AMENDMENT NO. 1 TO LICENSE AND COLLABORATION AGREEMENT
THIS AMENDMENT NO. 1 TO LICENSE AND COLLABORATION AGREEMENT
(this "Amendment"), effective as of September 29, 2000 (the "Effective Date"),
is entered into between THE IMMUNE RESPONSE CORPORATION, a Delaware corporation
("IRC"), and TRINITY MEDICAL GROUP USA, INC., a Florida corporation ("
Trinity"), with respect to the following facts.
R E C I T A L S
A. IRC and Trinity Medical Group, Co., Ltd., a Thai limited
company ("Trinity Thailand"), entered into the License and Collaboration
Agreement dated as of September 15, 1995 (the "Agreement").
B. Pursuant to the Assignment Agreement dated as of November
11, 1999, between Trinity Thailand and Trinity, Trinity Thailand assigned to
Trinity, and Trinity assumed, all of Trinity Thailand's rights and obligations
under the Agreement.
C. The parties now desire to amend the Agreement on the terms
and conditions set forth below.
NOW, THEREFORE, in consideration of the foregoing premises and
the mutual covenants set forth below, the parties hereby amend the Agreement and
otherwise agree as follows:
ARTICLE 1
AMENDMENT
1.1 Article 5 of the Agreement is amended to insert the following
new section after the last section thereof:
5.7 Trademarks.
5.7.1 License. IRC hereby grants to Trinity a
non-exclusive, non-transferable, limited right to use IRC's
trademark REMUNE(TM) (the "Mark") solely for the purpose of
promoting, marketing and selling the Product in the Territory.
Trinity shall not use the Mark for any other purpose.
<PAGE>
5.7.2 Use. Trinity shall use the Mark in accordance
with applicable trademark law and IRC's policies regarding
advertising and trademark usage as established and amended
from time to time. Trinity shall not use any other trademark
or service mark in proximity to the Mark without the prior
written approval of IRC.
5.7.3 Trademark Obligations. Whenever the Mark is
used in advertising or in any other manner, Trinity shall
clearly indicate IRC as the trademark owner. Trinity shall not
do or cause to be done any act or anything contesting or in
any way impairing or reducing IRC's right, title and interest
in the Mark. Trinity acknowledges that use of the Mark
hereunder shall not create any right, title or interest in or
to the use of the Mark and that all such uses and goodwill
associated with the Mark will inure to the benefit of IRC.
Trinity shall take all necessary steps to ensure its employees
comply with all the terms and conditions herein.
5.7.4 Quality. The nature and quality of any products
or services that Trinity supplies in connection with the Mark
shall conform to the standards set by IRC. Trinity shall
cooperate with IRC in facilitating IRC's monitoring and
control of the nature and quality of such products and
services, and shall supply IRC with specimens of use of the
Mark upon request. Prior to distributing any marketing
materials or other literature containing the Mark, Trinity
shall submit a specimen thereof to IRC for IRC's approval.
Trinity shall not distribute such materials or literature
without prior written approval by IRC. Should IRC notify
Trinity in writing that the use of the Mark does not conform
to the standards set by IRC, Trinity shall have ten (10) days
to bring such use into conformance and to provide IRC with
specimens of such conforming use.
5.7.5 Infringement Proceedings. Trinity shall use
reasonable efforts to promptly notify IRC of any unauthorized
use of the Mark by others that comes to Trinity's attention.
IRC shall have the sole right and discretion to bring legal or
administrative proceedings to enforce IRC's trademark rights
including actions for trademark infringement or unfair
competition proceedings involving the Mark.
5.7.6 Trademark Registrations. Trinity, at IRC's
request and expense, shall provide IRC with any specimens,
execute all applications for trademark registrations,
trademark assignments or similar documents, and shall perform
any other similar act reasonably necessary (i) for IRC to
secure or maintain any and all IRC trademark rights in the
Territory or (ii) to effectuate the lawful right to use
product names, designations or trademarks in the Territory as
reasonably required by IRC.
1.2 Section 11.1 of the Agreement is restated in its entirety to
read as follows:
Expiration. Unless terminated earlier pursuant to
Sections 11.2 or
-2-
<PAGE>
11.3 below, this Agreement shall expire upon the expiration of
the last to expire of IRC's rights in all patents and patent
applications in the Territory which cover the Product.
1.3 Section 11.2 of the Agreement is restated in its entirety to
read as follows:
Termination by IRC. This Agreement shall terminate,
at the option of IRC effective upon written notice thereof to
Trinity, if Trinity has not received the required marketing
approval from the governing health authority of Thailand for
the Product on or before the first to occur of (a) the date
which is eighteen (18) months after receipt of the required
marketing approval from the FDA for Product in the United
States, and (b) the date which is twenty-four (24) months
after completion of the Study 2101B clinical trial of the
Product in Thailand under the applicable Development Workplan.
ARTICLE 2
MISCELLANEOUS
2.1 Defined Terms. All terms used, but not defined, in this
Amendment shall have the respective meanings set forth in the Agreement.
2.2 Continuing Effect. This Amendment shall be effective for all
purposes as of the Effective Date. Except as otherwise expressly modified by
this Amendment, the Agreement shall remain in full force and effect in
accordance with its terms.
2.3 Governing Law. This Amendment shall be governed by and construed
in accordance with the laws of the State of California.
2.4 Counterparts. This Amendment may be executed in counterparts,
each of which shall be deemed to be an original and together shall be deemed to
be one and the same document.
-3-
<PAGE>
IN WITNESS WHEREOF, the undersigned have duly executed and
delivered this Amendment effective as of the Effective Date.
THE IMMUNE RESPONSE CORPORATION
By: /S/ Dennis J. Carlo, PH.D.
--------------------------------------
Dennis J. Carlo, Ph.D.
President and Chief Executive Officer
TRINITY MEDICAL GROUP USA, INC.
By: /s/ Vina Churdboonchart
--------------------------------------
Title: President
------------------------------------
By: /s/ James Namnath
--------------------------------------
Title: Chief Executive Officer
------------------------------------
-4-
