License Agreement [Amendment No. 1] - Adolor Corp. and EpiCept Corp.
AMENDMENT #1 TO
LICENSE AGREEMENT
THIS AMENDMENT #1 TO LICENSE AGREEMENT (this "Amendment #1"), dated as
of October 1, 2004 (the "Effective Date"), is made by and between Adolor
Corporation, a Delaware corporation having its principal office at 700
Pennsylvania Drive, Exton, Pennsylvania 19341 ("Adolor"), and EpiCept
Corporation, a Delaware corporation having its principal office at 270 Sylvan
Avenue, Englewood Cliffs, New Jersey 07632 ("EpiCept"). Adolor and EpiCept are
each sometimes referred to individually as a "Party" and together as the
"Parties."
WHEREAS, Adolor and EpiCept entered into that certain License Agreement
dated July 23, 2003 (the "Agreement"); and
WHEREAS, Adolor and EpiCept desire to amend the Agreement to facilitate
their respective clinical development activities.
NOW, THEREFORE, in consideration of the foregoing premises and the
representations, covenants and agreements contained herein, Adolor and EpiCept,
intending to be legally bound, hereby agree as follows:
1. Capitalized terms used herein and not otherwise defined shall have the
meanings given to them in the Agreement.
2. A new Section 3.4(c)is hereby added to the Agreement as follows:
Mutual Coordination. The Parties acknowledge and agree that
coordination of their independent pre-clinical and clinical activities
with respect to LidoPAIN SP may be mutually beneficial. Prior to
implementing any protocols intended to lead to marketing approval of
Licensed Products in a Party's territory, each Party, or its respective
Affiliate, licensee or sublicensee, as applicable, shall provide its
protocols to the other Party's contact person for review and comment.
The receiving Party shall have the right to provide the submitting
Party, or its Affiliate, licensee or sublicensee, as applicable, with
comments regarding any protocol within ten (10) days after the
receiving Party's receipt of the protocol. The submitting Party, or its
Affiliate, licensee or sublicensee, as applicable, shall take such
comments into consideration, provided that the submitting Party shall
retain final decision-making authority with respect to any and all
protocols.
EpiCept agrees that pursuant to this Section 3.4(c) EpiCept shall
provide at no cost to Adolor clinical trial data generated from
EpiCept's European clinical trial EPC 2004-01. EpiCept agrees to
provide the data in form and format reasonably requested by Adolor to
facilitate filing such data with the FDA. EpiCept agrees that Adolor
shall have the full right to use the clinical trial data for
development, regulatory and commercialization of Licensed Products.
Adolor agrees to provide to EpiCept, to the extent that it would not
violate the terms of any agreement between Adolor and a third party, in
form and format reasonably requested by EpiCept, data generated by
Adolor relating to the lidocaine patches manufactured
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by Corium International, Inc. ("Corium") which data is necessary for
EpiCept's use of such lidocaine patches in EpiCept's European clinical
trial EPC 2004-01, including without limitation stability and
toxicology data provided that it is understood that Adolor will not be
required to provide any data which it would not generate for its own
use. Adolor agrees that EpiCept shall have the full right to use such
data for the development, regulatory and commercialization of sterile
lidocaine patches.
3. A new Section 3.10(e) is hereby added to the Agreement as follows:
Clinical and Commercial Supply. The Parties acknowledge that Adolor is
working with Corium to develop and supply for Adolor a sterile
lidocaine patch for clinical and commercial supply. As provided in
Section 3.10(d), Adolor consents to EpiCept negotiating and entering
into a contract with Corium pursuant to which Corium manufactures for
and supplies to EpiCept clinical and commercial supplies of sterile
lidocaine patches for use by EpiCept, its Affiliates or licensees
outside the Territory. Adolor shall advise Corium that Corium may
disclose confidential information regarding the lidocaine patch
manufactured by Corium to EpiCept which information is required by
EpiCept to use the lidocaine patch manufactured by Corium in EpiCept's
European clinical trial EPC 2004-0l. With respect to clinical supplies
for EpiCept's European clinical trial EPC 2004-01, such patches shall
have the same specifications as the sterile lidocaine patches which
Corium is manufacturing' for Adolor. Within five (5) business days
after written request of EpiCept, Adolor shall give written notice of
such consent to Corium. The terms of such purchase and supply shall be
the subject of a separate agreement between EpiCept and Corium. Neither
party makes any representation and warranty with respect to (i)
supplies of sterile lidocaine patches purchased by either party from
Corium, (ii) analytical methods, release specifications, or any data or
information related to supplies of sterile lidocaine patches purchased
by either party from Corium. EpiCept and Adolor expressly acknowledge
and agree that neither party shall have any liability whatsoever to the
other party for any such sterile lidocaine patches purchased by a party
from Corium, analytical methods, release specifications, any data or
information or otherwise. As additional examples and in no way limiting
the foregoing, neither party makes any representation and warranty (i)
that any such sterile lidocaine patch made, used, sold or otherwise
purchased by either party from Corium is or will be free from
infringement of patents, copyrights, trademarks, industrial design or
other intellectual property rights of any Third Party; (ii) regarding
the effectiveness, value, safety, non toxicity, patentability, or
design of any such sterile lidocaine patch; and/or (iii) the accuracy
or completeness of any data or information provided by Corium to either
party. ADOLOR AND EPICEPT EXPRESSLY DISCLAIM AND RENOUNCE ANY AND ALL
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
This Amendment may be executed in counterparts and such counterparts
taken together shall constitute one and the same agreement. This Amendment may
be executed
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by facsimile signatures, which signatures shall have the same force and effect
as original signatures.
With respect to the foregoing amended and new sections, if there is a
conflict between the terms of the Agreement and the terms of this Amendment, the
terms of this Amendment shall govern.
Except as set forth in this Amendment #1, the Agreement shall remain in
full force and effect.
IN WITNESS WHEREOF, duly authorized representatives of the Parties have
duly executed this Amendment #1 as of the Effective Date.
EPICEPT CORPORATION
By: /s/ John V. Talley
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Name: John V. Talley
Title: Chief Executive Officer
ADOLOR CORPORATION
By: /s/ Michael R. Dougherty
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Name: Michael R. Dougherty
Title: Senior Vice President, Chief
Operating Officer and Chief
Financial Officer