CONFIDENTIAL TREATMENT
REQUESTED
Exhibit 10.25
AMENDMENT TO LICENSE AGREEMENT
REGARDING SUBLICENSING
THIS AMENDMENT TO LICENSE AGREEMENT REGARDING
SUBLICENSING (this
“Agreement”), dated as of this 18th day of November,
2008, but effective as of the Effective Date, is hereby entered
into by and between sanofi-aventis U.S. LLC, a Delaware limited
liability company with offices located at 55 Corporate Drive,
Bridgewater, NJ 08807 (“sanofi-aventis U.S.”) and
Albany Molecular Research, Inc., a Delaware corporation with
offices located at 26 Corporate Circle, Albany, New York 12203,
with its wholly-owned subsidiary, AMR Technology, Inc., a Vermont
corporation with offices located at 5429 Main Street, Manchester,
Vermont 05255, (collectively
“AMRI”). Sanofi-aventis U.S. and AMRI are
sometimes referred to individually as a “Party” and
collectively as the “Parties.”
WHEREAS, Albany Molecular Research Inc., and
sanofi-aventis U.S., through its predecessor Marion Merrell Dow
Inc., entered into a License Agreement—Terfenadine Acid
Metabolite on March 15, 1995, and License Agreement II dated
December 30, 1998, and amendments dated as of March 3, 2000, May 5,
2000, August 1, 2001, and March 24, 2005 (collectively the
“AMRI-SA License Agreement”);
WHEREAS, Under the AMRI-SA License Agreement, AMRI
granted an exclusive license, with the right to sublicense upon
prior written consent of AMRI, to sanofi-aventis U.S. under,
inter alia , the Albany Patent Applications and the Albany
Patents, as those terms are defined in the AMRI-SA License
Agreement (collectively the “AMRI Patent
Rights”);
WHEREAS, Beginning on March 5, 2004, AMRI, along with
sanofi-aventis U.S., filed suit in the U.S. District Court in New
Jersey against, inter alia , Barr Laboratories, Inc., and
Teva Pharmaceuticals USA, Inc., asserting infringement of certain
of the AMRI Patent Rights;
WHEREAS, AMRI and sanofi-aventis U.S. desire to settle
their litigations in the U.S. District Court in New Jersey against
Barr Laboratories, Inc. and Teva Pharmaceuticals USA, Inc. and
intend to enter into a Settlement and Release Agreement relating to
Allegra Single-Entity with Barr Laboratories, Inc.
and Teva Pharmaceuticals USA, Inc. (the “Single-Entity
Allegra Settlement Agreement”) and a Settlement Agreement
relating to Allegra D-12 with Barr Laboratories, Inc. (the
“Allegra D-12 Settlement Agreement” and together with
the Single-Entity Allegra Settlement Agreement, the
“Settlement Agreements” and each a “Settlement
Agreement”).
WHEREAS, as contemplated by the Settlement Agreements,
sanofi-aventis U.S. will enter into License
Agreements with Barr Laboratories, Inc. and Teva Pharmaceuticals
USA, Inc. relating to Allegra Single-Entity and with
Barr Laboratories, Inc. for Allegra D-12 (together the
“Sublicense Agreements”).
WHEREAS , in furtherance of the Settlement Agreements
and the Sublicense Agreements, the Parties desire to amend the
AMRI-SA License Agreement as set forth herein and
AMRI to consent to the sublicenses made under the Sublicense
Agreements;
Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of
the Exchange Act; [ *****
] denotes omissions.
NOW, THEREFORE, in consideration of the foregoing premises and
mutual covenants, agreements, and provisions herein contained, and
for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties agree as
follows:
1.
Definitions
Except where
otherwise noted, the capitalized terms used herein without
definition shall have the meanings ascribed to them in the AMRI-SA
License Agreement.
“AB-Rated” shall have the meaning given to it in the
Allegra D-12 Settlement Agreement.
“AB-Rated Allegra D-12
Product” means any
pharmaceutical product that is an AB-Rated version of Allegra D-12
in the Territory.
“Allegra Single-Entity”
means a pharmaceutical
composition containing fexofenadine hydrochloride as the
sole active ingredient, as an immediate release tablet or capsule
formulations for relief of seasonal allergy symptoms, which is
currently marketed by sanofi-aventis U.S. under the trade name
Allegra in the Territory, whether in prescription or
non-prescription form, but excluding the orally-disintegrating
tablet (NDA 21-909), oral-solution formulations (NDA 21-963) of the
product, and Allegra D-12 and Allegra D-24.
“Allegra D-12”
means a pharmaceutical composition
containing 60-mg fexofenadine hydrochloride and 120-mg
pseudoephedrine hydrochloride for relief of congestion and other
seasonal allergy symptoms, marketed by sanofi-aventis U.S. under
NDA 20-786, and by its sublicensee under the Sublicense Agreements,
Barr Laboratories, Inc. under NDA 20-786 or under ANDA 76-236,
whether in prescription or non-prescription form.
“Allegra D-24”
means a pharmaceutical composition
containing 180 mg fexofenadine hydrochloride and 240 mg
pseudoephedrine hydrochloride for relief of congestion and other
allergy symptoms, marketed by sanofi-aventis U.S. under NDA
21-704.
“Effective Date ” shall have the meaning given to it in
the Settlement Agreements and shall occur as of the Effective Date
of the first Settlement Agreement to be
effective. Notwithstanding the foregoing, if a
provision hereof refers to the Effective Date of a specific
Settlement Agreement, then the term shall have the meaning as set
forth in the referenced Settlement Agreement.
“Launch Date”
shall have the meaning given to it
in the Sublicense Agreement relating to Allegra D-12.
“Territory” means the United States of America and its
territories and possessions.
2.
Amendment to AMRI-SA License Agreement
CONFIDENTIAL TREATMENT
REQUESTED
This Agreement
is an amendment to the AMRI-SA License Agreement. Except
as otherwise modified herein, the definitions, rights, and
obligations of the Parties to the AMRI-SA License Agreement shall
remain in full force and effect.
3.
Sublicense
Consent
Subject to the
terms and conditions of this Agreement, AMRI hereby consents to the
Sublicense Agreements and sublicenses granted thereunder or as
otherwise contemplated by the Settlement Agreements; provided that
except as set forth in the Sublicense Agreements such sublicensed
rights may not be further sublicensed without AMRI’s written
consent, which consent shall not be unreasonably
withheld. The consent granted under this Section 3
shall not be deemed to be granted for any rights outside of the
Territory (except to the extent set forth in the Sublicense
Agreements) or to any party other than Barr Laboratories, Inc. and
Teva Pharmaceuticals USA, Inc.
4.
Payments by sanofi-aventis U.S. to AMRI
4.1
One-Time Payment. In consideration of the
consents granted
