Exhibit 10.55

 

SUPPLY AGREEMENT

 

BETWEEN

 

ACORDA THERAPEUTICS, INC.

 

AND

 

BIOGEN IDEC INTERNATIONAL GMBH

 

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

 

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TABLE OF CONTENTS

 

SUPPLY AGREEMENT

1

 

 

W I T N E S S E T H:

1

 

 

 

1.

DEFINITIONS

1

 

 

 

 

2.

COORDINATION; SUPPLY CHAIN MANAGEMENT

5

 

 

 

 

 

2.1

Relationship Managers

5

 

2.2

Joint Manufacturing Committee

5

 

2.3

Meetings

6

 

2.4

Decision Making; Authority

6

 

2.5

Third Party Manufacturers

7

 

 

 

 

3.

SUPPLY

7

 

 

 

 

 

3.1

Exclusive Supply

7

 

3.2

General Scope of Services

7

 

3.3

Quality Agreement

7

 

3.4

Third Party Manufacturers

7

 

 

 

 

4.

FORECASTS AND ORDERS

8

 

 

 

 

 

4.1

Forecast

8

 

4.2

Long-Term Forecast

8

 

4.3

Amending Forecasts

8

 

4.4

Launch Stocks

8

 

4.5

Purchase Orders

9

 

4.6

Fulfillment of Purchase Orders

9

 

4.7

Supply Uncertainty

10

 

4.8

Safety Stock

10

 

 

 

 

5.

PRODUCTION

10

 

 

 

 

 

5.1

Specifications

10

 

5.2

Changes to the Specifications, Processing or the Facility

11

 

5.3

Quality Assurance

12

 

5.4

Preservation of Samples

13

 

 

 

 

6.

DELIVERY AND PAYMENT

13

 

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6.1

Delivery

13

 

6.2

Price and Reimbursements

14

 

6.3

Elan Compensating Payment and Acorda Costs

14

 

6.4

Remittance of Payments

14

 

6.5

Tax Withholding

14

 

6.6

VAT

15

 

 

 

 

7.

REGULATORY

15

 

 

 

 

 

7.1

Information Provided to Manufacturers

15

 

7.2

Governmental Inspection

15

 

7.3

Right of Inspection

15

 

7.4

Records

16

 

 

 

 

8.

REPRESENTATIONS AND WARRANTIES

16

 

 

 

 

 

8.1

Mutual Representations and Warranties

16

 

8.2

Additional Representations and Warranties of Acorda

17

 

8.3

Additional Covenants of Acorda

17

 

8.4

Disclaimer

18

 

8.5

Limitation of Damages

18

 

 

 

 

9.

CONFIDENTIALITY

18

 

 

 

 

10.

TERM AND TERMINATION

18

 

 

 

 

 

10.1

Term

18

 

10.2

Termination

18

 

10.3

Rights Upon Termination

19

 

10.4

Effect of Termination

19

 

10.5

Survival

19

 

 

 

 

11.

GOVERNING LAW

19

 

 

 

 

 

11.1

Governing Law

19

 

11.2

Dispute Resolution

19

 

 

 

 

12.

MISCELLANEOUS

20

 

 

 

 

 

12.1

Notices

20

 

12.2

Entire Agreement

20

 

12.3

Amendment and Waiver

21

 

12.4

No Implied Waivers

21

 

2

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12.5

Order of Precedence

21

 

12.6

Covenant of Further Assurances

21

 

12.7

Relationship

21

 

12.8

Severability

21

 

12.9

Assignment

21

 

12.10

Force Majeure

22

 

12.11

Export Compliance

22

 

12.12

Performance by Affiliates and Third Party Distributors

22

 

12.13

Counterparts and Facsimile Signatures

22

 

 

 

 

Exhibit A

Acorda Supply Agreements

1

 

3

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SUPPLY AGREEMENT

 

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

 

W I T N E S S E T H:

 

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

 

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

 

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

 

1.                                       DEFINITIONS

 

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

 

1.1                                 “ACORDA” SHALL HAVE THE MEANING SET FORTH IN
THE PREAMBLE.

 

1.2                                 “ACORDA SUPPLY AGREEMENTS” SHALL HAVE THE
MEANING SET FORTH IN SECTION 3.4.

 

1.3                                 “AFFILIATE” SHALL MEAN ANY PERSON WHO
DIRECTLY OR INDIRECTLY CONTROLS OR IS CONTROLLED BY OR IS UNDER COMMON CONTROL
WITH ANOTHER PERSON.  FOR PURPOSES OF THIS DEFINITION, “CONTROL” OR “CONTROLLED”
MEANS OWNERSHIP, DIRECTLY OR THROUGH ONE OR MORE AFFILIATES, OF FIFTY PERCENT
(50%) OR MORE OF THE SHARES OF STOCK ENTITLED TO VOTE FOR THE ELECTION OF
DIRECTORS, IN THE CASE OF A CORPORATION, OR FIFTY PERCENT (50%) OR MORE OF THE
EQUITY INTEREST, IN THE CASE OF ANY OTHER TYPE OF LEGAL ENTITY, OR STATUS AS A
GENERAL PARTNER IN ANY PARTNERSHIP.  THE PARTIES ACKNOWLEDGE THAT, IN THE CASE
OF CERTAIN ENTITIES ORGANIZED UNDER THE LAWS OF CERTAIN COUNTRIES, THE MAXIMUM
PERCENTAGE OWNERSHIP PERMITTED BY LAW FOR A FOREIGN INVESTOR MAY BE LESS THAN
FIFTY PERCENT (50%), AND IN SUCH CASE SUCH LOWER PERCENTAGE SHALL BE SUBSTITUTED
IN THE PRECEDING SENTENCE; PROVIDED, THAT SUCH FOREIGN INVESTOR HAS THE POWER TO
DIRECT THE MANAGEMENT AND POLICIES OF SUCH ENTITY.

 

1.4                                 “AGREEMENT” SHALL HAVE THE MEANING SET FORTH
IN THE PREAMBLE.

 

1.5                                 “BATCH” SHALL MEAN A SPECIFIC QUANTITY OF
PRODUCT THAT IS PRODUCED ACCORDING TO A SINGLE MANUFACTURING ORDER DURING THE
SAME CYCLE OF MANUFACTURE.

 

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1.6                                 “BREACHING PARTY” SHALL HAVE THE MEANING SET
FORTH IN SECTION 10.2(A).

 

1.7                                 “BUSINESS DAY” SHALL MEAN A DAY OTHER THAN
SATURDAY OR SUNDAY ON WHICH THE BANKS IN NEW YORK, NEW YORK AND BOSTON,
MASSACHUSETTS ARE OPEN FOR BUSINESS.

 

1.8                                 “CALENDAR QUARTER” SHALL MEAN A CALENDAR
QUARTER ENDING ON THE LAST DAY OF MARCH, JUNE, SEPTEMBER OR DECEMBER.

 

1.9                                 “CALENDAR YEAR” SHALL MEAN A PERIOD OF TIME
COMMENCING ON JANUARY 1 AND ENDING ON THE FOLLOWING DECEMBER 31.

 

1.10                           “CGMP” SHALL MEAN CURRENT GOOD MANUFACTURING
PRACTICES AND STANDARDS AS PROVIDED FOR IN THE UNITED STATES CODE OF FEDERAL
REGULATIONS, AND THE REQUIREMENTS THEREUNDER IMPOSED BY THE FDA, ALL PROMULGATED
AND PUBLISHED, AND IN EC DIRECTIVE 91/356/EEC OF 13 JUNE 1991 AS WELL AS EC
DIRECTIVES 2003-94-EC AND 2005-28-EC AND IN ACCORDANCE WITH INDUSTRY PRACTICES.

 

1.11                           “DOCUMENTATION” SHALL HAVE THE MEANING SET FORTH
IN SECTION 5.3(B).

 

1.12                           “EFFECTIVE DATE” SHALL MEAN THAT DATE SET FORTH
IN THE PREAMBLE.

 

1.13                           “ELAN” SHALL MEAN ELAN PHARMA INTERNATIONAL
LIMITED, ITS SUCCESSORS AND ASSIGNS AND, AS APPLICABLE, ITS AFFILIATES.

 

1.14                           “ELAN COMPENSATING PAYMENT” SHALL MEAN THE AMOUNT
PAID OR PAYABLE TO ELAN PURSUANT TO SECTION 9.5 OF THE ELAN SUPPLY AGREEMENT.

 

1.15                           “ELAN CONSENT” MEANS THE CONSENT AMONG ACORDA,
LICENSEE AND ELAN, DATED ON OR ABOUT THE EFFECTIVE DATE.

 

1.16                           “ELAN SUPPLY AGREEMENT” SHALL MEAN THE SUPPLY
AGREEMENT BETWEEN ELAN AND ACORDA, DATED SEPTEMBER 26, 2003, AS AMENDED FROM
TIME TO TIME.

 

1.17                           “EMEA” SHALL MEAN THE EUROPEAN MEDICINES AGENCY
OR ANY SUCCESSOR AGENCY THEREOF.

 

1.18                           “EU” SHALL MEAN THE EUROPEAN UNION, AS IT MAY BE
EXPANDED OR CONTRACTED FROM TIME TO TIME, ICELAND, LIECHTENSTEIN AND NORWAY.

 

1.19                           “EXPERT PANEL” SHALL HAVE THE MEANING GIVEN TO IT
IN THE LICENSE AGREEMENT DISPUTES BETWEEN THE PARTIES UNDER THIS AGREEMENT THAT
ARE ELIGIBLE TO BE REFERRED TO AN EXPERT PANEL SHALL BE RESOLVED IN ACCORDANCE
WITH THE PROVISIONS SET FORTH IN SECTION 3.5(C)(III) OF THE LICENSE AGREEMENT.

 

1.20                           “FACILITY” SHALL MEAN ELAN’S MANUFACTURING
FACILITY IN MONKSLAND, ATHLONE, CO. WESTMEATH, IRELAND, OR SUCH OTHER FACILITY
AS ACORDA OR ITS THIRD PARTY MANUFACTURERS MAY USE TO PERFORM ACORDA’S
OBLIGATIONS UNDER THIS AGREEMENT.

 

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1.21                           “FDA” SHALL MEAN THE UNITED STATES FOOD AND DRUG
ADMINISTRATION OR ANY SUCCESSOR AGENCY THERETO.

 

1.22                           “FIRM PERIOD” SHALL HAVE THE MEANING SET FORTH IN
SECTION 4.1(A).

 

1.23                           “FORECAST” SHALL HAVE THE MEANING SET FORTH IN
SECTION 4.1.

 

1.24                           “JMC” SHALL HAVE THE MEANING SET FORTH IN
SECTION 2.2.

 

1.25                           “LATENT DEFECT” SHALL HAVE THE MEANING SET FORTH
IN SECTION 5.3(C).

 

1.26                           “LAUNCH STOCKS” SHALL MEAN THE QUANTITIES OF
STOCKS OF THE PRODUCT REQUIRED BY LICENSEE, AS DETERMINED IN ACCORDANCE WITH
SECTION 4.4, IN RELATION TO THE LAUNCH OF THE PRODUCT FOLLOWING REGULATORY
APPROVAL IN A MAJOR MARKET COUNTRY.

 

1.27                           “LAW” SHALL MEAN ANY LAW, STATUTE, RULE,
REGULATION, GOVERNMENT AGENCY GUIDANCE, ORDINANCE OR OTHER PRONOUNCEMENT HAVING
THE EFFECT OF LAW, OF ANY FEDERAL, NATIONAL, MULTINATIONAL, STATE, PROVINCIAL,
COUNTY, CITY OR OTHER POLITICAL SUBDIVISION, INCLUDING (A) CGMP, GOOD CLINICAL
PRACTICES AND ADVERSE EVENT REPORTING REQUIREMENTS, GUIDANCE FROM THE
INTERNATIONAL CONFERENCE ON HARMONIZATION OR OTHER GENERALLY ACCEPTED
CONVENTIONS, AND ALL OTHER RULES, REGULATIONS AND REQUIREMENTS OF THE FDA AND
OTHER APPLICABLE REGULATORY AUTHORITIES, (B) THE FOREIGN CORRUPT PRACTICES ACT
OF 1977, AS AMENDED, OR ANY COMPARABLE LAWS IN ANY COUNTRY, AND (C) ALL EXPORT
CONTROL LAWS.

 

1.28                           “LICENSE AGREEMENT” SHALL HAVE THE MEANING SET
FORTH IN THE PREAMBLE.

 

1.29                           “LICENSEE” SHALL HAVE THE MEANING SET FORTH IN
THE PREAMBLE.

 

1.30                           “MAJOR MARKET COUNTRIES” SHALL MEAN THE UNITED
KINGDOM, FRANCE, GERMANY, ITALY, SPAIN AND JAPAN.

 

1.31                           “NDA” SHALL MEAN A NEW DRUG APPLICATION FILED
WITH THE FDA OR SIMILAR FOREIGN APPLICATION OR SUBMISSION FOR REGULATORY
APPROVAL, INCLUDING A MAA.

 

1.32                           “NON-BREACHING PARTY” SHALL HAVE THE MEANING SET
FORTH IN SECTION 10.2(A).

 

1.33                           “PARTY” AND “PARTIES” SHALL HAVE THE RESPECTIVE
MEANINGS SET FORTH IN THE PREAMBLE.

 

1.34                           “PERSON” SHALL MEAN ANY INDIVIDUAL, LIMITED OR
GENERAL PARTNERSHIP, CORPORATION, LIMITED LIABILITY COMPANY, JOINT VENTURE,
UNINCORPORATED ORGANIZATION OR ASSOCIATION, ANY TRUST, GOVERNMENTAL BODY,
AUTHORITY, BUREAU OR AGENCY, OR ANY OTHER ENTITY OR BODY.

 

1.35                           “PROCESS” OR “PROCESSING” SHALL MEAN THE ACT OF
PREPARATION, FILLING, TESTING, PACKAGING, LABELING AND ANY OTHER PHARMACEUTICAL
MANUFACTURING PROCEDURES, OR ANY PART THEREOF (INCLUDING, BUT NOT LIMITED TO,
PRODUCT OR PROCESS SPECIFICATIONS, TESTING OR TEST METHODS, RAW MATERIAL
SPECIFICATIONS OR SUPPLIERS, EQUIPMENT, ETC.), RELATING TO THE PRODUCT.

 

3

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1.36                           “PRODUCT” SHALL MEAN ANY LICENSED PRODUCT (AS
DEFINED IN THE LICENSE AGREEMENT).

 

1.37                           “PURCHASE ORDER” SHALL MEAN A WRITTEN PURCHASE
ORDER DELIVERED BY LICENSEE TO ACORDA FOR PRODUCTS PURSUANT TO THIS AGREEMENT.

 

1.38                           “QUALITY AGREEMENT” SHALL MEAN A QUALITY
AGREEMENT ENTERED INTO BY ACORDA AND LICENSEE, OR BY LICENSEE AND A THIRD PARTY
MANUFACTURER, AS DESCRIBED IN SECTION 3.3.

 

1.39                           “REGULATORY AUTHORITY” SHALL MEAN ANY APPLICABLE
GOVERNMENT REGULATORY AUTHORITY INVOLVED IN GRANTING APPROVALS FOR THE MARKETING
AND COMMERCIAL SALE OF A PHARMACEUTICAL OR BIOLOGICAL PRODUCT OR MEDICAL DEVICE
IN A COUNTRY OR REGULATORY JURISDICTION (INCLUDING PRICING AND/OR REIMBURSEMENT
APPROVAL IN ANY COUNTRY IN WHICH PRICING AND/OR REIMBURSEMENT APPROVAL IS
REQUIRED BY APPLICABLE LAWS), INCLUDING THE FDA, THE EMEA AND FOREIGN
EQUIVALENTS THEREOF.

 

1.40                           “SECOND SOURCE AGREEMENT” SHALL HAVE THE MEANING
SET FORTH IN SECTION 8.3(B).

 

1.41                           “SEMI-FIRM PERIOD” SHALL HAVE THE MEANING SET
FORTH IN SECTION 4.1(A).

 

1.42                           “SEVERED CLAUSE” SHALL HAVE THE MEANING SET FORTH
IN SECTION 12.8.

 

1.43                           “SPECIFICATIONS” SHALL MEAN (A) WITH RESPECT TO
THE BULK LICENSED PRODUCT, THE SPECIFICATIONS FOR THE BULK LICENSED PRODUCT, AS
DETERMINED PURSUANT TO THE ELAN SUPPLY AGREEMENT AND SECTION 6.3 OF THE ELAN
LICENSE AGREEMENT AND AS MAY BE AMENDED IN ACCORDANCE WITH SECTION 5.1 OF THIS
AGREEMENT, AND (B) WITH RESPECT TO THE PACKAGING AND LABELING FOR ORDERS OF THE
LICENSED PRODUCT FOR SALE IN A PARTICULAR COUNTRY IN THE TERRITORY, THE
SPECIFICATIONS THEREFOR MUTUALLY AGREED UPON BY THE PARTIES IN ACCORDANCE WITH
SECTION 5.1(B).

 

1.44                           “SUPPLY SHORTAGE” SHALL HAVE THE MEANING SET
FORTH IN SECTION 4.7.

 

1.45                           “TERM” SHALL HAVE THE MEANING SET FORTH IN
SECTION 10.1.

 

1.46                           “THIRD PARTY” SHALL MEAN ANY PERSON WHO IS NOT A
PARTY OR AN AFFILIATE UNDER THIS AGREEMENT.

 

1.47                           “TRANSFER PRICE” SHALL MEAN THE PRICE ACORDA’S
THIRD PARTY MANUFACTURER(S) INVOICES ACORDA FOR PRODUCT MANUFACTURED BY SUCH
THIRD PARTY MANUFACTURER(S) SUPPLIED TO LICENSEE PURSUANT TO THE
AGREEMENT(S) BETWEEN ACORDA AND SUCH MANUFACTURER(S).

 

1.48                           CONSTRUCTION.  IN CONSTRUING THIS AGREEMENT,
UNLESS EXPRESSLY SPECIFIED OTHERWISE;

 

(A)                                  REFERENCES TO SECTIONS AND EXHIBITS ARE TO
SECTIONS OF, AND EXHIBITS TO, THIS AGREEMENT;

 

(B)                                 EXCEPT WHERE THE CONTEXT OTHERWISE REQUIRES,
USE OF EITHER GENDER INCLUDES THE OTHER GENDER, AND USE OF THE SINGULAR INCLUDES
THE PLURAL AND VICE VERSA;

 

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(C)                                  HEADINGS AND TITLES ARE FOR CONVENIENCE
ONLY AND DO NOT AFFECT THE INTERPRETATION OF THIS AGREEMENT;

 

(D)                                 ANY LIST OR EXAMPLES FOLLOWING THE WORD
“INCLUDING” SHALL BE INTERPRETED WITHOUT LIMITATION TO THE GENERALITY OF THE
PRECEDING WORDS;

 

(E)                                  EXCEPT WHERE THE CONTEXT OTHERWISE
REQUIRES, THE WORD “OR” IS USED IN THE INCLUSIVE SENSE;

 

(F)                                    ALL REFERENCES TO “DOLLARS” OR “$” HEREIN
SHALL MEAN U.S. DOLLARS; AND

 

(G)                                 EACH PARTY REPRESENTS THAT IT HAS BEEN
REPRESENTED BY LEGAL COUNSEL IN CONNECTION WITH THIS AGREEMENT AND ACKNOWLEDGES
THAT IT HAS PARTICIPATED IN THE DRAFTING HEREOF.  IN INTERPRETING AND APPLYING
THE TERMS AND PROVISIONS OF THIS AGREEMENT, THE PARTIES AGREE THAT NO
PRESUMPTION WILL APPLY AGAINST THE PARTY WHICH DRAFTED SUCH TERMS AND
PROVISIONS.

 

2.                                       COORDINATION; SUPPLY CHAIN MANAGEMENT

 

2.1                                 RELATIONSHIP MANAGERS.  EACH PARTY SHALL
APPOINT A MANUFACTURING LOGISTICS AND QUALITY ASSURANCE MANAGER TO SUPPORT THE
PARTIES’ RESPECTIVE MANUFACTURING ACTIVITIES, AND TO FUNCTION AS A LIAISON WITH
THE OTHER PARTY’S MANUFACTURING LOGISTICS AND QUALITY ASSURANCE MANAGER ON
MATTERS RELATING TO THE MANUFACTURE AND SUPPLY OF THE PRODUCT PURSUANT TO THIS
AGREEMENT.

 

2.2                                 JOINT MANUFACTURING COMMITTEE.

 

(A)                                  THE PARTIES SHALL ESTABLISH A JOINT
MANUFACTURING COMMITTEE (“JMC”) TO OVERSEE THE SUPPLY OF PRODUCT TO LICENSEE IN
ACCORDANCE WITH THIS AGREEMENT.  THE JMC SHALL CONSIST OF THREE
(3) REPRESENTATIVES DESIGNATED BY EACH PARTY.  ONE (1) REPRESENTATIVE FROM EACH
PARTY SHALL ALTERNATE IN ACTING AS THE CHAIRPERSON OF THE JMC FOR ONE CALENDAR
YEAR TERM, WITH ACORDA’S REPRESENTATIVE CHAIRING THE JMC FOR THE FIRST CALENDAR
YEAR.  THE CHAIRPERSON SHALL NOT HAVE ANY GREATER AUTHORITY THAN ANY OTHER
REPRESENTATIVE ON THE JMC.  AS SOON AS PRACTICABLE FOLLOWING THE EFFECTIVE DATE
(BUT IN NO EVENT MORE THAN THIRTY (30) DAYS FOLLOWING THE EFFECTIVE DATE), EACH
PARTY SHALL DESIGNATE ITS INITIAL REPRESENTATIVES ON THE JMC.  EACH PARTY SHALL
BE FREE TO CHANGE ITS REPRESENTATIVES ON NOTICE TO THE OTHER OR TO SEND A
SUBSTITUTE REPRESENTATIVE TO ANY JMC MEETING; PROVIDED, HOWEVER, THAT EACH PARTY
SHALL ENSURE THAT AT ALL TIMES DURING THE EXISTENCE OF THE JMC, ITS
REPRESENTATIVES ON SUCH COMMITTEE ARE APPROPRIATE IN TERMS OF SENIORITY AND
EXPERTISE WITH RESPECT TO THE MANUFACTURING OF PHARMACEUTICAL PRODUCTS AND HAVE
THE AUTHORITY TO BIND SUCH PARTY WITH RESPECT TO MATTERS WITHIN THE PURVIEW OF
THE JMC.  EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, THE JMC SHALL HAVE NO
AUTHORITY TO BIND THE PARTIES HEREUNDER AND THE JMC SHALL REPORT TO THE JSC,
SUBJECT TO SECTION 2.4 OF THIS AGREEMENT.

 

(B)                                 THE JMC SHALL BE RESPONSIBLE FOR
(I) MANAGING THE SUPPLY CHAIN FOR PRODUCT IN THE TERRITORY; (II) MONITORING
LOGISTICAL STRATEGIES, CAPACITY PLANNING AND INVENTORY LEVELS FOR THE PRODUCT
FOR COMMERCIALIZATION IN THE FIELD IN THE TERRITORY; AND (III) PROVIDING A FORUM
FOR THE PARTIES TO DISCUSS ANY MATERIAL QUALITY-RELATED ISSUES CONCERNING THE
PRODUCT.

 

5

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(C)                                  THE APPOINTMENT OF MEMBERS OF THE JMC IS A
RIGHT OF EACH PARTY AND NOT AN OBLIGATION AND SHALL NOT BE A “DELIVERABLE” AS
REFERENCED IN ANY EXISTING AUTHORITATIVE ACCOUNTING LITERATURE.  EACH PARTY
SHALL BE FREE TO DETERMINE NOT TO APPOINT MEMBERS TO THE JMC.  IF A PARTY DOES
NOT APPOINT MEMBERS OF THE JMC, IT SHALL NOT BE A BREACH OF THIS AGREEMENT, NOR
SHALL ANY CONSIDERATION BE REQUIRED TO BE RETURNED, AND UNLESS AND UNTIL SUCH
PERSONS ARE APPOINTED, ALL DECISIONS AND OBLIGATIONS WITHIN THE PURVIEW OF THE
COMMITTEE SHALL HENCEFORTH BE HANDLED DIRECTLY BETWEEN THE PARTIES; PROVIDED,
THAT IN THE EVENT OF ANY DISPUTES BETWEEN THE PARTIES, THE DISPUTE RESOLUTION
PROCEDURES SET FORTH IN SECTION 2.4(A) SHALL CONTINUE TO APPLY (SUBSTITUTING IN
SUCH PROVISION REFERENCES TO “THE PARTIES” INSTEAD OF “THE JMC”).

 

2.3                                 MEETINGS.   THE JMC SHALL HOLD AT LEAST ONE
(1) MEETING PER CALENDAR QUARTER AT SUCH TIMES DURING SUCH CALENDAR QUARTER AS
THE CHAIRPERSON ELECTS TO DO SO.  MEETINGS OF THE JMC SHALL BE EFFECTIVE ONLY IF
AT LEAST ONE (1) REPRESENTATIVE OF EACH PARTY IS PRESENT OR PARTICIPATING.  THE
JMC MAY MEET EITHER (A) IN PERSON AT EITHER PARTY’S FACILITIES OR AT SUCH
LOCATIONS AS THE PARTIES MAY OTHERWISE AGREE OR (B) BY AUDIO OR VIDEO
TELECONFERENCE; PROVIDED, THAT NO LESS THAN ONE (1) MEETING OF THE JMC DURING
EACH CALENDAR YEAR SHALL BE CONDUCTED IN PERSON.  OTHER REPRESENTATIVES OF EACH
PARTY INVOLVED WITH THE PRODUCT MAY ATTEND MEETINGS AS NON-VOTING PARTICIPANTS,
SUBJECT TO THE CONFIDENTIALITY PROVISIONS SET FORTH IN THIS AGREEMENT. 
ADDITIONAL MEETINGS OF THE JMC MAY ALSO BE HELD WITH THE CONSENT OF EACH PARTY,
OR AS REQUIRED UNDER THIS AGREEMENT, AND NEITHER PARTY SHALL UNREASONABLY
WITHHOLD ITS CONSENT TO HOLD SUCH ADDITIONAL MEETINGS.  EACH PARTY SHALL BE
RESPONSIBLE FOR ALL OF ITS OWN EXPENSES INCURRED IN CONNECTION WITH
PARTICIPATING IN THE JMC MEETINGS.

 

2.4                                 DECISION MAKING; AUTHORITY.

 

(A)                                  APPROVAL BY THE JMC.  SUBJECT TO THE
PROVISIONS OF THIS SECTION 2.4, THE JMC SHALL APPROVE MATTERS BEFORE IT ONLY
FOLLOWING A UNANIMOUS VOTE, WITH EACH PARTY HAVING ONE (1) VOTE.  IF THE JMC
FAILS TO REACH UNANIMOUS AGREEMENT ON A MATTER BEFORE IT FOR DECISION FOR A
PERIOD IN EXCESS OF THIRTY (30) DAYS, THE MATTER SHALL BE REFERRED TO THE JSC AS
CONSTITUTED UNDER AND IN ACCORDANCE WITH THE LICENSE AGREEMENT AND ANY DISPUTE
THAT MAY ARISE FROM SUCH MATTER SHALL BE RESOLVED PURSUANT TO THE TERMS OF
SECTION 3.5 OF THE LICENSE AGREEMENT.  NOTWITHSTANDING ANYTHING TO THE CONTRARY
IN THIS AGREEMENT OR THE LICENSE AGREEMENT, NEITHER ANY PARTY, THE JSC NOR ANY
EXPERT PANEL SHALL EXERCISE ITS RIGHT TO FINALLY RESOLVE A DISPUTE PURSUANT TO
THE LICENSE AGREEMENT IN A MANNER THAT (I) EXCUSES SUCH PARTY FROM ANY OF ITS
OBLIGATIONS SPECIFICALLY ENUMERATED UNDER THIS AGREEMENT, (II) NEGATES ANY
CONSENT RIGHTS OR OTHER RIGHTS SPECIFICALLY ALLOCATED TO THE OTHER PARTY UNDER
THIS AGREEMENT, (III) WOULD CAUSE ACORDA TO BREACH AN ACORDA THIRD PARTY
AGREEMENT (INCLUDING ANY ACORDA SUPPLY AGREEMENT) OR TO REQUIRE ANY THIRD PARTY
TO TAKE ANY ACTIONS NOT REQUIRED TO BE PERFORMED BY SUCH THIRD PARTY UNDER ANY
ACORDA THIRD PARTY AGREEMENT, (IV) INCREASES THE DEVELOPMENT PLAN COSTS FOR THE
OTHER PARTY FOR A GIVEN CALENDAR YEAR BY MORE THAN [*****] ABOVE THE THEN
CURRENT DEVELOPMENT BUDGET FOR THE CALENDAR YEAR, OR (V) WOULD REQUIRE EITHER
PARTY (OR REQUIRE ACORDA TO REQUIRE A THIRD PARTY)  TO PERFORM ANY ACT THAT IT
(OR SUCH THIRD PARTY) REASONABLY BELIEVES TO BE INCONSISTENT WITH ANY LAW OR ANY
APPROVAL, ORDER, POLICY OR GUIDELINES OF A REGULATORY AUTHORITY; PROVIDED, THAT,
IF SUCH DECISION WOULD REQUIRE ACORDA, IN ORDER TO COMPLY WITH SUCH DECISIONS,
TO COMPEL THE THIRD PARTY COUNTERPARTY TO AN ACORDA THIRD PARTY AGREEMENT TO
PERFORM ANY ACT OR TO REFRAIN FROM PERFORMING ANY ACT, LICENSEE ACKNOWLEDGES AND
AGREES THAT

 

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

 

6

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ACORDA SHALL ONLY BE OBLIGATED TO USE COMMERCIALLY REASONABLE EFFORTS TO COMPEL
SUCH ACTIVITY OR TO REFRAIN FROM PERFORMING SUCH ACTIVITY.  THE JMC SHALL HAVE
ONLY THE POWERS ASSIGNED EXPRESSLY TO IT IN THIS AGREEMENT AND SHALL NOT HAVE
ANY POWER TO AMEND, MODIFY OR WAIVE COMPLIANCE WITH THIS AGREEMENT OR THE ACORDA
THIRD PARTY AGREEMENTS.

 

(B)                                 NO LIMITATION ON REMEDIES.  NOTHING IN THIS
SECTION 2.4 SHALL AFFECT THE RIGHT OF A PARTY TO EXERCISE ITS RIGHTS OR REMEDIES
FOR A BREACH OF THIS AGREEMENT BY THE OTHER PARTY.

 

2.5                                 THIRD PARTY MANUFACTURERS.  WHERE THIS
AGREEMENT PROVIDES THAT ACORDA SHALL USE COMMERCIALLY REASONABLE EFFORTS TO
OBTAIN THE CONSENT OF OR RESPONSE FROM ONE OF ITS THIRD PARTY MANUFACTURERS,
THEN, TO THE EXTENT THAT LICENSEE HAS BEEN ALLOWED TO INTERACT DIRECTLY WITH
SUCH THIRD PARTY MANUFACTURER WITH RESPECT TO SUCH MATTERS, LICENSEE SHALL ALSO
BE REQUIRED TO USE COMMERCIALLY REASONABLE EFFORTS TO OBTAIN SUCH RESULT.

 

3.                                       SUPPLY

 

3.1                                 EXCLUSIVE SUPPLY.  EXCEPT AS EXPRESSLY
PROVIDED IN THIS AGREEMENT, LICENSEE SHALL EXCLUSIVELY PURCHASE FROM ACORDA ALL
PRODUCT IN ORDER TO MEET LICENSEE’S AND ITS AFFILIATES’ AND THIRD PARTY
DISTRIBUTORS’ REQUIREMENTS OF THE PRODUCT.

 

3.2                                 GENERAL SCOPE OF SERVICES.  ACORDA SHALL USE
COMMERCIALLY REASONABLE EFFORTS TO MANUFACTURE, OR ARRANGE FOR A THIRD
PARTY(IES) TO MANUFACTURE, AND SUPPLY LICENSEE’S REQUIREMENTS OF PRODUCT FOR USE
IN THE FIELD IN THE TERRITORY PURSUANT TO THE LICENSE AGREEMENT IN FINAL,
PACKAGED, LABELED FORM; PROVIDED, HOWEVER, THAT THE FOREGOING SHALL BE SUBJECT
TO ACORDA’S AND ITS THIRD PARTY MANUFACTURER(S)’ CAPACITY AND ABILITY TO
MANUFACTURE SUCH QUANTITIES IN THEIR CURRENT MANUFACTURING FACILITIES, TAKING
INTO ACCOUNT ACORDA’S AND SUCH THIRD PARTY MANUFACTURER(S)’ RESPONSIBILITIES TO
MANUFACTURE THE PRODUCT FOR USE OUTSIDE THE TERRITORY OR OUTSIDE THE FIELD AND
TO MANUFACTURE OTHER PHARMACEUTICAL PRODUCTS.

 

3.3                                 QUALITY AGREEMENT.  PROMPTLY AFTER THE
EFFECTIVE DATE, THE PARTIES SHALL NEGOTIATE AND EXECUTE A “QUALITY AGREEMENT”
SPECIFYING THE TESTING, STORAGE, RELEASE, CGMP, REGULATORY AND OTHER QUALITY
ASSURANCE REQUIREMENTS RELATING TO MANUFACTURE AND SHIPMENT OF PRODUCT BY OR ON
BEHALF OF ACORDA UNDER THIS AGREEMENT. TO THE EXTENT THAT ACORDA OR AN ACORDA
THIRD PARTY MANUFACTURER SUPPLYING PRODUCT HEREUNDER REASONABLY REQUESTS,
LICENSEE SHALL ALSO ENTER INTO A “QUALITY AGREEMENT” WITH SUCH THIRD PARTY
MANUFACTURER REGARDING SUPPLY OF PRODUCT.

 

3.4                                 THIRD PARTY MANUFACTURERS.  LICENSEE
ACKNOWLEDGES AND AGREES THAT THE PROVISIONS SET FORTH IN THIS AGREEMENT ARE
SUBJECT TO THE REQUIREMENTS AND LIMITATIONS OF THE AGREEMENTS SET FORTH IN
EXHIBIT A, INCLUDING THE ELAN SUPPLY AGREEMENT (COLLECTIVELY, SUCH AGREEMENTS,
THE “ACORDA SUPPLY AGREEMENTS”).  EXHIBIT A MAY BE UPDATED BY ACORDA FROM TIME
TO TIME AFTER THE DATE HEREOF UPON ACORDA PROVIDING TO LICENSEE TRUE AND CORRECT
COPIES OF ANY ADDITIONAL AGREEMENTS TO BE LISTED ON SUCH EXHIBIT A; PROVIDED,
HOWEVER, THAT ACORDA SHALL, PRIOR TO EXECUTING OR OTHERWISE AGREEING TO BE BOUND
BY ANY SUCH ADDITIONAL AGREEMENT, (I) SUPPLY MATERIAL DRAFTS, INCLUDING THE
FINAL DRAFT, OF SUCH AGREEMENT TO LICENSEE FOR ITS REVIEW, (II) ALLOW LICENSEE
TO COMMENT ON SUCH DRAFT WITHIN A REASONABLE PERIOD OF TIME FOLLOWING LICENSEE’S

 

7

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RECEIPT; AND (III) REASONABLY CONSIDER, IN GOOD FAITH, LICENSEE’S COMMENTS TO
SUCH DRAFT (BUT LICENSEE SHALL NOT HAVE THE RIGHT TO APPROVE SUCH AGREEMENT).

 

4.                                       FORECASTS AND ORDERS

 

4.1                                 FORECAST.  COMMENCING [*****] PRIOR TO THE
ANTICIPATED DATE OF FIRST REGULATORY APPROVAL IN ANY MAJOR MARKET COUNTRY,
LICENSEE SHALL SUBMIT TO ACORDA ON OR BEFORE THE FIRST BUSINESS DAY OF EACH
MONTH A [*****] ROLLING FORECAST THAT SETS FORTH THE TOTAL QUANTITY OF PRODUCT
FOR SUPPLY THAT LICENSEE EITHER HAS ORDERED, DESIRES TO ORDER, OR EXPECTS TO
ORDER FROM ACORDA WITHIN THE NEXT [*****] PERIOD (THE “FORECAST”). IN THE
FORECAST, LICENSEE SHALL INCLUDE A BREAKDOWN OF THE TOTAL QUANTITY OF PRODUCT
FORECAST ON A MONTH-BY-MONTH AND COUNTRY-BY-COUNTRY BASIS.

 

(A)                                  FIRM PERIOD AND SEMI-FIRM PERIOD.  ONCE
REGULATORY APPROVAL FOR THE PRODUCT HAS BEEN RECEIVED IN A MAJOR MARKET COUNTRY
OR THE UNITED STATES, THE MONTHLY BREAKDOWN OF THE [*****] OF THE FORECAST SHALL
INCLUDE A FIRM, IRREVOCABLE ORDER FOR THE FIRST [*****] OF THE FORECAST (“FIRM
PERIOD”), WHICH SHALL BE THE SUBJECT OF A BINDING PURCHASE ORDER DELIVERED IN
ACCORDANCE WITH SECTION 4.5.  FOR PURPOSES OF CLARITY, IN THE EVENT THAT A
FORECAST DELIVERED TO ACORDA IN ACCORDANCE WITH THE TERMS OF THIS AGREEMENT
LISTS A TOTAL QUANTITY OF PRODUCT FOR SUPPLY FOR EACH OF THE FIRST [*****] OF
SUCH FORECAST AS ZERO (0), THE FIRM ORDER FOR SUCH [*****] PERIOD SHALL BE FOR A
QUANTITY OF ZERO (0).  THE NEXT [*****] OF THE FORECAST PERIOD SHALL BE A
SEMI-FIRM PERIOD THAT IS NON-BINDING (“SEMI-FIRM PERIOD”); PROVIDED, THAT,
SUBJECT TO SECTION 4.3(C), IF LICENSEE REQUESTS MORE THAN A [*****] INCREASE IN
THE ORDERED QUANTITIES OF PRODUCT FOR SUCH SEMI-FIRM PERIOD, ACORDA SHALL HAVE
THE RIGHT TO CHANGE THE LEAD TIME FOR DELIVERY OF THE PRODUCT IF SUCH A CHANGE
IS COMMERCIALLY REASONABLE GIVEN THE INCREASE IN ORDERED PRODUCT QUANTITY.  THE
REMAINDER OF THE FORECAST IS NON-BINDING.

 

4.2                                 LONG-TERM FORECAST.  NOT LATER THAN
JULY 1ST IN EACH CALENDAR YEAR, LICENSEE SHALL PROVIDE ACORDA A [*****] FORECAST
OF ITS ESTIMATED REQUIREMENTS OF THE PRODUCT, BROKEN DOWN ON AN ANNUAL BASIS. 
FOR THE AVOIDANCE OF DOUBT, EXCEPT WITH RESPECT TO ANY FIRM PERIOD INCLUDED IN
SUCH [*****] FORECAST AND SUBJECT TO SECTION 4.3(C), ANY LONG-TERM FORECAST
PROVIDED BY LICENSEE UNDER THIS SECTION 4.2 SHALL BE NON-BINDING.

 

4.3                                 AMENDING FORECASTS.  ANY PORTION OF THE
FORECAST THAT IS NOT A FIRM PERIOD IS TO BE CONSIDERED AN ESTIMATED FORECAST TO
BE USED FOR PLANNING PURPOSES, AND SHALL NOT BE CONSTRUED AS A FIRM COMMITMENT
BY LICENSEE TO ACORDA; RATHER, IT CAN BE INCREASED OR REDUCED BY LICENSEE FROM
TIME TO TIME; PROVIDED, HOWEVER, THAT (A) LICENSEE MAY NOT DECREASE THE
QUANTITIES SPECIFIED IN ANY FORECAST WITH RESPECT TO ANY FIRM PERIOD; (B) IF
LICENSEE INCREASES THE QUANTITIES SPECIFIED IN ANY FORECAST WITH RESPECT TO ANY
FIRM PERIOD, ACORDA SHALL USE COMMERCIALLY REASONABLE EFFORTS (HAVING REGARD TO
ITS AND ITS THIRD PARTY MANUFACTURERS’ MANUFACTURING CAPACITY AND ABILITY), BUT
SHALL NOT BE OBLIGATED, TO SUPPLY SUCH ADDITIONAL PRODUCT; AND (C) LICENSEE MAY
NOT INCREASE OR DECREASE BY MORE THAN [*****] IN THE AGGREGATE THE AMOUNT OF
PRODUCT REQUIRED IN A CALENDAR QUARTER COMPARED TO THE PREVIOUS CALENDAR
QUARTER, EXCEPT FOR LAUNCH STOCKS OR UNLESS OTHERWISE AGREED BY ACORDA.

 

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

 

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

 

8

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SPECIFIC QUANTITIES OF LAUNCH STOCKS FOR LAUNCH OF THE PRODUCT IN THE APPLICABLE
MAJOR MARKET COUNTRY.  LAUNCH STOCKS SHALL BE ORDERED NOT LATER THAN [*****]
FROM RECEIPT BY LICENSEE OF AN APPROVAL LETTER FROM A REGULATORY AUTHORITY IN
RESPECT OF AN NDA IN A MAJOR MARKET COUNTRY.

 

4.5                                 PURCHASE ORDERS.

 

(A)                                  GENERAL.  LICENSEE SHALL ACCOMPANY ITS
MONTHLY UPDATE OF THE FORECAST WITH A PURCHASE ORDER FOR EACH FIRM PERIOD FOR
WHICH PRODUCT HAS NOT BEEN PREVIOUSLY ORDERED OR FOR WHICH ADDITIONAL PRODUCT IS
REQUIRED; PROVIDED, THAT IN THE EVENT THE FORECAST CONTAINS A BINDING FORECAST
FOR LAUNCH STOCKS PURSUANT TO SECTION 4.4, THE PURCHASE ORDER SHALL ALSO CONTAIN
AN ORDER FOR THE LAUNCH STOCKS.  EACH PURCHASE ORDER SHALL SPECIFY THE PRODUCT
ORDERED, THE QUANTITY OF PRODUCT ORDERED AND THE TIME, MANNER AND ADDRESS OF
DELIVERY, ALL OF WHICH SHALL BE SUBJECT TO THIS ARTICLE 4 AND SECTION 6.1.  IN
ORDER FOR THE PRODUCT TO BE PROPERLY LABELED AND PACKAGED, EACH SUCH PURCHASE
ORDER SHALL SPECIFY THE COUNTRIES IN WHICH THE PRODUCT FROM SUCH ORDER SHALL BE
MARKETED OR SOLD, THE QUANTITY OF PRODUCT FROM SUCH PURCHASE ORDER DESTINED FOR
EACH SUCH COUNTRY AND THE QUANTITY OF PRODUCT FOR PROMOTIONAL AND SAMPLE USE. 
EACH PURCHASE ORDER SHALL ALSO SPECIFY THE REQUESTED DATE OF DELIVERY AND THE
DELIVERY DESTINATION.

 

(B)                                 TERMS.  PURCHASE ORDERS ISSUED BY LICENSEE
OR ITS AFFILIATES SHALL BE EFFECTIVE SOLELY WITH RESPECT TO SPECIFYING THE
QUANTITY, REQUESTED DELIVERY DATE (SUBJECT TO THE TERMS OF THIS AGREEMENT) AND
MEANS OF SHIPMENT OF THE PRODUCT BEING ORDERED.  ALL OTHER TERMS AND CONDITIONS
PRINTED OR INCLUDED ON SUCH PURCHASE ORDERS SHALL BE OF NO EFFECT OR FORCE.

 

(C)                                  REJECTION OF PURCHASE ORDERS.  WITHIN
[*****] OF RECEIPT, ACORDA SHALL HAVE THE RIGHT TO REJECT ANY PURCHASE ORDER
ISSUED BY LICENSEE THAT ACORDA REASONABLY BELIEVES TO BE MATERIALLY INCONSISTENT
WITH THE TERMS OF THIS AGREEMENT.  SUBJECT TO ACORDA’S OBLIGATION SET FORTH IN
SECTION 4.3 TO USE COMMERCIALLY REASONABLE EFFORTS TO ADDRESS FLUCTUATIONS IN
LICENSEE’S PRODUCT DEMAND, IF ACORDA REASONABLY BELIEVES THAT A PURCHASE ORDER
IS MATERIALLY INCONSISTENT WITH THE FORECASTED QUANTITIES OF THE FIRM PERIOD
AND/OR THE LAUNCH STOCKS, IT SHALL HAVE THE RIGHT TO REJECT SUCH PURCHASE ORDER;
PROVIDED, THAT ACORDA SHALL REJECT NO PURCHASE ORDER SOLELY ON THE BASIS OF
QUANTITY SO LONG AS THE QUANTITY SPECIFIED IN SUCH PURCHASE ORDER IS WITHIN THE
AMOUNT REQUIRED TO BE ORDERED HEREUNDER.

 

4.6                                 FULFILLMENT OF PURCHASE ORDERS.  EXCEPT AS
OTHERWISE PROVIDED IN THIS AGREEMENT, ACORDA SHALL USE COMMERCIALLY REASONABLE
EFFORTS TO PRODUCE AND SUPPLY TO LICENSEE ITS REQUIREMENTS OF THE PRODUCT AS SET
FORTH IN AND IN RESPONSE TO PURCHASE ORDERS, WITHIN [*****] OF THE PURCHASE
ORDER (OR SUCH LATER DELIVERY DATE AS SET FORTH IN THE PURCHASE ORDER), OR
[*****] FOR LAUNCH STOCKS OR SAMPLES (OR SUCH LATER DELIVERY DATE AS SET FORTH
IN THE PURCHASE ORDER AND SUBJECT TO ANY REQUIRED EXTENSION DUE TO THE LEAD
TIMES OF SPECIFIC COMPONENTS OF SAMPLES).  NOTWITHSTANDING THE FOREGOING, ACORDA
SHALL HAVE NO OBLIGATION TO SUPPLY PRODUCT, UNLESS OTHERWISE MUTUALLY AGREED
UPON BY THE PARTIES:

 

(A)                                  FOR ANY FIRM PERIOD, IN EXCESS OF
LICENSEE’S FORECAST FOR SUCH FIRM PERIOD (BUT ACORDA WILL NEVERTHELESS USE ITS
COMMERCIALLY REASONABLE EFFORTS TO FULFILL LICENSEE’S REQUIREMENTS IN EXCESS OF
SUCH AMOUNTS, HAVING REGARD TO ITS AND ITS THIRD PARTY MANUFACTURERS’
MANUFACTURING CAPACITY AND ABILITY);

 

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

 

9

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(B)                                 FOR LESS THAN A MINIMUM ORDER OF [*****], OR
SUCH OTHER MINIMUM AMOUNT AS MAY BE REQUIRED BY ACORDA’S THIRD PARTY
MANUFACTURERS.

 

(C)                                  IN PARTIAL BATCHES;

 

(D)                                 WHERE PRODUCT IS SUPPLIED BY ELAN AND WHERE
[*****] OF THE MANUFACTURING COST (AS DEFINED IN THE ELAN SUPPLY AGREEMENT)
WOULD EXCEED THE TRANSFER PRICE; PROVIDED, THAT IN SUCH CASE, ACORDA SHALL USE
COMMERCIALLY REASONABLE EFFORTS TO SUPPLY PRODUCT USING A SECOND SOURCE (AS
DEFINED IN THE ELAN SUPPLY AGREEMENT); OR

 

(E)                                  PURSUANT TO A PURCHASE ORDER WHICH DOES NOT
CONFORM IN ALL MATERIAL RESPECTS TO THE TERMS OF THIS AGREEMENT; PROVIDED, THAT,
IF ACORDA DOES SUPPLY PRODUCT PURSUANT TO SUCH A PURCHASE ORDER IN ITS ABSOLUTE
DISCRETION, THAT FULFILLMENT SHALL NOT AFFECT ACORDA’S RIGHT TO REFUSE TO
FULFILL ANY SUBSEQUENT PURCHASE ORDER WHICH DOES NOT COMPLY IN ALL MATERIAL
RESPECTS WITH THIS AGREEMENT.

 

4.7                                 SUPPLY UNCERTAINTY.  ACORDA SHALL, WITHIN
[*****] AFTER RECEIPT OF LICENSEE’ FORECAST, NOTIFY LICENSEE IF IT BECOMES AWARE
OR BELIEVES THAT, BASED ON THE FORECASTS SUBMITTED BY LICENSEE, ANY SHORTAGE OF
SUPPLY OF PRODUCT TO LICENSEE WILL OCCUR (SUCH SHORTAGE, A “SUPPLY SHORTAGE”). 
THE PARTIES, THROUGH THE JMC, SHALL DISCUSS THE REASONS FOR THE ANTICIPATED
SUPPLY SHORTAGE.  UNLESS OTHERWISE MUTUALLY AGREED UPON BY THE PARTIES, IN THE
EVENT ACORDA HAS A SUPPLY SHORTAGE, AVAILABLE PRODUCT SUPPLY SHALL BE ALLOCATED
BETWEEN THE PARTIES ON A PRO-RATA BASIS, EACH PARTY TO RECEIVE A PERCENTAGE OF
PRODUCT SUPPLY EQUAL TO THE PERCENTAGE OF DOSAGE UNITS OF PRODUCT PURCHASED BY
SUCH PARTY AND ITS AFFILIATES DURING THE PREVIOUS [*****] PERIOD AS COMPARED TO
THE AGGREGATE DOSAGE UNITS OF PRODUCT PURCHASED BY BOTH PARTIES AND THEIR
RESPECTIVE AFFILIATES DURING SUCH PERIOD; PROVIDED, THAT, IN THE EVENT THE
SUPPLY SHORTAGE OCCURS WITHIN THE FIRST FIRM PERIOD OR THE [*****] PERIOD
FOLLOWING THE FIRST FIRM PERIOD, AVAILABLE PRODUCT SUPPLY SHALL BE ALLOCATED
BETWEEN THE PARTIES ON A PRO-RATA BASIS BASED ON THE GOOD FAITH FORECASTS
SUBMITTED BY EACH PARTY FOR SUCH TIME PERIOD.  NOTHING IN THIS SECTION 4.7 SHALL
LIMIT, MODIFY OR REPLACE LICENSEE’S REMEDIES UNDER THIS AGREEMENT IN THE EVENT
OF A SUPPLY SHORTAGE.

 

4.8                                 SAFETY STOCK.  LICENSEE SHALL: (A) PRIOR TO
THE REGULATORY APPROVAL OF PRODUCT IN THE FIELD IN ANY COUNTRY IN THE TERRITORY
AND UNTIL [*****] AFTER SUCH REGULATORY APPROVAL, MAINTAIN, AT ITS OWN RISK AND
EXPENSE, LAUNCH STOCK OF [*****] SUPPLY OF PRODUCT, MEASURED, AS OF ANY DATE,
BASED ON LICENSEE’S FORECAST; AND (B) BEGINNING [*****] AFTER REGULATORY
APPROVAL OF PRODUCT IN THE FIELD IN ANY COUNTRY IN THE TERRITORY HAS BEEN
OBTAINED, MAINTAIN, AT ITS OWN RISK AND EXPENSE, SAFETY STOCK OF [*****] SUPPLY
OF PRODUCT, MEASURED, AS OF ANY DATE, BY THE PURCHASE ORDERS DELIVERED TO ACORDA
BY LICENSEE DURING THE IMMEDIATELY PRECEDING [*****].

 

5.                                       PRODUCTION

 

5.1                                 Specifications.

 

(A)                                  THE SPECIFICATIONS FOR THE BULK LICENSED
PRODUCT MAY, SUBJECT TO THE ACORDA SUPPLY AGREEMENTS AND SECTION 6.3 OF THE ELAN
LICENSE AGREEMENT, BE AMENDED BY THE JMC OR AS OTHERWISE MUTUALLY AGREED BY THE
PARTIES.

 

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

 

10

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(B)                                 LICENSEE SHALL PROPOSE THE NECESSARY
SPECIFICATIONS FOR PACKAGING AND LABELING OF THE PRODUCT FOR EACH COUNTRY IN THE
TERRITORY.  ACORDA, IN CONSULTATION WITH ITS THIRD PARTY MANUFACTURERS, SHALL
REVIEW AND APPROVE ALL SUCH SPECIFICATIONS FOR PACKAGING AND LABELING, SUCH
APPROVAL NOT TO BE UNREASONABLY WITHHELD; PROVIDED, THAT, (I) SUCH
SPECIFICATIONS SHALL REQUIRE ELAN’S APPROVAL, WHICH ACORDA SHALL USE
COMMERCIALLY REASONABLE EFFORTS TO OBTAIN, AND (II) ACORDA SHALL NOT BE REQUIRED
TO APPROVE ANY SPECIFICATIONS IF (A) SUCH APPROVAL WOULD BE A VIOLATION UNDER
ANY ACORDA THIRD PARTY AGREEMENTS OR (B) ACORDA REASONABLY BELIEVES THAT SUCH
SPECIFICATIONS WOULD ADVERSELY AFFECT THE COMMERCIALIZATION OR THE
SPECIFICATIONS OF THE LICENSED PRODUCT IN THE ACORDA TERRITORY.  LICENSEE SHALL
BEAR [*****] COSTS AND EXPENSES TO OBTAIN APPROVAL OF ANY REGULATORY AUTHORITY
IN THE TERRITORY WITH RESPECT TO SUCH PACKAGING AND LABELING.

 

5.2                                 Changes to the Specifications, Processing or
the Facility.

 

(A)                                  CHANGES.  ACORDA OR ITS THIRD PARTY
MANUFACTURERS MAY MAKE SUCH CHANGES TO THE SPECIFICATIONS, PROCESSING OR THE
FACILITY AS ARE REQUIRED PURSUANT TO APPLICABLE LAW OR TO COMPLY WITH REGULATORY
APPROVALS; PROVIDED, THAT ACORDA SHALL HAVE PROMPTLY NOTIFIED LICENSEE UPON
ACORDA BECOMING AWARE OF SUCH REQUIRED CHANGE, AND PROVIDED, FURTHER, THAT
LICENSEE SHALL HAVE THE REASONABLE OPPORTUNITY TO DISPUTE THE NECESSITY OF SUCH
CHANGE PRIOR TO SUCH CHANGE’S ADOPTION BY ACORDA OR ITS THIRD PARTY
MANUFACTURERS.

 

(I)                                     CHANGES SPECIFIC TO PRODUCT IN
TERRITORY.  SUBJECT TO SECTION 5.2(A), TO THE EXTENT THAT CHANGES TO THE
SPECIFICATIONS, PROCESSING AND/OR FACILITY ARE REQUIRED PURSUANT TO LAW OR
REGULATORY APPROVALS APPLICABLE SOLELY TO THE PRODUCT IN THE TERRITORY, COSTS
INCURRED FOR SUCH CHANGES WITH RESPECT TO THE PRODUCT IN THE TERRITORY SHALL BE
PAID [*****] BY LICENSEE.

 

(II)                                  CHANGES SPECIFIC TO PRODUCT IN ACORDA’S
TERRITORY.  TO THE EXTENT THAT CHANGES TO THE SPECIFICATIONS, PROCESSING AND/OR
FACILITY ARE REQUIRED PURSUANT TO LAW OR REGULATORY APPROVALS APPLICABLE SOLELY
TO THE PRODUCT IN THE ACORDA TERRITORY, COSTS INCURRED FOR SUCH CHANGES WITH
RESPECT TO THE PRODUCT IN THE ACORDA TERRITORY SHALL BE PAID [*****] BY ACORDA;
AND, FOR CLARITY, NOTHING IN THIS AGREEMENT SHALL PRECLUDE ACORDA FROM MAKING
ANY SUCH CHANGES.

 

(III)                               NON-SPECIFIC OR JOINT CHANGES.  SUBJECT TO
SECTION 5.2(A), TO THE EXTENT THAT (A) CHANGES TO THE SPECIFICATIONS, PROCESSING
AND/OR FACILITY ARE REQUIRED PURSUANT TO LAW OR REGULATORY APPROVALS APPLICABLE
TO THE PRODUCT WORLDWIDE; (B) LICENSEE REQUESTS THAT A CHANGE MADE PURSUANT TO
SECTION 5.2(A)(II) BE ALSO MADE FOR THE PRODUCT IN THE TERRITORY; OR (C) ACORDA
REQUESTS THAT A CHANGE MADE PURSUANT TO SECTION 5.2(A)(I) BE ALSO MADE FOR THE
PRODUCT IN THE ACORDA TERRITORY, EACH PARTY SHALL PAY [*****] OF THE COSTS
INCURRED FOR SUCH CHANGES, BASED UPON THE MUTUALLY AGREED UPON ANTICIPATED SALES
OF PRODUCT, AS BETWEEN ACORDA AND LICENSEE, OVER THE NEXT [*****] PERIOD.

 

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

 

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

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

 

11

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COUNTRY, THE NOTIFIED PARTY SHALL PROMPTLY NOTIFY THE OTHER PARTY OF SUCH CHANGE
IN LAWS OR REGULATORY APPROVALS AND, IF SUCH CHANGE WILL AFFECT THE PRODUCT IN
THE TERRITORY, THE PARTIES SHALL NEGOTIATE IN GOOD FAITH A WRITTEN AGREEMENT
REGARDING THE EXTENT AND TIMING OF SUCH CHANGE.

 

(C)                                  CHANGES REQUESTED BY LICENSEE. 
NOTWITHSTANDING SECTION 5.1(A), IF LICENSEE, ON BEHALF OF ITSELF OR ANY OF ITS
AFFILIATES, REQUESTS ANY CHANGE TO SPECIFICATIONS WHICH IS NOT REQUIRED BY A
CHANGE IN LAWS OR REGULATORY APPROVALS IN ANY SUCH COUNTRY, ACORDA MAY, IN ITS
DISCRETION, CONSIDER SUCH REQUEST.  ACORDA SHALL CONSIDER SUCH REQUEST IN
ACCORDANCE WITH THE LICENSE AGREEMENT AS A PROPOSED AMENDMENT TO THE DEVELOPMENT
PLAN OR AS A DEVELOPMENT COLLABORATION PROPOSAL.  ALL COSTS WITH RESPECT THERETO
SHALL BE BORNE AS “DEVELOPMENT COSTS” IN ACCORDANCE WITH THE LICENSE AGREEMENT. 
LICENSEE SHALL REASONABLY COOPERATE WITH ACORDA AND ITS THIRD PARTY
MANUFACTURERS IN OBTAINING ANY APPROVALS NECESSARY FOR SUCH REQUESTED CHANGES.

 

(D)                                 CHANGES TO THE PROCESS OR FACILITY. 
LICENSEE ACKNOWLEDGES THAT ELAN HAS THE RIGHT TO CHANGE THE PROCESS OR FACILITY
PURSUANT TO SECTION 3.6 OF THE ELAN SUPPLY AGREEMENT.

 

5.3                                 Quality Assurance.

 

(A)                                  ACORDA SHALL USE COMMERCIALLY REASONABLE
EFFORTS TO OBTAIN FROM ITS THIRD PARTY MANUFACTURER(S) SUPPLYING PRODUCT FOR
LICENSEE REPRESENTATIONS AND WARRANTIES FOR THE BENEFIT OF LICENSEE THAT, AS OF
THE DATE OF PHYSICAL TRANSFER OF EACH ORDER OF PRODUCT TO LICENSEE, SUCH PRODUCT
(I) WAS MANUFACTURED IN ACCORDANCE WITH CGMP AND ALL APPLICABLE LAWS IN ALL
MATERIAL RESPECTS; (II) CONFORMS IN ALL MATERIAL RESPECTS TO THE APPLICABLE
SPECIFICATIONS; AND (III) DOES NOT CONTAIN ANY MATERIAL THAT WOULD CAUSE THE
PRODUCT TO BE ADULTERATED OR MISBRANDED UNDER APPLICABLE LAW.

 

(B)                                 DOCUMENTATION.  ACORDA OR ITS THIRD PARTY
MANUFACTURER SHALL DELIVER WITH EACH SHIPMENT OF PRODUCT (I) A CERTIFICATE OF
ANALYSIS FOR THE PRODUCT AND (II) THE BATCH RECORDS FOR SUCH PRODUCT (CLAUSES
(I) AND (II) OF THIS SENTENCE, COLLECTIVELY, THE “DOCUMENTATION”).

 

(C)                                  NON-CONFORMING PRODUCT.  SUBJECT TO ELAN’S
RIGHTS UNDER CLAUSE 6 OF THE ELAN SUPPLY AGREEMENT AND THE RIGHTS OF THE SECOND
SOURCE (AS DEFINED IN THE ELAN SUPPLY AGREEMENT) UNDER ANY ACORDA SUPPLY
AGREEMENT, INCLUDING THE MECHANISMS AND TIME FRAMES FOR THE RESOLUTION OF ANY
DISPUTES:

 

(I)                                     WITHIN (A) [*****] AFTER DELIVERY OF AN
ORDER OF PRODUCT TO LICENSEE OR (B) [*****] OF LICENSEE’S DISCOVERY OF AN ISSUE
WITH PRODUCT FOLLOWING LICENSEE’S ACCEPTANCE OF PRODUCT WHICH ISSUE CANNOT BE
ASCERTAINED BY REVIEWING THE DOCUMENTATION OR THE EXERCISE OF REASONABLE
DILIGENCE (INCLUDING THE PERFORMANCE OF THE ROUTINE TESTING PROTOCOL TO BE
AGREED IN THE QUALITY AGREEMENT) BY LICENSEE UPON RECEIPT OF SUCH PRODUCT (SUCH
ISSUE, A “LATENT DEFECT”), LICENSEE SHALL NOTIFY ACORDA IN WRITING IF SUCH
PRODUCT DOES NOT COMPLY WITH THE SPECIFICATIONS AT THE TIME OF DELIVERY TO
LICENSEE AND SHALL PROVIDE ACORDA WITH REASONABLE DETAILS OF THE ALLEGED
NON-CONFORMANCE AND SUPPORTING EVIDENCE AND UPON ACORDA’S REQUEST PERMIT ACORDA
TO RE-TEST THE PRODUCT.  LICENSEE SHALL ONLY MAKE SUCH CLAIMS IN GOOD FAITH.  
IF LICENSEE DOES NOT MAKE A CLAIM WITHIN SUCH [*****] PERIOD, LICENSEE SHALL BE
DEEMED TO HAVE ACCEPTED THE PRODUCT.

 

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

 

12

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(II)                                  IF ACORDA DOES NOT AGREE WITH THE
SUBSTANTIATING EVIDENCE PROVIDED BY LICENSEE, ACORDA SHALL PROVIDE LICENSEE WITH
A WRITTEN NOTICE OF SUCH DISAGREEMENT WITHIN TWENTY-FIVE (25) DAYS OF RECEIPT OF
LICENSEE’S NOTICE OF NON-CONFORMANCE, RESPONDING TO LICENSEE’S CLAIM.  THE
PARTIES SHALL USE COMMERCIALLY REASONABLE EFFORTS TO RESOLVE SUCH DISAGREEMENT
WITHIN TEN (10) DAYS OF LICENSEE’S RECEIPT OF NOTICE FROM ACORDA OF SUCH
DISAGREEMENT.  IN THE EVENT OF AN UNRESOLVED DISPUTE AS TO (A) CONFORMITY OF THE
PRODUCT WITH SPECIFICATIONS; OR (B) WHETHER DEFECTS IN THE PRODUCT ARE
ATTRIBUTABLE TO THE NEGLIGENT ACTS OR OMISSIONS OF ACORDA OR ITS THIRD PARTY
MANUFACTURERS OF PRODUCT, THE PARTIES SHALL, WITHIN THIRTY (30) DAYS AFTER
EXPIRATION OF SUCH TEN (10) DAY PERIOD, APPOINT A MUTUALLY ACCEPTABLE
INDEPENDENT LABORATORY TO UNDERTAKE THE RELEVANT TESTING AND ITS FINDINGS SHALL
BE CONCLUSIVE AND BINDING UPON THE PARTIES.  ALL COSTS RELATING TO THIS PROCESS
SHALL BE BORNE SOLELY BY THE PARTY WHOSE TESTING WAS IN ERROR.

 

(III)                               IF THE PARTIES AGREE OR THE INDEPENDENT
LABORATORY’S ANALYSIS CONFIRMS THAT LICENSEE’S COMPLAINT WAS VALID, ACORDA SHALL
USE COMMERCIALLY REASONABLE EFFORTS TO SUPPLY TO LICENSEE, AS PROMPTLY AS
REASONABLY PRACTICABLE, THE REMAINING QUANTITY OF THE PRODUCT CONFORMING TO THE
RELEVANT SPECIFICATIONS.  IF LICENSEE HAS ALREADY PAID FOR THE CONFORMING
QUANTITY OF PRODUCT ACORDA INITIALLY FAILED TO SUPPLY, THEN SUCH ADDITIONAL OR
REPLACEMENT QUANTITY SHALL BE PROVIDED BY ACORDA AT NO ADDITIONAL COST TO
LICENSEE; OTHERWISE, ACORDA SHALL INVOICE LICENSEE FOR SUCH CONFORMING PRODUCT
IN ACCORDANCE WITH SECTION 6.2.

 

(IV)                              ANY NONCONFORMING PRODUCT SHALL EITHER BE
DESTROYED BY LICENSEE OR RETURNED TO ACORDA FOR DESTRUCTION BY ACORDA, ACCORDING
TO ACORDA’S INSTRUCTIONS.  IN THE EVENT THAT THE NONCONFORMITY WAS SOLELY DUE TO
A FAULT OF LICENSEE, THEN LICENSEE SHALL BEAR ALL COSTS OF SUCH DESTRUCTION OR
RETURN AND LICENSEE SHALL NOT BE ENTITLED TO ANY CREDIT AS TO THE NON-CONFORMING
PRODUCT; IN THE EVENT THAT THE NONCONFORMITY WAS SOLELY DUE TO A FAULT OF
ACORDA, THEN ACORDA SHALL BEAR ALL COSTS OF SUCH DESTRUCTION OR RETURN; AND
OTHERWISE, THE PARTIES SHALL EQUALLY SHARE SUCH COSTS.

 

(V)                                 THE PRODUCT SHELF-LIFE SHALL BE AS SET FORTH
IN THE TECHNICAL AGREEMENT (AS DEFINED IN THE ELAN SUPPLY AGREEMENT).

 

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

 

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

 

6.                                       DELIVERY AND PAYMENT

 

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

 

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

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

 

13

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

 

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

 

6.3                                 Elan Compensating Payment and Acorda Costs.

 

(A)                                  LICENSEE SHALL PAY ACORDA THE PERCENTAGE OF
THE ELAN COMPENSATING PAYMENT THAT IS EQUAL TO THE PERCENTAGE OF PRODUCT
SUPPLIED TO LICENSEE THAT WAS MANUFACTURED BY THE SECOND SOURCE (AS DEFINED IN
THE ELAN SUPPLY AGREEMENT).  IF SUCH ELAN COMPENSATING PAYMENT IS PAYABLE BY
LICENSEE, THE CALCULATION OF SUCH AMOUNT SHALL BE INCLUDED ON AN INVOICE FROM
ACORDA FOR SUCH PAYMENT.

 

(B)                                 ALL COSTS AND EXPENSES, INCLUDING INTERNAL
COSTS, INCURRED BY ACORDA OR ITS AFFILIATES IN CONNECTION WITH THE SUPPLY OF
PRODUCT TO LICENSEE, ITS AFFILIATES AND THIRD PARTY DISTRIBUTORS HEREUNDER SHALL
BE REIMBURSED BY LICENSEE.

 

(C)                                  FOR THE SAKE OF CLARITY, LICENSEE SHALL PAY
TO ACORDA, IF APPLICABLE, ANY REMAINING AMOUNT WHICH IS PAYABLE TO ELAN PURSUANT
TO SECTION 9.3.3 OF THE ELAN SUPPLY AGREEMENT, REFLECTING THE DIFFERENCE BETWEEN
THE AMOUNT DUE PURSUANT TO THE ACTUAL NSP (AS DEFINED IN THE ELAN LICENSE
AGREEMENT) AND THE INITIAL PORTION OF THE TRANSFER PRICE INVOICED UPON SUPPLY OF
THE LICENSED PRODUCT (BASED ON THE THEN-APPLICABLE NOTIONAL NSP, AS DEFINED IN
THE ELAN LICENSE AGREEMENT).  LICENSEE SHALL PAY ACORDA SUCH AMOUNT WITHIN
THIRTY (30) DAYS AFTER THE END OF THE RELEVANT CALENDAR QUARTER, OR, IF EARLIER,
AT LEAST FIVE (5) BUSINESS DAYS BEFORE SUCH TIME AS SUCH PAYMENT IS OWED TO
ELAN. TO THE EXTENT THAT SUCH DIFFERENCE IS NEGATIVE, REFLECTING AN INITIAL
OVERPAYMENT BY LICENSEE, ACORDA SHALL CREDIT SUCH DIFFERENCE AGAINST THE PRICE
OF LICENSED PRODUCT TO BE SUPPLIED TO LICENSEE TO THE EXTENT OF ANY CREDIT
PROVIDED BY ELAN.

 

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

 

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

 

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

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

 

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

 

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

 

7.                                       REGULATORY

 

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

 

7.2                                 GOVERNMENTAL INSPECTION.  EACH PARTY SHALL
ADVISE THE OTHER OF ANY GOVERNMENTAL COMMUNICATION, INSPECTION OR REPORT WHICH
ADDRESSES OR AFFECTS THE PRODUCT PROMPTLY AFTER BECOMING AWARE OF IT AND THE JMC
SHALL TAKE ACTION AT ITS NEXT MEETING (OR, IF APPLICABLE, THE PARTIES AS SOON AS
PRACTICABLE SHALL MEET) TO DETERMINE THE PARTIES’ RESPONSE TO SUCH GOVERNMENTAL
COMMUNICATION, INSPECTION OR REPORT.

 

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

 

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

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

 

15

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

 

7.4                                 RECORDS.

 

(A)                                  FINANCIAL RECORDS.  ACORDA SHALL MAINTAIN
RECORDS WITH RESPECT TO ITS COSTS UNDER THIS AGREEMENT.  SPECIFICALLY, ACORDA
SHALL MAINTAIN ALL OF ITS RECORDS REASONABLY NECESSARY TO SUPPORT CHARGES TO
LICENSEE PURSUANT TO SECTION 6.  TO THE EXTENT LICENSEE REASONABLY BELIEVES THAT
THERE HAS BEEN AN OVERCHARGE FOR ANY AMOUNTS DUE HEREUNDER, [*****] ALL SUCH
RECORDS SHALL BE AVAILABLE FOR INSPECTION, AUDIT AND COPYING BY LICENSEE’S
INDEPENDENT THIRD PARTY AUDITORS, UPON REASONABLE REQUEST DURING NORMAL BUSINESS
HOURS.  THE RESULTS OF SUCH AUDIT SHALL BE MADE AVAILABLE TO ACORDA AND SHALL BE
CONSIDERED ACORDA’S CONFIDENTIAL INFORMATION.  LICENSEE SHALL BEAR THE COSTS OF
SUCH AUDIT, EXCEPT AS PROVIDED BELOW.  IF AN AUDIT UNDER THIS
SECTION 7.4(A) SHOWS ANY OVERPAYMENT BY LICENSEE, ACORDA SHALL REMIT TO LICENSEE
WITHIN THIRTY (30) DAYS AFTER THE RESULTS OF THE AUDIT ARE DELIVERED, THE AMOUNT
OF SUCH OVERPAYMENT AND, IF SUCH OVERPAYMENT EXCEEDS FIVE PERCENT (5%) OF THE
TOTAL AMOUNT OWED FOR THE PERIOD THEN BEING AUDITED, THE FEES AND EXPENSES OF
LICENSEE’S AUDITORS FOR SUCH AUDIT.  ALL SUCH RECORDS SHALL BE MAINTAINED FOR AT
LEAST [*****] AFTER THE END OF THE CALENDAR YEAR TO WHICH SUCH RECORDS RELATE,
OR SUCH LONGER PERIOD AS MAY BE REQUIRED BY APPLICABLE LAW.

 

(B)                                 PRODUCT RECORDS.  ACORDA SHALL MAINTAIN ALL
RECORDS NECESSARY FOR IT TO COMPLY WITH APPLICABLE LAW WITH RESPECT TO ITS
OBLIGATIONS UNDER THIS AGREEMENT.  ALL SUCH RECORDS SHALL BE AVAILABLE FOR
INSPECTION, AUDIT AND COPYING BY LICENSEE AND ITS REPRESENTATIVES AND AGENTS,
INCLUDING LICENSEE’S AUDITORS, AT NO COST TO LICENSEE, UPON REASONABLE REQUEST
DURING NORMAL BUSINESS HOURS.  ALL SUCH RECORDS SHALL BE MAINTAINED FOR THE
LONGEST PERIOD AS MAY BE REQUIRED BY APPLICABLE LAW AND PRIOR TO DESTRUCTION OF
ANY RECORD, ACORDA SHALL GIVE NOTICE TO LICENSEE, WHICH SHALL HAVE THE RIGHT TO
REQUEST AND RETAIN SUCH RECORD.

 

8.                                       REPRESENTATIONS AND WARRANTIES

 

8.1                                 MUTUAL REPRESENTATIONS AND WARRANTIES.  EACH
PARTY WARRANTS TO THE OTHER PARTY THAT:

 

(A)                                  AS OF THE EFFECTIVE DATE, IT IS A
CORPORATION DULY ORGANIZED AND IN GOOD STANDING UNDER THE LAWS OF THE
JURISDICTION OF ITS INCORPORATION, AND IT HAS FULL POWER AND AUTHORITY AND THE
LEGAL RIGHT TO OWN AND OPERATE ITS PROPERTY AND ASSETS AND TO CARRY ON ITS
BUSINESS AS IT IS NOW BEING CONDUCTED AND AS IT IS CONTEMPLATED TO BE CONDUCTED
BY THIS AGREEMENT;

 

(B)                                 AS OF THE EFFECTIVE DATE, IT HAS THE FULL
RIGHT, POWER AND AUTHORITY TO ENTER INTO THIS AGREEMENT AND TO GRANT THE RIGHTS
GRANTED BY IT UNDER THIS AGREEMENT;

 

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

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

 

16

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(C)                                  AS OF THE EFFECTIVE DATE, THERE ARE NO
EXISTING OR, TO ITS KNOWLEDGE, THREATENED ACTIONS, SUITS OR CLAIMS PENDING WITH
RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT OR ITS RIGHT TO ENTER INTO AND
PERFORM ITS OBLIGATIONS UNDER THIS AGREEMENT;

 

(D)                                 AS OF THE EFFECTIVE DATE, IT HAS TAKEN ALL
NECESSARY ACTION ON ITS PART TO AUTHORIZE THE EXECUTION AND DELIVERY OF THIS
AGREEMENT AND THE PERFORMANCE OF ITS OBLIGATIONS UNDER THIS AGREEMENT;

 

(E)                                  THIS AGREEMENT HAS BEEN DULY EXECUTED AND
DELIVERED ON BEHALF OF IT, AND CONSTITUTES A LEGAL, VALID, BINDING OBLIGATION,
ENFORCEABLE AGAINST IT IN ACCORDANCE WITH THE TERMS HEREOF, SUBJECT TO THE
GENERAL PRINCIPLES OF EQUITY AND TO BANKRUPTCY, INSOLVENCY, MORATORIUM AND OTHER
SIMILAR LAWS AFFECTING THE ENFORCEMENT OF CREDITORS’ RIGHTS GENERALLY;

 

(F)                                    AS OF THE EFFECTIVE DATE, ALL NECESSARY
CONSENTS, APPROVALS AND AUTHORIZATIONS OF ALL REGULATORY AND GOVERNMENTAL
AUTHORITIES AND OTHER PERSONS REQUIRED TO BE OBTAINED BY IT IN CONNECTION WITH
THE EXECUTION AND DELIVERY OF THIS AGREEMENT AND THE PERFORMANCE OF ITS
OBLIGATIONS UNDER THIS AGREEMENT HAVE BEEN OBTAINED; AND

 

(G)                                 THE EXECUTION AND DELIVERY OF THIS AGREEMENT
AND THE PERFORMANCE OF ITS OBLIGATIONS HEREUNDER DO NOT CONFLICT WITH ANY OF ITS
CONTRACTUAL OBLIGATIONS (EXCEPT THAT ACORDA MAKES NO REPRESENTATION OR WARRANTY
WITH RESPECT TO ITS OBLIGATIONS PURSUANT TO ACORDA THIRD PARTY AGREEMENTS) AND
DO NOT CONSTITUTE A DEFAULT UNDER ANY OF ITS CONTRACTUAL OBLIGATIONS.

 

8.2                                 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF
ACORDA.  IN ADDITION TO THE REPRESENTATIONS AND WARRANTIES MADE BY ACORDA IN THE
LICENSE AGREEMENT, ACORDA REPRESENTS AND WARRANTS THAT EXHIBIT A IDENTIFIES EACH
OF THE ACORDA SUPPLY AGREEMENTS THAT IS IN FULL FORCE AND EFFECT AS OF THE
EFFECTIVE DATE AND ACORDA HAS PROVIDED LICENSEE FULL AND COMPLETE COPIES OF EACH
SUCH ACORDA SUPPLY AGREEMENT

 

8.3                                 ADDITIONAL COVENANTS OF ACORDA.  ACORDA
AGREES THAT DURING THE TERM:

 

(A)                                  ACORDA SHALL COMPLY WITH AND GIVE ALL
NOTICES REQUIRED BY ANY APPLICABLE LAW RELATING TO ACORDA’S PERFORMANCE OF THIS
AGREEMENT;

 

(B)                                 ACORDA WILL USE COMMERCIALLY REASONABLE
EFFORTS TO, WITHIN ONE HUNDRED AND EIGHTY (180) DAYS FOLLOWING THE EFFECTIVE
DATE, ENTER INTO AN AGREEMENT WITH THE SECOND SOURCE (AS DEFINED IN THE ELAN
SUPPLY AGREEMENT) GOVERNING THE SUPPLY OF PRODUCT (THE “SECOND SOURCE
AGREEMENT”) TO ACORDA (INCLUDING IN THE EVENT THAT ELAN NO LONGER SUPPLIES
ACORDA UNDER THE ELAN SUPPLY AGREEMENT) AND LICENSEE SHALL HAVE THE RIGHT TO
REVIEW AND COMMENT ON (BUT NOT APPROVE) ANY SUCH AGREEMENT BEFORE ITS EXECUTION;

 

(C)                                  UPON ACORDA’S EXECUTION OF THE SECOND
SOURCE AGREEMENT, IT SHALL PROVIDE LICENSEE WITH A TRUE AND COMPLETE COPY OF
SUCH AGREEMENT AND, IN ACCORDANCE WITH SECTION 3.4, EXHIBIT A TO THIS AGREEMENT
WILL BE AMENDED TO INCLUDE THE SECOND SOURCE AGREEMENT AS AN ACORDA SUPPLY
AGREEMENT; AND

 

17

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(D)                                 ACORDA SHALL USE COMMERCIALLY REASONABLE
EFFORTS TO FULFILL ITS OBLIGATIONS UNDER THE ACORDA SUPPLY AGREEMENTS TO THE
EXTENT SUCH OBLIGATIONS HAVE NOT BEEN DELEGATED TO LICENSEE AND TO THE EXTENT
THAT FAILURE TO DO SO WOULD MATERIALLY ADVERSELY AFFECT LICENSEE OR ITS RIGHTS
HEREUNDER.

 

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

 

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

 

9.                                       CONFIDENTIALITY

 

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

 

10.                                 TERM AND TERMINATION

 

10.1                           TERM.  THIS AGREEMENT SHALL BE IN EFFECT FROM THE
EFFECTIVE DATE AND SHALL CONTINUE IN EFFECT UNTIL TERMINATED PURSUANT TO
SECTION 10.2 (THE “TERM”).

 

10.2                           TERMINATION.  THIS AGREEMENT MAY BE TERMINATED IN
ACCORDANCE WITH THE FOLLOWING SECTIONS:

 

(A)                                  BREACH.  IF EITHER PARTY (THE
“NON-BREACHING PARTY”) BELIEVES THAT THE OTHER PARTY (THE “BREACHING PARTY”) IS
IN MATERIAL BREACH OF THIS AGREEMENT (INCLUDING ANY BREACH OF A PAYMENT
OBLIGATION), THEN THE NON-BREACHING PARTY MAY DELIVER NOTICE OF SUCH BREACH TO
THE BREACHING PARTY.  IF THE BREACHING PARTY FAILS TO CURE SUCH BREACH WITHIN
THE SIXTY (60) DAY PERIOD (THIRTY (30) DAYS IN THE EVENT OF A PAYMENT BREACH)
AFTER THE BREACHING PARTY’S RECEIPT OF SUCH NOTICE, THE NON-BREACHING PARTY MAY
TERMINATE THIS AGREEMENT IN ITS ENTIRETY UPON WRITTEN NOTICE TO THE BREACHING
PARTY.

 

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(B)                                 INSOLVENCY.  TO THE EXTENT PERMITTED UNDER
APPLICABLE LAW, EITHER PARTY MAY TERMINATE THIS AGREEMENT EFFECTIVE IMMEDIATELY
UPON WRITTEN NOTICE (I) IF PROCEEDINGS IN VOLUNTARY OR INVOLUNTARY BANKRUPTCY
SHALL BE INITIATED BY, ON BEHALF OF OR AGAINST THE OTHER PARTY (AND, IN THE CASE
OF ANY SUCH INVOLUNTARY PROCEEDING, NOT DISMISSED WITHIN ONE HUNDRED TWENTY
(120) DAYS), OR (II) IF THE OTHER PARTY IS ADJUDICATED BANKRUPT, FILES A
PETITION UNDER INSOLVENCY LAWS, IS DISSOLVED OR HAS A RECEIVER APPOINTED FOR
SUBSTANTIALLY ALL OF ITS PROPERTY.

 

(C)                                  TERMINATION OF LICENSE AGREEMENT.  THIS
AGREEMENT SHALL AUTOMATICALLY TERMINATE UPON THE EXPIRATION OR TERMINATION OF
THE LICENSE AGREEMENT.

 

10.3                           RIGHTS UPON TERMINATION.

 

(A)                                  IN THE EVENT THIS AGREEMENT IS TERMINATED
PURSUANT TO SECTION 10.2, (I) ANY AND ALL OUTSTANDING UNDISPUTED PAYMENTS DUE
FROM LICENSEE FOR PRODUCT UNDER PURCHASE ORDERS ALREADY DELIVERED BY ACORDA IN
ACCORDANCE WITH THIS AGREEMENT SHALL BECOME IMMEDIATELY DUE AND PAYABLE AND
(II) IN ACCORDANCE WITH SECTION 6.2, LICENSEE SHALL BE RESPONSIBLE FOR PAYING
THE TRANSFER PRICE INVOICED TO ACORDA BY ITS THIRD PARTY MANUFACTURERS FOR ANY
PRODUCT ORDERED UNDER ANY PURCHASE ORDER DELIVERED TO ACORDA AS OF THE DATE OF
SUCH TERMINATION.

 

(B)                                 IN THE EVENT THIS AGREEMENT IS TERMINATED BY
LICENSEE PURSUANT TO SECTION 10.2(A), UPON LICENSEE’S REQUEST, ACORDA WILL AGREE
TO WAIVE THE EXCLUSIVITY REQUIREMENT PURSUANT TO SECTION 2.2 OF THE ELAN SUPPLY
AGREEMENT SOLELY IN ORDER TO PERMIT LICENSEE TO NEGOTIATE TERMS WITH ELAN FOR
THE SUPPLY OF PRODUCT TO LICENSEE IN THE TERRITORY; PROVIDED, THAT NOTHING IN
THIS SECTION 10.3 SHALL IMPOSE ANY OBLIGATION ON ELAN TO ENTER INTO NEGOTIATIONS
WITH LICENSEE TO SUPPLY LICENSEE PRODUCT.

 

10.4                           EFFECT OF TERMINATION.  TERMINATION OF THIS
AGREEMENT FOR ANY REASON IS WITHOUT PREJUDICE TO THE PARTIES’ ACCRUED RIGHTS AND
SHALL NOT BE CONSTRUED TO RELEASE EITHER PARTY OF ANY OBLIGATION MATURED PRIOR
TO THE EFFECTIVE DATE OF SUCH TERMINATION.

 

10.5                           SURVIVAL.  THE FOLLOWING PROVISIONS SHALL SURVIVE
THE EXPIRATION OR TERMINATION OF THIS AGREEMENT:  ARTICLES 9, 11 AND 12, AND
SECTIONS 5.3(D), 5.4, 6.4, 6.5, 6.6, 8.4, 8.5, 10.3, 10.4 AND 10.5.

 

11.                                 GOVERNING LAW

 

11.1                           GOVERNING LAW. THIS AGREEMENT SHALL BE GOVERNED
BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK, EXCLUDING
(A) ANY PRINCIPLE OF CONFLICT OR CHOICE OF LAWS CHOICE OF LAWS THAT WOULD CAUSE
THE APPLICATION OF THE LAWS OF ANY OTHER JURISDICTION; (B) THE UNITED NATIONS
CONVENTION ON CONTRACTS FOR THE INTERNATIONAL SALE OF GOODS; (C) THE 1974
CONVENTION ON THE LIMITATION PERIOD IN THE INTERNATIONAL SALE OF GOODS; AND
(D) THE PROTOCOL AMENDING THE 1974 CONVENTION ON THE LIMITATION PERIOD IN THE
INTERNATIONAL SALE OF GOODS, DONE AT VIENNA, APRIL 11, 1980.

 

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

 

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IN THIS AGREEMENT OR THE LICENSE AGREEMENT, EACH PARTY WILL BE FREE TO PURSUE
ALL RIGHTS AVAILABLE TO IT UNDER LAW OR EQUITY.

 

12.                                 MISCELLANEOUS

 

12.1                           NOTICES.  NOTICES TO LICENSEE SHALL BE ADDRESSED
TO:

 

Biogen Idec International GmbH
Landis & Gyr Strasse 3
CH-6300 Zug, Switzerland
Attention: Francis Marsland, VP Chief International Counsel
Fax: +41 41 392 1718

 

With a copy to:

 

Biogen Idec, Inc.
14 Cambridge Center
Cambridge, MA 02142
Attention : General Counsel
Fax: 866-546-2758

 

Notices to Acorda shall be addressed to:

 

Acorda Therapeutics, Inc.

15 Skyline Drive

Hawthorne, New York 10532, USA

Attention:  Chief Executive Officer

Fax:                           +1 914.347.4560

 

With a copy to:

 

Acorda Therapeutics, Inc.

15 Skyline Drive

Hawthorne, New York 10532, USA

Attention:  General Counsel

Fax:                           +1 914.347.4560

 

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

 

12.2                           ENTIRE AGREEMENT.  THIS AGREEMENT, THE LICENSE
AGREEMENT AND THE ELAN CONSENT CONSTITUTE THE ENTIRE AGREEMENT AMONG THE PARTIES
WITH RESPECT TO THE SUBJECT MATTER HEREIN AND THEREIN AND SUPERSEDE ALL PREVIOUS
AGREEMENTS (INCLUDING THE PRIOR CONFIDENTIALITY AGREEMENT), WHETHER WRITTEN OR
ORAL, WITH RESPECT TO SUCH SUBJECT MATTER.

 

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12.3                           AMENDMENT AND WAIVER.  THIS AGREEMENT MAY NOT BE
AMENDED, NOR ANY RIGHTS HEREUNDER WAIVED, EXCEPT IN A WRITING SIGNED BY THE
PROPERLY AUTHORIZED REPRESENTATIVES OF EACH PARTY.

 

12.4                           NO IMPLIED WAIVERS.  THE WAIVER BY A PARTY OF A
BREACH OF ANY PROVISION OF THIS AGREEMENT BY THE OTHER PARTY SHALL NOT BE
CONSTRUED AS A WAIVER OF ANY SUCCEEDING BREACH OF THE SAME OR ANY OTHER
PROVISION, NOR SHALL ANY DELAY OR OMISSION ON THE PART OF A PARTY TO EXERCISE OR
AVAIL ITSELF OF ANY RIGHT THAT IT HAS OR MAY HAVE HEREUNDER OPERATE AS A WAIVER
OF ANY RIGHT BY SUCH PARTY.

 

12.5                           ORDER OF PRECEDENCE.  IN THE EVENT OF A CONFLICT
OR INCONSISTENCY BETWEEN ANY OF THE TERMS OF THIS AGREEMENT (INCLUDING ALL
ATTACHMENTS AND EXHIBITS) AND THE LICENSE AGREEMENT, THE PARTIES SHALL ENTER
INTO GOOD FAITH DISCUSSIONS REGARDING THE INTENDED INTERPRETATION OF THE TERMS
UNDERLYING SUCH INCONSISTENCY OR CONFLICT AND, IF SUCH DISPUTE CANNOT BE
RESOLVED BY THE PARTIES WITHIN THIRTY (30) DAYS, EACH PARTY SHALL HAVE AVAILABLE
TO IT ALL RIGHTS UNDER SECTION 11.2.  ANY AMENDMENTS TO THESE DOCUMENTS ON WHICH
THE PARTIES MAY AGREE TO IN ACCORDANCE WITH THE TERMS OF EACH DOCUMENT SHALL
TAKE PRECEDENCE OVER ANY CONFLICTING TERMS IN THE PRIOR RELEASE OF EACH
DOCUMENT.  EACH PARTY SHALL PROMPTLY REPORT TO THE OTHER IN WRITING ANY
INCONSISTENCIES IN THESE DOCUMENTS.

 

12.6                           COVENANT OF FURTHER ASSURANCES.  THE PARTIES
COVENANT AND AGREE THAT, SUBSEQUENT TO THE EXECUTION AND DELIVERY OF THIS
AGREEMENT AND WITHOUT ANY ADDITIONAL CONSIDERATION, EACH OF THE PARTIES SHALL
EXECUTE AND DELIVER ANY FURTHER LEGAL INSTRUMENTS AND PERFORM SUCH ACTS WHICH
ARE OR MAY BECOME REASONABLY NECESSARY TO EFFECTUATE THE PURPOSES OF THIS
AGREEMENT.

 

12.7                           RELATIONSHIP.  THE PARTIES SHALL BE DEEMED
INDEPENDENT CONTRACTORS FOR ALL PURPOSES HEREUNDER.  THIS AGREEMENT DOES NOT
CONSTITUTE A PARTNERSHIP, JOINT VENTURE OR AGENCY BETWEEN THE PARTIES.  NEITHER
PARTY IS AN AGENT OF THE OTHER PARTY AND HAS NO AUTHORITY TO REPRESENT THE OTHER
PARTY AS TO ANY MATTERS.

 

12.8                           SEVERABILITY.  IF, UNDER APPLICABLE LAW, ANY
PROVISION OF THIS AGREEMENT IS INVALID OR UNENFORCEABLE, OR OTHERWISE DIRECTLY
OR INDIRECTLY AFFECTS THE VALIDITY OF ANY OTHER MATERIAL PROVISION(S) OF THIS
AGREEMENT (“SEVERED CLAUSE”), THE PARTIES MUTUALLY AGREE THAT THIS AGREEMENT
SHALL ENDURE EXCEPT FOR THE SEVERED CLAUSE.  THE PARTIES SHALL CONSULT AND USE
THEIR BEST EFFORTS TO AGREE UPON A VALID AND ENFORCEABLE PROVISION WHICH SHALL
BE A REASONABLE SUBSTITUTE FOR SUCH SEVERED CLAUSE IN LIGHT OF THE INTENT OF
THIS AGREEMENT.

 

12.9                           ASSIGNMENT.  NEITHER THIS AGREEMENT NOR ANY OF
THE RIGHTS OR OBLIGATIONS HEREUNDER MAY BE ASSIGNED BY A PARTY WITHOUT THE PRIOR
WRITTEN CONSENT OF THE OTHER PARTY, EXCEPT (A) EACH PARTY MAY ASSIGN THIS
AGREEMENT, IN WHOLE OR IN PART, TO AN AFFILIATE OF THE ASSIGNING PARTY, ONLY FOR
SO LONG AS SUCH ASSIGNEE REMAINS AN AFFILIATE OF THE ASSIGNING PARTY; PROVIDED,
THAT THE ASSIGNING PARTY SHALL REMAIN PRIMARILY LIABLE FOR PERFORMANCE OF ITS
OBLIGATIONS HEREUNDER, NOTWITHSTANDING SUCH ASSIGNMENT; AND (B) EACH PARTY MAY
ASSIGN THIS AGREEMENT, IN WHOLE, TO A THIRD PARTY THAT ACQUIRES, BY MERGER, SALE
OF ASSETS OR OTHERWISE, ALL OR SUBSTANTIALLY ALL OF THE BUSINESS OF THE
ASSIGNING PARTY TO WHICH THE SUBJECT MATTER OF THIS AGREEMENT RELATES. 
NOTWITHSTANDING THE FOREGOING, IN NO EVENT SHALL EITHER PARTY ASSIGN THIS
AGREEMENT TO ANY THIRD PARTY OR AN AFFILIATE UNLESS SUCH PARTY ALSO ASSIGNS THE
LICENSE AGREEMENT TO SUCH THIRD PARTY OR

 

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AFFILIATE.  ANY ASSIGNMENT NOT IN ACCORDANCE WITH THE FOREGOING SHALL BE VOID. 
SUBJECT TO THE FOREGOING, THIS AGREEMENT SHALL BE BINDING UPON, AND SHALL INURE
TO THE BENEFIT OF, ALL PERMITTED SUCCESSORS AND ASSIGNS.

 

12.10                     FORCE MAJEURE. NEITHER PARTY WILL BE DEEMED TO HAVE
BREACHED THIS AGREEMENT FOR FAILURE OR DELAY IN FULFILLING OR PERFORMING ANY
PROVISION OF THIS AGREEMENT WHEN SUCH FAILURE OR DELAY RESULTS FROM CAUSES
BEYOND THE REASONABLE CONTROL OF THE AFFECTED PARTY, WHICH MAY INCLUDE
EMBARGOES, ACTS OF WAR (WHETHER DECLARED OR NOT), INSURRECTIONS, RIOTS, CIVIL
COMMOTIONS, ACTS OF TERRORISM, STRIKES, LOCKOUTS OR OTHER LABOR DISTURBANCES,
SUPPLY FAILURES OF ACORDA’S THIRD PARTY MANUFACTURERS OF PRODUCT, FAILURE TO ACT
BY ELAN OR ITS AFFILIATES, OR ACTS OF GOD.  THE AFFECTED PARTY WILL NOTIFY THE
OTHER PARTY OF SUCH FORCE MAJEURE CIRCUMSTANCES AS SOON AS THE AFFECTED PARTY
BECOMES AWARE OF THE SAME (INCLUDING ITS BEST ESTIMATE OF THE LIKELY EXTENT AND
DURATION OF THE INTERFERENCE WITH ITS ACTIVITIES) AND WILL MAKE EVERY REASONABLE
EFFORT TO MITIGATE THE EFFECTS OF SUCH FORCE MAJEURE CIRCUMSTANCES.  IF A PARTY
IS SO DELAYED AND SUCH FAILURE OR OMISSION IS NOT CURED WITHIN NINETY (90) DAYS,
THE OTHER PARTY MAY TERMINATE THIS AGREEMENT.

 

12.11                     EXPORT COMPLIANCE.  THE PARTIES ACKNOWLEDGE THAT THE
EXPORTATION FROM THE UNITED STATES OR ANY OTHER COUNTRY OF MATERIALS, PRODUCTS
AND RELATED TECHNICAL DATA (AND THE RE-EXPORT FROM ELSEWHERE OF ITEMS
ORIGINATING IN A PARTICULAR COUNTRY) MAY BE SUBJECT TO COMPLIANCE WITH RELEVANT
EXPORT LAWS, INCLUDING LAWS WHICH RESTRICT EXPORT, RE-EXPORT AND RELEASE OF
MATERIALS, PRODUCTS AND THEIR RELATED TECHNICAL DATA, AND THE DIRECT PRODUCTS OF
SUCH TECHNICAL DATA.  THE PARTIES AGREE TO COMPLY WITH ALL EXPORT LAWS AND TO
COMMIT NO ACT THAT, DIRECTLY OR INDIRECTLY, WOULD VIOLATE ANY LAW, OR ANY OTHER
INTERNATIONAL TREATY OR AGREEMENT, RELATING TO THE EXPORT, RE-EXPORT, OR RELEASE
OF ANY MATERIALS, PRODUCTS OR THEIR RELATED TECHNICAL DATA TO WHICH THE UNITED
STATES ADHERES OR WITH WHICH THE UNITED STATES COMPLIES.

 

12.12                     PERFORMANCE BY AFFILIATES AND THIRD PARTY
DISTRIBUTORS.  TO THE EXTENT THAT THIS AGREEMENT IMPOSES OBLIGATIONS ON
AFFILIATES OF A PARTY AND, IN THE CASE OF LICENSEE, ITS THIRD PARTY
DISTRIBUTORS, SUCH PARTY AGREES TO CAUSE SUCH PARTY’S AFFILIATES, AND, IN THE
CASE OF LICENSEE, ITS THIRD PARTY DISTRIBUTORS, TO PERFORM SUCH OBLIGATIONS.

 

12.13                     COUNTERPARTS AND FACSIMILE SIGNATURES.  THIS AGREEMENT
MAY BE EXECUTED IN ANY NUMBER OF COUNTERPARTS, EACH OF WHICH SHALL BE DEEMED AN
ORIGINAL, AND ALL OF WHICH TOGETHER SHALL CONSTITUTE ONE AND THE SAME
INSTRUMENT.  SIGNATURES PROVIDED BY FACSIMILE TRANSMISSION OR IN ADOBE™ PORTABLE
DOCUMENT FORMAT (PDF) SENT BY ELECTRONIC MAIL SHALL BE DEEMED TO BE ORIGINAL
SIGNATURES.

 

[Remainder of Page Intentionally Left Blank]

 

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

 

 

ACORDA THERAPEUTICS, INC.

BIOGEN IDEC INTERNATIONAL GMBH

 

 

 

 

By:

/s/ Ron Cohen

 

By:

/s/ Anders Lundstrom

Name: Ron Cohen

Name: Anders Lundstrom

Title: Chief Executive Officer

Title: Authorized Signatory

 

 

[Signature Page to Supply Agreement]

 

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Exhibit A

 

Acorda Supply Agreements

 

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

 

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

 

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

 

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

 

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

 

·                                          Elan Consent

 

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