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[UNIVERSITY OF CALIFORNIA LETTERHEAD]
EXHIBIT 10.4
October 6, 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. 93-04-0784)
UC Case Nos. 91-261 and 92-231
Dear Xx. Xxxxxxxxx:
As we recently discussed, Cellegy sublicensed its rights under the
above-referenced Exclusive License Agreement ("Agreement") to Neutrogena
Corporation. Neutrogena was subsequently acquired by Xxxxxxx and Xxxxxxx.
Neither Neutrogena nor Xxxxxxx and Xxxxxxx diligently pursued the development
of a Licensed Product as required under the Agreement entered into between
Cellegy Pharmaceuticals, Inc. and The Regents of the University of California.
In as much as Cellegy is nearing completion of its negotiations with
Neutrogena/Xxxxxxx and Xxxxxxx and plans to regain control over the
technology, The Regents of the University of California agrees to amend the
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 On or before October 31, 1997, either terminate its
current agreement with Neutrogena/Xxxxxxx and Xxxxxxx to obtain for Licensee
exclusive control over the technology (in which case the diligence terms of
6.4b-6.4k will apply) or execute an agreement with Neutrogena/Xxxxxxx and
Xxxxxxx which recites diligence terms reasonably acceptable to The Regents for
the development of the technology; and
6.4b select a clinical candidate for evaluation in human
clinical trials by December 31, 1997; and
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Xx. Xxxxxxx Xxxxxxxxx
October 6, 1997
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6.4c complete proof-of-concept studies for the clinical candidate
selected in 6.4b by June 30, 1998; and
6.4d if Licensee elects not to market a non-prescription product,
enter into a corporate partnership for the marketing of a non-prescription
Licensed Product in either the cosmetic or over-the-counter drug markets by
December 31, 1998; and
6.4e commence commercial marketing of a non-prescription Licensed
Product in either the cosmetic or over-the-counter drug markets by December 31,
1999; and
6.4f submit an IND for a Licensed Product to the United States Food
and Drug Administration or the equivalent foreign regulatory authority in any
three of Japan, Germany, France or the United Kingdom by December 31, 2000;
and
6.4g complete a phase I/II and/or efficacy clinical trial for Licensed
Product by December 31, 2001; and
6.4h file for marketing 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 three of Japan, Germany, France or the United Kingdom by
August 30, 2002; and
6.4i obtain regulatory approval for a Licensed Product that is
intended for sale only pursuant to a physician's 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 three of Japan, Germany, France or the United
Kingdom by August 30, 2004; and
6.4j commence commercial marketing of a Licensed Product within twelve
(12) months of receiving approval of such Licensed Product in any country; and
6.4k reasonably fill the market demand for a Licensed Product in each
country following commencement of marketing in such country at all times during
the term of this Agreement."
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Xx. Xxxxxxx Xxxxxxxxx
October 6, 1997
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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. If such
termination is based on failure of diligence as to prescription use, such
termination shall be effective only as to such use. 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
Paragraphs 6.4f through 6.4k, 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 payments 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 rights to terminate this Agreement unless a
re-established date is not met."
In addition, the parties wish to amend the Agreement to provide for the payment
of a license maintenance fee to The Regents. Accordingly, the following
Paragraph 5.9 is added to Article 5 (Royalties) of the Agreement.
"5.9 The Licensee shall pay to The Regents a royalty in the form of a
license maintenance fee of [*] beginning January 1, 1999, and continuing
annually on January 1 of each subsequent year. The license maintenance fee
shall not be due and payable on any January 1 if on said date the Licensee is
commercially selling a Licensed Product and paying an earned royalty to The
Regents on the sales of that Licensed Product. For the first year of commercial
sales, the Licensee's obligation to pay the license maintenance fee will be
pro-rated for the number of full months in the year up until the commencement of
commercial sales. License maintenance fees are non-refundable and not an advance
against earned royalties."
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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
October 6, 1997
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All other 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
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AGREED:
CELLEGY PHARMACEUTICALS THE REGENTS OF THE
INC. UNIVERSITY OF CALIFORNIA
By: /s/ X. Xxxxxxx Xxxxxxx By:
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(Signature)
Name: /s/ X. Xxxxxxx Xxxxxxx Name: Xxxxxxx X. Xxxxxxxxx
--------------------------------
(please print)
Title: President & CEO Title: Executive Director
------------------------------- Research Administration and
Technology Transfer
Date: October 10, 1997 Date:
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Approved as to legal form: /s/XXXXX XXXXXXX 10/3/97
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Xxxxxx Xxxxxxx, Notary Date
Office of Technology Transfer
University of California