OR CORRESPONDENCE ISSUED TO *** THAT
RELATE TO PERFORMANCE OF ANY OF THE MANUFACTURING OR PROCESSING ACTIVITIES UNDER
THIS AGREEMENT.
9.3
PRE-APPROVAL INSPECTIONS.
*** WILL PREPARE
FOR AND BE RESPONSIBLE FOR PRODUCT PRE-APPROVAL INSPECTIONS AS REQUIRED BY
REGULATORY REQUIREMENTS.
*** WILL BE RESPONSIBLE FOR ENSURING THAT ***'S
MANUFACTURING FACILITY AND PRODUCT-RELATED EQUIPMENT, PROCESSES, TEST METHODS
AND REPORTS ARE PREPARED AND/OR QUALIFIED FOR SUCH PRE-APPROVAL INSPECTIONS, AS
11
DETERMINED IN GOOD FAITH BY SUPERGEN'S QUALITY ASSURANCE AUDIT TEAM ("PAI
READY") IN A TIME FRAME CONSISTENT WITH SUPERGEN'S PRODUCT-RELATED REGULATORY
STRATEGY AND CONSISTENT WITH REASONABLE TIMELINES AGREED BY THE PARTIES.
SUPERGEN WILL COOPERATE WITH *** TO ACHIEVE PAI READINESS BY SUCH DATE.
UNTIL
*** IS PAI READY, PROCESS VALIDATION WILL NOT COMMENCE.
THIS COOPERATION WILL
INCLUDE THE PERFORMANCE OF PERIODIC INSPECTIONS TO EVALUATE PROGRESS TOWARDS PAI
READINESS AND THE REPORTING TO *** OF ALL DEFICIENCIES IDENTIFIED DURING SUCH
INSPECTIONS.
IN TURN, *** WILL REMEDY ALL DEFICIENCIES, WHETHER OR NOT SUCH
DEFICIENCIES ARE IDENTIFIED BY A SUPERGEN INSPECTION, AND WILL COMPLY WITH ALL
NECESSARY REGULATORY REQUIREMENTS.
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN
THIS AGREEMENT, IF *** FAILS ANY PRE-APPROVAL INSPECTION BY ANY REGULATORY
AUTHORITY WITH RESPECT TO PRODUCT, THEN *** WILL STOP ALL MANUFACTURING AND
PROCESSING ACTIVITIES HEREUNDER (TO THE EXTENT UNDER SUCH REGULATORY AUTHORITY'S
JURISDICTION) UNLESS AND UNTIL ALL PROBLEMS AND ISSUES IDENTIFIED BY SUCH
REGULATORY AUTHORITY HAVE BEEN CORRECTED TO THE SATISFACTION OF SUCH REGULATORY
AUTHORITY.
9.4
PROCESS VALIDATION.
AFTER SUPERGEN AND ***
DETERMINE IN COLLABORATION THAT *** IS PAI READY IN ACCORDANCE WITH SECTION 9.3,
*** WILL COMPLETE PROTOCOLS FOR VALIDATION OF THE PRODUCT MANUFACTURING
PROCESSES, CLEANING PROCESSES, AND OTHER PROCESSES AND ACTIVITIES AS REQUIRED BY
CGMPS AND ANY OTHER APPLICABLE REGULATORY REQUIREMENTS.
SUPERGEN WILL REVIEW
AND APPROVE SUCH PROTOCOLS IN A TIMELY MANNER.
*** WILL COMPLETE SUCH PROCESS
VALIDATION WITHIN A TIMEFRAME CONSISTENT WITH SUPERGEN'S PRODUCT-RELATED
REGULATORY STRATEGY AND CONSISTENT WITH REASONABLE DEVELOPMENT TIMELINES
MUTUALLY AGREED BY THE PARTIES AND UPON COMPLETION, SHALL PROVIDE A VALIDATION
REPORT TO SUPERGEN FOR APPROVAL.
*** WILL ROUTINELY ASSEMBLE AND RETAIN ANY
REQUIRED VALIDATION/QUALIFICATION DOCUMENTS AND VALIDATION SUMMARY REPORTS
PERTAINING TO THE MANUFACTURING AND PROCESSING ACTIVITIES HEREUNDER IN
ACCORDANCE WITH SECTION 8.3.
*** WILL SUBMIT COPIES OF SUCH DOCUMENTS AND
REPORTS TO SUPERGEN FOR APPROVAL.
9.5
NOTIFICATION OF CHANGES TO THE MANUFACTURING
PROCESS.
*** WILL NOTIFY SUPERGEN IN WRITING AND PROVIDE SUPERGEN THE RIGHT TO
REVIEW AND REASONABLY APPROVE BEFORE SUBMITTING ANY DOCUMENTATION TO ANY
REGULATORY AUTHORITY REGARDING ANY MANUFACTURING PROCESS CHANGES APPROVED BY
SUPERGEN PURSUANT TO SECTION 3.9 ABOVE.
UPON REASONABLE NOTICE, SUPERGEN WILL
BE PERMITTED TO REVIEW ALL DOCUMENTATION PROPOSED TO BE FILED WITH ANY
REGULATORY AUTHORITY REGARDING SUCH CHANGES.
WITHIN FIFTEEN (15) DAYS AFTER
RECEIVING SUCH DOCUMENTATION, SUPERGEN WILL PROVIDE *** WITH COMMENTS, WHICH
COMMENTS WILL BE FULLY CONSIDERED IN GOOD FAITH BY *** FOR INCORPORATION INTO
THE DOCUMENTATION PRIOR TO FILING IT WITH ANY REGULATORY AUTHORITY.
*** WILL
OBTAIN SUPERGEN'S WRITTEN APPROVAL PRIOR TO SUBMITTING ANY SUCH DOCUMENTATION.
9.6
COOPERATION IN OBTAINING GOVERNMENT
APPROVALS.
*** WILL REASONABLY ASSIST