WWW.EXFILE.COM, INC. -- 14723 -- MATRITECH, INC. -- EXHIBIT 10.1 TO FORM 8-K


    EXHIBIT
      10.1

    


    Supply
      Agreement

    


    Supply
      Agreement made effective this 3rd day of November, 2006 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”) each “a Party” and together “the
      Parties”.

    


    Whereas,
      the Parties are desirous of entering into arrangements for the supply to
      Matritech of the NMP22®
      BladderChek®
      Test,


    


    Now,
      therefore, in consideration of the premises and for other good and valuable
      consideration, the receipt and legal sufficiency of which are hereby
      acknowledged, the Parties agree as follows:

    


    1.0    Definitions

    


    
      	
              1.1
                Affiliate

            	
              in
                relation to a Party means any other entity which directly or indirectly
                Controls is Controlled by or is under direct or indirect (e.g. through
                an
                intermediate subsidiary) common Control with that Party from time
                to
                time.

            
	 	 
	
              1.2
                Approved Custom 

            	 
	
              Manufacturers

            	
              means,
                collectively, the entities listed on Schedule 6 hereof, as it may
                be
                amended in Writing from time to time by Inverness and
                Matritech.

            
	
               

            	 
	
              1.3
                Inverness/Approved 

            	 
	
              Custom
                Manufacturer 

            	 
	
              Raw
                Materials

            	
              means
                any and all raw materials supplied by Inverness or an Approved Custom
                Manufacturer for incorporation into the Products.

            
	 	 
	
              1.4
                Biologicals

            	
              means
                all biological materials incorporated into the Products.
                

            
	 	 
	
              1.5
                Business Days

            	
              means
                any day excluding Saturday and Sunday or any public holidays in the
                country where either Party is based.

            
	 	 
	
              1.6
                Control

            	
              means
                that an entity owns fifty percent (50%) or more of the voting shares
                of a
                second entity, and Control and Controlled shall be interpreted
                accordingly. 

            
	 	 


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    
      	
              1.7
                Effective Date

            	
              means
                the date set forth in the first sentence of this
                Agreement.

            
	 	 
	
              1.8
                Firm Order

            	
              has
                the meaning given to it in clause 3.4, and refers to the first three
                (3)
                months of each Written forecast provided by Matritech to Inverness
                and the
                applicable Approved Custom Manufacturer.

            
	 	 
	
              1.9
                Force Majeure

            	
              means,
                in relation to a Party, any circumstance beyond the reasonable control
                of
                that Party; provided, however, that labor strife affecting a Party’s own
                workforce or that of an Approved Custom Manufacturer, such as strikes,
                lock-outs or other industrial actions, shall not constitute a Force
                Majeure circumstance.

            
	 	 
	
              1.10
                Identified Confidential 

            	 
	
              Information

            	
              means
                any information or data, regardless of whether it is in tangible
                form,
                disclosed by either Party (the “disclosing Party”) that the disclosing
                Party has either marked as confidential or proprietary, or has identified
                in Writing as confidential or proprietary within thirty (30) days
                of
                disclosure to the other Party (the “receiving Party”); provided,
                however,
                that reports and/or information related to a disclosing Party’s business
                plans, strategies, technology, research and development, current
                and
                prospective customers, billing records, and products or services
                shall be
                deemed Identified Confidential Information of the disclosing Party
                even if
                not so marked or identified. Information will not be deemed Identified
                Confidential Information hereunder if such information: (a) is known
                to
                the receiving Party prior to receipt from the disclosing Party directly
                or
                indirectly from a source other than one having an obligation of
                confidentiality to the disclosing Party; (b) becomes known (independently
                of disclosure by the disclosing Party) to the receiving Party directly
                or
                indirectly from a source other than one having an obligation of
                confidentiality to the disclosing Party; (c) becomes publicly known
                or
                otherwise ceases to be secret or confidential, except through a breach
                of
                this Agreement by the receiving Party; or (d) is independently developed
                by a receiving Party without reference to or use of the other Party’s
                Identified Confidential Information.

            
	 	 


    

     

    
      
        
        

      

      
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              1.11
                Intellectual

            	 
	
              Property
                

            	
              means:-

            
	 	 
	
               

            	
              
                i) 
                  copyrights, patents, database rights and rights in trademark designs,
                  know-how and confidential information (whether registered or
                  unregistered);

              

            
	
               

            	
              
                ii) 
                  applications for registration or the right to apply for registration
                  for
                  any of those rights; and

              

            
	
               

            	
              
                iii) 
                  all other intellectual property rights and the equivalent or similar
                  forms
                  of protection existing anywhere in the world.

              

            
	 	 
	
              1.12
                Inverness Patents

            	
              means
                those patents listed on Schedule 1.

            
	 	 
	
              1.13
                Matritech Raw 

            	 
	
              Materials

            	
              means
                any and all raw materials supplied by Matritech for incorporation
                into the
                Products as set out in Schedule 5, as it may be amended from time
                to time
                by the Parties in Writing.

            
	 	 
	
              1.14
                Matritech Technology

            	
              means
                any Technology of Matritech relating to the Products existing as
                of the
                Effective Date and disclosed by Matritech to Inverness from time
                to
                time.

            
	 	 
	
              1.15
                New Technology

            	
              means
                any Technology and/or Intellectual Property developed by Inverness
                or an
                Approved Custom Manufacturer in
                the manufacture of the Products and, for the avoidance of doubt,
                not
                including Matritech Technology.

            
	 	 
	
              1.16
                Price

            	
              means
                the price for the Product payable by Matritech to Inverness, which
                may
                vary depending on quantities ordered, calculated in accordance with
                Schedule 2. 

            
	 	 
	
              1.17
                Product Improvement

            	
              means
                any New Technology consisting of a development, enhancement or derivative
                of the Product, but only to the extent that such technology is applicable
                only to the Product.

            
	 	 
	
              1.18
                Products

            	
              means
                the products listed in Schedule 7, and subsequent versions thereof,
                and
                such additional products that the Parties may from time to time separately
                agree in Writing shall be governed by the terms of this Agreement.
                In the
                case of such agreement, Schedule 7 shall be replaced with an updated
                version including such additional products and Product shall mean
                each
                unit of those Products.

            
	 	 


    

     

    
      
        
        

      

      
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              1.19
                Professional Field

            	
              means all
                channels of distribution resulting in the distribution of a Product
                to (a)
                licensed professional health-care providers (including hospitals,
                physicians (acting as such), and licensed professional health-care
                centers, (b) other third parties trained to administer and/or analyze
                diagnostic test, and (c) professional diagnostic laboratories.
                

            
	 	 
	
              1.20
                Recall

            	
              means
                a recall or withdrawal of the Product and shall include any post-sale
                warning regarding such Product;

            
	 	 
	
              1.21
                Receiving Points

            	
              means
                the premises designated by Matritech as the destination for each
                order of
                Products under Section 8. 

            
	 	 
	
              1.22
                Specification

            	
              means
                the specifications for the Product set out in Schedule 3, as they
                may be
                amended from time to time under Section 6.0.

            
	 	 
	
              1.23
                Technology

            	
              means
                any methods, techniques, discoveries, inventions (whether patentable
                or
                not), formulae, formulations, technical and product specifications,
                equipment descriptions, plans, layouts, drawings, computer programs,
                assembly, quality control, installation and operating procedures,
                operating manuals, technical and marketing information, designs,
                data,
                know-how and other information.

            
	 	 
	
              1.24
                Trademarks

            	
              means
                the registered trademarks of Matritech and pending trademark applications
                related to the Product, which are listed in Schedule 4.

            
	 	 
	
              1.25
                Unit

            	
              means
                one item of the Product, e.g. one BladderChek Test.

            
	 	 
	
              1.26
                Valid Claim 

            	
              means,
                with respect to a particular country, a claim of an issued patent
                that (a)
                has not lapsed or become abandoned, disclaimed, denied, revoked,
                or
                admitted to be invalid or unenforceable through reissue or disclaimer
                or
                otherwise in such country, and (b) has not been declared invalid
                or
                unenforceable by a court of competent jurisdiction or an administrative
                agency for which there is no further right of appeal or for which
                the
                right of appeal is waived. 

            
	
               

            	 
	
              1.27
                Writing or Written

            	
              means
                any form of written communication and any other similar expression,
                includes facsimile transmission and comparable means of communication,
                but
                not electronic mail.

            


    

    


    
      
        
        

      

      
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    2.0    Roles
      of the Parties

    


    2.1    Matritech
      will be the customer purchasing Products from Inverness. Inverness will be
      a
      contract manufacturer. Inverness represents and warrants that it owns controls,
      or has licenses to the Inverness Patents. Certain Valid Claims of the Inverness
      Patents may cover the Products. Inverness further represents and warrants that
      the Inverness Patents include all of the patent rights in the lateral flow
      area
      (including issued patents and patent applications) owned, controlled, or
      licensed by Inverness or its Affiliates that cover the Products as of the
      Effective Date of this Agreement. The Inverness Patents are not being licensed
      to Matritech. The Price contemplates the existence of the Inverness Patents.
      Inverness may engage, as subcontract manufacturer, one or more Approved Custom
      Manufacturers to have Products manufactured. Inverness will sell to Matritech
      Products manufactured by Inverness or any such Approved Custom Manufacturer.
      Such Products may only be resold, distributed and used in the Professional
      Field
      by Matritech and its resellers, distributors and end-customers. Subject to
      the
      terms and conditions of this Agreement (including without limitation this clause
      2.1 and clause 5.4), Matritech may resell any such Product to Matritech’s
      end-user customers, resellers and distributors (in any such case, only for
      resale, distribution and use in the Professional Field), and such resales and
      use by resellers are also contemplated in the Price. Matritech will notify
      any
      such reseller, distributor and end-customer in writing that Products may only
      be
      distributed for use in the Professional Field. Inverness covenants that
      Inverness and its Affiliates shall not sue or otherwise assert any claim or
      counterclaim against Matritech, its Affiliates, or any of its or their
      resellers, distributors or end-customers, to the extent based on a claim that
      any such person or entity, with respect to such person’s or entity’s use,
      distribution or sale of Products in accordance with the terms and conditions
      of
      this Agreement, infringes upon any Inverness Patent. 

    


    2.2    The
      initial Approved Custom Manufacturers are listed on Schedule 6 hereof. If
      Inverness elects to use an Approved Custom Manufacturer, Inverness agrees that
      it will enter into, and maintain in full force and effect, agreements with
      such
      Approved Custom Manufacturers, for the duration of the Term of this Agreement,
      covering the manufacture by such Approved Custom Manufacturer of the Products
      for delivery to Matritech. To the extent that any Affiliate of an Approved
      Custom Manufacturer is approved by Matritech (an “Approved Affiliate”), then
      such Approved Affiliate(s) will also be an Approved Custom Manufacturer.


    


    2.3    The
      Parties shall meet at least once each year to review matters likely to be
      relevant to the manufacture and sale of the Product. 

    


    3.0    Orders
      for the Product.

    


    3.1    Inverness
      agrees to, or to cause one or more of the Approved Custom Manufacturers
      to, deliver
      to Matritech, in sufficient quantities to satisfy Matritech’s orders which are
      made in accordance with the terms of this Agreement and on the delivery schedule
      established in accordance with the terms of this Agreement, Product


     

    
      
        
        

      

      
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    manufactured
      by Inverness or such Approved Custom Manufacturer(s). Matritech
      agrees to purchase from Inverness such volumes of the Products as Matritech
      may
      order from time to time in accordance with the provisions of this Agreement.
      In
      the event that Inverness elects to use an Approved Custom Manufacturer,
      Matritech shall have the right with respect to each order of Products, to
      express a preference for a particular Approved Custom Manufacturer to
      manufacture the Products for Inverness to resell to Matritech pursuant to such
      order, however, the ultimate designation of an Approved Custom Manufacturer
      for
      each order shall be at Inverness’ sole discretion.

     

    3.2    Matritech
      shall provide Inverness and the applicable Approved Custom Manufacturer with
      a
      Written forecast of its estimated monthly purchases of the Products for the
      twelve (12) month period commencing with the calendar month following the month
      in which such forecast is delivered to Inverness, the first three (3) months
      of
      which shall be binding on both Parties. Such forecasts shall represent
      Matritech’s commercially reasonable, good-faith estimate of its Product
      requirements from Inverness for such twelve (12) month period. Except
      for the first three (3) months as described in the preceding sentence and except
      as provided in clause 3.4, such forecasts are for the convenience of Inverness
      and any applicable Approved Custom Manufacturer only, shall not constitute
      firm
      purchase or shipping orders and shall not be binding upon, or create any
      obligation or liability with respect to, Matritech, Inverness or any applicable
      Approved Custom Manufacturer.

    


    3.3    Contemporaneously
      with the execution of this Agreement, Matritech will deliver to Inverness or,
      if
      applicable, the applicable Approved Custom Manufacturer a sufficient quantity
      of
      Matritech Raw Materials to enable such Approved Custom Manufacturer to
      manufacture quantities of the Product covered by at least the first four (4)
      months of Matritech’s applicable forecast. Inverness will, or cause the
      applicable Approved Custom Manufacturer to, advise Matritech in Writing from
      time to time of the quantity of Matritech Raw Materials it has on hand and
      Matritech will supply additional quantities of Matritech Raw Materials so that
      Inverness or such Approved Custom Manufacturer always has an adequate supply
      of
      such Matritech Raw Materials to manufacture Product in accordance with this
      Agreement.

     

    3.4    At
      the
      time each Written forecast is delivered by Matritech to Inverness and the
      applicable Approved Custom Manufacturer pursuant to clause 3.2, the first three
      (3) months of such forecast (the “Firm Order Period”) shall be deemed a firm
      order for the Product (a “Firm Order”), which Firm Order shall state actual
      quantities and delivery dates for the Product for the Firm Order Period;
      provided that no delivery date shall be earlier than [ ** ] days after the
      date
      of submission of that forecast. For purposes of clarification, after the first
      forecast is delivered, the first month’s quantity in each subsequent forecast
      shall not constitute a new Firm Order for that quantity, except to the extent
      the quantity is increased as described in clause 3.5 hereof. Quantities of
      Product delivered pursuant to a Firm Order shall not vary more than plus or
      minus five percent (+/- 5%) of such Firm Order. Inverness shall, or shall cause
      the applicable Approved Custom Manufacturer to, deliver the Product on the
      delivery date specified by Matritech 

     

    
      
        
        

      

      
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    in
      the
      relevant Firm Order in accordance with the provisions of this clause 3.4 or
      up
      to ten (10) Business Days prior to or after such delivery date. 

    


    3.5    Once
      a
      Firm Order is submitted to Inverness and any applicable Approved Custom
      Manufacturer with respect to any given Firm Order Period, Matritech may
      reasonably revise that Firm Order by providing Written notice to Inverness
      and
      such Approved Custom Manufacturer; provided, however, that if the revised Firm
      Order is for a larger quantity of Product, Inverness shall have [ ** ] days
      from
      the day of such revised Firm Order notice in which to deliver, or to have the
      applicable Approved Custom Manufacturer deliver, the amount of Product that
      is
      in excess of the amount ordered by Matritech pursuant to the original Firm
      Order. Notwithstanding the immediately preceding sentence, in the event
      Matritech wishes to increase a Firm Order by greater than [ ** ], Inverness
      is
      only required to reasonable commercial efforts, or to cause the applicable
      Approved Custom Manufacturer to make reasonable commercial efforts, to produce
      such additional volume of Products for Matritech. 

    


    3.6    If
      Matritech decreases the quantity set forth in Matritech’s Firm Orders, Matritech
      shall be responsible for the reasonable cost of materials for the Product
      purchased by Inverness or the applicable Approved Custom Manufacturer in
      accordance with Matritech’s Firm Orders; provided, however, that Matritech shall
      not be responsible for the reasonable cost of any materials that are or will
      be
      subsequently used by Inverness or the Approved Custom Manufacturer in respect
      of
      the Products. At Matritech’s option, Matritech may instruct Inverness to, or to
      cause the applicable Approved Custom Manufacturer to, utilize such materials
      in
      the future supply of Product and Inverness agrees to follow any such
      instruction. In addition, Inverness shall to use commercially reasonable efforts
      to, or to cause the applicable Approved Custom Manufacturer to use commercially
      reasonable efforts to, utilize such materials in the supply of product or in
      the
      manufacture of goods for third parties so as to minimize the amount of such
      materials that remain unused.
      Inverness shall advise, or shall direct the applicable Approved Custom
      Manufacturer to advise, Matritech in Writing of the amount and cost of excess
      materials resulting from Matritech’s decrease of Firm Orders that have not been
      used in the future supply of Products or in the manufacture of goods for third
      parties within ninety (90) days after the month for which the Firm Order is
      decreased. Matritech shall have the right, at its option, to have the excess
      material delivered to it or to another supplier of its choice. 

    


    3.7    Orders
      for the Products shall be given by Matritech to Inverness and any applicable
      Approved Custom Manufacturer in Writing, pursuant to a process to be mutually
      defined by the Parties in consultation with any Approved Custom Manufacturers.
      

    


    3.8    In
      ordering and delivering Product, Matritech, Inverness and any applicable
      Approved Custom Manufacturer may employ their standard forms, but nothing in
      those forms shall be construed to modify or amend the terms of this Agreement,
      and, in the case of any conflict herewith, the terms of this Agreement shall
      control.

    


    
      
        
        

      

      
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    3.9    In
      partial consideration of sales of the Products, sales of the Products by
      Inverness to Matritech under this Agreement shall be at the Price calculated
      pursuant to Schedule 2 and shall be subject to credits as specified in such
      Schedule.

    


    3.10    Matritech
      agrees with and undertakes to Inverness that it shall place orders with
      Inverness for manufacture under this Agreement of a minimum quantity of Products
      as set forth below, subject to performance by Inverness of its obligations
      under
      this Agreement:

    


    
      	First 12 months (Year 1):  	[ ** ] Units  
	
              Second
                12 months (Year 2):  

            	[ ** ]
              Units 


    

     

    Notwithstanding
      the foregoing, if there is any shortfall in the number of units ordered by
      Matritech in Year 1 of this Agreement, Matritech shall have the right to roll
      that shortfall into Year 2 and order such Product during that period and any
      Year 1 shortfall in orders shall not be deemed to be a breach of this Agreement.
      

    


    After
      the
      second 12 months, no minimum order shall apply. 

    


    3.11    The
      Approved Custom Manufacturers are as specified on Schedule 6 hereof, but the
      Parties reserve the right to mutually agree in Writing to change such
      designation from time to time. Inverness agrees to cooperate with Matritech
      throughout the term of this Agreement to establish or develop alternate
      subcontract manufacturers for the Product to ensure Matritech will have an
      uninterrupted and adequate supply of Product. 

     

    4.0    Quality
      of the Products

    


    4.1    Inverness
      warrants to Matritech that all Products supplied to Matritech under this
      Agreement shall conform in all material respects to the Specification at the
      time of delivery and over the shelf life of the Product specified in clause
      4.7
      below. 

    


    4.2    Matritech
      may reject any of the Products which do not comply with clause 4.1 in accordance
      with the processes described in clause 4.6. 

    


    4.3    For
      the
      purposes of assuring to Matritech the quality of the Products required under
      this Agreement, Inverness shall, and shall cause each Approved Custom
      Manufacturer to, permit the duly authorized representatives of Matritech, at
      any
      time during normal working hours and on reasonable notice, to inspect, at its
      own expense, any premises of Inverness and/or the Approved Custom Manufacturer
      where any of the Products are manufactured or stored by such party. Such
      inspection shall only take place during the regular business hours of Inverness
      or the Approved Custom Manufacturer, and in such a manner as not to interfere
      unreasonably with the normal business activities 

     

    
      
        
        

      

      
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    of
      Inverness or the Approved Custom Manufacturer. Such inspections shall not be
      conducted hereunder more frequently than once every twelve (12) months,
      provided, however, that in the event that an inspection reveals material
      deficiencies in the Product, or customers have complained about specific quality
      or performance issues, Matritech may require additional inspections in such
      twelve (12) month period. Prior to commencing any such inspection, any
      representative of Matritech that is not subject to a binding and enforceable
      confidentiality agreement with Inverness or the Approved Custom Manufacturer
      shall enter into an agreement with Inverness and/or the Approved Custom
      Manufacturer which prohibits the disclosure of any information relating to
      Inverness or the Approved Custom Manufacturer to any party, including Matritech,
      except that such auditor may issue a report to Matritech, the sole purpose
      of
      which shall be to report to Matritech whether Inverness or the Approved Custom
      Manufacturer is in compliance with the requirements of clause 4.1 above,
      including a summary of and sufficient detail regarding the scope, quality,
      and
      methodology of such compliance or lack thereof.

    


    4.4    Inverness
      shall, or shall cause the applicable Approved Custom Manufacturer to, 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. Inverness or the applicable Approved Custom
      Manufacturer shall not commence any full production run until Matritech has
      communicated its approval of the trial production run samples to Inverness
      and
      the applicable Approved Custom Manufacturer in Writing. Approval shall not
      be
      unreasonably withheld or delayed by Matritech. If Written approval takes more
      than ten (10) Business Days, Inverness shall be deemed not to be in breach
      of
      any delivery obligations under this Agreement in respect of the Products
      affected by such delay in approval. Once Matritech has advised Inverness and
      the
      applicable Approved Custom Manufacturer in Writing of its approval of the trial
      production run samples, Inverness shall cause the full production run of the
      Product to be manufactured and delivered to Matritech. 

    


    4.5    The
      Parties will agree upon the quality control system which will be implemented
      at
      the premises of Inverness or the applicable Approved Custom Manufacturer prior
      to the dispatch of the Products, whether from a trial production run or a full
      production run. In the event of a change of Specification during the term of
      this Agreement or a regulatory change which results in the need for a revised
      quality control system, the Parties agree to cooperate in good faith to
      determine the revised quality control system to be implemented at the premises
      of Inverness or the applicable Approved Custom Manufacturer. Inverness agrees
      to, or to cause the Approved Custom Manufacturer to, implement and utilize
      the
      quality control system, as it is agreed to from time to time. 

    


    4.6    In
      the
      event of any Products failing to comply with the warranty set forth in clause
      4.1 above, Matritech shall notify Inverness and the applicable Approved Custom
      Manufacturer in Writing of the failure as soon as reasonably practicable.
 In
      the
      event that no such Written notice of warranty breach is given to Inverness
      and
      the 

     

    
      
        
        

      

      
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    applicable
      Approved Custom Manufacturer within ten (10) Business Days of the receipt of
      Product at the Receiving Point, then that shipment of Product shall be deemed
      to
      be accepted by Matritech, provided, however, that Matritech reserves the right
      to revoke its acceptance and reject the Products if subsequent testing, to
      occur
      within thirty (30) calendar months after Matritech’s receipt of the Product at
      the applicable Receiving Point, reveals that the Products fail to conform in
      material respects with the Specification. 

    


    4.7    The
      Parties agree that upon the Effective Date, the shelf life of the Products
      shall
      be [ ** ] and that any extension of the shelf life (and revision of the
      Specification to a shelf life longer than [ ** ]) shall only be made in writing
      during the term of this Agreement based upon accumulation of accelerated and/or
      real time data related to the Products. 

    


    4.8    Matritech
      shall inform Inverness and the applicable Approved Custom Manufacturer in
      Writing of any claim relating to quantitative defects in shipments (shortfall
      or
      overage) of Product within thirty (30) days following actual receipt of such
      shipments by Matritech at the Receiving Points, and Matritech shall provide
      Inverness and the applicable Approved Custom Manufacturer with copies of any
      appropriate documents relating to such quantitative defects that Matritech
      has
      in its possession. Inverness shall, or shall cause the applicable Approved
      Custom Manufacturer to, provide Matritech with any quantities of such Product
      missing as soon as reasonably possible after receipt of notice from Matritech.
      Matritech shall only be obligated to pay for actual quantities of Product
      received. Any claim for a quantitative defect which is not made within such
      thirty (30) day period shall be deemed to have been waived by
      Matritech.

    


    4.9    In
      the
      event of any Product failing to comply with the warranty set forth in clause
      4.1
      above, Matritech shall have the option of requiring Inverness to provide
      replacement Product manufactured by Inverness or the applicable Approved Custom
      Manufacturer or to issue a credit for the amount of the Product supplied which
      did not meet such warranty. In addition, Inverness shall pay Matritech the
      reasonable cost of the Matritech Raw Materials which were incorporated into
      the
      rejected Product and the cost of all shipping, insurance and other charges
      incurred by Matritech in connection with the transport of the Product failing
      to
      comply with the warranty set forth in clause 4.1 from Inverness or the
      applicable Approved Custom Manufacturer to the Receiving Point. Matritech shall
      notify Inverness and the applicable Approved Custom Manufacturer in Writing
      of
      its decision on whether it has elected either delivery of replacement Product
      or
      a credit within five (5) Business Days of notifying Inverness and the applicable
      Approved Custom Manufacturer of the failure of any Product to comply with the
      warranty set forth in clause 4.1 above. 

    


    4.10    Except
      as
      set forth in clauses 9.1, and this clause 4.10, Inverness’ and any Approved
      Customer Manufacturer’s only liability in respect of Product that does not
      comply with the warranty set forth in clause 4.1 above, or which is subject
      to a
      Recall as a result of the Product not conforming to this Specification or
      applicable U.S. FDA regulations shall be set forth in clause 4.9 above.


    


    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

    4.11    The
      Parties acknowledge and agree that in the event any problems occur with either
      the Matritech Raw Materials or the applicable Inverness/Approved Custom
      Manufacturer Raw Materials, Matritech will work with Inverness or the applicable
      Approved Custom Manufacturer and Inverness will, or will cause the applicable
      Approved Custom Manufacturer to, work with Matritech to attempt to troubleshoot
      any problems and in doing so such parties will act reasonably and in good faith.
      The time to troubleshoot any problems will be at least thirty (30) days unless
      the Parties agree to the contrary and during that 30 day period, no Party shall
      argue that the other is in breach of the terms of this Agreement.

    


    4.12    Matritech
      will assist each Inverness and Approved Custom Manufacturer in defining
      processes and procedures necessary to ensure compliance with all FDA
      requirements for Good Manufacturing Practices. Inverness will, or will cause
      each Approved Custom Manufacturer to, maintain a complete device history file
      as
      well as the records identified by Matritech including information regarding
      quantities, lot numbers and shipping data for at least two years beyond the
      expiration date of the Product. Inverness will deliver copies of all records
      that are not, or are not deemed by the Approved Custom Manufacturer to be,
      confidential for inclusion in a duplicate device history record.

    


    4.13    Matritech
      shall, from time to time during the period of manufacture of the Products and
      at
      the reasonable request of Inverness, consult with Inverness and any applicable
      Approved Custom Manufacturer with respect to the process of manufacture of
      the
      Product.

    


    4.14    Each
      of
      the Parties shall make available to the other Party and each Approved Custom
      Manufacturer a senior manager who shall be responsible for liaising in
      connection with the manufacture of the Product. Inverness shall cause each
      Approved Custom Manufacturer to make available to Matritech a senior manager
      who
      shall be responsible for liaising in connection with the manufacture of the
      Product. 

    


    4.15    EXCEPT
      AS
      OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, INVERNESS MAKES NO OTHER
      WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS AND HEREBY
      DISCLAIMS ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, INCLUDING, WITHOUT
      LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
      PURPOSE AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.


    


    5.0    Manufacture
      and Delivery of Products

    


    5.1    Inverness
      shall, or shall cause the applicable Approved Custom Manufacturer to, use
      commercially reasonable efforts to manufacture sufficient stocks of the Products
      to fulfil Inverness’ obligations under this Agreement.

    


    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    

    5.2    Matritech
      shall provide Inverness or the applicable Approved Custom Manufacturer with
      the
      Matritech Raw Materials free of charge, and Inverness or the applicable Approved
      Custom Manufacturer shall provide the Inverness/Approved Custom Manufacturer
      Raw
      Materials as part of the Price set forth in Schedule 2 hereof. 

    


    5.3    Inverness
      shall, or shall cause the applicable Approved Custom Manufacturer to, arrange
      for transport and insurance coverage of the Product from the premises of
      Inverness or such applicable Approved Custom Manufacturer to the Receiving
      Point
      in accordance with the shipping method, carrier and other details, if any,
      specified by Matritech. The costs of transport and insurance shall be included
      in the price, except as provided in clause 4.9 hereof.

    


    5.4    Title
      to and
      risk of loss of the Products shall pass from Inverness to Matritech once the
      Products reach the Receiving Point. The Receiving Points shall be as set forth
      on Schedule 8 hereof, which may be amended by mutual written agreement of the
      Parties.

    


    6.0    Product
      Improvements; Modifications; Changes 

    


    6.1    Inverness
      shall, or shall cause each Approved Custom Manufacturer to, promptly disclose
      to
      Matritech any Product Improvements developed in the course of Inverness or
      such
      Approved Custom Manufacturer’s manufacture of the Products. Matritech shall have
      the right to submit a Written request to change the Specification to incorporate
      the Product Improvements into the Product. 

    


    6.2    Whether
      or not a Product Improvement exists, Matritech shall have the right to request
      a
      change to the Specification or to create a separate new Specification to be
      applicable to some Products to be manufactured under the Agreement (each, a
      “Change”). If Inverness agrees to proceed with the requested Change, the Change
      will only be processed in accordance with a time frame agreed upon in Writing
      and in advance by Inverness and Matritech.

    


    6.3    The
      Parties agree that, in the event Matritech requests a Change for any reason,
      and
      provided that Inverness agrees in Writing to proceed with such Change, the
      Parties shall cooperate in good faith to attempt to mutually determine an
      appropriate Price adjustment which will, when negotiated, be memorialized in
      a
      revised Schedule 2. Matritech shall be responsible for all such Price
      adjustments resulting from each Change and for obtaining any regulatory
      approvals that may be required as a result of each Change. 

     

    6.4    In
      the
      event of a Change, Matritech may require Inverness to, or to cause the Approved
      Custom Manufacturer to, perform validation pilots prior to beginning production
      of the revised Product. Notwithstanding the foregoing to the contrary, Inverness
      shall not be required to, or to cause the Approved Custom Manufacturer to,
      perform validation pilots of the revised Product until such time as the Parties
      mutually agree in Writing on an equitable price for (a) Inverness’ or the
      Approved Custom Manufacturer’s work on the pilots, taking into consideration
      that the Product will not be 

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    

    resold
      by
      Matritech, and (b) any resulting Product which may be ordered and manufactured
      following successful completion of the validation pilots. 

    


    7.0    Price
      of the Products

    


    7.1    Subject
      to the following provisions of this Section 7.0, the Price for each of the
      Products paid by Matritech to Inverness shall be the Price reflected in or
      calculated in accordance with Schedule 2. Inverness reserves the right to
      increase prices once per year, at the beginning of each calendar year after
      2007, with 30 days written notice. Price increases will be limited to no more
      than [ ** ] or the percentage annual increase in PPI for in-vitro diagnostic
      products for the immediately preceding calendar year period, which ever is
      greater. Inverness owns or has a license to the Inverness Patents. Certain
      Valid
      Claims of the Inverness Patents may cover the Products. The Inverness Patents
      are not being licensed to Matritech. The Price contemplates the existence of
      the
      Inverness Patents. Inverness and its Affiliates shall not sue or otherwise
      assert any claim or counterclaim against Matritech, its Affiliates, or any
      of
      its or their resellers, distributors or end-customers, to the extent based
      on a
      claim that any such person or entity, with respect to such person’s or entity’s
      use, distribution or sale of Products prior to the Effective Date, infringed
      upon any Inverness Patent. 

    


    7.2    The
      Price
      for the Products shall be inclusive of any costs of shipping packaging, carriage
      and insurance of the Products. 

    


    7.3    Inverness
      shall invoice Matritech by the 14th
      (fourteenth) day of each month for the Price in respect of all deliveries of
      the
      Products made under this Agreement during the previous month, and Matritech
      shall pay all undisputed sums for Products complying with the terms of this
      Agreement in cleared funds to the bank nominated by Inverness within 30 (thirty)
      days from the date on which each invoice is submitted by Inverness. If Matritech
      is entitled to a credit under clause 4.9 above or Schedule 2 hereof, it may
      apply the credit to amounts due from it to Inverness under this Agreement.
      

    


    7.4    If
      Matritech fails to pay any undisputed sum on the due date, then without
      prejudice to clause 16.2:

    


    
      	
            	7.4.1	
              the
                unpaid amount shall bear interest from the due date until payment
                is made
                in full, both before and after any judgment, at [ ** ] per cent per
                annum
                over the rate quoted in the Wall Street Journal from time to time;
                and

            


    

    


    
      	
            	7.4.2	
              Inverness
                shall be entitled to suspend deliveries of the Products until the
                outstanding amount has been received by Inverness from
                Matritech.

            


    

    


    7.5    If
      Matritech disputes the amount of any invoice received from Inverness, it shall
      provide Inverness with Written notice of the dispute within ten (10) Business
      Days of receipt of the invoice. The Parties agree that they shall diligently
      attempt, in good 

     

    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

    

    faith,
      to
      expeditiously resolve any dispute regarding the correct amount of the invoice.
      If the dispute is not resolved within 30 days, any Party may resort to
      appropriate dispute resolution processes.

     

    8.0    Intellectual
      Property and Trademarks 

    


    8.1    The
      Parties agree that ownership of the Matritech Technology shall remain with
      Matritech.

    


    8.2    The
      Parties acknowledge and agree that all Product Improvements shall be owned
      by
      Matritech. Inverness agrees to assign and does hereby assign the Product
      Improvements along with all Intellectual Property in and to such Product
      Improvements to Matritech. Inverness shall require all Approved Contract
      Manufacturers contributing to the development of the Product Improvements to
      have executed written instruments with Inverness, assigning all right title
      and
      interest in and to the Product Improvements and the Intellectual Property in
      and
      to such Product Improvements to Inverness. 

    


    8.3    Matritech
      hereby grants, and will grant, to Inverness and any Approved Custom Manufacturer
      non-exclusive, fully paid up, royalty-free license, under all of Matritech’s
      Intellectual Property in, to and/or covering the Products and/or Product
      Improvements, to perform all obligations under this Agreement. 

    


    8.4    Matritech
      authorizes Inverness and any Approved Custom Manufacturer (as a subcontractor
      of
      Inverness) to apply the Trademarks listed in Schedule 4 to the Products for
      the
      purposes of performing its obligations under this Agreement. 

    


    8.5    Inverness
      will provide Written notice to Matritech within five Business Days after any
      loss of Inverness Patent rights by Inverness. Inverness agrees to provide
      Matritech with prompt Written notice of the occurrence of any event that may
      give rise to termination of any of rights of Inverness under the Inverness
      Patent, as well as Written notice of any receipt by Inverness of paperwork
      purporting to terminate any of its rights under the Inverness Patents.


    


    9.0    Liability
      and Indemnification 

    


    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 or (b) a claim that the manufacturing processes of
      Inverness or any Approved Custom Manufacturer 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.

    


    
      
        
        

      

      
        14

        
          

        

      

      
        
        

      

    

    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 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 (i) the use and/or sale of the Products; and
      (ii) 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)


    


    9.3    If
      a
      Claim is made against either Party hereto and the Party against whom said Claim
      is made intends to seek indemnification with respect thereto as set forth in
      this Section 9.0, the indemnitee will promptly give Written notice to the
      indemnifying Party of such Claim.

    


    9.4    An
      indemnifying Party may, but shall not be obligated to, take charge of the
      defense (including any settlements) of such a Claim, provided however that
      (a)
      the indemnifying Party shall keep indemnitee informed of, and consult with
      indemnitee in connection with the progress of such claim or settlement, (b)
      the
      indemnitee shall have the right to participate in such Claim or settlement
      thereof with counsel selected by indemnitee at indemnitee’s expense and (c) the
      indemnifying Party shall not have any right, without indemnitee’s Written
      consent, to settle any such claim if such settlement would adversely affect
      indemnitee. 

    


    10.0    Disclaimer
      of Damages.
      EXCEPT
      FOR LIABILITY ARISING UNDER SECTION 9 ABOVE, NO PARTY SHALL BE LIABLE TO ANOTHER
      PARTY UNDER THIS AGREEMENT FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTIAL, MULTIPLE
      OR PUNITIVE DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER
      OR
      NOT FOR BREACH OF CONTRACT, NEGLIGENCE OR OTHERWISE AND WHETHER OR NOT THE
      OTHER
      PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. THESE LIMITATIONS
      SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED
      REMEDY PROVIDED IN THIS AGREEMENT. 

    


    11.0    Recalls

    


    11.1    Inverness
      shall, and shall cause each Approved Custom Manufacturer to, comply and assist
      with any Recall initiated by Matritech. Inverness may not initiate a Recall
      if
      Matritech objects to such Recall, except to the extent, in the reasonable
      opinion of Inverness’ lawyers, Inverness is required to do so by applicable law
      and/or regulatory requirements. Matritech shall comply and assist with any
      such
      Recalls initiated by Inverness. Except for where Inverness initiates a Recall
      due to legal or regulatory requirements as described above, Matritech shall
      have
      sole responsibility for managing any Recall of the Product, provided that
      Matritech shall consult with Inverness prior to initiating any Recall.


    


    
      
        
        

      

      
        15

        
          

        

      

      
        
        

      

    

    11.2    Except
      as
      required by applicable law and/or regulatory requirements, all communications
      made in connection with any Recall shall come solely from Matritech, provided
      that Matritech shall consult with Inverness prior to sending such a
      communication and shall obtain Inverness’ Written acknowledgement prior to
      dispatching the communication. In the case of any permitted communications
      by
      Inverness in connection with any Recall, Inverness will not send any such
      communication without Matritech’s prior Written consent.

    


    11.3    Upon
      receiving from any authority having jurisdiction any direction to Recall any
      Product from the market, the receiving Party shall immediately notify the other
      Party in accordance with the terms hereof. 

    


    11.4    The
      cost
      of implementing any Recall shall be borne by Matritech except as provided in
      clause 4.10 hereof.

    


    12.0    Regulatory
      Approval

    


    12.1    As
      among
      the Parties, Matritech is solely responsible for obtaining regulatory approvals
      and registrations of the Product in all regulatory jurisdictions in which the
      Products are intended to be marketed and Matritech shall be the sole owner
      of
      such approvals and registrations. 

    


    12.2    Inverness
      shall, and shall cause the Approved Custom Manufacturer to, provide Matritech
      or, at the request of Matritech, any regulatory authority with any
      documentation, data and other information relating to the Products that may
      be
      necessary for Matritech’s regulatory approval and maintenance efforts with
      respect to the marketing of the Products. Matritech shall cooperate with
      Inverness and any Approved Custom Manufacturer with respect to the submission
      of
      any such documentation, data and other information to any regulatory
      authority.

    


    13.0    Confidentiality

    


    13.1    Except
      in
      accordance with the terms of this Agreement, neither Party shall, either during
      the period of this Agreement or at any subsequent time, disclose to any other
      person any Identified Confidential Information disclosed to it by the other
      Party under this Agreement, and each Party shall use commercially reasonable
      efforts, and in any event at least as rigorous as those it uses to protect
      its
      own confidential information, to keep the other Party’s Identified Confidential
      Information confidential. In addition, Inverness shall cause each Approved
      Custom Manufacturer to keep confidential and to refrain from disclosing any
      Matritech Identified Confidential Information. Any Identified Confidential
      Information of an Approved Custom Manufacturer shall be deemed Inverness’
Identified Confidential Information. 

    


    13.2     The
      Identified Confidential Information of a disclosing Party may be disclosed
      to:

    


    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    

    
      	
            	13.2.1	
              any
                employees of the receiving Party and any Affiliates of the receiving
                Party
                in question, or 

            


    

    


    
      	
            	13.2.2	
              any
                governmental or other authority or regulatory body,
                or

            


    

    


    
      	
            	13.2.3	
              in
                the case of disclosure of Matritech Identified Confidential Information
                by
                Inverness, any Approved Custom
                Manufacturer,

            


    

    


    but
      only
      to the extent necessary for the purposes of this Agreement or as required by
      law, and subject in the case of disclosure under clause 13.2.1 and 13.2.3 to
      the
      Party in question first obtaining a Written undertaking from the entity to
      whom
      the disclosure is made to be bound to maintain the confidentiality of the
      Information on terms at least as strict as the terms of this Agreement.


    


    13.3    No
      Party
      shall use the name of another Party in any publication, press release or
      advertising without the prior Written consent of the Party to be named.
      Notwithstanding the foregoing sentence, any Party may make such regulatory
      filings (and include such information therein) as it deems necessary or
      appropriate to comply with stock exchange or Securities and Exchange Commission
      rules and regulations or to comply with any court order or law.

     

    14.0    Technology
      Transfer

    


    14.1    At
      any
      time during the term of this Agreement and upon the termination of this
      Agreement for any reason, Inverness will at Matritech’s request (a) transfer, or
      cause the applicable Approved Custom Manufacturer to undertake a transfer of,
      the Product Improvements either to Matritech or to such third party as Matritech
      shall specify and (b) use commercially reasonable efforts to, or cause the
      applicable Approved Custom Manufacturer to use commercially reasonable efforts
      to, promptly and accurately transfer the Product Improvements.

    


    14.2    There
      shall be no Technology transfer fee applicable to any transfer of the Product
      Improvements, but Inverness, for itself or the applicable Approved Custom
      Manufacturer, may request from Matritech reasonable compensation for the time
      expended by its operations and/or technical personnel in undertaking the
      transfer. If Inverness does request such reasonable compensation, Matritech
      agrees to negotiate in good faith with Inverness to determine the amount of
      such
      compensation to be paid. 

    


    15.0    Force
      Majeure 

    


    15.1    If
      either
      Party is affected by any Force Majeure circumstance, it shall promptly notify
      the other Party of the nature and extent of the circumstance in
      question.

    


    15.2    Notwithstanding
      any other provision of this Agreement, neither Party shall be deemed to be
      in
      breach of this Agreement, or otherwise be liable to the other Party, for


     

    
      
        
        

      

      
        17

        
          

        

      

      
        
        

      

    

    any
      delay
      in performance or the non-performance of any of its obligations under this
      Agreement, to the extent that the delay or non-performance is due to any Force
      Majeure circumstance of which it has notified the other Party, and the time
      for
      performance of that obligation shall be extended accordingly.

    


    15.3    If
      the
      Force Majeure circumstance in question prevails for a continuous period in
      excess of 30 days, the Parties shall enter into bona fide discussions with
      a
      view to alleviating its effects, or to agreeing on such alternative arrangements
      as may be fair and reasonable. If no mutually satisfactory arrangement is agreed
      upon within 15 days, either Party shall have the right to terminate this
      Agreement. In the case of Inverness as a manufacturer, if the Force Majeure
      circumstance is preventing Matritech from obtaining Product, Matritech shall
      have the right to request that Inverness request that Inverness use an Approved
      Custom Manufacturer for such manufacture. In the case of an Approved Custom
      Manufacturer as a manufacturer, if the Force Majeure circumstance is preventing
      Matritech from obtaining Product manufactured by a specific Approved Custom
      Manufacturer, Matritech shall have the right to request that Inverness remove
      that entity from the status of Approved Custom Manufacturer under this Agreement
      and the right to request that Inverness substitute a different Approved Custom
      Manufacturer. Inverness shall evaluate any such request, however, the ultimate
      designation of an Approved Custom Manufacturer for each order and any
      substitutions thereof shall be at the sole discretion of Inverness.

     

    16.0    Duration
      and Termination

    


    16.1    This
      Agreement shall come into force immediately on the Effective Date and, subject
      to the following provisions of this Section 16.0, shall continue in force for
      a
      period of five (5) years. Thereafter, the Agreement shall renew automatically
      for additional one (1) year periods, unless or until terminated by either Party
      giving to the other Party at any time not less two hundred and seventy (270)
      days Written notice to expire on or at any time after the end of the initial
      period and/or applicable renewal period. 

    


    16.2    Inverness
      shall be entitled forthwith to terminate this Agreement by giving Written notice
      to the other Party if:

    


    
      	
            	16.2.1	
              Matritech
                commits any material breach of any of the provisions of this Agreement
                and, in the case of such a breach which is capable of remedy, fails
                to
                remedy the breach within thirty (30) days after receipt of a Written
                notice giving full particulars of the breach and requiring it to
                be
                remedied. In the case of such a breach which is not capable of remedy,
                there will be no opportunity to remedy and this Agreement will terminate
                upon receipt of such Written
                notice;

            


    

    


    
      	
            	16.2.2	
              Matritech
                commits any breach of clause 3.10
                above;

            


    

    


    
      
        
        

      

      
        18

        
          

        

      

      
        
        

      

    

    
      	
            	16.2.3	
              Matritech
                shall be adjudicated bankrupt, goes into receivership or trusteeship,
                makes a voluntary arrangement with its creditors or enters into any
                similar proceeding of the same
                nature;

            


    

    


    
      	
            	16.2.4	
              Matritech
                goes into liquidation (except for the purposes of an amalgamation,
                reconstruction or other reorganization and in such manner that the
                company
                resulting from the reorganization effectively agrees to be bound
                by or to
                assume the obligations imposed on Matritech under this Agreement);
                or

            


    

    


    
      	
            	16.2.5	
              Matritech
                ceases, or threatens to cease, to carry on
                business.

            


    

    


    16.3    Matritech
      shall be entitled forthwith to terminate this Agreement by giving Written notice
      to the other Party if:

    


    
      	
            	16.3.1	
              Inverness
                commits any material breach of any of the provisions of this Agreement
                and, in the case of such a breach which is capable of remedy, fails
                to
                remedy the breach within thirty (30) days after receipt of a Written
                notice giving full particulars of the breach and requiring it to
                be
                remedied. In the case of such a breach which is not capable of remedy,
                there will be no opportunity to remedy and this Agreement will terminate
                upon receipt of such Written
                notice;

            


    

    


    
      	
            	16.3.2	
              Inverness
                shall be adjudicated bankrupt, goes into receivership or trusteeship,
                makes a voluntary arrangement with its creditors or enters into any
                similar proceeding of the same
                nature;

            


    

    


    
      	
            	16.3.3	
              Inverness
                goes into liquidation (except for the purposes of an amalgamation,
                reconstruction or other reorganization and in such manner that the
                company
                resulting from the reorganization effectively agrees to be bound
                by or to
                assume the obligations imposed on Inverness under this Agreement);
                

            


    

    


    
      	
            	16.3.4	
              Inverness
                ceases, or threatens to cease, to carry on business;
                or

            


    

    


    
      	
            	16.3.5	
              Inverness
                loses rights to any of the Inverness
                Patents.

            


    

    


    16.4    As
      an
      alternative to termination of this Agreement in the event an Approved Custom
      Manufacturer is the cause of the conduct that gives grounds for termination
      under clauses 16.3.1 above, Matritech shall have the option of terminating
      the
      status of that Approved Custom Manufacturer and requesting the substitution
      of
      another Approved Custom Manufacturer in its place. 

    


    16.5    Any
      waiver by either Party of a breach of any provision of this Agreement shall
      not
      be considered as a waiver of any subsequent breach of the same or any other
      provision.

    


    
      
        
        

      

      
        19

        
          

        

      

      
        
        

      

    

    16.6    The
      rights to terminate this Agreement given by this Section 16.0 shall not
      prejudice any other right or remedy of either Party in respect of the breach
      concerned (if any) or any other breach.

    


    
      
        16.7    On
          the
          termination of this Agreement for any reason, Inverness shall, and if an
          Approved Custom Manufacturer is manufacturing the applicable Product, shall
          cause the applicable Approved Custom Manufacturer to:

      

    

    


    
      	 	
              16.8.1

            	
              cease
                to manufacture the Products; 

            


    

    


    
      	 	
              16.8.2

            	
              cease
                to use any of the Trademarks;

            


    

    


    
      	 	
              16.8.3

            	
              destroy
                any tangible copies of Matritech’s Identified Confidential Information;
                and

            


    

    


    
      	 	
              16.8.4

            	
              promptly
                return to Matritech all unused Matritech Raw
                Materials.

            


    

     

    16.9    On
      the
      termination of this Agreement for any reason, Inverness shall destroy any
      tangible copies of the Matritech’s Identified Confidential
      Information.


     

    16.10    On
      the
      termination of this Agreement for any reason, Matritech shall destroy any
      tangible copies of Inverness’ Identified Confidential
      Information.


     

    16.11    The
      provisions of 4, 8, 9, 10, 13, 17, and 18 shall continue in force in accordance
      with their terms, notwithstanding termination of this Agreement for any
      reason.

    


    17.0    Notices
      and Service

    


    17.1    Any
      notice required or authorized by this Agreement may be given by hand delivery;
      sent by certified or registered mail, return receipt requested; by facsimile
      transmission providing a confirmation of transmission, or sent by an
      internationally recognized courier service.

    


    17.2    Any
      notice delivered in hand shall be deemed given on the date of delivery. A notice
      given by certified or registered mail which is not returned to the sender as
      undelivered shall be deemed to have been given on the earlier of the date
      reflected for delivery on the signed return receipt or the fifth day after
      the
      envelope containing it was so posted if the return receipt is undated. A notice
      given by facsimile transmission shall be deemed given on the business day on
      which the transmission was sent if the confirmation reflects that it was
      successfully transmitted on or before 5:30 p.m. at the place of delivery (e.g.
      Wales or Massachusetts) on a business day at the place of delivery, or otherwise
      it shall be deemed delivered on the next business day. A notice given by
      internationally recognized courier service shall be deemed given on the second
      business day after depositing with the courier service. 

    


    
      
        
        

      

      
        20

        
          

        

      

      
        
        

      

    

    17.3    All
      notices concerning or arising out of this Agreement shall be addressed to the
      Parties as follows:

    


    
      	
            	If
              to Matritech:	
              Matritech,
                Inc.

            


    

    330
      Nevada Street

    Newton,
      MA 02460 USA

    Attn.:
      President

    (617)
      928-0821 (facsimile) 

    


    
      	
            	If
              to Inverness:	
              Inverness
                Medical Innovations, Inc.

            


    

    51
      Sawyer
      Road, Suite 200

    Waltham,
      MA 02453

    Attn:
      General Counsel’s office

    (617)
      647
      3939 (facsimile) 

    


    or
      to
      such other officer at such other address as may be specified from time to time
      by notice complying with the provisions hereof.

    


    18.0    Miscellaneous

    


    18.1    This
      Agreement is personal to the Parties and neither of them may, without the
      Written consent of the other, assign or transfer any of its rights, or
      sub-contract or otherwise delegate (other than as provided herein with respect
      to Approved Custom Manufacturers) any of its obligations, under this Agreement;
      provided, however, that a Party may assign this Agreement to an entity or person
      who acquires all or substantially all of its business (or segment, such as
      Matritech’s NMP22 product line) by merger, sale of assets or otherwise.
      Notwithstanding the foregoing, Matritech may not assign this Agreement to any
      competitor of Inverness that sells bladder cancer detection products without
      the
      prior Written consent of Inverness, which consent may be withheld by Inverness
      in its sole discretion. Any attempted assignment, delegation or transfer by
      a
      Party in violation hereof shall be null and void. Subject to the foregoing,
      this
      Agreement shall be binding on the parties and their successors and assigns.
      

    


    18.2    The
      relationship between the Parties established by this Agreement is that of
      independent contractors, and nothing contained in this Agreement shall be
      construed to (i) give either Party the power to direct and control the
      day-to-day activities of the other Party, (ii) create a franchise, partnership,
      agency, joint venture or employment relationship between the Parties, or (iii)
      allow a Party to create or assume any obligation on behalf of the other Party
      for any purpose whatsoever. 

    


    18.3    This
      Agreement contains the entire agreement between the Parties with respect to
      the
      subject matter hereof, supersedes all previous agreements and undertakings
      between the Parties, and may not be modified except by an instrument in Writing
      signed by the duly authorized representatives of the Parties.

    


    
      
        
        

      

      
        21

        
          

        

      

      
        
        

      

    

    18.4    The
      headings in this Agreement are for convenience only and shall not affect its
      interpretation.

    


    18.5    This
      Agreement may be executed in two or more counterparts, each of which shall
      be
      deemed an original, but all of which together shall constitute one and the
      same
      instrument. This Agreement and any amendment or notice required or permitted
      by
      this Agreement, may also be executed via facsimile, which shall be deemed an
      original.

    


    18.6    If
      any
      provision of this Agreement is held by any court or other competent authority
      to
      be void or unenforceable in whole or part, the other provisions of this
      Agreement and the remainder of the affected provisions shall continue to be
      valid and enforceable.

    


    18.7    This
      Agreement shall be governed by and construed in all respects in accordance
      with
      the laws of the Commonwealth of Massachusetts without giving effect to its
      conflicts of law principles. Each of the Parties consents to venue and
      jurisdiction in any court of competent jurisdiction sitting within the
      Commonwealth of Massachusetts. 

    


    In
      witness whereof, the Parties hereto have executed this Agreement as of the
      date
      first above Written. 

    


    


    
      	Inverness Medical Innovations,
              Inc. 	Matritech, Inc. 
	 	 
	By: /s/
              Ron
              Zwanziger                           
               	By: /s/
              Stephen D.
              Chubb                    
               
	Its: CEO                                                   
               	Its:
              CEO                                                   
               
	 	 
	By: __/s/
              Anne Warner___________ 	 
	Its _
              Asst. Sec’y____________    
              __    	 


    

       

     

    
      
        
        

      

      
        22

        
          

        

      

      
        
        

      

    


    List
      of Schedules

    


    


    Schedule
      1 - Inverness Patents

    Schedule
      2 - Price

    Schedule
      3 - Specification

    Schedule
      4 - Trade Marks

    Schedule
      5 - Matritech Raw Materials

    Schedule
      6 - Approved Custom Manufacturers

    Schedule
      7 - Products

    Schedule
      8 - Receiving Points

     


    
      
        
        

      

      
        23

        
          

        

      

      
        
        

      

    


    Schedule
      1

    Inverness
      Patents

    


    [
      ** ]


    


    



    
      
        
        

      

      
        24

        
          

        

      

      
        
        

      

    


    Schedule
      2

    Price

    


    $[
      ** ]
      per test, with devices packaged 24 to a box with 3-10 boxes per carton



    
      
        
        

      

      
        25

        
          

        

      

      
        
        

      

    


    Schedule
      3

    Specification

    


    Schedule
      3 - NMP22® BladderChek® Test Specification

    


    


    


    
      	1.	
              Purpose 

            


    

    


    This
      Specification is written to ensure the quality of the Matritech NMP22®
BladderChek® Test (Product) purchased from Inverness Medical and to ensure the
      Product’s suitability for its intended use.as described in its labeling. All
      Product must conform to the Specification and all applicable US and foreign
      regulations.

    


    
      	2.	
              Definitions 

            


    

    


    
      	
            	Test:	
              Each
                test consists of one test cassette, one transfer pipet, and one desiccant
                pack sealed in a foil pouch. 

            


    

     

    
      	
            	Test
              kit:	
              Each
                test kit consists of 24 BladderChek® Tests packed in a labeled
                carton
                with IFU and reorder reminder (2, non-CE, only).
                

            


    

     

    In
      achieving all specifications set forth below, the manufacturer must follow
      and
      conform to all procedures provided by Matritech, Inc. and must utilize the
      materials and components provided and/or specified and approved by Matritech,
      Inc.

     

    [
      ** ]


    


    
      	7.	
              Packing
                and Shipping

            


    

    


    
      	
            	7.1	
              Test
                kits must be packaged in shippers so as to minimize product
                damage.  Shippers
                must be received at the specified Receiving Point with no damage 
                to
                the Product.

            


    

    


    
      	
            	7.2	
              Product
                must be shipped at [ ** ]°C to arrive at the specified Receiving Point
                in
                no more than [ ** ] calendar days.

            


    

    


    
      	8.	
              Other

            


    

    


    
      	
            	8.1	
              A
                copy of the completed device history records must accompany the shipment
                or

            


    

     

    
      
        
        

      

      
        26

        
          

        

      

      
        
        

      

    

    
      	
            	 	
              be
                faxed or emailed separately if the shipment is intended for a Receiving
                Point other
                than Matritech, Newton, MA.

            


    

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    
 

    
      
        
        

      

      
        27

        
          

        

      

      
        
        

      

    


    Schedule
      4

    Trade
      Marks

    


    Matritech

    NMP22

    BladderChek

    NMP22
      BladderChek


    
      
        
        

      

      
        28

        
          

        

      

      
        
        

      

    


    Schedule
      5

    Matritech
      Raw Materials*

    


    Test
      line
      antibody

    Gold
      conjugate 

    


    *Unless
      provided by Inverness or an Approved Custom Manufacturer at the time of
      execution of this agreement 


    
      
        
        

      

      
        29

        
          

        

      

      
        
        

      

    


    Schedule
      6

    Approved
      Custom Manufacturers

    


    British
      Biocell International Limited

    Golden
      Gate

    Ty
      Glas
      Avenue

    Cardiff,
      CF14 5DX

    


    Unotech
      Diagnostics, Inc. 

    2245
      Polvorosa Avenue, Suite 220 

    San
      Leandro, CA 94577

    


    All
      manufacturing subsidiaries of Inverness, including without limitation those
      currently located in Bedford UK; Hangzhou, China; and Shanghai, China.



    
      
        
        

      

      
        30

        
          

        

      

      
        
        

      

    


    Schedule
      7

    Products

    


    NMP22
      BladderChek Test 


    
      
        
        

      

      
        31

        
          

        

      

      
        
        

      

    


    Schedule
      8

    Receiving
      Points

    


    Matritech,
      Inc., Newton, MA

    Matritech
      GmbH, Freiburg, Germany

    


    


    


    


    


    


    


    


    


    


    
      
        
        

      

      
        32