IF ALLOWED BY THE MASTER
PRODUCTION RECORD PRIOR TO HAUSER PROCESSING THE NEXT BATCH, OR (II) REQUEST
DISPOSAL OR RETURN OF THE NON-CONFORMING API IN ACCORDANCE WITH THE TERMS OF
THIS AGREEMENT.
SUPERGEN ACKNOWLEDGES HAUSER WILL HAVE MET ITS OBLIGATION UNDER
THIS AGREEMENT FOR PROCESSING A BATCH WHEN IT COMPLIES WITH THIS PROVISION.
8.5
SAMPLES.
WITHIN FIVE (5) BUSINESS DAYS FOLLOWING SUPERGEN'S REQUEST
FOR SAMPLES PURSUANT TO SECTION 6.1, HAUSER SHALL SHIP ROUTINE SAMPLES TAKEN AS
DIRECTED IN THE MASTER PRODUCTION RECORD, OR SUCH ADDITIONAL SAMPLES AS
REASONABLY REQUESTED BY SUPERGEN, AT SUPERGEN'S EXPENSE (RELEASE OF ADDITIONAL
SAMPLES IS SUBJECT TO DECISION OF THE MATERIAL REVIEW BOARD) TO SUCH
DESTINATIONS AS INSTRUCTED BY SUPERGEN, F.O.B. THE FACILITY, FOR PURPOSES OF
QUALITY CONTROL. SUPERGEN WILL NOTIFY HAUSER AT LEAST ONE (1) WEEK PRIOR TO THE
POINT IN PROCESSING AT WHICH SUPERGEN DESIRES HAUSER TO PULL THE ADDITIONAL
SAMPLES. THE COSTS ASSOCIATED WITH ANY ADDITIONAL SAMPLES NOT INCLUDED IN THE
MASTER PRODUCTION RECORD ARE NOT INCLUDED IN THE PROCESSING FEE FOR SUCH BATCH
AND WILL BE INVOICED BY HAUSER ACCORDINGLY.
SUPERGEN HAS THE OPTION TO
PERIODICALLY MONITOR THE ACCURACY AND RELIABILITY OF THE ANALYTICAL TESTS
PERFORMED BY HAUSER ON THE API.
9.
REGULATORY COMPLIANCE AND RELATED MATTERS
9.1
NDA SUPPLEMENT.
SUPERGEN SHALL (I) BE SOLELY RESPONSIBLE FOR APPLYING
FOR AND OBTAINING ALL APPROVALS FROM REGULATORY AUTHORITIES RELATING TO
REGISTRATION OF THE API; (II) PAY ANY APPLICABLE USER FEE FOR SUCH REGISTRATION
OF THE API; AND (III) OWN THE NDA SUPPLEMENT.
UPON THE REQUEST OF SUPERGEN,
HAUSER SHALL COOPERATE AS REASONABLY NECESSARY TO ASSIST SUPERGEN IN OBTAINING
SUCH APPROVALS.
9
9.2
INSPECTIONS.
HAUSER SHALL ALLOW REPRESENTATIVES OF REGULATORY
AUTHORITIES TO INSPECT AND AUDIT ITS FACILITIES.
TO THE EXTENT THAT
REPRESENTATIVES OF A REGULATORY AUTHORITY REQUEST AN INSPECTION AND AUDIT OF THE
FACILITIES FOR THE PURPOSE OF INSPECTING AND AUDITING THE DELIVERABLES OR ANY
COMPONENTS THEREOF, HAUSER SHALL NOTIFY SUPERGEN PROMPTLY, AND, IN ANY EVENT,
NOT LATER THAN ONE (1) BUSINESS DAY FOLLOWING THE REQUEST OF SUCH A REGULATORY
AUTHORITY.
UNLESS OTHERWISE PROHIBITED BY THE REGULATORY AUTHORITY, SUPERGEN
SHALL HAVE THE OPTION OF HAVING A REASONABLE NUMBER OF ITS REPRESENTATIVES
ONSITE AT (I) ANY SUCH INSPECTION OR AUDIT OR (II) ANY MEETING WITH SUCH
REGULATORY AUTHORITIES TO DISCUSS THE RESULTS OF SUCH INSPECTION OR AUDIT.
UNLESS OTHERWISE PROHIBITED BY THE REGULATORY AUTHORITY, AFTER THE INSPECTION
AND AUDIT HAS BEEN COMPLETED, HAUSER SHALL NOTIFY SUPERGEN IN WRITING OF THE
RESULTS OF SUCH INSPECTION OR AUDIT.
WITHIN FIVE (5) BUSINESS DAYS OF THE
RECEIPT BY HAUSER OF DOCUMENTATION FROM THE REGULATORY AUTHORITY PERFORMING SUCH
INSPECTION AND AUDIT HAUSER WILL PROVIDE SUPERGEN COPIES OF ANY RESULTING
DOCUMENT OF ACTION (INCLUDING FDA FORM 483 INSPECTION OBSERVATION REPORT AND
REGULATORY LETTERS, ETC.) RESULTING THEREFROM; PROVIDED, HOWEVER, HAUSER SHALL
HAVE NO OBLIGATION TO PROVIDE SUCH DOCUMENTATION TO SUPERGEN TO THE EXTENT SUCH
DOCUMENTATION IS NOT RELATED TO API OR TO THE SUITES OF THE FACILITY RESERVED
FOR PROCESSING THE API.
UNLESS THE REGULATORY AUTHORITY PROHIBITS DISCLOSURE OF
THE RESULTS