EXHIBIT 10.1
1ST AMENDMENT TO
THE EXCLUSIVE LICENSE AGREEMENT
BETWEEN
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
AND
COLLATERAL THERAPEUTICS
UC CASE NO. 98-128
AGREEMENT NO. 97-04-0349
1ST AMENDMENT TO THE EXCLUSIVE LICENSE AGREEMENT FOR GENE
THERAPY FOR CONGESTIVE HEART FAILURE
This first amendment (First Amendment) is effective this 11th day of March
1999 between The Regents of the University of California ("The Regents"), a
California corporation, having its statewide administrative offices at 0000
Xxxxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx 94607- 5200 and Collateral
Therapeutics ("Licensee"), a Delaware corporation, having a principal place
of business at 00000 Xx Xxxxxx Xxxx, Xxx Xxxxx Xxxxxxxxxx 00000.
RECITALS
Licensee and The Regents entered into a license agreement entitled "Exclusive
License Agreement for Gene Therapy for Congestive Heart Failure" effective on
January 22, 1997 (U.C. Agreement Control Number 97-04-0349) (the "Agreement").
Licensee has requested that some provisions of Article 5 (Due Diligence) be
extended so that Licensee can remain in compliance with the Agreement and
achieve product approval under feasible diligence provisions. The Regents has
agreed to this First Amendment so that the products licensed under the
Agreement may be developed for the benefit of the general public.
The Regents and the Licensee agree as follows:
Subparagraphs 5.3.1 through 5.3.4 of Article 5 (Due Diligence) are removed in
their entirety from the Agreement and replaced with the following:
5.3.1 file an investigational new drug application in Europe or with the
U.S. Food and Drug Administration on or before June 30, 2000;
5.3.2 begin phase I (small-scale) clinical trials in Europe or in the
United States for Patent Products on or before October 31, 2000;
5.3.3 submit a Phase III (large scale) clinical trial protocol to the U.S.
Food and Drug Administration on or before July 31, 2002;
5.3.4 apply for marketing approval in the United States for Patent Products
on or before October 31, 2004;
This First Amendment does not, expressly or by implication, affect any other
provision of the Agreement in any way.
The Regents and Licensee have executed this First Amendment, in duplicate
originals, by their respective and duly authorized officers on the day and
year written below.
COLLATERAL THERAPUETICS THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
By /s/ Xxxx X. Xxxxx, PH.D. By /s/ Xxxxxxx X. Xxxxxxx
-------------------------- ---------------------------
(Signature) (Signature)
Name Xxxx X. Xxxxx Name Xxxxxxx X. Xxxxxxx
Title President and CEO Title Associate Director
Office of Technology Transfer
Date April 8, 1999 Date April 23, 1999
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