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 AdobeTM 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