NON-CORPORATE
ENTITIES.
THE PARTIES ACKNOWLEDGE THAT IN THE CASE OF CERTAIN ENTITIES
ORGANIZED UNDER THE LAWS OF CERTAIN COUNTRIES OUTSIDE THE UNITED STATES, THE
MAXIMUM PERCENTAGE OWNERSHIP PERMITTED BY LAW FOR A FOREIGN INVESTOR MAY BE LESS
THAN FIFTY PERCENT (50%), AND THAT 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
1.2.
"[**]".
[**] MEANS (A) [**] (B) ITS AFFILIATES, (C) ANY PERSON
LICENSED TO DISTRIBUTE BY [**] OR ITS AFFILIATES FOR AN [**]-EQUIVALENT PRODUCT
(THE PERSONS DESCRIBED IN SECTIONS 1.2(A), (B) AND (C), COLLECTIVELY, THE "[**]
PERSONS"), AND (D) THE SUCCESSORS AND ASSIGNS OF ANY [**] PERSONS WITH RESPECT
TO ANY RIGHTS TO ANY [**]-EQUIVALENT PRODUCT.
1.3.
"ANNUAL COLLABORATION PLAN".
ANNUAL COLLABORATION PLAN MEANS,
WITH RESPECT TO A PRODUCT, THE DEVELOPMENT, COMMERCIALIZATION AND LEGAL
ACTIVITIES PLAN FOR SUCH PRODUCT, INCLUDING GOALS, RESPONSIBILITIES, BUDGETS AND
TIMELINES FOR SUCH ACTIVITIES, TO BE DEVELOPED BY THE APPLICABLE JPT, SUBMITTED
TO THE JOC, AND APPROVED BY THE JSC FOR EACH CONTRACT YEAR, AND INCLUDING
FORECASTS FOR SUBSEQUENT CONTRACT YEARS, IN ACCORDANCE WITH THIS AGREEMENT.
1.4.
"APPLICATION".
APPLICATION MEANS:
(A) WITH RESPECT TO THE U.S.
TERRITORY, ANY OF THE FOLLOWING:
(I) AN ABBREVIATED NEW DRUG APPLICATION FILED
WITH THE FDA OR ANY SUCCESSOR APPLICATIONS OR PROCEDURES SEEKING AUTHORIZATION
AND APPROVAL TO MANUFACTURE, PACKAGE, SHIP, AND SELL A PRODUCT IN THE U.S.
TERRITORY; (II) ANY OTHER REGULATORY FILING IN THE U.S. TERRITORY, INCLUDING
WITHOUT LIMITATION FILINGS THAT ARE SIMILAR TO FILINGS UNDER CLAUSE (I), SUCH AS
A BLA, AN NDA, SUPPLEMENTAL NDA OR AN APPLICATION PURSUANT TO SECTION 505(B)(2)
OF THE UNITED STATES FEDERAL FOOD, DRUG, AND COSMETIC ACT (THE "FD&C ACT") OR
PURSUANT TO THE UNITED STATES PUBLIC HEALTH SERVICE ACT; AND (III) ALL
SUPPLEMENTS AND AMENDMENTS THAT MAY BE FILED WITH RESPECT TO THE FOREGOING; AND
(B) WITH RESPECT TO ANY OTHER RELEVANT JURISDICTION IN THE WORLD, ANY EQUIVALENT
OF THE ITEMS IN CLAUSE (A) IN SUCH JURISDICTION, INCLUDING, WITHOUT LIMITATION,
ANY MARKETING APPROVAL APPLICATION FILED WITH ANY REGULATORY AUTHORITY
(INCLUDING THE EMEA AND THE EUROPEAN COMMISSION, AS APPLICABLE) IN THE EUROPEAN
TERRITORY.
1.5.
"APPLICATION FINAL APPROVAL".
APPLICATION FINAL APPROVAL MEANS,
WITH RESPECT TO A PRODUCT IN A COUNTRY IN THE RELEVANT TERRITORY OR, FOR THE
RELEVANT PURPOSES OF SECTION 4.2.1, A FULLY-SUBSTITUTABLE COPAXONE-EQUIVALENT
PRODUCT IN THE U.S. TERRITORY, THE GRANTING BY THE RELEVANT REGULATORY AUTHORITY
OF FINAL MARKETING APPROVAL (WITH "MARKETING APPROVAL" AND ITS INCORPORATED
TERMS APPLYING TO THE COPAXONE-EQUIVALENT PRODUCT TO THE SAME EXTENT AS THEY
APPLY TO PRODUCTS) FOR AN APPLICATION FOR SUCH PRODUCT OR FULLY-SUBSTITUTABLE
COPAXONE-EQUIVALENT PRODUCT, RESPECTIVELY, IN SUCH COUNTRY.
1.6.
"BUSINESS DAY".
BUSINESS DAY MEANS ANY DAY THAT IS NOT A
SATURDAY, SUNDAY OR OTHER DAY ON WHICH COMMERCIAL BANKS LOCATED IN THE STATE OF
NEW YORK AND MUNICH, GERMANY ARE AUTHORIZED OR REQUIRED TO BE CLOSED.
1.7.
"CGMP".
CGMP MEANS CURRENT GOOD MANUFACTURING PRACTICES AS SET
FORTH IN TITLE 21, PARTS 210