GlaxoSmithKline Letterhead
Exhibit 10.73
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.
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Gilead World Markets Limited |
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Xxxxxxxxxx Xxxxx |
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Xxxxx Xxxxxx Xxxxxx |
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PO Box 1234GT’ |
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Grand Cayman |
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Cayman Islands |
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9 January 2004 |
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 to the letter agreement dated 19 May 2003 and hereby confirm that with effect from the date hereof, Exhibit E of the Agreement (Safety Data Exchange Protocol) (“SDEP”) has been replaced with the 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,
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/s/ Xxxxxxxx Xxxxxxxxx |
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Glaxo Group Limited |
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Xxxxxxxx Xxxxxxxxx |
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Assistant Secretary |
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Gilead World Markets Limited |
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By: |
/s/ Xxxxx X. Xxxxx |
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Xxxxx X. Xxxxx, Director |
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Date: |
1/27/04 |
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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)
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2. LANGUAGE AND MEANS OF EXCHANGE
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3. SAFETY DATABASE
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4. CORE SAFETY INFORMATION
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5. EXPEDITED REPORTING
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6. PERIODIC REPORTING
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7. REGULATORY ENQUIRIES
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8. GENERAL MANAGEMENT OF SAFETY
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9. REVIEW AND REVISIONS
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10. TERMINATION OF THE SDE PROTOCOL
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11. CONTACTS
For GlaxoSmithKline
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For Gilead
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