DATA REQUIRED UNDER CGMPS AND OTHER REGULATORY
REQUIREMENTS.
*** WILL PROVIDE SUPERGEN WITH SUCH RECORDS PROMPTLY UPON
SUPERGEN'S REQUEST.
*** WILL ALSO MAINTAIN RECORDS WITH RESPECT TO ITS
OBLIGATIONS AND PERFORMANCE UNDER THIS AGREEMENT.
ALL SUCH RECORDS, AND ALL
SAMPLES REQUIRED TO BE MAINTAINED UNDER THIS AGREEMENT, SHALL BE MAINTAINED FOR
A PERIOD OF NOT LESS THAN FIVE (5) YEARS FROM THE DATE OF EXPIRATION OF PRODUCT
PRODUCED FROM EACH BATCH OF PRODUCT TO WHICH THOSE RECORDS AND SAMPLES PERTAIN
(OR, IF LONGER, FOR A PERIOD OF ONE (1) YEAR AFTER THE FINAL RESOLUTION OF ANY
DISPUTE TO WHICH SUCH RECORDS OR SAMPLES ARE RELEVANT), OR SUCH LONGER PERIOD AS
MAY BE REQUIRED BY REGULATORY REQUIREMENTS.
IF AND WHEN *** OPTS TO DISPOSE OF
RECORDS OR SAMPLES GENERATED IN CONJUNCTION WITH THIS AGREEMENT, IT WILL FIRST
OFFER TO TRANSFER SUCH RECORDS TO SUPERGEN OR ITS DESIGNEE AT SUPERGEN'S
EXPENSE.
ARTICLE 9 - REGULATORY MATTERS
9.1
PERMITS.
*** WILL MAINTAIN IN GOOD ORDER, AT
ITS SOLE COST AND EXPENSE, SUCH CURRENT GOVERNMENTAL REGISTRATIONS, PERMITS AND
LICENSES AS ARE REQUIRED BY GOVERNMENTAL AUTHORITIES AND ALL APPLICABLE LAWS IN
ORDER FOR *** TO PERFORM ALL OF ITS OBLIGATIONS UNDER THIS AGREEMENT.
*** WILL
MAKE COPIES OF REGISTRATIONS AND ALL RELATED DOCUMENTS AVAILABLE TO SUPERGEN AND
ITS DESIGNEES FOR INSPECTION, UPON REASONABLE REQUEST FROM SUPERGEN.
9.2
REGULATORY COMMUNICATIONS AND CORRESPONDENCE.
*** WILL PROMPTLY NOTIFY SUPERGEN OF ALL COMMUNICATIONS FROM AND TO THE FDA OR
OTHER REGULATORY AUTHORITIES THAT MAY IMPACT OR CHANGE THE MANUFACTURING OR
PROCESSING ACTIVITIES PERFORMED BY ***, OR AFFECT THE ABILITY OF *** TO COMPLY
WITH ITS OBLIGATIONS UNDER THIS AGREEMENT.
WITHOUT LIMITING THE FOREGOING, ***
WILL NOTIFY SUPERGEN OF ANY WRITTEN OR ORAL INQUIRIES, NOTIFICATIONS OR
INSPECTION ACTIVITIES BY ANY REGULATORY AUTHORITY IN REGARD TO THE PRODUCT OR
THE MANUFACTURING FACILITY WITHIN FIVE (5) DAYS OF *** OBTAINING KNOWLEDGE OF
SUCH INQUIRIES, NOTIFICATIONS OR INSPECTION ACTIVITIES.
MOREOVER, *** WILL
FURNISH TO SUPERGEN COPIES OF ALL INSPECTION REPORTS AND RELATED CORRESPONDENCE
OF SUCH REGULATORY AUTHORITY RELATED TO OR WHICH MIGHT REASONABLY AFFECT THE
PRODUCT OR THE PERFORMANCE OF ANY MANUFACTURING OR PROCESSING ACTIVITIES
HEREUNDER (INCLUDING ANY FDA FORM 483 OR OTHER INSPECTION REPORTS, WARNING
LETTERS, CITATIONS, INDICTMENTS, CLAIMS, LAWSUITS OR PROCEEDINGS ISSUED OR
INSTITUTED AGAINST ***, OR OF ANY REVOCATION OF ANY LICENSE OR PERMIT ISSUED TO
***) AND WHEN SUCH REPORTS AND CORRESPONDENCE BECOME AVAILABLE TO ***, BUT IN
ANY EVENT WITHIN FIVE (5) DAYS AFTER OBTAINING KNOWLEDGE OF SUCH INQUIRIES,
NOTIFICATIONS OR INSPECTION ACTIVITIES.
*** WILL DISCUSS WITH SUPERGEN ANY
REGULATORY AUTHORITY COMMENTS DIRECTLY RELATED TO AND AFFECTING THE PRODUCT OR
***'S PERFORMANCE OF ANY MANUFACTURING OR PROCESSING ACTIVITIES HEREUNDER, AND
BEFORE *** SUBMITS A FINAL RESPONSE TO SUCH COMMENTS, *** WILL GIVE SUPERGEN NO
FEWER THAN FIVE (5) DAYS TO COMMENT ON ITS PROPOSED RESPONSE TO SUCH COMMENTS,
AND ANY RESULTANT SUPERGEN COMMENTS WILL BE INCORPORATED TO THE RESPONSE, IF
REASONABLY POSSIBLE.
*** WILL PROMPTLY RECTIFY OR RESOLVE ANY DEFICIENCIES
NOTED BY A REGULATORY AUTHORITY IN A REPORT