MEANS THE CONSENT AMONG ACORDA,
LICENSEE AND ELAN, DATED ON OR ABOUT THE EFFECTIVE DATE.
1.16
"ELAN SUPPLY AGREEMENT" SHALL MEAN THE SUPPLY
AGREEMENT BETWEEN ELAN AND ACORDA, DATED SEPTEMBER 26, 2003, AS AMENDED FROM
TIME TO TIME.
1.17
"EMEA" SHALL MEAN THE EUROPEAN MEDICINES AGENCY
OR ANY SUCCESSOR AGENCY THEREOF.
1.18
"EU" SHALL MEAN THE EUROPEAN UNION, AS IT MAY BE
EXPANDED OR CONTRACTED FROM TIME TO TIME, ICELAND, LIECHTENSTEIN AND NORWAY.
1.19
"EXPERT PANEL" SHALL HAVE THE MEANING GIVEN TO IT
IN THE LICENSE AGREEMENT DISPUTES BETWEEN THE PARTIES UNDER THIS AGREEMENT THAT
ARE ELIGIBLE TO BE REFERRED TO AN EXPERT PANEL SHALL BE RESOLVED IN ACCORDANCE
WITH THE PROVISIONS SET FORTH IN SECTION 3.5(C)(III) OF THE LICENSE AGREEMENT.
1.20
"FACILITY" SHALL MEAN ELAN'S MANUFACTURING
FACILITY IN MONKSLAND, ATHLONE, CO. WESTMEATH, IRELAND, OR SUCH OTHER FACILITY
AS ACORDA OR ITS THIRD PARTY MANUFACTURERS MAY USE TO PERFORM ACORDA'S
OBLIGATIONS UNDER THIS AGREEMENT.
2
1.21
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG
ADMINISTRATION OR ANY SUCCESSOR AGENCY THERETO.
1.22
"FIRM PERIOD" SHALL HAVE THE MEANING SET FORTH IN
SECTION 4.1(A).
1.23
"FORECAST" SHALL HAVE THE MEANING SET FORTH IN
SECTION 4.1.
1.24
"JMC" SHALL HAVE THE MEANING SET FORTH IN
SECTION 2.2.
1.25
"LATENT DEFECT" SHALL HAVE THE MEANING SET FORTH
IN SECTION 5.3(C).
1.26
"LAUNCH STOCKS" SHALL MEAN THE QUANTITIES OF
STOCKS OF THE PRODUCT REQUIRED BY LICENSEE, AS DETERMINED IN ACCORDANCE WITH
SECTION 4.4, IN RELATION TO THE LAUNCH OF THE PRODUCT FOLLOWING REGULATORY
APPROVAL IN A MAJOR MARKET COUNTRY.
1.27
"LAW" SHALL MEAN ANY LAW, STATUTE, RULE,
REGULATION, GOVERNMENT AGENCY GUIDANCE, ORDINANCE OR OTHER PRONOUNCEMENT HAVING
THE EFFECT OF LAW, OF ANY FEDERAL, NATIONAL, MULTINATIONAL, STATE, PROVINCIAL,
COUNTY, CITY OR OTHER POLITICAL SUBDIVISION, INCLUDING (A) CGMP, GOOD CLINICAL
PRACTICES AND ADVERSE EVENT REPORTING REQUIREMENTS, GUIDANCE FROM THE
INTERNATIONAL CONFERENCE ON HARMONIZATION OR OTHER GENERALLY ACCEPTED
CONVENTIONS, AND ALL OTHER RULES, REGULATIONS AND REQUIREMENTS OF THE FDA AND
OTHER APPLICABLE REGULATORY AUTHORITIES, (B) THE FOREIGN CORRUPT PRACTICES ACT
OF 1977, AS AMENDED, OR ANY COMPARABLE LAWS IN ANY COUNTRY, AND (C) ALL EXPORT
CONTROL LAWS.
1.28
"LICENSE AGREEMENT" SHALL HAVE THE MEANING SET
FORTH IN THE PREAMBLE.
1.29
"LICENSEE" SHALL HAVE THE MEANING SET FORTH IN
THE PREAMBLE.
1.30
"MAJOR MARKET COUNTRIES" SHALL MEAN THE UNITED
KINGDOM, FRANCE, GERMANY, ITALY, SPAIN AND JAPAN.
1.31
"NDA" SHALL MEAN A NEW DRUG APPLICATION FILED
WITH THE FDA OR SIMILAR FOREIGN APPLICATION OR SUBMISSION FOR REGULATORY
APPROVAL, INCLUDING A MAA.
1.32
"NON-BREACHING PARTY" SHALL HAVE THE MEANING SET
FORTH IN SECTION 10.2(A).
1.33
"PARTY" AND "PARTIES" SHALL HAVE THE RESPECTIVE
MEANINGS SET FORTH IN THE PREAMBLE.
1.34
"PERSON" SHALL MEAN ANY INDIVIDUAL, LIMITED OR
GENERAL PARTNERSHIP, CORPORATION, LIMITED LIABILITY COMPANY, JOINT VENTURE,
UNINCORPORATED ORGANIZATION OR ASSOCIATION, ANY TRUST, GOVERNMENTAL BODY,
AUTHORITY, BUREAU OR AGENCY, OR ANY OTHER ENTITY OR BODY.
1.35
"PROCESS" OR "PROCESSING" SHALL MEAN THE ACT OF
PREPARATION, FILLING, TESTING, PACKAGING, LABELING AND ANY OTHER PHARMACEUTICAL
MANUFACTURING PROCEDURES, OR ANY PART THEREOF (INCLUDING, BUT NOT