Document:

Unassociated Document

    EXHIBIT
10.58

     

    Portions
of this exhibit have been omitted pursuant to a request for confidential
treatment. The omitted portions, marked by [***], have been separately filed
with the Securities and Exchange Commission.

     

    FIRST
AMENDMENT TO DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT

    

    This
First Amendment to Development, Manufacturing and Supply Agreement (the “Agreement Amendment”)
dated as of August  15, 2006 (the “Effective Date”)
between Kensey Nash Corporation, a Delaware corporation, having its principal
place of business at 735 Pennsylvania Avenue, Exton, PA  19341
(hereinafter referred to as “KNC”) and BioMimetic
Therapeutics, Inc. (formerly, BioMimetic Pharmaceuticals Inc.),
a  Delaware corporation, having its principal place of business at
389-A Nichol Mill Lane, Franklin, TN  37067 (hereinafter referred to
as “BMPI”).

    

    WHEREAS
KNC and BMPI entered into a Development, Manufacturing and Supply Agreement
dated June 28, 2005 (“Agreement”);

    

    WHEREAS
BMPI desires to have KNC available as an alternative source for the tricalcium
phosphate (“TCP”) component of the Commercial Products;

    

    WHEREAS
KNC has incurred greater than anticipated costs associated with developing and
testing Commercial Products, and BMPI has agreed to accelerate certain milestone
payments to compensate KNC for incurring such cost; and

    

    WHEREAS
pursuant to Section 16.2 of the Agreement the parties now desire to amend the
Agreement.

    

    NOW,
THEREFORE, IN CONSIDERATION of the mutual agreements contained herein, the
parties agree as follows:

    

    1.  Section
1.22 of the Agreement shall be replaced by the following:

    

    
      	
               
      

            	
              1.22

            	
              "Injectable Products" shall mean
      [***], as set forth in Schedule
C.

            

    

    

    2.  Section
1.39 of the Agreement shall be replaced by the following:

    

    
      	
               
      

            	
              1.39

            	
              "Putty Products" shall mean
      [***], as set forth in the Product Specifications in Schedule
      C.

            

    

    

    3.  Section
1.47 of the Agreement shall be replaced by the following:

    

    
      	
               
      

            	
              1.47

            	
              "Sheet
      Products" shall mean the sheet form carrier made from the Sheet Technology
      which may incorporate TCP (supplied either by BMPI or KNC as the Parties
      may elect), as set forth in the Product Specifications in Schedule
      C.

            

    

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        1

        
          

        

      

      
         

      

    

    4.  Section
4.5(a) of the Agreement shall be replaced by the following:

    

    
      	
            	
              4.5

            	
              BMPI
      agrees to:

            

    

    

    
      	
               
      

            	
              a.

            	
              timely
      provide KNC, at no charge, with either: (1) BMPI's TCP, and any required
      Proprietary Molecule(s), or (2) the required Proprietary Molecule(s)
      alone; such materials shall be provided in sufficient amounts in order to
      enable KNC to satisfy its manufacturing and delivery obligations with
      respect to the Products;

            

    

    

    5.  The
following Section 4.4(k) shall be hereby added to the Agreement, to further
define and limit KNC’s responsibility following any election, by BMPI, not to
supply TCP, under Section 4.5(a) of the Agreement:

    

    
      	
               
      

            	
              4.4

            	
              KNC
      agrees to:

            

    

    

    
      	
               
      

            	
              k.

            	
                perform
      additional testing necessary in order to satisfy that it meets the
      Specifications and supply the Certificate of Conformance and Certificate
      of Analysis, following any election by BMPI under Section 4.5(a), herein,
      to not supply TCP to KNC.  KNC shall not be responsible for any
      other additional testing that may be required as a result of such election
      by BMPI.

            

    

    

    6.  The
following Section 4.5(m) shall be hereby added to the Agreement, to further
define BMPI’s responsibility following any election not to supply TCP, under
Section 4.5(a) of the Agreement:

    

    
      	
               
      

            	
              4.5

            	
              BMPI
      agrees to:

            

    

    

    
      	
               
      

            	
              m.

            	
              be
      solely responsible for all necessary Approvals to market the Commercial
      Products including any re-approvals, in-vitro, in-vivo, and related tests
      (other than those tests for which KNC is responsible for under 4.4(k)),
      required due to BMPI’s election under Section 4.5(a), herein, to not
      supply TCP to KNC.

            

    

    

    7.  Section
14.4 of the Agreement shall be replaced by the following:

    

    
      	
               
      

            	
              14.4

            	
              If
      during the Term, including any Post-Term Supply, KNC intentionally
      discontinues supply of Product for any reason other than pursuant to
      Section 14.1, KNC shall: (1) supply BMPI with two years of Material at
      KNC’s then current list price based upon the most recent Purchase
      Commitment amount, (2) [***], for the balance of the then existing Term,
      but in no case less than three (3) years from the date of discontinuation
      of supply, and (3) provide BMPI with name of its TCP supplier(s) and the
      terms under which it purchases TCP from such
  supplier(s).

            

    

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

    8.  Schedule
D of the Agreement shall be replaced by the “Amended Schedule D” which is
attached hereto, and made part of this Amendment.

    

    9.  The
Amended Schedule D applies in cases wherein BMPI supplies both the required TCP
and the Proprietary Molecule, as indicated thereon; however, should BMPI elect
to not supply the TCP, pursuant to Section 4.5(a), as herein amended, the
pricing of Schedule D2, attached hereto and made a part hereof, shall
apply.

    

    10.  Section
6.1(f) of the Agreement shall be replaced by the following:

    

    
      	
               
      

            	
              f.

            	
              [***]
      upon receipt of Approval for marketing of the first Approved Commercial
      Product for percutaneous applications of such Approved Commercial Product
      for closed fractures;

            

    

    

    11.  As
consideration for all additional services provided by KNC in developing and
testing Commercial Products, the following subsections (m) and (n) shall be
added to Section 6.1 of the Agreement:

    

    
      	
               
      

            	
              m.

            	
              [***]
      upon the first enrollment of the first patient in a clinical trial for US
      or European Approval for use of a Commercial Product in an open surgical
      procedure; and

            

    

    

    
      	
               
      

            	
              n.

            	
              [***]
      upon the first enrollment of the first patient in a clinical trial for US
      or European Approval for use of a Commercial Product in a closed surgical
      procedure.

            

    

    

    12.  This
First Amendment is meant to amend, modify or supersede only those specific
Sections, rights, responsibilities, liabilities and/or covenants expressly
referred to in this First Amendment, and only to the extent so referred to; and
accordingly all other Sections and covenants of the Agreement shall remain
unaffected and shall continue to have full force and effect.

    

    IN
WITNESS WHEREOF, the parties have executed this Agreement Amendment through
their duly authorized representatives as of the date first written
above.

    

    
      
        	
                BIOMIMETIC
      THERAPEUTICS, INC.

              	 
      	
                KENSEY
      NASH CORPORATION

              
	 
      	 
      	 
      	 
      	 
      
	
                By:

              	
                /s/ Samuel E. Lynch

              	 
      	
                By:

              	
                /s/Joseph W. Kaufmann

              
	 
      	
                Samuel
      E. Lynch, DDS

              	 
      	 
      	
                Joseph
      W. Kaufmann

              
	 
      	
                President
      & CEO

              	 
      	 
      	
                President
      & CEO

              

      

    

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

    Amended
Schedule D

    

    Kensey
Nash Corporation and BioMimetic Therapeutics Inc.

    DEVELOPMENT,
MANUFACTURING AND SUPPLY AGREEMENT

    August  __,
2006

     

    Transfer
Price

     

    The
following pricing shall apply in the event that BMPI elects under 4.5(a) to
supply to KNC both the required TCP and Proprietary Molecule(s) in order to
produce the Product:

     

    Combined Annual Unit Volume
Pricing *

    

    
      
        
          
            
              
                
                  	 
      	 	
                          [***] Units

                        	 	 	
                          [***] Units

                        	 	 	
                          [***] Units

                        	 	 	
                          [***] Units

                          and greater

                        	 
	
                          Product
      Size and Configuration **

                        	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 
	
                          3
      cc Putty

                        	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	
                          5
      cc Putty

                        	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	
                          10
      cc Putty

                        	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          3
      cc Injectable

                        	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	
                          5
      cc Injectable

                        	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	
                          10
      cc Injectable

                        	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sheet

                        	 	
                          TBD

                        	 	 	
                          TBD

                        	 	 	
                          TBD

                        	 	 	
                          TBD

                        	 

                

              

            

          

        

      

    

    

    * Any
combination of product configurations purchased annually.

    ** Volume
after hydration with PDGF

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        4

        
          

        

      

      
         

      

    

    Schedule
D2

    

    Kensey
Nash Corporation and BioMimetic Therapeutics Inc.

    DEVELOPMENT,
MANUFACTURING AND SUPPLY AGREEMENT

    August
15, 2006

    
 

    The
following pricing shall apply in the event that BMPI elects under Section
4.5(a), as amended, not to supply to KNC the TCP required to produce the
Product:

    

    Combined
Annual Unit Volume Pricing *

    
 

    
      
        
          
            
              
                	 
      	 	
                        [***] Units

                      	 	 	
                        [***] Units

                      	 	 	
                        [***] Units

                      	 	 	
                        [***] Units

                        and
      greater

                      	 
	
                        Product
      Size and Configuration **

                      	 	
                        Assumes
      TCP Provided by KNC

                      	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 
	
                        3
      cc Putty

                      	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	
                        5
      cc Putty

                      	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	
                        10
      cc Putty

                      	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        3
      cc Injectable

                      	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	
                        5
      cc Injectable

                      	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	
                        10
      cc Injectable

                      	 	$	[***	]	 	$	[***	]	 	$	[***	]	 	$	[***	]
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sheet

                      	 	
                        TBD

                      	 	 	
                        TBD

                      	 	 	
                        TBD

                      	 	 	
                        TBD

                      	 

              

            

          

        

      

    

    

    * Any
combination of product configurations purchased annually.

    ** Volume
after hydration with PDGF

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        5Unassociated Document

    EXHIBIT
10.59

     

    Portions
of this exhibit have been omitted pursuant to a request for confidential
treatment. The omitted portions, marked by [***], have been separately filed
with the Securities and Exchange Commission.

     

    SECOND
AMENDMENT TO

    DEVELOPMENT,
MANUFACTURING AND SUPPLY AGREEMENT

    

    This
Second Amendment is made effective as of the first day of November, 2006, to the
Development, Manufacturing and Supply Agreement made June 28, 2005 (“the
Agreement”) by and between Kensey Nash Corporation, a Delaware corporation,
having its principal place of business at 735 Pennsylvania Avenue, Exton,
PA  19341 (hereinafter referred to as “KNC”) and BioMimetic
Therapeutics, Inc. (formerly, BioMimetic Pharmaceuticals Inc.),
a  Delaware corporation, having its principal place of business at
389-A Nichol Mill Lane, Franklin, TN  37067 (hereinafter referred to
as “BMTI”)(each,
individually a “Party” and collectively, the “Parties”).

     

    WHEREAS
the Agreement provides for certain milestone payments to be made to KNC relating
to the commercialization of an Approved Commercial product for tendon or
ligament injury treatment; and

     

    WHEREAS
BMTI and KNC have agreed to redefine the milestones triggering payments for
research & development services to be performed under a Research &
Development Plan (the R&D Plan) attached as Exhibit A to this Second
Amendment to the Agreement over an approximate 2 year period ending December 31,
2008.

     

    NOW,
THEREFORE, IN CONSIDERATION of the mutual agreements contained herein, pursuant
to Section 16.2 of the Agreement the Parties agree to amend the Agreement as
follows:

     

    1.  The
following new section 2.3 shall be added to the Agreement:

    

    
      
        	
              	
                2.3 

              	
                BMTI
      Termination.  BMTI may at anytime upon thirty (30) days
      notice to KNC terminate the development project relating to a product for
      tendon and ligament injury treatment if BMTI concludes in its sole
      discretion that the contemplated Commercial Product is not commercially
      viable for any reason.

              

      

    

    

    2.  Sections
6.1(k) and 6.1(l) of the Agreement shall be replaced by the
following:

    

    
      	
               
      

            	
              k.

            	
              [***]
      upon the First Commercial Sale of the first Approved Commercial Product
      for tendon or ligament injury
treatment;

            

    

    

    
      	
               
      

            	
              l.

            	
              [***]
      upon the one-year anniversary of the First Commercial Sale of the first
      Approved Commercial Product for tendon or ligament injury
      treatment.

            

    

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        1

        
          

        

      

      
         

      

    

    3.  The
following new sections 6.1(m) – (o) shall be added to the
Agreement:

    

    
      	
               
      

            	
              m.

            	
              [***]
      upon execution of this Second Amendment to recognize development work
      completed under the R&D Plan between the date of execution of the
      Agreement and the date of this Second Amendment on the ligament and tendon
      development project;

            

    

    

    
      	
               
      

            	
              n.

            	
              [***]
      payable in eight quarterly installments of [***] upon the close of each
      calendar quarter in 2007 and 2008 for development work yet to be performed
      under the R&D Plan on the ligament and tendon project over the
      specified  period;

            

    

    

    
      	
               
      

            	
              o.

            	
              In
      the event that BMTI terminates the ligament and tendon project pursuant to
      Section 2.3 of the Agreement prior to the end of 2008, the payments
      provided for in 6.1(n) shall cease, however KNC shall be entitled to
      receive a final pro-rated payment up to the date of termination of the
      project.

            

    

    

    4.  This
Second Amendment is meant to amend, modify or supersede only those specific
Sections, rights, responsibilities, liabilities and/or covenants expressly
referred to in this Second Amendment, and only to the extent so referred to; and
accordingly all other Sections and covenants of the Agreement, as amended by the
First Amendment, shall remain unaffected and shall continue to have full force
and effect.

    

    IN
WITNESS WHEREOF, the parties have executed this Agreement Amendment through
their duly authorized representatives as of the date first written
above.

    

    
      
        	
                BIOMIMETIC
      THERAPEUTICS, INC.

              	 
      	
                KENSEY
      NASH CORPORATION

              
	 
      	 
      	 
      	 
      	 
      
	
                By:

              	
                /s/ Samuel E. Lynch

              	 
      	
                By:

              	
                /s/ Joseph W. Kaufmann

              
	 
      	
                Samuel
      E. Lynch, DDS

              	 
      	 
      	
                Joseph
      W. Kaufmann

              
	 
      	
                President
      & CEO

              	 
      	 
      	
                President
      & CEO

              

      

    

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

    Schedule
D3

    
 

    Kensey
Nash Corporation and BioMimetic Therapautics Inc.

    DEVELOPMENT,
MANUFACTURING AND SUPPLY AGREEMENT

    
 

    November,
2006

    
 

    Tendon
Repair Product Transfer Price

    
 

    
      
        
          
            
              
                
                  
                    	
                            Product

                          	 	
                            Price
      Per Unit

                          	 
	 
      	 	
                            Annual
      Order Quantities

                          	 
	 
      	 	
                            <
      [***] Units

                          	 	 	
                            [***]
      Units

                          	 	 	
                            >
      [***]Units

                          	 
	 
      	 	 	 	 	 	 	 	 	 
	
                            [***]
      cm x [***] cm Sheet

                          	 	$	[***	]	 	$	[***	]	 	$	[***	]

                  

                

              

            

          

        

      

    

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

    Exhibit A
to the Second Amendment

    Tendon
Product Research and Development Plan

    

    [***]

    

    [***]  Redacted
pursuant to confidential treatment request.

    
      
         

      

      
        4

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