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EXHIBIT 10.3
[UNIVERSITY OF CALIFORNIA LETTERHEAD]
May 14, 1997
IN DUPLICATE
Xxxxxxx X. Xxxxxxxxx, Ph.D.
Vice President, Research and Development
Cellegy Pharmaceuticals, Inc.
0000 X. Xxxxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxx Xxxx, XX 00000
RE: Amendment to Exclusive License Agreement (UC Control No. 94-04-0139)
UC Case Nos. 93-252 and 93-253
Dear Xx. Xxxxxxxxx:
Per our recent discussions and meetings regarding Xxxxxxx's progress in the
development of Licensed Products under the above-referenced Exclusive License
Agreement ("Agreement"), The Regents of the University of California agrees to
amend the subject Agreement to revise and extend the due diligence milestones
recited in Paragraph 6.4. Thus, Paragraph 6.4 of the above-referenced Agreement
is hereby deleted and replaced with the following:
"6.4 The Licensee shall:
6.4a complete proof-of-concept studies in an animal
species, other than rodents, that demonstrate the feasibility of the
technology for use in the transdermal delivery of a pharmaceutical drug by
December 31, 1997; and
6.4b enter into a corporate partnership for the development
or marketing of a Licensed Product in the over-the-counter ("OTC") or
prescription markets by December 31, 1998; and
6.4c enter into a second corporate partnership for the
development or marketing of a Licensed Product in the OTC or prescription
markets by December 31, 1999; and
6.4d complete Phase I/II trials in humans for a Licensed
Product by June 30, 2000; and
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Xx. Xxxxxxx Xxxxxxxxx
May 14, 1997
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6.4e submit an application for regulatory approval for a Licensed
Product that is intended for sale only pursuant to a physicians prescription or
pharmacist's approval or similar limitation in the sale or use of such product
to the United States Food and Drug Administration (FDA), or the equivalent
foreign regulatory authority in any two of Germany, France or the United
Kingdom by June 30, 2002; and
6.4f obtain regulatory approval for a Licensed Product that is
intended for sale only pursuant to a physicians prescription or pharmacist's
approval or similar limitation in the sale or use of such product from the
United States Food and Drug Administration (FDA), or the equivalent foreign
regulatory authority in any two of Germany, France or the United Kingdom by
January 1, 2005; and
6.4g commence commercial marketing of a Licensed Product within
twelve (12) months of receiving approval of such Licensed Product in any
country; and
6.4h reasonably fill the market demand for the Licensed Product in
each country following commencement of marketing in such country at all times
during the term of this Agreement."
Paragraphs 6.5 and 6.6 are hereby added to the Agreement as follows:
"6.5 If the Licensee is unable to perform any of the provisions of
Paragraph 6.4, then The Regents has the right, subject to Paragraph 6.6, to
terminate this Agreement upon sixty (60) days' written notice. Should the
licensee fail to fulfill the diligence requirements within said sixty-day
period, the notice shall be effective at the end of said period. This right, if
exercised by The Regents, supersedes the rights granted in Article 2 (Xxxxx)
and is subject to Paragraph 6.6.
6.6 If the Licensee is unable to meet any of the dates set forth in
Paragraph 6.4, Licensee shall be entitled to a one-time extension of each of the
dates (which have not been met) by one (1) additional year upon payment of [*]
to The Regents, provided that such payment is received by The Regents within
sixty (60) days of receipt of written notice by The Regents that the Licensee
has not met a due diligence date. The [*] payment has the effect of extending
the subject date and all subsequent dates by one (1) year. The Regents shall not
exercise its right to terminate this Agreement unless a re-established date is
not met."
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*Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
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Xx. Xxxxxxx Xxxxxxxxx
May 14, 1997
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The remaining provisions of the Agreement remain in full force and effect.
If this Amendment is acceptable to you, please sign this letter and the
duplicate original in the spaces provided and return both to this office. I will
then have both originals executed on behalf of The Regents and return one
fully-executed original to you. This Amendment will be effective upon execution
of this letter by both parties.
Sincerely,
/s/ Xxxxxxxx Xxxxxxxx Xxxxxx, Ph.D.
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Xxxxxxxx Xxxxxxxx Xxxxxx, Ph.D.
Licensing Officer
________________________________________________________________________________
AGREED:
CELLEGY PHARMACEUTICALS THE REGENTS OF THE
INC. UNIVERSITY OF CALIFORNIA
By: /s/ Xxxxxxx Xxxxxxxxx By:
-------------------------------- -------------------------------
(signature)
Name: /s/ Xxxxxxx Xxxxxxxxx Name: Xxxxxxx X. Xxxxxxxxx
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(please print)
Title: VP R&D Title: Executive Director
----------------------------- Research Administration and
Technology Transfer
Date: August 1, 1997 Date:
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Approved as to legal form Xxxxx Xxxxxxx 5/13/97
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Xxxxx X. Xxxxxxx, Attorney
Office of Technology Transfer
University of California
