Amendment to Asset Purchase Agreement


    Exhibit
      10.1

    


    AMENDMENT


    


    This
      Amendment is
      made as of January 8, 2007 by and among DFB Biotech, Inc. a Delaware corporation
      (“Buyer”),
      and
      BioSpecifics Technologies Corp., a Delaware corporation (“BTC”),
      and its
      wholly-owned subsidiary Advance Biofactures Corporation, a New York corporation
      (“ABC”)
      (BTC and ABC
      each being hereinafter individually, and collectively where applicable, referred
      to as “Seller”).
      (Buyer and
      Seller are at times referred to herein collectively as the “Parties.”)


     

    RECITALS

     

    Whereas
      the Parties
      entered into an Asset Purchase Agreement dated March 3, 2006 (the “APA”);
      and

     

    Whereas
      the Parties
      now desire to amend the APA as detailed herein to clarify certain provisions
      of
      the APA in light of subsequent events;


     

    AGREEMENT

     

    Now,
      therefore, in
      consideration of the premises and mutual covenants herein contained as well
      as
      other good and valuable consideration, the receipt and adequacy of which are
      hereby acknowledged, the Parties intending to be legally bound agree as
      follows:


     

    
      	
              1.

            	
              Any
                capitalized term in this Amendment not defined herein shall have
                the same
                meaning as set forth in the APA.

            


    

     

    
      	
              2.

            	
              The
                following
                definitions shall be added as defined terms to Section 1.1 of the
                APA:

            


    

     

    “‘Auxilium’
      - shall mean
      Auxilium Pharmaceuticals, Inc., the Delaware corporation which is a party to
      the
      Auxilium License (as defined below).”

     

    “‘Retained
      API’
      - shall mean
      collagenase, excluding collagenase for dermal formulations labeled for topical
      administration, OMITTED AND FILED SEPARATELY WITH THE SECURITIES &
EXCHANGE COMMISSION.”

     

    “Transferred
      API’
      - shall mean
      collagenase, including but not limited to collagenase for dermal formulations
      labeled for topical administration, which is the active pharmaceutical
      ingredient of the Product, OMITTED AND FILED SEPARATELY WITH THE
      SECURITIES & EXCHANGE COMMISSION.”

     

    “‘Auxilium
      License’ -
      shall mean the
      Development and License Agreement by and between BTC and its Affiliates (as
      defined therein) and Auxilium, dated June 3, 2004, as amended May 10,
      2005.”

     

    “‘Auxilium
      Product’
      - shall mean
      pharmaceutical products, excluding all dermal formulations labeled for topical
      administration, which contain Retained API as an active
      ingredient.”

     

    “‘Competing
      Product’
      - shall mean a
      product that contains Retained API as an active ingredient and is sold in a
      country by a party (other than Auxilium its Affiliates or Sublicensees as
      defined in the Auxilium License) for

    
       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      an
        indication when
        Auxilium, its Afilliates or Sublicensees also markets an Auxilium Product
        approved for such indication in such country.”

       

    

    “‘Retained
      Cell Banks’
      - shall mean the
      cell banks of Seller as of the Closing Date, which are listed in Schedule
      1.1(h).”

     

    “‘Transferred
      Cell Banks’
      - shall mean the
      cell banks of Seller as of the Closing Date, which are listed in Schedule
      1.1(d).”

     

    
      	
              3.

            	
              Each
                definition below shall be deleted in its entirety from Section 1.1
                of the
                APA and replaced with the
                following:

            


    

     

    “‘API’
      - shall mean
      collagenase, which is the active pharmaceutical ingredient for the Product,
      obtained from fermentation of Clostridium.”

     

    “‘Overlap
      Intangible Assets’ -
      means the
      intangible assets (including Records relating to the Transferred API and
      Transferred Cell Banks) owned or licensed by ABC or BTC not solely related
      to
      topical uses and indications for collagenase, which are used in the research,
      development, use, commercialization, manufacture, sale or distribution of the
      Product, Retained and Transferred API, including those set forth in Schedule
      1.1(b).”

     

    “‘Product’ -
      means the
      collagenase ointment manufactured by Seller and marketed by Abbott Laboratories
      under the trademark SANTYL as successor to Knoll Pharmaceutical Company pursuant
      to the Knoll License Agreement, as well as all components of the SANTYL
      collagenase ointment including but not limited to the Transferred API but
      excluding the Retained API.”

     

    “‘Purchased
      Assets’ -
      means:


     

    (a)  to
      the extent
      exclusively related to or used in connection with the API, the Product, or
      Seller’s Topical Business, all items of inventory of the Seller and ABC-C,
      wherever located, including all finished goods, work in process, raw materials,
      spare parts, and all other related materials and supplies and listed on
Schedule
      1.1(c) (collectively
      the
“Purchased
      Inventories”);


     

    (b)  (i)
      the ELA, the
      Product, and the Transferred API; and (ii) all Records of Seller relating to
      the
      ELA, the Product, or related solely to the Transferred API; 

     

    (c)  the
      Transferred
      Cell Banks; 

     

    (d)  the
      ABC-C Shares;


     

    (e)  all
      the equipment
      and materials owned by BTC or ABC, located in the Lynbrook, New York or Curaçao
      facilities, which are used exclusively in Seller’s Topical Business and listed
      in Schedule
      1.1(e);


     

    (f)  the
      Knoll License
      Agreement and the Tufts License Agreement and all Intellectual Property
      thereunder; 

     

    (g)  all
      Contracts
      relating solely to Seller’s Topical Business to which Seller or ABC-C is a party
      and listed in Schedule
      1.1(f) (the
“Seller
      Contracts”);


     

    (h)  to
      the extent
      related to the Transferred Employees, all personnel Records and other Records
      that Seller is not required by law to retain in its possession; 

     

    (i)  except
      as provided
      in Section 7.14(a) , all Intellectual Property owned or controlled by Seller
      or
      ABC-C

    
       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      relating
        solely to
        (i) Seller’s Topical Business, (ii) the Product, (iii) the Transferred API, (iv)
        the ELA, or (v) topical uses and indications for collagenase, all as listed
        on
Schedule
        1.1(g),
        (collectively the
“Intellectual
        Property Assets”);


       

    

    (j)  all
      clinical and
      other data, reports and communications to the extent solely related to topical
      indications and uses for collagenase or Seller’s Topical Business; and


     

    (k)  all
      governmental
      authorizations and pending applications therefor, and registrations, to the
      extent assignable, to the extent solely related to topical uses and indications
      for collagenase or Seller’s Topical Business.”

     

    “‘Seller
      Injectable Assets’ -
      means any
      tangible or intangible assets (including, patents, trademarks, copyrights,
      or
      other Intellectual Property asset, equipment, inventory, Contract or other
      asset) owned, licensed or leased prior to the Closing Date by Seller, or any
      Affiliate of Seller, relating to the research, development, use,
      commercialization, manufacture, sale or distribution of the Auxilium Product,
      and set forth in Schedule
      1.1(h).”

     

    
      	
              4.

            	
              Section
                2.1(b) of the APA shall be deleted in its entirety and replaced with
                the
                following:

            


    

     

    “(b)  Overlap
      Intangible Assets.
      Upon the terms
      and subject to the conditions set forth herein, at the Closing, but effective
      as
      of the Effective Time, Seller shall exclusively (even as to Seller),
      perpetually, without royalty, and irrevocably license to Buyer the right to
      use
      the Overlap Intangible Assets for the research, development, use,
      commercialization, manufacture, marketing, and sale of topical products, free
      and clear of any Encumbrances, and Buyer shall accept such license from Seller
      of, the Overlap Intangible Assets.”

     

    
      	
              5.

            	
              The
                following
                shall be added to the APA as Section
                2.2(o):

            


    

     

    “(o).  any
      drug master
      file owned by Seller, its Affiliates or sublicensees, including Auxilium. For
      purposes of clarity, the Parties agree that the ELA is not, nor shall it be
      construed to be, a drug master file.”

     

    
      	
              6.

            	
              Section
                7.7(a) of the APA shall be deleted in its entirety and replaced with
                the
                following:

            


    

     

    OMITTED
      AND
      FILED

    SEPARATELY
      WITH THE

    SECURITIES
      & EXCHANGE COMMISSION

    


    
      	
              7.

            	
              Section
                7.15
                of the APA shall be deleted in its entirety and replaced with the
                following:

            


    

     

    “7.15  Maintenance
      and Defense of Overlap Intangible Assets

     

    Seller
      agrees that
      all patents and other Intellectual Property included within the definition
      of
      Overlap Intangible Assets shall be maintained
      and defended in
      all relevant jurisdictions throughout the OMITTED
      AND
      FILED SEPARATELY WITH THE SECURITIES & EXCHANGE
      COMMISSION.
      Upon OMITTED
      AND
      FILED SEPARATELY WITH THE SECURITIES & EXCHANGE
      COMMISSION,
      if a decision is
      made not to defend or maintain any such patent or other Intellectual Property,
      then Seller agrees that Buyer may maintain or defend 

     

    
      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      such
        patent or
        other Intellectual Property and Seller shall provide, at Buyer’s expense, all
        reasonable assistance requested by Buyer related to such maintenance or
        defense.”

      
      

    

     

    
      	
              8.

            	
              The
                following
                shall be added to the APA as Section
                7.18:

            


    

     

    “7.18  Buyer
      Acknowledgment of Auxilium License

     

    To
      the extent
Records
      included in
      the Purchased Assets are subject to the Auxilium License, Buyer acknowledges
      that Auxilium may have limited rights
      to such Records.
      Therefore upon Auxilium’s reasonable written request
      and provided that
      such Records are in Buyer’s actual possession,
      Buyer will grant
      Auxilium a
limited
      right to
      access, cross-reference, and use (at Auxilium’s sole cost and expense) such
      Records
      to the extent (a)
      they are subject to the Auxilium License and (b) they are reasonably
      required
      in regulatory filings for the Auxilium Product.”


     

    
      
        	
                9.

              	
                The
                  following
                  shall be added to the APA as Section
                  7.19:

              


      

       

    

    OMITTED
      AND
      FILED

    SEPARATELY
      WITH THE

    SECURITIES
      & EXCHANGE COMMISSION

    


    
      	
              10.

            	
              The
                references to “API” in Schedule 1.1(b) and Schedule 1.1(g) shall be
                amended to refer to “Transferred
                API.”

            


    

     

    
      
        	
                11.

              	
                Except
                  as
                  expressly amended or modified hereby the APA shall remain in full
                  force
                  and effect in accordance with its original
                  terms.

              


      

       

    

     

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      of
      page intentionally left blank]

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    IN
      WITNESS
      WHEREOF, the
      Parties have
      caused this Amendment to be executed in triplicate originals as of the date
      and
      year first above written.


     

    

      
        	
                SELLER:

                 

              	 	 
	
                BioSpecifics
                  Technologies Corp.

                 

                 

              	 	Advance
                Biofactures Corporation
	
                By:

              	
                /s/
                  Thomas
                  Wegman

              	 	
                By:

              	
                /s/
                  Thomas
                  Wegman

              
	 	
                Name:
                  Thomas
                  Wegman

              	 	 	
                Name:
                  Thomas
                  Wegman

              
	 	
                Title:
                  President

                 

                 

              	 	 	
                Title:
                  President

                 

              
	 	 	 	 	 
	
                BUYER:

                 

              	 	 	 
	
                DFB
                  Biotech, Inc.

                 

                 

              	 	 	 
	
                By:

              	
                /s/
                  Paul
                  Dorman

              	 	 	 
	 	
                Name:____________________________________

              	 	 	 
	 	
                Title:______________________________________