THE SUBSEQUENT TWO CALENDAR YEARS (SUCH PLAN
AND BUDGET, TOGETHER WITH ANY UPDATES THERETO IN ACCORDANCE WITH THIS AGREEMENT,
THE "COMMERCIALIZATION PLAN"). BEGINNING IN CALENDAR YEAR 2005, BY OCTOBER 1 OF
EACH CALENDAR YEAR, MGI SHALL SUBMIT TO SUPERGEN FOR ITS REVIEW AND COMMENT A
PROPOSED COMMERCIALIZATION PLAN FOR THE NEXT CALENDAR YEAR AND FOR THE TWO
SUCCEEDING CALENDAR YEARS. THE COMMERCIALIZATION PLAN SHALL BE UPDATED NOT LESS
THAN ANNUALLY, AS WELL AS MORE FREQUENTLY AS NEEDED IN MGI'S REASONABLE
DISCRETION TO TAKE INTO ACCOUNT COMPLETION, COMMENCEMENT OR CESSATION OF
DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES NOT CONTEMPLATED BY THE THEN
CURRENT COMMERCIALIZATION PLAN. MGI AGREES TO PROVIDE TO SUPERGEN FOR ITS REVIEW
AND COMMENT NO LATER THAN TWENTY ONE (21) DAYS IN ADVANCE OF EACH JSC MEETING
ALL INTERIM UPDATES TO THE COMMERCIALIZATION PLAN. MGI SHALL REASONABLY CONSIDER
SUPERGEN'S INPUT AND COMMENTS. NOTWITHSTANDING THE FOREGOING OR THE TERMS OF
SECTION 4.1.2, MGI SHALL NOT BE REQUIRED TO UPDATE IN THE COMMERCIALIZATION PLAN
THE BUDGET FOR COMMERCIALIZATION OF A LICENSED PRODUCT AFTER THE FIRST
ANNIVERSARY OF FIRST COMMERCIAL SALE OF THE LICENSED PRODUCT.
4.1.2
CONTENTS. THE COMMERCIALIZATION PLAN SHALL BE
CONSISTENT WITH MGI'S DILIGENT EFFORTS OBLIGATIONS UNDER ARTICLES 5, 6 AND 7
BELOW, AND SHALL BE REASONABLY DETAILED AND BROKEN DOWN BY COUNTRY. THE
COMMERCIALIZATION PLAN SHALL INCLUDE, WITHOUT LIMITATION, (I) WITH RESPECT TO
DEVELOPMENT OF EACH LICENSED PRODUCT IN EACH MAJOR COUNTRY:
THE LEVEL OF
RESOURCES, EFFORT AND STAFFING; THE COUNTRIES TO BE TARGETED; REGULATORY
STRATEGY; ANY PRE-CLINICAL OR CLINICAL TRIALS TO BE CONDUCTED; A SCHEDULE FOR
PREPARATION OF REGULATORY DOCUMENTATION; TIMEFRAMES FOR FILING MAAS AND
OBTAINING MARKETING AUTHORIZATIONS; AND A BUDGET FOR ALL DEVELOPMENT ACTIVITIES,
AND (II) WITH RESPECT TO COMMERCIALIZATION OF EACH LICENSED PRODUCT IN EACH
MAJOR COUNTRY:
LEVEL OF RESOURCES, EFFORT AND STAFFING (INCLUDING NUMBERS OF
SALES REPS FOR EACH MAJOR COUNTRY); PRODUCT POSITIONING; PRICING AND
REIMBURSEMENT STRATEGY; A REASONABLY DETAILED DESCRIPTION OF ALL
COMMERCIALIZATION ACTIVITIES (INCLUDING PLANNED PARTICIPATION AT TRADE SHOWS,
ADVERTISING AND EDUCATIONAL EFFORTS AND ANY PUBLICATIONS); AND A BUDGET FOR ALL
COMMERCIALIZATION ACTIVITIES.
4.2
JOINT STEERING COMMITTEE. THE PARTIES SHALL
ESTABLISH A COMMITTEE (THE "JOINT STEERING COMMITTEE" OR "JSC") TO REVIEW AND
DISCUSS THE DEVELOPMENT, MANUFACTURING, AND OTHER
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Commercialization activities relating to the Licensed Product in the Territory.
The JSC will consist of three (3) representatives from each Party, one of whom
shall be a senior executive of each Party and in the case of MGI at least two of
whom shall be responsible for managing and overseeing the strategic and
day-to-day Development, Manufacturing and Commercialization of the Licensed
Products. Subject to the foregoing, each Party shall have the right to change
its members of the JSC by providing written notice to the other.
4.2.1
RESPONSIBILITIES. THE JSC WILL (A) REVIEW AND
DISCUSS THE PROGRESS UNDER AND REVIEW PROPOSED UPDATES TO THE COMMERCIALIZATION
PLAN, (B) REVIEW AND DISCUSS DEVELOPMENT STRATEGY AND ACTIVITIES AND THE
ASSOCIATED BUDGETS, (C) REVIEW AND DISCUSS THE REGULATORY DOCUMENTATION, PRODUCT
LABELING, AND FILINGS (D) REVIEW AND DISCUSS MANUFACTURING PLANS