Exhibit 10.4.2 




Confidential portions of this
document have been omitted and filed separately with the Commission. The omitted portions
have been marked as follows: “***”. 




SECOND AMENDMENT TO
DISTRIBUTION AGREEMENT                                                          
and
             
FIRST AMENDMENT TO ASSIGNMENT OF DISTRIBUTION AGREEMENT 




        This
Second Amendment to the Distribution Agreement and First Amendment to the Assignment of
Distribution Agreement (this “Amendment”), dated as of September 11, 2003, is by and
between Par Pharmaceutical, Inc., a Delaware corporation (successor by merger to Par
Pharmaceutical, Inc., a New Jersey corporation) (“Par”), and Quintiles Ireland Limited, a
company incorporated in the Republic of Ireland (“Quintiles”). 



        WHEREAS,
Par and Bioglan Pharma, Inc., a Delaware corporation (“Bioglan”), have entered into that
certain Distribution Agreement, dated as of December 27, 2000 (the “Original Agreement”),
relating to the supply and distribution of doxycycline; 



        WHEREAS,
Par, Quintiles and Bioglan have entered into that certain Assignment of Distribution
Agreement (the “Assignment and First Amendment”), pursuant to which, among other matters,
(i) Bioglan assigned all of its right, title and interest in and to the Original
Agreement to Quintiles, (ii) Quintiles assumed certain obligations of Bioglan under the
Original Agreement, (iii) Par consented to the foregoing assignment and assumption and
(iv) the parties amended certain provisions of the Original Agreement, all as set forth
therein (the Original Agreement, as amended by the Assignment and First Amendment, is
hereinafter referred to as the “Agreement”); and 



        WHEREAS,
Par and Quintiles now desire to amend certain terms of the Assignment and First Amendment
(and, thereby, the Agreement) and to amend further certain terms of the Agreement, as set
forth herein. 



        NOW,
THEREFORE, in consideration of the mutual covenants contained herein, Par and Quintiles
hereby agree as follows: 



1. Effective Time of
the Assignment and First Amendment. 



        Par
and Quintiles hereby acknowledge and agree that the “Effective Time” of the Assignment
and First Amendment, as such term is used therein, was March 22, 2002. 



2. Amendment of the
Assignment and First Amendment. 



        Par
and Quintiles hereby amend Section 2 of the Assignment and First Amendment by deleting
clause (ii) of Section 2 and replacing it with the following: 



	  	
“(ii)
upon advance written notice to Par, any subsequent assignment by
Quintiles to any affiliate of Quintiles; provided, that Quintiles shall
remain liable for the performance of its duties and obligations under
the Agreement.”  






3. Amendment of the
Agreement. 



        (a)
Par and Quintiles hereby amend Section 1.4 of the Agreement by deleting the fifth
sentence thereof in its entirety and replacing it with the following: 















	  	
Where
Quintiles’s nets sales of the Tablets  *** (as                   defined below, if any)
supplied by Par, at the end of any                   calendar year following December 31,
2003, are less than                   *** in the aggregate for such year, for
reasons other                   than Par’s failure to supply Product in accordance with
the                   terms and conditions of this Agreement, Par shall have the
                  right to manufacture and distribute a generic version of the
                  Tablets ***, as the case may be, which is in the same dosage
                  form, has the same active ingredient, has the same strength
                  and is for the same indication as the Tablets ***, as the case may be.  






        (b)
Par and Quintiles hereby amend the Agreement by inserting, after Section 2.2 thereof, the
following new Section 2.3: 



	  	        2.3
***: 







	   	                  (a)  	  	*** 






	   	                  (b)  	  	***






 
	 	
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	  	 *** 






	   	                  (c)  	  	***







        (c)
Par and Quintiles hereby amend Section 5.1(a) of the Agreement by deleting the third and
fourth sentences of Section 5.1(a) in their entirety and replacing them with the
following three sentences: 



	  	
“The
purchase price payable by Quintiles for the Additional                   Tablets supplied
to it by Par shall be *** per bottle of 50                   tablets (75 mg dosage),
*** per bottle of 100 tablets (75                   mg dosage) and *** per bottle
of 500 tablets (75 mg                   dosage). ***






        (d)
Par and Quintiles hereby amend Section 5.1(a) of the Agreement by deleting from the last
two sentences of Section 5.1(a) each occurrence of the following phrase: 



	  	
“Par’s
direct, out-of-pocket, documented costs for raw materials” 






and replacing it with the following
phrase: 



	  	
“any
of Par’s direct costs, out-of-pocket costs or documented raw materials costs” 






        (e)
Par and Quintiles hereby amend Section 5.1(c) of the Agreement by deleting the third
sentence of Section 5.1(c) in its entirety and replacing it with the following sentence: 



	  	 “Thereafter,
      the price for Product to be used by Quintiles as samples, including Additional
      Tablets to be used as samples, shall equal the sum of Par’s aggregate
      direct costs, out-of-pocket costs and documented raw material costs for
      such Product.” 






 
	 	
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        (f)
Par and Quintiles hereby amend Section 5.3 of the Agreement by deleting Section 5.3 in
its entirety and replacing it with the following: 



	  	
“As
additional consideration for the Tablets, Quintiles shall                   pay to Par
***, and as additional consideration ***,                   Quintiles shall pay to Par ***,                   of the net sales (gross sales less returns
and allowances                   other than allowances for bad debts or doubtful
accounts) by                   Quintiles and its affiliates of Tablets ***, as the case may be, to unrelated
                  third-party customers, which additional consideration shall be
                  paid to Par as part of the purchase price for the Tablets
                  *** sold and shall not
                  be treated as a royalty or similar payment.” 






        (g)
Except as expressly modified hereby, the Agreement remains in full force and effect. 



4. Noncontravention. Each party
hereto severally represents and warrants that the execution and delivery by it of this
Amendment and the performance by it of its obligations under the Agreement, as amended
hereby, do not and will not (with or without the giving of notice or the passage of time)
(a) contravene or conflict with or constitute a violation of any provision of law
applicable to it or its properties, assets or activities, (b) result in the creation or
imposition of any lien upon any of its properties or assets or (c) constitute a default
or breach under or a violation of, or give rise to any right of termination, cancellation
or acceleration of, any material contract or agreement to which it is a party or is
otherwise bound.  



5. Additional Representation of
Quintiles. Quintiles hereby represents and warrants that, as of the date hereof, it has
not assigned or delegated, in whole or in part, any portion of its rights or obligations
under the Agreement to any affiliate or to any other entity.  



6. Governing Law/Counterparts. This
Amendment shall be deemed to have been made under, and shall be governed by, the laws of
the State of New York. This Amendment may be executed in counterparts, each of which
shall be deemed an original and all of which shall constitute a single agreement.  



[SIGNATURE PAGE
FOLLOWS] 



 
	 	
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        IN
WITNESS WHEREOF, this Amendment has been executed as of the date set forth above by a
duly authorized representative of the parties hereto. 



	 	
       PAR PHARMACEUTICAL,
        INC.

    
	 	 	 
	 	By:	 /s/ Michael
      Graves 

      
      

      Name: Michael Graves 

      Title: Vice President of Marketing and Business Development
	 	 	 
	 	
       QUINTILES IRELAND
        LIMITED 

    
	 	 	 
	 	By: 	/s/ John Vaughan
      

      
      

      Name: John Vaughan 

      Title: Financial Controller and 

      Acting Managing Director - Q Products Division 






 
	 	
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