DISCOVERS THAT THE PRODUCT OR DELIVERABLE FAILS TO CONFORM WITH
THE SPECIFICATIONS OR OTHER APPLICABLE REGULATORY REQUIREMENTS, THE WARRANTIES
SET FORTH IN SECTION 12.4 BELOW, OR EXHIBIT B, AS THE CASE MAY BE, SUPERGEN OR
SUCH DESIGNEE MAY NOT ACCEPT SUCH PRODUCT OR DELIVERABLE, WHICH
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NONACCEPTANCE SHALL BE ACCOMPLISHED BY GIVING WRITTEN NOTICE TO *** SPECIFYING
THE MANNER IN WHICH SUCH PRODUCT OR DELIVERABLE FAILS TO MEET THE FOREGOING
REQUIREMENTS AND RETURNING THE NONCONFORMING PRODUCT OR DELIVERABLE IN
ACCORDANCE WITH ***'S REASONABLE INSTRUCTIONS AT ***'S EXPENSE.
IF THE PARTIES
DISAGREE AS TO WHETHER ANY PRODUCT OR DELIVERABLE CONFORMS TO THE APPLICABLE
SPECIFICATION, THEN THE PARTIES WILL REFER THE QUESTION OF WHETHER THE PRODUCT
OR DELIVERABLE DOES OR DOES NOT CONFORM TO A MUTUALLY AGREEABLE INDEPENDENT
TESTING LABORATORY FOR A FINAL DETERMINATION.
THE DETERMINATION OF SUCH
INDEPENDENT TESTING LABORATORY WILL BE BINDING ON BOTH PARTIES FOR PURPOSES OF
PAYMENT UNDER THIS AGREEMENT AND THE PARTY AGAINST WHICH THE DETERMINATION IS
MADE WILL BEAR ALL OUT-OF-POCKET COSTS AND EXPENSES INCURRED TO OBTAIN SUCH
DETERMINATION.
NOTWITHSTANDING SUCH DETERMINATION, *** SHALL USE ITS BEST
EFFORTS TO REPLACE ANY PRODUCT OR DELIVERABLE RETURNED BY SUPERGEN WITHIN THE
SHORTEST POSSIBLE TIME.
7.3
BATCH.
EACH BATCH OF PRODUCT MANUFACTURED BY
*** SHALL MEET THE APPLICABLE SPECIFICATIONS.
IF A DEVIATION FROM SUCH PRODUCT
SPECIFICATIONS OCCURS, THEN *** WILL PREPARE AND DELIVER TO SUPERGEN A DEVIATION
REPORT AND THE PARTIES WILL RESOLVE SUCH SITUATION IN ACCORDANCE WITH APPLICABLE
CGMP AND REGULATORY REQUIREMENTS.
7.4
CERTIFICATES.
WITH RESPECT TO EACH DELIVERY
OF PRODUCT HEREUNDER, *** WILL PROVIDE SUPERGEN WITH A CERTIFICATE OF ANALYSIS
CERTIFYING THAT THE PRODUCT BEING DELIVERED WAS MANUFACTURED IN COMPLIANCE WITH
CGMP AND CONFORMS TO THE SPECIFICATIONS.
7.5
SHIPPING DOCUMENTATION.
*** WILL ASSURE THAT
EACH PRODUCT DELIVERY INCLUDES COMMERCIALLY APPROPRIATE SHIPPING DOCUMENTATION
(INCLUDING BILLS OF LADING), WHICH WILL, AT A MINIMUM:
7.5.1
DESCRIBE THE SHIPMENT AND STATE THE BATCH
IDENTIFICATION NUMBERS FOR THE SHIPMENT,
7.5.2
STATE ANY ORDER NUMBER FOR THE SHIPMENT THAT HAS BEEN
PROVIDED BY SUPERGEN, AND
7.5.3
SHOW THE DESTINATION TO WHICH SUCH SHIPMENT IS BEING
SENT.
In addition, *** will assure that each shipment is accompanied by a Material
Safety Data Sheet and samples (for identification testing) and such additional
documentation as SuperGen may reasonably require from time to time.
7.6
SUPPORTING DATA.
AT SUPERGEN'S REQUEST, ***
WILL PROVIDE SUPERGEN WITH REASONABLE ACCESS TO ANY APPLICABLE SUPPORTING DATA
RELATING TO THE PRODUCT INFORMATION, DOCUMENTATION, AND WORK PERFORMED UNDER THE
DEVELOPMENT PROGRAM (INCLUDING BATCH RECORDS AND LABORATORY NOTEBOOKS).
7.7
SAMPLE RETENTION.
*** WILL PROPERLY STORE AND
RETAIN REPRESENTATIVE SAMPLES (IDENTIFIED BY BATCH NUMBER) (COLLECTIVELY, THE
"RETAINED SAMPLES") OF ALL PRODUCT AND ALL MATERIALS (EXCEPT WATER AND
COMPRESSED GASES) USED TO MANUFACTURE PRODUCT, IN EACH CASE IN CONDITIONS AND
FOR TIMES CONSISTENT WITH ALL APPLICABLE REGULATORY REQUIREMENTS, THE QUALITY
SYSTEMS AGREEMENT AND TO PERMIT APPROPRIATE OR REQUIRED INTERNAL AND REGULATORY
CHECKS AND REFERENCES.
*** WILL PROVIDE SUPERGEN WITH REASONABLE ACCESS TO AND
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PORTIONS OF THE RETAINED SAMPLES FOR TESTING, TROUBLE-SHOOTING AND OTHER