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 purposes of this
Agreement as License Revenues to the extent that they would have been so
regarded if they had been paid by Biogen to Acorda in respect of the rights
granted to Biogen under the Partner Agreements.

 

2.3.11                  Elan shall be provided with audit and inspection rights
vis a vis the Third Party Distributors no less extensive than those which it has
vis-a-vis Acorda.

 

2.3.12                  Acorda shall reimburse Elan in respect of any adverse
tax consequences for Elan resulting from such Third Party Distributor
arrangement.

 

2.3                                 Reasonable Assistance Directly to Biogen. 
The Elan License Agreement is amended by the addition of the following
Section 3.9:

 

In order to assist Biogen to prepare and file marketing authorizations (or
equivalent authorizations) in the Sublicensed Territory, Elan shall provide the
documentation which is required to be provided under Section 3.8 or elsewhere in
this Agreement or the Supply Agreement to either Acorda or Biogen, as directed
by Acorda.  Acorda (itself or through Biogen) shall promptly notify Elan of the
date of any regulatory filings or regulatory approvals that are filed/issued in
the Sublicensed Territory and of the date of the commercial launch of Product in
any country in the Sublicensed Territory.

 

2.4                                 Packaging.  The Elan Supply Agreement is
amended by the addition of the following Clause 5.6:

 

Acorda may, by written notice to Elan, elect to allow Biogen to package the
Product for onward supply in the Sublicensed Territory, in which case Acorda
shall specify in each of its orders the number of batches to be so delivered in
bulk packaging.  Elan shall supply such batches, packaged in bulk and in
suitable containers for transit.  Elan shall deduct, from the price set out in
Clause 9, the amounts that Elan would have charged Acorda to perform such
packaging (an amount that shall be consistent with charges Elan applies to other
similarly packaged products), less any additional charges incurred in bulk
packaging such Product.  Forthwith following such an election, Elan and Acorda
shall negotiate in good faith appropriate amendments to the Technical Agreement
to take account of these revised packaging arrangements.

 

2.                                       Third Source.  Clause 7 of the Elan
Supply Agreement is amended by the addition of the following Clause 7.9:

 

In the event of failures by the Manufacturer to supply Product which would, if
by Elan, constitute Serious Failure to Supply or Force Majeure, then:

 

--------------------------------------------------------------------------------

 

7.9.1                        Acorda shall be entitled by written notice to Elan
to require the establishment of a third source of supply of the Product (“Third
Source”);

 

7.9.2                        at Acorda’s election, the Third Source shall be
either (1) another Elan facility; or (2) the facility of a third party of
Acorda’s choice, reasonably acceptable to Elan;

 

7.9.3                        if the Third Source is that of a third party, then:

 

7.9.3.1               Acorda shall be entitled to qualify the facility of the
Third Source.  For this purpose, Elan shall provide the assistance and
documentation required under Clause 7.1, and subject to the same provisions. 
Elan, Acorda and the operator of the Third Source shall negotiate in good faith
a detailed technology transfer plan and technology transfer agreement for the
purposes of effecting such transfer.  As between Acorda and Elan, the costs of
such transfer, including work performed by Elan, shall be paid by Acorda.

 

7.9.3.2               Following such technology transfer, the Third Source and
its operator shall be deemed to replace the Second Source and the Manufacturer
respectively for all purposes of this Agreement, other than this Clause 7.9. 
Without prejudice to the generality of the foregoing, Acorda shall not be
entitled to purchase further supplies of Product from Patheon Inc., and for the
avoidance of doubt, the compensating payment referred to in Clause 9.5 shall
apply in respect of Product sourced from the Third Source.  Further, Acorda
shall procure that Manufacturer forthwith returns, or at Elan’s option destroys,
all Confidential Information of Elan in its possession or control.

 

Further Provisions

 

3.1                                 Elan Enforcement Rights. Biogen hereby
agrees that insofar as the Partner Agreements expressly purport to grant any
right to Elan (and/or its affiliates) or provide for any obligation of Biogen
expressly for Elan’s (and/or it’s affiliates’) benefit with respect to:
(a) auditing or inspecting Biogen, its Affiliates, or its Third Party
Distributors, (b) protection of Elan Confidential Information (as defined in the
Elan License Agreement), (c) rights of indemnification as an “Acorda Indemnitee”
in a Partner Agreement, and/or (d) in relation to the Elan Trademarks (under
Sections 7.5(b)(iii) and 9.1(b) of the Partner License Agreement), Elan (and/or
its affiliates as the case may be) shall be entitled to enforce such provisions
as if it were a party to such agreement(s).  Acorda and Biogen shall not amend
any such provision insofar as it may affect Elan or its affiliates without
Elan’s prior written consent.  The Parties agree that nothing in this or any of
the other agreements referred to herein shall make or be deemed to have made
Elan a party to or, without prejudice to the foregoing, third party beneficiary
of the Partner Agreements.

 

--------------------------------------------------------------------------------

 

3.2                                 Confidentiality.  Any confidential
information disclosed between the Parties pursuant to this Amendment and Consent
Agreement, the Elan Agreements and the Partner Agreements shall be used
exclusively for the purposes of fulfilling the receiving Party’s obligations and
exercising rights under same and for no other purpose.  Elan and Biogen further
confirm to each other that they shall maintain each other’s Confidential
Information in confidence and in accordance with the applicable terms and
conditions of the Elan Agreements as if they were set out herein at length and
applied to Biogen in place of Acorda.  For the avoidance of doubt, the foregoing
applies in respect of Elan Confidential Information whether such Confidential
Information is received from Elan or Acorda, but this does not constitute any
waiver by Elan in respect of any of Acorda’s non-disclosure obligations or
permission to disclose such Confidential Information except as set out in the
Elan Agreements.

 

3.3                                 Cooperation Committee.

 

(a)                              Elan, Acorda and Biogen shall establish a
committee (the “Cooperation Committee”) to provide for sharing of information,
and where required, the oversight, review and coordination of activities
provided under the Elan Agreements by the parties with respect to (i) the
progress of development of Product in the Sublicensed Territory, (ii) the
manufacture and supply of Product for the Sublicensed Territory,  and (iii) the
commercialization of Product in the Sublicensed Territory.  Where necessary and
appropriate and mutually agreed by all three parties, the Cooperation Committee
may also organize and delegate working groups to resolve operational issues.
Unless otherwise agreed by all three parties, (i) the Cooperation Committee
shall be comprised of six members, two from each Party, and (ii) the members
shall meet once a calendar quarter, in person, by phone or otherwise as may
reasonably necessary for such purposes.

 

(b)                                 The Parties agree that, to the extent Acorda
so authorizes and it is operationally feasible for the parties to do so, Biogen
(on behalf of Acorda) and Elan shall coordinate directly with respect to
forecast, ordering, batch review, acceptance and rejection of the Product in the
Sublicensed Territories under the Elan Supply Agreement (“Supply
Communications”).  In such case, Acorda shall be kept fully informed by Biogen
of all of the Supply Communications. The Parties may also discuss supply issues
through the Cooperation Committee.  If Elan so requests, Biogen shall enter into
a quality agreement with Elan, to be negotiated in good faith by Biogen and
Elan.

 

(c)                                  The foregoing obligations are in addition
to and not in substitution for the obligations of Elan and Acorda under
Article 10 of the Elan License Agreement.

 

3.4                                 No Privity in Elan Agreements.  The Parties
agree that nothing in this or any of the other Agreements referred to herein
shall make or be deemed to have made Biogen a party to or third party
beneficiary of the Elan License Agreement or the Elan Supply Agreement.

 

General

 

4.1                                 Conditionality.  This Amendment and Consent
Agreement shall be null and void and have no further force or effect if either
(i) Acorda and Biogen do not execute the Partner Agreements prior to  July 31,
2009 or (ii) the Partner Agreements are terminated before they

 

--------------------------------------------------------------------------------

 

become effective in accordance with their terms.  For the avoidance of doubt, in
the event of circumstance (ii) in the previous sentence, Acorda and Elan shall
revert to their status with respect to the Elan Agreements as if this Amendment
and Consent Agreement had not be executed.

 

4.2                                 Counterparts and Facsimile Signatures.  This
Amendment and Consent Agreement  may be executed in any number of counterparts,
each of which shall be deemed an original, and all of which together shall
constitute one and the same instrument.  Signatures provided by facsimile
transmission or in Adobe™ Portable Document Format (PDF) sent by electronic mail
shall be deemed to be original signatures.

 

4.3                                 No Other Amendments.  Except as expressly
set out in this Amendment and Consent Agreement, all terms and conditions of the
Elan Agreements remain unchanged and continue to be in full force and effect,
and for the avoidance of doubt nothing in this Amendment and Consent Agreement
shall be deemed to extend the scope of the license granted to Acorda under the
Elan License Agreement.

 

4.4                                 Modification.  This Amendment and Consent
Agreement  may not be modified unless made in writing and signed by the Parties
by their respective officers thereunto duly authorized.

 

4.5                                 Governing Law.  This Amendment and Consent
Agreement shall be governed by and construed in accordance with the laws of the
State of New York, without regard to its conflicts of laws principles.

 

4.6                                 Severability.  If, under applicable Law, any
provision of this Amendment and Consent Agreement  is invalid or unenforceable,
or otherwise directly or indirectly affects the validity of any other material
provision(s) of this Amendment and Consent Agreement  (“Severed Clause”), the
Parties mutually agree that this Amendment and Consent Agreement shall endure
except for the Severed Clause.  The Parties shall consult and use their best
efforts to agree upon a valid and enforceable provision that shall be a
reasonable substitute for such Severed Clause in light of the intent of this
Amendment and Consent Agreement.

 

[signatures appear on the following page]

 

--------------------------------------------------------------------------------

 

IN WITNESS WHEREOF, the Parties hereto have caused this Consent to be executed
as of the Execution Date by their duly authorized representatives.

 

 

Elan Pharma International Limited

Acorda Therapeutics, Inc.

 

 

 

 

By:

/s/ William F. Daniel

 

By:

/s/ Ron Cohen

William F. Daniel

Ron Cohen

 

 

 

 

BIOGEN IDEC INTERNATIONAL GMBH

 

 

 

 

 

By:

/s/ Anders Lundstrom

 

 

 

Anders Lundstrom

 

 

--------------------------------------------------------------------------------

 

EXHIBIT A

 

ELAN LICENSE AGREEMENT

 

--------------------------------------------------------------------------------

 

EXHIBIT B

 

ELAN SUPPLY AGREEMENT

 

--------------------------------------------------------------------------------

 

EXHIBIT C

 

RUSH PAYMENT AGREEMENT AND AMENDMENT

 

--------------------------------------------------------------------------------

 

EXHIBIT D

 

PARTNER  LICENSE AGREEMENT

 

--------------------------------------------------------------------------------

 

EXHIBIT E

 

PARTNER SUPPLY AGREEMENT

 

--------------------------------------------------------------------------------

 

EXHIBIT F

 

TECHNICAL AGREEMENT

 

--------------------------------------------------------------------------------