ASSIGN SUCH AGREEMENT TO SUPERGEN IN
THE EVENT OF EXPIRATION OR TERMINATION OF THIS AGREEMENT PURSUANT TO THE
PROVISIONS OF ARTICLE 14.
6.2
MANUFACTURING PLAN. THE JSC SHALL MONITOR, REVIEW, AND DISCUSS THE
ARRANGEMENTS AND ACTIVITIES FOR THE MANUFACTURE OF LICENSED PRODUCTS, AND MGI
SHALL KEEP THE JSC APPRISED OF THE STATUS OF ALL MANUFACTURING ACTIVITIES,
WHETHER CONDUCTED INTERNALLY OR BY THIRD PARTIES. THE COMMERCIALIZATION PLAN
PROVIDED BY MGI TO SUPERGEN
SHALL INCLUDE A REASONABLY DETAILED MANUFACTURING
PLAN AND BUDGET SPECIFYING THE SCALE UP, QUALIFICATION, VALIDATION AND
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regulatory activities planned for the Manufacture of Licensed Products, with
such plan designed to satisfy world-wide demand.
6.3
SECOND SOURCE. QUALIFICATION OF A SECOND SOURCE FOR THE MANUFACTURE OF
DECITABINE AND THE LICENSED PRODUCTS SHALL BEGIN NO LATER THAN THE FIRST
MARKETING AUTHORIZATION OF THE EXISTING LICENSED PRODUCT. SUCH QUALIFICATION
SHALL INCLUDE: IDENTIFYING A NON-AFFILIATE THIRD PARTY THAT IS INDEPENDENT OF
THE PRIMARY MANUFACTURER OF THE LICENSED PRODUCTS AND THAT IS CAPABLE OF, AND
WILLING TO, SUPPLY THE LICENSED PRODUCTS IN QUANTITIES SUFFICIENT FOR MEETING
WORLDWIDE DEMAND.
6.4
INSPECTIONS. IF ANY FACILITIES RELATED TO A LICENSED PRODUCT, OR A
COMPONENT OR RAW MATERIAL THEREFOR, ARE TO BE INSPECTED BY A REGULATORY
AUTHORITY, MGI SHALL PROMPTLY NOTIFY SUPERGEN OF THE INSPECTION IN ADVANCE. MGI
SHALL PROVIDE THE JSC WITH A WRITTEN REPORT OF ANY SUCH INSPECTION, NOTING WITH
SPECIFICITY ANY RECORDS OR DOCUMENTS REVIEWED BY THE REGULATORY INSPECTOR, AND
INCLUDING COPIES OF ANY FDA 483S (OR THEIR FOREIGN EQUIVALENT) OR WRITTEN
COMMUNICATIONS PROVIDED BY ANY REGULATORY AUTHORITY RELATING TO SUCH INSPECTION.
MGI SHALL
PROVIDE COPIES OF ALL COMMUNICATIONS TO AND FROM ANY REGULATORY
AUTHORITY RELATING THERETO TO THE JSC. WHEN A COPY OF A DOCUMENT OR RECORD IS
SUPPLIED TO AN INSPECTOR ON REQUEST, THAT FACT WILL BE NOTED IN THE REPORT. THE
INSPECTED PARTY SHALL KEEP COPIES OF EACH OF THESE RECORDS AND DOCUMENTS IN A
SEPARATE INSPECTION FILE AND, ON THE REQUEST OF SUPERGEN, WILL PROVIDE COPIES OF
THESE DOCUMENTS AND RECORDS TO SUPERGEN. MGI SHALL ENSURE THAT AGREEMENTS WITH
CONTRACT MANUFACTURERS AND OTHER THIRD PARTIES REQUIRE THAT SUCH ENTITIES
COOPERATE IN SUCH MANNER WITH RESPECT TO SUCH INSPECTIONS. NOTWITHSTANDING THE
FOREGOING, THIS SECTION 6.4 SHALL APPLY ONLY IF SUPERGEN RETAINS OBLIGATIONS TO
SUPPLY DECITABINE TO THIRD PARTIES UNDER THE THIRD PARTY AGREEMENTS.
6.5
SUPPLY OF DECITABINE SAMPLES. UPON REQUEST OF SUPERGEN, MGI SHALL SUPPLY TO
SUPERGEN ONCE IN EACH CALENDAR YEAR, AT MGI'S DIRECT COST FOR PROVIDING SUCH
PRODUCT, AND AT SUPERGEN'S EXPENSE, SUPERGEN'S REQUIREMENTS FOR DECITABINE
SUFFICIENT TO FULFILL ITS OBLIGATIONS UNDER EXISTING THIRD PARTIES AGREEMENTS
THAT MGI HAS NOT ASSUMED RESPONSIBILITY FOR PURSUANT TO THE PROVISIONS OF
SECTION 9.8, IN ADDITION TO 100 GRAMS OF DECITABINE API PER YEAR, 100 GRAMS OF
C-137 STARTING MATERIAL PER YEAR AND 100 GRAMS OF ISOLATED INTERMEDIATE PER YEAR
AND SUCH ADDITIONAL QUANTITIES AS REASONABLY REQUESTED BY SUPERGEN FOR
SUPERGEN'S INTERNAL USE. SUPERGEN SHALL BE ENTITLED TO PURCHASE ITS REQUIREMENTS
OF DECITABINE AND LICENSED PRODUCTS DIRECTLY FROM MGI OR ITS THIRD