EX-10.3 FIRST AMENDMENT TO MANUFACTURING AGREEMENT



 





EXHIBIT 10.3




*Certain portions of this exhibit have been omitted pursuant to a request for confidential

treatment which has been filed separately with the SEC.




FIRST AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT

FOR N-ACETYLCYSTEINE




     THIS FIRST AMENDMENT (the “First Amendment”) to that certain Manufacturing and Supply
Agreement for N-Acetylcysteine (the "Agreement”), dated as of January 15, 2002,
as modified by that certain Novation Agreement, dated as of January 27, 2006 (to be attached
hereto), is entered into by and between CUMBERLAND PHARMACEUTICALS INC., a corporation organized
and existing under the laws of Tennessee, United States (“CUMBERLAND”), and BIONICHE
TEORANTA, a corporation organized and existing under the laws of Ireland (“BIONICHE”), and
is effective as of November 16, 2006. Capitalized terms used but not defined in this First
Amendment shall have the meanings that are set forth in the Agreement.



WITNESSETH:




     WHEREAS, BIONICHE is the assignee under the Agreement of BIONICHE PHARMA GROUP LIMITED, an
Affiliate thereof.



     WHEREAS, CUMBERLAND and BIONICHE agree that the exceptions to the exclusivity provisions set
forth in Paragraph 5.6 of the Agreement which permit BIONICHE to (i) sell Excluded Products or
Other Products or (ii) market or distribute Excluded Products or Other Products in association with
any third Person other than CUMBERLAND in certain circumstances shall be deleted from the
Agreement.



     NOW, THEREFORE, in consideration of the mutual covenants, agreements, representation and
warranties contained herein, and for other good and valuable consideration, the receipt of which is
hereby acknowledged, the parties hereto hereby agree as follows:




	 	1.	 	Paragraph 1.7 is amended and restated in its entirety as follows:
	 
	 	 	 	DRUG PRODUCT shall mean the N-acetylcysteine pharmaceutical product developed by
CUMBERLAND and marketed for any current or future approved indications under the
trade name ACETADOTE or any other trade name selected by CUMBERLAND.
	 
	 	2.	 	Paragraph 1.9 is hereby amended and restated as follows:
	 
	 	 	 	FACILITY shall mean the manufacturing facility and the real property underlying such
manufacturing facility operated by BIONICHE, located at Inverin, Co, Galway,
Republic of Ireland.
	 
	 	3.	 	Paragraph 1.18 defines TERRITORY as having the meaning set forth in Schedule
III. Schedule III of the Agreement, and therefore the TERRITORY, is hereby amended and
restated as follows:
	 
	 	 	 	The United States of America and all its possessions and
territories, and Australia.





 









 






	 	4.	 	Paragraph 3.1 is amended and restated in its entirety as follows:
	 
	 	 	 	This Agreement shall commence on the date first above written and will continue until
January 23, 2011, unless sooner terminated pursuant to Paragraphs 3.2 or 3.3 hereof or
extended pursuant to this Paragraph 3.1. CUMBERLAND shall have the option to extend the
duration of this Agreement for five (5) years upon prior written notice provided by
CUMBERLAND to BIONICHE at least 180 days prior to January 23, 2011; otherwise, the
Agreement shall expire on such date in accordance with its terms. If CUMBERLAND
exercises such option, then subject to Paragraphs 3.2 and 3.3, the Agreement shall be
automatically renewed for successive three-year terms after expiration of the initial
extended term, unless either party notifies the other party in writing at least twelve
(12) months in advance of the expiration of the then current term that the party is
terminating the Agreement.
	 
	 	5.	 	Subparagraphs 3.2(d) and (e) are deleted from the Agreement in their entirety and
Subparagraph 3.2(f) is re-lettered as 3.2(d).
	 
	 	6.	 	Paragraph 3.5 is amended by adding a reference to Paragraph 3.4 thereto (such that
Paragraph 3.4 is identified as a “surviving” provision.)
	 
	 	7.	 	Subparagraph 5.6(a) is amended and restated in its entirety as follows:
	 
	 	(a)	 	Neither BIONICHE nor any Affiliate thereof will sell, give away, or deliver to any
other person, firm, or corporation any form of the Drug Product in the Territory for
any indications, while this Agreement is effective and for two years after the
termination of this Agreement; provided that such restrictions shall not apply in the
event of termination by BIONICHE pursuant to Subparagraphs 3.2(a) or (b), or Paragraph
3.3.
	 
	 	8.	 	Subparagraphs 5.6(b), (c), (d), and (e) are deleted from the Agreement in their entirety;
Subparagraphs 5.6(f) and (g) are re-lettered as 5.6(b) and (c), respectively; and
Subparagraph 5.6(f) (re-lettered 5.6(b)) is amended and restated in its entirety as
follows:
	 
	 	(b)	 	Except in the event that BIONICHE fails to supply all Drug Product ordered within
[***] of receipt of a Purchase Order in accordance with Paragraph 2.7, or in the event
of Force Majeure, CUMBERLAND will order its entire requirement of the Drug Product for
the Territory from BIONICHE. If CUMBERLAND notifies BIONICHE that it intends to
distribute the Drug Product in countries not included in the Territory, then the
parties shall negotiate in good faith, for a period not to exceed [***] after
CUMBERLAND provides such notice, to amend this Agreement to expand the Territory
hereunder (and to add additional minimum purchase quantities for such expanded
Territory, as contemplated under Paragraph 5.7); provided that, if the parties fail to
agree upon the terms of supply for an expanded Territory within such [***], CUMBERLAND
shall have no obligation to purchase requirements of such Drug Products for such other
countries





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from BIONICHE, but its obligations hereunder with respect to the Territory shall
remain in full force and effect.




	 	9.	 	Paragraph 5.7 is amended and restated in its entirety as follows:
	 
	 	 	 	CUMBERLAND shall use its best efforts to achieve the minimum purchase quantities set forth
in Schedule V to this Agreement for each format of Drug Product sold in the Territory by
CUMBERLAND. In the event CUMBERLAND is required to procure Drug Product from other sources
in accordance with Paragraph 2.7, the minimum annual purchase obligation set out in Schedule
V shall be decreased by the quantity BIONICHE failed to deliver hereunder.
	 
	 	 	 	Schedule V of the Agreement is hereby stated as follows:
	 
	 	 	 	CUMBERLAND’s annual minimum purchase requirements shall
be ***% of the average actual purchases for the prior three (3) years.






	 	10.	 	Paragraph 11.1 is amended by replacing the address for notice (and relevant copies) for
CUMBERLAND and BIONICHE, as follows:





	 	 	 	 	 	 	 
	 	 	If to CUMBERLAND:	 	CUMBERLAND PHARMACEUTICALS INC.
	 

	 	 	 	 	 	2525 West End Avenue, Suite 950
	 

	 	 	 	 	 	Nashville, Tennessee 37203
	 

	 	 	 	 	 	Attn: Chief Executive Officer
	 

	 	 	 	 	 	Telephone:          615-255-0068
	 

	 	 	 	 	 	Facsimile:            615-255-0094
	 
	 	 	 	 	 	 
	 	 	If to BIONICHE:	 	BIONICHE TEORANTA
	 

	 	 	 	 	 	Inverin,

Co. Galway,
	 

	 	 	 	 	 	Ireland
	 

	 	 	 	 	 	Attn: Managing Director
	 

	 	 	 	 	 	Telephone:          +353 91 593202
	 

	 	 	 	 	 	Facsimile:            +353 91 593228







	 	11.	 	Miscellaneous.
	 
	 	 	 	(a) Authorization. Each party to this First Amendment hereby represents and warrants
that the execution, delivery and performance of this First Amendment is within the powers of
such party and has been duly authorized by the party, is in accordance with all applicable
laws and regulations, and this First Amendment constitutes the valid and enforceable
obligation of each party in accordance with its terms.
	 
	 	 	 	(b)Effect of First Amendment. Each party acknowledges that this First Amendment
constitutes a written instrument as contemplated by Paragraph 11.2 of the Agreement. Except
as specifically amended above, the Agreement shall remain in full force and effect, and is
hereby ratified and confirmed.





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(c) Counterparts. This First Amendment may be executed in any number of
counterparts, each of which may be executed by only one of the parties hereto, and
each of which shall be enforceable against the party actually executing such
counterpart, and all of which shall together constitute one instrument.




(d) Titles and Subtitles. The titles and subtitles used in this First
Amendment are used for convenience only and are not to be considered in construing or
interpreting this First Amendment.




(e) Governing Law and Dispute Resolution. This First Amendment shall be
construed in accordance with the laws of the State of New York without regard to
applicable conflicts of laws provisions and any dispute, controversy, or claim
arising out of or relating to this First Amendment shall be governed by the
provisions of Paragraph 11.7 of the Agreement.




(f) Severability. Should any part of this First Amendment be invalid or
unenforceable, such invalidity or unenforceability shall not affect the validity and
enforceability of the remaining portion.



     IN WITNESS WHEREOF, each of the undersigned has caused this First Amendment to be
executed as of the date first above written.



	 	 	 	 	 	 	 
	 	 	CUMBERLAND:	 	 
	 
	 	 	 	 	 	 
	 	 	CUMBERLAND PHARMACEUTICALS INC.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ A.J. Kazimi	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	Title:
	 	Chief Executive Officer	 	 
	 
	 	 	 	 	 	 
	 

	 	Date:
	 	December 13, 2006	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	BIONICHE:	 	 
	 
	 	 	 	 	 	 
	 	 	BIONICHE TEORANTA	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ John Kavanagh	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	Title:
	 	Managing Director	 	 
	 
	 	 	 	 	 	 
	 

	 	Date:
	 	November 16, 2006	 	 
	 

	 	 	 	 	 	 






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