Document:

Exhibit 10.55

 

SUPPLY
AGREEMENT

 

BETWEEN

 

ACORDA THERAPEUTICS, INC.

 

AND

 

BIOGEN IDEC INTERNATIONAL GMBH

 

* PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED PURSUANT TO A
CONFIDENTIAL TREATMENT REQUEST.

 

 

TABLE OF CONTENTS

 

	
  SUPPLY AGREEMENT

  	
  1

  
	
   

  	
   

  
	
  W I T N E S S E T H:

  	
  1

  
	
   

  	
   

  	
   

  
	
  1.

  	
  DEFINITIONS

  	
  1

  
	
   

  	
   

  	
   

  	
   

  
	
  2.

  	
  COORDINATION; SUPPLY
  CHAIN MANAGEMENT

  	
  5

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.1

  	
  Relationship Managers

  	
  5

  
	
   

  	
  2.2

  	
  Joint Manufacturing
  Committee

  	
  5

  
	
   

  	
  2.3

  	
  Meetings

  	
  6

  
	
   

  	
  2.4

  	
  Decision Making;
  Authority

  	
  6

  
	
   

  	
  2.5

  	
  Third Party
  Manufacturers

  	
  7

  
	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
  SUPPLY

  	
  7

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.1

  	
  Exclusive Supply

  	
  7

  
	
   

  	
  3.2

  	
  General Scope of
  Services

  	
  7

  
	
   

  	
  3.3

  	
  Quality Agreement

  	
  7

  
	
   

  	
  3.4

  	
  Third Party
  Manufacturers

  	
  7

  
	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
  FORECASTS AND ORDERS

  	
  8

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.1

  	
  Forecast

  	
  8

  
	
   

  	
  4.2

  	
  Long-Term Forecast

  	
  8

  
	
   

  	
  4.3

  	
  Amending Forecasts

  	
  8

  
	
   

  	
  4.4

  	
  Launch Stocks

  	
  8

  
	
   

  	
  4.5

  	
  Purchase Orders

  	
  9

  
	
   

  	
  4.6

  	
  Fulfillment of Purchase
  Orders

  	
  9

  
	
   

  	
  4.7

  	
  Supply Uncertainty

  	
  10

  
	
   

  	
  4.8

  	
  Safety Stock

  	
  10

  
	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
  PRODUCTION

  	
  10

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.1

  	
  Specifications

  	
  10

  
	
   

  	
  5.2

  	
  Changes to the
  Specifications, Processing or the Facility

  	
  11

  
	
   

  	
  5.3

  	
  Quality Assurance

  	
  12

  
	
   

  	
  5.4

  	
  Preservation of Samples

  	
  13

  
	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
  DELIVERY AND PAYMENT

  	
  13

  

 

 

	
   

  	
  6.1

  	
  Delivery

  	
  13

  
	
   

  	
  6.2

  	
  Price and
  Reimbursements

  	
  14

  
	
   

  	
  6.3

  	
  Elan Compensating
  Payment and Acorda Costs

  	
  14

  
	
   

  	
  6.4

  	
  Remittance of Payments

  	
  14

  
	
   

  	
  6.5

  	
  Tax Withholding

  	
  14

  
	
   

  	
  6.6

  	
  VAT

  	
  15

  
	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
  REGULATORY

  	
  15

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.1

  	
  Information Provided to
  Manufacturers

  	
  15

  
	
   

  	
  7.2

  	
  Governmental Inspection

  	
  15

  
	
   

  	
  7.3

  	
  Right of Inspection

  	
  15

  
	
   

  	
  7.4

  	
  Records

  	
  16

  
	
   

  	
   

  	
   

  	
   

  
	
  8.

  	
  REPRESENTATIONS AND
  WARRANTIES

  	
  16

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.1

  	
  Mutual Representations
  and Warranties

  	
  16

  
	
   

  	
  8.2

  	
  Additional
  Representations and Warranties of Acorda

  	
  17

  
	
   

  	
  8.3

  	
  Additional Covenants of
  Acorda

  	
  17

  
	
   

  	
  8.4

  	
  Disclaimer

  	
  18

  
	
   

  	
  8.5

  	
  Limitation of Damages

  	
  18

  
	
   

  	
   

  	
   

  	
   

  
	
  9.

  	
  CONFIDENTIALITY

  	
  18

  
	
   

  	
   

  	
   

  	
   

  
	
  10.

  	
  TERM AND TERMINATION

  	
  18

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.1

  	
  Term

  	
  18

  
	
   

  	
  10.2

  	
  Termination

  	
  18

  
	
   

  	
  10.3

  	
  Rights Upon Termination

  	
  19

  
	
   

  	
  10.4

  	
  Effect of Termination

  	
  19

  
	
   

  	
  10.5

  	
  Survival

  	
  19

  
	
   

  	
   

  	
   

  	
   

  
	
  11.

  	
  GOVERNING LAW

  	
  19

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  11.1

  	
  Governing Law

  	
  19

  
	
   

  	
  11.2

  	
  Dispute Resolution

  	
  19

  
	
   

  	
   

  	
   

  	
   

  
	
  12.

  	
  MISCELLANEOUS

  	
  20

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.1

  	
  Notices

  	
  20

  
	
   

  	
  12.2

  	
  Entire Agreement

  	
  20

  
	
   

  	
  12.3

  	
  Amendment and Waiver

  	
  21

  
	
   

  	
  12.4

  	
  No Implied Waivers

  	
  21

  

 

2

 

	
   

  	
  12.5

  	
  Order of Precedence

  	
  21

  
	
   

  	
  12.6

  	
  Covenant of Further
  Assurances

  	
  21

  
	
   

  	
  12.7

  	
  Relationship

  	
  21

  
	
   

  	
  12.8

  	
  Severability

  	
  21

  
	
   

  	
  12.9

  	
  Assignment

  	
  21

  
	
   

  	
  12.10

  	
  Force Majeure

  	
  22

  
	
   

  	
  12.11

  	
  Export Compliance

  	
  22

  
	
   

  	
  12.12

  	
  Performance by
  Affiliates and Third Party Distributors

  	
  22

  
	
   

  	
  12.13

  	
  Counterparts and
  Facsimile Signatures

  	
  22

  
	
   

  	
   

  	
   

  	
   

  
	
  Exhibit A

  	
  Acorda Supply Agreements

  	
  1

  

 

3

 

SUPPLY AGREEMENT

 

This Supply Agreement (the “Agreement”) is entered into as of
the 30th day of June 2009 (the “Effective Date”)
by and between Acorda Therapeutics, Inc., a company organized under the
laws of the State of Delaware with its principal place of business at 15
Skyline Drive, Hawthorne, New York 10532, USA (“Acorda”), and Biogen
Idec International GmbH, a company organized under the laws of Switzerland,
with its principal place of business at Landis & Gyr Strasse 3,
CH-6300 Zug, Switzerland (“Licensee”) (hereinafter, each of Licensee and
Acorda, a “Party” and, collectively, the “Parties”).

 

W I T N E S S E T H:

 

WHEREAS, Acorda and Licensee have entered into a
Collaboration and License Agreement of even date herewith (the “License
Agreement”) pursuant to which the Parties will jointly develop Product;

 

WHEREAS, Licensee desires to obtain supplies of Product and
Acorda is willing to supply Product to Licensee, on such terms and conditions
as are set forth herein.

 

NOW THEREFORE, in consideration of the foregoing premises, which
are incorporated into and made a part of this Agreement, and of the mutual
covenants which are recited herein, the Parties agree as follows:

 

1.                                       DEFINITIONS

 

Capitalized
terms used herein and not defined shall have the meaning given thereto in the
License Agreement.  Other terms are
defined as follows:

 

1.1                                 “Acorda” shall have the meaning
set forth in the Preamble.

 

1.2                                 “Acorda Supply Agreements” shall
have the meaning set forth in Section 3.4.

 

1.3                                 “Affiliate” shall mean any Person
who directly or indirectly controls or is controlled by or is under common
control with another Person.  For
purposes of this definition, “control” or “controlled” means ownership,
directly or through one or more Affiliates, of fifty percent (50%) or more of
the shares of stock entitled to vote for the election of directors, in the case
of a corporation, or fifty percent (50%) or more of the equity interest, in the
case of any other type of legal entity, or status as a general partner in any
partnership.  The Parties acknowledge
that, in the case of certain entities organized under the laws of certain
countries, the maximum percentage ownership permitted by Law for a foreign
investor may be less than fifty percent (50%), and in such case such lower percentage
shall be substituted in the preceding sentence; provided, that such
foreign investor has the power to direct the management and policies of such
entity.

 

1.4                                 “Agreement” shall have the meaning
set forth in the Preamble.

 

1.5                                 “Batch” shall mean a specific quantity of Product that is
produced according to a single manufacturing order during the same cycle of
manufacture.

 

 

1.6                                 “Breaching
Party” shall have the meaning set forth in Section 10.2(a).

 

1.7                                 “Business Day” shall mean a day
other than Saturday or Sunday on which the banks in New York, New York and
Boston, Massachusetts are open for business.

 

1.8                                 “Calendar Quarter” shall mean a
calendar quarter ending on the last day of March, June, September or
December.

 

1.9                                 “Calendar Year” shall mean a period
of time commencing on January 1 and ending on the following December 31.

 

1.10                           “cGMP” shall mean current Good
Manufacturing Practices and standards as provided for in the United States Code
of Federal Regulations, and the requirements thereunder imposed by the FDA, all
promulgated and published, and in EC Directive 91/356/EEC of 13 June 1991
as well as EC Directives 2003-94-EC and 2005-28-EC and in accordance with
industry practices.

 

1.11                           “Documentation” shall have the
meaning set forth in Section 5.3(b).

 

1.12                           “Effective Date” shall mean that
date set forth in the Preamble.

 

1.13                           “Elan” shall mean Elan Pharma
International Limited, its successors and assigns and, as applicable, its
Affiliates.

 

1.14                           “Elan Compensating Payment” shall
mean the amount paid or payable to Elan pursuant to Section 9.5 of the
Elan Supply Agreement.

 

1.15                           “Elan Consent” means the consent
among Acorda, Licensee and Elan, dated on or about the Effective Date.

 

1.16                           “Elan Supply Agreement” shall mean
the Supply Agreement between Elan and Acorda, dated September 26, 2003, as
amended from time to time.

 

1.17                           “EMEA” shall mean the European
Medicines Agency or any successor agency thereof.

 

1.18                           “EU” shall mean the European
Union, as it may be expanded or contracted from time to time, Iceland,
Liechtenstein and Norway.

 

1.19                           “Expert Panel” shall have the
meaning given to it in the License Agreement Disputes between the Parties under
this Agreement that are eligible to be referred to an Expert Panel shall be
resolved in accordance with the provisions set forth in Section 3.5(c)(iii) of
the License Agreement.

 

1.20                           “Facility” shall mean Elan’s
manufacturing facility in Monksland, Athlone, Co. Westmeath, Ireland, or such
other facility as Acorda or its Third Party manufacturers may use to perform
Acorda’s obligations under this Agreement.

 

2

 

1.21                           “FDA” shall mean the United States
Food and Drug Administration or any successor agency thereto.

 

1.22                           “Firm Period” shall have the
meaning set forth in Section 4.1(a).

 

1.23                           “Forecast” shall have the meaning
set forth in Section 4.1.

 

1.24                           “JMC” shall have the meaning set
forth in Section 2.2.

 

1.25                           “Latent Defect” shall have the
meaning set forth in Section 5.3(c).

 

1.26                           “Launch Stocks” shall mean the quantities of stocks of the
Product required by Licensee, as determined in accordance with Section 4.4,
in relation to the launch of the Product following Regulatory Approval in a
Major Market Country.

 

1.27                           “Law” shall mean any law, statute,
rule, regulation, government agency guidance, ordinance or other pronouncement
having the effect of law, of any federal, national, multinational, state,
provincial, county, city or other political subdivision, including (a) cGMP,
good clinical practices and adverse event reporting requirements, guidance from
the International Conference on Harmonization or other generally accepted
conventions, and all other rules, regulations and requirements of the FDA and
other applicable Regulatory Authorities, (b) the Foreign Corrupt Practices
Act of 1977, as amended, or any comparable laws in any country, and (c) all
export control laws.

 

1.28                           “License Agreement” shall have the
meaning set forth in the Preamble.

 

1.29                           “Licensee” shall have the meaning
set forth in the Preamble.

 

1.30                           “Major Market Countries” shall
mean the United Kingdom, France, Germany, Italy, Spain and Japan.

 

1.31                           “NDA” shall mean a New Drug
Application filed with the FDA or similar foreign application or submission for
Regulatory Approval, including a MAA.

 

1.32                           “Non-Breaching Party” shall have
the meaning set forth in Section 10.2(a).

 

1.33                           “Party” and “Parties” shall
have the respective meanings set forth in the Preamble.

 

1.34                           “Person” shall mean any
individual, limited or general partnership, corporation, limited liability
company, joint venture, unincorporated organization or association, any trust,
governmental body, authority, bureau or agency, or any other entity or body.

 

1.35                           “Process” or “Processing”
shall mean the act of preparation, filling, testing, packaging, labeling and
any other pharmaceutical manufacturing procedures, or any part thereof
(including, but not limited to, product or process specifications, testing or
test methods, raw material specifications or suppliers, equipment, etc.), relating
to the Product.

 

3

 

1.36                           “Product” shall mean any Licensed
Product (as defined in the License Agreement).

 

1.37                           “Purchase Order” shall mean a
written purchase order delivered by Licensee to Acorda for Products pursuant to
this Agreement.

 

1.38                           “Quality Agreement” shall mean a
quality agreement entered into by Acorda and Licensee, or by Licensee and a
Third Party manufacturer, as described in Section 3.3.

 

1.39                           “Regulatory Authority” shall mean
any applicable government regulatory authority involved in granting approvals
for the marketing and commercial sale of a pharmaceutical or biological product
or medical device in a country or regulatory jurisdiction (including pricing
and/or reimbursement approval in any country in which pricing and/or
reimbursement approval is required by applicable Laws), including the FDA, the
EMEA and foreign equivalents thereof.

 

1.40                           “Second Source Agreement” shall
have the meaning set forth in Section 8.3(b).

 

1.41                           “Semi-Firm Period” shall have the
meaning set forth in Section 4.1(a).

 

1.42                           “Severed Clause” shall have the
meaning set forth in Section 12.8.

 

1.43                           “Specifications” shall mean (a) with
respect to the bulk Licensed Product, the specifications for the bulk Licensed
Product, as determined pursuant to the Elan Supply Agreement and Section 6.3
of the Elan License Agreement and as may be amended in accordance with Section 5.1
of this Agreement, and (b) with respect to the packaging and labeling for
orders of the Licensed Product for sale in a particular country in the
Territory, the specifications therefor mutually agreed upon by the Parties in
accordance with Section 5.1(b).

 

1.44                           “Supply Shortage” shall have the
meaning set forth in Section 4.7.

 

1.45                           “Term” shall have the meaning set
forth in Section 10.1.

 

1.46                           “Third Party” shall mean any
Person who is not a Party or an Affiliate under this Agreement.

 

1.47                           “Transfer Price” shall mean the
price Acorda’s Third Party manufacturer(s) invoices Acorda for Product
Manufactured by such Third Party manufacturer(s) supplied to Licensee
pursuant to the agreement(s) between Acorda and such manufacturer(s).

 

1.48                           Construction. 
In construing this Agreement, unless expressly specified otherwise;

 

(a)                                  references to Sections and Exhibits are
to sections of, and exhibits to, this Agreement;

 

(b)                                 except where the context otherwise
requires, use of either gender includes the other gender, and use of the
singular includes the plural and vice versa;

 

4

 

(c)                                  headings and titles are for convenience
only and do not affect the interpretation of this Agreement;

 

(d)                                 any list or examples following the word “including”
shall be interpreted without limitation to the generality of the preceding
words;

 

(e)                                  except where the context otherwise
requires, the word “or” is used in the inclusive sense;

 

(f)                                    all references to “dollars” or “$” herein
shall mean U.S. Dollars; and

 

(g)                                 each Party represents that it has been
represented by legal counsel in connection with this Agreement and acknowledges
that it has participated in the drafting hereof.  In interpreting and applying the terms and
provisions of this Agreement, the Parties agree that no presumption will apply
against the Party which drafted such terms and provisions.

 

2.                                       COORDINATION; SUPPLY CHAIN MANAGEMENT

 

2.1                                 Relationship Managers.  Each Party shall appoint a manufacturing logistics and
quality assurance manager to support the Parties’ respective manufacturing
activities, and to function as a liaison with the other Party’s manufacturing
logistics and quality assurance manager on matters relating to the manufacture
and supply of the Product pursuant to this Agreement.

 

2.2                                 Joint Manufacturing Committee.

 

(a)                                  The Parties shall establish a joint
manufacturing committee (“JMC”) to oversee the supply of Product to
Licensee in accordance with this Agreement. 
The JMC shall consist of three (3) representatives designated by
each Party.  One (1) representative
from each Party shall alternate in acting as the chairperson of the JMC for one
Calendar Year term, with Acorda’s representative chairing the JMC for the first
Calendar Year.  The chairperson shall not
have any greater authority than any other representative on the JMC.  As soon as practicable following the
Effective Date (but in no event more than thirty (30) days following the
Effective Date), each Party shall designate its initial representatives on the
JMC.  Each Party shall be free to change
its representatives on notice to the other or to send a substitute
representative to any JMC meeting; provided, however, that each
Party shall ensure that at all times during the existence of the JMC, its
representatives on such committee are appropriate in terms of seniority and
expertise with respect to the manufacturing of pharmaceutical products and have
the authority to bind such Party with respect to matters within the purview of
the JMC.  Except as expressly provided in
this Agreement, the JMC shall have no authority to bind the Parties hereunder
and the JMC shall report to the JSC, subject to Section 2.4 of this
Agreement.

 

(b)                                 The JMC shall be responsible for (i) managing
the supply chain for Product in the Territory; (ii) monitoring logistical
strategies, capacity planning and inventory levels for the Product for
Commercialization in the Field in the Territory; and (iii) providing a
forum for the Parties to discuss any material quality-related issues concerning
the Product.

 

5

 

(c)                                  The appointment of members of the JMC is
a right of each Party and not an obligation and shall not be a “deliverable” as
referenced in any existing authoritative accounting literature.  Each Party shall be free to determine not to
appoint members to the JMC.  If a Party
does not appoint members of the JMC, it shall not be a breach of this
Agreement, nor shall any consideration be required to be returned, and unless
and until such persons are appointed, all decisions and obligations within the
purview of the committee shall henceforth be handled directly between the
Parties; provided, that in the event of any disputes between the
Parties, the dispute resolution procedures set forth in Section 2.4(a) shall
continue to apply (substituting in such provision references to “the Parties”
instead of “the JMC”).

 

2.3                                 Meetings.   The JMC
shall hold at least one (1) meeting per Calendar Quarter at such times
during such Calendar Quarter as the chairperson elects to do so.  Meetings of the JMC shall be effective only
if at least one (1) representative of each Party is present or
participating.  The JMC may meet either (a) in
person at either Party’s facilities or at such locations as the Parties may
otherwise agree or (b) by audio or video teleconference; provided,
that no less than one (1) meeting of the JMC during each Calendar Year
shall be conducted in person.  Other
representatives of each Party involved with the Product may attend meetings as
non-voting participants, subject to the confidentiality provisions set forth in
this Agreement.  Additional meetings of
the JMC may also be held with the consent of each Party, or as required under
this Agreement, and neither Party shall unreasonably withhold its consent to
hold such additional meetings.  Each
Party shall be responsible for all of its own expenses incurred in connection
with participating in the JMC meetings.

 

2.4                                 Decision Making; Authority.

 

(a)                                  Approval by the JMC. 
Subject to the provisions of this Section 2.4, the JMC shall
approve matters before it only following a unanimous vote, with each Party
having one (1) vote.  If the JMC
fails to reach unanimous agreement on a matter before it for decision for a
period in excess of thirty (30) days, the matter shall be referred to the JSC
as constituted under and in accordance with the License Agreement and any
dispute that may arise from such matter shall be resolved pursuant to the terms
of Section 3.5 of the License Agreement. 
Notwithstanding anything to the contrary in this Agreement or the
License Agreement, neither any Party, the JSC nor any Expert Panel shall
exercise its right to finally resolve a dispute pursuant to the License
Agreement in a manner that (i) excuses such Party from any of its
obligations specifically enumerated under this Agreement, (ii) negates any
consent rights or other rights specifically allocated to the other Party under
this Agreement, (iii) would cause Acorda to breach an Acorda Third Party
Agreement (including any Acorda Supply Agreement) or to require any Third Party
to take any actions not required to be performed by such Third Party under any
Acorda Third Party Agreement, (iv) increases the Development Plan costs
for the other Party for a given Calendar Year by more than [*****] above the
then current Development Budget for the Calendar Year, or (v) would require
either Party (or require Acorda to require a Third Party)  to perform any act that it (or such Third
Party) reasonably believes to be inconsistent with any Law or any approval,
order, policy or guidelines of a Regulatory Authority; provided, that,
if such decision would require Acorda, in order to comply with such decisions,
to compel the Third Party counterparty to an Acorda Third Party Agreement to
perform any act or to refrain from performing any act, Licensee acknowledges
and agrees that 

 

*****Omitted pursuant to
a confidential treatment request.

 

6

 

Acorda shall only
be obligated to use Commercially Reasonable Efforts to compel such activity or
to refrain from performing such activity. 
The JMC shall have only the powers assigned expressly to it in this
Agreement and shall not have any power to amend, modify or waive compliance
with this Agreement or the Acorda Third Party Agreements.

 

(b)                                 No Limitation on Remedies. 
Nothing in this Section 2.4 shall affect the right of a Party to
exercise its rights or remedies for a breach of this Agreement by the other
Party.

 

2.5                                 Third Party Manufacturers. 
Where this Agreement provides that Acorda shall use Commercially
Reasonable Efforts to obtain the consent of or response from one of its Third
Party manufacturers, then, to the extent that Licensee has been allowed to
interact directly with such Third party Manufacturer with respect to such
matters, Licensee shall also be required to use Commercially Reasonable Efforts
to obtain such result.

 

3.                                       SUPPLY

 

3.1                                 Exclusive Supply. 
Except as expressly provided in this Agreement, Licensee shall
exclusively purchase from Acorda all Product in order to meet Licensee’s and
its Affiliates’ and Third Party Distributors’ requirements of the Product.

 

3.2                                 General Scope of Services. 
Acorda shall use Commercially Reasonable Efforts to manufacture, or
arrange for a Third Party(ies) to manufacture, and supply Licensee’s
requirements of Product for use in the Field in the Territory pursuant to the
License Agreement in final, packaged, labeled form; provided, however,
that the foregoing shall be subject to Acorda’s and its Third Party
manufacturer(s)’ capacity and ability to manufacture such quantities in their
current manufacturing facilities, taking into account Acorda’s and such Third
Party manufacturer(s)’ responsibilities to manufacture the Product for use
outside the Territory or outside the Field and to manufacture other
pharmaceutical products.

 

3.3                                 Quality Agreement. 
Promptly after the Effective Date, the Parties shall negotiate and
execute a “Quality Agreement” specifying the testing, storage, release, cGMP,
regulatory and other quality assurance requirements relating to manufacture and
shipment of Product by or on behalf of Acorda under this Agreement. To the
extent that Acorda or an Acorda Third Party manufacturer supplying Product
hereunder reasonably requests, Licensee shall also enter into a “Quality
Agreement” with such Third Party manufacturer regarding supply of Product.

 

3.4                                 Third Party Manufacturers. 
Licensee acknowledges and agrees that the provisions set forth in this
Agreement are subject to the requirements and limitations of the agreements set
forth in Exhibit A, including the Elan Supply Agreement
(collectively, such agreements, the “Acorda Supply Agreements”).  Exhibit A may be updated by
Acorda from time to time after the date hereof upon Acorda providing to
Licensee true and correct copies of any additional agreements to be listed on
such Exhibit A; provided, however, that Acorda shall,
prior to executing or otherwise agreeing to be bound by any such additional
agreement, (i) supply material drafts, including the final draft, of such
agreement to Licensee for its review, (ii) allow Licensee to comment on
such draft within a reasonable period of time following Licensee’s 

 

7

 

receipt; and (iii) reasonably
consider, in good faith, Licensee’s comments to such draft (but Licensee shall
not have the right to approve such agreement).

 

4.                                       FORECASTS AND ORDERS

 

4.1                                 Forecast.  Commencing
[*****] prior to the anticipated date of first Regulatory Approval in any Major
Market Country, Licensee shall submit to Acorda on or before the first Business
Day of each month a [*****] rolling forecast that sets forth the total quantity
of Product for supply that Licensee either has ordered, desires to order, or
expects to order from Acorda within the next [*****] period (the “Forecast”).
In the Forecast, Licensee shall include a breakdown of the total quantity of
Product forecast on a month-by-month and country-by-country basis.

 

(a)                                  Firm Period and Semi-Firm Period. 
Once Regulatory Approval for the Product has been received in a Major
Market Country or the United States, the monthly breakdown of the [*****] of
the Forecast shall include a firm, irrevocable order for the first [*****] of
the Forecast (“Firm Period”), which shall be the subject of a binding
Purchase Order delivered in accordance with Section 4.5.  For purposes of clarity, in the event that a
Forecast delivered to Acorda in accordance with the terms of this Agreement
lists a total quantity of Product for supply for each of the first [*****] of
such Forecast as zero (0), the Firm Order for such [*****] period shall be for
a quantity of zero (0).  The next [*****]
of the Forecast period shall be a semi-firm period that is non-binding (“Semi-Firm
Period”); provided, that, subject to Section 4.3(c), if
Licensee requests more than a [*****] increase in the ordered quantities of Product
for such Semi-Firm Period, Acorda shall have the right to change the lead time
for delivery of the Product if such a change is commercially reasonable given
the increase in ordered Product quantity. 
The remainder of the Forecast is non-binding.

 

4.2                                 Long-Term Forecast. 
Not later than July 1st in each Calendar Year, Licensee shall provide
Acorda a [*****] forecast of its estimated requirements of the Product, broken
down on an annual basis.  For the
avoidance of doubt, except with respect to any Firm Period included in such
[*****] forecast and subject to Section 4.3(c), any long-term forecast
provided by Licensee under this Section 4.2 shall be non-binding.

 

4.3                                 Amending Forecasts. 
Any portion of the Forecast that is not a Firm Period is to be considered
an estimated forecast to be used for planning purposes, and shall not be
construed as a firm commitment by Licensee to Acorda; rather, it can be
increased or reduced by Licensee from time to time; provided, however,
that (a) Licensee may not decrease the quantities specified in any
Forecast with respect to any Firm Period; (b) if Licensee increases the
quantities specified in any Forecast with respect to any Firm Period, Acorda
shall use Commercially Reasonable Efforts (having regard to its and its Third
Party manufacturers’ manufacturing capacity and ability), but shall not be
obligated, to supply such additional Product; and (c) Licensee may not
increase or decrease by more than [*****] in the aggregate the amount of
Product required in a Calendar Quarter compared to the previous Calendar
Quarter, except for Launch Stocks or unless otherwise agreed by Acorda.

 

4.4                                 Launch Stocks. 
At least
[*****] prior to an anticipated Regulatory Approval in a Major Market Country,
the Parties shall discuss and agree upon the manufacture and purchase of 

 

*****Omitted pursuant to
a confidential treatment request.

 

8

 

specific
quantities of Launch Stocks for launch of the Product in the applicable Major
Market Country.  Launch Stocks shall be
ordered not later than [*****] from receipt by Licensee of an approval letter
from a Regulatory Authority in respect of an NDA in a Major Market Country.

 

4.5                                 Purchase Orders.

 

(a)                                  General.  Licensee
shall accompany its monthly update of the Forecast with a Purchase Order for
each Firm Period for which Product has not been previously ordered or for which
additional Product is required; provided, that in the event the Forecast
contains a binding forecast for Launch Stocks pursuant to Section 4.4, the
Purchase Order shall also contain an order for the Launch Stocks.  Each Purchase Order shall specify the Product
ordered, the quantity of Product ordered and the time, manner and address of
delivery, all of which shall be subject to this Article 4 and Section 6.1.  In order for the Product to be properly
labeled and packaged, each such Purchase Order shall specify the countries in
which the Product from such order shall be marketed or sold, the quantity of
Product from such Purchase Order destined for each such country and the
quantity of Product for promotional and sample use.  Each Purchase Order shall also specify the
requested date of delivery and the delivery destination.

 

(b)                                 Terms.  Purchase
Orders issued by Licensee or its Affiliates shall be effective solely with
respect to specifying the quantity, requested delivery date (subject to the
terms of this Agreement) and means of shipment of the Product being
ordered.  All other terms and conditions printed
or included on such Purchase Orders shall be of no effect or force.

 

(c)                                  Rejection of Purchase Orders. 
Within [*****] of receipt, Acorda shall have the right to reject any
Purchase Order issued by Licensee that Acorda reasonably believes to be
materially inconsistent with the terms of this Agreement.  Subject to Acorda’s obligation set forth in Section 4.3
to use Commercially Reasonable Efforts to address fluctuations in Licensee’s
Product demand, if Acorda reasonably believes that a Purchase Order is
materially inconsistent with the forecasted quantities of the Firm Period
and/or the Launch Stocks, it shall have the right to reject such Purchase
Order; provided, that Acorda shall reject no Purchase Order solely on
the basis of quantity so long as the quantity specified in such Purchase Order
is within the amount required to be ordered hereunder.

 

4.6                                 Fulfillment of Purchase Orders. 
Except as otherwise provided in this Agreement, Acorda shall use
Commercially Reasonable Efforts to produce and supply to Licensee its
requirements of the Product as set forth in and in response to Purchase Orders,
within [*****] of the Purchase Order (or such later delivery date as set forth
in the Purchase Order), or [*****] for Launch Stocks or samples (or such later
delivery date as set forth in the Purchase Order and subject to any required
extension due to the lead times of specific components of samples).  Notwithstanding the foregoing, Acorda shall
have no obligation to supply Product, unless otherwise mutually agreed upon by
the Parties:

 

(a)                                  for any Firm Period, in excess of
Licensee’s Forecast for such Firm Period (but Acorda will nevertheless use its
Commercially Reasonable Efforts to fulfill Licensee’s requirements in excess of
such amounts, having regard to its and its Third Party manufacturers’ manufacturing
capacity and ability);

 

*****Omitted pursuant to
a confidential treatment request.

 

9

 

(b)                                 for less than a minimum order of [*****],
or such other minimum amount as may be required by Acorda’s Third Party
manufacturers.

 

(c)                                  in partial Batches;

 

(d)                                 where Product is supplied by Elan and
where [*****] of the Manufacturing Cost (as defined in the Elan Supply
Agreement) would exceed the Transfer Price; provided, that in such case,
Acorda shall use Commercially Reasonable Efforts to supply Product using a
Second Source (as defined in the Elan Supply Agreement); or

 

(e)                                  pursuant to a Purchase Order which does
not conform in all material respects to the terms of this Agreement; provided,
that, if Acorda does supply Product pursuant to such a Purchase Order in its
absolute discretion, that fulfillment shall not affect Acorda’s right to refuse
to fulfill any subsequent Purchase Order which does not comply in all material
respects with this Agreement.

 

4.7                                 Supply Uncertainty. 
Acorda shall, within [*****] after receipt of Licensee’ Forecast, notify
Licensee if it becomes aware or believes that, based on the Forecasts submitted
by Licensee, any shortage of supply of Product to Licensee will occur (such
shortage, a “Supply Shortage”). 
The Parties, through the JMC, shall discuss the reasons for the
anticipated Supply Shortage.  Unless
otherwise mutually agreed upon by the Parties, in the event Acorda has a Supply
Shortage, available Product supply shall be allocated between the Parties on a
pro-rata basis, each Party to receive a percentage of Product supply equal to
the percentage of dosage units of Product purchased by such Party and its
Affiliates during the previous [*****] period as compared to the aggregate
dosage units of Product purchased by both Parties and their respective
Affiliates during such period; provided, that, in the event the Supply
Shortage occurs within the first Firm Period or the [*****] period following
the first Firm Period, available Product supply shall be allocated between the
Parties on a pro-rata basis based on the good faith forecasts submitted by each
Party for such time period.  Nothing in
this Section 4.7 shall limit, modify or replace Licensee’s remedies under
this Agreement in the event of a Supply Shortage.

 

4.8                                 Safety Stock. 
Licensee shall: (a) prior to the Regulatory Approval of Product in
the Field in any country in the Territory and until [*****] after such
Regulatory Approval, maintain, at its own risk and expense, Launch Stock of
[*****] supply of Product, measured, as of any date, based on Licensee’s
Forecast; and (b) beginning [*****] after Regulatory Approval of Product
in the Field in any country in the Territory has been obtained, maintain, at
its own risk and expense, safety stock of [*****] supply of Product, measured,
as of any date, by the Purchase Orders delivered to Acorda by Licensee during
the immediately preceding [*****].

 

5.                                       PRODUCTION

 

5.1                                 Specifications.

 

(a)                                  The Specifications for the bulk Licensed
Product may, subject to the Acorda Supply Agreements and Section 6.3 of
the Elan License Agreement, be amended by the JMC or as otherwise mutually
agreed by the Parties.

 

*****Omitted pursuant to
a confidential treatment request.

 

10

 

(b)                                 Licensee shall propose the necessary
Specifications for packaging and labeling of the Product for each country in
the Territory.  Acorda, in consultation
with its Third Party manufacturers, shall review and approve all such
Specifications for packaging and labeling, such approval not to be unreasonably
withheld; provided, that, (i) such Specifications shall require
Elan’s approval, which Acorda shall use Commercially Reasonable Efforts to
obtain, and (ii) Acorda shall not be required to approve any Specifications
if (A) such approval would be a violation under any Acorda Third Party
Agreements or (B) Acorda reasonably believes that such Specifications
would adversely affect the Commercialization or the specifications of the
Licensed Product in the Acorda Territory. 
Licensee shall bear [*****] costs and expenses to obtain approval of any
Regulatory Authority in the Territory with respect to such packaging and
labeling.

 

5.2                                 Changes to the Specifications, Processing
or the Facility.

 

(a)                                  Changes.  Acorda or its
Third Party manufacturers may make such changes to the Specifications,
Processing or the Facility as are required pursuant to applicable Law or to
comply with Regulatory Approvals; provided, that Acorda shall have
promptly notified Licensee upon Acorda becoming aware of such required change,
and provided, further, that Licensee shall have the reasonable
opportunity to dispute the necessity of such change prior to such change’s
adoption by Acorda or its Third Party manufacturers.

 

(i)                                     Changes Specific to Product in Territory. 
Subject to Section 5.2(a), to the extent that changes to the
Specifications, Processing and/or Facility are required pursuant to Law or
Regulatory Approvals applicable solely to the Product in the Territory, costs
incurred for such changes with respect to the Product in the Territory shall be
paid [*****] by Licensee.

 

(ii)                                  Changes Specific to Product in Acorda’s
Territory.  To the extent that changes to the
Specifications, Processing and/or Facility are required pursuant to Law or
Regulatory Approvals applicable solely to the Product in the Acorda Territory,
costs incurred for such changes with respect to the Product in the Acorda
Territory shall be paid [*****] by Acorda; and, for clarity, nothing in this
Agreement shall preclude Acorda from making any such changes.

 

(iii)                               Non-Specific or Joint Changes. 
Subject to Section 5.2(a), to the extent that (A) changes to
the Specifications, Processing and/or Facility are required pursuant to Law or
Regulatory Approvals applicable to the Product worldwide; (B) Licensee
requests that a change made pursuant to Section 5.2(a)(ii) be also
made for the Product in the Territory; or (C) Acorda requests that a
change made pursuant to Section 5.2(a)(i) be also made for the
Product in the Acorda Territory, each Party shall pay [*****] of the costs
incurred for such changes, based upon the mutually agreed upon anticipated
sales of Product, as between Acorda and Licensee, over the next [*****] period.

 

(b)                                 Notice of Required Changes. 
If either Party is notified of or otherwise learns of any change in Laws
or Regulatory Approvals in any country in which a Party and/or its Affiliates
or Licensee’s Third Party Distributors are, or are reasonably anticipating,
marketing or selling the Product, which change would or could require a change
to Specifications in such

 

*****Omitted pursuant to
a confidential treatment request.

 

11

 

country, the
notified Party shall promptly notify the other Party of such change in Laws or
Regulatory Approvals and, if such change will affect the Product in the
Territory, the Parties shall negotiate in good faith a written agreement
regarding the extent and timing of such change.

 

(c)                                  Changes Requested by Licensee. 
Notwithstanding Section 5.1(a), if Licensee, on behalf of itself or
any of its Affiliates, requests any change to Specifications which is not
required by a change in Laws or Regulatory Approvals in any such country,
Acorda may, in its discretion, consider such request.  Acorda shall consider such request in
accordance with the License Agreement as a proposed amendment to the
Development Plan or as a Development Collaboration Proposal.  All costs with respect thereto shall be borne
as “Development Costs” in accordance with the License Agreement.  Licensee shall reasonably cooperate with
Acorda and its Third Party manufacturers in obtaining any approvals necessary
for such requested changes.

 

(d)                                 Changes to the Process or Facility. 
Licensee acknowledges that Elan has the right to change the Process or
Facility pursuant to Section 3.6 of the Elan Supply Agreement.

 

5.3                                 Quality Assurance.

 

(a)                                  Acorda shall use Commercially Reasonable
Efforts to obtain from its Third Party manufacturer(s) supplying Product
for Licensee representations and warranties for the benefit of Licensee that,
as of the date of physical transfer of each order of Product to Licensee, such
Product (i) was manufactured in accordance with cGMP and all applicable
Laws in all material respects; (ii) conforms in all material respects to
the applicable Specifications; and (iii) does not contain any material
that would cause the Product to be adulterated or misbranded under applicable
Law.

 

(b)                                 Documentation. 
Acorda or its Third Party manufacturer shall deliver with each shipment
of Product (i) a Certificate of Analysis for the Product and (ii) the
batch records for such Product (clauses (i) and (ii) of this
sentence, collectively, the “Documentation”).

 

(c)                                  Non-Conforming Product. 
Subject to Elan’s rights under Clause 6 of the Elan Supply Agreement and
the rights of the Second Source (as defined in the Elan Supply Agreement) under
any Acorda Supply Agreement, including the mechanisms and time frames for the
resolution of any disputes:

 

(i)                                     Within (A) [*****] after delivery of
an order of Product to Licensee or (B) [*****] of Licensee’s discovery of
an issue with Product following Licensee’s acceptance of Product which issue
cannot be ascertained by reviewing the Documentation or the exercise of
reasonable diligence (including the performance of the routine testing protocol
to be agreed in the Quality Agreement) by Licensee upon receipt of such Product
(such issue, a “Latent Defect”), Licensee shall notify Acorda in writing
if such Product does not comply with the Specifications at the time of delivery
to Licensee and shall provide Acorda with reasonable details of the alleged
non-conformance and supporting evidence and upon Acorda’s request permit Acorda
to re-test the Product.  Licensee shall
only make such claims in good faith.   If
Licensee does not make a claim within such [*****] period, Licensee shall be
deemed to have accepted the Product.

 

*****Omitted pursuant to
a confidential treatment request.

 

12

 

(ii)                                  If Acorda does not agree with the
substantiating evidence provided by Licensee, Acorda shall provide Licensee
with a written notice of such disagreement within twenty-five (25) days of
receipt of Licensee’s notice of non-conformance, responding to Licensee’s
claim.  The Parties shall use
Commercially Reasonable Efforts to resolve such disagreement within ten (10) days
of Licensee’s receipt of notice from Acorda of such disagreement.  In the event of an unresolved dispute as to (A) conformity
of the Product with Specifications; or (B) whether defects in the Product
are attributable to the negligent acts or omissions of Acorda or its Third
Party manufacturers of Product, the Parties shall, within thirty (30) days
after expiration of such ten (10) day period, appoint a mutually
acceptable independent laboratory to undertake the relevant testing and its
findings shall be conclusive and binding upon the Parties.  All costs relating to this process shall be
borne solely by the Party whose testing was in error.

 

(iii)                               If the Parties agree or the independent laboratory’s
analysis confirms that Licensee’s complaint was valid, Acorda shall use
Commercially Reasonable Efforts to supply to Licensee, as promptly as
reasonably practicable, the remaining quantity of the Product conforming to the
relevant Specifications.  If Licensee has
already paid for the conforming quantity of Product Acorda initially failed to
supply, then such additional or replacement quantity shall be provided by Acorda
at no additional cost to Licensee; otherwise, Acorda shall invoice Licensee for
such conforming Product in accordance with Section 6.2.

 

(iv)                              Any nonconforming Product shall either be
destroyed by Licensee or returned to Acorda for destruction by Acorda,
according to Acorda’s instructions.  In
the event that the nonconformity was solely due to a fault of Licensee, then
Licensee shall bear all costs of such destruction or return and Licensee shall
not be entitled to any credit as to the non-conforming Product; in the event
that the nonconformity was solely due to a fault of Acorda, then Acorda shall
bear all costs of such destruction or return; and otherwise, the Parties shall
equally share such costs.

 

(v)                                 The Product shelf-life shall be as set
forth in the Technical Agreement (as defined in the Elan Supply Agreement).

 

(d)                                 THE PROVISIONS HEREIN SHALL BE ACORDA’S
EXCLUSIVE LIABILITY AND LICENSEE’S SOLE REMEDY WITH RESPECT TO ACORDA’S FAILURE
TO SUPPLY THE ORDERED QUANTITIES OF PRODUCT CONFORMING TO THE SPECIFICATIONS
AND THE WARRANTIES HEREUNDER.

 

5.4                                 Preservation of Samples. 
Licensee shall retain and store preservation samples from each lot
number of Product received by Licensee hereunder for a period of no less than
[*****] after the expiration date of the Product, in accordance with Law.

 

6.                                       DELIVERY AND PAYMENT

 

6.1                                 Delivery.  The delivery
dates for Product shall be as mutually agreed upon by the Parties; provided,
however, that any delivery date for any order of Product will be
determined based on the manufacturing runs of Product scheduled by Acorda and
its Third Party manufacturer(s) and any delay in delivery as a result of
the scheduling of such manufacturing 

 

*****Omitted pursuant to
a confidential treatment request.

 

13

 

runs shall not be a breach of this Agreement by Acorda.  Acorda shall deliver Product ordered in the
relevant Purchase Order, according to Incoterms 2000 EXW (“ex-works”) the
Facility or a distribution warehouse designated by Acorda, in Acorda’s sole
discretion.  Title to the delivered
quantity of Product shall pass to Licensee or its designee upon such delivery.

 

6.2                                 Price and Reimbursements. 
The price for Product shall be the Transfer Price.  Upon shipment of the Product, Acorda shall
issue an invoice for such shipment.  Such
invoice shall list separately those expenses subject to reimbursement by
Licensee under this Agreement.

 

6.3                                 Elan Compensating Payment and Acorda
Costs.

 

(a)                                  Licensee shall pay Acorda the percentage
of the Elan Compensating Payment that is equal to the percentage of Product
supplied to Licensee that was manufactured by the Second Source (as defined in
the Elan Supply Agreement).  If such Elan
Compensating Payment is payable by Licensee, the calculation of such amount
shall be included on an invoice from Acorda for such payment.

 

(b)                                 All costs and expenses, including
internal costs, incurred by Acorda or its Affiliates in connection with the
supply of Product to Licensee, its Affiliates and Third Party Distributors
hereunder shall be reimbursed by Licensee.

 

(c)                                  For the sake of clarity, Licensee shall
pay to Acorda, if applicable, any remaining amount which is payable to Elan
pursuant to Section 9.3.3 of the Elan Supply Agreement, reflecting the
difference between the amount due pursuant to the actual NSP (as defined in the
Elan License Agreement) and the initial portion of the Transfer Price invoiced
upon supply of the Licensed Product (based on the then-applicable Notional NSP,
as defined in the Elan License Agreement). 
Licensee shall pay Acorda such amount within thirty (30) days after the
end of the relevant Calendar Quarter, or, if earlier, at least five (5) Business
Days before such time as such payment is owed to Elan. To the extent that such
difference is negative, reflecting an initial overpayment by Licensee, Acorda
shall credit such difference against the price of Licensed Product to be
supplied to Licensee to the extent of any credit provided by Elan.

 

6.4                                 Remittance of Payments. 
For the first two (2) years following the first commercial sale of
the Product in any country, all payments from Licensee to Acorda hereunder
shall be due within forty-five (45) days after Licensee’s receipt of an invoice
therefor.  Thereafter, payment shall be
made within twenty (20) days after Licensee’s receipt of an invoice
therefor.  Payments made more than twenty
(20) days after the due date shall bear interest per month in an amount equal
to [*****] from the due date until paid in full or, if less, the maximum
interest rate permitted by applicable Law. 
Notwithstanding anything in this Section 6.4 to the contrary, no
interest shall accrue on any payment disputed in good faith by Licensee until
such payment dispute has been resolved, at which time, if Licensee is found to
have erroneously withheld such payment, interest will be deemed to have accrued
as of the due date.  In addition,
Licensee shall reimburse Acorda for all costs and expenses, including
reasonable attorney fees and legal expenses, incurred in the collection of late
payments

 

6.5                                 Tax Withholding. 
Licensee shall inform Acorda of any withholding tax obligation on
payments due to Acorda under this Agreement as soon as Licensee becomes aware 

 

*****Omitted pursuant to
a confidential treatment request.

 

14

 

of the withholding tax obligation. 
The Parties shall meet promptly thereafter to discuss how best to
minimize the amount of such withholding tax obligation in accordance with Law,
and Licensee shall take all reasonable and lawful steps to minimize the amount
of any such withholding tax obligation. 
The Parties agree to cooperate in good faith to provide one another with
such documents and certifications as are reasonably necessary to enable
Licensee and Acorda to minimize and/or recover any withholding tax
obligation.  Upon Acorda’s request,
Licensee shall provide to Acorda documentation of the payment of any
withholding tax that is paid pursuant to this Section 6.5.

 

6.6                                 VAT.   All prices
for the Product and other amounts in this Agreement are exclusive of any
applicable value added or any other sales tax, for which Licensee will be
additionally liable, if payable.

 

7.                                       REGULATORY

 

7.1                                 Information Provided to Manufacturers. 
Acorda may fully disclose to its Affiliates and to its Third Party
manufacturers of the Product hereunder (a) any Regulatory Approvals or
other information necessary for such Affiliates or Third Party manufacturers to
comply with any reporting requirements or to fulfill obligations under any
supply agreement with Acorda; or (b) any information regarding
non-conforming Products or safety issues regarding Products, including all
communications with Regulatory Authorities with respect thereto.  Acorda shall promptly disclose to Licensee
all materials described in clause (b) of the preceding sentence that could
have a significant impact on Product in the Field in the Territory, including
copies of the related communications with Regulatory Authorities disclosed by
Acorda to Acorda’s Affiliates and Third Party manufacturers.  Subject to any relevant Third Party
manufacturer’s consent, at either Party’s request, Licensee (and to the extent
requested by either Party, its Affiliates and Third Party Distributors) shall
participate in discussions with Acorda, its Affiliates and Third Party manufacturers
regarding such Products or safety requests received from Regulatory
Authorities.  Licensee shall, and shall
ensure that its Affiliates and Third Party Distributors, otherwise cooperate
with Acorda, its Affiliates and Third Party manufacturers to resolve any issues
with respect to this Section 7.1. 
Each Party shall, and shall ensure that its Affiliates and in the case
of Acorda, its licensees (other than Licensee), and in the case of Licensee,
its Third Party Distributors, provide information for the worldwide safety
database referred to in Section 6.2(a) of the License Agreement as
described in and required by such section.

 

7.2                                 Governmental Inspection. 
Each Party shall advise the other of any governmental communication,
inspection or report which addresses or affects the Product promptly after
becoming aware of it and the JMC shall take action at its next meeting (or, if
applicable, the Parties as soon as practicable shall meet) to determine the
Parties’ response to such governmental communication, inspection or report.

 

7.3                                 Right of Inspection. 
No more than [*****] during the Term and upon thirty (30) days’ prior
written notice to Acorda, Licensee shall have the right to inspect, during
Acorda’s normal business, Acorda’s facilities (including, as permitted under
any Acorda Supply Agreement, any Third Party manufacturer’s facilities) and
documentation relating to Acorda’s performance hereunder; provided,
that, to the extent Licensee identifies any issues during such 

 

*****Omitted pursuant to
a confidential treatment request.

 

15

 

inspections
that would reasonably be expected to have a material adverse effect on Product
for supply in the Territory, Licensee may, as permitted under the relevant
Acorda Supply Agreement, conduct a follow-up inspection as reasonably necessary
to assure quality of the Product and to conduct quality compliance audits (and
enable any relevant Regulatory Authorities to do so, if necessary).  Acorda agrees to use Commercially Reasonable
Efforts to correct, and cause to be corrected, all material deficiencies
identified by Licensee.

 

7.4                                 Records.

 

(a)                                  Financial Records. 
Acorda shall maintain records with respect to its costs under this
Agreement.  Specifically, Acorda shall
maintain all of its records reasonably necessary to support charges to Licensee
pursuant to Section 6.  To the
extent Licensee reasonably believes that there has been an overcharge for any
amounts due hereunder, [*****] all such records shall be available for
inspection, audit and copying by Licensee’s independent Third Party auditors,
upon reasonable request during normal business hours.  The results of such audit shall be made
available to Acorda and shall be considered Acorda’s Confidential
Information.  Licensee shall bear the
costs of such audit, except as provided below. 
If an audit under this Section 7.4(a) shows any overpayment by
Licensee, Acorda shall remit to Licensee within thirty (30) days after the
results of the audit are delivered, the amount of such overpayment and, if such
overpayment exceeds five percent (5%) of the total amount owed for the period
then being audited, the fees and expenses of Licensee’s auditors for such
audit.  All such records shall be
maintained for at least [*****] after the end of the Calendar Year to which
such records relate, or such longer period as may be required by applicable
Law.

 

(b)                                 Product Records. 
Acorda shall maintain all records necessary for it to comply with
applicable Law with respect to its obligations under this Agreement.  All such records shall be available for
inspection, audit and copying by Licensee and its representatives and agents,
including Licensee’s auditors, at no cost to Licensee, upon reasonable request
during normal business hours.  All such
records shall be maintained for the longest period as may be required by
applicable Law and prior to destruction of any record, Acorda shall give notice
to Licensee, which shall have the right to request and retain such record.

 

8.                                       REPRESENTATIONS AND WARRANTIES

 

8.1                                 Mutual Representations and Warranties. 
Each Party warrants to the other Party that:

 

(a)                                  as of the Effective Date, it is a
corporation duly organized and in good standing under the Laws of the
jurisdiction of its incorporation, and it has full power and authority and the
legal right to own and operate its property and assets and to carry on its
business as it is now being conducted and as it is contemplated to be conducted
by this Agreement;

 

(b)                                 as of the Effective Date, it has the full
right, power and authority to enter into this Agreement and to grant the rights
granted by it under this Agreement;

 

*****Omitted pursuant to
a confidential treatment request.

 

16

 

(c)                                  as of the Effective Date, there are no
existing or, to its knowledge, threatened actions, suits or claims pending with
respect to the subject matter of this Agreement or its right to enter into and
perform its obligations under this Agreement;

 

(d)                                 as of the Effective Date, it has taken
all necessary action on its part to authorize the execution and delivery of
this Agreement and the performance of its obligations under this Agreement;

 

(e)                                  this Agreement has been duly executed and
delivered on behalf of it, and constitutes a legal, valid, binding obligation,
enforceable against it in accordance with the terms hereof, subject to the
general principles of equity and to bankruptcy, insolvency, moratorium and
other similar Laws affecting the enforcement of creditors’ rights generally;

 

(f)                                    as of the Effective Date, all necessary
consents, approvals and authorizations of all regulatory and governmental
authorities and other Persons required to be obtained by it in connection with
the execution and delivery of this Agreement and the performance of its
obligations under this Agreement have been obtained; and

 

(g)                                 the execution and delivery of this
Agreement and the performance of its obligations hereunder do not conflict with
any of its contractual obligations (except that Acorda makes no representation
or warranty with respect to its obligations pursuant to Acorda Third Party
Agreements) and do not constitute a default under any of its contractual
obligations.

 

8.2                                 Additional Representations and Warranties
of Acorda.  In addition to the representations and
warranties made by Acorda in the License Agreement, Acorda represents and
warrants that Exhibit A identifies each of the Acorda Supply
Agreements that is in full force and effect as of the Effective Date and Acorda
has provided Licensee full and complete copies of each such Acorda Supply
Agreement

 

8.3                                 Additional Covenants of Acorda. 
Acorda agrees that during the Term:

 

(a)                                  Acorda shall
comply with and give all notices required by any applicable Law relating to
Acorda’s performance of this Agreement;

 

(b)                                 Acorda will use Commercially Reasonable
Efforts to, within one hundred and eighty (180) days following the Effective
Date, enter into an agreement with the Second Source (as defined in the Elan
Supply Agreement) governing the supply of Product (the “Second Source
Agreement”) to Acorda (including in the event that Elan no longer supplies
Acorda under the Elan Supply Agreement) and Licensee shall have the right to
review and comment on (but not approve) any such agreement before its execution;

 

(c)                                  Upon Acorda’s execution of the Second
Source Agreement, it shall provide Licensee with a true and complete copy of
such agreement and, in accordance with Section 3.4, Exhibit A to this
Agreement will be amended to include the Second Source Agreement as an Acorda
Supply Agreement; and

 

17

 

(d)                                 Acorda shall use Commercially Reasonable
Efforts to fulfill its obligations under the Acorda Supply Agreements to the
extent such obligations have not been delegated to Licensee and to the extent
that failure to do so would materially adversely affect Licensee or its rights
hereunder.

 

8.4                                 Disclaimer.  EXCEPT AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT OR IN THE LICENSE AGREEMENT,
NEITHER PARTY, AND IN THE CASE OF ACORDA, ITS LICENSORS AND THIRD PARTY
MANUFACTURERS, MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, QUALITY,
FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR VALIDITY OF PATENT
CLAIMS.

 

8.5                                 Limitation of Damages. 
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT AND THE LICENSE
AGREEMENT, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES
FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL EXEMPLARY, PUNITIVE, MULTIPLE OR OTHER
INDIRECT DAMAGES, OR FOR LOSS OF PROFITS, LOSS OF DATA, LOSS OF REVENUE, OR
LOSS OF USE DAMAGES, ARISING FROM OR RELATING TO THIS AGREEMENT, WHETHER BASED
UPON WARRANTY, CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE,
REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 8.5 IS
INTENDED TO LIMIT OR RESTRICT THE CONFIDENTIALITY OR INDEMNIFICATION RIGHTS OR
OBLIGATIONS OF EITHER PARTY UNDER THIS AGREEMENT OR THE LICENSE AGREEMENT.

 

9.                                       CONFIDENTIALITY

 

All information provided by one Party to the other
Party in connection with this Agreement (including the Specifications,
Documentations and Forecasts) is subject to the confidentiality and non-use
obligations under Article 10 of the License Agreement, which are hereby
incorporated into this Agreement by reference.

 

10.                                 TERM AND TERMINATION

 

10.1                           Term.  This
Agreement shall be in effect from the Effective Date and shall continue in
effect until terminated pursuant to Section 10.2 (the “Term”).

 

10.2                           Termination. 
This Agreement may be terminated in accordance with the following
sections:

 

(a)                                  Breach.  If either
Party (the “Non-Breaching Party”) believes that the other Party (the “Breaching
Party”) is in material breach of this Agreement (including any breach of a payment
obligation), then the Non-Breaching Party may deliver notice of such breach to
the Breaching Party.  If the Breaching
Party fails to cure such breach within the sixty (60) day period (thirty (30)
days in the event of a payment breach) after the Breaching Party’s receipt of
such notice, the Non-Breaching Party may terminate this Agreement in its
entirety upon written notice to the Breaching Party.

 

18

 

(b)                                 Insolvency.  To the extent
permitted under applicable Law, either Party may terminate this Agreement
effective immediately upon written notice (i) if proceedings in voluntary
or involuntary bankruptcy shall be initiated by, on behalf of or against the
other Party (and, in the case of any such involuntary proceeding, not dismissed
within one hundred twenty (120) days), or (ii) if the other Party is
adjudicated bankrupt, files a petition under insolvency Laws, is dissolved or
has a receiver appointed for substantially all of its property.

 

(c)                                  Termination of License Agreement. 
This Agreement shall automatically terminate upon the expiration or termination
of the License Agreement.

 

10.3                           Rights Upon Termination.

 

(a)                                  In the event this Agreement is terminated
pursuant to Section 10.2, (i) any and all outstanding undisputed
payments due from Licensee for Product under Purchase Orders already delivered
by Acorda in accordance with this Agreement shall become immediately due and
payable and (ii) in accordance with Section 6.2, Licensee shall be
responsible for paying the Transfer Price invoiced to Acorda by its Third Party
manufacturers for any Product ordered under any Purchase Order delivered to
Acorda as of the date of such termination.

 

(b)                                 In the event this Agreement is terminated
by Licensee pursuant to Section 10.2(a), upon Licensee’s request, Acorda
will agree to waive the exclusivity requirement pursuant to Section 2.2 of
the Elan Supply Agreement solely in order to permit Licensee to negotiate terms
with Elan for the supply of Product to Licensee in the Territory; provided,
that nothing in this Section 10.3 shall impose any obligation on Elan to
enter into negotiations with Licensee to supply Licensee Product.

 

10.4                           Effect of Termination. 
Termination of this Agreement for any reason is without prejudice to the
Parties’ accrued rights and shall not be construed to release either Party of
any obligation matured prior to the effective date of such termination.

 

10.5                           Survival.  The following
provisions shall survive the expiration or termination of this Agreement:  Articles 9, 11 and 12, and Sections 5.3(d),
5.4, 6.4, 6.5, 6.6, 8.4, 8.5, 10.3, 10.4 and 10.5.

 

11.                                 GOVERNING LAW

 

11.1                           Governing Law. This Agreement shall be governed by and
construed in accordance with the laws of the State of New York, excluding (a) any
principle of conflict or choice of laws choice of laws that would cause the
application of the Laws of any other jurisdiction; (b) the United Nations
Convention on Contracts for the International Sale of Goods; (c) the 1974
Convention on the Limitation Period in the International Sale of Goods; and (d) the
Protocol amending the 1974 Convention on the Limitation Period in the
International Sale of Goods, done at Vienna, April 11, 1980.

 

11.2                           Dispute Resolution. 
With respect to any disputes between the Parties concerning this
Agreement which are not resolved pursuant to Section 2.4 or as otherwise
explicitly set forth 

 

19

 

in this Agreement
or the License Agreement, each Party will be free to pursue all rights
available to it under law or equity.

 

12.                                 MISCELLANEOUS

 

12.1                           Notices.  Notices to Licensee
shall be addressed to:

 

Biogen Idec International GmbH 

Landis & Gyr Strasse 3 

CH-6300 Zug, Switzerland 

Attention: Francis Marsland, VP Chief International Counsel 

Fax: +41 41 392 1718

 

With a copy to:

 

Biogen Idec, Inc.

14 Cambridge Center

Cambridge, MA 02142

Attention : General Counsel

Fax: 866-546-2758

 

Notices to Acorda shall be addressed to:

 

Acorda Therapeutics, Inc.

15 Skyline Drive

Hawthorne, New York 10532, USA

Attention: 
Chief Executive Officer

Fax:                           +1 914.347.4560

 

With a copy to:

 

Acorda Therapeutics, Inc.

15 Skyline Drive

Hawthorne, New York 10532, USA

Attention: 
General Counsel

Fax:                           +1 914.347.4560

 

Any
Party may change its address by giving notice to the other Party in the manner
provided in this Section 12.1.  Any
notice required or provided for by the terms of this Agreement shall be in
writing, in the English language, and shall be (a) sent by certified or
registered mail, return receipt requested, postage prepaid, (b) sent via a
reputable overnight international courier service, (c) sent by facsimile
transmission, or (d) delivered by hand. 
The effective date of the notice shall be the actual date of receipt by
the receiving Party.

 

12.2                           Entire Agreement. 
This Agreement, the License Agreement and the Elan Consent constitute
the entire agreement among the Parties with respect to the subject matter
herein and therein and supersede all previous agreements (including the Prior
Confidentiality Agreement), whether written or oral, with respect to such
subject matter.

 

20

 

12.3                           Amendment and Waiver. 
This Agreement may not be amended, nor any rights hereunder waived,
except in a writing signed by the properly authorized representatives of each
Party.

 

12.4                           No Implied Waivers. 
The waiver by a Party of a breach of any provision of this Agreement by
the other Party shall not be construed as a waiver of any succeeding breach of
the same or any other provision, nor shall any delay or omission on the part of
a Party to exercise or avail itself of any right that it has or may have
hereunder operate as a waiver of any right by such Party.

 

12.5                           Order of Precedence. 
In the event of a conflict or inconsistency between any of the terms of
this Agreement (including all attachments and exhibits) and the License
Agreement, the Parties shall enter into good faith discussions regarding the
intended interpretation of the terms underlying such inconsistency or conflict
and, if such dispute cannot be resolved by the Parties within thirty (30) days,
each Party shall have available to it all rights under Section 11.2.  Any amendments to these documents on which
the Parties may agree to in accordance with the terms of each document shall
take precedence over any conflicting terms in the prior release of each document.  Each Party shall promptly report to the other
in writing any inconsistencies in these documents.

 

12.6                           Covenant of Further Assurances. 
The Parties covenant and agree that, subsequent to the execution and
delivery of this Agreement and without any additional consideration, each of
the Parties shall execute and deliver any further legal instruments and perform
such acts which are or may become reasonably necessary to effectuate the
purposes of this Agreement.

 

12.7                           Relationship. 
The Parties shall be deemed independent contractors for all purposes
hereunder.  This Agreement does not
constitute a partnership, joint venture or agency between the Parties.  Neither Party is an agent of the other Party
and has no authority to represent the other Party as to any matters.

 

12.8                           Severability. 
If, under applicable Law, any provision of this Agreement is invalid or
unenforceable, or otherwise directly or indirectly affects the validity of any
other material provision(s) of this Agreement (“Severed Clause”),
the Parties mutually agree that this 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 which shall be a reasonable substitute for such Severed Clause in light
of the intent of this Agreement.

 

12.9                           Assignment.  Neither this
Agreement nor any of the rights or obligations hereunder may be assigned by a
Party without the prior written consent of the other Party, except (a) each
Party may assign this Agreement, in whole or in part, to an Affiliate of the
assigning Party, only for so long as such assignee remains an Affiliate of the
assigning Party; provided, that the assigning Party shall remain
primarily liable for performance of its obligations hereunder, notwithstanding
such assignment; and (b) each Party may assign this Agreement, in whole,
to a Third Party that acquires, by merger, sale of assets or otherwise, all or
substantially all of the business of the assigning Party to which the subject
matter of this Agreement relates. 
Notwithstanding the foregoing, in no event shall either Party assign
this Agreement to any Third Party or an Affiliate unless such Party also
assigns the License Agreement to such Third Party or 

 

21

 

Affiliate.  Any assignment not in accordance with the
foregoing shall be void.  Subject to the
foregoing, this Agreement shall be binding upon, and shall inure to the benefit
of, all permitted successors and assigns.

 

12.10                     Force Majeure. Neither Party will be deemed to have
breached this Agreement for failure or delay in fulfilling or performing any
provision of this Agreement when such failure or delay results from causes
beyond the reasonable control of the affected Party, which may include embargoes,
acts of war (whether declared or not), insurrections, riots, civil commotions,
acts of terrorism, strikes, lockouts or other labor disturbances, supply
failures of Acorda’s Third party manufacturers of Product, failure to act by
Elan or its Affiliates, or acts of God. 
The affected Party will notify the other Party of such force majeure
circumstances as soon as the affected Party becomes aware of the same
(including its best estimate of the likely extent and duration of the
interference with its activities) and will make every reasonable effort to
mitigate the effects of such force majeure circumstances.  If a Party is so delayed and such failure or
omission is not cured within ninety (90) days, the other Party may terminate
this Agreement.

 

12.11                     Export Compliance. 
The Parties acknowledge that the exportation from the United States or
any other country of materials, products and related technical data (and the
re-export from elsewhere of items originating in a particular country) may be
subject to compliance with relevant export Laws, including Laws which restrict
export, re-export and release of materials, products and their related
technical data, and the direct products of such technical data.  The Parties agree to comply with all export
Laws and to commit no act that, directly or indirectly, would violate any Law,
or any other international treaty or agreement, relating to the export,
re-export, or release of any materials, products or their related technical
data to which the United States adheres or with which the United States
complies.

 

12.12                     Performance by Affiliates and Third Party
Distributors.  To the extent that this Agreement imposes
obligations on Affiliates of a Party and, in the case of Licensee, its Third
Party Distributors, such Party agrees to cause such Party’s Affiliates, and, in
the case of Licensee, its Third Party Distributors, to perform such
obligations.

 

12.13                     Counterparts and Facsimile Signatures. 
This 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.

 

[Remainder of Page Intentionally Left Blank]

 

22

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their respective officers hereunto duly authorized as of the
Effective Date.

 

 

	
  ACORDA THERAPEUTICS,
  INC.

  	
  BIOGEN IDEC
  INTERNATIONAL GMBH

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Ron Cohen

  	
   

  	
  By:

  	
  /s/ Anders Lundstrom 

  
	
  Name: Ron Cohen 

  	
  Name: Anders Lundstrom 

  
	
  Title: Chief Executive
  Officer

  	
  Title: Authorized
  Signatory

  
					

 

 

[Signature Page to Supply Agreement]

 

23

 

Exhibit A

 

Acorda Supply Agreements

 

This Exhibit A
contains a list of certain agreements in effect as of the Effective Date
between Acorda and certain Third Parties, as amended from time to time in
accordance with this Agreement, that place certain encumbrances and limitations
on the rights granted to Licensee hereunder and impose certain obligations on
Licensee.

 

·                                          Amended and Restated License Agreement
between Elan Corporation plc and Acorda, dated September 26, 2003

 

·                                          Supply Agreement between Elan Pharma
International Limited and Acorda, dated September 26, 2003

 

·                                          Technical Agreement between Elan Pharma
International Limited and Acorda, dated December 19, 2005

 

·                                          Patheon Inc. Proposal No. ELN-FQ-0001-1002-RF,
entitled “Fampridine Tablets (10mg, 20mg, 25mg) Technical Transfer Program
Proposal for Commercial Registration for Acorda Therapeutics, dated February 26,
2003

 

·                                          Elan ConsentExhibit
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

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