CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT
HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES
AND EXCHANGE COMMISSION
Exhibit 10.121
AMENDMENT TO LICENSE AGREEMENT
THIS AMENDMENT dated June 22, 2001 (this "Amendment"), to the License
Agreement (the "Agreement") dated December 23, 1999, between Interneuron
Pharmaceuticals, Inc.("Interneuron") and Xxxxxx-Xxxxxxx Company ("Warner")
related to the development and commercialization of the pharmaceutical compound
known as pagoclone.
RECITALS
A. The Agreement provides that Warner shall either achieve certain steps in
clinical development of the Product by specified dates or, in the event of
its failure to achieve such steps, make certain payments to Interneuron,
and also provides that Warner shall make specified payments to Interneuron
upon the achievement of particular development milestones; and
X. Xxxxxx and Interneuron wish to amend the Agreement as it relates the date
and payment concerning the commencement of Phase III clinical trials for
General Anxiety Disorder.
THEREFORE, for good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged, Warner and Interneuron hereby agree as
follows:
1. Except as may be specifically defined herein, any term used as a defined
term in this Amendment shall have the meaning as defined in the
Agreement.
2. Section 3.7 (b)(3) of the Agreement is amended in its entirety to
provide as follows:
"3. Either dose the first patient in a Phase III Clinical
Trial for General Anxiety Disorder by the 30 month anniversary
of the date that this Agreement is fully signed by authorized
representatives of each party, or pay to Interneuron the
amount set forth in Section 4.2(a)(2) (which payment shall be
deemed to be in lieu of the obligation to make such payment
under Section 4.2(a)) less any amounts paid under Section
3.7(b)(2) above; provided, however, that if Warner shall be
unable to conduct such Phase III Clinical Trial for General
Anxiety Disorder due to action on the part of the FDA or any
foreign equivalent, including, without limitation, the
placement of a clinical hold on such clinical trial, then
(except in a case where such circumstance is directly caused
by any negligent act or omission of Warner) the aforementioned
30 month anniversary shall be extended by a period of time
equal to the period during which Warner shall be unable to
conduct such trial due to such action on the part of the FDA
or any foreign equivalent."
Page 2 of 3
3. Section 3.7 (c) is deleted from the Agreement.
4. Section 4.2 (a)(2) of the Agreement is amended by changing the term "$
[*]" to the term "$ [*]".
5. Article 8 of the Agreement is amended by adding thereto a new Section
8.6 providing as follows:
"8.6 Termination by Warner Before 30 Month Anniversary of the
Agreement. Notwithstanding any term or provision of this Agreement,
including, without limitation, Section 3.7(b)(3), the first sentence of
Section 8.1, Section 8.3 and the first sentence of Section 8.5, if
Warner shall give notice of exercise of its right to terminate this
Agreement under Section 8.1 or under the first sentence of Section 8.3
hereof on or before the 30 month anniversary of the date that this
Agreement is fully signed by authorized representatives of each party
(or, if applicable, on or before the date to which such 30 month
anniversary shall be extended pursuant to Section 3.7(b)(3)), and at
the time of the giving of such notice Warner shall not have dosed the
first patient in a Phase III Clinical Trial for General Anxiety
Disorder, then Warner shall nevertheless not be obliged to make the
payment provided for in Section 3.7 (b)(3) hereof, notwithstanding the
circumstance that this Agreement may remain in effect for a period
after such anniversary (or, for a period after the date to which such
anniversary may be so extended) (i) due to the operation of the six
month notice provision contained in Section 8. 1, or (ii) due to the
operation of the provisions of Section 8.3 that give the Breaching
Party a right to cure a material breach hereof, provided, however, that
if the Breaching Party shall cure such breach in compliance with the
provisions of Section 8.3, and as a result of such cure this Agreement
shall continue in effect after such thirty month anniversary (or after
such date to which such anniversary may be so extended) then, subject
to the terms hereof, Warner shall be obliged to make such payment
provided for under Section 3.7 (b)(3)."
*Confidential Treatment Requested.
Page 3 of 3
6. Except as amended by this Amendment, the Agreement, including, without
limitation'. Article 8 thereof, shall remain in full force and effect.
IN WITNESS WHEREOF, Warner and Interneuron have executed this Amendment
to License Agreement in duplicate originals by their proper officers.
INTERNEURON PHARMACEUTICALS, INC. XXXXXX-XXXXXXX COMPANY
By /s/ Xxxx Xxxxxx By /s/ Xxxx Xxxxxx
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Title: EVP Title: Vice President
Date: 6/21/01 Date: 6/22/01
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