Unassociated Document


    
      CONFIDENTIAL
TREATMENT REQUESTED

       

       

    

    Exhibit
10.25

     

    AMENDMENT TO LICENSE
AGREEMENT REGARDING SUBLICENSING

     

    THIS AMENDMENT TO LICENSE AGREEMENT
REGARDING SUBLICENSING (this “Agreement”), dated as of this 18th day of
November, 2008, but effective as of the Effective Date, is hereby entered into
by and between sanofi-aventis U.S. LLC, a Delaware limited liability company
with offices located at 55 Corporate Drive, Bridgewater, NJ 08807
(“sanofi-aventis U.S.”) and Albany Molecular
Research, Inc., a Delaware corporation with offices located at 26
Corporate Circle, Albany, New York 12203, with its wholly-owned subsidiary, AMR
Technology, Inc., a Vermont corporation with offices located at 5429 Main
Street, Manchester, Vermont 05255, (collectively
“AMRI”).  Sanofi-aventis U.S. and AMRI are sometimes referred to
individually as a “Party” and collectively as the “Parties.”

     

    WHEREAS, Albany Molecular
Research Inc., and sanofi-aventis U.S., through its predecessor Marion Merrell
Dow Inc., entered into a License Agreement—Terfenadine Acid Metabolite on March
15, 1995, and License Agreement II dated December 30, 1998, and amendments dated
as of March 3, 2000, May 5, 2000, August 1, 2001, and March 24, 2005
(collectively the “AMRI-SA License Agreement”);

     

    WHEREAS, Under the AMRI-SA
License Agreement, AMRI granted an exclusive license, with the right to
sublicense upon prior written consent of AMRI, to sanofi-aventis U.S. under,
inter alia, the Albany
Patent Applications and the Albany Patents, as those terms are defined in the
AMRI-SA License Agreement (collectively the “AMRI Patent Rights”);

    


    WHEREAS, Beginning on March 5,
2004, AMRI, along with sanofi-aventis U.S., filed suit in the U.S. District
Court in New Jersey against, inter alia, Barr
Laboratories, Inc., and Teva Pharmaceuticals USA, Inc., asserting infringement
of certain of the AMRI Patent Rights;

     

    WHEREAS, AMRI and
sanofi-aventis U.S. desire to settle their litigations in the U.S. District
Court in New Jersey against Barr Laboratories, Inc. and Teva Pharmaceuticals
USA, Inc. and intend to enter into a Settlement
and Release Agreement relating to Allegra Single-Entity with Barr
Laboratories, Inc. and Teva Pharmaceuticals USA,
Inc. (the “Single-Entity Allegra Settlement Agreement”) and a Settlement
Agreement relating to Allegra D-12 with Barr Laboratories, Inc. (the
“Allegra D-12 Settlement Agreement” and together with the Single-Entity Allegra
Settlement Agreement, the “Settlement Agreements” and each a “Settlement
Agreement”).

     

    WHEREAS,  as
contemplated by the Settlement Agreements, sanofi-aventis U.S. will
enter into License Agreements with Barr Laboratories, Inc. and Teva Pharmaceuticals USA, Inc. relating to
Allegra Single-Entity and with Barr Laboratories,
Inc. for Allegra D-12 (together the “Sublicense
Agreements”).

     

    WHEREAS, in furtherance of the
Settlement Agreements and the Sublicense
Agreements, the Parties desire to amend the AMRI-SA License Agreement as
set forth herein and AMRI to
consent to the sublicenses made under the Sublicense Agreements;

     

    Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under Rule 24b-2 of
the Exchange Act; [*****] denotes
omissions.

    


    
      
        
           


        

        
           


          
            

          

        

        
           


        

      

    

    


    NOW, THEREFORE, in
consideration of the foregoing premises and mutual covenants, agreements, and
provisions herein contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties agree as
follows:

     

    1.         
   Definitions

    


    Except
where otherwise noted, the capitalized terms used herein without definition
shall have the meanings ascribed to them in the AMRI-SA License
Agreement.

    


    “AB-Rated” shall have the
meaning given to it in the Allegra D-12 Settlement Agreement.

    


    “AB-Rated Allegra D-12
Product” means any pharmaceutical product that is an AB-Rated version of
Allegra D-12 in the Territory.

    


    “Allegra Single-Entity”
means a
pharmaceutical composition containing  fexofenadine hydrochloride as
the sole active ingredient, as an immediate release tablet or capsule
formulations for relief of seasonal allergy symptoms, which is currently
marketed by sanofi-aventis U.S. under the trade name Allegra in the Territory,
whether in prescription or non-prescription form, but excluding the
orally-disintegrating tablet (NDA 21-909), oral-solution formulations (NDA
21-963) of the product, and Allegra D-12 and Allegra D-24. 

    


    “Allegra D-12” means a
pharmaceutical composition containing 60-mg fexofenadine hydrochloride and
120-mg pseudoephedrine hydrochloride for relief of congestion and other seasonal
allergy symptoms, marketed by sanofi-aventis U.S. under NDA 20-786, and by its
sublicensee under the Sublicense Agreements, Barr Laboratories, Inc. under NDA
20-786 or under ANDA 76-236, whether in
prescription or non-prescription form.

    


    “Allegra D-24” means a
pharmaceutical composition containing 180 mg fexofenadine hydrochloride and 240
mg pseudoephedrine hydrochloride for relief of congestion and other allergy
symptoms, marketed by sanofi-aventis U.S. under NDA 21-704.

    


    “Effective Date” shall have
the meaning given to it in the Settlement Agreements and shall occur as of the
Effective Date of the first Settlement Agreement to be
effective.   Notwithstanding the foregoing, if a provision hereof
refers to the Effective Date of a specific Settlement Agreement, then the term
shall have the meaning as set forth in the referenced Settlement
Agreement.

    


    “Launch Date” shall have the
meaning given to it in the Sublicense Agreement relating to Allegra
D-12.

    


    “Territory” means the United
States of America and its territories and possessions.

     

    


    2.           
 Amendment to
AMRI-SA License Agreement

     

    
      
        
           


        

        
           


          
            

          

        

        
           


        

      

    

    
       

      CONFIDENTIAL
TREATMENT REQUESTED

    

    


    This
Agreement is an amendment to the AMRI-SA License Agreement.  Except as
otherwise modified herein, the definitions, rights, and obligations of the
Parties to the AMRI-SA License Agreement shall remain in full force and
effect.

    


    3.      
      Sublicense
Consent

    


    Subject
to the terms and conditions of this Agreement, AMRI hereby consents to the
Sublicense Agreements and sublicenses granted thereunder or as otherwise
contemplated by the Settlement Agreements; provided that except as set forth in
the Sublicense Agreements such sublicensed
rights may not be further sublicensed without AMRI’s written consent, which
consent shall not be unreasonably withheld.   The consent granted
under this Section 3 shall not be deemed to be granted for any rights outside of
the Territory (except to the extent set forth in the Sublicense Agreements) or to any party other than
Barr Laboratories, Inc. and Teva Pharmaceuticals USA, Inc.

    


    4.            
Payments by
sanofi-aventis U.S. to AMRI

    


    4.1         
One-Time
Payment.  In consideration of the consents granted hereunder,
within three (3) business days of the Effective Date of the Single-Entity
Allegra Settlement Agreement, sanofi-aventis U.S. shall pay AMRI a sublicense
fee of [*****] (U.S.) dollars ($[*****]).  The one-time payment made
under this Section 4.1 shall be non-refundable when paid; except, to the extent
sanofi-aventis U.S., AMRI or their Affiliates reinstitutes the Litigation (as
defined in the Allegra Single-Entity Settlement Agreement), then the sublicense
fee shall be refundable based on a prorated scale over the time frame from the
Effective Date ($[*****]) to the date of expiration of the last-to-expire AMRI
Patent Rights licensed under the AMRI-SA License Agreement
($[*****])

     

    
      
        
          	
                	
                  4.2 

                	
                  Allegra
      Single-Entity: Unmodified Royalty Rate. The rates for
      royalties due to AMRI on Sales of Allegra Single-Entity by sanofi-aventis
      U.S. and its authorized generic under
      the AMRI-SA License Agreement shall continue unamended and following the
      Effective Date (as defined in the Allegra Single-Entity Settlement
      Agreement) and the payments due to AMRI shall also include amounts based
      on those rates set forth in Section 4.3.1 of the AMRI-SA License Agreement
      based on the Net Sales by the sublicensee under the applicable Sublicense
      Agreement.  For purposes of Article 4, Net Sales (not Net Sales
      Revenue) shall have the meaning given to it in the applicable Sublicense
      Agreement.

                


        

      

    

     

    
      	
            	
              4.3

            	Fixed Royalty Period for
      Allegra D-12.  For
      the period beginning on the Launch Date  and ending on July 31,
      2010 (the “Fixed Period”) and in lieu of royalties otherwise due on Sales
      of Allegra D-12 during the Fixed Period, each of the quarterly royalties
      due under Section 4.3.1 of the AMRI-SA License Agreement relating to Sales
      of Allegra D-12 in the Territory shall be modified to be equal to the
      royalties paid on Sales of Allegra D-12 in the Territory for the quarterly
      period from April 1, 2009 through June 30, 2009 (the “Fixed
      Royalty”).  Royalties payable


    

     

    
      Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under Rule 24b-2 of
the Exchange Act; [*****] denotes
omissions.



    
      
        
           


        

        
           


          
            

          

        

        
           


        

      

    

     

    
      CONFIDENTIAL
TREATMENT REQUESTED

    

     

    
      	
            	
               

            	for any partial quarters shall be prorated,
      with the portion that represents the Fixed Period being paid the pro-rated
      portion of the Fixed Royalty, and the time period representing time
      outside the Fixed Period being paid as set forth in the AMRI-SA License
      Agreement for royalties on Sales of Allegra
      D-12.    Such quarterly sublicense royalty payments
      shall be made in accordance with Article 4 of the AMRI-SA License
      Agreement.  Following the Fixed Period, the Royalty due on Sales
      by sanofi-aventis U.S. of Allegra D-12 in the Territory shall revert to
      those terms set forth in Section 4.3.1 of the AMRI-SA License Agreement
      and the payments due to AMRI shall include royalties pursuant to those
      terms set forth in Section 4.3.1 based on the Net Sales by the sublicensee
      under the applicable Sublicense.


    

     

    
      	
            	
              4.4

            	Royalty Rate for Allegra
      D-24.  Effective
      January 1, 2009, provided that the Effective Date of both Settlement
      Agreements have occurred and for the period both Settlement Agreements
      remain in effect and have not been terminated, the following shall occur
      specifically for and solely relating to Sales of the Allegra D-24
      Product:


    

     

    
      	
               
      

            	
              (a)

            	
              The
      royalty rate under Section 4.3.1(a) of the AMRI-SA License Agreement shall
      be [*****]% of the Net Sales Revenue from Sales of Allegra D-24 Product in
      the Territory by sanofi-aventis U.S., its Affiliates and Sublicensees for
      so long as sanofi-aventis U.S. or any of its Affiliates and Sublicensees
      utilizes a process which, in the absence the AMRI-SA License Agreement
      would otherwise infringe the Process Manufacturing Claim or the AMR
      Patent.  Solely for purposes of computing royalties on Sales of
      Allegra D-24, the provisions of Section 4.3.1(h) of the AMRI-SA License
      Agreement shall be inapplicable to this
  computation.

            


    

    


    
      	
               
      

            	
              (b)

            	
              The
      royalty rate under Section 2.1 of the Second Supplemental Agreement, dated
      as of August 1, 2001, between the Parties (the “Second Supplemental
      Agreement”) shall be [*****]% of the Net Sales Revenue from Sales of
      Allegra D-24 Product in the Territory by sanofi-aventis U.S., its
      Affiliates or Sublicensees until the date, if ever, that the U.S. Patent
      No. 5,578,610 is subject to a final adjudication, by a court of
      competition jurisdiction of invalidity and/or unenforceability or until
      said Patent expires, as more explicitly set forth in the Second
      Supplemental Agreement (or for any Albany Patent containing a
      Substantially Pure Claim in the U.S., for the period set forth under
      Section 4.3.1(d) of the AMRI-SA License Agreement).  Solely for
      purposes of computing royalties on Sales of Allegra D-24, the provisions
      of Section 4.3.1(h) of the AMRI-SA License Agreement shall be inapplicable
      to this computation.

            


    

    


    If either
or both Settlement Agreements’ Effective Date (as defined therein) has not
occurred as of January 1, 2009, then the provisions of this Section 4.4 shall
not be effective until the both Settlement Agreements Effective Dates have
occurred (the later to occur), and then the provisions of this Section 4.4 shall
have effectiveness retroactively to January 1, 2009.

    


    
      Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under Rule 24b-2 of
the Exchange Act; [*****] denotes
omissions.



    
      
        
           


        

        
           


          
            

          

        

        
           


        

      

    

     

    
      	
            	
              4.5

            	Sanofi-aventis U.S. shall require Barr
      Laboratories, Inc. and Teva Pharmaceuticals USA, Inc. to maintain records
      and permit audits as set forth in the Sublicense Agreements, a copy of
      which has been delivered to AMRI, and notwithstanding anything in Section
      9.2 of the AMRI-SA License Agreement, AMRI hereby consents to the audit
      provisions set forth in the Sublicense
Agreements.


    

     

    5.          
 Antitrust
Indemnification

    


    In
addition to the indemnities provided under the AMRI-SA License
Agreement,  at sanofi-aventis U.S.’s cost and expense, sanofi-aventis
U.S. agrees to defend AMRI, its Affiliates and their respective directors,
officers, employees and agents (collectively, the “AMRI Indemnitees”) against
and shall indemnify and hold harmless the AMRI Indemnitees from and against any
losses, costs, damages, fees and/or expenses (including reasonable attorneys’
fees) (“Losses”) whatsoever arising out of any claim, action, lawsuit,
government investigation, regulatory review or other proceeding that relate to
alleged antitrust law violations arising out of this Agreement or the Settlement
Agreements (a “Claim”).  AMRI shall provide prompt notice of any such
Claim.  Sanofi-aventis U.S. shall have the right to control the
defense of any such suit brought against sanofi-aventis U.S. or any of its
Assignees, Affiliates, or Sublicensees and shall do so at its own expense.
sanofi-aventis U.S. shall have the right to require AMRI's reasonable cooperation in any such suit, upon
written notice to AMRI, and AMRI shall have the obligation to participate as
requested by sanofi-aventis U.S. and sanofi-aventis U.S. shall bear the costs of
AMRI’s participation. Sanof-aventis U.S. shall have the right to enter into any
settlement, provided that it is indemnifying for AMRI’s Losses under any such
settlement.

    


    
      	
              6. 


            	
              Termination.

            


    

    


    The
obligations hereunder shall terminate immediately upon and contemporaneously
with the termination or expiration of both Sublicense Agreements (the later to
occur) for any reason, and the obligations under the AMRI-SA License Agreement
shall continue in full force and effect as in effect immediately prior to
entering into this Agreement.    In the event that the
Sublicense Agreement relating to the Allegra Single-Entity shall terminate, but
not the Sublicense Agreement relating to Allegra D-12, then the provisions of
Section 4.2 and 4.4 hereof shall terminate
contemporaneously.    In the event that the Sublicense
Agreement relating to the Allegra D-12 shall terminate, but not the Sublicense
Agreement relating to Allegra Single-Entity, then the provisions of Section 4.3
and 4.4 hereof shall terminate contemporaneously.

    


    
      	
              7.

            	
              Confidential
      Information.

            


    

    


    This
Agreement shall be deemed Confidential Information under the AMRI- SA License
Agreement, and shall be treated accordingly.  Should AMRI need to file
the terms hereof with the Securities and Exchange Commission, it will provide
sanofi-aventis U.S. with notice of the filing and an opportunity to comment, and
will request confidential treatment for the financial terms hereof and any other
terms or recitals that sanofi-aventis U.S. may reasonably
request.  This provision is binding upon execution hereof, without
respect to the Effective Date.

     

    
      
        
           


        

        
           


          
            

          

        

        
           


        

      

    

    


    8.          
 Joint
Agreement/Consent of AMRI

    


    AMRI,
Inc. together with its wholly-owned subsidiary, AMR Technology, Inc., which is
the holder of the Licensed Patents, amongst other things, jointly make the
agreements hereunder.

    


    9.       
    Severability.

    


    If any of
the provisions of this Agreement are found or deemed by a court to be invalid or
unenforceable, they shall be severable from the remainder of this Agreement and
shall not cause the invalidity or unenforceability of the remainder of this
Agreement.

    


    


    


    [Signature
page follows]

    


    
      
        
           


        

        
           


          
            

          

        

        
           


        

      

    

    


               IN WITNESS WHEREOF, the
Parties have each caused this Agreement to be executed by their authorized
representatives as of the date first set forth above.

    


    


    


    SANOFI-AVENTIS
U.S. LLC.

    


    By:        /s/
Hugh O'Neill ___________

    


    Name:
       Hugh
O'Neill ____________

    


    Title:  _ Vice President of Market
Access and Business Development

    


    


     

    By:
___/s/ Laurent
Gilhodes _________

    


    Name:
_    Laurent
Gilhodes _________

    


    Title:
        Chief
Financial Officer ____

    


    


    


     

    ALBANY
MOLECULAR RESEARCH INC.

     

    By:       /s/
Thomas D’Ambra     _______

     

    Name:
___Thomas
D’Ambra     _______

     

    Title:         Chief
Executive Officer_____

     

    


     

    AMR
TECHNOLOGY, INC.

     

    By:       /s/
Thomas D’Ambra     _______

     

    Name:
__ Thomas
D’Ambra     _______

     

    Title:         President                        ____