exv10w2








    Exhibit 10.2



 




    FIRST
    AMENDMENT TO LICENSE, DISTRIBUTION, MANUFACTURING AND

    SUPPLY AGREEMENT



 



    This First Amendment to License, Distribution, Manufacturing and
    Supply Agreement (this “First Amendment”) is made and
    entered into as of September   , 2008, by and
    between LUITPOLD PHARMACEUTICALS, INC., a corporation duly
    organized and existing under the applicable laws of the State of
    New York, and having a principal place of business in Shirley,
    New York (hereinafter referred to as “Luitpold”),
    AMERICAN REGENT, INC., a corporation duly organized and existing
    under the applicable laws of the State of New York, and having a
    principal place of business in Shirley, New York (hereinafter
    referred to as “AR”, and Luitpold and AR collectively
    referred to as “Luitpold/AR”), FRESENIUS USA
    MANUFACTURING, INC., a corporation duly organized and existing
    under the applicable laws of the State of Delaware, and having a
    principal place of business in Waltham, Massachusetts
    (hereinafter referred to as “FUSA”), and VIFOR
    (INTERNATIONAL), INC., a Swiss corporation having its principal
    place of business at Rechenstrasse 37, CH-9001 St. Gallen
    (Switzerland) (hereinafter referred to as “Vifor”).



 



    WHEREAS, the parties hereto are parties to a LICENSE,
    DISTRIBUTION, MANUFACTURING AND SUPPLY AGREEMENT, dated
    May 30, 2008 (the “License Agreement”); and



 



    WHEREAS, the parties hereto desire to amend the License
    Agreement to correct certain provisions thereof to the intent of
    the parties



 



    NOW, THEREFORE, the parties hereto, intending to be
    legally bound, agree as follows:



 



    1. Section 1.01 of the License Agreement is amended as
    follows:



 



    A. [*]



 



    B. [*]



 



    C. The definition of “Effective Date” is replaced
    in its entirety by the following:



 



    “Effective Date” means (i) the first day of the
    month immediately following at least thirty (30) days
    following the date on which all conditions set forth in
    Section 13.01 have been satisfied or waived in writing or
    (ii) such earlier date on which FUSA and Luitpold/AR may
    mutually agree in writing.



 



    D. The definition of “Intellectual Property” is
    amended by replacing the term “Annual Period” with the
    term “Contract Year.”



 



    E. [*]



 



    F. [*]



 



    G. [*]



 



    2. [*]



 



    3. Section 6.10 of the License Agreement is revised by
    changing the term “Annual Period” to “Contract
    Year.”



 



    4. [*]



 



    5. The numbering of Schedules/Exhibits to the License
    Agreement is amended to be as follows:



 


	 	 	 
	

    Exhibit 1.01-A


	
 
	
    [*]

	

    Exhibit 1.01-B


	
 
	
    [*]

	

    Exhibit 1.01-C


	
 
	
    [*]

	

    Exhibit 1.01-D


	
 
	
    [*]

	

    Exhibit 1.01-E


	
 
	
    [*]

	

    Exhibit 2.01(c)


	
 
	
    [*]

	

    Exhibit 2.01(d-1)


	
 
	
    [*]

	

    Exhibit 2.01(d-2)


	
 
	
    [*]














 





	 	 	 
	

    Exhibit 3.11


	
 
	
    [*]

	

    Exhibit 5.01(a)


	
 
	
    [*]

	

    Exhibit 6.01


	
 
	
    [*]

	

    Exhibit 6.03


	
 
	
    [*]

	

    Exhibit 6.06


	
 
	
    [*]

	

    Exhibit 6.08


	
 
	
    [*]

	

    Exhibit 6.11


	
 
	
    [*]

	

    Exhibit 6.11(h)


	
 
	
    [*]

	

    Exhibit 7.05(a)


	
 
	
    [*]









 



    6. [*]



 



    7. [*]



 



    8. Final versions of the Schedules/Exhibits are attached to
    this First Amendment as follows:



 


	 	 	 
	

    Schedule 7.02(d)


	
 
	
    [*]

	

    Exhibit 1.01-C


	
 
	
    [*]

	

    Exhibit 1.01-E


	
 
	
    [*]

	

    Exhibit 2.01(c)


	
 
	
    [*]

	

    Exhibit 2.01(d-1)


	
 
	
    [*]

	

    Exhibit 2.01(d-2)


	
 
	
    [*]

	

    Exhibit 3.11


	
 
	
    [*]

	

    Exhibit 5.01(a)


	
 
	
    [*]

	

    Exhibit 6.01


	
 
	
    [*]

	

    Exhibit 6.03


	
 
	
    [*]

	

    Exhibit 6.06


	
 
	
    [*]

	

    Exhibit 6.08


	
 
	
    [*]

	

    Exhibit 6.11


	
 
	
    [*]

	

    Exhibit 6.11(h)


	
 
	
    [*]

	

    Exhibit 7.05(a)


	
 
	
    [*]









 



    9. Except as expressly amended by this First Amendment, the
    License Agreement shall remain in full force and effect. The
    representations, warranties and covenants of the Parties
    contained in the Agreement are true and correct in all material
    respects as of and on the date hereof as if made again on the
    date hereof or as of the Effective Date (as applicable) and each
    Party shall have performed and complied with all of its
    covenants and agreements contained in the Agreement required to
    be performed and complied with by it at or prior to the
    Effective Date. If requested, each Party shall provide to the
    other a certificate to the matters set forth in this section
    signed on behalf of such Party by an authorized officer.



 



    10. This First Amendment may be executed in facsimile
    counterparts, each of which shall have the legal binding effect
    of an original signature, but all of which together shall
    constitute one and the same instrument.



 




    [Signatures
    are on the following page.]
    













 






    IN WITNESS WHEREOF, the parties hereto have duly executed this
    First Amendment to License, Distribution, Manufacturing and
    Supply Agreement as of the date first set forth above.



 



    LUITPOLD PHARMACEUTICALS, INC.



 


			
	 	    By: 
	
    /s/  Mary
    Jane Helenek









    Name:     Mary Jane Helenek



			
	 	    Title: 
	
    President & CEO 9-13-08




 



    AMERICAN REGENT, INC.



 


			
	 	    By: 
	
    /s/  Mary
    Jane Helenek









    Name:     Mary Jane Helenek



			
	 	    Title: 
	
    President & CEO




 



    FRESENIUS USA MANUFACTURING, INC.



 


			
	 	    By: 
	
    /s/  Rice
    Powell









    Name:     



			
	 	    Title: 
	





 



    VIFOR (INTERNATIONAL),
    INC.1




 


			
	 	    By: 
	
    /s/  Anthony
    Coombs









    Name:     A. Coombs



			
	 	    Title: 
	
    CEO Vifor Pharma




 


			
	 	        
	
    /s/  G.
    Zampieri









    Name:     G. Zampieri



			
	 	    Title: 
	
    Deputy CEO Vifor Pharma



 

 


    1 Executing

    this Agreement to indicate its acknowledgement of and consent to
    the terms and provisions hereof, and to agree to be bound to
    those provisions hereof that pertain to it.













 







    SCHEDULE 7.02 (D)



 




    [*]
    













 







    EXHIBIT 1.01-A



 




    [*]
    













 







    EXHIBIT
    1.01-C



 




    [*]
    













 







    EXHIBIT 1.01-E



 




    [*]
    













 







    EXHIBIT 2.01 (C)



 




    [*]
    













 







    EXHIBIT 2.01 (D-1)



 




    [*]
    













 







    EXHIBIT 2.01 (D-2)



 




    [*]
    













 







    EXHIBIT 3.11



 




    [*]
    













 







    EXHIBIT 5.01 (A)



 




    [*]
    













 







    EXHIBIT 6.01



 




    [*]
    













 







    EXHIBIT 6.03



 




    [*]
    













 







    EXHIBIT 6.06



 




    [*]
    













 







    EXHIBIT 6.08



 




    [*]
    













 







    EXHIBIT 6.11



 




    [*]
    













 







    EXHIBIT 6.11 (H)



 




    [*]
    













 







    EXHIBIT 7.05 (a)



 




    [*]