SUCH PRODUCT, AS SUCH WRITTEN PLAN MAY BE AMENDED, MODIFIED OR
UPDATED IN ACCORDANCE WITH SECTION 3.1.2.
FOR PURPOSES OF CLARITY, IT IS THE
EXPECTATION OF THE PARTIES THAT THE INITIAL GLOBAL DEVELOPMENT PLAN SHALL
DESCRIBE THE DEVELOPMENT ACTIVITIES TO BE CONDUCTED FOR THE THREE (3) YEAR
PERIOD COMMENCING AS OF THE EFFECTIVE DATE AND CONTINUING UNTIL [***] AND SHALL
BE REVIEWED AND UPDATED BY THE JSC (AND JDC WITH RESPECT TO THE U.S. TERRITORY)
NOT LESS THAN ONCE EACH CALENDAR YEAR.
1.49
"GLP" MEANS THE THEN CURRENT GOOD LABORATORY PRACTICE STANDARDS
PROMULGATED OR ENDORSED BY THE FDA OR IN THE CASE OF FOREIGN JURISDICTIONS,
COMPARABLE REGULATORY STANDARDS PROMULGATED OR ENDORSED BY THE APPLICABLE
REGULATORY AUTHORITY, INCLUDING THOSE PROCEDURES EXPRESSED IN OR CONTEMPLATED BY
ANY REGULATORY FILINGS.
1.50
"GMP" MEANS CURRENT GOOD MANUFACTURING PRACTICES THAT APPLY TO THE
MANUFACTURE OF API AND CLINICAL OR COMMERCIAL SUPPLY OF PRODUCT, INCLUDING,
WITHOUT LIMITATION, THE UNITED STATES REGULATIONS SET FORTH UNDER TITLE 21 OF
THE UNITED STATES CODE OF FEDERAL REGULATIONS, PARTS 210 AND 211, AS MAY BE
AMENDED FROM TIME-TO-TIME, AS WELL AS ALL APPLICABLE GUIDANCE PUBLISHED FROM
TIME-TO-TIME BY THE FDA AND THE INTERNATIONAL CONFERENCE ON HARMONISATION
GUIDELINES ICHQ7A GOOD MANUFACTURING PRACTICE GUIDANCE FOR API AND/OR THE
PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICES FOR MEDICINAL PRODUCTS
AS DEFINED WITH EC DIRECTIVE 2003/94/EC AND ASSOCIATED EC GUIDE TO GOOD
MANUFACTURING PRACTICE.
1.51
"GSK CO-COMMERCIALIZATION ACTIVITIES" MEANS (A) WITH RESPECT TO THE
CO-COMMERCIALIZED PRODUCT FOR THE INDICATION OF [***], THE FOLLOWING ACTIVITIES
AS DEEMED NECESSARY BY THE JCC: (I) INTERACTIONS WITH [***]; (II) [***]
ACTIVITIES, INCLUDING RELEVANT [***] GROUPS; (III) THE CONDUCT OF [***];
(IV) INTERACTING WITH AND PROMOTING PRODUCTS TO [***]; (V) INTERACTING WITH AND
PROMOTING PRODUCTS TO [***]AND [***]; (VI) THE CONDUCT OF OPERATIONAL ACTIVITIES
WITH RESPECT TO CO-COMMERCIALIZED PRODUCTS, INCLUDING WITHOUT LIMITATION [***]
MANAGEMENT, MANAGEMENT OF [***], [***] MANAGEMENT (FOR BOTH [***]) AND [***],
[***] PROGRAMS, [***], [***], THE MAINTENANCE OF [***] CENTERS, [***] RESOURCE
CENTERS AND [***] PROGRAMS, ADMINISTRATION MATTERS, [***], [***], SALES [***],
[***] MANAGEMENT AND [***] MANAGEMENT; (VII) [***]; AND (VIII) [***] WITH SYNTA
[***] [***] ACTIVITIES AND (IX) TAKING A ROLE IN DEFINING THE [***], [***] AND
[***] OF THE PRODUCT; AND (B) WITH RESPECT TO THE CO-COMMERCIALIZED PRODUCT FOR
ANY INDICATION OTHER THAN [***], [***]; PROVIDED, THAT THE ACTIVITIES SET FORTH
UNDER SECTIONS 1.51(A)(I), (A)(III), (A)(IV), (A)(VI), (A)(VII) AND
(A)(IX) SHALL [***] GSK'S RESPONSIBILITY FOR [***] PRODUCTS IN [***]
INDICATIONS, SUBJECT TO SECTION 8 OF SCHEDULE 6.
1.52
"GSK DECISION" MEANS ANY [***] DECISION THAT IS NOT A [***] (OTHER
THAN AS PROVIDED IN SECTION 2.1.5) WITH RESPECT TO (A) THE DEVELOPMENT AND/OR
COMMERCIALIZATION OF A
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
8
PRODUCT FOR [***]; (B) ALL [***] MATTERS WITH RESPECT TO THE COMMERCIALIZATION
OF ANY CO-COMMERCIALIZED PRODUCT FOR ANY [***] TERRITORY, INCLUDING