Ex. 10.12(e)
CONSENT AND AMENDMENT AGREEMENT
AGREEMENT pursuant to the provisions of the Letter of Intent dated
February 10, 1995 and signed between LES LABORATOIRES SERVIER, ORSEM, AMERICAN
HOME PRODUCTS CORPORATION, AMERICAN CYANAMID COMPANY and INTERNEURON
PHARMACEUTICALS, INC. I. Effective as of November 21, 1994, Interneuron
Pharmaceuticals, Inc. and American Cyanamid Company amend the Patent and
Know-How Sublicense and Supply Agreement dated November 19, 1992 (the
"Sublicense Agreement") as follows:
1. Paragraph 1.1 is amended to read in its entirety:
"AFFILIATES" shall mean any corporation or business entity
other than a joint venture controlled by, controlling or under
common control with CYANAMID or INTERNEURON, as the case may
be. (For this purpose, "control" shall mean direct or indirect
beneficial ownership of more than forty percent (40%) of the
voting stock of, or a forty percent (40%) or greater interest
in the income of such corporation or other business entity, or
such other relationship as, in fact, constitutes actual
control.) Notwithstanding ownership of more than forty percent
(40%) of the voting stock of a business entity, if such
business entity is not actually controlled by or under common
control with a party because of a governance or similar
agreement, then such business entity will not be considered an
AFFILIATE for purposes of this AGREEMENT.
2. The following is added as Paragraph 2.4:
2.4 MARKET
CYANAMID and INTERNEURON acknowledge that the
SPECIALITY is intended to be marketed in the TERRITORY solely
as a prescription product.
3. The following is added as Paragraph 5.6:
5.6 COORDINATION COMMITTEE
5.6.1 The parties and SERVIER shall establish a
Coordination Committee which shall consist of up to six
members, with an equal number of appropriate representatives
from CYANAMID, INTERNEURON and SERVIER, with the understanding
that such number may be changed by the parties and SERVIER.
-1-
5.6.2 The Coordination Committee shall:
(i) address and coordinate key matters relating to:
(A) the regulatory process and approvals for the
PRODUCT, including development and clinical studies
related thereto, retention of consultants, and entry
into other agreements related to the PRODUCT; and (B)
the expeditious receipt and coordination of
information regarding the promotion, pre- marketing
and marketing of the approved SPECIALITY;
(ii) be comprised of representatives of each party
and SERVIER who are appropriate designees to address
the issues outlined in (i) above; and
(iii) meet at least once each year at SERVIER's
location and at least once each year at a mutually
agreed location in the United States.
4. Paragraph 9.4.4 is amended to read in its entirety:
CYANAMID shall not during the TERM OF THIS AGREEMENT develop
any product in the TERRITORY in which COMPOUND is combined
with any other active ingredient for the treatment of obesity
without the prior written consent of INTERNEURON, which
consent will not be unreasonably withheld. The prior consent
of SERVIER thereto shall be a precondition in any case to
INTERNEURON's consent. The provisions of the immediately
preceding two sentences shall not apply to products whose
development was started before February 10, 1995 by AMERICAN
HOME PRODUCTS CORPORATION or its AFFILIATES (other than
CYANAMID). CYANAMID also shall not during the TERM OF THIS
AGREEMENT market any substance, rights to which were acquired
from any person not an AFFILIATE, whose indication for use as
a human drug is directly competitive with SPECIALITY. If
CYANAMID or an AFFILIATE develops during the TERM of THIS
AGREEMENT any drug the primary mode of action of which is
identical to PRODUCT, and which competes directly with
SPECIALTY, then, prior to marketing such a drug in the
TERRITORY, SERVIER and CYANAMID shall meet to determine the
averse financial impact, if any, upon the sales of the
SPECIALTY in the TERRITORY, and, if such an impact is found,
CYANAMID and SERVIER shall agree to an appropriate
compensation to SERVIER from CYANAMID. In the event a business
entity of which 40% or more of voting stock is owned or
controlled by CYANAMID or its AFFILIATES intends to market in
the TERRITORY any drug the primary mode of action of which is
identical to PRODUCT and which competes directly with
SPECIALTY, then prior to marketing such a drug in the
TERRITORY, SERVIER and CYANAMID shall meet to determine the
adverse financial impact, if any, upon the sales of the
SPECIALTY in the TERRITORY,
-2-
and if such impact is found, CYANAMID and SERVIER shall agree
to an appropriate compensation to SERVIER from CYANAMID.
CYANAMID shall sell SPECIALTY exclusively within the TERRITORY
during the TERM OF THIS AGREEMENT. SERVIER shall not market in
the TERRITORY any pharmaceutical specialty containing PRODUCT
which directly competes with SPECIALTY in the treatment
obesity, including but not limited to obesity caused by
abnormal carbohydrate craving, without the prior written
consent of CYANAMID, which consent shall not be unreasonably
withheld.
5. Paragraph 9.4.3 is amended to read in its entirety:
9.4.3 CYANAMID understands that, as set forth in Paragraphs
2.2.7 of the SERVIER PATENT AGREEMENT and of the ORSEM
TRADEMARK AGREEMENT, this AGREEMENT may terminate in the event
of the termination of said SERVIER AGREEMENTS, at SERVIER's
Option. INTERNEURON agrees to exercise its best efforts to
avoid any such termination. Provided CYANAMID is not then in
default of this AGREEMENT, SERVIER agrees upon termination of
the SERVIER AGREEMENTS to take over INTERNEURON's position in
this AGREEMENT directly with CYANAMID on the same terms as
those set forth in this AGREEMENT, except as SERVIER and
CYANAMID may otherwise agree at the time, and SERVIER and
CYANAMID agree to continue this AGREEMENT thereafter for the
full term hereof with SERVIER substituted for INTERNEURON
hereunder.
-3-
II. Effective as of November 21, 1994, ORSEM, INTERNEURON PHARMACEUTICALS,
INC. and AMERICAN CYANAMID COMPANY amend the Trademark License Agreement
dated November 19, 1992 (the "Trademark Agreement") as follows:
1. Paragraph 1.a. is amended to read in its entirety:
"Affiliate" shall mean any corporation or business entity
controlled by, controlling or under common control with ORSEM,
CYANAMID or INTERNEURON, as the case may be. (For this
purpose, "control" shall mean direct or indirect beneficial
ownership of more than forty percent (40%) of the voting stock
of, or a forty percent (40%) or greater interest in the income
of such corporation or other business entity, or such other
relationship as, in fact, constitutes actual control.)
Notwithstanding ownership of more than forty percent (40%) of
the voting stock of a business entity, if such business entity
is not actually controlled by or under common control with a
party because of a governance or similar agreement, then such
business entity will not be considered an Affiliate for
purposes of this Agreement.
2. Paragraph 4.b. is amended to read in its entirety:
-4-
b. Except with ORSEM's prior written approval, as defined in
Section 2.2.2 of the Trademark Agreement, CYANAMID shall not
display or use any other trademark, service xxxx, trade name,
logo type, label design or other source- identifying symbol or
designation in connection with or in close proximity to the
Trademark, other than CYANAMID's own C DEVICE AND WORK
CYANAMID logo, the LEDERLY IN SCRIPT IN OVAL logo, the
ADVANTUS PHARMACEUTICALS logo, and WYETH and WYETH-AYERST in
any typeface or design and any and all logos associated
therewith, and any modification or replacements for same.
III. Nothwithstanding the provisions of Paragraph 9.4.4 of the Sublicense
Agreement, American Cyanamid Company, Interneuron Pharmaceuticals, Inc. and Les
Laboratoires Servier agree that American Home Products Corporation shall be free
to continue to market Pondimin and Mazindol subject to the following
requirements: (1) for as long as Dexfenfluramine remains commercially viable,
American Home Products Corporation will differentiate Dexfenfluramine for
promotional and marketing purposes and will not promote or market Pondimin or
Mazindol or any other product for the anti-obesity indication which competes
directly with Dexfenfluramine in a manner in each case which negatively affects
the existing or future market for Dexfenfluramine, and (2) the provisions of
this Section III will not apply to any product which American Cyanamid has under
development as of February 10, 1995, as to which Paragraph 9.4.4 of the
Sublicense Agreement will apply.
IV. Effective as of November 21, 1994, American Home Products Corporation,
acting through its Wyeth-Ayerst Laboratories division ("Wyerth-Ayerst"), is
subject to and benefits from all terms and conditions of the Sublicense
Agreement and the Trademark Agreement, as amended, except as expressly set forth
in this Consent and Amendment Agreement. Wyeth- Ayerst shall perform, or cause
to be performed, the obligations of American Cyanamid Company under the
Sublicense Agreement and the Trademark Agreement, as amended.
-5-
V. Les Laboratoires Servier and Orsem hereby consent to the continuation of the
Sublicense Agreement and the Trademark Agreement, with the amendments set forth
above. Les Laboratoires Servier hereby irrevocably waives any right, express or
implied, that it may have to terminate the sublicense rights in the sublicense
Agreement, or to receive or claim any compensation, on account of the
acquisition of American Cyanamid Company by American Home Products Corporation,
and the merger of a subsidiary of American Home Products Corporation into
American Cyanamid Company.
IN WITNESS WHEREOF, the parties have caused this AGREEMENT to be
executed by their duly authorized officers effective as of the date first
written above.
Acknowledged and Agreed by: Acknowledged and Agreed by:
INTERNEURON PHARMACEUTICALS, INC. ORSEM
Proxy
Name: /S/ XXXXX X. XXXXXX Name: /S/ X. XXXXXX-XXXXXXXX
-------------------------- -------------------------
Title: PRESIDENT Title: VICE PRESIDENT
Acknowledge and Agreed by: Acknowledge and Agreed by:
AMERICAN CYANAMID COMPANY LES LABORATOIRES SERVIER
Name: /S/ XXXXXX XXXXXX Name: /S/ X. XXXXXX-XXXXXXXX
-------------------------- --------------------------
Title: PRESIDENT Title: VICE PRESIDENT
Acknowledge and Agreed by:
AMERICAN HOME PRODUCTS CORPORATION
Name: /S/ XXXXXXX X. XXXX
--------------------------
Title: ASSISTANT SECRETARY
-6-
