BY HAUSER, THE COST OF
WHICH WILL BE BORNE BY SUPERGEN.
AS USED IN THIS SECTION 11.1, "RECORDS" SHALL
MEAN BATCH RECORDS, RECORDS OF PURCHASE ORDERS, HAUSER INVOICES AND PAYMENTS
RECEIVED FROM SUPERGEN, CERTIFICATES OF ANALYSIS FROM VENDORS FOR RAW MATERIALS
RECEIVED, RECORDS OF PENTOSTATIN CRUDE CONCENTRATE FURNISHED, API AND
DELIVERABLES PROCESSED, WORKS-IN-PROCESS, PENTOSTATIN CRUDE CONCENTRATE AND API
ANALYSES, AND FILE SAMPLES KEPT IN THE ORDINARY COURSE, IN EACH CASE "RECORDS"
SHALL ONLY MEAN THOSE "RECORDS REQUIRED BY CGMP" DIRECTLY RELATED TO PROCESSING
THE API. TO THE EXTENT REQUIRED BY LAW, HAUSER SHALL ALSO KEEP AND MAINTAIN
RECORDS RELATING TO REGULATORY COMPLIANCE, ENVIRONMENTAL, HEALTH OR SAFETY AND
QUALITY ASSURANCE AND QUALITY CONTROL OF THE API.
HAUSER SHALL MAKE ALL SUCH
RECORDS AVAILABLE FOR INSPECTION BY SUPERGEN OR ITS REPRESENTATIVES AND SHALL
ALLOW SUPERGEN TO COPY SUCH RECORDS AS SUPERGEN MAY DESIGNATE.
THE COST OF
ADDITIONAL COPIES FOR SUPERGEN SHALL BE BORNE SOLELY BY SUPERGEN.
EACH PARTY
ACKNOWLEDGES THAT IT HAS LEGAL OBLIGATIONS REGARDING RECORD-KEEPING, AND WILL
USE ITS BEST EFFORTS TO COMPLY WITH THOSE OBLIGATIONS.
11
11.2
BY SUPERGEN.
WITH THE EXCEPTION OF THE DOCUMENTATION REQUIRED TO BE
MADE OR KEPT BY HAUSER PURSUANT TO SECTION 11.1, SUPERGEN SHALL MAINTAIN SUCH
DOCUMENTATION RELATING TO THE MANUFACTURE, SALE AND DISTRIBUTION OF ANY FINAL
DRUG OR PHARMACEUTICAL INCORPORATING THE DELIVERABLES AS IS REQUIRED BY ALL
APPLICABLE RULES, LAWS AND REGULATIONS.
12.
REVISIONS TO MASTER PRODUCTION RECORD OR SPECIFICATIONS
12.1
MASTER PRODUCTION RECORD.
ANY PROPOSED CHANGE TO THE MASTER PRODUCTION
RECORD MUST BE APPROVED BY BOTH PARTIES.
NO REVISIONS TO THE MASTER PRODUCTION
RECORD THAT WOULD AFFECT THE PROCESSING OF THE API OR DELIVERABLES SHALL BE
SUBMITTED TO THE FDA UNLESS APPROVED BY BOTH PARTIES IN WRITING.
BOTH PARTIES
ACKNOWLEDGE THAT IMPLEMENTATION DUE TO CHANGES MAY DELAY PROCESSING.
12.2
DIFFERENCE IN COST.
SUPERGEN SHALL NOTIFY HAUSER IN WRITING OF ANY
PROPOSED REVISIONS TO THE MASTER PRODUCTION RECORD, TEST METHODS OR THE
SPECIFICATIONS (THE "PROPOSED REVISIONS").
TO THE EXTENT THE PROPOSED REVISIONS
ARE GREATER THAN REQUIRED UNDER CGMP, SUPERGEN SHALL BE RESPONSIBLE FOR COSTS
INCURRED IN IMPLEMENTING THE PROPOSED REVISIONS.
HAUSER SHALL, WITHIN THIRTY
(30) CALENDAR DAYS OF RECEIPT OF SUCH NOTICE, NOTIFY SUPERGEN IN WRITING WHETHER
AND THE EXTENT TO WHICH THE FOREGOING PROCESSING COSTS FOR THE API WILL INCREASE
OR DECREASE AS A RESULT OF SUCH PROPOSED REVISIONS (I.E., COSTS NOT RELATED TO
THE FACILITY OR ITS MAINTENANCE AS REQUIRED BY CGMP).
ANY PROPOSED INCREASE IN
HAUSER'S COSTS SHALL BE SUPPORTED BY DOCUMENTATION AND SUBMITTED TO SUPERGEN FOR
APPROVAL.
IF SUPERGEN ELECTS TO ADOPT THE PROPOSED REVISION, THE THEN CURRENT
PROCESSING FEES AND/OR STABILITY STUDY FEE (AS SET FORTH IN SCHEDULE A) WILL BE
ADJUSTED AND THE RELATED SCHEDULES WILL BE AMENDED ACCORDINGLY.
HAUSER SHALL
NOT IMPLEMENT A PROPOSED REVISION UNTIL SUPERGEN ELECTS TO ADOPT THE PROPOSED
REVISION.
12.3
HAUSER UNABLE TO COMPLY.
IF HAUSER DETERMINES IT IS TECHNICALLY UNABLE
TO COMPLY WITH A PROPOSED REVISION IT SHALL SO INFORM SUPERGEN.
TO THE EXTENT A
PROPOSED REVISION IS REQUIRED BY CGMP