Unassociated Document


    Exhibit
      10.7

    


    Amendment
      No. 1 to 

     

    DEVELOPMENT
      AND LICENSE AGREEMENT 

     

    THIS
      AMENDMENT NO. 1 TO THE DEVELOPMENT AND LICENSE AGREEMENT (“Amendment No.
      1”)
      is
      entered into by and between Auxilium Pharmaceuticals, Inc., a company
      incorporated under the laws of Delaware with offices at 160 W. Germantown Pike,
      Norristown, PA 19401 and its Affiliate (collectively, “Auxilium”) and
      BioSpecifics Technologies Corp. a company organized and existing under the
      laws
      of the State of Delaware with offices located at 35 Wilbur Street, Lynbrook,
      New
      York 11563 and its Affiliates (collectively, “BTC”). 

     

    Whereas,
      Auxilium and BTC (the “Parties”)
      have
      entered into that certain Development and License Agreement dated June 3, 2004
      (the “License Agreement”); and 

     

    Whereas,
      the
      Parties desire to amend the License Agreement in various respects. 

     

    NOW,
      THEREFORE,
      for
      good and valuable consideration, AND
      INTENDING TO BE LEGALLY BOUND,
      BTC and
      Auxilium hereby agree as follows: 

     

    
      	
              1.

            	
              AMENDMENTS

            


    

     

    1.1 SECTION
      1.4. The following sentence shall be added to Section 1.4 of the License
      Agreement: 

     

    “For
      purposes of clarity, Auxilium Holdings Inc. is an Affiliate of Auxilium
      Pharmaceuticals, Inc. and Advance BioFactures of Curacao, NV and Advance
      BioFactures Corporation are Affiliates of BioSpecifics Technologies, Inc. and
      such Affiliates are parties to this Agreement.” 

     

    1.2 Section
      6.1. Section 6.1(a) of the License Agreement is hereby deleted in its entirety
      and replaced with the following language: 

     

    “6.1
      Joint
      Manufacturing Committee.
      

     

    (a) BTC
      and
      Auxilium will establish a Joint Manufacturing Committee (the “JMC”) made up of
      two (2) representatives designated by each Party hereto which shall oversee
      the
      scale-up and manufacturing of Product on a worldwide basis, including the
      planning, manufacturing and supply (including supply chain management). Each
      of
      BTC and Auxilium shall have one vote on the JMC. The objective of the JMC shall
      be to reach agreement by consensus on all matters falling within its authority
      hereunder. In the event of a deadlock with respect to any action involving
      or
      related to the manufacture of clinical supplies of Product, the vote of
      Auxilium, after reasonable opportunity for open discussion among the members
      of
      the JMC, shall control. In the event of a deadlock with respect to any action
      involving or related to the manufacture of commercial supplies of Product,
      the
      vote of Auxilium after reasonable opportunity for open discussion among
      the

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    members
      of the JMC shall control until such time as BTC is providing Auxilium with
      fifty
      percent (50%) of its commercial supplies pursuant to the terms of this
      Agreement. At that point, in the event of a deadlock with respect to any action
      involving or related to the manufacture of commercial supplies of Product,
      the
      vote of BTC after reasonable opportunity for open discussion among the members
      of the JMC shall control. 

     

    1.3 SECTION
      6.2. Section 6.2 of the License Agreement is hereby deleted in its entirety
      and
      replaced with the following language: 

     

    “6.2
      Development
      and Scale Up.
      Auxilium shall, at its own cost and expense, utilizing the Back-Up Supplier
      (defined below),
      develop the formulation and the finished dosage form and scale up the
      Manufacture for clinical supply of the Enzyme and the Product for each
      Indication for use in the Field, including the lyophilized injection
      formulation, to be registered with Regulatory Authorities in accordance with
      Law
      and in sufficient time prior to anticipated commercial launch of a Product
      to
      provide for sufficient Supply of Product for use in the Field. Auxilium will
      have the sole right and responsibility for selecting the finished dosage form
      and presentation for the Product in the Field. The costs paid to third parties
      to develop the lyophilization of the injection formulation shall be shared
      equally by the Parties. 

     

    1.4 SECTION
      6.3. Section 6.3 (a) through (c) of the License Agreement are hereby deleted
      in
      their entirety and replaced with the following language: 

     

    “6.3
      Clinical
      Supply.
      

     

    (a) Back-Up
      Suppliers.
      Auxilium shall qualify one or more back-up suppliers for the Manufacture of
      clinical and commercial supplies of Product in the Field promptly after the
      Effective Date (the “Back-Up Suppliers”.) For purposes of clarity, the term
      Back-Up Suppliers shall include one or more entities in the supply chain, as
      may
      be necessary to Manufacture Product for clinical and/or, if applicable,
      commercial use. Auxilium’s agreement(s) with the proposed Back-Up Suppliers
      shall be consistent with the respective rights and obligations of Auxilium
      and
      BTC hereunder and a copy of which, redacted with respect to financial terms,
      shall be provided to BTC upon the execution of this Agreement and promptly
      after
      the execution thereof, as to any such agreements executed after the date hereof.
      BTC will use Commercially Reasonable Efforts to provide such Back-Up Suppliers
      with sufficient know-how to Manufacture Product, including (i) providing all
      protocols, registration applications and other substantive regulatory documents,
      including, but not limited to, all data, scientific dossiers and governmental
      authorizations; (ii) providing access and reference to all regulatory dossiers
      and filings produced by BTC, its Affiliates and sublicensees relating to the
      Product; (iii) providing access to BTC Know-How in reasonably satisfactory
      form,
      and (iv) providing all technical assistance reasonably requested by the Back-Up
      Suppliers related to the Manufacture of the Product. Auxilium will require
      that
      the Back-Up Suppliers execute a written confidentiality agreement with Auxilium
      and a written materials transfer agreement with BTC, in a form reasonably
      acceptable to BTC and consistent with industry standards, which includes, among
      other things, an undertaking by the Back-Up Suppliers to keep confidential
      the
      Manufacturing and Product information and know-how disclosed to the Back-Up
      Suppliers by BTC. In addition,

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    


    Auxilium
      will require and the Back-Up Suppliers shall be obligated promptly to provide
      BTC and Auxilium with such information and know-how whether patentable or not
      concerning the Manufacture of the Product that Back-Up Suppliers may develop
      or
      acquire from time to time in connection with such Manufacture and the Product,
      except for information and know-how unrelated to the Manufacture of the Product
      that is proprietary to the Back-Up Suppliers (“Back-Up Suppliers’ Proprietary
      Information”). Such information may be utilized by BTC and Auxilium, without
      cost or other obligation to the Back-Up Supplier, consistent with the terms
      of
      this Agreement. 

     

    (b) Supply
      Obligations.
      During
      the Term Auxilium is entitled to and shall be responsible for arranging, through
      the Back-Up Suppliers, for the supply of all Product for use by Auxilium in
      Clinical Trials. After the Effective Date, Auxilium shall purchase, at its
      own
      cost and expense, sufficient quantities of the Product to conduct all of its
      requisite Clinical Trials from the Back-Up Suppliers. 

     

    (c) BTC
      shall
      have the right to purchase and Auxilium shall sell to BTC, at Auxilium’s cost
      therefore, such supplies of Product as BTC may require for pre-clinical and
      clinical trials approved by JDC and such other non-preclinical and non-clinical
      purposes (i.e. process development, manufacturing and related activities) as
      are
      consistent with BTC’s rights under this Agreement. Auxilium will invoice BTC for
      the costs associated with such supplies which will be payable by BTC within
      sixty (60) days of receipt. 

     

    1.5 SECTION
      6.4. Section 6.4 (a) is hereby deleted in its entirety and replaced with the
      following language: 

     

    “6.4
      Commercial
      Supply; Supply Agreement.
      BTC
      shall have the option (the “Supply Option”) exercisable no later than six (6)
      months after FDA approval of the first NDA or BLA with respect to a Product.
      (the “Approval Date”) to assume the right and obligation to supply or arrange
      for the supply, from a third party other than the Back-Up Suppliers, of that
      portion of commercial quantities of the Product in the Territory described
      below
      (the “BTC Supply Portion”). Auxilium and BTC shall each keep the other
      reasonably informed of their respective progress in securing FDA approval of
      the
      appropriate BLA or NDA and the timing thereof and other relevant matters
      affecting the contemplated supply by BTC of commercial quantities of the
      Product. Upon the Approval Date, Auxilium shall withhold $<OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>
of
      Milestone No 4 (the “the Retention Amount”) until BTC notifies Auxilium of its
      decision regarding the exercise of the Supply Option. If BTC exercises the
      Supply Option, Auxilium will retain the Retention Amount until the sooner of
      (1)
      date on which an agreement between BTC and a third party contractor is executed
      for the commercial manufacture of the Product for the benefit of Auxilium which
      contains milestones requiring such contractor to successfully complete
      validation batches for the Product on or before the Supply Date, a copy of
      which, with financial information redacted, will be provided to Auxilium; or
      (2)
      the date on which BTC commences construction by breaking ground for a cGMP
      facility for the commercial manufacture of Product for the benefit of Auxilium,
      provided, however that construction plans and timelines for such facility shall
      be promptly provided to Auxilium prior to commencement of such construction.
      If
      BTC does not exercise the Supply Option, the Retained Amount will
      be

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    


    released
      to BTC within thirty (30) days after BTC notifies Auxilium in writing of its
      decision not to exercise the Supply Option. If BTC exercises the Supply Option,
      commencing on the date 3.75 years from the Approval Date (the “Supply Date”) BTC
      shall be responsible for supplying Auxilium either itself or through a third
      party other than the Back-up Supplier and Auxilium shall purchase from BTC
      the
      BTC Supply Portion of Auxilium’s requirements of commercial supplies of Product
      during the Term. If BTC does not exercise the Supply Option, Auxilium shall
      be
      responsible for arranging for all commercial supplies of Product during the
      Term. Except as specifically provided otherwise in the Agreement, in no event
      shall BTC Manufacture or supply the Enzyme or Product to any third party. In
      the
      event BTC exercises the Supply Option, the Parties shall use Commercially
      Reasonable Efforts to enter into a commercial supply agreement on customary
      and
      reasonable terms and conditions which are not worse than those with the Back-Up
      Suppliers, within six (6) months after the Supply Option is exercised (the
      “Supply Agreement”). For the purposes of this Agreement “BTC Supply Portion”
shall mean the following amounts for each of years 1 through 4 commencing on
      the
      Supply Date (“Year 1” through “Year 4” respectively): 

     

    
      	 	
              ·

            	
              Year
                1— an amount less than or equal to <OMITTED
                AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
                COMMISSION>
                percent (<OMITTED
                AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
                COMMISSION>
                %)
                of Auxilium’s commercial requirements for Product
                

            


    

     

    
      	 	
              ·

            	
              Year
                2— an amount less than or equal to <OMITTED
                AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
                COMMISSION>
                percent (<OMITTED
                AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
                COMMISSION>
                %)
                of Auxilium’s commercial requirements for Product
                

            


    

     

    
      	 	
              ·

            	
              Year
                3— an amount less than or equal to <OMITTED
                AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
                COMMISSION>
                percent (<OMITTED
                AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
                COMMISSION>
                %)
                of Auxilium’s commercial requirements for Product
                

            


    

     

    
      	 	
              ·

            	
              Year
                4— an amount less than or equal to <OMITTED
                AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
                COMMISSION>
                percent (<OMITTED
                AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
                COMMISSION>
                %)
                of Auxilium’s commercial requirements for Product
                

            


    

     

    If
      BTC
      exercises the Supply Option, Auxilium will cooperate with BTC in the latter’s
      efforts to secure FDA approval of BTC, or its designee, as an FDA approved
      supplier of commercial supplies of the Product, including, without limitation,
      by providing timely access to relevant manufacturing and regulatory data from
      the Back-Up Suppliers, permission to cross file to Auxilium’s NDA, as
      appropriate. 

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    


    (a) Royalty.
      Auxilium will pay BTC on a country-by-country and Product by Product basis
      a
      royalty payment of <OMITTED AND FILED SEPARATELY WITH THE SECURITIES
      AND EXCHANGE COMMISSION> percent (<OMITTED AND FILED
      SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> %) of Net
      Sales of Products in the Field for the Term in respect of any sale of Product
      Manufactured by or on behalf of BTC. In the event BTC elects not to exercise
      the
      Supply Option, Auxilium will pay BTC on a country-by-country and Product by
      Product basis a royalty payment equal to <OMITTED AND FILED
      SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> percent
      (<OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION> %) of Net Sales of Products in the Field for the Term,
      provided, however, that in the event BTC exercises the Supply Option and
      Auxilium thereafter exercises its Stand-By Rights pursuant to Section 6.4 (d)
      (formerly 6.4(c)) of the Agreement, the <OMITTED AND FILED SEPARATELY
      WITH THE SECURITIES AND EXCHANGE COMMISSION> % Royalty payable
      hereunder shall not apply for so long as and to the extent BTC fails to supply
      ordered commercial quantities of the Product, i.e., the <OMITTED AND
      FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> %
      Royalty shall not be payable on that portion of Product ordered from and
      supplied by the Back-Up Suppliers up to the quantity of Product ordered from
      but
      not supplied by BTC. Any royalty payable hereunder may be reduced as follows:
      

     

    (i) Competing
      Product Sales.
      If
      during a period that BTC is not supplying commercial quantities of the Product
      a
      Competing Product is sold in a country in the Territory with a unit based market
      share of <OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      % or
      greater, then the royalty due for sales in that country in the Territory shall
      be reduced to <OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      percent
      (<OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      %) of
      Net Sales of Products in that country in the Territory.

     

    (ii) Third
      Party Royalties.
      If the
      Manufacturing, Development or Commercialization of the Product by the Parties
      in
      accordance with this Agreement would, but for a license from such Third Party,
      infringe on such Third Party Patents, any royalties or other payments due to
      Third Parties pursuant to a license acquired by Auxilium then the royalty may
      be
      reduced by up to <OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      % of
      such royalty to compensate for payments to such Third Parties but in no event
      shall royalties payable to BTC be reduced by more than <OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      percent
      (<OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      %) in
      any case.” 

     

    (iii) Payment
      of Royalties.
      Royalties under this Agreement shall be paid within thirty (30) days in the
      case
      of no sublicense and sixty (60) days in case of royalties received from a
      sublicensee, following the last day of the Calendar Quarter in which the
      royalties and other amounts accrue. 

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    


    In
      addition, 6.4(b) (i) shall be deleted in its entirety and replaced with the
      following language:

     

    “(i)
      Supply
      Price.
      In
      event BTC exercises the Supply Option, the Supply Agreement shall afford
      Auxilium supply terms for Year 1 that are not less favorable than the average
      price afforded to Auxilium by the Back-Up Suppliers for the year immediately
      preceding the Supply Date and supply terms for each successive year that are
      not
      less favorable than the average price afforded to Auxilium by the Back-Up
      Suppliers for each preceding year as applicable.” 

     

    In
      addition the following language shall be added to Section 6.4:


     

    “(c)
      Additional
      Payment.
      In
      addition to the royalty payments to be made to BTC under Section 6.4(a),
      Auxilium shall pay to BTC an amount equal to a <OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      percent
      (<OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      %)
      mark-up of the Cost of Goods, as set forth in Schedule 1.16, in respect of
      any
      sale by Auxilium of Product that is not Manufactured by or on behalf of BTC
      provided, however, that in the event BTC exercises the Supply Option and
      Auxilium thereafter exercises its Stand-By Rights pursuant to Section 6.4 (d)
      (formerly 6.4(c)) of the Agreement, the <OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>
      %
      mark-up payable hereunder shall not apply for so long as and to the extent
      BTC
      fails to supply ordered commercial quantities of the Product as provided in
      Section 6.4 hereof.” 

     

    In
      addition, the remaining paragraphs of Section 6.4 are renumbered as appropriate.
      

     

    In
      addition the following language is added to Section 6.4 (d) [formerly Section
      6.4 (c)]. 

     

    “(iv)
      Inability
      to Manufacture.
      In the
      event that BTC after exercising the Supply Option, becomes unable to Manufacture
      the Product or to furnish Product to Auxilium that is Manufactured on BTC’s
      behalf for any reason including, without limitation, as a result of a force
      majeure, Auxilium will be entitled, upon written notification to BTC, to seek
      all of its requirements of Product from the Back-Up Suppliers until such time,
      if any, as BTC, or another party on BTC’s behalf, shall re-commence Manufacture
      of the Product; provided, however, that in the event BTC either itself or
      through a third party re-commences the Manufacture of Product, Auxilium’s
      obligation to purchase some or all of the Product from or through BTC shall
      be
      subject to Auxilium’s contractual obligations to the Back-Up Suppliers. BTC
      shall notify Auxilium as soon as practical in advance of its intent to
      recommence the manufacture of the Product. After BTC has given the notice,
      the
      Parties shall negotiate in good faith the specifics of the transfer process
      such
      as timing of transfer and gradual increases of quantities manufactured by BTC
      over time. The transfer shall afford Auxilium supply terms that are not less
      favorable than those afforded to Auxilium by the Back-Up Suppliers and
      sufficient time to scale down the manufacture of Product by the Back-Up
      Suppliers. 

     

    1.6 SECTION
      7.2. Section 7.2 (c) is hereby deleted in its entirety and replaced with the
      following language: 

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    


    BTC
      will
      immediately, but in no event later than June 30, 2005, use the proceeds of
      Milestone No. 3 to pay off its debts in their entirety (including the principal
      and accrued interest) owed to BioPartners LP and Korpodeko thereby releasing
      all
      real, personal, tangible and intangible property and/or other assets, of BTC
      including, without limitation patents and all other intellectual property
      rights, identified in and/or used as a collateral against the loans granted
      by
      BioPartners and Korpodeko (collectively the “Released Collateral”). In addition,
      BTC shall immediately, but not later than June 30, 2005 take all necessary
      steps
      and file all necessary documents to remove and/or otherwise clear any liens,
      security interests or other encumbrances on the Released Collateral.


     

    1.7 SECTION
      8. Section 8.1 is hereby deleted in its entirety and replaced with the following
      language: 

     

    8.1
“BTC
      Patentable Inventions and Know-How. 

     

    (a) Patent
      Prosecution. 

     

    (i) During
      the term of the Agreement, Auxilium shall, on behalf of BTC and in the
      reasonable exercise of its commercial discretion, prepare, file, prosecute,
      maintain, renew and defend BTC Patents in the countries where such BTC Patents
      are filed as of the Effective Date and any new patents directly relating to
      the
      Enzyme or Product. 

     

    (ii) If
      Auxilium does not intend to file for patent protection or does not wish to
      continue preparation, prosecution, or maintenance of a BTC Patent, then it
      shall
      give at least thirty (30) days advance notice, and in no event less than a
      reasonable period of time for BTC to act. 

     

    (A) In
      such
      case, BTC may elect at its sole discretion to continue preparation, filing
      and
      prosecution or maintenance of the discontinued BTC Patent at its sole expense.
      

     

    (B) Discontinuance
      may be elected on a country-by-country basis or for a patent application or
      patent series in total. 

     

    (b) Cooperation.
      BTC
      will cooperate with Auxilium and provide Auxilium with all necessary assistance
      and documentation in connection with the filing prosecution and maintenance
      of
      BTC Patents. Auxilium will consult with BTC and will keep BTC informed of all
      matters relating such filing, prosecution and maintenance of BTC Patents.
      Auxilium will provide BTC with copies of intended filings in advance and will
      consider BTC’s comments in good faith. 

     

    (c) Fees
      and Expenses.
      

     

    (i) Fees
      and
      Expenses which Auxilium is incurs while filing prosecuting and/or maintaining
      BTC Patents as provided in section 8.1. (a) shall be handled as follows:


     

    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

    


    (A) Auxilium
      shall pay one hundred percent (100%) of fees and expenses in connection with
      patents for the Product in the Field and/or in connection with Additional
      Indications which for which Auxilium has exercised the Additional Indication
      Option pursuant to Section 2.2; provided, however, that fifty percent (50%)
      of
      such fees and expenses will be credited against future royalties payable by
      Auxilium on Net Sales of the Product. 

     

    (B) In
      the
      event Auxilium declines to exercise the Additional Indication Option with
      respect to any Additional Indication and BTC either by itself or pursuant to
      an
      Agreement with a Third Party (a “Partner Agreement”) pursues such Additional
      Indication, BTC shall reimburse Auxilium for one hundred percent (100%) of
      fees
      and expenses in connection with the filing, prosecution and/or maintenance
      of
      all patents pertaining to each such Additional Indication as follows:


     

    (1) In
      the
      event BTC pursues any such Additional Indication pursuant to a Partner
      Agreement, BTC shall reimburse Auxilium in full upon execution of such Partner
      Agreement. 

     

    (2) In
      the
      event BTC pursues any such Additional Indication itself, BTC shall reimburse
      Auxilium in full on the date BTC first initiates further development activity
      with respect to any such Additional Indication. 

     

    1.8 SECTION
      9. Section 9(b) is hereby deleted in its entirety and replaced with the
      following language: 

     

    “(b)
      As
      of the Effective Date BTC is the owner or licensee of BTC Patents and BTC Know
      How and all other rights necessary to make, use and sell all technology covered
      by the BTC Patents. BTC has the full right power and authority to grant the
      licenses and other rights granted to Auxilium and the granting of the licenses
      and other rights to Auxilium hereunder does not violate any right known to
      BTC
      of any Third Party.” 

     

    In
      addition, Section 9(h) is hereby deleted in its entirety and replaced with
      the
      following language: 

     

    “(h)
      BioSpecifics Technologies, Corp is duly organized and validly existing under
      the
      laws of the state of Delaware and its Affiliates are validly existing under
      the
      laws of the jurisdiction of their respective incorporation and have full legal
      power and authority to enter into this Agreement; and” 

     

    1.9 SECTION
      11.4. The following language is hereby added to Section 11.4:


     

    “(b)
      Auxilium may terminate this Agreement immediately upon written notice to BTC,
      given on or prior to September 30, 2005, provided that Auxilium has determined,
      in the good faith exercise of its reasonable business judgment, after a
      technical transfer to its Back-Up Supplier pursuant to Section 6.3, that no
      viable Product is or can be made available. For purposes of clarity, a
      non-viable Product is one that cannot be produced in

     

    
      
        
        

      

      
        8

        
          

        

      

      
        
        

      

    


    commercially
      reasonable quantities, using Commercially Reasonable Efforts and at commercially
      reasonable costs and/or cannot be characterized as comparable to the Product
      or
      Enzyme used in pre-clinical and clinical trials conducted by or on behalf of
      BTC
      prior to the Effective Date of the License Agreement.” 

     

    1.10 Section
      13.1 shall be deleted in its entirety and replaced with the following language:
      

     

    “13.1
      Dispute
      Resolution.
      In the
      event of any controversy or claim arising out of relating to or in connection
      with any provision of this Agreement, or the rights or obligations hereunder,
      the Parties shall try to settle their differences amicably between themselves
      through good faith negotiations. If they are unable to resolve the dispute
      within thirty (30) days of initiating such negotiations, the Parties agree
      first
      to submit the dispute to non-binding mediation before resorting to litigation
      or
      other mutually agreed dispute resolution mechanism. The dispute resolution
      procedures set forth herein shall not limit a court from granting a temporary
      restraining order or a preliminary injunction in order to preserve the status
      quo of the Parties pending arbitration or to protect a Party’s trademark or
      confidential or proprietary information.” 

     

    
      	
              2.

            	
              EFFECTIVE
                DATE OF AMENDMENT 

            


    

     

    This
      Amendment No. 1 shall be effective as of the Effective Date of the Agreement.
      

     

    
      	
              3.

            	
              MISCELLANEOUS
                

            


    

     

    Except
      as
      expressly provided to the contrary in this Amendment No. 1 all other
      definitions, terms and conditions of the License Agreement shall continue in
      full force and effect. 

     

    IN
      WITNESS WHEREOF,
      the
      parties hereto have executed this Amendment No. 1 by their duly authorized
      officers as of the date set forth below. 

     

    ACCEPTED
      AND APPROVED BY AND BETWEEN: 

     

    
      	
              BioSpecifics
                Technologies Corp.

            	 	
              Auxilium
                Pharmaceuticals Inc.

            
	 	 	 
	 	 	 
	
              By:

            	
              /s/
                Edwin H. Wegman

            	 	
              By:

            	
              /s/
                Geraldine A. Henwood

            
	
              Name:

            	
              Edwin
                H. Wegman

            	 	
              Name:

            	
              Geraldine
                A. Henwood

            
	
              Title:

            	
              President

            	 	
              Title:

            	
              Chief
                Executive Officer

            
	
              Date:

            	
              May
                10, 2005

            	 	
              Date:

            	
              May
                10, 2005

            


    

    


    
      
        
        

      

      
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