exv10w58






Exhibit 10.58





			 
	Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request
for 

confidential treatment that has been filed with the Securities and Exchange Commission.





AMENDMENT NUMBER 1

TO EXPANSION AGREEMENT



THIS AMENDMENT NUMBER 1 to the Expansion Agreement (the “Amendment”) is made and entered into
as of the 10th day of September, 2010, by and between Glaxo Group Limited, registered
in England as company number 305979, having its principal office at Glaxo Wellcome House, Berkley
Avenue, Greenford, Middlesex, UB6 0NN, United Kingdom (“GSK”), and Amgen Inc., a Delaware
corporation with a place of business at 1 Amgen Center Drive, Thousand Oaks, CA 91320
(“Amgen”).



WHEREAS, Amgen and GSK have previously entered into and executed the Expansion Agreement dated
27th of July, 2009 (the “Agreement”);



WHEREAS, Amgen and GSK desire to amend certain terms of the Agreement upon the terms and
conditions noted below.



NOW, THEREFORE, in consideration of the premises, the mutual covenants contained herein and
other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereby agree as follows:




	1.	 	Section 2.9.2 of the Agreement shall be amended by deleting from such section the word [*].
	 
	2.	 	Section 2.10.3 of the Agreement shall be amended by deleting from such section the word [*].
	 
	3.	 	Clause (v) of Section 2.13 of the Agreement shall be replaced by the following:




“(v) overseeing any field alert or other similar action (including letters to healthcare
professionals) related to Ivory in the Expansion Scope.”




	4.	 	Section 5.7.2 of the Agreement shall be replaced by the following:





“5.7.2. Recalls or Other Corrective Action. The Parties shall establish a joint product
incident review team to consider any proposed recall, market withdrawal, notification to
Governmental Authorities, or other corrective action with respect to Ivory in the Expansion
Territory (each, a “Recall”). If either Party is aware of a defect, incident or other
information in respect of Ivory which they believe may lead to a Recall, then it shall promptly inform the other Party’s primary
contact on the product incident review team. Upon such notice, the product incident review
team shall promptly meet to consider the appropriate action. Each Party shall cooperate
fully with the other with respect to the consideration of any such matter. If the product
incident review team cannot agree upon how to proceed, such matter shall be escalated to
[*]. In the event of a deadlock on such matter, [*]; except that, after such deadlock, [*].



The conduct of any Recall will be handled in accordance with the Quality Agreement. For the
avoidance of doubt, none of the ECC, the EDC, the EOC, the ERC or the ESC shall have any


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	 	 	responsibility for decisions in respect of a Recall. If the Recall is implemented at the
initiative of Amgen, Amgen will bear all costs in respect of the conduct of such action. If
the Recall is implemented at the initiative of GSK, GSK will bear all costs in respect of
the conduct of such action.”
	 
	5.	 	Except as provided herein, all other terms, conditions and provisions of the Agreement shall
remain in full force and effect.
	 
	6.	 	This Amendment and the Agreement, including all documents referred to herein and attached
hereto, constitutes the entire agreement of the parties on the subject matter hereof and
supersedes all prior representations, understandings and agreements between the parties with
respect to such subject matter.
	 
	7.	 	This Amendment shall be governed by the same laws and subject to the same dispute resolution
procedures as the Agreement.





IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed by their duly
authorized corporate officers or representatives as of the date first above written.



	 	 	 	 	 	 	 	 
	Amgen Inc.	 	Glaxo Group Limited	 
	 
	 	 	 	 	 	 	 
	By:

	 	/s/ Robert A. Bradway
	 	By:
	 	/s/ Gerry Absaiom	 
	 

	 	 
	 	 	 	 	 
	Name: Robert A. Bradway

	 	Name: Gerry Absaiom	 
	Title: President and Chief Operating Officer

	 	Title: Corporate Director	 







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