REPRESENTATIVES THE SAME CONFIDENTIAL INFORMATION, REGULATORY DOCUMENTATION, AND
SUPPORTING DATA THAT ARE PROVIDED OR MADE AVAILABLE, RESPECTIVELY, TO MGI
REPRESENTATIVES ON THE JSC OR THE MEMBERS OF MGI'S INTERNAL PROJECT TEAMS FOR
THE LICENSED PRODUCTS AND SUCH ADDITIONAL INFORMATION AS JSC REPRESENTATIVES MAY
REASONABLY REQUEST FROM TIME TO TIME.
(B)
SUBJECT TO THE PROVISIONS OF SECTION 2.3, SUPERGEN MAY USE AND DISCLOSE
CONFIDENTIAL INFORMATION, REGULATORY DOCUMENTATION, AND SUPPORTING DATA OBTAINED
UNDER THIS AGREEMENT AS IS REASONABLY NECESSARY OR USEFUL FOR (I) REVIEW AND
COMMENT ON THE DEVELOPMENT, MANUFACTURE AND OTHER COMMERCIALIZATION OF LICENSED
PRODUCTS UNDER THIS AGREEMENT; (II) THE DEVELOPMENT AND COMMERCIALIZATION OF
PRODUCTS OTHER THAN LICENSED PRODUCTS, INCLUDING WITHOUT LIMITATION FOR USE BY
THIRD PARTIES AND FOR CROSS-REFERENCING DRUG MASTER FILES OR OTHER REGULATORY
DOCUMENTATION, PROVIDED THAT THE DISCLOSURE OF SUCH CONFIDENTIAL INFORMATION,
SUPPORTING DATA AND REGULATORY DOCUMENTATION TO A NON-GOVERNMENTAL THIRD PARTY
IS MADE UNDER REASONABLE AND
19
customary confidentiality restrictions; and (iii) the exercise of its rights
upon termination as set forth in Article 15 below.
5.4
RECORDS; REPORTS.
5.4.1
RECORDS. MGI SHALL MAINTAIN RECORDS OF THE RESEARCH
AND DEVELOPMENT OF THE LICENSED PRODUCTS (OR CAUSE SUCH RECORDS TO BE
MAINTAINED), AS APPLICABLE, IN SUFFICIENT DETAIL AND IN A GOOD SCIENTIFIC MANNER
AS WILL PROPERLY REFLECT ALL WORK DONE AND RESULTS ACHIEVED IN THE PERFORMANCE
OF THE RESEARCH AND DEVELOPMENT.
5.4.2
REPORTS. WITHIN FORTY-FIVE (45) DAYS FOLLOWING THE
END OF EACH CALENDAR YEAR DURING THE TERM OF THIS AGREEMENT, MGI SHALL PROVIDE
TO SUPERGEN A WRITTEN PROGRESS REPORT IN ENGLISH WHICH SHALL DESCRIBE IN
REASONABLE DETAIL THE PROGRESS OF DEVELOPMENT (INCLUDING REGULATORY ACTIVITIES),
AND THE COMMERCIALIZATION ACTIVITIES PLANNED AND TAKEN,
BY AND UNDER AUTHORITY
OF MGI, AND THE RESULTS THEREOF, RELATING TO LICENSED PRODUCT IN THE TERRITORY,
INCLUDING PROGRESS AND STATUS WITH RESPECT TO THE ACTIVITIES, EXPENDITURES AND
TIMING SET FORTH IN THE COMMERCIALIZATION PLAN; THE WORK PERFORMED TO DATE ON
THE RESEARCH, DEVELOPMENT, AND COMMERCIALIZATION OF THE LICENSED PRODUCTS; THE
RESULTS OF SUCH WORK, THE STATUS OF MANUFACTURING EFFORTS, INCLUDING THOSE SET
FORTH UNDER ARTICLE 6, THE STATUS OF COMMERCIALIZATION EFFORTS, INCLUDING THOSE
SET FORTH UNDER ARTICLE 7, AND SUCH OTHER INFORMATION AS IS REASONABLY REQUESTED
BY SUPERGEN.
5.5
THIRD PARTIES. MGI SHALL CAUSE ITS
AFFILIATES, LICENSEES, AND OTHER THIRD PARTIES HAVING RESPONSIBILITIES IN
CONNECTION WITH THE DEVELOPMENT AND/OR COMMERCIALIZATION OF THE LICENSED
PRODUCTS TO PERFORM THEIR RESPONSIBILITIES IN ACCORDANCE WITH ALL APPLICABLE
TERMS AND CONDITIONS OF THIS AGREEMENT.
6.
MANUFACTURING
6.1
DILIGENCE. MGI SHALL USE DILIGENT EFFORTS TO ESTABLISH, QUALIFY, VALIDATE
AND MAINTAIN SUFFICIENT MANUFACTURING FACILITIES AND CAPACITY TO MANUFACTURE
LICENSED PRODUCTS AND MEET WORLDWIDE DEMAND. THE PARTIES ACKNOWLEDGE THAT MGI
WILL HAVE LICENSED PRODUCTS MANUFACTURED ON ITS BEHALF BY A THIRD PARTY
MANUFACTURER.. SUPERGEN SHALL REASONABLY CONSULT WITH MGI REGARDING THE
IDENTIFICATION AND COMMERCIAL SCALE UP OF SUCH THIRD PARTY MANUFACTURERS AS
MUTUALLY AGREED AND PROVIDED THAT MGI REIMBURSES SUPERGEN FOR THE COSTS AND
EXPENSES THEREOF. MGI SHALL USE REASONABLE EFFORTS TO
INCLUDE IN ANY AGREEMENTS
WITH THIRD PARTY MANUFACTURERS THE RIGHT TO