exv10w16



 






Exhibit 10.16




“[ * ]” = confidential portions of this document that have been omitted and have been separately

filed with the Securities and Exchange Commission pursuant to an application for confidential

treatment under Rule 24b-2 under the Securities Exchange Act of 1934, as amended.




AMENDMENT NO. 3 TO AMENDED AND RESTATED PROMOTION AGREEMENT




     This Amendment No. 3 (this “Amendment”), entered into as of this 19th day
of April, 2005 and effective as of the 1st day of January, 2005 (the “Effective
Date”), is made by and among Wyeth, a Delaware corporation (formerly American Home Products
Corporation, “Wyeth”), Amgen Inc., a Delaware corporation (“Amgen”), and Immunex
Corporation, a Washington corporation and wholly-owned subsidiary of Amgen (“Immunex”) and
amends the Amended and Restated Promotion Agreement dated as of December 16, 2001 which became
effective on July 15, 2002, as amended by Amendment No. 1 to Collaboration and Global Supply
Agreement, Amended and Restated Promotion Agreement, and TNFR License and Development Agreement
effective as of July 8, 2003 among Wyeth, Amgen and Immunex and by Amendment No. 2 to Collaboration
and Global Supply Agreement and Amended and Restated Promotion Agreement effective as of April 20,
2004 among Wyeth, Amgen and Immunex (as amended, the “Promotion Agreement”).



Recitals




     WHEREAS, Wyeth, Amgen and Immunex entered into the Promotion Agreement pursuant to which the
parties set forth certain terms and conditions relating to the promotion of Enbrel in the United
States and Canada; and



     WHEREAS, the parties wish to amend certain portions of the Promotion Agreement to agree to
share costs for certain full time equivalents employed by Wyeth and Amgen performing medical
affairs functions pursuant to the terms and conditions of the Promotion Agreement, all on the terms
and conditions set forth in this Amendment.



Agreement




     NOW, THEREFORE, in consideration of the mutual covenants, promises, and agreements contained
herein, and intending to be legally bound hereby, as of the Effective Date, Immunex, Wyeth and
Amgen agree as follows:



 









 





Article 1

Promotion Agreement




     1.1     Capitalized Terms and Amendment. All capitalized terms used in this Article 1 but
not otherwise defined in this Amendment shall have the meanings assigned to them in the Promotion
Agreement. Wyeth, Amgen and Immunex hereby amend the Promotion Agreement as follows in this
Article 1.



     1.2     Medical Affairs FTEs. A new Section 1.35a shall be inserted into the Promotion
Agreement as follows:




1.35a.     “Medical Affairs FTE” shall mean a total of [ * ] employee
hours per year of work relating to (a) medical strategic consultation, scientific
strategic consultation, medical review of promotional materials, medical review of
publication planning, and medical work on clinical trial design; (b) responses to
medical inquiries; and (c) implementation and execution of clinical programs,
including, without limitation, managing contract research organizations, collecting
and analyzing clinical trial data, collecting safety information, managing
investigator relationships, and collating information into manuscripts, abstracts,
posters, review articles, or other publications. All such work shall be carried out
by employees of a Party having the appropriate expertise to conduct such activities.



     1.3     Responsibilities of the EMC. The following new sentences shall be added to the
end of Section 3.2 of the Promotion Agreement: “Beginning in 2005, the EMC shall also agree
annually in advance of each Calendar Year on the number of Medical Affairs FTEs whose cost shall be
shared as set forth in Section 6.2; provided, however, that the number of Medical Affairs FTEs in
any given Calendar Year shall not exceed [ * ]. The EMC shall also determine which of Wyeth and
Amgen shall employ the Medical Affairs FTEs and the scope of responsibility for each of the Medical
Affairs FTEs. [ * ] Each Party shall have the right to monitor and evaluate on a quarterly
basis the performance of each Medical Affairs FTE employed by another Party. No other full time
equivalent costs for work performed by any Party in furtherance of marketing and promotional
activities in the Territory shall be shared by the Parties. Wyeth and/or Amgen may propose to the
EMC that the Agreement be amended to provide for sharing of additional full time equivalent costs,
but no such cost sharing shall take effect unless set forth in a written amendment to this
Agreement.”



     1.4     Expenses for Medical Affairs FTEs. The heading for Article 6 of the Promotion
Agreement shall be stricken and replaced with the following heading: “COMMERCIAL



 









 







EXPENSES AND COSTS FOR MEDICAL AFFAIRS FTES.” A new Section 6.2 shall be inserted into the
Promotion Agreement as follows:




	 	6.2  	Medical Affairs FTEs. Wyeth and Immunex shall share
equally all reasonable costs of Medical Affairs FTEs which are approved by the
EMC as set forth in Section 3.2 in an amount not to exceed the sum of [ * ]
per Medical Affairs FTE. Reconciling payments for Medical Affairs FTEs shall
be made within thirty (30) days following the end of each Calendar Quarter at
the same time as reconciling payments are made for Commercial Expenses as set
forth in Section 6.1(c).





     1.5     Post-Market Launch Commercial Expenses. Due to the addition of a new sentence at
the end of Section 3.2 of the Promotion Agreement, the phrase, “the last sentence of Section 3.2”
within Section 6.1(c)(2) of the Promotion Agreement shall be replaced with the phrase “ the third
sentence of Section 3.2”.



Article 2

Miscellaneous




     2.1     Further Assurances. Each party hereto shall execute and deliver such additional
documents and take all such further action as may be necessary or desirable to comply with and
ensure that Amgen, Immunex and Wyeth each receive the full benefit of this Amendment.



     2.2     Headings. The headings contained in this Amendment are for reference purposes
only and shall not affect in any way the meaning or interpretation of this Amendment.



     2.3     Severability. If any term or other provision of this Amendment is invalid,
illegal or incapable of being enforced by any rule of law or public policy, all other conditions
and provisions of this Amendment shall nevertheless remain in full force and effect so long as the
economic or legal substance of the transactions contemplated hereby is not affected in any manner
materially adverse to any party. Upon such determination that any term or other provision is
invalid, illegal or incapable of being enforced, the parties hereto shall negotiate in good faith
to modify this Amendment so as to effect the original intent of the parties as closely as possible
in an acceptable manner to the end that transactions contemplated hereby are fulfilled to the
extent possible.



     2.4     Effect of Amendment. In the event of any conflict between the terms of this
Amendment and the Promotion Agreement, the terms of this Amendment shall control. Except as
modified by the terms of this Amendment, the terms and provisions of the Promotion Agreement shall
remain in full force and effect.



 









 





     2.5     Counterparts. This Amendment may be executed in one or more counterparts, and by
the different parties hereto in separate counterparts, each of which when executed shall be deemed
to be an original but all of which taken together shall constitute one and the same agreement.



 









 





     IN WITNESS WHEREOF, the parties have caused this Amendment to be duly executed by persons duly
authorized as of the date first above written.


	 	 	 	 	 
	 	WYETH


 	 
	 	                                              /s/ William M. Haskel
 	 
	 	By: William M. Haskel 	 
	 	Title:  	Vice President and Associate General
Counsel 	 
	 
	 	IMMUNEX CORPORATION


 	 
	 	                                              /s/ Laura Hamill
 	 
	 	By: Laura Hamill 	 
	 	Title:  	Vice President, General Manager Inflammation 	 
	 
	 	AMGEN INC.


 	 
	 	                                              /s/ Laura Hamill
 	 
	 	By: Laura Hamill 	 
	 	Title:  	Vice President, General Manager Inflammation 	 
	 





 









 





EXHIBIT 3




FIRST ORDER




(Attached)




 









 





EXHIBIT 4




SECOND ORDER




(Attached)