      “The
        Parties agree that upon the Effective Date, the shelf life of the Products
        manufactured by Unotech Diagnostics, Inc. as Approved Custom Manufacturer
        shall
        be [ ** ] and the Specification for the Product manufactured by Unotech
        Diagnostics, Inc. as Approved Custom Manufacturer shall provide for a [ **
        ]
        shelf life.  The shelf life of the Products manufactured by any other
        Approved Custom Manufacturer shall, at the time of commencement of supply
        by
        such Approved Custom Manufacturer, be [ ** ] and the Specification initially
        applicable to Products manufactured by such other Approved Custom Manufacturer
        shall provide for a [ ** ] shelf life.  The Parties agree that the
        shelf life of the Products manufactured by such other Approved Custom
        Manufacturer shall be extended during the term of this Agreement (and the
        corresponding revision of the Specification to a shelf life longer than [
        **
        ] shall be effected) based upon accumulation of
        accelerated and/or real time data related to the Products, by written agreement
        of the Parties, which agreement shall not be unreasonably withheld, conditioned
        or delayed.  In the event that the Parties do not, for any reason,
        agree to extend the shelf life of Products manufactured by such other Approved
        Custom Manufacturer to at least [ ** ] by a date no later than [ ** ] after
        commencement of manufacture by such other Approved Custom Manufacturer, then
        Matritech shall have the right to designate the particular Approved Custom
        Manufacturer for any order rather than merely expressing a preference as
        provided in Section 3.1 hereof.  Commencement of manufacture shall
        mean the manufacture of the first validation pilot of the Product by the
        Approved Custom Manufacturer.”

      


      
        
           

        

        
           

          
            

          

        

        
           

        

      

      5.           Section
        4.12 of the Agreement is amended by adding the following sentences at the
        end of
        the existing provision: “Before manufacture of the Product manufactured by any
        new Approved Custom Manufacturer commences, Matritech, Inverness and the
        new
        Approved Custom Manufacturer shall arrange for a cross function design review
        team made up of personnel of Matritech, Inverness and the new Approved Custom
        Manufacturer to assess whether Technical Information Transfer (as hereinafter
        defined) has taken place.  Inverness’s obligations to supply the
        Product manufactured by a new Approved Custom Manufacturer shall not begin
        until
        Matritech, Inverness and the new Approved Custom Manufacturer have agreed
        in
        writing that Technical Information Transfer has taken place; provided that
        the
        agreement of Inverness and the new Approved Custom Manufacturer that Technical
        Information Transfer has taken place shall not be unreasonably withheld,
        conditioned or delayed.   Promptly after Technical Information
        Transfer or after any Change agreed pursuant to Section 6, Inverness will
        identify to Matritech any specific manufacturing processes necessary for
        the
        manufacture of the Product and different from the manufacturing processes
        used
        by its Approved Custom Manufacturer for the manufacture of similar
        products.  If Inverness, its Approved Custom Manufacturer and
        Matritech agree that such manufacturing processes are different from the
        manufacturing processes used by its Approved Custom Manufacturer for the
        manufacture of similar products and ought reasonably to be excluded from
        Inverness’s indemnification set forth in Section 9.1(b)(such agreement of
        Matritech not to be unreasonably withheld), the parties shall record such
        processes in writing, and such processes will be “Specific Manufacturing
        Processes” for the purposes of Section 9 hereof.  “Technical
        Information Transfer” shall mean the provision to Inverness and the new Approved
        Custom Manufacturer of technical information and explanations relating to
        the
        manufacturing processes used for the Product, for the purpose of assisting
        the
        new Approved Custom Manufacturer to manufacture the Product in accordance
        with
        the Specification.”

      


      6.           Insert
        the following new Section 4.15, and re-number current Section 4.15 as 4.16:
        “Notwithstanding any other provision of this Agreement Inverness shall have
        no
        liability whatsoever under any provision of Section 4, Section 9 or any other
        provision of this Agreement in the event that any of the Products fail to
        conform in all material respects to the Specification at the time of manufacture
        and/or at the time of delivery and/or during the period of the shelf life
        of the
        Product, if such failure to conform results from any failure at any time
        of the
        Matritech Raw Materials and/or such Matritech Raw Materials failing to comply
        to
        the Specification insofar as it relates to them and in particular without
        prejudice to the generality of the foregoing Inverness shall have no liability
        whatsoever in respect of any Product failing to conform to the Specification
        which results from any failure in the reproducibility or the stability of
        any
        gold materials which form part of the Matritech Raw Materials which are utilized
        in the Products.”

       

      
        7.
          Sections 9.1 and 9.2 are deleted in their entirety and replaced with the
          following:

      

      


      “9.1           Inverness
        shall indemnify and hold Matritech harmless from and against any and all
        third
        party suits, actions, losses, obligations, deficiencies, liabilities, claims,
        damages, cost and expense (including court costs and reasonable attorney
        fees)
        (collectively, “Claims”) which arise out of, are caused by, relate to or result
        or occur from or in connection with (a) the failure of any Product manufactured
        by Inverness or an Approved Custom Manufacturer to comply with the warranty
        set
        forth in clause 4.1 above, unless such failure is caused by the Matritech
        Raw
        Materials or (b) a claim that the manufacturing processes of Inverness or
        any
        Approved Custom Manufacturer (except any Specific Manufacturing Process agreed
        pursuant to Section 4.12) infringes or misappropriates the Intellectual Property
        of a Third Party.   For purposes of clarity, a Third Party is a
        party other than Inverness and Matritech.

      


      9.2           Except
        for liability which is contemplated by Section 9.1, Matritech agrees to
        indemnify and hold Inverness and each Approved Custom Manufacturer harmless
        from
        and against any and all Claims which arise out of, are caused by, relate
        to or
        result or occur from or in connection with any and 

       

      
        
           

        

        
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      all
        Products and components thereof, including, without limitation, all Biologicals,
        including without limitation, Claims which arise out of, are caused by, relate
        to or result or occur from or in connection with (a) the use and/or sale
        of the
        Products; (b) any allegation that the Products infringe the Intellectual
        Property Rights of a Third Party (except to the extent that such allegations
        concern a Claim for which Matritech is entitled to indemnification pursuant
        to
        clause 9.1) (c) any failure of the Matritech Raw Materials; and (d) any
        allegation that any Specific Manufacturing Process agreed pursuant to Section
        4.12 infringes the Intellectual Property Rights of a Third Party.”

      


      9.           This
        Amendment is effective as of the date of the original Agreement.

      


      10.           Except
        as expressly set forth in this Amendment, all provisions of the Agreement
        shall
        continue in full force and effect.

      


      In
        witness whereof, the parties have
        executed this Amendment as of the date first above written.

      
 

      
        	
                Inverness
                  Medical Innovations, Inc. 

                 

                
                  By:__________________________

                   

                  Its:__________________________

                   

                  
                     

                    By:__________________________

                     

                    Its:__________________________

                  
 

              	
                Matritech,
                  Inc.

                 

                By:_____________________________

                 

                Its:_____________________________

                 

              


      

    

     

     

    
      
         

      

      
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