Exhibit 10.56
Execution Copy
AMENDMENT NO. 1
AGREEMENT
to the Amended and Restated
License Agreement dated 26 September 2003 between Elan
Corporation, plc and Acorda Therapeutics, Inc.
and
to the Supply Agreement dated 26
September 2003 between Elan Corporation, plc and Acorda
Therapeutics, Inc.
and
CONSENT TO SUBLICENSE certain of
Acorda’s rights under the above Amended and Restated License
Agreement
This AMENDMENT NO. 1 AGREEMENT
and CONSENT TO SUBLICENSE (the “ Amendment and
Consent Agreement ”) dated as of the 30th day of June,
2009 (the “ Effective Date ”) is by and among
Elan Pharma International Limited, a company incorporated under the
laws of Ireland and having its registered office at Monksland,
Athlone, County Westmeath, Ireland (“ Elan ”),
Acorda Therapeutics, Inc., a Delaware corporation with an
office at 15 Skyline Drive, Hawthorne, New York 10532, USA (“
Acorda ”), and Biogen Idec International GmbH , a
Swiss company with an office at Landis & Gyr Strasse 3,
CH-6300 Zug, Switzerland (“ Biogen
”). Elan, Acorda and Biogen are each a “
Party ” and collectively, the “ Parties
”.
Recitals
Acorda and Elan Corporation, plc.
were parties to the Amended and Restated License Agreement dated
September 26, 2003 (the “ Elan License Agreement
”), attached hereto as Exhibit A, the Supply Agreement
dated September 26, 2003 (the “ Elan Supply
Agreement ”), attached hereto as Exhibit B, and the
Rush Payment Agreement dated September 26, 2003 as amended and
certain related agreements, attached hereto as Exhibit C
(collectively, the “ Elan Agreements ”).
Pursuant to assignments of the foregoing, which in the case of the
Elan License Agreement is made under Section 12.2.2
thereof and in the case of the Elan Supply Agreement is made under
Clause 14.3.3 thereof, Elan is the successor in title of all of
Elan Corporation, plc’s rights and obligations under the Elan
Agreements, as Acorda hereby acknowledges.
Acorda and Biogen are anticipating
entering into a collaboration and license agreement and a supply
agreement (collectively “ Partner Agreements ”,
attached hereto as Exhibits D and E, respectively), pursuant to
which Biogen will receive certain rights with respect to a Product,
as said term is defined in the Elan License Agreement (the “
Product ”). These rights include the
right to commercialize the Product in certain
territories (“ Sublicensed Territory ” as
defined below in the definition to be inserted into the Elan
License Agreement).
Pursuant to Section 2.3.1 of
the Elan License Agreement, Elan’s consent is required for
Acorda to provide certain rights to Biogen. This Amendment
and Consent Agreement sets forth Elan’s consent, the
conditions under which such consent is provided and certain
amendments to the Elan License Agreement, and other provisions to
which all parties to this Agreement wish to be bound, to facilitate
the commercialization of the Product in the Sublicensed Territory,
on the terms and conditions set out below.
Consent
1.
Consent to Sublicense
. Elan hereby consents to the
sublicense by Acorda to Biogen of its rights to package, use,
import, export, promote, distribute, offer for sale, sell and
otherwise exploit the Product in the Sublicensed Territory under
Clause 2.1 of the Elan License Agreement (including those
amendments to the License Agreement agreed to pursuant to this
Amendment and Consent Agreement) to the extent that such rights are
to be sub-licensed to Biogen pursuant to the Partner License
Agreement (as defined below) as disclosed to Elan prior to the date
of this Amendment and Consent Agreement.
Amendments
2.
Elan and Acorda agree that the Elan
Agreements shall be amended as follows, with effect from the time
at which the last of the Partner Agreements becomes
effective.
2.1
Definitions
. Section 1.1 of the Elan
License Agreement is amended by the insertion of the following
defined terms:
“ Amendment and Consent
Effective Date ” shall mean June 30,
2009.
“ Biogen ” shall
mean Biogen Idec International GmbH, a Swiss corporation with an
office at Landis & Gyr Strasse 3, CH-6300 Zug,
Switzerland.
“ Cooperation Committee
” shall mean the committee to be established pursuant to
Article 10A.
“ Partner Agreements
” shall mean, collectively, the Partner License Agreement and
the Partner Supply Agreement.
“ Partner License
Agreement ” shall mean that certain collaboration and
license agreement dated as of June 30, 2009 between Acorda and
Biogen, pursuant to which inter alia Acorda has sub-licensed to
Biogen certain of its rights hereunder in the Sublicensed Territory
and attached hereto as Exhibit D.
“ Partner Supply
Agreement ” shall mean that certain supply agreement
dated as of June 30, 2009 between Acorda and Biogen and
attached hereto as Exhibit E.
“ Sublicensed Territory
” shall mean all the countries of the world, excluding the
United States, each Terminated Country (as defined in the Partner
License Agreement) and each of their respective territories and
possessions.
“ Technical Agreement
” shall mean the Technical Agreement between Elan
and
Acorda attached hereto as
Exhibit F.
“ Third Party
Distributor ” shall have the meaning set forth in
Section 2.3.4.
2.2
Sublicense to
Distributors .
Section 2.3 of the Elan License Agreement is amended by the
addition of the following subsections:
2.3.4
Subject to Sections 2.3.5 to 2.3.12
inclusive, in addition to the foregoing, Acorda may permit Biogen
to sub-sublicense the sublicense rights granted to Biogen by Acorda
under the Partner License Agreement to distribute, package, label,
import, market, promote and sell the Product in individual
countries in the Sublicensed Territory to unaffiliated distributors
who may also perform such activities for other products in such
individual country (each, a “ Third Party Distributor
”), but without the right to further sub-license such
rights.
2.3.5
A Third Party Distributor may only
be appointed if neither Biogen nor its affiliates are distributing,
marketing, promoting and selling their own products in the same or
similar therapeutic areas without the use of an unaffiliated
distributor in such country.
2.3.6
Acorda shall provide Elan, or
procure that Biogen provides Elan, with the name and address of any
such Third Party Distributors and a description of the proposed
sub-sublicense arrangement.
2.3.7
Each Third Party Distributor must be
competent and have the financial capacity to be involved in the
registration and/or distribution of patented pharmaceutical
products.
2.3.8
Confidential Information of Elan
which is contained in the CMC Section and/or related data
shall not be transferred to such Third Party Distributor without
Elan’s prior written consent, which shall not be unreasonably
withheld or delayed, and then only upon terms which are no less
onerous than those applicable in this Agreement; and as a
pre-condition of making such transfer, Biogen shall provide Elan
with its binding agreement to enforce such provisions in accordance
with Elan’s reasonable instructions from time to time and at
Biogen’s sole cost and expense.
2.3.9
Each Third Party Distributor shall
be regarded as Acorda’s Designee, so that for the avoidance
of doubt sales by Third Party Distributors shall be regarded as In
Market sales and not transfers from Acorda or Biogen to such Third
Party Distributor.
2.3.10
Any and all payments by Third Party
Distributor to Biogen in respect of the grant of such rights, other
than payments for Product delivered or to be delivered, shall be
regarded for the p
