Exhibit 10.7D
SECOND
AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT
This S ECOND A MENDMENT TO THE L ICENSE AND C OLLABORATION A GREEMENT (this “Second Amendment”) is made
effective as of the 25th day of November, 2003 by and between
Tercica, Inc., a Delaware corporation having an office
located at 651 Gateway Boulevard, Suite 950, South San Francisco,
California 94080 (formerly, Tercica Medica, Inc., “TM”)
and Genentech, Inc., a Delaware corporation having an office
at 1 DNA Way, South San Francisco, California 94080
(“GNE”). TM and GNE are sometimes referred to herein
individually as a “Party” and collectively as the
“Parties.”
R
ECITALS
WHEREAS, GNE and TM have entered
into that certain License and Collaboration Agreement, dated
April 15, 2002, as amended (the “Agreement”),
whereby GNE transferred certain materials and information to TM
relating to IGF-I and granted to TM certain rights to develop and
commercialize IGF-I in the United States; and
WHEREAS, the Parties wish to enter
into an amendment to the Agreement in order to amend certain terms
set forth therein.
NOW, THEREFORE, for good and
valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties agree as follows:
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1.
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All capitalized
terms not defined in this Second Amendment shall have the meanings
given to them in the Agreement.
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2.
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The second
sentence of Section 8.1(a) shall be amended to read as follows
(addition in italics :) “TM agrees that such supply
shall not be used for human use, unless it agrees to the terms
of section 8.1 (c) below.
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3.
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A new section
shall be added as Section 8.1 (c) as follows:
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(c) Use of Supply in
Humans. In the event TM
decides to use any IGF-I received from GNE pursuant to this
Section 8.1 in humans as part of a human clinical trial or
otherwise, TM agrees that TM is fully responsible for
complying
with any and all applicable laws,
regulations and requirements regarding such use, including without
limitation, any FDA regulations relating to the QA/QC testing,
safety, expiration extension, labeling and distribution of such
product. TM fu
