This Amendment Agreement is made this 9 th day of January 2003 (“Effective Date”) by and between:
(1) AVANT IMMUNOTHERAPEUTICS INC , having a place of business at 119 Fourth Avenue,
Needham, MA 02494-2725, United States of America (“ AVANT ”); and
(2) SMITHKLINE BEECHAM PLC , having its registered office at 980 Great West Road, Brentford,
Middlesex TW8 9GS, United Kingdom (“ GSK ”).
(A) AVANT (as legal successor of Virus Research Institute, Inc.) and GSK entered in to a License
Agreement dated 1 December 1997 (the “Agreement”) relating to the field of Rotavirus.
(B) As a result of, amongst other things, increased requirements of regulatory authorities for clinical safety
data, the initiation of a Phase III clinical study under an IND in the US, and therefore payment of the
second milestone fee, has been delayed.
(C) Whereas GSK is proposing to undertake a Phase III clinical study in Latin America.
(D) The parties hereto (“Parties”) wish to amend the Agreement on the terms set out in this Amendment
Therefore, the Parties have agreed for good and valuable consideration, receipt of which is hereby
1. Paragraph 5.01 shall be deleted and replaced by the following:
“5.01 Subject to the provisions of Paragraph 5.02 below and the further provisions of this Paragraph
5.01, LICENSEE will, in accordance with LICENSEE’s reasonable business and scientific
judgement, exercise its reasonable efforts and diligence in developing VACCINE.
Only in the event that:
(a) a competitor vaccine product against rotavirus is registered in one or more MAJOR
MARKETS (each a “RELEVANT MAJOR MARKET”): a