PURPOSES AS SUPERGEN MAY REASONABLY REQUIRE FROM TIME TO TIME.
7.8
NO OTHER DISPOSITION.
EXCEPT AS EXPRESSLY
PERMITTED UNDER THIS AGREEMENT, *** WILL NOT DISPOSE OF ANY PRODUCT WITHOUT THE
ADVANCE WRITTEN APPROVAL OF SUPERGEN.
IF SUPERGEN APPROVES ANY SUCH DISPOSITION
OF PRODUCT, THEN *** WILL CARRY OUT SUCH DISPOSITION IN ACCORDANCE WITH
APPLICABLE REGULATORY REQUIREMENTS.
ARTICLE 8 - INSPECTIONS AND AUDITS
8.1
INSPECTION BY QUALITY ASSURANCE.
SUPERGEN'S
QUALITY ASSURANCE PERSONNEL OR ITS AGENTS WILL HAVE THE RIGHT, UPON REASONABLE
ADVANCE NOTICE AND DURING REGULAR BUSINESS HOURS, TO INSPECT, OBSERVE AND AUDIT:
8.1.1
THE MANUFACTURING FACILITY AND
8.1.2
ANY OF ***'S MANUFACTURING AND QUALITY CONTROL RECORDS
AND OTHER DOCUMENTATION RELATING TO THE MANUFACTURING AND PROCESSING ACTIVITIES
(INCLUDING ANY INTERNAL QUALITY CONTROL AUDITS OR REVIEWS CONDUCTED BY ***) FOR
THE PRODUCT.
Such inspections, observations and audits shall be for the purpose of
ascertaining compliance with Regulatory Requirements, cGMPs, the Quality Systems
Agreement and this Agreement, reviewing correspondence, reports, filings and
other documents from or to Regulatory Authorities to the extent related to the
manufacturing and processing activities, approving all variances from applicable
requirements hereunder or under the Quality Systems Agreement, and evaluating
the implementation of all manufacturing and process changes pursuant to this
Agreement.
Any information obtained by SuperGen through such inspections and
audits shall be treated as Confidential Information of ***, provided that
SuperGen shall be permitted to disclose such information to Third Parties under
an obligation of confidentiality.
SuperGen will conduct such inspections and
audits in a manner designed to minimize disruption of ***'s business operations.
8.2
NOTICE OF NON-COMPLIANCE.
IF SUPERGEN
REASONABLY DETERMINES DURING ANY INSPECTION OR AUDIT OF A MANUFACTURING FACILITY
OR OTHER FACILITY AT WHICH ANY OF THE MANUFACTURING OR PROCESSING ACTIVITIES ARE
PERFORMED, OR THE RECORDS BEING MAINTAINED BY *** IN CONNECTION WITH SUCH
MANUFACTURE (INCLUDING BATCH RECORDS), THAT *** IS NOT IN COMPLIANCE WITH
REGULATORY REQUIREMENTS, CGMPS, THE QUALITY SYSTEMS AGREEMENT OR THIS AGREEMENT,
THEN SUPERGEN WILL GIVE *** A WRITTEN NOTICE DETAILING THE SUSPECTED
NON-COMPLIANCE.
WHEN *** RECEIVES ANY SUCH NOTICE FROM SUPERGEN, *** WILL
PROVIDE SUPERGEN WITH A CORRECTIVE ACTION PLAN WITHIN THIRTY (30) DAYS AND THEN,
AS SOON AS REASONABLY PRACTICABLE, REMEDY OR CAUSE TO BE REMEDIED ANY ACTUAL
NON-COMPLIANCE, AT ***'S EXPENSE, IN ACCORDANCE WITH A MUTUALLY AGREED
SCHEDULE.
*** WILL PROVIDE SUPERGEN WITH REASONABLE DOCUMENTARY AND OTHER
EVIDENCE OF SUCH CORRECTION.
SUPERGEN WILL THEN HAVE THE RIGHT TO RE-INSPECT
AND RE-AUDIT SUCH MANUFACTURING FACILITY OR OTHER FACILITY, OR THE RECORDS BEING
MAINTAINED BY *** IN CONNECTION WITH SUCH MANUFACTURE, UPON REASONABLE NOTICE
AND DURING REGULAR BUSINESS HOURS TO DETERMINE WHETHER *** HAS REMEDIED OR
CAUSED TO BE REMEDIED SUCH NON-COMPLIANCE.
8.3
RECORDS.
*** WILL MAINTAIN COMPLETE AND
ACCURATE RECORDS (INCLUDING FILES, CERTIFICATES AND AUTHORIZATIONS) NECESSARY TO
EVIDENCE COMPLIANCE WITH ALL APPLICABLE LAWS AND OTHER REQUIREMENTS OF
APPLICABLE GOVERNMENTAL AUTHORITIES RELATING TO THE DEVELOPMENT
10
PROGRAM OR MANUFACTURE OF PRODUCT, INCLUDING ALL VALIDATION DATA, STABILITY
TESTING DATA, DEVELOPMENT REPORTS, BATCH RECORDS, QUALITY CONTROL AND LABORATORY
TESTING, AND ANY OTHER