exv10w61



 






Exhibit 10.61




AMENDMENT NO. 4

TO THE

ENBREL® SUPPLY AGREEMENT




     This Amendment No 4 (this “Amendment No. 4”) is made as of this 21st day of
May, 2004 (the “Amendment No. 4 Effective Date”) by and among Immunex Corporation, a Washington
corporation having its principal place of business at One Amgen Center Drive, Thousand Oaks,
California 91320 (together with its Affiliates, “Immunex”), Wyeth (formerly, “American Home
Products Corporation”), a Delaware corporation having its corporate headquarters at Five Giralda
Farms, Madison, New Jersey 07940, acting through its Wyeth Pharmaceuticals division (together with
its Affiliates, “Wyeth”), and Boehringer Ingelheim Pharma GmbH & Co. KG, a German
corporation having a place of business at Birkendorfer Straße 65, 88397 Biberach an der Riss,
Federal Republic of Germany (“BIP”), and amends the Enbrel® Supply Agreement effective as
of November 5, 1998, as amended by Amendment No. 1 effective June 27, 2000, Amendment No. 2
effective June 3, 2002, and Amendment No. 3 effective December 18, 2002 (the “Agreement”).



     WHEREAS, Immunex, Wyeth and BIP have entered into the Agreement for BIP’s supply of Enbrel®
(etanercept) to Immunex and Wyeth; and



     WHEREAS, the Parties have determined that in addition to the rights and obligations set forth
in the Agreement, they wish to have BIP manufacture and supply Immunex and Wyeth with vials of
Enbrel® in 50 mg. dosage forms.



     NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good
and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties hereto, each intended to be legally bound, hereby agree as follows:



     1. Capitalized Terms. All initially capitalized terms used herein and not defined
shall have the meanings set forth in the Agreement.



     2. Drug Product and Finished Product Including 50 mg. Dosage Forms. Beginning on the
Amendment No. 4 Effective Date, all reference to vials of Drug Product or Finished Product in the
Agreement shall include vials containing fifty (50) mg. of lyophilized Bulk Drug Substance, as well
as vials containing ten (10) mg. and twenty-five (25) mg. of lyophilized Bulk Drug Substance.
Exhibit B and Exhibit C attached to the Agreement shall be stricken and replaced with the revised
Exhibit B and Exhibit C attached to this Amendment No. 4.



     3. Price for Filling and Lyophilization Services. Exhibit E attached to the Agreement
shall be stricken and replaced with Exhibit E attached to this Amendment No. 4, which includes the
price for filling and lyophilization services.



     4. Price for Labeling Services. Exhibit F attached to the Agreement shall be stricken
and replaced with Exhibit F attached to this Amendment No. 4, which includes the price for labeling
services.



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     5. Logistics. All logistical matters (including forecasting and detailed ordering)
shall take place according to the existing procedures laid down in the Agreement.



     6. Effect of Amendment No. 4 on Agreement. In the event of any conflict between the
terms and conditions of the Agreement and the terms and conditions of this Amendment No. 4, the
terms and conditions of this Amendment No. 4 shall control. Except as otherwise set forth in this
Amendment No. 4, all other terms and provisions of the Agreement shall remain in full force and

effect.



     7. Agreement between Immunex and Wyeth. Except as expressly set forth herein, this
Amendment No. 4, represents the entire agreement among Immunex, Wyeth, and BIP with respect to the
addition of the fifty (50) mg. dosage form vials to the Agreement, and the terms of this Amendment
No. 4 cannot be amended except by a written agreement signed by all of the Parties. As regards the
individual rights of Immunex and Wyeth with respect to the fifty (50) mg. dosage form vials, the
same shall be governed by the Collaboration and Global Supply Agreement by and between Immunex and
Wyeth effective November 6, 2001, as amended.



     8. Counterparts. This Amendment No. 4 may be executed in one or more counterparts,
each of which shall constitute together the same document.



     IN WITNESS WHEREOF, the Parties have, by their duly authorized persons, executed this
Amendment No. 4 as of the Amendment No. 4 Effective Date.



	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Boehringer Ingelheim Pharma GmbH & Co. KG	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	ppa.	 	 	 	 	 	 	 	 
	By:	 	/s/ Wolfram Carius	 	 	 	/s/ Hans Michelberger
	 	 	 	 	 	 	 
	Name:

	 	Dr. Wolfram Carius
	 	 	 	Name:
	 	Dr. Hans Michelberger	 	 	 	 	 	 
	 

	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Title:

	 	Vice President, Biopharmaceuticals
	 	 	 	Title:
	 	Head of Legal Dept.	 	 	 	 	 	 
	 

	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Immunex Corporation	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Efi Cohen-Arazi	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Name:

	 	Efi Cohen-Arazi	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title:

	 	VP Corporate Manufacturing	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Wyeth, acting through its Wyeth

Pharmaceuticals division	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ William M. Haskel	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Name:

	 	William M. Haskel	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title:

	 	Vice President and Associate General Counsel	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 





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List of Exhibits:




	 	 	 
	Exhibit B:

	 	Drug Product Specifications of the 10/25/50 mg. vials
	 
	 	 
	Exhibit C:

	 	Finished Product Specifications of the 10/25/50 mg. vials
	 
	 	 
	Exhibit E:

	 	Supply Price for Fill and Lyophilization Services
	 
	 	 
	Exhibit F:

	 	Supply Price for Labeling Services







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