CLINICAL TRIAL AGREEMENT
This Agreement is entered into on _______________, 1999, by and between VaxGen, Inc., 1000 Marina Boulevard, Brisbane, California 94005, a Delaware Corporation ("VaxGen"), and________________________, ______________________________, a_______________ corporation (the "Study Center").
WITNESSETH
WHEREAS, VaxGen will supply specified funds and Investigational New Drug, AIDSVAX (TM), to Study Center for a clinical trial which will be conducted under the oversight and in the clinic of Investigator;
WHEREAS, this is a double-blind, placebo-controlled, registrational clinical trial, and the results of this trial will be submitted for review and approval by the U. S. Food and Drug Administration;
WHEREAS, VaxGen has developed the Investigational New Drug (as hereinafter defined) as a vaccine for the prevention of HIV;
WHEREAS, in order to comply with certain regulatory approval obligations, VaxGen intends to conduct a multi-center clinical trial with respect to the Investigational New Drug, of which the Study (as hereinafter defined) is a part;
WHEREAS, the Study Center is qualified to perform the Study and such performance would further the Study Center's instructional and research objectives;
WHEREAS, VaxGen desires the Study Center to perform, and the Study Center desires to so perform, the Study on the terms set forth herein;
NOW THEREFORE, in consideration of the promises and the mutual covenants and conditions hereinafter recited, the parties do hereby agree as follows:
1. DEFINITIONS.
For purposes of this Agreement:
1.1 "CFR" means the United States Code of Federal Regulations.
1.2 "CRFs" means "Case Report Forms" as that term is defined in the Protocol.
1.3 "Confidential Information" has the meaning set forth in Section 10.2.
1.4 "Discoveries" has the meaning set forth in Section 13.1.
1.5 "Effective Period" has the meaning set forth in Section 2.3.
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