Exhibit 10.54


 


COLLABORATION AND LICENSE
AGREEMENT


 


BETWEEN


 


ACORDA THERAPEUTICS, INC.


 


AND


 


BIOGEN IDEC INTERNATIONAL GMBH


 






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


 

















 


Confidential


 


	
  1.

  	
  DEFINITIONS

  	
  1

  
	
   

  	
   

  	
   

  
	
  2.

  	
  LICENSES

  	
  17

  
	
   

  	
   

  	
   

  
	
   

  	
  2.1

  	
  Licenses to Licensee

  	
  17

  
	
   

  	
  2.2

  	
  Limitation on License Grants

  	
  19

  
	
   

  	
  2.3

  	
  Acknowledgments Regarding Know-How

  	
  21

  
	
   

  	
  2.4

  	
  Licenses to Acorda

  	
  21

  
	
   

  	
  2.5

  	
  Retained Rights

  	
  21

  
	
   

  	
  2.6

  	
  Non-Compete

  	
  22

  
	
   

  	
  2.7

  	
  Supply Agreement

  	
  22

  
	
   

  	
  2.8

  	
  In-Licensed Technology

  	
  22

  
	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
  GOVERNANCE

  	
  24

  
	
   

  	
   

  	
   

  
	
   

  	
  3.1

  	
  Joint Steering Committee

  	
  24

  
	
   

  	
  3.2

  	
  Subcommittees

  	
  24

  
	
   

  	
  3.3

  	
  Committee Membership

  	
  26

  
	
   

  	
  3.4

  	
  Committee Meetings

  	
  27

  
	
   

  	
  3.5

  	
  Decisions

  	
  27

  
	
   

  	
  3.6

  	
  Authority

  	
  29

  
	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
  SHARING OF INFORMATION

  	
  30

  
	
   

  	
   

  	
   

  
	
   

  	
  4.1

  	
  Initial Information Transfer

  	
  30

  
	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
  DEVELOPMENT

  	
  31

  
	
   

  	
   

  	
   

  
	
   

  	
  5.1

  	
  Overview

  	
  31

  
	
   

  	
  5.2

  	
  Development Plan

  	
  31

  
	
   

  	
  5.3

  	
  Reports

  	
  32

  
	
   

  	
  5.4

  	
  Updating and Amending Development Plan and Development
  Budget; Additional Development Activities

  	
  33

  
	
   

  	
  5.5

  	
  Development Costs

  	
  35

  
	
   

  	
  5.6

  	
  Development Costs Budget and Timeline Overruns

  	
  36

  
	
   

  	
  5.7

  	
  Review of Clinical Trial Summaries

  	
  37

  
	
   

  	
  5.8

  	
  Review of Promotional Material Educational Materials and
  Activities

  	
  38

  
	
   

  	
  5.9

  	
  Contracted Services

  	
  39

  
	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
  REGULATORY; MARKETING AND MEDICAL AFFAIRS

  	
  40

  
	
   

  	
   

  	
   

  
	
   

  	
  6.1

  	
  Regulatory Filings and Regulatory Approvals

  	
  40

  
	
   

  	
  6.2

  	
  Pharmacovigilance

  	
  42

  
	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
  COMMERCIALIZATION

  	
  44

  
	
   

  	
   

  	
   

  
	
   

  	
  7.1

  	
  Commercialization in the Field in the Territory

  	
  44

  
	
   

  	
  7.2

  	
  Licensee’s Performance

  	
  44

  



 


i

















 


	
   

  	
  7.3

  	
  Reports

  	
  48

  
	
   

  	
  7.4

  	
  Promotional Materials and Educational Materials and
  Activities

  	
  49

  
	
   

  	
  7.5

  	
  Product Branding

  	
  49

  
	
   

  	
   

  	
   

  	
   

  
	
  8.

  	
  PAYMENTS

  	
  51

  
	
   

  	
   

  	
   

  
	
   

  	
  8.1

  	
  Up-front Fee

  	
  51

  
	
   

  	
  8.2

  	
  Milestone Payments

  	
  51

  
	
   

  	
  8.3

  	
  Royalties Payable by Licensee

  	
  53

  
	
   

  	
  8.4

  	
  Restrictions on Sales

  	
  54

  
	
   

  	
  8.5

  	
  Reports and Payment

  	
  54

  
	
   

  	
  8.6

  	
  Tax Withholding

  	
  55

  
	
   

  	
  8.7

  	
  Blocked Payments

  	
  55

  
	
   

  	
  8.8

  	
  Late Payments

  	
  55

  
	
   

  	
  8.9

  	
  Financial Records

  	
  55

  
	
   

  	
  8.10

  	
  Audit Right

  	
  55

  
	
   

  	
   

  	
   

  	
   

  
	
  9.

  	
  INTELLECTUAL PROPERTY

  	
  56

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.1

  	
  Ownership; Trademarks

  	
  56

  
	
   

  	
  9.2

  	
  Filing, Prosecution and Maintenance of Patent Rights

  	
  58

  
	
   

  	
  9.3

  	
  Enforcement

  	
  61

  
	
   

  	
  9.4

  	
  Invalidity Claims

  	
  63

  
	
   

  	
  9.5

  	
  Patent Marking

  	
  63

  
	
   

  	
   

  	
   

  	
   

  
	
  10.

  	
  CONFIDENTIAL INFORMATION

  	
  64

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.1

  	
  Non-Use and Non-Disclosure of Confidential Information

  	
  64

  
	
   

  	
  10.2

  	
  Permitted Disclosures

  	
  64

  
	
   

  	
  10.3

  	
  Scientific Publications

  	
  65

  
	
   

  	
  10.4

  	
  Publicity

  	
  65

  
	
   

  	
  10.5

  	
  Relationship to the Prior Confidentiality Agreement

  	
  67

  
	
   

  	
  10.6

  	
  Survival

  	
  67

  
	
   

  	
   

  	
   

  	
   

  
	
  11.

  	
  INDEMNIFICATION

  	
  67

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  11.1

  	
  Indemnification by Licensee

  	
  67

  
	
   

  	
  11.2

  	
  Indemnification by Acorda

  	
  67

  
	
   

  	
  11.3

  	
  Procedure

  	
  68

  
	
   

  	
  11.4

  	
  Allocation

  	
  68

  
	
   

  	
   

  	
   

  	
   

  
	
  12.

  	
  INSURANCE

  	
  69

  
	
   

  	
   

  	
   

  
	
   

  	
  12.1

  	
  Insurance

  	
  69

  
	
   

  	
   

  	
   

  	
   

  
	
  13.

  	
  WARRANTIES AND COVENANTS

  	
  69

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  13.1

  	
  Mutual Warranties

  	
  69

  



 


ii

















 


	
   

  	
  13.2

  	
  Additional Acorda Warranties

  	
  70

  
	
   

  	
  13.3

  	
  Additional Covenants Regarding Acorda Third Party
  Agreements

  	
  71

  
	
   

  	
  13.4

  	
  Compliance

  	
  72

  
	
   

  	
  13.5

  	
  Standstill

  	
  72

  
	
   

  	
  13.6

  	
  Disclaimer

  	
  73

  
	
   

  	
   

  	
   

  	
   

  
	
  14.

  	
  LIMITATION OF LIABILITY

  	
  73

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  14.1

  	
  Limitation of Liability

  	
  73

  
	
   

  	
   

  	
   

  	
   

  
	
  15.

  	
  TERMINATION

  	
  74

  
	
   

  	
   

  	
   

  
	
   

  	
  15.1

  	
  Term

  	
  74

  
	
   

  	
  15.2

  	
  Termination

  	
  74

  
	
   

  	
  15.3

  	
  Effects Of Termination

  	
  75

  
	
   

  	
   

  	
   

  	
   

  
	
  16.

  	
  MISCELLANEOUS

  	
  78

  
	
   

  	
   

  	
   

  
	
   

  	
  16.1

  	
  Assignment

  	
  78

  
	
   

  	
  16.2

  	
  Change of Control; Licensee Acquisition of Elan

  	
  79

  
	
   

  	
  16.3

  	
  Guaranty

  	
  80

  
	
   

  	
  16.4

  	
  Force Majeure

  	
  80

  
	
   

  	
  16.5

  	
  Notices

  	
  80

  
	
   

  	
  16.6

  	
  Relationship of the Parties

  	
  81

  
	
   

  	
  16.7

  	
  Governing Law

  	
  81

  
	
   

  	
  16.8

  	
  Dispute Resolution

  	
  81

  
	
   

  	
  16.9

  	
  Injunctive Relief

  	
  81

  
	
   

  	
  16.10

  	
  Severability

  	
  81

  
	
   

  	
  16.11

  	
  Entire Agreement

  	
  82

  
	
   

  	
  16.12

  	
  Amendment and Waiver

  	
  82

  
	
   

  	
  16.13

  	
  No Implied Waivers

  	
  82

  
	
   

  	
  16.14

  	
  Export Compliance

  	
  82

  
	
   

  	
  16.15

  	
  Counterparts and Facsimile Signatures

  	
  82

  
	
   

  	
  16.16

  	
  Performance by Affiliates

  	
  82

  



 


	
  Exhibit A:
   Acorda Patent Rights

  
	
  Exhibit B:
   [Reserved for Future Use]

  
	
  Exhibit C:
   [Reserved for Future Use]

  
	
  Exhibit D:
   Acorda Third Party Agreements

  
	
  Exhibit E:
   Supply Agreement

  
	
  Exhibit F:
   Press Release

  
	
  Exhibit G:
   Regions

  
	
  Exhibit H:
   Parent Guaranty

  
	
  Exhibit I:
   Commercialization Metrics Forecast

  



 


iii














 


Confidential


 


COLLABORATION AND LICENSE
AGREEMENT


 


This
Collaboration and License 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”).


 


INTRODUCTION


 


1.                                       Acorda and
Licensee are each in the business of discovering, developing and
commercializing pharmaceutical products.


 


2.                                       Acorda has
developed aspects of and proprietary rights in and relating to the compound
known as fampridine, and Controls certain intellectual property relating to
such compound.


 


3.                                       Licensee
desires to exclusively license from Acorda such intellectual property for the
purpose of developing and commercializing products containing fampridine, and
Acorda desires to grant such a license to Licensee in accordance with the terms
and conditions of this Agreement.


 


In
consideration of the mutual covenants contained herein, and other good and
valuable consideration, the receipt of which is hereby acknowledged, Licensee
and Acorda agree as follows:


 


1.                                       DEFINITIONS


 


When
used in this Agreement, each of the following terms, whether used in the
singular or plural, shall have the meanings set forth in this Article 1.


 


1.1           “Acorda”
has the meaning set forth in the preamble.


 


1.2           “Acorda
Indemnitees” means Acorda, its Affiliates and the directors, officers,
employees and agents of Acorda and its Affiliates, and Elan, Elan’s Affiliates
and Acorda’s other licensors.


 


1.3           “Acorda
IP” means, collectively, Acorda Know-How and Acorda Patent Rights; provided, however,
that Acorda IP specifically excludes Joint IP.


 


1.4           “Acorda
Know-How” means all Know-How that (a) is Controlled by Acorda as of
the Effective Date or that comes under the Control of Acorda or its Affiliates
during the Term and (b) is necessary for or developed by Acorda primarily
for use in the Development or Commercialization of the Compound or the Licensed
Product in the Field; provided, however, that Acorda Know-How (y) includes
the Elan Know-How and (z) specifically excludes Joint Know-How.


 


1

















 


1.5           “Acorda
Patent Costs” means, subject to Section 9.2(e), all Out-of-Pocket
Costs incurred by Acorda in preparing, filing, prosecuting and maintaining
Licensed Patent Rights in the Territory in the Field and in conducting related
interference, opposition and similar proceedings in the Territory.  For the avoidance of doubt, any Out-of-Pocket
Costs incurred by Acorda for preparing, filing, prosecuting and/or maintaining
Licensed Patent Rights which are reasonably believed by Acorda to be necessary
to allow Licensee to use the Licensed Patent Rights in the Territory in
accordance with the rights granted to Licensee hereunder shall be deemed Acorda
Patent Costs under this Agreement.


 


1.6           “Acorda
Patent Right” means any Patent Right that (a) is Controlled by Acorda
or its Affiliates as of the Effective Date or that comes under the Control of
Acorda or its Affiliates during the Term and (b) Covers the composition,
use, Manufacture of or otherwise relates to the Compound or the Licensed
Product in the Field in the Territory or claims Acorda Know-How or the use
thereof, including the Patent Rights set forth in Exhibit A; provided, however,
that Acorda Patent Rights specifically exclude (i) Joint Patent Rights and
(ii) the Patent Rights licensed to Acorda pursuant to the License
Agreement between Acorda and Cornell Research Foundation, Inc., dated February 3,
2003 as such agreement may be amended.


 


1.7           “Acorda
Royalty Rate” has the meaning set forth in Section 8.3(a).


 


1.8           “Acorda
Territory” means the United States, each Terminated Country, and each of
their respective territories and possessions, including in the case of the
United States, the Commonwealth of Puerto Rico.


 


1.9           “Acorda
Third Party Agreements” means (a) the agreements which are set forth
on Exhibit D, (b) the Acorda Supply Agreements (as defined in
the Supply Agreement) and (c) any agreement pursuant to which Acorda
licenses or acquires Patent Rights or Know-How that relates to the Compound or
the Licensed Product in the Field in the Territory after the Effective Date
pursuant to an agreement with a Third Party which Licensee and Acorda agree,
pursuant to Section 2.8, shall be deemed an Acorda Third Party Agreement,
in which case Exhibit D shall be amended accordingly.


 


1.10         “Adverse
Drug Experience” has the meaning set forth in Section 6.2(b).


 


1.11         “Affiliate”
means 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.


 


1.12         “Agreement”
has the meaning set forth in the preamble.


 


2

















 


1.13         “Bankruptcy
Code” has the meaning set forth in Section 2.9.


 


1.14         “Breaching
Party” has the meaning set forth in Section 15.2(b).


 


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


 


1.16         “Buy-In
Party” has the meaning set forth in Section 5.4(b)(ii)(B).


 


1.17         “Buy-In
Amount” has the meaning set forth in Section 5.4(b)(ii)(C).


 


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


 


1.19         “Calendar
Year” means a period of time commencing on January 1 and ending on the
following December 31.


 


1.20         “CFR”
means the United States Code of Federal Regulations.


 


1.21         “Change
of Control” means (a) the closing of a merger, tender offer, share exchange,
reorganization, consolidation or other similar transaction involving Licensee
or Licensee Parent in which its shareholders immediately prior to such
transaction would hold [*****] or less of the securities or other ownership or
voting interests representing the equity of the surviving or resulting entity
immediately after such transaction, (b) the individuals who, as of the
Effective Date, constitute the board of directors of Licensee or Licensee
Parent (the “Incumbent Board”) ceasing for any reason to, as applicable,
constitute [*****] or more of the board of directors of Licensee or Licensee
Parent; provided, that any individual becoming a director subsequent to
the Effective Date whose election, or nomination for election by Licensee’s or
Licensee Parent’s stockholders, was approved by a vote of at least a majority
of the directors then comprising the Incumbent Board shall be considered as
though such individual were a member of the Incumbent Board, but excluding, for
this purpose, any such individual whose initial assumption of office occurs (i) as
a result of an actual or threatened election contest with respect to the
election or removal of directors or other actual or threatened solicitation of
proxies or consents by or on behalf of a Person other than the board of
directors of Licensee or Licensee Parent, or (ii) through the exercise of
a contractual or similar right granted by Licensee or Licensee Parent at or
around the time of such assumption of office, or (c) any Disposition or
series of Dispositions of assets (including securities) of the Licensee Parent,
Licensee or any Affiliate of Licensee Parent (each, for the purposes of this Section 1.21,
a “Licensee Change of Control Party”) which (i) occurs after the
Effective Date; and (ii) involves assets that constitute or account
for [*****] or more or the consolidated net revenues, net income or assets
of the relevant Licensee Change of Control Party (for an individual
Disposition, measured as of the time of the Disposition and for a series
of Dispositions, measured as of the time of the then-most recent
Disposition).  For the purposes of this Section 1.21,
a “Disposition” means any disposition of assets, including any
direct or indirect sale, lease, exchange, transfer, contribution, license, spinoff,
recapitalization, dividend, grant or other disposition, with or without
value; provided, however that any sale of inventory by a Licensee
Change of Control Party in the ordinary course of business, an offering of debt
or equity securities in a public financing, or any


 






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


 


3

















 


pledge
of assets to secure acquisition debt financing on customary terms which would
not involve the issuance of equity that would otherwise result in a Change of
Control, shall not be deemed a Disposition hereunder.


 


1.22         “Clinical
Trial” means a Phase 1 Clinical Trial, a Phase 2 Clinical Trial, a Phase 3
Clinical Trial or a Phase 4 Clinical Trial.


 


1.23         “Clinical
Trial Summary” has the meaning set forth in Section 5.7(a).


 


1.24         “CMC”
means the chemistry, manufacturing and controls section of an NDA.


 


1.25         “Combination
Product” means any product that comprises (a) the Compound and (b) at
least one clinically active therapeutic, prophylactic or diagnostic ingredient
or component (whether packaged together or in the same formulation) that is not
the Compound.


 


1.26         “Commercialization
Force” has the meaning set forth in Section 16.2(b).


 


1.27         “Commercialization
Plan” has the meaning set forth in Section 7.2(a)(i).


 


1.28         “Commercialize”,
“Commercializing” or “Commercialization” means all activities
directed to the marketing, promotion, selling or offering for sale of a
product, including obtaining pricing and reimbursement approvals, planning,
market research, pre-marketing, advertising, educating, marketing, promoting,
importing, exporting, distributing and post-marketing safety surveillance and
reporting.  For clarity, “Commercialization”
shall not include any activities related to clinical research, Manufacturing or
Development of Licensed Product.


 


1.29         “Commercially
Reasonable Efforts” means, with respect to the efforts to be expended by a
Party with respect to any objective, reasonable, diligent, good faith efforts
to accomplish such objective as a similarly situated (with respect to size,
stage of development, and assets) biotechnology or pharmaceutical company, as
the case may be, would use to accomplish a similar objective under similar
circumstances exercising reasonable business judgment; provided, that,
with respect to the Development and Commercialization of the Compound or the
Licensed Product, such efforts shall be substantially equivalent to those
efforts and resources that a similarly situated (with respect to stage of development)
biotechnology or pharmaceutical company, as the case may be, would typically
devote to its own internally discovered compounds or products of similar market
potential at a similar stage in their development or product life, including
those with respect to which it does not owe license payments, milestone
payments, royalties or similar financial obligations to licensors or other
Persons, and based on conditions then prevailing, with the goal of maximizing
revenue potential.  Commercially Reasonable
Efforts shall be determined on a country-by-country basis.


 


1.30         “Competing
Licensed Product” means any pharmaceutical or biologic product or medical
device that either contains (a) the Compound or (b) other compounds
that act at least in part through direct interaction with potassium channels to
improve neurological function in MS, spinal cord injury or other demyelinating
conditions.


 


4

















 


1.31                           “Compound”
means any compound known as an aminopyridine, as well as isomers, salts and
derivatives thereof, alone or in combination with other active or inactive
components, including 4-aminopyridine and 3-4 di-aminopyridine.


 


1.32                           “Confidential
Information” means, with respect to a Party or its Affiliates (the “Disclosing
Party”), information, regardless of the form in which that information is
constituted, which (a) is treated by the Disclosing Party as confidential;
and (b) relates either directly or indirectly to the business of such
Disclosing Party.  For the avoidance of
doubt, reports delivered under Sections 5.3 and 7.3 of this Agreement shall be
deemed the Confidential Information of the Party delivering such report.


 


Confidential
Information of the Disclosing Party excludes any information that the other
Party or its Affiliates (the “Receiving Party”) can establish by written
records:


 


(a)           was
known by the Receiving Party prior to the receipt from the Disclosing Party;


 


(b)           was
disclosed to the Receiving Party by a Third Party having the right to do so;


 


(c)           was,
or subsequently became, publicly known through no fault of the Receiving Party,
its Affiliates or any of the officers, directors, employees or agents of the
Receiving Party or its Affiliates; or


 


(d)           was
concurrently or subsequently developed by personnel of the Receiving Party
without having had access to the Disclosing Party’s Confidential Information.


 


1.33                           “Control”
or “Controlled” means, with respect to any Know-How or Patent Right, the
possession by a Party or its Affiliate, whether by ownership, license or
otherwise (other than pursuant to a license granted under this Agreement), of
the ability to grant the right to access or use, or to grant a license or a
sublicense under, or to grant the right to disclose or transfer, such Know-How
or Patent Right, without violating the terms of any agreement or other
arrangement with, or the rights of, any Third Party; provided, however,
that any Know-How or Patent Rights licensed or acquired by either Party after
the Effective Date pursuant to an agreement with a Third Party shall only be
deemed to be Controlled by such Party if the Parties agree to such addition in
accordance with Section 2.8.


 


1.34                           “Cover”,
“Covered” or “Covering” means, (a) with respect to a patent,
that, in the absence of a license granted to a Person under a Valid Claim
included in such patent, the practice by such Person of an invention claimed in
such patent would infringe such Valid Claim, or (b) with respect to a
patent application, that, in the absence of a license granted to a Person under
a Valid Claim included in such patent application, the practice by such Person
of an invention claimed in such patent application would infringe such Valid
Claim if such patent application were to issue as a patent.


 


1.35                           “Curable
Elan Agreement Breach” has the meaning set forth in Section 7.2(c)(i).


 


5

















 


1.36         “Curable
Elan Agreement Cure” has the meaning set forth in Section 7.2(c)(i).


 


1.37         “De
Minimis Overage Amount” has the meaning set forth in Section 5.6(a).


 


1.38         “Develop”
or “Development” means discovery, research, preclinical development,
clinical development, and regulatory activities with respect to the Compound
and/or the Licensed Product, including test method development and stability
testing, design, compatibility testing, toxicology, animal efficacy studies, invivo, exvivo and invitro studies, formulation, quality assurance/quality
control development, statistical analysis, conducting Clinical Trials,
regulatory affairs, product approval and registration, whether before or after
Regulatory Approval for the Licensed Product has been obtained.  For the sake of clarity, “Development”
includes any of the foregoing activities conducted by any Third Party,
including any Third Party physician, to whom a Party or its Affiliates have
provided financial or other consideration (including providing the Compound or
Licensed Product) in order for such Third Party to conduct such activities (“Funded
Development”).  For clarity, “Development”
shall not include any activities related to Manufacturing or Commercialization
of Licensed Product.


 


1.39         “Development
Budget” has the meaning set forth in Section 5.2(b)(iii).


 


1.40         “Development
Collaboration Proposal” has the meaning set forth in Section 5.4(b)(ii).


 


1.41         “Development
Costs” means the costs and expenses incurred by a Party or its Affiliates
attributable to, or reasonably allocable to, the Development of Licensed
Product and that are consistent, if applicable, with the Development Plan and
costs for all other Development- related activities that are deemed by the JDC
to be useful for the Development of Licensed Product.  “Development Costs” shall include (i) Out-of-Pocket
Costs and (ii) FTE Costs of internal personnel that are attributable or
reasonably allocable to the Development of Licensed Product determined in
accordance with GAAP.


 


1.42         “Development
Plan” has the meaning set forth in Section 5.2(c).


 


1.43         “Disposition”
has the meaning set forth in Section 1.21.


 


1.44         “DMF”
means a Drug Master File, as defined in 21 CFR Section 314.420, as the
same may be amended or re-promulgated from time to time, or any successor
filing or procedure and/or its foreign equivalents.


 


1.45         “Disclosing
Party” has the meaning set forth in Section 1.32.


 


1.46         “Educational
Materials and Activities” means any non-promotional (a) printed
materials, visual aids or other materials used to educate Third Parties,
including physicians and other medical personnel, and (b) continuing
education, seminars, exhibits, advisory boards, consulting meetings and other
medical affairs activities and efforts, in each case of clause (a) and
(b), relating to or directly or indirectly regarding the (x) Licensed
Product in the Field in the Territory or (y) except with respect to
materials and activities relating to and intended for the 


 


6

















 


support
of products of a Party and/or its Affiliates other than Licensed Products,
disease areas in which the Licensed Product might be used in the Field in the
Territory.


 


1.47         “Effective
Date” has the meaning set forth in the preamble.


 


1.48         “Elan”
means Elan Pharma International Limited and, as applicable, its Affiliates and
its successors and assigns.


 


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


 


1.50         “Elan
License Agreement” means the Amended and Restated License Agreement between
Elan (as assignee of Elan Corporation, plc) and Acorda, dated September 26,
2003, as amended from time to time.


 


1.51         “Elan
Know-How” means all Elan Know-How (as defined in the Elan License
Agreement) as licensed and provided to Acorda pursuant to the Elan License
Agreement.


 


1.52         “Elan
Patent Rights” means all Patent Rights licensed to Acorda under the Elan
License Agreement, all of which Elan Patent Rights that are in existence as of
the Effective Date are included with certain other Patent Rights Controlled by
Acorda in Exhibit A.


 


1.53         “Elan
Royalty Rate” has the meaning set forth in Section 8.3(b).


 


1.54         “Elan
Supply Agreement” means the Supply Agreement between Elan (as assignee of
Elan Corporation, plc) and Acorda, dated September 26, 2003, as amended
from time to time.


 


1.55         “Elan
Trademark” has the meaning set forth in Section 7.5(b)(iii).


 


1.56         “EMEA”
means the European Medicines Agency or any successor agency thereof.


 


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


 


1.58         “Excess Overage
Amount” has the meaning set forth in Section 5.6(a).


 


1.59         “Exchange Act”
has the meaning set forth in Section 13.5(a).


 


1.60         “Executive Officer”
has the meaning set forth in Section 3.5(b).


 


1.61         “Expert Panel”
has the meaning set forth in Section 3.5(c)(i).


 


1.62         “Exploit” and,
with correlative meaning, “Exploitation” means to Develop,
Commercialize, make, have made, package, use, import, export, promote,
distribute, offer for sale, sell and otherwise exploit.


 


7

















 


1.63         “FDA”
means the United States Food and Drug Administration or any successor agency
thereto.


 


1.64         “Field”
means the Treatment of all Indications and all forms of administration in
humans; provided, however, that if Licensee declines to
participate in the Development of an Indication or form of administration in
accordance with Section 5.4(b)(ii), such Indication and/or form of
administration (in such case, only with respect to the Indication for which the
form of administration is so Developed) shall no longer be deemed part of the
Field; provided, further, that notwithstanding anything in this
Agreement, in no event shall the following be excluded from the Field:  (a) oral administration of the Licensed
Product for the Treatment of MS or any sign or symptom of MS or (b) the
Treatment of any Indication through any dosage or form that also Treats or can
be reasonably expected to Treat MS or any sign or symptom of MS.  With respect to any intellectual property
rights licensed, owned or controlled by Elan, the Field shall be limited to
oral prescription medicine for the treatment of humans and shall be subject to
and limited by any contractual obligations of Elan under the Technology
Transfer and License Agreement dated July 26, 1999 between Merck &
Co. Inc. and Elan (the “Merck/Elan Agreement”).


 


1.65         “First
Commercial Sale” means, with respect to the Licensed Product in a country
in the Territory, the first sale, for use or consumption by the general public,
of the Licensed Product in such country by Licensee or its Affiliate or Third
Party Distributors after the granting by the relevant Regulatory Authorities of
Regulatory Approval of the Licensed Product in the Field.  Sales or transfers of reasonable quantities
of the Licensed Product for Clinical Trial purposes or for compassionate or
similar use, shall not be considered a First Commercial Sale.


 


1.66         “FTE”
shall mean [*****] hours of work devoted to or in support of Development of the
Licensed Product in accordance with the Development Plan that is carried out by
one or more employees, contract personnel or consultants of a Party, measured
in accordance with such Party’s normal time allocation practices from time to
time.  In no event shall an individual
account for more than one FTE year in any Calendar Year.


 


1.67         “FTE
Cost” means, for any period, the FTE Rate multiplied by the number of FTEs
in such period.


 


1.68         “FTE
Rate” means a rate of [*****] dollars ($[*****]) per FTE per Calendar Year
(pro-rated for the period beginning on the Effective Date and ending at the end
of the first Calendar Year) for personnel engaged in Development activities.
The FTE Rate is “fully burdened” and will cover employee salaries and such
facilities and equipment and other materials and services including ordinary
laboratory consumables procured from distributors of laboratory products as
they may use.


 


1.69         “Funded Development”
has the meaning set forth in Section 1.38.


 


1.70         “GAAP”
means United States Generally Accepted Accounting Principles, consistently
applied.


 


1.71         “Global
Branding Strategy” has the meaning set forth in Section 7.5(a).


 






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


 


8

















 


1.72         “Incumbent
Board” has the meaning set forth in Section 1.21.


 


1.73         “IND”
means an Investigational New Drug Application filed with the FDA under 21 CFR Part 312
or similar foreign application or submission in any country or group of
countries for permission to conduct human clinical investigations.


 


1.74         “Indemnified
Party” means (a) Acorda, with respect to any claim for which an Acorda
Indemnitee is entitled to indemnification from Licensee pursuant to Section 11.1,
or (b) Licensee, with respect to any claim for which a Licensee Indemnitee
is entitled to indemnification from Acorda pursuant to Section 11.2.


 


1.75         “Indemnifying Party”
has the meaning set forth in Section 11.3.


 


1.76         “Indication”
shall mean any human disease or condition, or sign or symptom of a human
disease or condition.


 


1.77         “JCC” has the
meaning set forth in Section 3.2.


 


1.78         “JDC” has the
meaning set forth in Section 3.2.


 


1.79         “Joint
IP” means Joint Know-How and Joint Patent Rights.


 


1.80         “Joint
Know-How” means all Know-How invented, developed, conceived, reduced to
practice or authored jointly by or on behalf of Licensee or its Affiliates, on
the one hand, and Acorda or its Affiliates, on the other hand, during the Term
that arise out of or relate to this Agreement, including the Exploitation of
the Compound or Licensed Product.


 


1.81         “Joint
Patent Rights” means all Patent Rights throughout the world covering the
Joint Know-How.


 


1.82         “Joint
Steering Committee” or “JSC” means the joint steering committee
formed by the Parties as described in Section 3.1(a).


 


1.83         “Know-How”
means any non-public information, ideas, data, inventions, works of authorship,
trade secrets technology, or materials, including formulations, molecules,
assays, reagents, compounds, compositions, human or animal tissue, samples or
specimens, and combinations or components thereof, whether or not proprietary
or patentable, and whether stored or transmitted in oral, documentary,
electronic or other form, including all Regulatory Documentation.


 


1.84         “Law”
means any law, statute, rule, regulation, ordinance, regulatory guidance or
other pronouncement having the effect of law, of any federal, national,
multinational, state, provincial, county, city or other political subdivision,
including (a) 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.


 


9

















 


1.85         “LIBOR
Rate”  means, for any applicable interest
period, the rate per annum equal to the average of the one-month U.S. Dollar
British Bankers Association LIBOR Rate (“BBA LIBOR”), as published by
Thomson Reuters (or, if Thomson Reuters does not publish quotations of BBA
LIBOR, another commercially available source providing quotations of BBA LIBOR
as reasonably selected by agreement of the Parties), with the average
determined by adding the BBA LIBOR for each day on which the BBA LIBOR is
published during the applicable period, divided by the number of such days
during such period.  If such rate is not
available at such time for any reason, then the rate for that interest period
will be determined by such alternate method as reasonably selected by agreement
of the Parties.


 


1.86         “Licensed
IP” means, collectively, Acorda IP and Acorda’s and its Affiliates’
interest in Joint IP.


 


1.87         “Licensed
Know-How” means, collectively, Acorda Know-How and Acorda’s and its
Affiliates’ interest in Joint Know-How.


 


1.88         “Licensed
Patent Rights” means, collectively, Acorda Patent Rights and Acorda’s and
its Affiliates’ interest in Joint Patent Rights.


 


1.89         “Licensed
Product” means any pharmaceutical product containing the Compound, alone or
in combination with other active or inactive components.  As used in this Agreement, except where not
appropriate in context, the Licensed Product also means the Compound contained
in the Licensed Product.


 


1.90         “Licensed Product
Trade Dress” has the meaning set forth in Section 7.5(b)(ii).


 


1.91         “Licensed Product
Trademark” has the meaning set forth in Section 7.5(b)(ii).


 


1.92         “Licensee” has
the meaning set forth in the preamble.


 


1.93         “Licensee Change of
Control Party” has the meaning set forth in Section 1.21.


 


1.94         “Licensee
Indemnitees” means Licensee, its Affiliates and the directors, officers,
employees and agents of Licensee and its Affiliates.


 


1.95         “Licensee
IP” means, collectively, Licensee Know-How and Licensee Patent Rights; provided, however,
that Licensee IP specifically excludes Joint IP.


 


1.96         “Licensee
Know-How” means all Know-How that is Controlled by Licensee or its
Affiliates as of the Effective Date or that comes under the Control of Licensee
or its Affiliates during the Term, that arise out of or relate to this
Agreement and which (a) is at any time actually used or anticipated or
intended to be used by Licensee in connection with the Development or
Commercialization of the Licensed Product, (b) is the subject of a joint
Development activity conducted by or with the agreement of the Parties in
connection with the Development or Commercialization of the Licensed Product or
(c) Licensee otherwise agrees is Licensee Know-How; provided, however, that Licensee
Know-How specifically excludes Joint Know-How.


 


1.97         “Licensee Parent”
means Biogen Idec, Inc.


 


10














 


1.98                           “Licensee Patent Rights”
means all Patent Rights Controlled by Licensee or its Affiliates as of the
Effective Date or that comes under the Control of Licensee or its Affiliates
during the Term, that arise out of or relate to this Agreement and that (a) Cover
the composition of the Compound or the Licensed Product; (b) Cover the
Licensee’s actual or anticipated or intended use or Manufacture of the Compound
or the Licensed Product; or (c) Cover Licensee Know-How or the use
thereof; provided, however, that Licensee Patent Rights
specifically excludes Joint Patent Rights.


 


1.99                           “Licensee
Trademarks” has the meaning set forth in Section 7.5(b)(ii).


 


1.100                     “Losses” has the
meaning set forth in Section 11.1.


 


1.101                     “Major Market Countries”
means the United Kingdom, France, Germany, Italy, Spain and Japan.


 


1.102                     “Manufacture” or “Manufacturing”
means, as applicable, all activities associated with the production,
manufacture, supply, processing, filling, packaging, labeling, shipping, and
storage of Licensed Product and/or any components thereof, including process
and formulation development, process validation, stability testing,
manufacturing scale-up, preclinical, clinical and commercial manufacture and
analytical development, product characterization, quality assurance and quality
control development, testing and release.


 


1.103                     “Marketing Authorization
Application” or “MAA” means an application to the appropriate
Regulatory Authority for approval to sell the Licensed Product (but excluding
pricing approval) in any particular country or regulatory jurisdiction in the
EU, including such application filed with the EMEA pursuant to the centralized
procedure or with the applicable Regulatory Authority of a country in the EU in
accordance with the decentralized or mutual recognition procedures or any other
national approval procedure.


 


1.104                     “MS” means multiple
sclerosis.


 


1.105                     “Merck/Elan Agreement”
has the meaning set forth in Section 1.64.


 


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


 


1.107                     “Net Sales” means the
gross amounts invoiced by Licensee and Licensee’s Affiliates and Third Party
Distributors on sales or other dispositions (excluding sales or dispositions
for use in Clinical Trials or other scientific testing or reasonable quantities
of samples, in each case for which Licensee, its Affiliates and its Third Party
Distributors receive no revenue) of the Licensed Product to unrelated Third
Parties in bona fide arm’s-length transactions, less only the following items
to the extent included in the gross invoiced sales price of such Licensed
Product and not separately invoiced:


 


(a)                                  trade, cash and quantity
discounts actually allowed and taken specifically with respect to sales or
other dispositions of the Licensed Product;


 


11

















 


(b)                                 tariffs, duties, excises and
sales taxes imposed upon and paid directly with respect to such sales or other
dispositions (reduced by any refunds of such taxes deducted in the calculation
of Net Sales for prior periods and, for the avoidance of doubt, no deduction
shall be permitted for income, withholding, corporate or similar taxes);


 


(c)                                  amounts repaid or credited
by reason of rejections, defects, recalls or returns (not to exceed [*****] of
amounts invoiced) or because of adjustments or billing errors;


 


(d)                                 amounts invoiced for
freight, shipping, insurance and other transportation expenses, provided,
that, if a shipment contains product(s) other than the Licensed Product,
then a reasonable allocation shall be made that does not allocate freight,
shipping, insurance and other transportation expenses disproportionately to the
Licensed Product as compared to such other product(s); and


 


(e)                                  government mandated rebates
(such as those granted pursuant to programs similar to any state or federal
Medicare, Medicaid or similar program).


 


There
shall be no double counting in determining the foregoing deductions from gross
amounts invoiced to calculate Net Sales. 
The deductions set forth above in this Section 1.107 shall be
determined in accordance with GAAP, as consistently applied by Licensee and
Licensee’s Affiliates and Third Party Distributors across all of their
products.  The amounts set forth in
clause (a) above shall only be deducted from gross invoiced sales where
gross invoiced sales before deductions are non-discounted gross sales amounts.


 


Transfers
of the Licensed Product among Licensee, Licensee’s Affiliates and Licensee’s
Third Party Distributors for the purpose of subsequent resale to Third Parties
will not generate Net Sales; with respect to such transfers, the gross amounts
invoiced in connection with the subsequent resale of the Licensed Product to
Third Parties will be included in the calculation of Net Sales.


 


In
the event Licensee, its Affiliates or Third Party Distributors sells the
Licensed Product together with other products to Third Parties in a particular
country and the price attributable to the Licensed Product is less than the
average price of “arms length” sales of the Licensed Product alone in the
particular country for the reporting period in which such sales occur (such
sales to be excluded from the calculation of the average price of “arms length”
sales), Net Sales for any such sales shall be the average price of “arms length”
sales by Licensee, its Affiliates or Third Party Distributors of the Licensed
Product alone and in the country during the reporting period in which such
sales occur.  If the average price of “arms
length” sale of the Licensed Product cannot be determined in any given country,
the Net Sales will be determined by the value of the Licensed Product sold to
similar customers in countries with similar pricing and reimbursement
structures and for similar quantities. 
Any dispute as to the determination of fair market value that cannot be
resolved through discussion between the Parties shall be determined in
accordance with Section 3.5(c)(iii).


 


Notwithstanding
the foregoing, in the event a Licensed Product is sold as a Combination
Product, in determining the Acorda Royalty Rate due hereunder Net Sales shall
be calculated by [*****]. In the event no such separate sales are made by
Licensee or its Affiliates or Third Party 


 






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


 


12

















 


Distributors, Net
Sales of the Combination Product shall be calculated in a manner to be
negotiated and agreed upon by the Parties, reasonably and in good faith, prior to
any sale of such Combination Product, which shall be based upon the respective
fair market values of the active components of such Combination Product.  If the Parties are unable to reach agreement
regarding such issue within thirty (30) days after commencing good faith
negotiations, the issue shall be referred to the JCC (and will be subject to
dispute resolution in accordance with Section 3.5(c)(iii)); provided,
that, unless Acorda otherwise agrees, in Acorda’s sole discretion, such
negotiated method for calculating Net Sales of a Combination Product shall not
result in average per unit attributed price for the Licensed Product, on a per
unit of Combination Product basis, that is less than [*****] of the average per unit price over the
preceding [*****] for which the Licensed Product was sold in such country as a
non-combination product.  For purposes of
clarity, this paragraph shall not apply to the Elan Royalty Rate.


 


1.108                     “Non-Breaching Party”
has the meaning set forth in Section 15.2(b).


 


1.109                     “Notifying Party” has
the meaning set forth in Section 6.2(b).


 


1.110                     “Out-of-Pocket
Costs” means, with respect to certain activities hereunder, direct expenses
paid or payable by either Party or its Affiliates to Third Parties and
specifically identifiable and incurred to conduct such activities for the
Licensed Product (which may include items such as general laboratory supplies
used in Development or database acquisition or expansion in accordance with Section 6.2(a)).


 


1.111                     “Party” means Acorda
or Licensee, “Parties” means Acorda and Licensee.


 


1.112                     “Patent Rights” means
(a) patent applications (including provisional applications); (b) any
patents issuing from such patent applications (including certificates of
invention); (c) all patents and patent applications based on,
corresponding to or claiming the priority date(s) of any of the foregoing;
(d) rights derived from any of (a)-(c), including any substitutions,
extensions (including supplemental protection certificates), registrations,
confirmations, reissues, divisionals, continuations, continuations-in-part,
re-examinations, renewals, revalidations, revivals, patents of addition and
foreign counterparts thereof; and (e) all patents and patent applications
claiming overlapping priority therefrom.


 


1.113                     “Patent Term Extension”
means any patent term extension, adjustment or restoration or supplemental
protection certificates.


 


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


 


1.115                     “Person Day” means
eight (8) hours of work.


 


1.116                     “Pharmacovigilance
Agreement” has the meaning set forth in Section 6.2(f).


 


1.117                     “Phase 1 Clinical Trial”
means a human clinical trial that provides for the first introduction into
humans of the Licensed Product and that is intended to initially evaluate the 


 






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


 


13

















 


safety,
tolerance or pharmacological or antigenic effects of the Licensed Product in
human subjects, or that is otherwise described in 21 CFR §312.21(a) or its
foreign counterpart.


 


1.118                     “Phase 2 Clinical Trial”
means a human clinical trial that is intended to initially evaluate the dosing
and effectiveness of the Licensed Product, and to further evaluate the safety
of the Licensed Product, or that is otherwise described in 21 CFR §312.21(b) or
its foreign counterpart.


 


1.119                     “Phase 3 Clinical Trial”
means a human clinical trial that is prospectively designed to demonstrate
statistically whether the Licensed Product is safe and effective to control,
mitigate, prevent, treat or cure a particular Indication in a manner sufficient
to obtain Regulatory Approval to market such Licensed Product, or that is
otherwise described in 21 CFR §312.21(c) or its foreign counterpart.


 


1.120                     “Phase 4 Clinical Trial”  means a human clinical trial (other than a
Phase 1 Clinical Trial, Phase 2 Clinical Trial or Phase 3 Clinical Trial) which
is conducted on the Licensed Product and after Regulatory Approval of the
Licensed Product has been obtained from an appropriate Regulatory Authority,
and includes (a) trials conducted voluntarily after Regulatory Approval by
one or both of the Parties for enhancing marketing or scientific knowledge of
an approved Indication or (b) trials conducted after Regulatory Approval
due to request or requirement of a Regulatory Authority or as a condition of a
previously granted Regulatory Approval.


 


1.121                     “Prior Confidentiality
Agreement” means the Confidential Disclosure Agreement between the Parties,
dated March 16, 2009, as amended on April 16, 2009.


 


1.122                     “Promotional Materials”
means any printed or other materials bearing the name (trade name or generic
name) used to promote the Licensed Product in any country in the world,
including brochures, journal ads, selling aids, posters, reprints, video or
audio tapes, press releases, Internet pages and websites, radio or television
advertisements and textbooks created or distributed by a Party, its Affiliates
or, with respect to Acorda, its licensees (other than Licensee) and, with
respect to Licensee, its Third Party Distributors, and any other items defined
as labeling or advertisements in accordance with applicable Law.


 


1.123                     “Proposed Development
Plan Amendment” has the meaning set forth in Section 5.4(b)(i).


 


1.124                     “Publication” means
any publication in a scientific journal, any abstract to be presented to any
scientific audience, any presentation at any scientific conference, any other
scientific presentation and any other oral, written or electronic disclosure
directed to a scientific audience which pertains to the Compound, the Licensed
Product or the use of the Licensed Product.


 


1.125                     “Receiving Party” has
the meaning set forth in Section 1.32.


 


1.126                     “Reconciliation Payment”
has the meaning set forth in Section 5.6(c).


 


14

















 


1.127                     “Region” means each
group of countries identified as a “Region” in Exhibit G.


 


1.128                     “Regulatory Approval”
means, with respect to a pharmaceutical or biological product or medical device
in a country or regulatory jurisdiction, the act of a Regulatory Authority
necessary for the marketing and commercial sale of such product in such 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 approval of a NDA by the FDA.


 


1.129                     “Regulatory Authority”
means any applicable government regulatory authority involved in the granting
of Regulatory Approval for a Licensed Product in a country or regulatory
jurisdiction, including the FDA, the EMEA and foreign equivalents thereof.


 


1.130                     “Regulatory Documentation”
means, with respect to the Compound and Licensed Product, all INDs or other
regulatory applications submitted to any Regulatory Authority, Regulatory
Approvals, pre-clinical and clinical data and information, regulatory materials,
drug dossiers, master files (including DMFs), and any other reports, records,
regulatory correspondence and other materials relating to Development or
Regulatory Approval of the Compound or Licensed Product including those
materials necessary to Develop, Manufacture, distribute, sell or otherwise
Commercialize the Licensed Product, including any information that relates to
pharmacology, toxicology, chemistry, manufacturing and controls data, batch
records, safety and efficacy, and any safety database.


 


1.131                     “Regulatory Exclusivity”
means, with respect to a country, any exclusive marketing rights or data
exclusivity rights conferred by any applicable Regulatory Authority with
respect to the Licensed Product in such country, other than a Patent Right.


 


1.132                     “Right of Reference or
Use” means a “Right of Reference or Use” as that term is defined in 21 CFR
§314.3(b), and any foreign equivalents.


 


1.133                     “Royalty Term” means,
with respect to the Licensed Product and a country in the Territory, the period
of time beginning on the Effective Date and continuing until the earlier of (a) the
termination of this Agreement, pursuant to and to the extent set forth in Article 15,
and (b) the latest of (i) the expiration of the last Valid Claim of
the Licensed Patent Rights which Covers the Exploitation of the Licensed
Product in such country; (ii) fifteen (15) years after the First
Commercial Sale of the Licensed Product in such country; (iii) the
expiration of Regulatory Exclusivity in such country; and (iv) the existence
of Competition (as defined in the Elan License Agreement) in such country.


 


1.134                     “SEC” has the meaning
set forth in Section 10.2(c).


 


1.135                     “Serious Adverse Drug
Experience” has the meaning set forth in Section 6.2(b).


 


1.136                     “Severed Clause” has
the meaning set forth in Section 16.10.


 


1.137                     “Specifications”
means (a) with respect to the bulk Licensed Product, the specifications
for the bulk Licensed Product, as determined pursuant to the Elan Supply 


 


15

















 


Agreement
and Section 6.3 of the Elan License Agreement and as may be amended in
accordance with the Supply 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 the Supply Agreement.


 


1.138                     “Subject Disclosure”
has the meaning set forth in Section 10.4.


 


1.139                     “Supply Agreement”
means the supply agreement entered into by Acorda and Licensee as described in Section 2.7.


 


1.140                     “Term” has the
meaning set forth in Section 15.1.


 


1.141                     “Terminated Country”
means with respect to a termination of this Agreement pursuant to Section 15.2,
16.2 or 16.4, as applicable, (i) the country(ies) subject to such
termination; (ii) with respect to one or more Regions subject to such
termination, all country(ies) in such Region(s) and (iii) with
respect to termination of this Agreement in its entirety, all countries in the
world.


 


1.142                     “Territory” means the
world, excluding the Acorda Territory.


 


1.143                     “Third Party” means
any Person other than the Parties and their Affiliates.


 


1.144                     “Third Party Distributor”
has the meaning set forth in Section 2.1(c)(i).


 


1.145                     “Time-Constrained
Commercial Diligence Determination” has the meaning set forth in Section 7.2(c)(ii).


 


1.146                     “Treatment” (or, when
required by context, “Treat” or “Treats”) means, with respect to
an Indication, the treatment, control, mitigation, prevention, cure or
diagnosis of such Indication.


 


1.147                     “Unexpected Adverse Drug
Experience” has the meaning set forth in Section 6.2(b).


 


1.148                     “Valid Claim” means a
claim (a) of any issued, unexpired patent that has not been revoked or
held unenforceable or invalid by a decision of a court or governmental agency
of competent jurisdiction from which no appeal can be taken, or with respect to
which an appeal is not taken within the time (including any extensions) allowed
for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise, or (b) of any patent application
that has been pending less than [*****] from the earliest date on which such
patent application claims priority and which claim has not been irretrievably
cancelled, withdrawn or abandoned, provided, that, if, at any time after
such [*****] period, a patent issues from such patent application with such
claim, such claim shall be a Valid Claim, effective as of the date of issue of
such patent.


 






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


 


16

















 


1.149                     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;


 


(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.                                       LICENSES


 


2.1                                 Licenses to
Licensee.


 


(a)                                  Licensed IP.  Subject to the terms and conditions of this
Agreement, Acorda hereby grants to Licensee and its Affiliates during the Term
an exclusive, royalty-bearing, non-sublicenseable (except in accordance with Section 2.1(c)),
non-transferable (except in accordance with Section 16.1) license, under
the Licensed IP, to (i) Exploit (other than to make or have made) the
Licensed Product in the Field in the Territory and (ii) Develop the
Licensed Product outside the Territory for the sole purpose of Exploiting the
Licensed Product in the Territory; provided, that Licensee has first
submitted a proposal to conduct such activity in accordance with Section 5.4(b)(ii),
and such proposal has been reviewed by the JDC and all disputes regarding it,
if any, have been resolved in accordance with Section 3.5(c).


 


(b)                                 Trademarks and Trade Dress. Subject to
the terms and conditions of this Agreement, Acorda hereby grants to Licensee
and its Affiliates during the Term a non-exclusive, non-sublicenseable (except
in accordance with Section 2.1(c)), non-transferable (except in accordance
with Section 16.1) license to use the Licensed Product Trademarks and
Licensed Product Trade Dress solely to Exploit (other than to make or have
made) the Licensed Product in the Field in the Territory.


 


17

















 


(c)                                  Sublicenses to
Third Party Distributors.


 


(i)                                     Notwithstanding
anything in this Agreement to the contrary, Licensee and its Affiliates shall
be permitted to sublicense to a Third Party (such Third Party sublicensee, a “Third
Party Distributor”) the rights to distribute, import, market, promote and
sell the Licensed Product granted to Licensee in Sections 2.1(a) and 2.1(b) in
a country or countries in the Territory solely to the extent (A) with
respect to any Patent Rights or Know How of Elan, as permitted by Elan; (B) that
neither Licensee nor its Affiliates are distributing, marketing, promoting and
selling their own products, without the use of a Third Party distributor, in
such country or countries; (C) such rights are necessary for such Third
Party Distributor to distribute, market, promote and sell the Licensed Product
in such country or countries; and (D) Licensee agrees to reimburse Acorda
and Elan in respect of any adverse tax consequences for Acorda or Elan
resulting from such Third Party Distributor arrangement; provided, however
that no Third Party Distributor shall have the right to sublicense the rights
granted to it in this Section 2.1(c).


 


(ii)                                  Notwithstanding
anything in this Agreement to the contrary but subject to Elan’s consent,
during the Term, Licensee and its Affiliates shall be permitted to sublicense
to a Third Party Distributor the rights to package and label the Licensed
Product in a country or countries in the Territory solely to the extent that
such rights are necessary for such Third Party Distributor to package and label
the Licensed Product in such country or countries.  Acorda represents and warrants that Elan has
agreed in writing to consent to sublicenses to be granted under this Section 2.1(c)(ii) to
the extent provided in the Elan Consent. 
Except to the extent set forth in Section 2.1(c)(i) above, in
no event shall a sublicense granted under this Section 2.1(c)(ii) give
a Third Party Distributor the rights to Commercialize a Licensed Product.  Licensee shall provide to Acorda, and Acorda
shall provide to Elan, all amounts to which Elan is entitled under the Elan
License Agreement and the Elan Supply Agreement as a result of the granting of
such rights to such Third Party Distributor.


 


(iii)                               In the event
that a Third Party Distributor is entitled to access to Confidential
Information disclosed by Acorda to Licensee, the agreement between the Third
Party Distributor and Licensee shall contain obligations of confidentiality no
less onerous than those set out in this Agreement.  Acorda shall be furnished with a copy of the
executed sublicense or other agreement contemplated by this Section 2.1(c).  Any sublicense permitted by this Section 2.1(c) shall
be subject to the terms of this Agreement, but excluding the right to grant a
further sublicense, and must be consistent with and require the Third Party
Distributor to meet all applicable obligations and requirements of this
Agreement and the Acorda Third Party Agreements.  Licensee shall ensure that Acorda and Elan
shall have the same rights of audit and inspection with respect to a Third
Party Distributor as granted to Acorda and Elan, respectively, pursuant to this
Agreement concerning Licensee.  Licensee
shall remain responsible for all acts and omissions of any Third Party
Distributor as if such acts and omissions were by Licensee.  Any sublicense or other agreement permitted
by this Section 2.1(c) shall automatically and immediately terminate
to the extent of termination of this Agreement in whole or as to the relevant
country or countries.


 


18

















 


2.2                                 Limitation on
License Grants.


 


(a)                                  In the event that Licensee
or its Affiliates wish to Exploit a Combination Product for the treatment of
spinal cord injury, Licensee shall seek the prior written consent of Acorda to
extend the licenses granted by Acorda to Licensee pursuant to this Agreement to
Exploit such Combination Product.  Acorda
shall not withhold consent to a request by Licensee under this Section 2.2(a) unless
Elan withholds its consent under the Elan License Agreement to extend such
license.  In the event that Acorda’s
consent is furnished, the Parties shall negotiate in good faith the terms of an
agreement with respect to such Combination Product, including, where
applicable, such amendments as are appropriate to this Agreement.  If the Parties are
unable to reach agreement on such terms, the matter shall be referred to
resolution in accordance with Section 3.5(c)(iii).


 


(b)                                 Third Party Agreements.  Licensee acknowledges and agrees that it has
received a copy of the Acorda Third Party Agreements listed in Exhibit D,
including the Elan License Agreement, and that the rights, licenses and
sublicenses granted by Acorda to Licensee in this Agreement are subject to the
terms of the Acorda Third Party Agreements and the rights granted to the Third
Party counterparties thereunder. 
Licensee covenants to comply with, and to cause its Affiliates and Third
Party Distributors to comply with, the Acorda Third Party Agreements, and to
take any action reasonably requested by Acorda, to prevent any potential breach
of any terms of such Acorda Third Party Agreements.  To the extent there is a conflict between the
terms of any Acorda Third Party Agreement and the rights granted to licensee
hereunder, the terms of such Acorda Third Party Agreement shall control solely
with respect to the Patent Rights and Know-How owned or controlled by such
Third Party licensor.


 


(c)                                  Restrictive Covenants.


 


(i)                                     Subject to the rights granted
to Licensee, its Affiliates and its Third Party Distributors in Section 2.1
and applicable Law, Licensee hereby covenants and agrees that it shall not (and
shall cause its Affiliates and its Third Party Distributors not to), either
directly or indirectly (A) Exploit the Licensed Product outside the
Territory or Field, including through the actions of key opinion leaders, or (B) market,
detail, promote, offer to sell, sell, have sold, distribute or export the
Licensed Product to any purchaser if Licensee, its Affiliate or Third Party
Distributor knows or has reason to believe that such purchaser intends to
market, detail, promote, offer to sell, sell, have sold, distribute or export
the Licensed Product outside the Territory or outside the Field.  If Licensee knows or should reasonably
suspect that a customer or distributor, or a customer’s distributor or
customer, is engaged in the sale or distribution of the Licensed Product for
use outside the Territory or outside the Field, then Licensee shall (1) within
three (3) Business Days of gaining knowledge, or a reasonable suspicion,
of such activities notify Acorda regarding such activities and provide all
information that Acorda may reasonably request concerning such activities and (2) take
all reasonable steps (including cessation of sales to such customer) necessary
to limit such sale or distribution for use outside the Territory or outside the
Field.  All inquiries or orders received
by Licensee, its Affiliates or its Third Party Distributors for the Licensed
Product to be delivered outside the Territory or outside the Field shall be
referred to Acorda.


 


19

















 


(ii)                                  Subject to the rights
granted to Acorda and its Affiliates in Section 2.4 and applicable Law,
Acorda hereby covenants and agrees that it shall not (and shall cause its
Affiliates not to), either directly or indirectly, (A) Exploit the
Licensed Product in the Field outside the Acorda Territory, including through
the actions of key opinion leaders or (B) market, detail, promote, offer
to sell, sell, have sold, distribute or export the Licensed Product to any
purchaser if Acorda or its Affiliate, knows or has reason to believe that such
purchaser intends to market, detail, promote, offer to sell, sell, have sold,
distribute or export the Licensed Product in the Field outside the Acorda
Territory.  If Acorda knows or should
reasonably suspect that a customer or distributor, or a customer’s distributor
or customer, is engaged in the sale or distribution of the Licensed Product for
use in the Field outside the Acorda Territory, then Acorda shall (1) within
three (3) Business Days of gaining knowledge, or a reasonable suspicion,
of such activities notify Licensee regarding such activities and provide all
information that Licensee may reasonably request concerning such activities and
(2) take all reasonable steps (including cessation of sales to such
customer) necessary to limit such sale or distribution for use in the Field
outside the Acorda Territory.  All inquiries
or orders received by Acorda or its Affiliates for the Licensed Product in the
Field to be delivered outside the Acorda Territory shall be referred to
Licensee.


 


(iii)                               Licensee shall,
and shall require its Affiliates and Third Party Distributors to, use
Commercially Reasonable Efforts to prevent importation of the Licensed Product
into the Acorda Territory, and to use (A) those methods commonly used in
the industry for such purpose, including, to the extent reasonably practical,
by using different packaging for the Licensed Product in the Territory than
that used in the Acorda Territory, and (B) those methods commonly used by
Licensee for such purpose, including (1) providing Forecasts (as defined
in the Supply Agreement) for supply in each country (including Canada) in the
Territory that is generally known to be a source for prescription drugs for
purchase for importation to the Acorda Territory, on a country-by-country
basis, based on a reasonable assessment of the number of units of Licensed
Product expected to be prescribed for use by patients in such country, and (2) limiting
the amount of Licensed Product shipped to each country in the Territory from
which importation into the Acorda Territory is likely to occur to the
percentage of Licensed Product reasonably anticipated to be sold for use in
such country, based on such Forecasts provided in the preceding subclause
(1).  Licensee shall use Commercially
Reasonable Efforts to monitor exports of Licensed Products from the Territory,
using methods commonly used in the industry for such purpose and those methods
commonly used by Licensee for such purpose, including the utilization of a
stock management program.  Licensee shall
promptly inform Acorda of any exports of Licensed Products from the Territory and
Licensee’s actions taken to prevent such exports.  Licensee shall, and shall require its
Affiliates and Third Party Distributors to, take any actions which are
reasonably requested by Acorda in writing and permitted by applicable Laws, to
prevent exports of Licensed Products from the Territory.  Failure of Licensee to take such action shall
be deemed a material breach of this Agreement.


 


(iv)                              To help ensure
adequate supply within Canada and to comply with Licensee’s obligation to sell
Licensed Product only in the Territory, the Parties agree that, in the event
Acorda reasonably believes that the quantity of Licensed Product requested by
Licensee pursuant to a Forecast (as defined in the Supply Agreement) for supply
in Canada in a [*****] period exceeds a reasonably necessary amount or Acorda
otherwise in good faith has concerns


 






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


 


20














 


that Licensee’s sale of Licensed Product is
impacting the sales of Licensed Product in the Acorda Territory, Acorda shall
be entitled to refer such dispute to the Executive Officers of the Parties for
resolution.  In the event that the
Executive Officers cannot reach agreement on the matter, the matter will be
referred to an Expert Panel composed of individuals with expertise in
commercial matters for final binding resolution in accordance with the
procedures set forth in Section 3.5(c)(iii).


 


2.3           Acknowledgments Regarding Know-How.  Licensee acknowledges that the Licensed
Know-How comprises valuable trade secrets and other proprietary information and
that the royalties set forth in Section 8.3 with respect to such Licensed
Know-How are fair and reasonable compensation for the rights granted hereunder
to such Licensed Know-How.


 


2.4           Grants to Acorda.


 


(a)           Licenses to Acorda.   Subject to the terms and conditions of this
Agreement, Licensee grants to Acorda and its Affiliates (i) an exclusive,
royalty-free, sublicenseable, non-transferable (except in accordance with Section
16.1) license, under Licensee IP and Licensee’s and its Affiliates’ interests
in Joint IP, to Exploit the Licensed Product in the Acorda Territory; (ii) an
exclusive, royalty-free, sublicenseable, non-transferable (except in accordance
with Section 16.1) license, under Licensee IP and Licensee’s and its Affiliates’
interests in Joint IP, to Exploit the Licensed Product outside the Field in the
Territory; and (iii) an exclusive, royalty-free, sublicenseable,
non-transferable (except in accordance with Section 16.1) license, under
Licensee IP and Licensee’s and its Affiliates’ interests in Joint IP, to
Exploit the Licensed Product inside the Territory for purposes of exercising
Acorda’s rights set forth in Section 2.5(a).


 


(b)           Covenant not to Sue.  Licensee, on behalf of itself and its
Affiliates and Third Party Distributors, hereby covenants not to sue Acorda, or
its Affiliates, licensees, contractors, distributors or customers, in the event
that the Exploitation of the Licensed Product, as it exists as of the Effective
Date or as Developed in accordance with and pursuant to Section 5.4 of this
Agreement (i) in the Acorda Territory, (ii) outside the Field in the Territory
or (iii) in the Territory for purposes of exercising Acorda’s rights set forth
in Section 2.5(a), by Acorda or its Affiliates, licensees, contractors or
distributors, would, in such case, infringe a claim of any Patent Rights which Licensee, its
Affiliates or Third Party Distributors own or control as of the Effective Date
and which Patent Rights are not
covered by the grant in Section 2.4(a).


 


2.5           Retained Rights.


 


(a)           Except as expressly provided in Sections 2.1 and
7.5(b), all rights in and to the Acorda IP, and any trademarks or other Patent
Rights or Know-How of Acorda and its Affiliates, are hereby retained by Acorda
and its Affiliates or its licensors, as applicable.  Notwithstanding Section 2.1, Acorda retains
the right to Develop, Manufacture and have Manufactured Licensed Product in the
Territory for the sole purpose of Developing and Manufacturing the Licensed
Product for sale, offer for sale, use or distribution in, and importation into,
the Acorda Territory or outside the Field in the Territory or for sale to
Licensee and its Affiliates and Third Party Distributors.


 


21

















 


(b)           Except as expressly provided in Sections 2.4, 7.5(b)
and 15.3, all rights in and to the Licensee IP, and any trademarks or other
Patent Rights or Know-How of Licensee and its Affiliates, are hereby retained
by Licensee and its Affiliates.


 


(c)           Acorda and Licensee acknowledge that Elan retains,
and the Development activities conducted by the Parties pursuant to this
Agreement shall not limit, Elan’s rights with respect to the Elan Know-How and
Elan Patent Rights as set forth in the Elan License Agreement.


 


2.6           Non-Compete.


 


(a)           Restriction on Licensee.  During the Term, and for a period of [*****]
following the Term, Licensee agrees not to, and shall cause its Affiliates not
to, directly or indirectly, including through any ownership interest (other
than through an ownership interest of [*****] or less of a public company),
Exploit any Competing Licensed Product in any country.  For the avoidance of doubt, Licensee may,
during the Term, Exploit (other than to make or have made) Licensed Product
solely as provided in this Agreement.


 


(b)           Restriction on Acorda.  During the Term, and for a period of [*****]
following the Term, Acorda agrees not to, and shall cause its Affiliates not
to, directly or indirectly, including through any ownership interest (other
than through an ownership interest of [*****] or less of a public company),
Exploit any Competing Licensed Product in the Territory.  For the avoidance of doubt, Acorda may,
during the Term and thereafter, Exploit Licensed Product (i) in the Acorda
Territory, and (ii) in the Territory as provided in Section 2.5(a) or following
termination of this Agreement.


 


2.7           Supply Agreement.  Contemporaneously with the execution of this
Agreement, the Parties have entered into a supply agreement, in the form set
forth in Exhibit E, pursuant to which Acorda will supply the Licensed
Product to Licensee.  Licensee shall
purchase all of its and its Affiliates’ and Third Party Distributors’
requirements for the Licensed Product from Acorda to the extent required under
the Supply Agreement.


 


2.8           In-Licensed Technology.


 


(a)           After the Effective Date, if either Party, its
Affiliates or, in the case of Licensee, its Third Party Distributors, identify
the need for, or are otherwise offered, a license, covenant not to sue or
similar rights to Third Party Patent Rights or Know-How that such Party, its
Affiliates or, in the case of Licensee, its Third Party Distributors, in good faith
believes are (i) necessary to avoid infringement or misappropriation of such
Patent Right or Know-How based on the Exploitation of the Licensed Product in
the Field in the Territory or (ii) necessary or useful for the Exploitation of
the Licensed Product in the Field in the Territory, prior to commencing
negotiations or entering into an agreement with respect to any such Third Party
license or covenant, such Party shall promptly notify the other Party.  The Parties shall thereafter conduct good
faith discussions regarding whether such Third Party Patent Rights or Know-How
are necessary or useful for the Exploitation of the Licensed Product.


 






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


 


22

















 


(b)           If the Parties agree that such Third Party Patent
Rights or Know-How are necessary or useful for the Exploitation of the Licensed
Product in the Field in the Territory, Acorda shall have the first right to
in-license such rights on a worldwide basis; provided, however
that no definitive license agreement shall be signed by either Party with
regard to such rights without the other Party’s written consent, which shall
not be unreasonably withheld or delayed. 
The Parties shall share in the costs of such in-licensed rights as
follows:


 


(i)            Each Party shall pay [*****]
of any up-front license fee or other acquisition cost and milestones based on
the principle that such rights in the Acorda Territory  constitute
[*****] of such cost and
such rights in the Territory constitute [*****] of such cost; provided
that if such Third Party license rights are available only in one Party’s
territory, such Party shall be responsible for [*****] of such costs.  Notwithstanding anything in this Section 2.8(b)(i)
to the contrary, if such Third Party license rights are available, necessary or
useful in a portion of, but not in the entirety of, a Party’s territory, the
Parties shall conduct good faith negotiations regarding the appropriate
percentage of acquisition costs to be paid by each Party.


 


(ii)           Regardless of which Party
licenses such rights, (A) each Party shall pay to the applicable Third Party
licensor (or as applicable, to the licensing Party for delivery to such Third
Party) [*****] royalties payable in respect of sales of products by such Party,
its Affiliates, Third Party Distributors or sublicensees and (B) to the extent
the Parties agree, or to the extent it is decided pursuant to Section 2.8(d),
that such in-licensed rights are necessary to Exploit the Licensed Product in
the Field and in the Territory without infringing such Third Party Patent
Rights, Licensee shall reduce the royalty paid to Acorda pursuant to Section 8.3(a)
in accordance with Section 8.3(c).  The
Party that receives a sublicense from the other Party under such Third Party
Patent Rights or Know-How shall submit payment to the licensing Party of all
payments due under Section 2.8(b)(i) and this Section 2.8(b)(ii) promptly (but
no later than fifteen (15) days after) receipt of a written request from the
licensing Party.


 


(iii)          If Acorda is the Party to
license such rights, Acorda’s agreement with such licensor shall thereafter be
considered an Acorda Third Party Agreement and such Patent Rights and Know-How
shall be included in the Acorda IP licensed hereunder.


 


(c)           To the extent that after the Effective Date either
Party enters into an agreement with a Third Party pursuant to which such Party
in-licenses intellectual property that is sublicensed to the other Party, the
in-licensing Party shall provide a copy of the in-license agreement to the
other Party.


 


(d)           If the Parties disagree on whether Third Party
Patent Rights or Know-How are necessary or useful for the Exploitation of the
Licensed Product in the Field in the Territory, the matter shall be referred to
the JDC and any disputes elevated from the JDC shall be resolved in accordance
with Section 3.5(c)(iii).


 


2.9           Section 365(n) of the
Bankruptcy Code.  All rights
and licenses granted under or pursuant to any section of this Agreement are and
will otherwise be deemed to be for purposes of Section 365(n) of the United
States Bankruptcy Code (Title 11, U.S. Code), as amended (the “Bankruptcy
Code”), licenses of rights to “intellectual property” as defined in Section
101(35A) of the Bankruptcy Code.  The
Parties will retain and may fully exercise all of 


 






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


 


23

















 


their respective rights and elections under
the Bankruptcy Code.  Each Party agrees
that the other Party, as licensee of such rights under this Agreement, will retain
and may fully exercise all of its rights and elections under the Bankruptcy
Code or any other provisions of applicable Law outside the United States that
provide similar protection for “intellectual property.”  The Parties further agree that, in the event
of the commencement of a bankruptcy proceeding by or against a Party under the
U.S. Bankruptcy Code or analogous provisions of applicable Law outside the
United States, the other Party will be entitled to a complete duplicate of (or
complete access to, as appropriate) such intellectual property and all
embodiments of such intellectual property, which, if not already in such Party’s
possession, will be promptly delivered to it upon such Party’s written request
thereof.  Any agreements supplemental
hereto will be deemed to be “agreements supplementary to” this Agreement for
purposes of Section 365(n) of the Bankruptcy Code.


 


3.             GOVERNANCE


 


3.1           Joint Steering Committee.


 


(a)           The Parties shall establish a Joint Steering
Committee within thirty (30) days after the Effective Date that will have the
responsibility for the overall coordination and oversight of the Parties’
activities under this Agreement.  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 JSC.  One (1) representative
from each Party shall alternate in acting as the chairperson of the JSC for one
Calendar Year term, with Acorda’s representative chairing the JSC for the first
Calendar Year.  The chairperson shall not
have any greater authority than any other representative on the JSC and shall
conduct the following activities of the Joint Steering Committee: (a) calling
meetings of the JSC, (b) preparing and issuing minutes of each such meeting
within thirty (30) days thereafter, and (c) preparing and circulating an agenda
for the upcoming meeting; provided, that the chairperson shall include
any agenda items proposed by the Party of which the chairperson is not a
representative.


 


(b)           Responsibilities.  The JSC shall have responsibility for:  (i) attempting to resolve any disputes and to
consider any other issues brought to its attention by the Parties (including
disputes regarding any proposed amendments to the Development Plan or the
Commercialization Plan); and (ii) performing such other functions as
appropriate to further the purposes of this Agreement, as mutually agreed upon
by the Parties in writing.


 


3.2           Subcommittees.  Acorda and Licensee may establish such
subcommittees of the JSC as deemed necessary by the Parties.  Each such subcommittee shall consist of the
same number of representatives designated by each Party, which number shall be
mutually agreed by the Parties.  Each
Party shall be free to change its representatives on notice to the other or to
send a substitute representative to any subcommittee meeting; provided, however,
that each Party shall ensure that at all times during the existence of any
subcommittee, its representatives on such subcommittee are appropriate in terms
of expertise and seniority for the then-current stage of Development and
Commercialization of the Licensed Product in the Field in the Territory.  Except as expressly provided in this
Agreement, no subcommittee shall have the authority to bind the Parties
hereunder and each subcommittee shall report to, and any decisions shall be 


 


24

















 


made
by, the JSC, subject to Section 3.5.  The
initial two subcommittees of the JSC will be the joint development committee
(the “JDC”) and the joint commercialization committee (“JCC”).


 


(a)           Joint Development Committee.


 


(i)            The JDC shall oversee Development of the Licensed
Product in the Field in the Territory and any joint Development activities
undertaken by the Parties.  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 JDC.  Acorda shall
appoint a person from among its representatives on the JDC to serve as the
chairperson of the JDC.  The chairperson
shall coordinate administrative activities of the JDC, but shall not have any
greater authority than any other representative on the JDC.  Each Party shall be free to change its
representatives on notice to the other or to send a substitute representative
to any JDC meeting; provided, however, that each Party shall
ensure that at all times during the existence of the JDC, its representatives
on the JDC are appropriate in terms of expertise and seniority (including at
least one member of senior management) for the then-current stage of
Development of the Licensed Product in the Field in the Territory and have the
authority to bind such Party with respect to matters within the purview of the
JDC.


 


(ii)           Responsibilities.  The JDC shall have responsibility for (A) setting
overall strategic objectives and plans related to the Development of the Licensed
Product in the Field in the Territory; (B) reviewing and approving, as
applicable, the Development Plan, and any amendments or revisions thereto,
including any joint Development activity and all Licensee Development reports
provided in accordance with Section 5.3 for the Licensed Product in the Field
for the Territory; (C) monitoring each Party’s performance against the
then-current Development Plan; (D) reviewing, commenting on and approving, as
necessary, any Clinical Trial Summary or Clinical Trial protocol submitted by a
Party to the JDC in accordance with Section 5.7; (E) reviewing and approving
the Pharmacovigilance Agreement in accordance with Section 6.2; (F) reviewing
and approving Licensee’s regulatory strategies for the Licensed Product in the
Field for the Territory; (G) reviewing
Development activities for Licensed Product for the Territory that may impact Development of the Licensed Product by Acorda
for the Acorda Territory; (H) reviewing Development activities for the Licensed
Product for the Acorda Territory that
Acorda submits to the JDC in accordance with its reporting obligations under Section
5.3(b); and (I) facilitating the exchange of information between the
Parties under this Agreement regarding the strategy for implementing the Development
activities, including sharing Development data created pursuant to this
Agreement and establishing procedures for the efficient sharing of information
and materials necessary for the Parties’ Development of the Licensed Product
for the Field in the Territory; and (J) such
other responsibilities as may be assigned to the JDC pursuant to this Agreement
or as may be mutually agreed upon by the Parties from time to time.


 


(b)           Joint Commercialization
Committee.


 


(i)            The JCC shall oversee
Commercialization of the Licensed Product in the Field in the Territory.  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
JCC.  Licensee shall appoint a person
from among its representatives to 


 


25

















 


serve
as the chairperson of the JCC.  The
chairperson shall coordinate administrative activities of the JCC, but shall
not have any greater authority than any other representative on the JCC.  Each Party shall be free to change its
representatives on notice to the other or to send a substitute representative
to any JCC meeting; provided, however, that each Party shall
ensure that at all times during the existence of the JCC, its representatives
on the JCC are appropriate in terms of expertise and seniority (including at
least one member of senior management) for the then-current stage of
Commercialization of Licensed Product in the Field in the Territory and have
the authority to bind such Party with respect to matters within the purview of
the JCC.


 


(ii)           Responsibilities.  The JCC shall have responsibility for (A) setting
overall strategic objectives and plans related to Commercialization of Licensed
Product in the Field in the Territory; (B) reviewing, commenting on and
approving the Commercialization Plan; (C) reviewing, commenting on or
approving, as necessary, any Promotional Materials and/or Educational Materials
and Activities submitted by a Party to the JCC in accordance with Section 5.8; (D) monitoring Licensee’s performance against
the then-current Commercialization Plan; (E) reviewing
Commercialization issues for Licensed Product in the Field in the Territory
that will have an impact on Commercialization of Licensed Product in the Acorda
Territory; (F) reviewing Commercialization activities for the Licensed
Product in the Acorda Territory that Acorda
submits to the JCC in accordance with its reporting obligations under Section 7.3(b);
(G) providing a forum for the Parties to discuss the Commercialization of the
Licensed Product in the Field in the Territory in the broader context of the
Global Branding Strategy; and (H) such other
responsibilities as may be assigned to the JCC pursuant to this Agreement or as
may be mutually agreed upon by the Parties from time to time.  Notwithstanding anything to the contrary in
this Agreement, Licensee, its Affiliates and its Third Party Distributors, as
applicable, shall determine the price at which Licensee, its Affiliates and its
Third Party Distributors offer for sale and sell the Licensed Product in the
Field in the Territory and Acorda, its Affiliates, licensees and distributors,
as applicable shall determine the price at which Acorda, its Affiliates,
licensees and distributors offer for sale and sell Licensed Product in the
Acorda Territory or outside the Field (to the extent it is reasonably possible
to obtain a separate price for that Indication outside the Field in the
Territory).


 


3.3           Committee Membership.


 


(a)           General.  Acorda and Licensee shall each designate
three (3) representatives to serve on each of the JSC, JDC and JCC by written
notice to the other Party.  Either Party
may designate a substitute for any of its representatives who is unable to be
present at a meeting.  From time to time
each Party may replace its representatives by written notice to the other Party
specifying the prior representative(s) and their replacement(s).  Each Party shall ensure that at all times
during the existence of the JSC, JDC and JCC, its representatives on such
committee are appropriate in terms of expertise and seniority (including at
least one member of senior management) for the then-current stage of
Development and Commercialization of the Licensed Product in the Field in the
Territory and have the authority to bind such Party with respect to matters
within the purview of the JSC, JDC or JCC, as applicable.  Each Party’s representatives and any
substitute for a representative shall be bound by the obligations of
confidentiality set forth in Article 10.


 


26

















 


(b)           Appointment is a Right.  The appointment of members of the JSC, JDC,
JCC and any other subcommittee of the JSC 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 JSC, JDC, JCC or any other
subcommittee of the JSC.


 


(c)           Consequence of Non-Appointment.  If a Party does not appoint members of the
JSC, JDC, JCC or any other subcommittee of the JSC, it shall not be a breach of
this Agreement, nor shall any consideration be required to be returned, and
unless and until such members are appointed, all decisions and obligations
within the purview of such 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 Sections
3.5(b), (c) and (d) shall continue to apply (substituting in the provisions of
Sections 3.5(b), (c) and (d) references to “the Parties” instead of “the JSC”
or “the Joint Steering Committee”).


 


3.4           Committee Meetings.  The JSC, JDC and JCC shall each
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 JSC, JDC and JCC,
respectively, shall be effective only if at least one (1) representative of
each Party is present or participating. 
The JSC, JDC and JCC may meet either (i) in person at either Party’s
facilities or at such locations as the Parties may otherwise agree or (ii) by
audio or video teleconference; provided, that no less than one (1) meeting
of the JSC, JDC or JCC, as applicable, during each Calendar Year shall be
conducted in person.  Other
representatives of each Party involved with the Licensed Product may attend
meetings as non-voting participants, subject to the confidentiality provisions
set forth in Article 10.  Additional
meetings of the JSC, JDC or JCC 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 JSC, JDC and
JCC meetings.


 


3.5           Decisions.


 


(a)           Initial Dispute Resolution Procedures.  Subject to the provisions of this Section 3.5,
actions to be taken by the JSC, JDC and JCC shall be taken only following a
unanimous vote, with each Party having one (1) vote.  If the JDC or JCC 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.


 


(b)           Referral to Executive Officers.  If the JSC 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 Chief Executive Officer of each Party, or a
designee of the Chief Executive Officer with decision-making authority (the
Chief Executive Officer or such designee, the “Executive Officer”) for
resolution.  In the event that the
Executive Officers are unable to resolve such dispute within ten (10) days of such
dispute being referred to the Executive Officers, then the provisions of Section
3.5(c) shall apply.


 


(c)           Subsequent Dispute Resolution Procedures.  To the extent a dispute of the JSC has not
been resolved pursuant to Section 3.5(a) or 3.5(b), the following shall apply:


 


27

















 


(i)            Subject to Section 3.5(c)(iii), the Licensee
Executive Officer shall have the final decision-making authority with respect
to any dispute involving the Development or Commercialization of the Licensed
Product in the Field in the Territory; provided, that if Acorda
reasonably believes that an activity approved by the Licensee Executive Officer
(A) will materially adversely affect the Development or Commercialization of
the Licensed Product in the Acorda Territory or outside the Field; or (B) will
result in a material safety concern, the dispute shall be resolved by an
independent three-member expert panel (an “Expert Panel”).


 


(ii)           Subject to Section 3.5(c)(iii) and the terms of the
Supply Agreement, the Acorda Executive Officer shall have the final
decision-making authority with respect to any dispute involving the Development
or Commercialization of the Licensed Product in the Acorda Territory or the
Manufacture of Licensed Product; provided, that if Licensee reasonably
believes that an activity approved by the Acorda Executive Officer (A) will
result in a material safety concern, (B) will result in a change in the
Manufacturing process for the Licensed Product supplied for the Territory in
the Field, or (C) will materially adversely affect the Commercialization or
Development of the Licensed Product in or for the Territory, the dispute shall
be resolved by an Expert Panel.


 


(iii)          In the event a dispute is submitted to the Expert
Panel, each Party shall have the right to select one member of the Expert
Panel, with the third member of the Expert Panel jointly selected by the two
members selected by the Parties.  Each
Party shall provide the other within ten (10) days the name of the member it
has selected and, within five (5) days of the members’ selection, the members
will jointly select the third member of the Expert Panel and notify the
Parties.  All members of the Expert Panel
must be free of any conflicts of interest with respect to either or both
Parties and their Affiliates and shall have expertise in the matters concerning
the unresolved dispute.  In order to
align the expertise of the members of the Expert Panels with the subject matter
of the respective issues, unless the Parties otherwise agree, a new Expert
Panel shall be set up for each dispute. 
However, each Party shall be entitled to decide whether to designate the
same or a different member for each Expert Panel.


 


(A)          Each Party shall within fifteen (15) days following
the designation of all of the members of the Expert Panel present to the Expert
Panel a written summary of its position with respect to the issue (including
factual and documentary evidence with respect to the issue).  The Expert Panel will establish appropriate rules
for such proceeding.  The Expert Panel
shall, within fifteen (15) days of the Parties’ submission of written
summaries, hold a hearing to review the matter, at which time they will
consider the summaries and other evidence submitted by each Party as well as
reasonable presentations that each Party may present.


 


(B)           The Expert Panel shall not be permitted to take into
account prioritization and resource allocation factors within either Party’s
portfolio of products or any matters not raised in the Parties’ written
summaries submitted pursuant to Section 3.5(c)(iii)(A). The Expert Panel in
resolving disputes shall take into account, giving appropriate weighting
depending on the issue raised, the relative merits of the Parties’ positions,
the actual and potential commercial market for the Licensed Product in each
Party’s territory (including any potential effect a Party’s actions in its
territory may have on the Exploitation of the Licensed Product in the other
Party’s territory) and public health and safety, provided, that in all
cases the 


 


28

















 


Expert
Panel’s decision shall be subject to the relevant provisions of this Agreement
and applicable Law.


 


(C)           The issue shall be determined by majority vote of the
Expert Panel.  Decisions of the Expert
Panel under this Section 3.5 shall be binding.


 


(D)          All proceedings and determinations pursuant to this Section
3.5 and information disclosed in connection therewith, whether or not written,
shall remain the Confidential Information of both Parties and shall not be used
by either Party for any purpose other than the proceedings set forth in this Section
3.5.


 


(E)           The fees for engaging the Expert Panel shall be
shared equally by the Parties.  Each
Party shall otherwise bear its own costs.


 


(iv)          Notwithstanding the foregoing provisions of this Section
3.5(c):


 


(A)          neither Party shall exercise its right to finally
resolve a dispute pursuant to the foregoing clause (i) or (ii), as applicable,
and no Expert Panel shall exercise its right to finally resolve a dispute
pursuant to the foregoing clause (iii), in a manner that:  (1) excuses such Party from any of its
obligations specifically enumerated under this Agreement, (2) negates any
consent rights or other rights specifically allocated to the other Party under
this Agreement; (3) would cause Acorda to breach an Acorda Third Party
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; (4) 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 (5) 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 Acorda
shall only be obligated to use Commercially Reasonable Efforts to compel such
activity or to refrain from performing such activity.  In addition, the deciding Party in resolving
a dispute pursuant to the foregoing clause (i) or (ii) as applicable, shall act
in good faith; and


 


(B)           resolution of any disputes shall be subject to Elan’s
rights under Section 10.3 of the Elan License Agreement and any time-frames set
forth in this Section 3.5(c) shall, to the extent necessary to comply with such
rights, be modified to accommodate the time-frames for dispute resolution under
the Elan License Agreement.


 


(d)           No Limitation on Remedies.  Nothing in this Section 3.5 shall affect the
right of a Party to exercise its rights or remedies for a breach of this
Agreement by the other Party.


 


3.6           Authority.  The JSC and any subcommittee (including the
JDC and JCC) shall have only the powers assigned expressly to it in this Article
3 and elsewhere in this Agreement, and shall not have any power to amend,
modify or waive compliance with this Agreement. 
In 


 






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


 


29

















 


furtherance
thereof, each Party shall retain the rights, powers and discretion granted to
it under this Agreement and no such rights, powers or discretion shall be
delegated or vested in the JSC or any subcommittee unless such delegation or
vesting of rights is expressly provided for in this Agreement or the Parties
expressly so agree in writing.  Without
limiting the generality of the foregoing, neither the JSC nor any subcommittee
shall have any decision-making authority with respect to any matters related to
the (i) Manufacture and supply of the Licensed Product for Development or
Commercialization in the Field for the Territory (which shall be governed by
the Supply Agreement) or (ii) the Development  or Commercialization of the
Licensed Product outside the Field or outside of the Territory.


 


4.             SHARING OF INFORMATION


 


4.1           Initial Information Transfer.


 


(a)           Initial Information Transfer to Licensee.  Within a reasonable period of time after the
Effective Date (but in no event later than thirty (30) Business Days after the
Effective Date), (i) Acorda shall make available to Licensee, in a
mutually-agreed upon format, (A) material data included in the Acorda Know-How
and (B) other information regarding the Acorda IP that is necessary for
Development and Commercialization of the Licensed Product in the Field in the
Territory, and (ii) from the Effective Date through the first anniversary
thereof, not to exceed a total of [*****] Person Days unless otherwise mutually
agreed upon by the Parties, upon Licensee’s request reasonably in advance,
Acorda shall make its relevant scientific and technical personnel available to
Licensee at Acorda’s offices, at reasonable times
during
Acorda’s normal business hours, to answer any questions or
provide instruction as reasonably requested by Licensee concerning the
information delivered pursuant to this Section 4.1(a).  For the avoidance of doubt, Acorda shall
transfer to Licensee Manufacturing information and confidential information
belonging to or controlled by Elan and its Affiliates, in each case whether or
not included in the Acorda IP, only to the extent permitted by Elan and subject
to the terms of the Elan License Agreement, the Elan Supply Agreement and the
Elan Consent. SUBJECT TO THE REPRESENTATIONS AND WARRANTIES
OF ACORDA IN THIS AGREEMENT, ALL ACORDA IP OR OTHER INFORMATION TRANSFERRED
PURSUANT TO THIS SECTION 4.1(a) SHALL BE PROVIDED ON AN “AS IS” BASIS AND
ACORDA DISCLAIMS ALL IMPLIED WARRANTIES REGARDING SUCH ACORDA IP OR OTHER
INFORMATION, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE AND NONINFRINGEMENT.


 


(b)           Right of Reference or Use.  Acorda hereby grants to Licensee solely for
the purposes set forth in this Agreement a Right of Reference or Use to any and
all Regulatory Documentation Controlled by Acorda prior to the Effective Date,
including such Regulatory Documentation generated from any Clinical Trial
commenced by Acorda prior to the Effective Date, and agrees to sign, and cause
its Affiliates to sign, any instruments reasonably requested by Licensee in
order to effect such grant. 
Notwithstanding the foregoing, nothing in this Section 4.1 is intended
to imply the existence of any particular data, information, DMF or other
Regulatory Documentation.  Licensee shall
not, and shall ensure that its Affiliates do not, exercise such Right of
Reference or Use for the purpose of making or having made the Compound or the
Licensed Product.


 






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


 


30














 


(c)           Other Assistance.  Except as expressly provided in this Section 4.1
or Sections 5.4(b) or 5.5(c), Acorda shall not have any obligation to (i) grant
Licensee any right of Reference or Use to any data generated by or on behalf of
Acorda or (ii) transfer technology or provide data, information or other
assistance to Licensee.  Except as
expressly set forth in this Section 4.1 or Sections 5.4(b) or 5.5(c), neither
Party shall have any right under this Agreement to use for purposes of seeking
Regulatory Approval any data generated in Clinical Trials conducted or funded
by the other Party and commenced after the Effective Date.


 


5.                                       DEVELOPMENT


 


5.1           Overview.  From and after the Effective Date, (a) Licensee
will, subject to the terms of this Agreement, be responsible for Development of
the Licensed Product in the Field for the Territory, and (b) Acorda will remain
responsible for Development of the Licensed Product in the Field in the Acorda
Territory, the Manufacture of the Licensed Product worldwide, and the worldwide
Development and Commercialization of the Licensed Product outside the
Field.  While the Parties may choose, at
their sole discretion, to work together on particular projects (including in
accordance with Section 5.4(b)(ii)(A)), except as otherwise provided in this
Agreement, the Parties will operate independently in their activities for their
respective Development of the Licensed Product, but will provide access to
certain information to the JSC (or any subcommittee thereof) and to each other
as expressly described in this Agreement. 
The Specifications shall only be changed in accordance with the Elan
License Agreement, the Elan Supply Agreement and the Supply Agreement.


 


5.2           Development Plan.  Subject to Elan’s review and consultation
rights under Sections 3.1, 10.1 and 10.2 of the Elan License Agreement with
respect to Development plans for Licensed Product:


 


(a)           Initial Development Plan. Licensee
shall develop, and submit to the JDC for approval, no later than [*****] after
the Effective Date, the initial Development Plan for the Licensed Product for [*****],
including all plans for obtaining and maintaining Regulatory Approvals in the
Field in [*****].  As soon as reasonably
practicable after such initial Development Plan’s development and submission,
Licensee shall expand such Development Plan for the remainder of the Territory
and submit such expanded Development Plan to the JDC for approval.  The JDC shall promptly review the initial
Development Plan, and any subsequent additions or amendments to the Development
Plan, after submission of such plan.


 


(b)           Content of Development Plan.  The Development Plan shall set forth, among
other things, the following:


 


(i)            any preclinical studies, toxicology studies,
pharmaco-economic studies, process development studies and other clinical
studies, whether pre- or post-approval and whether sponsored or merely
supported by the Party, in each case, together with all protocols, endpoints
and investigators conducting such studies, with respect to the Product in the
Field in the Territory;


 






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


 


31

















 


(ii)           all regulatory plans and other elements of obtaining
and maintaining Regulatory Approvals in the Field in each country in the
Territory, consistent with the use of Commercially Reasonable Efforts;


 


(iii)          a detailed annual budget for all Development Costs
for the activities in the applicable Development Plan (the “Development
Budget”);


 


(iv)          the allocation of the Development activities to be
conducted by each Party, and as applicable, Elan, and the timeline for
completing such Development activities; and


 


(v)           the plans and timeline for preparing the necessary
Regulatory Documentation and for obtaining Regulatory Approval in the Field in
the Territory.


 


(c)   Each Party shall use
Commercially Reasonable Efforts to conduct the activities allocated to such
Party for the Development of Licensed Product for use in the Field in the
Territory and any joint Development activities undertaken by the Parties, if
any, pursuant to a comprehensive Development plan (the “Development Plan”).


 


5.3           Reports.


 


(a)           Of Licensee.  In addition to information and reports
required elsewhere in this Agreement (including Article 3 and Section 7.3),
Licensee shall provide Acorda and the JDC with a written quarterly report
summarizing in reasonable detail, on a country-by-country basis, Licensee’s and
its Affiliates’ activities and progress related to the Development of the
Licensed Product in the Field for the Territory, including conduct of
non-clinical activities and Clinical Trials, information regarding the status
of Regulatory Approvals, the status of Commercialization activities and any future planned activities.  If an Acorda Third Party Agreement requires
that Acorda disclose information in Licensee’s Development reports submitted
hereunder, Acorda may make such disclosure to the Third Party counterparties to
the Acorda Third Party Agreements; provided, that any such disclosed
information shall be deemed “confidential information” of Acorda or the
equivalent thereof under each relevant Acorda Third Party Agreement; provided,
further, that if an Acorda Third Party Agreement places no
confidentiality obligations on the Third Party counterparty, then any
disclosure of information under this Section 5.3(a) shall only be made subject
to confidentiality obligations no less onerous than the provisions herein.  Acorda
shall have the opportunity to reasonably seek further explanation or
clarification of matters covered in such reports and to provide observations
and suggestions to Licensee regarding the subject matter thereof, and Licensee
shall provide such explanation or clarification and shall consider such
observations and suggestions in good faith. 
Furthermore, if after receiving such a report Acorda wishes to meet with
Licensee to discuss such report, Licensee shall meet with Acorda at a site
reasonably requested by Acorda within thirty (30) days after Acorda requests
such meeting.


 


(b)           Of Acorda.  Acorda shall: (i) provide
Licensee and the JDC with a written quarterly report summarizing in
reasonable detail the major activities
performed by Acorda under the Development Plan during the prior Calendar Quarter, as well as the results and
status of such activities; (ii) disclose to Licensee and the JDC a
high-level summary of Acorda’s plans 


 


32

















 


for
the Development of the Licensed Product in the Acorda Territory; and (iii) disclose
to Licensee and the JDC information regarding any matter that either (A) could
reasonably be expected to potentially have an adverse regulatory or safety
impact on Licensee’s Development or Commercialization of the Licensed Product
in the Field in the Territory or (B) Licensee must or reasonably should
disclose to a Regulatory Authority or safety authority.


 


5.4           Updating and Amending
Development Plan and Development Budget; Additional Development Activities.


 


(a)           Development Plan Reviews and Updates. On or before January
1st of each Calendar Year during the Term (except as set forth in Section 5.2(a)),
the JDC shall review, update and approve the Development Plan (including the
Development Budget contained therein) which shall cover the Development
activities to be conducted with respect to the Development of Licensed Product
for use in the Field in the Territory during the upcoming Calendar Year, and
the JDC shall, on at least a quarterly basis, review and update, as
appropriate, the then-current Development Plan (including the Development
Budget) to reflect any changes, reprioritizations of, or additions to the
Development Plan.


 


(b)           Amendments to Development
Plan; New Development Collaboration Proposals.


 


(i)            Amendments to Development
Plan.  From time to time during the
Term, either Party may submit to the JDC any proposed amendment of the
Development Plan to amend the then-currently approved Development activities
(such proposed amendment, a “Proposed Development Plan Amendment”) for
the JDC’s review and approval.  Any proposed amendment to the Development
Plan shall contain, at a minimum, information supporting the rationale for the
Proposed Development Plan Amendment related to the Licensed Product from a
scientific, regulatory and commercial standpoint, as well as an estimated
developmental critical path, and an estimate of the cost of such
Development.  The JDC shall consider any
submitted Proposed Development Plan Amendment during its next scheduled
meeting.  Once approved by the JDC (or
otherwise resolved pursuant to Section 3.5), each amended Development Plan
(including the Development Budget contained therein) shall become effective and
supersede the previous Development Plan and Development Budget as of the date
of such approval or at such other time as decided by the JDC.


 


(ii)           New Development
Collaboration Proposals.  If
either Party proposes to conduct new Development activities in connection with
the Development of a Licensed Product not included in the then approved
Development Plan, including any proposal to collaborate to develop new
Indication(s), dosage amount(s), dosage form(s) or route(s) of administration
with respect to the Licensed Product for use in the Field whether in the
Territory or the Acorda Territory (such proposal, a “Development
Collaboration Proposal”), such Party shall submit the Development
Collaboration Proposal to the JDC for its approval.  Every Development Collaboration Proposal
shall include a proposal to collaborate with the other Party for such Development
activities so that, subject to the terms of this Agreement, with respect to the
Development activities underlying the Development Collaboration Proposal,
Licensee shall be able to Develop the Licensed Product for Commercialization in
the Field in the Territory and Acorda shall be able to Develop the Licensed
Product for Commercialization in the Field in the 


 


33

















 


Acorda Territory. 
Any Development Collaboration Proposal approved by the JDC that relates
to the Development of the Licensed Product in the Territory shall constitute an
amendment to the Development Plan hereunder.


 


(A)          In the event the JDC approves a Development
Collaboration Proposal and the Parties agree to collaborate to conduct the
Development activities underlying the Development Collaboration Proposal with
respect to the Licensed Product, each Party shall use Commercially Reasonable
Efforts to perform the activities allocated to it under the approved
Development Collaboration Proposal, and the Parties shall share in the payment
of Development Costs incurred in connection with such activities in accordance
with Section 5.5(c)(i).


 


(B)           In the event the JDC approves a Development
Collaboration Proposal submitted by a Party pursuant to Section 5.4(b)(ii) (or
such Development Collaboration Proposal has otherwise been approved in
accordance with Section 3.5(c)) and the other Party declines to participate in
and share the funding of such activity 
(the “Buy-In Party”), the submitting Party may proceed with the
activities described in such Development Collaboration Proposal at its sole
expense.  Once during each Calendar
Quarter following the commencement of, and until the completion of, the
activities described in the Development Collaboration Proposal, the Buy-In
Party may request that the Party conducting such Development activity provide a
summary of the current status of such Development activity, the Development
Costs incurred to date, any significant milestones achieved and any topline
initial results of such Development activity.


 


(C)           The Buy-In Party may obtain access to and use of the
clinical data generated pursuant to the relevant Development activities in
accordance with the procedure described in this paragraph.  Subject to Section 5.4(ii)(D), at any time
following the commencement of the activities described in the Development
Collaboration Proposal, the Buy-In Party shall provide the other Party with
written notice of its election to buy-in to such Development, and promptly
thereafter the other Party shall provide the Buy-In Party with an invoice for
[*****] of the applicable percentage allocated to the Buy-In Party in Section 5.5(c)(i)
of the Development Costs incurred by a Party in the generation of such clinical
data as of the date of the Buy-In Party’s written request (the “Buy-in
Amount”), which invoice the Buy-In Party shall pay within thirty (30) days
after receipt.  Each Party shall
thereafter share, in accordance with the allocation of costs set forth in Section
5.5(c)(i), in the Development Costs incurred after the date of the Buy-In Party’s
written request in connection with such Development activities under such
Development Collaboration Proposal.  For
the avoidance of doubt, if Acorda is the submitting Party under this Section 5.4(b)(ii)(C),
Acorda shall have the ability to conduct the Development activities underlying
the Development Collaboration Proposal in the Territory or in the Acorda
Territory; provided, however, subject to Acorda’s retained rights
set forth in Section 2.5(a), nothing in this Section 5.4(b) shall give Acorda
any further right to Exploit (including the right to Commercialize) the
Licensed Product in the Field in the Territory.


 


(D)          If (1) Acorda submits a Development Collaboration
Proposal to the JDC or Development activities for an Indication other than MS,
a form of administration other than oral administration, or other Development
of the Licensed Product, and 


 






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


 


34

















 


(2)
Licensee does not (y) participate in such activity and pay its share of the
Development Costs for such activity in accordance with Section 5.4(b)(ii)(A) or
(z) prior to completion of such activity, exercise its buy-in right under Section
5.4(b)(ii)(C), then (I) Acorda shall provide Licensee notice when it completes
such Development activity and shall deliver to Licensee a topline summary of
the final results of such Development activity within thirty (30) days of such
completion (or such longer period of time as may be reasonably necessary to
prepare such summary) and (II) Licensee may exercise its buy-in right under Section
5.4(b)(ii)(C) within sixty (60) days after Acorda completes such Development
activity (extended, as necessary, to reflect any extension pursuant to clause
(I)); provided, that, if Licensee does not exercise its buy-in rights as
set forth in this Section 5.4(b)(ii)(D), then, subject to Sections 1.64(a) and
(b), Licensee will be deemed to have forfeited its rights to Develop and
Commercialize the Licensed Product for such Indication, form of administration
or other Development and such rights shall revert to Acorda and be excluded
from the Field.


 


5.5           Development Costs.


 


(a)           Territory Exclusive Development Activities. Except as
provided in Section 5.5(c) and for Development activities conducted by a Party
at its own expense pursuant to Section 5.4(b)(ii)(B), Licensee shall be
responsible for [*****] of all Development Costs (whether incurred by Licensee
or Acorda (if the activities and their cost are agreed to in advance in writing
by Licensee) or their respective Affiliates or Elan) set forth in the
applicable Development Budget with respect to any Development activities that
are conducted for the primary purpose of obtaining or maintaining Regulatory Approval
for the Licensed Product in the Field in any country or other regulatory
jurisdiction in the Territory.  Licensee
shall disclose to Acorda a summary of efficacy results and detailed safety
information Controlled by Licensee and generated in the course of such
Development activities within sixty (60) days after the completion of such
activities.


 


(b)           Acorda Territory Exclusive Development Activities.  Except as provided in Section 5.5(c) and for
Development activities conducted by a Party at its own expense pursuant to Section
5.4(b)(ii)(B), Acorda shall be responsible for [*****] of all Development Costs
(whether incurred by Licensee (if the activities and their costs are agreed to
in advance in writing by Acorda) or Acorda or their respective Affiliates or
Elan) set forth in the applicable Development Budget with respect to any
Development activities that are conducted for the primary purpose of obtaining
or maintaining Regulatory Approval for the Licensed Product in the Field in any
country or other regulatory jurisdiction in the Acorda Territory or outside the
Field.  Acorda shall disclose to Licensee
a summary of efficacy results and detailed safety information Controlled by
Licensee and generated in the course of such Development activities within sixty
(60) days after the completion of such activities.


 


(c)           Joint Development Activities.  Except for Development activities conducted
by a Party at its own expense pursuant to Section 5.4(b)(ii)(B), with respect
to any Development activities conducted for the primary purpose of obtaining or
maintaining Regulatory Approval for the Licensed Product (i) both in and
outside the Field and/or (ii) both in the Field in the Territory and in the
Acorda Territory (including Development activities with respect to which a
Party has paid the Buy-in Amount in accordance with Section 5.4(b)(ii)(C)) 


 






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


 


35

















 


pursuant
to the Development Plan and, to the extent not included in the Development
Plan, any Development Collaboration Proposal:


 


(i)            subject to Section 5.6,
Licensee shall pay [*****] and Acorda shall pay [*****] of all Development
Costs (whether incurred by Licensee or Acorda or their respective Affiliates),


 


(ii)           each Party shall disclose to
the other Party all clinical data and related Regulatory Documentation
Controlled by such Party and generated in the course of such Development
activities within sixty (60) days after the completion of such activities,


 


(iii)          each Party shall have the
right to use all clinical data and related Regulatory Documentation Controlled
by either Party and generated in the course of such Development activities in
order to Develop, obtain Regulatory Approval for and Commercialize the Licensed
Product in the Field in such Party’s territory, in accordance with the terms of
this Agreement, and


 


(iv)          each Party hereby grants to
the other Party a Right of Reference or Use to any and all such Regulatory
Documentation, and agrees to sign, and cause its Affiliates to sign, any
instruments reasonably requested by such other Party in order to effect such
grant.


 


5.6           Development Costs Budget and
Timeline Overruns.


 


(a)           Budget Overruns.  With respect to any Development Costs which,
pursuant to this Agreement and/or a Development Plan or an approved Development
Collaboration Proposal, are meant to be allocated between the Parties (rather
than [*****]), each Party shall promptly inform the other Party upon
determining that it is likely to exceed the budget amounts set forth in the
annual Development Budget for the activities such Party is responsible for
under the Development Plan.  To the
extent that a Party (or its Affiliates) incurs Development Costs for the activities
such Party is responsible for under the Development Plan for a particular
Calendar Year which on an aggregate basis for that year exceed the Development
Costs allocated for such activity in the Development Budget by [*****] or less
(a “De Minimis Overage Amount”), then such De Minimis Overage Amount
shall automatically be included in the Development Budget for such year.  However, to the extent that a Party (or its
Affiliates) incurs Development Costs for the activities such Party is
responsible for under the Development Plan for a particular Calendar Year which
on an aggregate basis for that year exceed the Development Costs allocated for
such activity in the Development Budget by more than [*****] (such excess over
[*****], the “Excess Overage Amount”), the Party that has so exceeded its
budget shall provide to the JDC a full explanation for so exceeding its budget
and such Excess Overage Amount shall only be included in the Development Budget
to the extent that the JDC agrees to allow some or all of the Excess Overage
Amount to be included in the Development Budget as it considers equitable under
the circumstances.  By way of example, if
a Party incurs Development Costs which are in excess of the Development Budget
by [*****], then the first [*****] thereof will automatically be included in
the applicable budget as a De Minimis Overage Amount and the remaining [*****]
will constitute an Excess Overage Amount and shall only be included in the applicable
budget to the extent agreed to by the JDC as set forth in this Section 5.6.  To the extent that the JDC does not agree to
treat the Excess Overage Amount as 


 






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


 


36

















 


Development
Costs, the Party that has exceeded its budget shall be solely responsible for
the Excess Overage Amount.


 


(b)           Timeline Overruns.  Each Party shall promptly inform the other
Party upon determining that it is likely to miss a Development date set forth
in the Development Plan.  To the extent
that a Party (or its Affiliates) misses such a date by two (2) weeks or more,
the Party that has experienced such Development timeline failure shall provide
to the JDC a full explanation for such Development timeline failure.  Such notification shall not serve to excuse a
Party from its diligence or other obligations under this Agreement.


 


(c)           Reconciliation.  Within fifteen (15) days following the end of
each Calendar Quarter beginning with the Effective Date, each Party shall
prepare and deliver to the other Party a quarterly report detailing its
Development Costs incurred during such period, with Licensee reporting on all
such Development Costs incurred with respect to the Territory or Development
Collaboration Proposals, and Acorda reporting on all such Development Costs incurred
with respect to Development Collaboration Proposals.  Each Party shall submit any additional
information reasonably requested by the other Party related to the Development
Costs included in its report within three (3) Business Days of its receipt of such
request.  Within ten (10) days after the
receipt of the report delivered by Licensee pursuant to this Section 5.6(c),
Acorda shall prepare and deliver to Licensee a composite report that (i) summarizes
the Development Costs incurred by each Party for such Calendar Quarter, (ii) applies
the percentage of such costs for which each Party is responsible for the total
Development Costs attributable to the Development activities for such Calendar
Quarter pursuant to Section 5.5, and (iii) computes the amount due to Acorda or
Licensee, as applicable, for such Calendar Quarter in order for the Parties to
share the total Development Costs for such quarter based on the Development
Plan and the principles set forth in Section 5.5 (each, a “Reconciliation
Payment”).  The Party to whom a
Reconciliation Payment is due shall issue an invoice to the other Party for the
Reconciliation Payment, and such other Party shall pay the Reconciliation
Payment within thirty (30) days after its receipt of the invoice.  Each Party shall have the right to audit the
records of the other Party with respect to any purported Development Costs
included in such reports, in accordance with Section 8.10.


 


5.7           Review of Clinical Trial Summaries.  Subject to Elan’s review and consultation
rights, and the time-frames given to Elan for such review, under Sections 3.1,
10.1 and 10.2 of the Elan License Agreement with respect to Clinical Trials for
Licensed Product:


 


(a)           At least sixty (60) days prior to the first
submission of any Clinical Trial protocol, and each amendment thereto, with
respect to the Compound or the Licensed Product to any institutional review
board (or similar body), by Licensee or its Affiliates or through Funded
Development (unless such protocol and/or amendment has been prepared by or on
behalf of Acorda), Licensee shall submit the proposed protocol for such
proposed Clinical Trial and a written summary, in a form mutually agreed by the
Parties, of such Clinical Trial (each a “Clinical Trial Summary”) to the
JDC for review.  The JDC shall have
thirty (30) days after its receipt of such Clinical Trial Summary or proposed
Clinical Trial protocol to provide comments to Licensee.  Licensee shall consider in good faith all
comments provided by the JDC with respect to the Clinical Trial Summary and/or
proposed Clinical Trial protocol, but, except as provided in Section 5.7(b),
shall have no obligation to incorporate such comments into its plans 


 


37

















 


for
the Development of the Licensed Product or any proposed Clinical Trial protocol
or into its plans for the Commercialization of the Licensed Product.


 


(b)           If the JDC or Acorda provides comments to either the
Clinical Trial Summary or the proposed Clinical Trial protocol indicating that
the JDC or Acorda believes that the conduct of a Clinical Trial is reasonably
likely to result in a material safety concern or materially adversely affect
the Development or Commercialization of the Licensed Product in the Acorda
Territory, then the Parties shall promptly commence good faith discussions (for
a period not to exceed fifteen (15) days) for the purpose of arriving at a
mutually acceptable resolution to the concerns raised by the JDC or
Acorda.  If the Parties cannot resolve
such matter within such fifteen (15) day period, such matter shall be referred
to an Expert Panel in accordance with the procedure described in Section 3.5(c)(i)
for a determination as to whether the proposed Clinical Trial is reasonably
likely to result in a material safety concern or have such material adverse
affect on the Development or Commercialization of the Licensed Product.  Licensee shall not commence any disputed
Clinical Trial or other Development activity related to the Licensed Product in
the Field for the Territory until such dispute is so resolved.


 


5.8           Review of Promotional Material and Educational
Materials and Activities. 
Subject to Elan’s review and consultation rights, if any, under the Elan
License Agreement (including Sections 2.10, 10.1 and 10.2) with respect to
Promotional Materials and Educational Materials and Activities for Licensed
Product, and the time-frames given to Elan for such review and consultations:


 


(a)           Licensee shall wherever possible give due
acknowledgement in all Promotional Materials and Educational Materials and
Activities regarding the Licensed Product that the Licensed Product is made
under license from, or if applicable, manufactured by, Elan; provided,
that Elan shall have the right to review and approve any such uses.


 


(b)           At least [*****] prior to the introduction to the
market by Licensee or its Affiliates or Third Party Distributors of any
Promotional Materials or Educational Materials and Activities with respect to
the Compound or the Licensed Product, Licensee shall submit such proposed
Promotional Materials or Educational Materials and Activities to the JCC for
review.


 


(c)           The JCC shall have [*****] after its receipt of such
Promotional Material or Educational Materials and Activities to provide
comments to Licensee.  Licensee shall
consider in good faith all comments provided by the JCC with respect to the
proposed Promotional Material or Educational Materials and Activities, but,
except as provided in Section 5.8(e), shall have no obligation to incorporate
such comments into its plans the Commercialization of the Licensed Product or
any proposed Promotional Materials or Educational Materials and
Activities.  To the extent that any
Promotional Materials or Educational Materials and Activities state that the
Licensed Product is under license from, or if applicable, manufactured by,
Elan, the prior approval of Elan shall be required as to the format and content
of such Promotional Material or Educational Materials and Activities as it
relates to a description of, or other reference to, the application of Elan
intellectual property.


 


(d)           Notwithstanding anything to the contrary in this Section
5.8, the further consent of the JCC and/or, to the extent its further approval
is not required in accordance with 


 






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


 


38

















 


Elan
License Agreement, Elan, as the case may be, shall not be required for
Promotional Materials and Educational Materials and Activities where the format
and content of such Promotional Materials and Educational Materials and
Activities is substantively materially similar as the materials previously
furnished to and approved by the JCC under this Agreement or Elan,
respectively.


 


(e)           If the JCC or Acorda provides comments to the
proposed Promotional Material or Educational Materials and Activities
indicating that the JCC or Acorda believes that the proposed Promotional
Material or Educational Materials and Activities raises a material safety
concern or will materially adversely affect the Development or
Commercialization of the Licensed Product in the Acorda Territory, then the
Parties shall promptly commence good faith discussions (for a period not to
exceed fifteen (15) days) for the purpose of arriving at a mutually acceptable
resolution to the concerns raised by the JCC or Acorda.  If the Parties cannot resolve such matter
within such fifteen (15) day period, such matter shall be resolved in
accordance with Section 3.5(c).  Licensee
shall not use any disputed Promotional Material(s) or Educational Materials and
Activities until such dispute is so resolved.


 


5.9           Contracted Services.


 


(a)           If Licensee contracts with or funds research to be
conducted by a Third Party (including any physicians, contract research
organizations, academic institutions or other service providers) for the
Development of Licensed Product in the Territory, Licensee shall ensure in an
agreement with such Third Party that it owns (except that, with respect to
academic or non-profit institutions where such ownership is prohibited by such
academic or non-profit institutions policies with respect to inventions and
intellectual property rights, Licensee shall ensure that it has the maximum
rights to such inventions and intellectual property rights, including at least
an option to own) all data, Know-How and Patent Rights generated in the course
of such Development that are necessary for the Development of Licensed Product
or that otherwise relate to this Agreement, and such data and Know-How shall be
included within Licensee Know-How and such IP shall be included within Licensee
IP.


 


(b)           If either Party contracts with or funds research to
be conducted by a Third Party (including any physicians, contract research
organizations, academic institutions or other service providers) for the
Development of Licensed Product under Section 5.4(b)(ii)(A), such Party shall
ensure in an agreement with such Third Party that it owns (except that, with
respect to academic or non-profit institutions where such ownership is prohibited
by such academic or non-profit institutions policies with respect to inventions
and intellectual property rights, the applicable Party shall ensure that it has
the maximum rights to such inventions and intellectual property rights,
including at least an option to own) data, Know-How and Patent Rights generated
in the course of such Development that are necessary for the Development of
Licensed Product or that otherwise relate to this Agreement, and such data
and  Know-How shall be included within
Joint Know-How and such IP shall be included within Joint IP.


 


39

















 


6.                                       REGULATORY;
MARKETING AND MEDICAL AFFAIRS


 


6.1           Regulatory Filings and
Regulatory Approvals.


 


(a)           General.  The JDC shall be responsible for formulating
regulatory strategy for obtaining and maintaining Regulatory Approvals for the
sale of the Licensed Product in the Field in the Territory.  Subject to Elan’s rights under  the Elan License Agreement, if any (including
under Sections 3.1, 6.2, 6.5, 6.6, 6.8 
10.1 and 10.2) to review, access and use any Regulatory Documentation
and Regulatory Approvals and the time frames for providing Elan such review,
access and use, Licensee shall be solely responsible for (and shall use
Commercially Reasonable Efforts toward) the preparation and filing of all
Regulatory Documentation necessary or desirable for obtaining and maintaining
such Regulatory Approvals in all countries in the Territory, including in
connection with package inserts, labeling and packaging for the Licensed
Product in the Field in the Territory and shall own all such Regulatory
Documentation subject to the rights of Acorda or its Affiliates, Elan or its
Affiliates, or any other Third Party in any DMF, CMC section or Acorda Know-How
included in such Regulatory Documentation filed with a Regulatory Authority and
Regulatory Approvals resulting therefrom. 
Licensee shall submit such Regulatory Documentation to the applicable
Regulatory Authorities in the Territory. 
Licensee shall keep Acorda informed on an ongoing basis of Licensee’s
strategy for seeking, and the results it obtains in seeking, such Regulatory
Approvals in the Territory, including the results of any material discussion or
other communication with relevant Regulatory Authorities regarding such
Regulatory Approvals.


 


(b)           Manufacturing Related Sections.  Notwithstanding the provisions of Section 6.1(a),
Acorda shall, itself or through its manufacturer of Licensed Product, be solely
responsible for preparing and submitting those portions of any Regulatory
Documentation related to the Manufacture of the Licensed Product for sale in
the Field in the Territory, including any DMFs and the CMC (or equivalent
thereof) section of any Regulatory Documentation.  At least sixty (60) days prior to any
submission of Regulatory Documentation, Acorda shall, to the extent permitted
by the Elan License Agreement, deliver such Regulatory Documentation, including
all relevant underlying materials to Licensee and Licensee shall have the right
to review and comment on such materials prior to submission.


 


(c)           Cost of Regulatory Activities.  [*****] reasonable costs and expenses
incurred by either Party or their Affiliates or Elan or its Affiliates after
the Effective Date in connection with the preparation or maintenance of
Regulatory Documentation and Regulatory Approvals for sale of the Licensed
Product in the Field in the Territory shall be borne [*****].  Acorda shall invoice Licensee for all amounts
due to Acorda or its Affiliates for all such costs and expenses and such
invoice shall be payable by Licensee within thirty (30) days of receipt.


 


(d)           Reporting and Review.


 


(i)            Each Party shall keep the
JDC reasonably and regularly informed in connection with its Development of the
Product in its respective Territory, which in the case of Licensee shall
include information regarding the preparation of all Regulatory Documentation,
receipt of Regulatory Approval, Regulatory Authority review of Regulatory
Documentation and Regulatory Approvals, annual reports, annual re-assessments,
and variations and labeling, in


 






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


 


40














 


each case with respect to the Licensed Product in
the Field in the Territory, including by providing prompt and full reports of
such information at JDC meetings. 
Licensee shall provide the JDC, in a timely manner, with copies of all
notices, questions, requests for information in tangible form and other
material correspondence with any Regulatory Authority in the Territory with
respect to the Licensed Product in the Field in the Territory; provided,
however that (x) Licensee shall provide Acorda any comments from a
Regulatory Authority relating to the CMC section as soon as practicable, (y) Licensee
shall provide Acorda a copy of any NDA or other regulatory filings or material
correspondence within fifteen (15) days of the submission thereof to a
Regulatory Authority in a Major Market Country, and (z) Licensee shall
have the right to redact any information to the extent not related to the
Licensed Product in the Field.  Licensee
shall respond within a reasonable time frame to all reasonable inquiries by Acorda
with respect to any information provided pursuant to this Section 6.1(d).  Unless already the Confidential Information
of a Party, any information disclosed pursuant to this Section 6.1(d) shall
be the Confidential Information of the disclosing Party.


 


(ii)                                  Subject to Elan’s
consultation and review rights, if any, and the timing for the exercise of such
rights, including under Sections 3.1, 6.2, 6.5, 6.6, 6.8 10.1 and 10.2 of the
Elan License Agreement with respect to dealings with Regulatory Authorities in
Major Market Countries, Licensee shall be responsible for interfacing,
corresponding and meeting with the Regulatory Authorities throughout the
Territory with respect to Licensed Product in the Field.  To the extent permitted by Regulatory
Authorities, Acorda shall have the right to have a senior, experienced employee
participate as an observer in meetings with the EMEA or other Regulatory
Authorities or their agents, including the EMEA Committee for Medicinal
Products for Human Use (“CHMP”), rapporteurs and member states, as well
as participate in internal meetings or discussions of Licensee occurring
immediately before or after, and related to, such meetings, and shall be
provided with advance access to Licensee’s materials prepared for such
meetings.  Acorda
shall also have the right to review and comment upon any correspondence with
the EMEA or other Regulatory Authority or their agents in the Territory related
to such meetings.  Licensee shall provide
Acorda regularly prepared minutes of material meetings with any Regulatory
Authority regarding the Licensed Product in the Field in the Territory and
available material teleconference reports with any Regulatory Authority
pertaining to the Licensed Product in the Field in the Territory.


 


(iii)                               Subject to Elan’s
consultation and review rights, if any, and the timing for the exercise of such
rights, including under Sections 3.1, 6.2, 6.5, 6.6, 6.8 10.1 and 10.2 of the
Elan License Agreement with respect to dealings with Regulatory Authorities in
Major Market Countries, Acorda shall be responsible for interfacing,
corresponding and meeting with the Regulatory Authorities throughout the Acorda
Territory with respect to Licensed Product in the Field.   Licensee shall also have the right to review
and comment upon any correspondence with the FDA or their agents in the Acorda
Territory related to such meetings. 
Acorda shall provide Licensee regularly prepared minutes of material
meetings with any Regulatory Authority regarding the Licensed Product in the
Field in the Acorda Territory and available material teleconference reports
with any Regulatory Authority pertaining to the Licensed Product in the Field
in the Acorda Territory.


 


41

















 


6.2                                 Pharmacovigilance.


 


(a)                                  Global Database.  Following the earliest to occur of (i) initiation
of Clinical Trials regarding the Licensed Product by Licensee or its Affiliates
in the Territory, (ii) as applicable, the transfer of the MAA (or the
application therefor) from Acorda to Licensee or the filing of the MAA (or
application therefore) by Licensee, or (iii) First Commercial Sale of
Licensed Product in the Territory, Acorda shall, itself or through its
Affiliate or a mutually agreeable Third Party (or, upon mutual written agreement
of the Parties, through Licensee or its Affiliates), establish and maintain a
worldwide safety database for the Licensed Product.  Such database shall comply with all Laws
applicable to pharmacovigilance anywhere where the Licensed Product is being or
has been Developed or Commercialized. 
The Parties shall equally share in the Out-of-Pocket Costs associated
with establishing and maintaining such database; provided, that Licensee
shall reimburse Acorda any FTE Costs incurred by Acorda with respect to the
establishment and maintenance of such database to the extent solely
attributable to the Territory.  After the
transfer to or filing by Licensee or its Affiliate of an NDA covering the
Licensed Product in the Territory, Acorda shall continue to be responsible for
maintaining such a worldwide safety database, but the Party with obligations
under Law to maintain the safety database with respect to a given country in
the Territory shall have primary responsibility for the safety database for
such country in the Territory.  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 on a
prompt basis and as required by the most stringent Law in any jurisdiction
where the Licensed Product is being or has been Developed or Commercialized by
either Party, its Affiliates, and, in the case of Acorda, its other licensees,
and in the case of Licensee, its Third Party Distributors.  Appropriate personnel of both Parties, their
Affiliates, and in the case of Acorda, its other licensees shall have full and
immediate access to such database (including electronic access to the extent
practicable), and shall be authorized to submit data from the database to
applicable Regulatory Authorities as required or permitted by Law.


 


(b)                                 Adverse Events.  Each Party (the “Notifying Party”)
shall notify the other Party of all information coming to the Notifying Party’s
attention, regardless of the origin of such information, and including such
information coming to its attention through clinical and non-clinical sources
(including journal publications and other media), regarding Adverse Drug
Experiences associated with the Licensed Product, whether in the Territory or
in the Acorda Territory, as follows:


 


(i)                                     for each Adverse Drug
Experience that is both a Serious Adverse Drug Experience and an Unexpected
Adverse Drug Experience, notification to the other Party shall be made promptly
in accordance with the Pharmacovigilance Agreement, but in no event later than
required for the other Party to comply with the most stringent Law in any
jurisdiction where the Licensed Product is being or has been Developed or
Commercialized by either Party or its Affiliates.  The Notifying Party shall also notify the
other Party of submissions made to the FDA or any other Regulatory Authority
contemporaneously with the submission of such reports; and


 


(ii)                                  for all other Adverse Drug
Experiences, notification shall be provided to the other Party in accordance
with the Pharmacovigilance Agreement.


 


42

















 


For
purposes of this Section 6.2, “Adverse Drug Experience,” “Serious Adverse
Drug Experience” and “Unexpected Adverse Drug Experience” shall have the
meanings set forth in 21 CFR §§600.80 and 312.32 or other applicable Law.


 


(c)                                  Other Safety-Related
Information.  In addition
to any Adverse Drug Experience that comes to a Party’s attention, each Notifying
Party shall notify the other Party in writing of all other safety-related
information coming to the Notifying Party’s attention, regardless of the origin
of such information, and including such information coming to its attention
through clinical and non-clinical sources (including journal publications,
periodic safety reports and other media), associated with the Licensed Product,
whether in the Territory or in the Acorda Territory according to the
Pharmacovigilance Agreement in compliance with the most stringent Law in any
jurisdiction where the Licensed Product is being or has been Developed or
Commercialized by either Party or its Affiliates.


 


(d)                                 Coordination.  Each Party shall ensure that its Affiliates
and subcontractors promptly provide to such Party all information which such
Party would be obligated to disclose to the other Party pursuant to this Section 6.2
if such information were otherwise developed by, or to come to the attention
of, such Party.


 


(e)                                  Recalls.  If any Regulatory Authority issues or
requests a recall or market withdrawal of the Licensed Product, or if either
Party determines that an event, incident or circumstance has occurred that may
result in the need for a recall or market withdrawal of the Licensed Product in
such Party’s territory, the Party notified of such recall or withdrawal, or the
Party that desires such recall or withdrawal, will advise the other Party
thereof by telephone or facsimile within twenty-four (24) hours of (i) its
receipt of notice from a Regulatory Authority requiring or requesting a recall
or withdrawal or (ii) such Party’s determination that it may need to
institute a recall or withdrawal, and the JCC shall convene a joint telephonic
meeting to discuss such recall or withdrawal request within twenty-four (24)
hours of such notification. 
Notwithstanding Section 3.5, Licensee shall be responsible for
making decisions regarding recalls or withdrawals of the Licensed Product in
the Field in the Territory, and Acorda shall be responsible for making decisions
regarding recalls or withdrawals of the Licensed Product in the Acorda
Territory and Licensed Product Commercialized by Acorda or its Affiliates
outside the Field in the Territory; provided, however, that, if (A) Acorda
believes in good faith that a recall or withdrawal of the Licensed Product is
required to protect the health or safety of any individual, then Acorda shall
so advise Licensee and Licensee shall promptly conduct, or have conducted, such
recall or withdrawal unless Licensee can reasonably convince Acorda that such
recall or withdrawal is unnecessary and (B) Licensee believes in good
faith that a recall or withdrawal of the Licensed Product in the Acorda
Territory is required to protect the health or safety of any individual, then
Licensee shall so advise Acorda and Acorda shall promptly conduct, or have
conducted, such recall or withdrawal unless Acorda can reasonably convince
Licensee that such recall or withdrawal is unnecessary.  The Parties shall cooperate with each other
to allow such recall or withdrawal to occur under the direction of the Party
granted decision-making authority under this Section 6.2(e) and in
implementing such recalls or withdrawals, including the reshipment, storage and
disposal of recalled Licensed Product, the preparation and maintenance of
relevant reports and records, and the notification to any Third Party
recipients or users of the Licensed Product. 
Licensee shall bear [*****] costs and 


 






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


 


43

















 


expenses
incurred by either Party for a recall or withdrawal in the Field and in the
Territory and shall reimburse such costs and expenses incurred by Acorda within
thirty (30) days after receipt of any invoice therefor except to the extent the
recall or market withdrawal of the Licensed Product in the Field and in the  Territory was attributable to Acorda’s actions (which for
the avoidance of doubt shall not include any acts or omissions of Elan), in
which case Acorda shall bear [*****] applicable costs and expenses incurred by
either Party for such recall or withdrawal.


 


(f)                                    Pharmacovigilance Agreement.  As soon as reasonably practicable following
the Effective Date, the pharmacovigilance departments of each of Acorda and
Licensee shall meet and determine the approach to be taken for the collection,
review, assessment, tracking, exchange and filing of information related to
adverse events associated with the Licensed Product, consistent with the
provisions of this Section 6.2. 
Such approach shall be documented in a separate and appropriate written
pharmacovigilance agreement between the Parties which shall control with
respect to the subject matter covered therein (the “Pharmacovigilance
Agreement”).  Such agreement will be
in accordance with, and enable the Parties and their Affiliates to fulfill,
local and international regulatory reporting obligations to Regulatory
Authorities and other applicable Law.


 


7.                                       COMMERCIALIZATION


 


7.1                                 Commercialization in the
Field in the Territory. 
During the Term, Licensee shall be solely responsible for
Commercializing the Licensed Product in the Territory for use in the Field,
which Commercialization shall be in accordance with the Commercialization Plan and
this Agreement with the goal of maximizing the commercial potential of the
Licensed Product in the Field in the Territory. 
Licensee shall be responsible for [*****] of the expenses (including
pre-launch marketing and other Commercialization expenses) incurred in
connection with the Commercialization of the Licensed Product in the Territory
for use in the Field. Licensee shall use Commercially Reasonable Efforts to
Commercialize the Licensed Product in the Field in the Territory in accordance
with the Commercialization Plan and in accordance with the time frames set
forth in the Commercialization Plan.


 


7.2                                 Licensee’s Performance.   Subject to Elan’s review and consultation
rights, if any, including under Sections 2.11.4.3, 10.1 and 10.2 of the Elan
License Agreement with respect to Commercialization plans for Licensed Product:


 


(a)                                  Commercialization Plan.


 


(i)                                     The initial
Commercialization plan for Licensed Product in the Field in the Territory (the “Commercialization
Plan”) shall be prepared by Licensee within [*****] after establishment of
the JCC and submitted to the JCC for review and approval within [*****] of
submission of such plan.


 


(ii)                                  On an annual basis no later
than at least [*****] of each Calendar Year during the Term (except as set
forth in Section 7.2(a)(i)), Licensee shall create and submit to the JCC
for its review and approval annual updates to the Commercialization Plan for
the following Calendar Year.  Each
Commercialization Plan shall contain a [*****] rolling annual 


 






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


 


44

















 


plan
for the Commercialization of the Licensed Product in the Territory for use in
the Field.  The first [*****] of such
plan, as finally approved by the JCC (except the initial Commercialization Plan
as set forth in Section 7.2(a)(i)), shall constitute the plan and budget
for the first [*****] and the remaining [*****] shall be for planning purposes
only (provided, that Licensee shall use its best efforts to prepare such
[*****] portion in accordance with its good faith anticipated activities).  Upon approval by the JCC, such annual plan
and budget shall be the Commercialization Plan for such following Calendar
Year; provided, however, that to the extent the JCC does not
agree on the contents of such Commercialization Plan, the provisions of Section 3.5
shall apply with respect to any such dispute. 
From time to time during a given Calendar Year, Licensee may propose
written updates to the Commercialization Plan for review and approval by the
JCC; provided, however, that the Commercialization Plan shall not
be updated unless and until agreed to by the JCC (provided, that the
provisions of Section 3.5 shall apply with respect to any dispute in
connection therewith).  Licensee shall
conduct all Commercialization of the Licensed Product in the Territory in
accordance with the Commercialization Plan.


 


(iii)                               Each annual
Commercialization Plan shall include and set forth on a country-by-country
basis and as consistent with the use of Commercially Reasonable Efforts, among
other things, the following items in connection with the Commercialization of
the Licensed Product in the Territory for use in the Field:


 


(A)                              a description of the short-
and long-term vision for the Licensed Product and Licensed Product positioning;
a situation analysis; a Strengths, Weaknesses, Opportunities and Threats (SWOT)
analysis; and a description of critical issues, strategic imperatives and
tactics by strategic imperative with timelines and budget, all of the foregoing
from each of the following perspectives: 
marketing, sales, and reimbursement;


 


(B)                                a summary of the minimum
level of sales efforts to be dedicated to the promotion of the Licensed
Product, including the anticipated number of details and targets of such details;


 


(C)                                a description of any
Promotional Materials and campaigns, public relations, life cycle management
and Educational Materials and Activities, to be used in connection with the
Licensed Product in the Field;


 


(D)                               a detailed budget for the
Commercialization activities (including advertisement, promotion, medical
education, public relations, life cycle management and publication costs) for
the applicable period; and


 


(E)                                 a detailed budget of all
forecasted discounts and allowances.


 


(b)                                 Specific Commercialization
Obligations.  Without
limiting the generality of the provisions of Section 7.1, in connection
with the Commercialization of the Licensed Product in the Territory for use in
the Field by Licensee hereunder, during the Term:


 






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


 


45

















 


(i)                                     Licensee shall use
Commercially Reasonable Efforts to file and obtain Regulatory Approval for the
Product in each country in the Territory within a commercially reasonable time,
which filing shall be made, with respect to each Major Market Country, within a
commercially reasonable time after completion and receipt of positive data from
all pre-clinical and clinical studies required for the related NDA, as determined
by the JCC.


 


(ii)                                  Licensee shall use
Commercially Reasonable Efforts to launch the Licensed Product in each country
(or other regulatory jurisdiction) in the Territory within a commercially
reasonable time after all applicable Regulatory Approvals for the Licensed
Product in such country (or other regulatory jurisdiction) have been obtained; provided,
however, that, notwithstanding the foregoing, Licensee shall effect a
national launch (including effecting the First Commercial Sale) of the Licensed
Product in each Major Market Country within [*****] after the receipt of
Regulatory Approval of the Licensed Product in such country and Licensee shall
effect a national launch (including effecting the First Commercial Sale) of the
Licensed Product in each other country in the Territory within [*****] after
the receipt of Regulatory Approval of the Licensed Product in such country.


 


(iii)                               Licensee shall be solely
responsible for (i) receiving, accepting and filling orders for the
Licensed Product in the Field in the Territory, (ii) handling all returns
of the Licensed Product in the Field in the Territory, (iii) controlling
invoicing, order processing and collection of accounts receivable for the sales
of the Licensed Product in the Field in the Territory, (iv) booking and
recording sales of the Licensed Product in the Field in the Territory in its
books of account and (v) distributing and managing inventory of the
Licensed Product in the Field in the Territory, in each case in accordance with
GAAP to the extent applicable.


 


(iv)                              Licensee shall,
after consultation with Acorda, provide Acorda a [*****] rolling forecast, to
be updated annually at the end of each Calendar Year during the Term, detailing
the following metrics as agreed by the Parties: 
[*****].  Licensee shall perform
its Commercialization activities in accordance with such forecast; provided,
that (y) [*****] may decrease by no more than [*****] in any given
Calendar Year from the prior Calendar Year, and (z) Licensee shall
increase its forecast from time to time if Licensee reasonably determines that
the commercial potential for the Licensed Product is greater than earlier
anticipated; provided, further, that, notwithstanding the
requirements in the preceding subclauses (y) and (z), relevant changes in
Laws, reimbursement status, or other significant issues not within Licensee’s
control that increase or decrease Licensee’s ability to conduct sales and
marketing activities may be taken into account with respect to assessing the
amounts and forecasts required under those subclauses.  The minimum amounts to be included in
Licensee’s first such rolling forecast (which forecast shall be approved by the
JCC) are included in the attached Exhibit I.


 


(c)                                  Diligence
Failures.


 


(i)                                     If Acorda
believes in good faith that Licensee has failed to utilize Commercially
Reasonable Efforts or otherwise has failed to satisfy the requirements set
forth in subclause (b)(i) or (ii) with respect to the
Commercialization of the Licensed Product in the Field in the Territory or a country(ies)
in the Territory pursuant to this Agreement, then Acorda shall first raise such
issue to Licensee through the JCC, identifying the country(ies) at issue and
specific reasons underlying such allegation. 
Within thirty (30) days following Licensee’s receipt 


 






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


 


46

















 


of any such notice from Acorda, Licensee
shall provide Acorda with a written response specifying, in reasonable detail,
how it is using or has begun to use such Commercially Reasonable Efforts or
fulfilled such other requirements.  If
Licensee does not provide a written response which demonstrates, in reasonable
detail and to Acorda’s reasonable satisfaction, how it has complied with, and
will continue to comply with, its obligation to use Commercially Reasonable
Efforts to Commercialize the Licensed Product in the Field in the Territory or,
as applicable, satisfy its requirements under Section 7.2(b)(i) or
7.2(b)(ii), within thirty (30) days after the receipt of such notice (or to the
extent Licensee does not thereafter comply with such obligations), then,
effective upon the expiration of such thirty (30) day period (or immediately
upon written notice to the extent Licensee does not thereafter comply with such
obligations), Acorda may, in its sole discretion, immediately terminate this
Agreement for the country(ies) at issue upon prior written notice to Licensee; provided,
that, if such termination is due to a Time-Constrained Commercial Diligence
Determination (as defined below) that is based on a curable breach of Section 2.11
of the Elan License Agreement that would give Elan the right to terminate the
Elan License Agreement under Section 12.5.3 of the Elan License Agreement
(and for purposes of clarity, would not give Elan the right to terminate the
Elan License Agreement pursuant to Section 12.5.2 of the Elan License
Agreement) (a “Curable Elan Agreement Breach”), Acorda shall provide
Licensee written notice of termination and this Agreement shall so terminate on
the thirtieth (30th) day from such
notice unless Licensee has cured such breach by such thirtieth (30th) day or such cure is
underway and Acorda, in its sole discretion, determines that Licensee is
diligently pursuing such cure and will cure such breach on or before the date
on which Elan’s termination of the Elan License Agreement shall become
effective (such cure or Acorda’s termination that such cure is likely to occur,
“a Curable Elan Agreement Cure”).


 


(ii)                                  In the event
Licensee disagrees with Acorda’s conclusion that Licensee has failed to utilize
Commercially Reasonable Efforts or otherwise has failed to satisfy the
requirements set forth in subclause (b)(i) or (ii) with respect to
the Commercialization of the Licensed Product in the Field in the Territory or
a country(ies) in the Territory pursuant to this Agreement (other than Acorda’s
determination that (A) Licensee has failed to effect the First Commercial
Sale in any country in the Territory within [*****] of receipt of Regulatory
Approval in such country or (B) Licensee has otherwise failed to use
Commercially Reasonable Efforts to Commercialize the Licensed Product in the
Field in the Territory in a manner consistent with Acorda’s obligations
pursuant to Section 2.11 of the Elan License Agreement (such
determination, a “Time-Constrained Commercial Diligence Determination”)),
it may seek the determination of an Expert Panel in accordance with Section 3.5(c)(iii) to
determine if Licensee has failed to use Commercially Reasonable Efforts to
Commercialize the Licensed Product in the Field in the Territory.  Members of such Expert Panel shall have
expertise in the matters concerning the unresolved dispute.  Decisions of the Expert Panel under this Section 7.2(c)(ii) shall
be binding on the Parties, subject to Elan’s rights under the Elan License
Agreement and the Elan Supply Agreement. 
If Licensee is found by the Expert Panel to have materially breached its
Commercialization diligence obligations as described in this Section7.2(c)(ii),
Licensee shall have [*****] to correct such breach.  If Licensee has not cured such breach within
such [*****] period, Acorda may, under Section 15.2(b) of this Agreement,
immediately terminate this Agreement for the country(ies) with respect to which
such failure has occurred upon prior written notice to Licensee and with the
effects set forth in Section 15.3(a).


 






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


 


47

















 


(iii)                               Notwithstanding
anything to the contrary in Section 7.2(c)(i) or (ii), in the event
of a Time-Constrained Commercial Diligence Determination:  (1) Acorda’s exercise of such
termination right shall not be subject to the dispute resolution procedures of
Sections 3.5 and 16.8 and shall not limit Acorda’s other rights under this
Agreement; (2) Licensee shall not be entitled to injunctive relief to
prevent or delay such termination; (3) Licensee shall only be entitled to
monetary damages in the event that it thereafter disputes such termination
pursuant to Section 16.8 and the relevant court determines as a final,
non-appealable matter that Acorda had not properly exercised its termination
right hereunder; and (4) Acorda shall have the rights set forth in Section 15.3(a) and
Licensee shall conduct the transfer of information and materials as set forth
in Section 15.3(a) on an expedited basis to enable Acorda to meet its
obligations under the Elan License Agreement.


 


(d)         If Licensee indicates to
Acorda that it does not intend to file to obtain Regulatory Approval or to
Commercialize Licensed Product in a particular country or countries in the
Territory, Acorda shall be entitled to terminate the license to Licensee with
respect to such countries and Acorda shall have the rights set forth in Section 15.3(a).


 


7.3                                 Reports.


 


(a)                                  Of Licensee.  Subject to Elan’s rights to review and
comment on information, and time-frames given to Elan to exercise such rights
under Sections 2.11, 10.1 and 10.2 of the Elan License Agreement, regarding the
Commercialization of Licensed Product, Licensee shall update the JCC at each
meeting regarding the expected and actual date of First Commercial Sale in each
country in the Territory, its significant Commercialization activities
involving the Licensed Product, including a written report summarizing such
significant Commercialization activities in the Territory, the timing and costs
of such activities and a comparison of such timing and costs to the
Commercialization budget and timeline included in the Commercialization
Plan.  Such reports submitted by Licensee
shall cover the subject matter at a level of detail reasonably sufficient to
enable Acorda to determine Licensee’s compliance with its diligence obligations
pursuant to this Article 7.  Acorda
shall have the opportunity to seek further explanation or clarification of
matters covered in such reports and to provide observations and suggestions to
Licensee regarding the subject matter thereof and Licensee shall promptly
provide such explanation or clarification and shall consider such observations
and suggestions in good faith. 
Furthermore, if after receiving such a report Acorda wishes to meet with
Licensee to discuss such report, Licensee shall meet with Acorda at Acorda’s
offices (or any other site as reasonably requested by Acorda) within thirty
(30) days after such meeting is requested by Acorda.


 


(b)                                 Of Acorda.  Acorda shall disclose to Licensee and the JDC
information regarding any matter related to Commercialization of the Licensed
Product in the Acorda Territory or outside the Field that either (a) could
reasonably be expected to potentially have an adverse regulatory or safety
impact on Licensee’s Development or Commercialization of the Licensed Product
in the Field in the Territory or (b) Licensee must or reasonably should
disclose to a Regulatory Authority or safety authority.


 


48

















 


7.4                                 Promotional
Materials and Educational Materials and Activities.


 


(a)                                  Creation.  Licensee will create and develop Promotional
Materials and Educational Materials and Activities for the Territory in
accordance with the Commercialization Plan, the Regulatory Approvals and
applicable Laws.  To the extent Licensee
includes the name or trademarks of Acorda or its licensors, other licensees or
manufacturers in the Promotional Materials and/or Educational Materials and
Activities, Licensee shall comply with Acorda’s or its licensor’s, licensee’s
or manufacturer’s then-current guidelines for trademark usage, a copy of which
shall be provided to Licensee from time to time.


 


(b)                                 Licensee Ownership.  During the Term, Licensee shall own all
right, title and interest in and to any Promotional Materials and/or
Educational Materials and Activities created by Licensee hereunder relating to
the Licensed Product in the Field in the Territory, but excluding trademarks,
names, logos and other marks owned by or on behalf of Acorda or its Affiliates,
licensors, other licensees or manufacturers.


 


(c)                                  Use of Materials Exclusively
for the Licensed Product.  The
Promotional Materials and Educational Materials and Activities, and any aspects
of those uniquely related to the Licensed Product, shall be used by Licensee
exclusively in connection with the Commercialization of the Licensed Product in
the Field in the Territory in accordance with the terms of this Agreement, and
Licensee shall not use, or allow any other Person to use, any such Promotional
Materials and/or Educational Materials and Activities except in accordance with
this Agreement.


 


7.5                                 Product Branding.


 


(a)                                  Global Branding Strategy.  Acorda shall have the right, from time to
time during the Term, to implement (and thereafter modify and update) a global
branding strategy, including global messaging, for the Licensed Product for use
in the Field throughout the world (the “Global Branding Strategy”).  To the extent Acorda determines to utilize
such Global Branding Strategy, Licensee shall use Commercially Reasonable
Efforts to adhere to the Global Branding Strategy in its Commercialization of
the Licensed Product in the Territory, including with respect to any
Promotional Materials.


 


(b)                                 Trademarks and
Trade Dress.


 


(i)                                     Party’s House Marks.  To the extent permitted or required by
applicable Law and subject to obtaining necessary Regulatory Authority
approvals, with respect to Licensed Product to be sold by Licensee or on behalf
of Licensee or any of its Affiliates in the Territory, the Acorda house mark
and the Licensee house mark shall be given equal prominence on all package
inserts utilized by Licensee.  Licensee
hereby grants to Acorda a non-exclusive, royalty-free, sublicenseable right and
license during the Term to utilize the Licensee house mark (including all
trademarks, names and logos) in order to perform the Manufacturing and other
activities required to be performed by or on behalf of Acorda hereunder and
under the Supply Agreement, and Acorda hereby grants to Licensee a
non-exclusive, royalty-free right and license during the Term to utilize the
Acorda house mark (including all trademarks, names and logos) in order to
perform the Commercialization activities required to be performed by Licensee 


 


49

















 


hereunder
in accordance with the terms of this Agreement. 
Each Party shall only use the house mark of the other Party with the
necessary trademark designations, and each Party shall use the other Party’s
house marks in a manner that does not derogate from such Party’s rights in its
trademarks, names and logos.  Each Party
will take no action that will interfere with or diminish the other’s rights in
its respective trademarks, names and logos, and if a Party reasonably believes
that the use of its trademarks, names and logos by the other Party hereunder is
interfering with or diminishing its rights, such Party shall notify the other
Party thereof in writing and such other Party shall promptly cease use of such
trademarks, names or logos in such manner. 
Each Party agrees that all use of the other Party’s trademarks, names
and logos will inure to the benefit of such other Party, including all goodwill
in connection therewith.  Each Party
agrees not to register, seek to register or cause to be registered any
trademarks, trade dress, logos or slogans owned by the other Party or any
variation thereof or any trademark, name or logo confusingly similar thereto.


 


(ii)                                  Licensed Product Trademarks
and Trade Dress.  Licensee shall Commercialize
the Licensed Product in the Field in the Territory under the trademark(s) and
trade dress designated by Acorda, in its sole discretion (or such other
trademark(s) and trade dress as the Parties mutually agree upon) (the “Licensed
Product Trademarks” and the “Licensed Product Trade Dress”,
respectively).  All uses of the Licensed
Product Trademarks and Licensed Product Trade Dress to identify and/or in
connection with the Commercialization of the Licensed Product in the Field in
the Territory shall be reviewed by the JCC, shall be in accordance with the
Commercialization Plan, Regulatory Approvals and all applicable Laws and shall
be subject to the approval of Acorda in its reasonable discretion.  The Licensed Product Trademarks and Licensed
Product Trade Dress under which the Licensed Product is marketed or sold (other
than Licensee’s corporate trademarks or trade names) shall be used by Licensee
only pursuant to the terms of this Agreement to identify and in connection with
the Commercialization of the Licensed Product in the Field in the Territory,
and shall not be used by Licensee to identify or in connection with the
marketing of any other products. 
Licensee agrees not to register, seek to register or cause to be
registered the Licensed Product Trademarks, any variation thereof or any
trademark, name or logo confusingly similar to the Licensed Product Trademarks.  At no time during or after the Term shall
Licensee challenge or assist others to challenge the Licensed Product
Trademarks or the registrations thereof. 
Notwithstanding the foregoing, in the event that, subject to the
approval of the JCC, the Licensee determines or a Regulatory Authority requires
that a trademark(s) other than the Licensed Product Trademark should be
used to Commercialize Licensed Product in the Field in a country in the
Territory (“Licensee Trademarks”), Licensee may, with Acorda’s prior
written consent, register such Licensee Trademark and use such Licensee
Trademark for Commercialization of Licensed Product in the Field in the
Territory.  Licensee hereby grants to
Acorda a non-exclusive, royalty-free, sublicenseable right and license during
the Term to utilize Licensee Trademarks in connection with Acorda’s
Commercialization of Licensed Product in the Acorda Territory and in order to
perform the Manufacturing and other activities required to be performed by or
on behalf of Acorda hereunder and under the Supply Agreement.


 


(iii)                               Elan Trademarks.  At Acorda’s request, Licensee shall use the
Elan Trademark to identify the applicable Elan technology embodied in the
Licensed Product.  When packaged, and to
the extent permitted by Law, labels for Licensed Product shall include an 


 


50














 


acknowledgement that the Licensed Product is made
under license from, or, if applicable, manufactured by, Elan.  In the event Licensee is required to use such
Elan Trademark, Acorda hereby grants to Licensee a non-exclusive, royalty-free,
license during the Term and in the Territory to utilize such trademark in
connection with Licensee’s Commercialization of Licensed Product in the Field
in the Territory.  Licensee agrees not to
register, seek to register or cause to be registered the Elan Trademarks, any variation
thereof or any trademark, name or logo confusingly similar to the Elan
Trademark.  At no time during or after
the Term shall Licensee challenge or assist others to challenge the Elan
Trademark or the registration thereof. 
For purposes of this Agreement, “Elan Trademark” means any
trademark which relates to the Elan technology applicable to the Licensed
Product and that is licensed to Acorda pursuant to the Elan License
Agreement.  Elan Trademark specifically
excludes any trademark owned or controlled by Elan which identifies a product.


 


(c)                                  Product Web Site.  Acorda shall own rights to any Internet
domain names incorporating the Licensed Product Trademarks or any variation or
part of such Licensed Product Trademarks as its URL address or any part of such
address, and Licensee shall not establish any Internet domain name or URL
incorporating such Licensed Product Trademarks, or anything confusingly similar
to the Licensed Product Trademarks, without the prior written consent of
Acorda, such consent not to be unreasonably withheld; provided, that (i) Licensee
shall be responsible for [*****] reasonable costs incurred by Acorda with
respect to such Internet domain names or URLs to the extent solely used for the
Commercialization of the Licensed Product in the Territory, (ii) Acorda
shall be responsible for [*****] costs incurred by Acorda with respect to such
Internet domain name or URLs to the extent solely used for the
Commercialization of the Licensed Product in the Acorda Territory and (iii) the
Parties shall equally share in all costs incurred by Acorda with respect to
such Internet domain names or URLs to the extent beneficial for the
Commercialization of the Licensed Product worldwide.  The JCC shall be responsible for coordinating
the content on any Web sites relevant to Commercialization of Licensed Product
in the Field in the Territory.


 


8.                                       PAYMENTS


 


8.1                                 Up-front Fee.  In partial consideration for Acorda’s past
Development costs and the license granted to Licensee under the Licensed IP,
Licensee shall pay to Acorda, by wire transfer to an account designated by
Acorda, a non-refundable, non-creditable license fee in the amount of One
Hundred Ten Million U.S. Dollars (US $110,000,000) on the Effective Date.


 


8.2                                 Milestone
Payments.


 


(a)                                  Licensee shall pay to
Acorda, by wire transfer to an account designated by Acorda, the applicable
non-refundable, non-creditable, one-time milestone payment listed below within
thirty (30) days after the achievement of each milestone event by the Licensed
Product:


 


	
  Milestone Event:

  	
   

  	
  Milestone
  Payment:

  
	
   

  	
   

  	
   

  
	
  (i)  [*****]

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  



 






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


 


51

















 


	
  Milestone Event:

  	
   

  	
  Milestone
  Payment:

  
	
   

  	
   

  	
   

  
	
  (ii)  [*****]

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  
	
   

  	
   

  	
   

  
	
  (iii)  [*****]

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  
	
   

  	
   

  	
   

  
	
  (iv) [*****]

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  
	
   

  	
   

  	
   

  
	
  (v) [*****]

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  



 


If
an event described in a clause of this Section 8.2(a) occurs before
or concurrently with an event described in a preceding clause, Licensee shall
also pay the milestone payment described in such earlier clause when the
milestone payment described in such later clause is paid, even if the earlier described
milestone has not been achieved.


 


(b)                                 Licensee shall pay to
Acorda, by wire transfer to an account designated by Acorda, the applicable
non-refundable, non-creditable, one-time milestone payment listed below within
thirty (30) days after the end of the Calendar Quarter in which the related
milestone event for the Licensed Product is first achieved:


 


	
  Milestone
  Event:

  	
   

  	
  Milestone Payment:

  
	
   

  	
   

  	
   

  
	
  (i)  [*****] in which
  Net Sales exceed [*****] U.S. Dollars (US $[*****])

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  
	
   

  	
   

  	
   

  
	
  (ii) [*****] in which
  Net Sales exceed [*****] U.S. Dollars (US $[*****])

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  
	
   

  	
   

  	
   

  
	
  (iii) [*****] in
  which Net Sales exceed [*****] U.S. Dollars (US $[*****])

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  
	
   

  	
   

  	
   

  
	
  (iv) [*****] in which
  Net Sales exceed [*****] U.S. Dollars (US $[*****])

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  
	
   

  	
   

  	
   

  
	
  (v) [*****] in which
  Net Sales exceed [*****] U.S. Dollars (US $[*****])

  	
   

  	
  [*****] U.S. Dollars

  (US $[*****])

  



 


Each of the milestone payments set forth in
this Section 8.2(b) shall be payable once.  If an event described in a clause in this Section 8.2(b) occurs
before or concurrently with an event described in a preceding clause, Licensee
shall also pay the milestone payment described in such earlier 


 






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


 


52

















 


clause
when the milestone payment described in such later clause is paid.  By way of example, if, during [*****], Net
Sales first exceed the thresholds set forth in Sections 8.2(b)(ii) and
(iii), Licensee shall pay Acorda the milestone payments set forth in both
Sections 8.2(b)(ii) and (iii) on or before [*****].


 


8.3                                 Royalties
Payable by Licensee.


 


(a)                                  Acorda Royalty Rate.  Subject to this Section 8.3, during the
Royalty Term, Licensee shall pay to Acorda royalties on aggregate Net Sales of
Licensed Product in the Territory at the following rates (such applicable
rate(s), the “Acorda Royalty Rate”), from which Acorda shall pay any
royalties owed to Acorda’s licensors other than Elan in accordance with Acorda’s
agreements with such licensors:


 


	
  For Portion of Aggregate Net
  Sales of Licensed

  Product in Territory during Calendar Year:

  	
   

  	
  Acorda
  Royalty Rate

  (% of Aggregate Net Sales of Licensed Product 

  in the Territory during a Calendar Year)

  
	
   

  	
   

  	
   

  
	
  (i) 
  Less than or equal to [*****] U.S. Dollars (US $[*****])

  	
   

  	
  [*****]%

  
	
   

  	
   

  	
   

  
	
  (ii) 
  Greater than [*****] U.S. Dollars (US $[*****]), but less than or equal to
  [*****] U.S. Dollars (US $[*****]).

  	
   

  	
  [*****]%

  
	
   

  	
   

  	
   

  
	
  (iii) 
  Greater than [*****] U.S. Dollars (US $[*****])

  	
   

  	
  [*****]%

  



 


(b)         Elan Royalty Rate.  Subject to this Section 8.3, during the
Royalty Term, Licensee shall pay to Acorda a royalty of [*****] of aggregate
Net Sales of Licensed Product in the Territory (the “Elan Royalty Rate”),
which Acorda shall pay to Elan in accordance with the Elan License Agreement,
with (i) [*****] of the Notional NSP (as defined in the Elan License
Agreement) for quantities of Licensed Product ordered by or on behalf of
Licensee and to be delivered pursuant to the Supply Agreement, including any
orders for Launch Stock (as defined in the Supply Agreement) which shall be due
to Acorda upon Licensee’s, its Affiliates’ or Third Party Distributors’ receipt
of an invoice from Acorda or Elan and (ii) the remainder of such royalty,
calculated by subtracting the amounts paid pursuant to subclause (i) from
[*****] of aggregate Net Sales of such Licensed Product, due in accordance with
Section 8.5; provided, that (A) Licensee shall be responsible
for providing in good faith any estimations or subjective determinations that
comprise part of the calculation of Notional NSP (as defined in the Elan
License Agreement) for the quantities of Licensed Product ordered by or on
behalf of Licensee and delivered pursuant to the Supply Agreement, including
any orders for launch stock, (B) Acorda shall submit to Elan such
estimations or determinations provided by Licensee for the purposes of Notional
NSP calculation, (C) Licensee shall be responsible for any payments
stemming from such Notional NSP calculation, including any additional payments
(including interest payments), in the event that Elan disagrees with Licensee’s
calculation and Licensee is unable to reach agreement with Elan regarding the
appropriate amount, to the extent required by 


 






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


 


53

















 


the Elan License Agreement, and (D) with
respect to Licensed Product supplied to Licensee, to the extent the amounts
paid by Licensee in accordance with subclause (i) are greater than [*****]
of aggregate Net Sales of such Licensed Product, then, to the extent of any
credit made by Elan, Acorda shall credit such difference against the price of
Licensed Product to be supplied to Licensee pursuant to the Supply
Agreement.  Notwithstanding anything in
this Agreement, the amount of the Elan Royalty Rate payable by Licensee to
Acorda shall in no event be more than the Elan Royalty (as defined in the Elan
License Agreement) payable by Acorda to Elan under the Elan License
Agreement.  By way of example, if the
Elan Royalty Rate is reduced from [*****] under the terms of the Elan License
Agreement, the Elan Royalty Rate hereunder shall be [*****].  The Parties acknowledge that the cost of
Launch Stocks pursuant to the Supply Agreement is [*****] of Manufacturing Cost
(as defined in the Elan Supply Agreement) and all other Licensed Product
supplied to Licensee under the Supply Agreement will be supplied at the
applicable Transfer Price (as defined in the Supply Agreement).  The Parties acknowledge that Licensee shall
pay Acorda the royalties under the Elan Royalty Rate for sales of Launch Stocks
no less than five (5) Business Days before such time as the Elan Royalty
Rate with respect thereto is owed to Elan. 
Acorda shall provide to Licensee a copy of all royalty reports submitted
to Elan pursuant to the Elan Agreement related to payments made pursuant to
this Agreement promptly after such reports are submitted to Elan.


 


(c)                                  Adjustments to Royalties.  Subject to Section 2.8, the Acorda
Royalty Rate shall be reduced by [*****] of the amount of royalties paid by
Licensee or any of its Affiliates to any Third Party in consideration for a
license of Patent Rights in the absence of which Licensee in good faith
believes it would infringe those Patent Rights by its Exploitation of the
Licensed Product; provided, that, in no event shall the aggregate
deductions under this Section 8.3(c) reduce any quarterly Acorda
Royalty Rate payment by Licensee in respect of Net Sales of the Licensed
Product to less than [*****] of the royalty otherwise payable to Acorda with
respect to the Licensed Product.


 


8.4                                 Restrictions on Sales.  Licensee shall not, and shall ensure that its
Affiliates and Third Party Distributors do not, sell or distribute the Licensed
Product at a discount (or without consideration) in return for (i) concessions
or consideration received in transactions involving products or services other
than the Licensed Product or (ii) concessions from any government or
governmental authority relating to products or services other than Licensed
Product.


 


8.5                                 Reports and Payments.  Licensee shall deliver to Acorda, (a) within
thirty (30) days after the end of each Calendar Quarter, a royalty report, in a
format agreed to by the Parties, for such Calendar Quarter, together with the
required payments, and (b) within fifteen (15) days after the end of each
calendar month, a preliminary monthly sales report for such month in a format
specified by Acorda.  Such reports shall
indicate gross sales and all deductions taken from gross sales, on a
country-by-country basis, the calculation of Net Sales and the calculation of
royalties from Net Sales with respect thereto, each determined in accordance
with GAAP.   Milestone and royalty
payments based on Net Sales of the Licensed Product in the Territory shall be
made in U.S. Dollars, after being converted by Licensee into U.S. Dollars (if
applicable) at the rate of exchange for the currency of the country or
jurisdiction in which the Licensed Product was sold into U.S. Dollars
calculated by using the simple average of the selling and buying rates of U.S.
Dollars published in the East Coast Edition of The Wall Street Journal
for the day prior 


 






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


 


54

















 


to
the date on which the payment by Licensee is made.  For the purpose of calculating the
achievement of the thresholds related to Net Sales under Section 8.2(b) and
Section 8.3(a), conversion from any foreign currency to U.S. Dollars shall
be made according to the method set forth in the preceding sentence.  All payments due to
Acorda pursuant to this Agreement shall be made in United States Dollars by
wire transfer in immediately available funds from a Licensee account in the
United States to an account designated in advance by Acorda.


 


8.6                                 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 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.  Licensee
shall provide to Acorda documentation of the payment of any withholding tax
that is paid pursuant to this Section 8.6.


 


8.7                                 Blocked Payments.  In the event that, by reason of applicable
Law in any country, it becomes impossible or illegal for Licensee, or its
Affiliates, to transfer, or have transferred on its behalf, royalties or other
payments to Acorda, such royalties or other payments shall be deposited in
local currency in the relevant country to the credit of Acorda in a recognized
banking institution designated by Acorda or, if none is designated by Acorda
within a period of thirty (30) days, in a recognized banking institution
selected by Licensee or such Affiliate and identified in a notice in writing
given to Acorda.


 


8.8                                 Late Payments.  Any payments that are not made by Licensee on
or before the due date shall bear interest at a rate equal to [*****] from the
due date until paid in full or, if less, the maximum interest rate permitted by
applicable Law.  Interest shall be
payable for the period from the date on which such payment was due through the
date on which payment is actually made. 
In addition, Licensee shall reimburse Acorda for all costs and expenses,
including attorney fees and legal expenses, incurred in the collection of late
payments.


 


8.9                                 Financial Records.  Licensee shall maintain all of its and its
Affiliates’ full, true and accurate books of accounts and other records
relating to the transactions and activities contemplated by this Agreement in
sufficient detail to verify the information included in the reports provided
pursuant to Section 8.5 and compliance with the terms of this
Agreement.  Licensee shall maintain such
records for at least [*****] after the end of the Calendar Year to which such
records relate.


 


8.10                           Audit Right.  (a) [*****], Acorda may retain an
independent certified public accountant reasonably acceptable to Licensee to
audit the records described in Section 8.9, upon reasonable notice to
Licensee, (b) Elan may retain an independent certified public accountant
reasonably acceptable to Licensee to audit the records described in Section 8.9,
upon reasonable notice to Licensee (and, for the sake of clarity, Licensee
acknowledges that Elan’s audit right shall extend for the [*****] period
following the close of each Calendar Year during the term of the Elan License
Agreement), and (c) [*****], each Party may retain an independent
certified 


 






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


 


55

















 


public
accountant reasonably acceptable to the other Party to audit the records
described in Section 5.6(c), upon reasonable notice to the other Party, in
each case during regular business hours and under a reasonable obligation of
confidentiality to the audited Party. 
The auditing Party or Elan, as applicable, shall bear the costs of such
audit, except as provided below.  The results
of such audit shall be made available to both Parties and, as applicable, Elan,
but shall be considered the audited Party’s Confidential Information (and
Licensee acknowledges that Elan is obligated to retain any information provided
to it in confidence only as required pursuant to the terms of the Elan License
Agreement and the June 2, 2009 Confidentiality Agreement among Elan,
Acorda and Licensee).  If the audit
demonstrates that the payments owed under this Agreement have been understated,
the audited Party shall pay the balance to the auditing Party or Elan, as
applicable, together with interest in accordance with Section 8.8.  Further, if the amount of the understatement
is greater than five percent (5%) of the amount owed to the auditing Party with
respect to the audited period, then the audited Party shall reimburse the auditing
Party and/or Elan for the reasonable cost of the audit.  If the audit demonstrates that the payments
owed under this Agreement have been overstated, the audited Party shall be
entitled to credit such amount against payments due to the auditing Party.  All payments owed by a Party under this Section 8.10
shall be made within thirty (30) days after the results of the audit are
delivered to the Parties.


 


9.                                       INTELLECTUAL
PROPERTY


 


9.1                                 Ownership;
Trademarks.


 


(a)                                  Know-How and
Patent Rights.


 


(i)                                     Ownership.  As between the Parties, (A) Acorda shall
solely own all of the Acorda IP, (B) Licensee shall solely own all of the
Licensee IP and (C) the Parties shall jointly own all Joint IP on the
basis of an undivided interest.  Except
as expressly provided in this Agreement and subject to the licenses granted
hereunder, each Party shall have the right to use, license, sublicense and
otherwise exercise all rights under Joint IP in its Territory without the
consent of the other Party and with no duty to account to the other Party.


 


(ii)                                  Inventorship.  Ownership, for the purposes of this Section 9.1(a),
shall be determined by the Parties in accordance with United States patent laws
based on inventorship as set forth in Title 35 of the U.S. Code.


 


(b)                                 Trademarks.


 


(i)                                     Licensed
Product Trademarks.


 


(A)                              As between the
Parties, Acorda is and shall remain the owner of the Licensed Product
Trademarks, and all goodwill associated therewith, in all countries of the
world, and all uses of the Licensed Product Trademarks by Licensee, its
Affiliates and Third Party Distributors shall inure to the benefit of
Acorda.  Licensee shall have the right to
review and comment on any documentation related to the filing, prosecution,
defense or maintenance of the Licensed Product Trademarks in the Territory and
Acorda shall consider in good faith any comments made by Licensee.  If and to the extent that Licensee or its
Affiliates or 


 


56

















 


Third
Party Distributors obtain any rights (other than the licenses granted herein)
to the Licensed Product Trademarks in any country in the world, Licensee shall
immediately and automatically assign, and ensure that its Affiliates and Third
Party Distributors immediately and automatically assign, to Acorda all right,
title and interest in and to the Licensed Product Trademarks, and all goodwill
with respect thereto, subject to the licenses granted to Licensee
hereunder.  Acorda shall deliver copies
of all filings related to the Licensed Product Trademarks in the Territory,
including responses and other correspondence with the relevant registrar
promptly to Licensee upon the distribution or receipt of such materials.


 


(B)                                Licensee shall reimburse
Acorda for [*****] reasonable Out-of- Pocket costs and expenses incurred by
Acorda after the Effective Date relating to the preparation, filing,
prosecution and maintenance of the Licensed Product Trademarks in the Territory
within thirty (30) days after receiving an invoice from Acorda for such costs
and expenses.


 


(C)                                In the event that either
Party becomes aware of actual or threatened infringement of or challenge to a
Licensed Product Trademarks anywhere in the Territory in the Field, that Party
will promptly notify the other Party in writing.  In respect of the protection and/or defense
of a Licensed Product Trademarks in the Territory in the Field, Acorda will
have the initial right to bring suit and to take action against such infringer
or challenger.  Licensee shall, and shall
ensure that its Affiliates and Third Party Distributors shall, provide
reasonable assistance and co-operation as Acorda may reasonably request.  If Acorda does not commence and pursue a
legal action to enjoin such infringement or challenge within [*****] (or such
shorter period of time as required by applicable Law to avoid loss of material
enforcement rights) of being notified or otherwise becoming aware of such
infringement or challenge, Licensee may, at its expense, commence the action in
the Territory.


 


(D)                               Any recoveries resulting
from an action described in Section 9.1(b)(i)(C) shall be applied as
follows:  (1) first, to reimburse
each Party for all out-of-pocket costs in connection with such proceeding (on a
pro rata basis, based on each Party’s respective litigation costs, to the
extent the recovery was less than all such litigation costs); and (2) second,
any remainder shall be paid [*****] to Acorda and [*****] to Licensee.


 


(ii)                                  Elan Trademark.


 


(A)                              Elan is and shall remain the
owner of the Elan Trademarks, and all goodwill associated therewith, in all
countries of the world, and all uses of the Elan Trademarks by Licensee, its
Affiliates and sublicensees shall inure to the benefit of Elan.  If and to the extent that Licensee, its
Affiliates or Third Party Distributors obtain any rights (other than the
licenses granted herein) to the Elan Trademarks in any country in the world,
Licensee shall immediately and automatically assign, and ensure that its
Affiliates and Third Party Distributors immediately and automatically assign,
to Elan all right, title and interest in and to the Elan Trademarks, and all
goodwill with respect thereto.


 


(B)                                In the event
that Licensee becomes aware of actual or threatened infringement of or
challenge to an Elan Trademark anywhere in the world, Licensee will promptly
notify Acorda in writing and provide full particulars of such infringement or 






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


 


57

















 


challenge.  Licensee shall not make any comment or
admission to any Third Party in respect of any such infringement or
challenge.   In respect of the protection
and/or defense of an Elan Trademark, Elan will have the sole right to bring
suit and to take action against such infringer or challenger.


 


(iii)                               Licensee Trademarks.


 


(A)                              As between the Parties,
Licensee is and shall remain the owner of the Licensee Trademarks, and all
goodwill associated therewith, in all countries of the world, and all uses of
the Licensee Trademarks by Acorda, its Affiliates and sublicensees shall inure
to the benefit of Licensee.  If and to
the extent that Acorda or its Affiliates obtain any rights (other than the
licenses granted herein) to the Licensee Trademarks in any country in the
world, Acorda shall immediately and automatically assign, and ensure that its
Affiliates immediately and automatically assign, to Licensee all right, title
and interest in and to the Licensee Trademarks, and all goodwill with respect
thereto, subject to the licenses granted to Acorda hereunder.


 


(B)                                Licensee shall be
responsible for [*****] costs and expenses incurred by Licensee or its
Affiliates relating to the preparation, filing, prosecution and maintenance of
the Licensee Trademarks.


 


(C)                                In the event that either
Party becomes aware of actual or threatened infringement of or challenge to a
Licensee Trademark anywhere in the Territory in the Field, that Party will
promptly notify the other Party in writing. 
In respect of the protection and/or defense of a Licensee Trademark in
the Territory in the Field, Licensee will have the sole right to bring suit and
to take action against such infringer or challenger.  Acorda shall, at Licensee’s expense, provide
reasonable assistance and co-operation as Licensee may reasonably request.  Any recoveries resulting from an action
described in this Section 9.1(b)(iii) shall be applied as
follows:  (1) first, to reimburse
each Party for all out-of-pocket costs in connection with such proceeding (on a
pro rata basis, based on each Party’s respective litigation costs, to the
extent the recovery was less than all such litigation costs); and (2) second,
any remainder shall be paid [*****] to Acorda and [*****] to Licensee.


 


9.2           Filing,
Prosecution and Maintenance of Patent Rights.


 


(a)           Initial Right.  As between the Parties:


 


(i)            Licensee shall
have the initial right to file, prosecute and maintain the Licensee Patent
Rights, at Licensee’s expense.  If
Licensee declines to file, prosecute or maintain any Licensee Patent Right in
any country of the world, desires to allow any Licensee Patent Right to lapse
in any country of the world, or desires to abandon any Licensee Patent Right in
any country of the world before all appeals within the respective jurisdiction
have been exhausted, then:


 


(A)          Licensee shall
provide Acorda with reasonable written notice of such decision so as to permit
Acorda to decide whether to file, prosecute or maintain such Licensee Patent
Right and to take any necessary action.


 






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


 


58














 


(B)           By providing
prompt written notice thereof to Licensee (following notice from Licensee
pursuant to clause (A)), Acorda may assume control of the filing, prosecution
and/or maintenance of such Licensee Patent Right in the name of the owner(s) of
such Licensee Patent Right, at Acorda’s expense.  Only following such notice from Acorda to
Licensee, the following provisions shall apply:


 


(1)           Licensee shall,
at Acorda’s expense and reasonable request, assist and cooperate in the filing,
prosecution and maintenance of or any related necessary action for such
Licensee Patent Right.


 


(2)           Acorda shall
provide Licensee, sufficiently in advance for Licensee to comment, with copies
of all patent applications and other material submissions and correspondence
with any patent counsel or patent authorities pertaining to such Licensee
Patent Right.


 


(3)           Acorda shall
give due consideration to Licensee’s comments, but shall have the final say in
determining whether or not to incorporate such comments.


 


(4)           Each Party
shall promptly provide the other with copies of all material correspondence
received from any patent counsel or patent authorities pertaining to such
Licensee Patent Right.


 


(ii)           Acorda shall
have the initial right to file, prosecute and maintain the Joint Patent Rights
anywhere in the world in both Parties’ names, as follows:


 


(A)          Licensee shall,
at Acorda’s reasonable request, assist and cooperate in the filing, prosecution
and maintenance of such Joint Patent Rights.


 


(B)           Acorda shall
provide Licensee, sufficiently in advance for Licensee to comment, with copies
of all patent applications and other material submissions and correspondence
with any patent counsel or patent authorities pertaining to such Joint Patent
Rights.


 


(C)           Acorda shall
give due consideration to Licensee’s comments, but Acorda shall have the final
say in determining whether or not to incorporate such comments.


 


(D)          Each Party
shall promptly provide the other Party with copies of all material
correspondence received from any patent counsel or patent authorities
pertaining to such Joint Patent Rights.


 


(iii)          Acorda shall
have the initial right to file, prosecute and maintain the Acorda Patent Rights
anywhere in the world.


 


(b)           Licensee’s
Step-In Rights.  Subject to
the requirements and limitations of the Acorda Third Party Agreements, with
respect to the filing, prosecution and maintenance of 


 


59

















 


the
Licensed IP, including any rights of, and time-frames for, such Third Party
licensors to comment on and review any filings and correspondence related
thereto, the Parties agree:


 


(i)            If Acorda
declines to file, prosecute or maintain any Licensed Patent Right, desires to
allow any Licensed Patent Right to lapse, or desires to abandon any Licensed Patent
Right before all appeals within the respective patent office have been
exhausted, then:


 


(A)          Acorda shall
provide Licensee with reasonable written notice of such decision so as to
permit Licensee to decide whether to file, prosecute or maintain such Licensed
Patent Right and to take any necessary action.


 


(B)           By providing
prompt written notice thereof to Acorda following notice from Acorda pursuant
to clause (A), Licensee may assume control of the filing, prosecution and/or
maintenance of such Licensed Patent Right in the name of the owner(s) of
such Licensed Patent Right, at Licensee’s expense.  Only following such notice from Licensee to
Acorda, the following provisions shall apply:


 


(1)           Acorda shall,
at Licensee’s expense and reasonable request, assist and cooperate in the
filing, prosecution and maintenance of such Licensed Patent Right.


 


(2)           Licensee shall
provide Acorda, sufficiently in advance for Acorda to comment, with copies of
all patent applications and other material submissions and correspondence with
any patent counsel or patent authorities pertaining to such Licensed Patent
Right.


 


(3)           Licensee shall
give due consideration to Acorda’s comments, but shall have the final say in
determining whether or not to incorporate such comments.


 


(4)           Each Party
shall promptly provide the other with copies of all material correspondence
received from any patent counsel or patent authorities pertaining to such
Licensed Patent Right.


 


(c)           Patent Rights
Term Extensions.  Acorda may
select which, if any, Licensed Patent Rights for which a Patent Term Extension is to be sought or obtained
in any country in the Territory. 
Licensee shall promptly provide Acorda with such information as Acorda
may reasonably request to comply with any filing requirements in connection
with any such Patent Term Extension. Acorda may file for all such Patent Term
Extensions at Licensee’s expense, and Licensee shall, and shall ensure that its
Affiliates and Third Party Distributors, execute such authorizations and other
documents and take such other actions as may be reasonably requested to obtain
such Patent Term Extensions, including designating Acorda as its agent for such
purpose.


 


(d)           Patent Rights
Listings. To the extent required or permitted by applicable
Law, the Party filing an NDA with respect to the Licensed Product in any
country(ies) may list 


 


60

















 


with
the applicable Regulatory Authorities information regarding any Licensed Patent
Right or Licensee Patent Right.  In
connection with such listings, the Parties shall meet to evaluate and identify
all potentially applicable Licensed Patent Rights or Licensee Patent Rights; provided, however,
that (i) Licensee will not unreasonably refuse to list, and maintain the
listing for, any Licensed Patent Rights that Acorda requests that Licensee list
pursuant to a notice given by Acorda at least ten (10) days prior to the
listing deadline and the listing of which is consistent with applicable Law;
and (ii) subject to the foregoing clause (i), the Party filing the NDA
shall retain final decision making authority over the decision to list (or
de-list) any Patent Rights covering the Licensed Product.


 


(e)           Costs and
Expenses.  Licensee
shall bear its own costs and expenses in preparing, filing, prosecuting and
maintaining Patent Rights prosecuted and maintained by Licensee and in
conducting related interference, opposition and similar proceedings as provided
in this Agreement.  Licensee shall
reimburse Acorda for [*****] of Acorda Patent Costs incurred after the
Effective Date relating to the preparation, filing, prosecution and maintenance
of Licensed Patent Rights; provided, however, that Licensee’s
obligation to reimburse such Acorda Patent Costs for Indications not related to
MS is contingent upon Acorda obtaining Licensee’s prior written consent prior
to expenditure for any costs related to an Indication not related to MS.  Licensee shall reimburse Acorda for [*****]
Acorda Patent Costs subject to Licensee’s reimbursement obligations under this Section 9.2(e) within
thirty (30) days after receiving an invoice from Acorda for such costs.  To the extent Licensee declines to reimburse
Acorda the Acorda Patent Costs incurred with respect to a particular Licensed
Patent Right, such Licensed Patent Right shall no longer be licensed to
Licensee and its Affiliates under Section 2.1 and, notwithstanding
anything else in this Agreement, Acorda shall be entitled to take whatever
steps it determines are appropriate to enforce such Patent Right against Licensee.


 


9.3           Enforcement.  Subject to the requirements and limitations
of the Acorda Third Party Agreements with respect to the enforcement of Patent
Rights, including any rights of, and timeframes for, such Third Party licensors
to comment on and review any filings or materials related thereto, the Parties
agree:


 


(a)           Licensee Patent
Rights.  As between the Parties, except
as provided in Section 9.3(c), Licensee shall have the sole right to
protect the Licensee Patent Rights from any actual or suspected infringement or
any claim that the Licensee Patent Rights are invalid or otherwise
unenforceable, at Licensee’s expense, and to retain all recoveries with respect
thereto.


 


(b)           Licensed Patent
Rights.


 


(i)            Notice.  Each Party shall provide the other Party with
written notice reasonably detailing any known or alleged infringement by a
Third Party of the Licensed Patent Rights, including any declaratory judgment,
opposition, or similar action alleging the invalidity, unenforceability or
non-infringement of the Licensed Patent Rights, within ten (10) Business
Days of becoming aware of such infringement. 
Each Party shall provide the other Party any evidence available
pertaining to such known or alleged infringement or action.


 


(ii)           Licensee’s
Initial Right.  As between
the Parties, Licensee shall have the initial right to protect the Licensed
Patent Rights in the Field in the Territory from any 


 






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


 


61

















 


actual
or suspected infringement or misappropriation by a Third Party’s Exploitation
(other than Manufacturing) of a product that contains Compound or any other
mono- or di-aminopyridine.  In any legal
action so brought by Licensee, Acorda shall join in such action as a party at
Licensee’s request and expense in the event that an adverse party asserts, the
court rules or other Laws provide, or Licensee determines in good faith,
that a court would lack jurisdiction based on Acorda’s absence as a party in
such suit; but control of such action shall remain with Licensee.  Acorda may also at any time join in such
action and may be represented by counsel of its choice, at Acorda’s expense;
but in any event control of such action shall remain with Licensee.  At Licensee’s reasonable request and expense,
Acorda shall provide reasonable assistance to Licensee in connection with such
action.  Any recoveries resulting from
such an action shall be applied as follows:


 


(A)          First, to
reimburse each Party for all out-of-pocket costs in connection with such
proceeding (on a pro rata basis, based on each Party’s respective litigation
costs, to the extent the recovery was less than all such litigation costs); and


 


(B)           Second, any
remainder shall be paid [*****] to Licensee and [*****] to Acorda; provided,
that in the event such Licensed Patent Right is an Elan Patent Right, [*****]
of the remainder shall be paid to Elan and Acorda and Licensee shall each
receive [*****] of the remainder.


 


(iii)          Acorda Step-In
Right.  If Licensee does not commence
and vigorously pursue a legal action to enjoin such infringement described in Section 9.3(b)(ii) within
[*****] (or such shorter period of time as required by applicable Law to avoid
loss of material enforcement rights) of being notified or otherwise becoming
aware of such infringement, Acorda may, at its expense, commence the
action.  Licensee shall join in such
action as a party at Acorda’s request and expense in the event that an adverse
party asserts, the court rules or other Laws provide, or Acorda determines
in good faith, that a court would lack jurisdiction based on Licensee’s absence
as a party in such suit, but control of such action shall remain with
Acorda.  At Acorda’s reasonable request
and expense, Licensee shall provide reasonable assistance to Acorda in
connection with such action.  Any
recoveries resulting from such an action shall be retained by Acorda.


 


(c)                                  Licensee Patent
Rights in Connection with a Competitive Infringement.


 


(i)            Acorda’s
Initial Right.  With
respect to any actual or suspected infringement of the Licensee Patent Rights
by a Third Party making, using or selling (i) in the Acorda Territory a
product that is or may be competitive with the Licensed Product or (ii) in
the Territory a product that is or may be competitive with the Licensed Product
outside the Field, the following provisions shall apply:  Acorda shall have the right to initiate a
legal action to enforce any Licensee Patent Right.  Licensee shall join in such action as a party
at Acorda’s request and expense in the event that an adverse party asserts, the
court rules or other Laws provide, or Acorda determines in good faith,
that a court would lack jurisdiction based on Licensee’s absence as a party in
such suit.  Licensee may also at any time
join in such action and may be represented by counsel of its choice, at
Licensee’s expense; but in any event control of such action shall remain with
Acorda.  At Acorda’s reasonable request
and expense, Licensee shall 


 






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


 


62

















 


provide
reasonable assistance to Acorda in connection with such action.  Any recoveries resulting from an action
described in this Section 9.3(c) shall be applied as follows:


 


(A)          First, to
reimburse each Party for all out-of-pocket costs in connection with such
proceeding (on a pro rata basis, based on each Party’s respective litigation
costs, to the extent the recovery was less than all such litigation costs; and


 


(B)           Second, any
remainder shall be paid [*****] to Acorda and [*****] to Licensee.


 


(ii)           Licensee
Step-In Right.  If Acorda
does not commence and vigorously pursue a legal action to enjoin such
infringement within [*****] (or such shorter period of time as required by
applicable Law to avoid loss of material enforcement rights) of being notified
or otherwise becoming aware of such infringement, Licensee may, at its expense,
commence the action.  Acorda shall join
in such action as a party at Licensee’s request and expense in the event that
an adverse party asserts, the court rules or other Laws provide, or
Licensee determines in good faith, that a court would lack jurisdiction based
on Acorda’s absence as a party in such suit, but control of such action shall
remain with Licensee.  At Licensee’s
reasonable request and expense, Acorda shall provide reasonable assistance to
Licensee in connection with such action. 
Any recoveries resulting from such an action shall be retained by
Licensee.  For the avoidance of doubt,
with respect to any actual or suspected infringement of the Licensee Patent
Rights by a Third Party making, using or selling in the Territory a product
that is or may be competitive with the Licensed Product in the Territory in the
Field, Licensee shall have the right to initiate a legal action to enforce any
such Licensee Patent Right.


 


(d)           Information
Sharing.  The Party involved in any
action or proceeding described in this Section 9.3 shall keep the other
Party reasonably informed of the progress of such action or proceeding.


 


9.4           Invalidity
Claims.  Notwithstanding the foregoing,
if a Third Party at any time asserts a claim that Licensed IP is invalid or
otherwise unenforceable, whether as a defense in an infringement action brought
by a Party pursuant to Section 9.3 or in an action brought against a
Party, including in any proceeding before a patent office or in a similar
administrative forum, Acorda shall have the right to control all decisions
regarding the defense against any such claim. 
In no event shall Licensee, without the prior written consent of Acorda,
admit to the invalidity of or enter into any settlement admitting the
invalidity of, or otherwise impairing Acorda’s rights in, Licensed Patent
Rights.


 


9.5           Patent Marking.  Licensee shall mark Licensed Product marketed
and sold by Licensee (or its Affiliate or distributor) hereunder with
appropriate patent numbers or indicia or otherwise in accordance with
applicable Law in the country or countries of Manufacture and sale thereof.


 






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


 


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10.           CONFIDENTIAL
INFORMATION


 


10.1         Non-Use and
Non-Disclosure of Confidential Information.  Each Receiving Party agrees that all
Confidential Information of the Disclosing Party (a) shall not be used by
the Receiving Party or its Affiliates except to perform the Receiving Party’s
obligations or exercise the Receiving Party’s rights under this Agreement; (b) shall
be maintained in confidence by the Receiving Party and its Affiliates; (c) shall
be maintained with the precautions such Party normally takes with its own
Confidential Information, but in no case with any less degree than reasonable
care; and (d) except as permitted by Sections 10.2, 10.3 and 10.4, shall
not be disclosed by the Receiving Party or its Affiliates to any Person without
the prior written consent of the Disclosing Party.


 


10.2         Permitted
Disclosures.  The
Receiving Party may provide the Disclosing Party’s Confidential Information:


 


(a)           to the
Receiving Party’s and its Affiliates’ employees, consultants and advisors who
have a need to know such Confidential Information and are bound by an
obligation to maintain the confidentiality of the Disclosing Party’s
Confidential Information to the same extent as if they were parties hereto;


 


(b)           to patent
offices in order to seek or obtain Patent Rights or to Regulatory Authorities
in order to seek or obtain approval to conduct Clinical Trials or to gain
Regulatory Approval with respect to the Licensed Product as contemplated by
this Agreement; provided, that such disclosure may be made only
following reasonable notice to the Disclosing Party and to the extent
reasonably necessary to seek or obtain such Patent Rights or approvals;


 


(c)           if such
disclosure is required by Law (including by rules or regulations of the
United States Securities and Exchange Commission (“SEC”), any other
relevant securities commission in any country, any securities exchange or
NASDAQ) or to defend or prosecute litigation or arbitration; provided,
that prior to such disclosure, to the extent permitted by Law or such rules or
regulations, the Receiving Party promptly notifies the Disclosing Party of such
requirement and furnishes only that portion of the Disclosing Party’s
Confidential Information that the Receiving Party is legally required to
furnish; and


 


(d)           Acorda may
disclose (i) to Acorda’s licensors the reports provided by Licensee
pursuant to Sections 5.3 and 7.3, (ii) to Acorda’s licensors the audit
reports obtained pursuant to Section 8.10, and (iii) to any Third
Party counterparty of an Acorda Third Party Agreement, any other information
required to be disclosed pursuant to such agreements; provided, that any
such disclosed information shall be deemed “confidential information” of Acorda
or the equivalent thereof under each relevant license agreement or Acorda Third
Party Agreement; provided, further, that if a license agreement
or Acorda Third Party Agreement places no confidentiality obligations on the
Third Party counterparty or licensor, then any disclosure of information under
this Section 10.2(d) shall only be made subject to confidentiality
obligations no less onerous than the provisions herein, unless that would cause
Acorda to breach any such license agreement or Acorda Third Party Agreement (in
which case Acorda shall seek to impose on such licensor or counterparty
confidentiality provisions as close to those contained in this Agreement as it
can).


 


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Additionally,
Acorda may disclose Licensee’s Confidential Information to Acorda’s licensees
and potential licensees who have a need to know such Confidential Information
for purposes of Acorda granting licenses or sublicenses under such Confidential
Information (and any intellectual property rights therein) as permitted herein
and are bound by an obligation to maintain the confidentiality of Licensee’s
Confidential Information to the same extent as if they were parties hereto.


 


10.3         Scientific
Publications.  Each Party
and its Affiliates, and, with respect to Acorda, its licensees, and, with
respect to Licensee, its Third Party Distributors, shall have the right to make
disclosures pertaining to the Compound or the Licensed Product to Third Parties
in Publications in accordance with the following procedure, and subject to Section 10.4:  The publishing Party shall provide the
non-publishing Party with an advance copy of the proposed Publication, and the
non-publishing Party shall then have [*****] prior to submission for any
Publication in which to recommend any changes it reasonably believes are
necessary to preserve any Patent Rights or Know-How belonging in whole or in
part to the non-publishing Party.  Acorda
shall have the right to consent to each such Publication proposed by Licensee,
which consent shall not be unreasonably withheld or delayed.  If the non-publishing Party informs the
publishing Party that such Publication, in the non-publishing Party’s
reasonable judgment, would have a material adverse effect on any patentable
invention owned by or licensed, in whole or in part, to the non-publishing
Party (other than pursuant to a license granted under this Agreement), or on
any Know-How which is Confidential Information of the non-publishing Party, the
publishing Party shall delay or prevent such Publication as follows:  (a) with respect to a patentable
invention, such Publication shall be delayed sufficiently long (not to exceed [*****])
to permit the timely preparation and filing of a patent application; and (b) with
respect to Know-How which is Confidential Information of such non-publishing
Party, such Know-How shall be deleted from the Publication.


 


10.4         Publicity.  During the Term, neither Party may issue any
press release or make any public disclosure relating to this Agreement or the
Supply Agreement or the Parties’ activities under this Agreement or the Supply
Agreement (each such press release or public disclosure, a “Subject
Disclosure”) except as follows:


 


(a)           On the first
Business Day following the execution of this Agreement (or, in Acorda’s sole
discretion, as early as any time after execution), the Parties shall issue the
press release attached hereto as Exhibit F.


 


(b)           Each Party may
disclose the terms of this Agreement and the Supply Agreement to the extent
such Party is advised by counsel that such Subject Disclosure is required by
applicable Law (including by rules or regulations of the SEC, any other
relevant securities commission in any country, any securities exchange or
NASDAQ); provided, that, (i) prior to such disclosure, to the
extent permitted by Law or such rules or regulations, the disclosing Party
promptly notifies the other Party of such requirement and the disclosing Party
furnishes only those terms of this Agreement or the Supply Agreement that the
disclosing Party is legally required to furnish, and (ii) specifically
with respect to a filing of this Agreement or the Supply Agreement pursuant to
the rules or regulations of the SEC, any other securities commission, any
securities exchange or NASDAQ, the disclosing Party shall request, and use
Commercially Reasonable Efforts to obtain, confidential treatment of terms
permitted to be redacted from the 


 






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


 


65

















 


forms
of such agreements so filed under the applicable rules and regulations of
the SEC, such securities commission, any securities exchange or NASDAQ, as
applicable.


 


(c)           Either Party
may make a Subject Disclosure to the extent that such Subject Disclosure
describes the commencement and/or “top-line” results of Clinical Trials of the
Licensed Product by Licensee, the achievement of any Development events with
respect to the Licensed Product or the filing for or receipt of Regulatory
Approval with respect to the Licensed Product by Licensee and amounts paid to
Acorda in respect of the achievement of any milestone events.  Prior to any such issuance, the disclosing
Party shall provide, to the extent permitted by Law, the other Party with a
draft Subject Disclosure at least two (2) Business Days prior to making
any such Subject Disclosure for the other Party’s review and comment.  Acorda may make a Subject Disclosure to the
extent that such Subject Disclosure describes activities or the results of
activities with respect to the Licensed Product outside of the Territory or
outside the Field without providing such notice to Licensee.


 


(d)           Subject to Section 10.3
and 10.4(c), either Party may disclose such Party’s own Development and
Commercialization activities with respect to the Licensed Product hereunder.


 


(e)           Acorda may
disclose this Agreement and the Supply Agreement to (i) Elan and its
Affiliates, to the extent required under the Elan License Agreement or Elan
Supply Agreement (and Licensee acknowledges that Elan and its Affiliates are
obligated to retain any information provided to them in confidence only as
required pursuant to the terms of the Elan License Agreement or Elan Supply
Agreement or any other agreements between Elan and Acorda related to this
Agreement); (ii) Acorda’s manufacturer(s) (other than Elan and its
Affiliates) of Licensed Product, to the extent required under Acorda’s
agreement with such manufacturer(s) (and Licensee acknowledges that such
manufacturer(s) is obligated to retain any information provided to them in
confidence only as required pursuant to the terms of Acorda’s agreement with
such manufacturer(s)) and (iii) subject to clauses (i) and (ii),
Acorda’s then-current and potential Third Party licensors and licensees of the
Licensed IP, and Acorda’s then-current and potential investors, lenders and
acquirers; provided, that such Persons receiving disclosed information
in clauses (ii) — (iii) of this Section 10.4(e) are bound
to maintain the confidentiality of this Agreement to the same extent as if they
were parties hereto.


 


(f)            Licensee may
disclose the financial terms of this Agreement and the Supply Agreement to
Licensee’s then-current and potential lenders, acquirers and distributors; provided,
that such Persons receiving disclosure under this Section 10.4(f) are
bound to maintain the confidentiality of such terms to the same extent as if
they were parties hereto.


 


(g)           Each Party may
make subsequent disclosures of information which has been previously made
public other than though a breach of this Agreement by such Party.


 


(h)           Unless
otherwise provided above, either Party may make a Subject Disclosure with the
prior written consent of the other Party, which consent shall not be
unreasonably withheld, delayed or conditioned.


 


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10.5         Relationship to
the Prior Confidentiality Agreement.  This Agreement supersedes the Prior
Confidentiality Agreement; provided, that all “Confidential Information”
disclosed or received by the Parties thereunder shall be deemed “Confidential
Information” hereunder and shall be subject to the terms and conditions of this
Agreement.


 


10.6         Survival.  The confidentiality obligations set forth in
this Article 10 shall survive for [*****] after the Term; provided,
that with respect to any Confidential Information licensed or otherwise
provided under the Elan License Agreement, the confidentiality obligations
shall survive for [*****] after the longer of (a) the Term, (b) the
last to expire Elan Patent Right, or (c) the term of the Elan License
Agreement.


 


11.           INDEMNIFICATION


 


11.1         Indemnification
by Licensee.  Licensee
shall hold harmless the Acorda Indemnitees from and against any and all losses,
damages, fees, expenses, settlement amounts or costs (including reasonable
attorneys’ fees and witness fees) (“Losses”) relating to or in
connection with a Third Party claim arising out of (a) any actual or
alleged death, personal bodily injury or damage to real or tangible personal
property claimed to result, directly or indirectly, from the possession, use or
consumption of, or treatment with, the Compound or the Licensed Product
Exploited by or on behalf of Licensee or its Affiliates or Third Party
Distributors, including any product liability claims; (b) any actual or
alleged infringement or unauthorized use or misappropriation of any Patent
Right or other intellectual property right of a Third Party with respect to the
activities of Licensee or its Affiliates or Third Party Distributors hereunder;
(c) any breach by Licensee of its representations, warranties or covenants
made under this Agreement or the Supply Agreement; or (d) any negligent
act or omission or willful misconduct of Licensee or its Affiliates or Third
Party Distributors or any of their employees, contractors or agents, in
performing Licensee’s obligations or exercising Licensee’s rights under this
Agreement or the Supply Agreement; provided, however, that
the foregoing indemnity shall not apply to the extent that any such Losses (i) are
attributable to the negligence or willful misconduct of the Acorda Indemnitees,
or (ii) are otherwise subject to an obligation by Acorda to indemnify the
Licensee Indemnitees under Section 11.2.


 


11.2         Indemnification
by Acorda.  Acorda
shall hold harmless the Licensee Indemnitees from and against any and all
Losses relating to or in connection with a Third Party claim arising out of (a) any
breach by Acorda of its representations, warranties or covenants made under
this Agreement or the Supply Agreement, (b) any negligent act or omission
or willful misconduct of Acorda or its Affiliates, or any of their employees,
contractors or agents, in performing Acorda’s obligations or exercising
Acorda’s rights under this Agreement or the Supply Agreement, or (c) any
actual or alleged death, personal bodily injury or damage to real or tangible
personal property claimed to result, directly or indirectly, from the
possession, use or consumption of, or treatment with, the Compound or the
Licensed Product Exploited by or on behalf of Acorda or its Affiliates in the
Acorda Territory, including any product liability claims; provided, however,
that the foregoing indemnity shall not apply to the extent that any such Losses
are attributable to (i) the negligence or willful misconduct of the Licensee
Indemnitees, or (ii) are otherwise subject to an obligation by Licensee to
indemnify the Acorda Indemnitees under Section 11.1.  For purposes of clarity, Acorda shall not be
liable for any Losses resulting from (x) any claim that results from any
acts or omissions of Licensee, its Affiliates or Third Party Distributors, even
if 


 






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


 


67

















 


Acorda
had knowledge of, reviewed, commented on, or approved such acts or omissions of
Licensee’s or its Affiliates or Third Party Distributors plans with respect
thereto and (y) any actions or failures to act by Elan and its Affiliates.


 


11.3         Procedure.  In the event of a claim by a Third Party
against any Person entitled to indemnification under this Agreement, the
relevant Indemnified Party shall promptly notify the other Party (in such
capacity, the “Indemnifying Party”) in writing of the claim (it being
understood that the failure by the Indemnified Party to give prompt notice of a
Third Party claim as provided in this Section 11.3 shall not relieve the
Indemnifying Party of its indemnification obligation under this Agreement
except and only to the extent that such Indemnifying Party is actually
prejudiced as a result of such failure to give prompt notice).  Within thirty (30) days after delivery of
such notification, the Indemnifying Party may, upon written notice thereof to
the Indemnified Party, undertake and solely manage and control, at its sole
expense and with counsel reasonably satisfactory to the Indemnified Party, the
defense of the claim.  If the
Indemnifying Party does not undertake such defense, the Indemnified Party shall
control such defense.  The Party not
controlling such defense shall cooperate with the other Party and may, at its
option and expense, participate in such defense; provided, that, if the
Indemnifying Party assumes control of such defense and the Indemnified Party in
good faith concludes, based on advice from counsel, that the Indemnifying Party
and the Indemnified Party (or the relevant Acorda Indemnitee or Licensee
Indemnitee seeking indemnification) have conflicting interests with respect to
such action, suit, proceeding or claim, the Indemnified Party’s counsel may
fully participate in such defense and the Indemnifying Party shall be
responsible for the reasonable fees and expenses of counsel to the indemnified
Persons solely in connection therewith. 
The Party controlling such defense shall keep the other Party advised of
the status of such action, suit, proceeding or claim and the defense thereof
and shall consider recommendations made by the other Party with respect
thereto.  Except if the Indemnifying
Party did not undertake defense of the claim or if the Indemnifying Party and the
Indemnified Party (or the relevant Acorda Indemnitee or Licensee Indemnitee
seeking indemnification) have conflicting interests with respect to such
action, suit, proceeding or claim and the Indemnified Party engages separate
counsel, as provided above, the Indemnifying Party shall not be liable for any
litigation costs or expenses incurred by the Indemnified Party without the
Indemnifying Party’s written consent. 
The Indemnified Party shall not settle any such action, suit, proceeding
or claim without the prior written consent of the Indemnifying Party, which
shall not be unreasonably withheld, delayed or conditioned.  The Indemnifying Party shall not settle,
without the prior written consent of the Indemnified Party, any such action,
suit, proceeding or claim, or consent to any judgment in respect thereof, that
does not include a complete and unconditional release of the Indemnified Party
from all liability with respect thereto, that imposes any liability or
obligation on the Indemnified Party or that acknowledges fault by the
Indemnified Party.


 


11.4         Allocation.  In the event a claim is based partially on an
indemnified claim and partially on a non-indemnified claim or based partially
on a claim indemnified by one Party and partially on a claim indemnified by the
other Party, any payments in connection with such claims are to be apportioned
between the Parties in accordance with the degree of cause attributable to each
Party.


 


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12.                                 INSURANCE


 


12.1         Insurance.  Licensee shall maintain an insurance policy
that includes coverage for general liability and products liability claims
(including coverage for Clinical Trials) with reputable and financially secure
insurance carriers, with coverage limits of not less than [*****] United States
dollars ($[*****]) per claim and subject to such deductibles and policy
exclusions as are reasonable and customary for pharmaceutical companies of size
and activities comparable to those of Licensee. 
Licensee shall designate Acorda as an additional insured under its
applicable insurance policies and Acorda shall have the right to request, and
Licensee shall promptly provide, certificates of insurance for the purpose of
confirming the sufficiency and currency of such coverage.  The foregoing coverage shall continue during
the Term and for a period of [*****] thereafter.  Notwithstanding the foregoing, Licensee may
self-insure to the extent that it self-insures for its other products; provided,
that, Licensee’s sales of pharmaceutical products exceeds [*****] United States
dollars ($[*****]) in the most recently completed Calendar Year.


 


13.                                 WARRANTIES AND
COVENANTS


 


13.1         Mutual
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 and licenses granted by it under this
Agreement;


 


(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;


 






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


 


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(g)           neither
such Party nor, to the actual knowledge of such Party, any employee, agent or
subcontractor of such Party involved or to be involved in the Development and
Commercialization of the Licensed Product has been debarred under Subsection (a) or
(b) of Section 306 of the United States Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 335a); (ii) no Person who is known by such Party
to have been debarred under Subsection (a) or (b) of Section 306
of such Act will be employed by such Party in the performance of any activities
hereunder; and (iii) to the actual knowledge of such Party, no Person on
any of the FDA clinical investigator enforcement lists (including the (1) Disqualified/Totally
Restricted List, (2) Restricted List and (3) Adequate Assurances
List) will participate in the performance of any activities hereunder; and


 


(h)           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.


 


13.2         Additional
Acorda Warranties.  Acorda hereby
represents and warrants to Licensee that, as of the Effective Date,


 


(a)           Except
as previously disclosed in writing to Licensee, neither Acorda nor its
Affiliates has received any notice in writing or otherwise has knowledge of any
facts which have led Acorda to believe that any of the regulatory filings
relating to the Licensed Product are not currently in good standing with the
FDA;


 


(b)           No
claim or demand of any Person has been asserted to Acorda in writing that
challenges the rights of Acorda to Exploit the Licensed Product in the Field in
the Territory except where such claim or demand would not materially adversely
affect the ability of the Parties to conduct the Development or
Commercialization of the Licensed Product hereunder;


 


(c)           Acorda
Controls all Acorda Patent Rights, including the patents and patent applications
listed on Exhibit A;


 


(d)           There
are no claims, judgments or settlements against or owed by Acorda, nor, to the
knowledge of Acorda, any pending reissue, reexamination, interference,
opposition or similar proceedings, with respect to the Acorda IP, and Acorda
has not received written notice of any threatened claims or litigation or any
reissue, reexamination, interference, opposition or similar proceedings seeking
to invalidate or otherwise challenge the Acorda IP;


 


(e)           Exhibit D
identifies each of the Acorda Third Party 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 Third Party Agreement; provided, however,
that, to Acorda’s knowledge, it does not have, and therefore has not provided
to Licensee, a copy of the Merck/Elan Agreement;


 


(f)            To the knowledge of Acorda, Acorda is not in default with
respect to a material obligation under, and the relevant Third Party
counterparty has not claimed that Acorda nor, to the knowledge of Acorda, has
grounds upon which to claim, that Acorda is in default with 


 


70

















 


respect
to a material obligation under, any Acorda Third Party Agreement, including the
Elan License Agreement;


 


(g)           Acorda
has not waived or allowed to lapse any of its material rights under any of the
Acorda Third Party Agreements, and no such rights  have lapsed or otherwise expired or been
terminated that would have a material adverse effect on the rights granted to
Licensee and its Affiliates hereunder;


 


(h)           Acorda
has made available to Licensee all material Regulatory Documentation owned by
Acorda regarding or related to the Licensed Products.  To the knowledge of Acorda, Acorda has
prepared, maintained or retained all material Regulatory Documentations
required to be maintained or reported pursuant to and in accordance with cGCP
and cGLP, to the extent required, and applicable Laws, and the Regulatory
Documentation does not contain any materially false or misleading statements;
and


 


(i)            Acorda
has used reasonable efforts to disclose to Licensee those domestic or foreign
patents or patent applications related to the Licensed Patent Rights which
Acorda has ceased prosecuting or maintaining.


 


13.3 Additional Covenants Regarding Acorda Third Party Agreements.  Acorda agrees that during the Term:


 


(a)           Acorda
shall use Commercially Reasonable Efforts to fulfill its obligations under the
Acorda Third Party 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;


 


(b)           Acorda
shall not enter into any subsequent agreement with any other party to an Acorda
Third Party Agreement that modifies or amends any Acorda Third Party Agreement
in any way that would materially adversely affect Licensee’s rights or interest
under this Agreement without Licensee’s prior written consent, which shall not
be unreasonably withheld, and shall provide Licensee with a copy of all
modifications to or amendments of the Acorda Third Party Agreements, regardless
of whether Licensee’s consent was required with respect thereto;


 


(c)           Acorda
shall not terminate any Acorda Third Party Agreement in whole or in part
without Licensee’s prior written consent if such termination would materially
adversely affect Licensee’s license granted hereunder; however, for clarity,
Acorda may (a) terminate any Acorda Third Party Agreements by acquiring
all of the intellectual property licensed thereunder, in which case Licensee
agrees to consent to such termination of such Acorda Third Party Agreement, or (b) terminate
its obligation to make royalty and milestone payments by making a lump-sum
payment, and Acorda shall promptly notify Licensee after the occurrence of each
such event;


 


(d)           Acorda
shall promptly furnish Licensee with copies of all material communications
Acorda receives from any other party to an Acorda Third Party Agreement that
directly relate to the Exploitation of Licensed Product in the Field in the
Territory;


 


71

















 


(e)           Acorda
shall promptly furnish Licensee with copies of all material reports and other
communications that Acorda furnishes to any party to an Acorda Third Party
Agreement that directly relate to the Exploitation of Licensed Product in the
Field in the Territory, and to the extent any such reports or communications
relate to the efforts of Licensee under this Agreement, Acorda shall, to the
extent permitted under such Acorda Third Party Agreement, give Licensee a
reasonable opportunity to review and comment upon such portion of the reports
or communications that relate to Licensee’s efforts before they are transmitted
to any such other party; and


 


(f)            Acorda
shall, within five (5) Business Days after Acorda’s receipt thereof,
furnish Licensee with copies of all notices received by Acorda relating to any
alleged breach or default by Acorda under any Acorda Third Party Agreement that
would materially adversely affect Licensee and, if Acorda determines that it
cannot or chooses not to cure or otherwise resolve any such alleged breach or
default, Acorda shall so notify Licensee within five (5) Business Days of
such determination.


 


13.4         Compliance.
 Licensee
shall, in Developing and Commercializing the Licensed Product, comply with all
applicable Laws, including the U.S. Foreign Corrupt Practices Act, as well as
all applicable Regulatory Approvals for the Licensed Product.  In addition, Licensee shall not use in any
capacity, in connection with its Development or Commercialization of the
Licensed Product hereunder, any Person who has been debarred pursuant to Section 306
of the FD&C Act (or similar Law outside of the U.S.), or who is the subject
of a conviction described in such section, and Licensee shall inform Acorda in
writing immediately if it or any Person who is performing services for Licensee
hereunder is debarred or is the subject of a conviction described in Section 306
(or similar Law outside of the U.S.), or if any action, suit, claim,
investigation or legal administrative proceeding is pending or, to the Licensee’s
knowledge, is threatened, relating to the debarment of Licensee or any Person
used in any capacity by Licensee in connection with its Development or Commercialization
the Licensed Product hereunder.


 


13.5         Standstill.


 


(a)           For
a period of [*****] from the Effective Date, unless specifically invited in
writing in advance by the Board of Directors of the other Party to so act, each
Party agrees not to and to cause its Affiliates not to, acting along or as part
of a “group” (within the meaning of Section 13(d)(3) of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”),
directly or indirectly:


 


(i)            effect or seek, offer or propose (whether publicly or
otherwise) to effect, or cause or participate in or in any way assist any other
person to effect or seek, offer or propose (whether publicly or otherwise) to
effect or participate in, (A) any acquisition of any securities (or
beneficial ownership thereof) or assets of the other Party or any of its
subsidiaries; (B) any tender or exchange offer, merger or other business
combination involving the other Party or any of its subsidiaries; (C) any
recapitalization, restructuring, liquidation, dissolution or other
extraordinary transaction with respect to the other Party or any of its
subsidiaries; or (D) any “solicitation” of “proxies” (as such terms are
defined in the Exchange Act) to vote any securities of Party or to provide or
withhold consents with respect to any securities of a Party;


 






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


 


72

















 


(ii)           form, advise, join or in any way participate in a group in
connection with any of the types of matters set forth in paragraph (i) above;


 


(iii)          otherwise act, alone or in concert with others, to seek to
control or influence the management, Board of Directors or policies of the
other Party or any of its subsidiaries;


 


(iv)          take any action which might force the other Party to make a
public announcement regarding any of the types of matters set forth in
paragraph (i) above;


 


(v)           publicly announce any intention, plan or arrangement
inconsistent with the foregoing, or


 


(vi)          enter into any discussions or arrangements with any third
party with respect to any of the foregoing.


 


(b)           Each
Party also agrees during such period not to request the other Party (or its
directors, officers, employees or agents), directly or indirectly, to amend or
waive any provision of this Section 13.5 (including this sentence).


 


(c)           The
obligations under this Section 13.5 shall terminate as to a Party and its
Affiliates in the event that (i) any Third Party unaffiliated with the
other Party initiates a tender or exchange offer for, or otherwise publicly
proposes or agrees to acquire, [*****] of the outstanding common stock or
voting power of the other Party, (b) it is publicly disclosed that voting
securities representing at least [*****] of the total voting power of the other
Party then outstanding have been acquired by any person or group unaffiliated
with the other Party, or (c) the other Party enters into any agreement to
merge with, or sell or dispose of assets or securities representing [*****] or
more of its earning power to, any person not affiliated with the other Party.


 


(d)           For
the purposes of clarity, the Parties agree that the acquisition by any employee
benefit plan of Licensee or Acorda or their respective Affiliates in any
diversified index, mutual or pension fund managed by an independent business
advisor, which fund in turn holds, directly or indirectly, the other Party’s
securities shall not be deemed a breach of this Section 13.5.


 


13.6         Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
THIS ARTICLE 13 OR IN THE SUPPLY AGREEMENT, NEITHER PARTY, AND IN THE CASE OF
ACORDA, ITS LICENSORS, 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.


 


14.                                 LIMITATION OF
LIABILITY


 


14.1         Limitation of Liability.  UNLESS RESULTING FROM A PARTY’S WILLFUL
MISCONDUCT OR FROM A PARTY’S BREACH OF ARTICLE 10 OR SECTIONS 2.2(c) 


 






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


 


73

















 


OR
2.6 OR AS EXPRESSLY SET FORTH IN THE SUPPLY 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 OR THE SUPPLY AGREEMENT, WHETHER BASED UPON
WARRANTY, CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, REGARDLESS
OF ANY NOTICE OF SUCH DAMAGES.  NOTHING
IN THIS SECTION 14.1 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS AGREEMENT OR THE SUPPLY
AGREEMENT.


 


15.                                 TERMINATION


 


15.1         Term.  This Agreement becomes effective as of the
Effective Date and shall continue until the earlier of (a) the termination
of this Agreement in accordance with Section 15.2 or (b) following
the First Commercial Sale of the Licensed Product in any country in the Territory,
the expiration of the last-to-expire of all Royalty Terms with respect to the
Licensed Product (the “Term”).


 


15.2         Termination


 


(a)           Termination
For Convenience.  Licensee may elect
to terminate this Agreement in its entirety or on a country-by-country basis at
any time by providing one hundred eighty (180) days prior written notice to
Acorda; provided, that at any time after such notice by Licensee, Acorda
may accelerate the effective date of such termination by providing sixty (60)
days’ prior written notice to Licensee of such accelerated effective date.


 


(b)           Termination
For Material 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 to
the extent set forth in this Section 15.2(b) upon written notice to
the Breaching Party.  If the
Non-Breaching Party is Licensee, then Licensee may terminate this Agreement in its
entirety in the event of an uncured material breach by Acorda as set forth in
this Section 15.2(b).  If the
Non-Breaching Party is Acorda and (i) the material uncured breach by
Licensee relates to a particular country or countries, then Acorda shall be
entitled to terminate this Agreement only with respect to such country or
countries; provided, that (A) if such material uncured breach by
Licensee relates to any of the Key Countries set forth on Exhibit G,
then Acorda in its sole discretion shall also be entitled to terminate this
Agreement in all countries in the Region in which such Key Country or Key
Countries are located, in accordance with this Section 15.2(b); (B) if
such material uncured breach by Licensee relates to [*****] Major Market
Countries, then Acorda in its sole discretion shall be entitled to terminate
this Agreement in its entirety, and (ii) if the material uncured breach by
Licensee does not relate to a particular country or countries, then Acorda
shall be entitled to terminate this Agreement in its entirety in 


 






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


 


74

















 


accordance
with this Section 15.2(b). 
Notwithstanding the foregoing, in the event that Acorda believes that
Licensee has breached its obligation to use Commercially Reasonable Efforts to
Commercialize the Licensed Product or otherwise comply with the obligations in Section 7.2(b)(i) or
7.2(b)(ii), the matter shall be determined and resolved in accordance with Section 7.2(c).


 


(c)           Termination
for Bankruptcy.  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.


 


(d)           Termination
if Licensee Challenges Acorda IP.  If
Licensee or any of Licensee’s Affiliates, directly or indirectly, (i) initiates
or request an interference or opposition proceeding with respect to any
Licensed Patent Right or Joint Patent Right, (ii) makes, files or
maintains any claim, demand, lawsuit or cause of action to challenge the
validity or enforceability of any Acorda Patent Right or Joint Patent Right or (iii) opposes
any extension of, or the grant of a supplementary protection certificate with
respect to, any Acorda Patent Right or Joint Patent Right, Acorda shall have
the right to terminate this Agreement upon notice to Licensee.


 


(e)           Termination
of Supply Agreement.  This Agreement
shall automatically terminate upon the termination of the Supply Agreement for
any reason other than termination by Licensee due to Acorda’s material breach
of the Supply Agreement.


 


(f)            Termination
of Elan License Agreement.  This
Agreement shall automatically terminate upon the termination of the Elan
License Agreement in whole or with respect to the Territory pursuant to Section 12.5.2
or 12.5.3 of the Elan License Agreement.


 


15.3         Effects Of Termination.


 


(a)           Upon termination of this Agreement in whole or with
respect to one or more Terminated Countries by Licensee pursuant to Sections
15.2(a), 15.2(c), 15.3(b)(ii) or 16.4, by Acorda pursuant to Section 15.2(b),15.2(c),15.2(d),16.2(b) or
16.4, or pursuant to Section 15.2(e) or 15.2(f):


 


(i)            all
licenses granted by Acorda to Licensee with respect to each Terminated Country
hereunder shall terminate and Licensee shall not have any rights to use or
exercise any rights under the Acorda IP with respect to any Terminated Country;


 


(ii)           Licensee
shall provide to Acorda a fair and accurate detailed written description of the
status of the Development and Commercialization of the Licensed Product in each
Terminated Country through the effective date of termination within thirty (30)
days of such termination;


 


75

















 


(iii)          Licensee
hereby grants to Acorda, exercisable from and after such termination, an
exclusive, worldwide, perpetual, irrevocable, royalty-free, fully-paid license,
with the right to grant sublicenses, under the Licensee IP and Licensee’s and
its Affiliates’ interest in the Joint IP, to Exploit the Licensed Product in
each Terminated Country;


 


(iv)          the
covenant not to sue granted pursuant to Section 2.4(b) shall remain
in effect;


 


(v)           if
applicable, Licensee shall promptly transfer and assign to Acorda all of
Licensee’s and Licensee’s Affiliates’ rights, title and interests in and to the
Licensee Trademark(s) used for the Licensed Product in each Terminated
Country;


 


(vi)          Licensee
shall promptly transfer and assign to Acorda all Regulatory Documentation and
other technical and other information or materials in Licensee’s or its
Affiliates’ possession or control which are necessary or useful for the
Exploitation of the Compound or the Licensed Product in each Terminated Country
or, if no country remains in the Territory, anywhere in the world; provided,
that Licensee may retain a single copy of such items for its records.  Within thirty (30) days after Acorda’s
receipt of a proper invoice therefor, Acorda shall reimburse Licensee for
Licensee’s and its Affiliates’ reasonable Out-of-Pocket Costs incurred in
connection with such transfers and assignment (but not the generation, creation
or development of such information and materials);


 


(vii)         the
provisions of Sections 9.2(a)(i), 9.3(a), 9.3(c) and 9.3(d) (to the
extent applicable to Licensee Patent Rights) shall remain in effect;


 


(viii)        Acorda
may select which, if any, Licensee Patent Rights and Joint Patent Rights for
which a Patent Term Extension is to be sought or obtained in the Acorda
Territory.  Acorda may file for all such
Patent Term Extensions at Acorda’s expense, and Licensee shall, and shall
ensure that its Affiliates shall, execute such authorizations and other
documents and take such other actions as may be reasonably requested to obtain
such Patent Term Extensions, including designating Acorda as its agent for such
purpose;


 


(ix)           Acorda
may list with the applicable Regulatory Authorities in the Acorda Territory
information regarding any Licensee Patent Right.  In connection with such listings, the Parties
shall meet to evaluate and identify all potentially applicable Licensed
Licensee Patent Rights;


 


(x)            Licensee
and Licensee’s Affiliates shall provide Acorda written notice of the quantity
of Licensed Product that Licensee has in inventory for sale in each Terminated
Country and permit Acorda, at Acorda’s option, to purchase all or any part of
Licensee’s worldwide unsold inventory of such Licensed Product at the price
Licensee paid to Acorda for such Licensed Product; and


 


(xi)           Acorda shall have the option, exercisable within thirty
(30) days following the effective date of such termination, to purchase any
inventory of the Licensed Product affected by such termination at the price for
which such Licensed Product was sold to Licensee by Acorda pursuant to the
Supply Agreement.  Acorda may exercise
such option by 


 


76

















 


written
notice to Licensee during such thirty (30) day period; provided, however,
that in the event Acorda exercises such right to purchase such inventory,
Licensee shall grant, and hereby does grant, a royalty-free right and license
to any housemarks, trademarks, names and logos of Licensee contained therein
for a period of [*****] in order to sell such inventory.  Upon such exercise, the Parties will
establish mutually agreeable payment and delivery terms for the sale of such
inventory.


 


(b)           If Licensee has the right to terminate this Agreement by
Licensee pursuant to Section 15.2(b), then Licensee may, by written notice
to Acorda, elect to continue the Agreement or terminate the Agreement, with the
consequences set forth in either Section 15.3(b)(i) or Section 15.3(b)(ii),
as applicable:


 


(i)            If Licensee elects to continue this Agreement:  (A) effective as of the date Licensee
would have had the right to terminate this Agreement, the Acorda Royalty Rate
shall be reduced by [*****]; and (B) all
other provisions of this Agreement shall remain in full force and effect without
change.


 


(ii)           If Licensee elects to terminate this Agreement, then,
as of the effective date of such termination, all rights and obligations of the
Parties shall terminate, with the effects of termination provided in Section 15.3(a) and
Section 15.3(c); provided, however, that the Parties shall
negotiate in good faith the amount of consideration (if any) to be paid to
Licensee by Acorda in exchange for, and reflecting the net value of, the assets
transferred and ongoing obligations provided to Acorda pursuant to Sections
15.3(a) and 15.3(c) (after taking into consideration the benefit to
Licensee of no longer being bound by certain obligations owed by Licensee
hereunder (including the diligence obligations, committee activities and
payments due hereunder) and any value contributed by Acorda to the Licensed
Product in the Field in the Territory hereunder, whether through the payment of
Development Costs or otherwise hereunder), and, in the event that the Parties
cannot mutually agree upon such amount within thirty (30) days following the
effective date of termination, the Parties will, as soon as reasonably
practicable and in no event later than ten (10) days following the
expiration of such 30-day period, mutually decide upon an independent third
party valuation firm which shall make a final and binding determination of the
net value of such assets and ongoing obligations and both Parties shall
promptly provide all reasonable materials and information requested by such
valuation firm and shall share equally in the expenses of such valuation
firm.  The Parties agree that in no event
shall amount exceed the total payments received by Acorda pursuant to Sections
8.1, 8.2 or 8.3(a) of this Agreement prior to the date of such termination
(excluding any payment by Licensee of Development Costs), which amount of total
payments shall not otherwise influence the amount of consideration (if any) to
be paid to Licensee hereunder, whether negotiated by the Parties or determined
by the valuation firm.  The amount agreed
upon by the Parties or determined by such valuation firm shall be paid by
Acorda to Licensee within thirty (30) days of such agreement or determination,
as applicable, except to the extent the Parties agree to a payment over time
(whether in the form of milestone payments, royalties or otherwise).


 


(c)           The
following provisions shall survive (or come into effect upon) the expiration or
termination of this Agreement:


 






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


 


77

















 


(i)            Articles
1, 10, 11, 12, 14 and 16, Sections 2.4, 2.5(b) and 2.6, Sections 8.6, 8.8,
8.9, 8.10, 9.1(a), 9.1(b)(i) (solely with respect to the ownership
provisions), 9.2(a)(ii), 9.2(c), 9.4 (subject to the provisions of this Section 15.3(c)),
13.5, 13.6 and 15.3;


 


(ii)           Sections
6.2(b), (c) and (d), but only with respect to Licensee and only for the
two (2) year period after the date of expiration or termination of this
Agreement in its entirety);


 


(iii)          solely
with respect to the Calendar Quarter in which such expiration or termination
occurs, Section 8.4;


 


(iv)          solely
with respect to Joint IP, but with respect to each country in the world,
Sections 9.2(e) (provided, that Licensee’s reimbursement obligation
shall be reduced to [*****] of such Acorda Patent Costs) and 9.3(d);


 


(v)           all
rights in and to the Acorda IP, and any trademarks or other Patent Rights or
Know-How of Acorda and its Affiliates, are retained by Acorda and its
Affiliates or its licensors, as applicable;


 


(vi)          Acorda
shall have the sole right to protect the Joint Patent Rights from any actual or
suspected infringement or misappropriation by a Third Party’s Exploitation
(other than Manufacturing) of a product that contains Compound or any other
mono- or di-aminopyridine and Licensee shall, at Acorda’s reasonable request
and expense, provide reasonable assistance to Acorda in connection with any
action protecting the Joint Patent Rights and shall join such action; Acorda
shall retain all recoveries with respect to any such action;


 


(vii)         all payment obligations under this Agreement owed as
of the effective date of such expiration or termination shall remain in effect,
along with Section 8.7; and


 


(viii)        termination
of this Agreement shall be in addition to, and shall not prejudice, the Parties’
remedies at law or in equity, including the Parties’ ability to receive legal
damages and/or equitable relief with respect to any breach of this Agreement,
regardless of whether or not such breach was the reason for the termination.


 


(d)           For
the sake of clarity, if, as a result of termination of this Agreement, no
country remains in the Territory (whether because (i) this Agreement has
been terminated in its entirety pursuant to Section 15.2, 16.2 and/or
16.4, or (ii) this Agreement has been terminated with respect to one or
more Terminated Countries pursuant to Section 15.2 (including pursuant to
a breach of Section 7.2) through one or more exercises of such termination
right by Acorda or Licensee, as applicable, and, as result, no country remains
in the Territory), this Agreement shall be terminated in its entirety, except
as expressly provided in this Section 15.3.


 


16.                                 MISCELLANEOUS


 


16.1         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 


 






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


 


78














 


(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) subject to Acorda’s rights under Section 16.2,
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 Supply Agreement to such Third
Party or 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.  Each Party agrees that, notwithstanding any
provisions of this Agreement to the contrary, in the event that a Party merges
with or is acquired by another Person, the other Party shall not obtain any
rights or access to the Know-How, Patent Rights, trademarks or other
intellectual property rights of the acquirer.


 


16.2         Change of Control; Licensee Acquisition of Elan.


 


(a)           Licensee
shall notify Acorda promptly after Licensee Parent or any of its Affiliates
enters into any commitment which would trigger a Change of Control under Section 1.21(c).


 


(b)           With
respect to each Change of Control, if, at any time during the [*****] period
following such Change of Control, more than [*****] of Licensee’s sales and
marketing personnel responsible for coordinating and overseeing the
Commercialization of the Licensed Product in the Field in the Territory
immediately prior to the Change of Control (the “Commercialization Force”)
have been terminated or removed from performing such activities for the
Licensed Product by Licensee or the successor Third Party resulting from such
Change of Control, Acorda may elect, in a written notice provided to the
Licensee or its successor at any time before the end of the [*****] period
following such Change of Control, to terminate this Agreement in its entirety
upon [*****] notice; provided, however, that, (i) upon
receipt of such notice, Licensee or its successor shall have fifteen (15) days
to reasonably demonstrate to Acorda that the sales and marketing personnel
primarily responsible for coordinating and overseeing the Commercialization of
the Licensed Product in the Field in the Territory after such Change of Control
have similar or better capabilities than the terminated or removed members of
the Commercialization Force; and (ii) if Acorda, after a good faith
consideration of such demonstration, agrees with Licensee’s or its successor’s
assessment of such, Acorda may withdraw its notice of termination.


 


(c)           In the event Licensee or any of its Affiliates acquires
Elan, by merger, purchase of assets or otherwise, and a breach by Licensee of
this Agreement results in a breach by Acorda of the Elan License Agreement or
the Elan Supply Agreement: (i) such breach shall not be cited by Licensee
or its Affiliates against Acorda as a breach of the Elan License Agreement and Acorda shall have time to cure such breach that
is no less the time that Licensee had either to perform such activity or to
cure such breach; provided, that Acorda takes reasonable steps,
and is acting in good faith, to cure such breach; (ii) if such breach
relates to Licensee’s failure to make any payment due hereunder which amount is
owed to Elan under the Elan 






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


 


79

















 


License
Agreement or the Elan Supply Agreement, Acorda shall have no obligation to make
the corresponding payment to Elan; and (iii) if such breach is incapable
of cure using Commercially Reasonable Efforts, it shall not be deemed a breach
of either this Agreement, the Elan License Agreement, or the Elan Supply
Agreement, and neither Licensee nor its Affiliates shall be entitled to take
any further action against Acorda with respect to such breach.


 


16.3         Guaranty. 
Biogen Idec, Inc. will execute a guaranty of Licensee’s performance of its
obligations under this Agreement in the form of Exhibit H hereto.


 


16.4         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 manufacturers of Licensed Product,
acts or failure to act by Elan, 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.


 


16.5         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, USA


Attention:  General Counsel


Fax:  +1 866-546-2758


 


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


 


80

















 


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 16.5.  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.


 


16.6         Relationship
of the Parties.  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.


 


16.7         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 that would cause
the application of the Laws of any other jurisdiction; (b) the United
Nations Conventions 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.


 


16.8         Dispute
Resolution.  With respect to any
disputes between the Parties concerning this Agreement which are not resolved
pursuant to Section 3.5 or as otherwise explicitly set forth in this
Agreement, each Party will be free to pursue all rights available to it under
law or equity.


 


16.9         Injunctive
Relief.  Each Party acknowledges and
agrees that there can be no adequate remedy at law for any breach of its
obligations under Article 10 or Section 2.6, and that any such breach
may allow such Party or Third Parties to unfairly compete with the other Party
resulting in irreparable harm to such other Party, and therefore, that upon any
such breach or any threat thereof, such other Party shall be entitled to
appropriate equitable relief in addition to whatever remedies it might have at
law, without the necessity of showing actual damages.


 


16.10       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 that shall be a reasonable substitute for such
Severed Clause in light of the intent of this Agreement.


 


81

















 


16.11       Entire
Agreement.  This Agreement, the
Supply 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.


 


16.12       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.


 


16.13       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.


 


16.14       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.


 


16.15       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.


 


16.16       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.


 


[Remainder of Page Intentionally
Left Blank]


 


82

















 


Confidential


 


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.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/
  Ron Cohen

  
	
   

  	
   

  	
  Name:
  Ron Cohen

  
	
   

  	
   

  	
  Title:
  Chief Executive Officer

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  BIOGEN
  IDEC INTERNATIONAL GMBH

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/
  Anders Lundstrom

  
	
   

  	
   

  	
  Name:
  Anders Lundstrom

  
	
   

  	
   

  	
  Title:
  Authorized Signatory

  



 


 


[Signature Page to License Agreement]


 














 


EXHIBIT A

ACORDA PATENT RIGHTS


 


	
  Application No.

  	
   

  	
  Country

  	
   

  	
  Patent

  Number

  	
   

  	
  Docket Name

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
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[*****]


 






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


 


A-1

















 


	
  Application No.

  	
   

  	
  Country

  	
   

  	
  Patent

  Number

  	
   

  	
  Docket Name

  
	
  [*****]

  	
   

  	
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[*****]


 






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


 


A-2

















 


	
  Application No.

  	
   

  	
  Country

  	
   

  	
  Patent

  Number

  	
   

  	
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[*****]


 






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


 


A-3

















 


EXHIBIT B


 


[Reserved for Future Use]


 


B-1

















 


EXHIBIT C


 


[Reserved for Future Use]


 


C-1














 


EXHIBIT D


 


ACORDA THIRD PARTY AGREEMENT
TERMS


 


This
Exhibit D 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 licenses and sublicenses granted to Licensee hereunder and
imposes certain obligations on Licensee.


 


·                                          Amended and
Restated License Agreement between Elan Pharma International Limited (as
assigned of Elan Corporation plc) and Acorda, dated September 26, 2003
(which the Parties acknowledge is subject to the Merck/Elan Agreement)


 


·                                          Supply
Agreement between Elan Pharma International Limited (as assigned of Elan
Corporation plc) and Acorda, dated September 26, 2003


 


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


 


·                                          License
Agreement between Rush-Presbyterian-St. Luke’s Medical Center (“Rush”)
and Acorda, dated September 26, 2003


 


·                                          Rush Payments
Agreement between Elan and Acorda, dated September 26, 2003 and Amendment No. 1
to Rush Payments Agreement, dated October 27, 2003


 


·                                          Side Agreement
among Rush, Acorda, Elan and Elan Drug Delivery, Inc., dated September 26,
2003


 


·                                          Amended and
Restated License Agreement between Canadian Spinal Research Organization and
Acorda, dated August 1, 2003


 


·                                          Asset Purchase
Agreement between Neurorecovery, Inc. and Acorda, dated February 1,
2008


 


·                                          License
Agreement between The UAB Research Foundation and Neurorecovery, Inc.,
dated May 17, 1999


 


·                                          Elan Consent


 


D-1

















 


EXHIBIT E


 


SUPPLY AGREEMENT


 


[attached]


 


E-1

















 


EXHIBIT F


 


PRESS RELEASE


 


[attached]


 


F-1

















 





 





 


ACORDA
THERAPEUTICS CONTACT:

Jeff Macdonald


(914)
347-4300 ext. 232


jmacdonald@acorda.com


 


BIOGEN
IDEC CONTACTS:


Media:
Jennifer Neiman (617) 914-6524

Investor: Eric Hoffman (617) 679-2812


 


FOR
IMMEDIATE RELEASE


 


Biogen
Idec and Acorda Therapeutics Announce Collaboration Agreement to Develop and
Commercialize MS Therapy Fampridine-SR in Markets Outside the U.S.


 


·                  Acorda to
Continue to Develop and Commercialize Fampridine-SR in the U.S.


·                  Upfront Payment
of $110 Million; Potential Deal Value Over $500 Million


·                  Acorda to Host
Conference Call at 8:30 a.m. Eastern Time Today


 


CAMBRIDGE, MA and HAWTHORNE,
NY, July 1, 2009 – Biogen Idec (NASDAQ: BIIB) and Acorda
Therapeutics, Inc. (NASDAQ: ACOR) today announced that they have
entered into an exclusive collaboration and license agreement to develop and
commercialize Fampridine-SR, a multiple sclerosis (MS) therapy, in markets
outside the United States. Fampridine-SR is a novel, oral sustained-release
compound being developed to improve walking ability in people with MS.  The parties have also entered into a related
supply agreement.  The transaction
represents a sublicensing of an existing license agreement between Acorda and
Elan Pharma International Limited, a subsidiary of Elan Corporation plc (NYSE:
ELN).


 


Under the terms of the
agreement, Biogen Idec will commercialize Fampridine-SR and any aminopyridine
products developed under the agreement in ex-U.S. markets worldwide and will
also have responsibility for regulatory activities and future clinical
development of Fampridine-SR in those markets. Acorda will receive an upfront
payment of $110 million and additional payments of up to $400 million based on
the successful achievement of future regulatory and sales milestones.  Biogen Idec will make tiered, double-digit
royalty payments to Acorda on ex-U.S. sales, and, in addition, the consideration that Biogen Idec
pays for products will reflect all amounts due from Acorda to Elan for ex-US
sales, including royalties 


 


F-2

















 


owed.  The
parties can also carry out future joint development activities under a
cost-sharing arrangement.


 


Elan will continue to
manufacture commercial supply of Fampridine-SR, based on its existing supply
agreement with Acorda.  Under the
existing agreements with Elan, Acorda will pay Elan seven percent of the
upfront and milestone payments that Acorda receives from Biogen Idec.


 


“Biogen Idec has outstanding
capabilities in commercializing neurology and oncology products and is known
globally for its reputation as an innovative leader in the field of multiple
sclerosis.  We are delighted to be
working with them to make Fampridine-SR, if approved, available to people
living with MS in Europe, Canada, Australia and other areas of the world,” said
Ron Cohen, M.D., President and CEO of Acorda. “We believe that Biogen Idec’s
international expertise in MS and neurology also will help us optimize future
development of Fampridine-SR and maximize its value in markets outside the U.S.”


 


“We are very pleased to
partner with Acorda, a leader in the development of therapies for spinal cord,
MS, and related nervous system disorders, to help make Fampridine-SR available
to MS patients outside of the United States,” said Jim Mullen, President and
CEO of Biogen Idec.  “As we look to expand our global MS
leadership, we believe Fampridine-SR has the potential to become an important
oral therapy that may help improve the walking ability of a wide range of
patients — including patients with relapsing forms of MS, as well as primary
and secondary progressive MS.”


 


MS is a chronic disease of
the central nervous system that affects approximately two million people
worldwide.


 


Acorda previously announced
that the European Medicines Agency (EMEA) notified the Company that
Fampridine-SR is eligible to be submitted for a Marketing Authorization
Application (MAA) via the Agency’s Centralized Procedure as a new active
substance. The Centralized Procedure provides for a single, coordinated review
that is conducted by the EMEA on behalf of all European Union (EU) member
states.


 


Acorda will continue to
develop and commercialize Fampridine-SR independently in the U.S.  The U.S. Food and Drug Administration (FDA)
is currently reviewing a New Drug Application (NDA) for Fampridine-SR. The NDA
was assigned Priority Review and a Prescription Drug User Fee Act (PDUFA) date
of October 22, 2009; the PDUFA date is the target date for the FDA to
complete its review of Fampridine-SR.


 


Conference Call and Audiocast


 


Ron Cohen, President and
Chief Executive Officer of Acorda Therapeutics, will host a conference call
today at 8:30 a.m. ET.


 


To participate in the
conference call, please dial 800-706-7745 (domestic) or 617-614-3472
(international) and reference the access code 68235234. The presentation will
be available via a live webcast at
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&eventID=2303543.


 


A replay of the call will
be available from 11:30 a.m. ET on July 1, 2009 until midnight on August 1,
2009. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888
(international) and reference the access code 96152771. The archived webcast
will be available for 30 days in the Investor Relations section of the Acorda
website at http://www.acorda.com.


 


About Fampridine-SR


 


Fampridine-SR is a
sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine
or 4-AP). Fampridine has completed two successful Phase 3 clinical trials
demonstrating improved walking ability in people with MS.  It has been found to improve impulse
conduction in nerve fibers in which the insulating layer, called myelin, has
been damaged. Fampridine-SR was developed 


 


F-3

















 


using Elan’s proprietary
Oral Controlled Release MXDASTM (MatriX Drug Absorption System) Technology and
will be manufactured by Elan based on an existing supply agreement with Acorda.


 


About Acorda
Therapeutics


 


Acorda
Therapeutics is a biotechnology company developing therapies for spinal cord
injury, multiple sclerosis and related nervous system disorders. The Company’s
marketed products include Zanaflex Capsules® (tizanidine
hydrochloride), a short-acting drug for the management of spasticity. The
Company’s pipeline includes a number of products in development for the
treatment, regeneration and repair of the spinal cord and brain.


 


About Biogen Idec


 


Biogen
Idec creates new standards of care in therapeutic areas with high unmet medical
needs. Founded in 1978, Biogen Idec is a global leader in the discovery,
development, manufacturing, and commercialization of innovative therapies.
Patients in more than 90 countries benefit from Biogen Idec’s significant
products that address diseases such as lymphoma, multiple sclerosis, and
rheumatoid arthritis. For product labeling, press releases and additional
information about the company, please visit www.biogenidec.com


 


About
Elan Drug Technologies


 


Elan
Drug Technologies (EDT) is the world’s leading drug delivery provider and is a
business unit of Elan Corporation plc. EDT developed Fampridine-SR, using one
of their proprietary Oral Controlled Release Technologies, the MXDASTM (MatriX
Drug Absorption System) Technology. Products are developed by EDT through Elan
Pharma International Limited and other Elan affiliates. EDT aims to deliver
clinically meaningful benefits to patients by using their extensive experience
and proprietary delivery technologies in partnership with pharmaceutical
companies. More information is available at www.elandrugtechnologies.com


 


Forward-Looking
Statements


 


This press release
includes forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements, other than statements
of historical facts, regarding management’s expectations, beliefs, goals, plans
or prospects should be considered forward-looking. These statements are subject
to risks and uncertainties that could cause actual results to differ
materially, including delays in obtaining or failure to obtain regulatory
approval of Fampridine-SR, the risk of unfavorable results from future studies
of Fampridine-SR, adverse safety events, dependence on a third party to supply
Fampridine-SR, Acorda Therapeutics’ and Biogen Idec’s ability to successfully
market and sell Fampridine-SR, if approved, competitive pressures, the
availability of reimbursement from third party payors, failure to protect intellectual
property or to defend against the intellectual property claims of others, and
Acorda Therapeutics’  ability to obtain
additional financing to support its operations.. These and other risks are
described in greater detail in Acorda Therapeutics’ and Biogen Idec’s
respective filings with the Securities and Exchange Commission. Acorda
Therapeutics and Biogen Idec may not actually achieve the goals or plans
described in any forward-looking statements included in this press release, and
investors should not place undue reliance on these statements. Any
forward-looking statements speak only as of the date of this press
release.  Acorda Therapeutics and Biogen
Idec disclaim any intent or obligation to update any forward-looking statements
as a result of developments occurring after the date of this press release.


 


F-4






 










 


EXHIBIT G


 


REGIONS


 


	
  The
  geographic area covered by each of the regions set forth below (as defined by
  the United Nations as of the Effective Date, as set forth
  inhttp://unstats.un.org/unsd/methods/m49/m49regin.htm, excerpted below)

  	
   

  	
  Key
  countries within such area (or, with respect to a country, the successor to
  such country which successor covers more than 50% of the geographic area
  covered by such country on the Effective Date) (each, a “Key Country”)

  
	
   

  	
   

  	
   

  
	
  Asia
  (excluding Japan and Western Asia)

  	
   

  	
  [*****]

  
	
   

  	
   

  	
   

  
	
  Japan

  	
   

  	
  Japan

  
	
   

  	
   

  	
   

  
	
  Oceania
  and Antarctica

  	
   

  	
  [*****]

  
	
   

  	
   

  	
   

  
	
  Europe
  (excluding Eastern Europe)

  	
   

  	
  [*****]

  
	
   

  	
   

  	
   

  
	
  Eastern
  Europe

  	
   

  	
  [*****]

  
	
   

  	
   

  	
   

  
	
  Americas
  (excluding the United States of America)

  	
   

  	
  [*****]

  
	
   

  	
   

  	
   

  
	
  Africa
  and Western Asia

  	
   

  	
  [*****]

  



 


Excerpt from http://unstats.un.org/unsd/methods/m49/m49regin.htm:


 


Composition of macro geographical (continental) regions, geographical
sub-regions, and selected economic and other groupings


 


	
  Numerical code

  	
   

  	
  Geographical
  region and composition of each region

  
	
   

  	
   

  	
   

  
	
  002

  	
   

  	
  (a)
  Africa  a/

  
	
   

  	
   

  	
   

  
	
  014

  	
   

  	
  Eastern Africa

  
	
  108

  	
   

  	
  Burundi

  
	
  174

  	
   

  	
  Comoros

  
	
  262

  	
   

  	
  Djibouti

  
	
  232

  	
   

  	
  Eritrea

  
	
  231

  	
   

  	
  Ethiopia

  
	
  404

  	
   

  	
  Kenya

  
	
  450

  	
   

  	
  Madagascar

  
	
  454

  	
   

  	
  Malawi

  
	
  480

  	
   

  	
  Mauritius

  
	
  175

  	
   

  	
  Mayotte

  
	
  508

  	
   

  	
  Mozambique

  
	
  638

  	
   

  	
  Réunion

  
	
  646

  	
   

  	
  Rwanda

  



 






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


 


G-1

















 


	
  Numerical code

  	
   

  	
  Geographical
  region and composition of each region

  
	
   

  	
   

  	
   

  
	
  690

  	
   

  	
  Seychelles

  
	
  706

  	
   

  	
  Somalia

  
	
  800

  	
   

  	
  Uganda

  
	
  834

  	
   

  	
  United
  Republic of Tanzania

  
	
  894

  	
   

  	
  Zambia

  
	
  716

  	
   

  	
  Zimbabwe

  
	
   

  	
   

  	
   

  
	
  017

  	
   

  	
  Middle Africa

  
	
  024

  	
   

  	
  Angola

  
	
  120

  	
   

  	
  Cameroon

  
	
  140

  	
   

  	
  Central
  African Republic

  
	
  148

  	
   

  	
  Chad

  
	
  178

  	
   

  	
  Congo

  
	
  180

  	
   

  	
  Democratic
  Republic of the Congo

  
	
  226

  	
   

  	
  Equatorial
  Guinea

  
	
  266

  	
   

  	
  Gabon

  
	
  678

  	
   

  	
  Sao
  Tome and Principe

  
	
   

  	
   

  	
   

  
	
  015

  	
   

  	
  Northern Africa

  
	
  012

  	
   

  	
  Algeria

  
	
  818

  	
   

  	
  Egypt

  
	
  434

  	
   

  	
  Libyan
  Arab Jamahiriya

  
	
  504

  	
   

  	
  Morocco

  
	
  736

  	
   

  	
  Sudan

  
	
  788

  	
   

  	
  Tunisia

  
	
  732

  	
   

  	
  Western
  Sahara

  
	
   

  	
   

  	
   

  
	
  018

  	
   

  	
  Southern Africa

  
	
  072

  	
   

  	
  Botswana

  
	
  426

  	
   

  	
  Lesotho

  
	
  516

  	
   

  	
  Namibia

  
	
  710

  	
   

  	
  South
  Africa

  
	
  748

  	
   

  	
  Swaziland

  
	
   

  	
   

  	
   

  
	
  011

  	
   

  	
  Western Africa

  
	
  204

  	
   

  	
  Benin

  
	
  854

  	
   

  	
  Burkina
  Faso

  
	
  132

  	
   

  	
  Cape
  Verde

  
	
  384

  	
   

  	
  Cote
  d’Ivoire

  
	
  270

  	
   

  	
  Gambia

  
	
  288

  	
   

  	
  Ghana

  
	
  324

  	
   

  	
  Guinea

  
	
  624

  	
   

  	
  Guinea-Bissau

  
	
  430

  	
   

  	
  Liberia

  
	
  466

  	
   

  	
  Mali

  
	
  478

  	
   

  	
  Mauritania

  
	
  562

  	
   

  	
  Niger

  
	
  566

  	
   

  	
  Nigeria

  
	
  654

  	
   

  	
  Saint
  Helena

  
	
  686

  	
   

  	
  Senegal

  
	
  694

  	
   

  	
  Sierra
  Leone

  
	
  768

  	
   

  	
  Togo

  
	
   

  	
   

  	
   

  
	
  019

  	
   

  	
  (b) Americas

  
	
   

  	
   

  	
   

  
	
  419

  	
   

  	
  Latin America and the Caribbean

  
	
   

  	
   

  	
   

  
	
  029

  	
   

  	
  Caribbean

  
	
  660

  	
   

  	
  Anguilla

  
	
  028

  	
   

  	
  Antigua
  and Barbuda

  
	
  533

  	
   

  	
  Aruba

  



 


G-2

















 


	
  Numerical code

  	
   

  	
  Geographical
  region and composition of each region

  
	
   

  	
   

  	
   

  
	
  044

  	
   

  	
  Bahamas

  
	
  052

  	
   

  	
  Barbados

  
	
  092

  	
   

  	
  British
  Virgin Islands

  
	
  136

  	
   

  	
  Cayman
  Islands

  
	
  192

  	
   

  	
  Cuba

  
	
  212

  	
   

  	
  Dominica

  
	
  214

  	
   

  	
  Dominican
  Republic

  
	
  308

  	
   

  	
  Grenada

  
	
  312

  	
   

  	
  Guadeloupe

  
	
  332

  	
   

  	
  Haiti

  
	
  388

  	
   

  	
  Jamaica

  
	
  474

  	
   

  	
  Martinique

  
	
  500

  	
   

  	
  Montserrat

  
	
  530

  	
   

  	
  Netherlands
  Antilles

  
	
  630

  	
   

  	
  Puerto
  Rico

  
	
  652

  	
   

  	
  Saint-Barthélemy

  
	
  659

  	
   

  	
  Saint
  Kitts and Nevis

  
	
  662

  	
   

  	
  Saint
  Lucia

  
	
  663

  	
   

  	
  Saint
  Martin (French part)

  
	
  670

  	
   

  	
  Saint
  Vincent and the Grenadines

  
	
  780

  	
   

  	
  Trinidad
  and Tobago

  
	
  796

  	
   

  	
  Turks
  and Caicos Islands

  
	
  850

  	
   

  	
  United
  States Virgin Islands

  
	
   

  	
   

  	
   

  
	
  013

  	
   

  	
  Central America

  
	
  084

  	
   

  	
  Belize

  
	
  188

  	
   

  	
  Costa
  Rica

  
	
  222

  	
   

  	
  El
  Salvador

  
	
  320

  	
   

  	
  Guatemala

  
	
  340

  	
   

  	
  Honduras

  
	
  484

  	
   

  	
  Mexico

  
	
  558

  	
   

  	
  Nicaragua

  
	
  591

  	
   

  	
  Panama

  
	
   

  	
   

  	
   

  
	
  005

  	
   

  	
  South America

  
	
  032

  	
   

  	
  Argentina

  
	
  068

  	
   

  	
  Bolivia
  (Plurinational State of)

  
	
  076

  	
   

  	
  Brazil

  
	
  152

  	
   

  	
  Chile

  
	
  170

  	
   

  	
  Colombia

  
	
  218

  	
   

  	
  Ecuador

  
	
  238

  	
   

  	
  Falkland
  Islands (Malvinas)

  
	
  254

  	
   

  	
  French
  Guiana

  
	
  328

  	
   

  	
  Guyana

  
	
  600

  	
   

  	
  Paraguay

  
	
  604

  	
   

  	
  Peru

  
	
  740

  	
   

  	
  Suriname

  
	
  858

  	
   

  	
  Uruguay

  
	
  862

  	
   

  	
  Venezuela
  (Bolivarian Republic of)

  
	
   

  	
   

  	
   

  
	
  021

  	
   

  	
  Northern America  b/

  
	
  060

  	
   

  	
  Bermuda

  
	
  124

  	
   

  	
  Canada

  
	
  304

  	
   

  	
  Greenland

  
	
  666

  	
   

  	
  Saint
  Pierre and Miquelon

  
	
  840

  	
   

  	
  United
  States of America

  
	
   

  	
   

  	
   

  
	
  142

  	
   

  	
  (c)
  Asia

  
	
   

  	
   

  	
   

  
	
  143

  	
   

  	
  Central Asia

  
	
  398

  	
   

  	
  Kazakhstan

  



 


G-3

















 


	
  Numerical code

  	
   

  	
  Geographical
  region and composition of each region

  
	
   

  	
   

  	
   

  
	
  417

  	
   

  	
  Kyrgyzstan

  
	
  762

  	
   

  	
  Tajikistan

  
	
  795

  	
   

  	
  Turkmenistan

  
	
  860

  	
   

  	
  Uzbekistan

  
	
   

  	
   

  	
   

  
	
  030

  	
   

  	
  Eastern Asia

  
	
  156

  	
   

  	
  China

  
	
  344

  	
   

  	
  Hong
  Kong Special Administrative Region of China

  
	
  446

  	
   

  	
  Macao
  Special Administrative Region of China

  
	
  408

  	
   

  	
  Democratic
  People’s Republic of Korea

  
	
  392

  	
   

  	
  Japan

  
	
  496

  	
   

  	
  Mongolia

  
	
  410

  	
   

  	
  Republic
  of Korea

  
	
   

  	
   

  	
   

  
	
  034

  	
   

  	
  Southern Asia

  
	
  004

  	
   

  	
  Afghanistan

  
	
  050

  	
   

  	
  Bangladesh

  
	
  064

  	
   

  	
  Bhutan

  
	
  356

  	
   

  	
  India

  
	
  364

  	
   

  	
  Iran
  (Islamic Republic of)

  
	
  462

  	
   

  	
  Maldives

  
	
  524

  	
   

  	
  Nepal

  
	
  586

  	
   

  	
  Pakistan

  
	
  144

  	
   

  	
  Sri
  Lanka

  
	
   

  	
   

  	
   

  
	
  035

  	
   

  	
  South-Eastern Asia

  
	
  096

  	
   

  	
  Brunei
  Darussalam

  
	
  116

  	
   

  	
  Cambodia

  
	
  360

  	
   

  	
  Indonesia

  
	
  418

  	
   

  	
  Lao
  People’s Democratic Republic

  
	
  458

  	
   

  	
  Malaysia

  
	
  104

  	
   

  	
  Myanmar

  
	
  608

  	
   

  	
  Philippines

  
	
  702

  	
   

  	
  Singapore

  
	
  764

  	
   

  	
  Thailand

  
	
  626

  	
   

  	
  Timor-Leste

  
	
  704

  	
   

  	
  Viet
  Nam

  
	
   

  	
   

  	
   

  
	
  145

  	
   

  	
  Western Asia

  
	
  051

  	
   

  	
  Armenia

  
	
  031

  	
   

  	
  Azerbaijan

  
	
  048

  	
   

  	
  Bahrain

  
	
  196

  	
   

  	
  Cyprus

  
	
  268

  	
   

  	
  Georgia

  
	
  368

  	
   

  	
  Iraq

  
	
  376

  	
   

  	
  Israel

  
	
  400

  	
   

  	
  Jordan

  
	
  414

  	
   

  	
  Kuwait

  
	
  422

  	
   

  	
  Lebanon

  
	
  275

  	
   

  	
  Occupied
  Palestinian Territory

  
	
  512

  	
   

  	
  Oman

  
	
  634

  	
   

  	
  Qatar

  
	
  682

  	
   

  	
  Saudi
  Arabia

  
	
  760

  	
   

  	
  Syrian
  Arab Republic

  
	
  792

  	
   

  	
  Turkey

  
	
  784

  	
   

  	
  United
  Arab Emirates

  
	
  887

  	
   

  	
  Yemen

  



 


G-4

















 


	
  Numerical code

  	
   

  	
  Geographical
  region and composition of each region

  
	
   

  	
   

  	
   

  
	
  150

  	
   

  	
  (d)
  Europe

  
	
   

  	
   

  	
   

  
	
  151

  	
   

  	
  Eastern Europe

  
	
  112

  	
   

  	
  Belarus

  
	
  100

  	
   

  	
  Bulgaria

  
	
  203

  	
   

  	
  Czech
  Republic

  
	
  348

  	
   

  	
  Hungary

  
	
  616

  	
   

  	
  Poland

  
	
  498

  	
   

  	
  Republic
  of Moldova

  
	
  642

  	
   

  	
  Romania

  
	
  643

  	
   

  	
  Russian
  Federation

  
	
  703

  	
   

  	
  Slovakia

  
	
  804

  	
   

  	
  Ukraine

  
	
   

  	
   

  	
   

  
	
  154

  	
   

  	
  Northern Europe

  
	
  248

  	
   

  	
  Åland
  Islands

  
	
  830

  	
   

  	
  Channel
  Islands

  
	
  208

  	
   

  	
  Denmark

  
	
  233

  	
   

  	
  Estonia

  
	
  234

  	
   

  	
  Faeroe
  Islands

  
	
  246

  	
   

  	
  Finland

  
	
  831

  	
   

  	
  Guernsey

  
	
  352

  	
   

  	
  Iceland

  
	
  372

  	
   

  	
  Ireland

  
	
  833

  	
   

  	
  Isle
  of Man

  
	
  832

  	
   

  	
  Jersey

  
	
  428

  	
   

  	
  Latvia

  
	
  440

  	
   

  	
  Lithuania

  
	
  578

  	
   

  	
  Norway

  
	
  744

  	
   

  	
  Svalbard
  and Jan Mayen Islands

  
	
  752

  	
   

  	
  Sweden

  
	
  826

  	
   

  	
  United
  Kingdom of Great Britain and Northern Ireland

  
	
   

  	
   

  	
   

  
	
  039

  	
   

  	
  Southern Europe

  
	
  008

  	
   

  	
  Albania

  
	
  020

  	
   

  	
  Andorra

  
	
  070

  	
   

  	
  Bosnia
  and Herzegovina

  
	
  191

  	
   

  	
  Croatia

  
	
  292

  	
   

  	
  Gibraltar

  
	
  300

  	
   

  	
  Greece

  
	
  336

  	
   

  	
  Holy
  See

  
	
  380

  	
   

  	
  Italy

  
	
  470

  	
   

  	
  Malta

  
	
  499

  	
   

  	
  Montenegro

  
	
  620

  	
   

  	
  Portugal

  
	
  674

  	
   

  	
  San
  Marino

  
	
  688

  	
   

  	
  Serbia

  
	
  705

  	
   

  	
  Slovenia

  
	
  724

  	
   

  	
  Spain

  
	
  807

  	
   

  	
  The
  former Yugoslav Republic of Macedonia

  
	
   

  	
   

  	
   

  
	
  155

  	
   

  	
  Western Europe

  
	
  040

  	
   

  	
  Austria

  
	
  056

  	
   

  	
  Belgium

  
	
  250

  	
   

  	
  France

  
	
  276

  	
   

  	
  Germany

  
	
  438

  	
   

  	
  Liechtenstein

  
	
  442

  	
   

  	
  Luxembourg

  
	
  492

  	
   

  	
  Monaco

  
	
  528

  	
   

  	
  Netherlands

  
	
  756

  	
   

  	
  Switzerland

  



 


G-5

















 


	
  Numerical code

  	
   

  	
  Geographical
  region and composition of each region

  
	
   

  	
   

  	
   

  
	
  009

  	
   

  	
  (e)
  Oceania

  
	
   

  	
   

  	
   

  
	
  053

  	
   

  	
  Australia and New Zealand

  
	
  036

  	
   

  	
  Australia

  
	
  554

  	
   

  	
  New
  Zealand

  
	
  574

  	
   

  	
  Norfolk
  Island

  
	
   

  	
   

  	
   

  
	
  054

  	
   

  	
  Melanesia

  
	
  242

  	
   

  	
  Fiji

  
	
  540

  	
   

  	
  New
  Caledonia

  
	
  598

  	
   

  	
  Papua
  New Guinea

  
	
  090

  	
   

  	
  Solomon
  Islands

  
	
  548

  	
   

  	
  Vanuatu

  
	
   

  	
   

  	
   

  
	
  057

  	
   

  	
  Micronesia

  
	
  316

  	
   

  	
  Guam

  
	
  296

  	
   

  	
  Kiribati

  
	
  584

  	
   

  	
  Marshall
  Islands

  
	
  583

  	
   

  	
  Micronesia
  (Federated States of)

  
	
  520

  	
   

  	
  Nauru

  
	
  580

  	
   

  	
  Northern
  Mariana Islands

  
	
  585

  	
   

  	
  Palau

  
	
   

  	
   

  	
   

  
	
  061

  	
   

  	
  Polynesia

  
	
  016

  	
   

  	
  American
  Samoa

  
	
  184

  	
   

  	
  Cook
  Islands

  
	
  258

  	
   

  	
  French
  Polynesia

  
	
  570

  	
   

  	
  Niue

  
	
  612

  	
   

  	
  Pitcairn

  
	
  882

  	
   

  	
  Samoa

  
	
  772

  	
   

  	
  Tokelau

  
	
  776

  	
   

  	
  Tonga

  
	
  798

  	
   

  	
  Tuvalu

  
	
  876

  	
   

  	
  Wallis
  and Futuna Islands

  



 


G-6

















 


EXHIBIT H


 


PARENT GUARANTY


 


By
executing below, Biogen Idec Inc., a company organized and existing under the
laws of the state of Delaware, on behalf of its successors, hereby
unconditionally guarantees the full and complete performance of the obligations
of its subsidiary, Biogen Idec International GmbH, a company organized under
the laws of Switzerland, its successors and permitted assigns, under the Collaboration
and License Agreement and the Supply Agreement, entered into with Acorda
Therapeutics, Inc., a company organized under the laws of the State of
Delaware, dated June 30, 2009, as each such agreement may be amended from
time to time in accordance with its terms.


 


Executed
by a duly authorized officer of Biogen Idec Inc.


 


	
   

  	
  BIOGEN
  IDEC INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Paul J. Clancy

  
	
   

  	
   

  	
  Name: Paul J. Clancy

  
	
   

  	
   

  	
  Title: EVP & Chief Financial Officer

  
	
   

  	
  Date:

  	
  June
  30, 2009

  



 


H-1

















 


EXHIBIT I


 


COMMERCIALIZATION METRICS
FORECAST


 


A)                                       Aggregate amount of money to
be spent by Licensee, its Affiliates and Third Party Distributors on
Commercialization activities


 


	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  



 


B)                                         Total Calls per
Year in Major Markets


 


	
   

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  



 






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


 


I-1