Exhibit
10.72


 


GlaxoSmithKline Letterhead


 


CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 


	
  Gilead World Markets Limited

  	
   

  	
   

  
	
  Queensgate House

  	
   

  	
   

  
	
  South Church Street

  	
   

  	
   

  
	
  PO Box 1234GT’

  	
   

  	
   

  
	
  Grand Cayman

  	
   

  	
   

  
	
  Cayman Islands

  	
   

  	
  19 May 2003

  



 


Dear Sirs,


 


Licensing Agreement dated 26 April 2002 made
by and between (1) Glaxo Group Limited and (2) Gilead World Markets
Limited (“Agreement”)


 


We refer to the Agreement and hereby confirm that with effect from 28
April 2003 Exhibit E of the Agreement (Safety Data Exchange Protocol)
(“SDEP”) has been replaced with a revised SDEP the terms of which are attached
as Appendix 1 hereof.


 


We would be grateful if you could execute and return to us the
duplicate copy of this letter which is enclosed herewith to acknowledge and
confirm your acceptance of its terms.


 


Yours faithfully,


 


 


	
  /s/ Victoria Llewellyn

  	
   

  	
   

  
	
  Glaxo Group Limited

  	
   

  	
   

  
	
  Victoria Llewellyn

  	
   

  	
   

  
	
  Assistant Secretary

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Gilead World Markets Limited

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Gregg H. Alton

  	
   

  	
   

  
	
   

  	
   Gregg H. Alton, Director

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date:

  	
  5/23/03

  	
   

  	
   

  
					



 

















 


EXHIBIT
E


 


SAFETY
DATA EXCHANGE PROTOCOL


Safety monitoring of adefovir
dipivoxil

between

Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline

And

Global Drug Safety,  Gilead Sciences


 


 


This Safety Data Exchange Protocol is agreed
by Glaxo Group Limited and Gilead World Markets, Limited in connection with the
Licensing Agreement between them dated as of April 2002 (“Licensing Agreement”)
and will govern safety data exchange for adefovir dipivoxil by them or by their
Affiliates.  “Gilead” shall refer to
Gilead World Markets, Limited or its Affiliates performing safety data exchange
under this Protocol; “GlaxoSmithKline” shall refer to Glaxo Group Limited or
its Affiliates performing safety data exchange under this Protocol.  Capitalized terms used but not otherwise
defined herein shall have the meanings given such terms in the Licensing
Agreement to the extent defined therein.


 


 


1.              DEFINITIONS (CONSISTENT WITH ICH GUIDELINE E2A)


[*]


 


2.              LANGUAGE AND MEANS OF EXCHANGE


 


[*]


 


3.              SAFETY DATABASE


 


[*]


 


4.              CORE SAFETY INFORMATION


 


[*]


 


5.              EXPEDITED REPORTING


 


[*]


 


6.              PERIODIC REPORTING


 


[*]


 


7.              REGULATORY ENQUIRIES


 


[*]


 


8.              GENERAL MANAGEMENT OF SAFETY


 


[*]


 

















 


9.              REVIEW AND REVISIONS


 


[*]


 


10.       TERMINATION OF THE SDE PROTOCOL


 


[*]


 


11.       CONTACTS


 


[*]


 


For Gilead


[*]