SUPERGEN, AT SUPERGEN'S REQUEST, TO
SECURE AND MAINTAIN GOVERNMENTAL APPROVALS FOR THE PRODUCT AND WILL PARTICIPATE
AS IS REASONABLY NECESSARY AND AS MAY BE REQUESTED IN RESOLVING THE CONCERNS OF
ANY REGULATORY AUTHORITY ARISING WITH RESPECT TO THE MANUFACTURE OF PRODUCT FOR
SUPERGEN.
WITHOUT LIMITING THE FOREGOING, *** WILL PRODUCE STABILITY BATCHES
AND VALIDATION BATCHES AND PERFORM TESTING AS IS NECESSARY FOR SUPERGEN TO
RECEIVE APPROVALS FOR PRODUCT FROM REGULATORY AUTHORITIES.
9.7
ACCIDENT REPORTS.
EACH PARTY WILL REPORT TO
THE OTHER AS SOON AS POSSIBLE ALL MATERIAL ACCIDENTS RELATED TO THE MANUFACTURE,
HANDLING, USE OR STORAGE OF ANY MATERIALS OR PRODUCT, INCLUDING:
12
9.7.1
ACCIDENTS RESULTING IN SIGNIFICANT PERSONAL INJURY
REQUIRING MORE THAN FIRST AID TREATMENT,
9.7.2
ACCIDENTS RESULTING IN CHRONIC ILLNESS OR LOSS OF
CONSCIOUSNESS,
9.7.3
ACCIDENTS RESULTING IN MATERIAL PROPERTY DAMAGE,
9.7.4
ACCIDENTS RESULTING IN MATERIAL ENVIRONMENTAL RELEASE,
AND
9.7.5
ACCIDENTS THAT RESULT IN REGULATORY, SAFETY, HEALTH OR
ENVIRONMENTAL AUDITS.
9.8
SUPERGEN ACCESS TO MANUFACTURING DATA AND
DOCUMENTATION.
SUPERGEN SHALL HAVE FULL ACCESS TO AND THE RIGHT TO USE AND
REFERENCE ANY REGULATORY FILINGS, CORRESPONDENCE, VALIDATION DOCUMENTATION,
BATCH RECORDS, REPORTS, ANALYSES, AND ANY OTHER INFORMATION AND DOCUMENTATION IN
***'S POSSESSION OR CONTROL RELATED TO THE MANUFACTURING ACTIVITIES CONDUCTED BY
*** HEREUNDER, OR THAT ARE NECESSARY OR USEFUL FOR SUPERGEN TO APPLY FOR, OBTAIN
AND THEREAFTER MAINTAIN REGULATORY FILINGS FOR THE PRODUCT, INCLUDING
INFORMATION RELATING TO THE MANUFACTURING FACILITY, PROCESS, METHODOLOGY OR
COMPONENTS USED IN THE MANUFACTURE OF THE PRODUCT OR OTHER SUCH INFORMATION
REQUIRED TO BE SUBMITTED TO THE FDA (OR ITS FOREIGN EQUIVALENT) IN THE FORM OF A
MARKETING APPLICATION.
WITHOUT LIMITING THE FOREGOING, *** AGREES TO
IMMEDIATELY INFORM SUPERGEN WHEN ANY SUCH INFORMATION IS NO LONGER CURRENT AND
REFLECTIVE OF CURRENT MANUFACTURING PRACTICES, PROCEDURES OR THE SPECIFICATIONS
AND TO PROMPTLY PROVIDE UPDATED INFORMATION TO SUPERGEN.
ARTICLE 10 - RECALLS
10.1
NOTIFICATION.
EACH PARTY WILL KEEP THE OTHER PARTY
FULLY INFORMED OF ANY NOTIFICATION, OR OTHER INFORMATION OF WHICH IT HAS ACTUAL
KNOWLEDGE, WHICH MIGHT RESULT IN THE RECALL (AS DEFINED BELOW) OR SEIZURE OF THE
PRODUCT.
10.2
***'S RECALL OR WITHDRAWAL SUGGESTION.
IF ***
INDEPENDENTLY BELIEVES THAT A PRODUCT RECALL OR PRODUCT WITHDRAWAL MAY BE
NECESSARY OR APPROPRIATE, *** WILL SO NOTIFY SUPERGEN OF ***'S CONCLUSION WITHIN
TWENTY-FOUR (24) HOURS AND THE PARTIES WILL COOPERATE WITH EACH OTHER TO
ASCERTAIN THE NECESSITY AND NATURE OF SUCH ACTION.
10.3
RECALL DETERMINATION BY SUPERGEN.
PROMPTLY AFTER
SUPERGEN DETERMINES THAT A RECALL OR PRODUCT WITHDRAWAL IS NECESSARY, AND BEFORE
SUPERGEN NOTIFIES A REGULATORY AUTHORITY OF A PRODUCT WITHDRAWAL OR PRODUCT
RECALL, SUPERGEN WILL NOTIFY *** OF SUPERGEN'S DETERMINATION AND THE BASIS
THEREFOR.
*** WILL ASSIST SUPERGEN, AT SUPERGEN'S REASONABLE REQUEST, IN ITS
INVESTIGATION TO DETERMINE THE CAUSE AND EXTENT OF THE PROBLEM.
10.4
SUPERGEN DISCRETION.
SUPERGEN WILL BE SOLELY
RESPONSIBLE FOR MAKING THE FINAL DECISION WHETHER PRODUCT IS WITHDRAWN OR
RECALLED.
SUPERGEN WILL BE SOLELY RESPONSIBLE FOR ANY RESULTING PRODUCT
LIABILITY CLAIMS, EXCEPT TO THE EXTENT SUCH PRODUCT LIABILITY CLAIMS ARE
ATTRIBUTABLE TO ***'S OR ANY OF ITS