supplies of Product and Acorda is willing to
supply Product to Licensee, on such terms and conditions as are set forth
herein.
NOW THEREFORE, in consideration of the foregoing premises, which are
incorporated into and made a part of this Agreement, and of the mutual covenants
which are recited herein, the Parties agree as follows:
1.
DEFINITIONS
Capitalized terms used herein and not defined shall have the meaning given
thereto in the License Agreement.
Other terms are defined as follows:
1.1
"ACORDA" SHALL HAVE THE MEANING SET FORTH IN
THE PREAMBLE.
1.2
"ACORDA SUPPLY AGREEMENTS" SHALL HAVE THE
MEANING SET FORTH IN SECTION 3.4.
1.3
"AFFILIATE" SHALL MEAN ANY PERSON WHO
DIRECTLY OR INDIRECTLY CONTROLS OR IS CONTROLLED BY OR IS UNDER COMMON CONTROL
WITH ANOTHER PERSON.
FOR PURPOSES OF THIS DEFINITION, "CONTROL" OR "CONTROLLED"
MEANS OWNERSHIP, DIRECTLY OR THROUGH ONE OR MORE AFFILIATES, OF FIFTY PERCENT
(50%) OR MORE OF THE SHARES OF STOCK ENTITLED TO VOTE FOR THE ELECTION OF
DIRECTORS, IN THE CASE OF A CORPORATION, OR FIFTY PERCENT (50%) OR MORE OF THE
EQUITY INTEREST, IN THE CASE OF ANY OTHER TYPE OF LEGAL ENTITY, OR STATUS AS A
GENERAL PARTNER IN ANY PARTNERSHIP.
THE PARTIES ACKNOWLEDGE THAT, IN THE CASE
OF CERTAIN ENTITIES ORGANIZED UNDER THE LAWS OF CERTAIN COUNTRIES, THE MAXIMUM
PERCENTAGE OWNERSHIP PERMITTED BY LAW FOR A FOREIGN INVESTOR MAY BE LESS THAN
FIFTY PERCENT (50%), AND IN SUCH CASE SUCH LOWER PERCENTAGE SHALL BE SUBSTITUTED
IN THE PRECEDING SENTENCE; PROVIDED, THAT SUCH FOREIGN INVESTOR HAS THE POWER TO
DIRECT THE MANAGEMENT AND POLICIES OF SUCH ENTITY.
1.4
"AGREEMENT" SHALL HAVE THE MEANING SET FORTH
IN THE PREAMBLE.
1.5
"BATCH" SHALL MEAN A SPECIFIC QUANTITY OF
PRODUCT THAT IS PRODUCED ACCORDING TO A SINGLE MANUFACTURING ORDER DURING THE
SAME CYCLE OF MANUFACTURE.
1.6
"BREACHING PARTY" SHALL HAVE THE MEANING SET
FORTH IN SECTION 10.2(A).
1.7
"BUSINESS DAY" SHALL MEAN A DAY OTHER THAN
SATURDAY OR SUNDAY ON WHICH THE BANKS IN NEW YORK, NEW YORK AND BOSTON,
MASSACHUSETTS ARE OPEN FOR BUSINESS.
1.8
"CALENDAR QUARTER" SHALL MEAN A CALENDAR
QUARTER ENDING ON THE LAST DAY OF MARCH, JUNE, SEPTEMBER OR DECEMBER.
1.9
"CALENDAR YEAR" SHALL MEAN A PERIOD OF TIME
COMMENCING ON JANUARY 1 AND ENDING ON THE FOLLOWING DECEMBER 31.
1.10
"CGMP" SHALL MEAN CURRENT GOOD MANUFACTURING
PRACTICES AND STANDARDS AS PROVIDED FOR IN THE UNITED STATES CODE OF FEDERAL
REGULATIONS, AND THE REQUIREMENTS THEREUNDER IMPOSED BY THE FDA, ALL PROMULGATED
AND PUBLISHED, AND IN EC DIRECTIVE 91/356/EEC OF 13 JUNE 1991 AS WELL AS EC
DIRECTIVES 2003-94-EC AND 2005-28-EC AND IN ACCORDANCE WITH INDUSTRY PRACTICES.
1.11
"DOCUMENTATION" SHALL HAVE THE MEANING SET FORTH
IN SECTION 5.3(B).
1.12
"EFFECTIVE DATE" SHALL MEAN THAT DATE SET FORTH
IN THE PREAMBLE.
1.13
"ELAN" SHALL MEAN ELAN PHARMA INTERNATIONAL
LIMITED, ITS SUCCESSORS AND ASSIGNS AND, AS APPLICABLE, ITS AFFILIATES.
1.14
"ELAN COMPENSATING PAYMENT" SHALL MEAN THE AMOUNT
PAID OR PAYABLE TO ELAN PURSUANT TO SECTION 9.5 OF THE ELAN SUPPLY AGREEMENT.
1.15
"ELAN CONSENT"