Exhibit
10.25

       

      AMENDMENT
TO PRODUCT DEVELOPMENT AND LICENSE AGREEMENT

       

      This
Amendment to the Product Development and License Agreement, effective as of
February 24, 2009, is by and between Shire LLC, Shire Biopharmaceuticals
Holdings (formerly known as Shire plc) (collectively “Shire”) and Duramed
Pharmaceuticals, Inc. (“Duramed”). Shire and Duramed are referred to together as
the “Parties”.

       

      WHEREAS,
Shire and Duramed entered into the Product Development and License Agreement
(the “Agreement”) dated as of August 14, 2006, pursuant to which the Parties
have cooperated on continued research and development of certain pharmaceutical
products, with the results of such cooperation to be commercialized by Shire in
the Shire Territory and by Duramed in the Duramed Territory;

       

      WHEREAS,
Shire has determined that, despite the Parties’ diligence, commercialization of
the Collaboration Products by Shire in the Shire Territory is unlikely and,
therefore, continued cooperation by the Parties on research and development will
not be productive for the Parties;

       

      WHEREAS,
pursuant to Section 17.1 of the Agreement, the Parties desire to amend the
Agreement in the manner set forth herein;

       

      NOW,
THEREFORE, in consideration of the mutual promises and covenants contained
herein, the Parties agree to amend the Agreement as follows:

       

      1.           Capitalized Terms.
Capitalized terms used and not defined in this Amendment shall have the meanings
ascribed to them in the Agreement.

       

      2.           Rights to Collaboration
Products. The Parties agree that, effective as of the execution date of
this Amendment, any and all rights and interests of Shire in the Collaboration
Products are returned to Duramed.

       

      3.           Acknowledgement of
Previously Reimbursed Development Expenses. Shire acknowledges and agrees
that the $39,376,991  in Development Expenses previously invoiced by
Duramed and paid by Shire qualified for expense reimbursement under the
Agreement, and Shire waives any audit rights with respect to such
payments.

       

      4.           Payment of Outstanding
Invoice. Shire will pay the outstanding January 26, 2009 invoice for
Development Expenses incurred in 2008 in the amount of $5,058,380 within three
(3) business days of the execution of this Amendment, by wire transfer to an
account designated by Duramed, and Shire waives any audit rights with respect to
such payment.

       

      5.           Reimbursement for
Development Expenses. Pursuant to Section 7.2.1 of the Agreement, Shire
will reimburse Duramed for Development Expenses incurred by Duramed between
January 1, 2009 and December 31, 2009 and/or Carryover Expenses incurred by
Duramed prior to January 1, 2009, up to an aggregate amount of Thirty Million
Dollars ($30,000,000). Shire acknowledges that the $1,152,037 of Development
Expenses Duramed incurred during 2008 in excess of the $30 Million Maximum
Annual 

       

       

      
        
           

        

        
           

          
            

          

        

        
           

        

      

       

       

      Reimbursement
Amount for 2008 are recoverable as Carryover Expenses in 2009, subject to the
Maximum Annual Reimbursement Amount of $30 Million on the recoverability of
Development Expenses and Carryover Expenses for calendar year 2009. In addition,
Shire acknowledges and agrees that Duramed properly designated the Micronized
Progestin Oral Dosage Product as a Replacement Product under the Agreement and
hereby accepts that designation.

       

      6.           Shire Payment. Shire
agrees to pay Duramed the amount of Ten Million Dollars ($10,000,000), payment
to be made within three (3) business days of the execution of this Amendment by
wire transfer to an account designated by Duramed.

       

      7.           Forgiveness of Certain
Obligations of Barr Laboratories, Inc. Shire agrees to forgive the
obligation of Duramed’s affiliate, Barr Laboratories, Inc. (“Barr”), to make the
first Twenty Five Million Dollars ($25,000,000) in payments that would otherwise
be due and owing to Shire under Articles 5 and/or 9 of the License Agreement
between Barr and Duramed dated as of August 14, 2006 (“License Agreement”) for
supply of AG Product and/or sale of AG Product or Barr Product (all as defined
in the License Agreement) during 2009.

       

      8.           Commitment to Supply [*] to
Barr Laboratories, Inc. Shire shall supply Barr with [*] of AG Product,
to be delivered by Shire [*]. These bottles shall be in addition to any amounts
of AG Product that Barr is otherwise entitled to purchase under the License
Agreement, and shall be disregarded in determining whether or the extent to
which the amount ordered by Barr for [*] or the Purchase Order Period that [*],
deviates from the previous forecast under Section 5.5 of the License Agreement.
[*]

       

      9.           No Additional
Payments. Other than the amounts set forth in Sections 4, 5 and 6 of this
Amendment, no additional amounts will be or become due and the maximum amount
payable by Shire under the Agreement, in excess of the $44,435,371 that has
already been paid to Duramed or will be paid to Duramed under the outstanding
January 26, 2009 invoice, is capped at $40,000,000.

       

      10.           Termination. The
Agreement shall terminate effective December 31, 2009. Pursuant to Section 5 of
this Amendment, and Section 7.2.1 of the Agreement, any final Shire
reimbursement for Fourth Quarter 2009 Development Expenses will be made during
the First Quarter of 2010.

       

      11           Third Party
Beneficiary. Shire acknowledges and agrees that Barr is an intended third
party beneficiary of Shire’s obligations under Sections 7 and 8 of this
Amendment.

       

      12.           Agency Review. Within
ten (10) business days following the execution of the Amendment, each Party
shall file with the U.S. Federal Trade Commission Bureau of Competition and the
Antitrust Division of the U.S. Department of Justice this Amendment and any
notifications required to be filed pursuant to Title XI of the Medicare
Prescription Drug Improvement and Modernization Act (Subtitle B – Federal Trade
Commission Review) signed into law December 8, 2003 and any other applicable
law.

       

       

      
        
           

        

        
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      13.           Consent Decree
Filings. Duramed shall make or cause to be made all such filings as are
required by the final order entered into in connection with the litigation
captioned State of Colorado et al v. Barr Pharmaceuticals, Inc. Civil Action No.
1:05-cv-02182-CKK-AK, in the U.S. District Court for the District of Columbia
within ten (10) business days after the execution of this
Amendment.

      


       

      Except as
provided hereinabove, all of the terms and conditions contained in the Agreement
shall remain unchanged and in full force and effect.

       

      IN
WITNESS WHEREOF, the Parties have executed this Amendment as of the date first
written above.

       

      
        	
                DURAMED
      PHARMACEUTICALS, INC.

              
	 
	
                By:

              	 
    
	
                Name:

              
	
                Title:

              


      

      


      


      
        	
                SHIRE
      LLC

              
	 
	
                By:

              	 
    
	
                Name:

              
	
                Title:

              


      

      


      


      
        	
                SHIRE
      BIOPHARMACEUTICALS HOLDINGS

              
	 
	
                By:

              	 
    
	
                Name:

              
	
                Title:

              


      

      


    

     

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