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

 

 

 

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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

 

[*]

 

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9.              REVIEW AND REVISIONS

 

[*]

 

10.       TERMINATION OF THE SDE PROTOCOL

 

[*]

 

11.       CONTACTS

 

[*]

 

For Gilead

[*]

 

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