THE TERM CONTAINED
IN THIS AGREEMENT SHALL PREVAIL.
8.2.
BATCH RELEASE.
(A)
BATCH REVIEW AND RELEASE OF PRODUCT SHALL BE THE RESPONSIBILITY
OF THE COMPANY.
(B)
FOR EACH BATCH OF PRODUCT RELEASED FOR SALE BY THE DISTRIBUTOR,
THE COMPANY SHALL DELIVER TO THE DISTRIBUTOR: (1) A CERTIFICATE OF ANALYSIS AS
DESCRIBED IN SECTION 4.6(A); (2) A CERTIFICATE OF COMPLIANCE AS DESCRIBED IN
SECTION 4.6(B); AND (3) A PACKING LIST FOR EACH BATCH OF PRODUCT.
(C)
THE COMPANY SHALL NOTIFY THE DISTRIBUTOR WITHIN THREE
(3) BUSINESS DAYS OF BECOMING AWARE OF THE SAME IN THE EVENT OF ANY MATERIAL
DEVIATION DURING MANUFACTURE OR WHEN ANY TEST REVEALS CONTAMINATION OR
DEGRADATION IN ANY BATCH OF PRODUCT.
8.3.
BATCH DOCUMENTATION; RETENTION SAMPLES.
(A)
ORIGINALS OF ALL BATCH DOCUMENTATION SHALL BE RETAINED BY THE
COMPANY FOR A PERIOD OF AT LEAST TWELVE (12) MONTHS PAST THE EXPIRY DATE OF THE
PRODUCT, OR SUCH LONGER PERIOD AS MAY BE REQUIRED BY APPLICABLE LAWS.
(B)
AT THE REQUEST OF THE DISTRIBUTOR, THE COMPANY SHALL PROVIDE A
COPY OF ANY OF THE EXECUTED BATCH DOCUMENTS RELATING TO PRODUCT TO THE
DISTRIBUTOR BY FACSIMILE OR COURIER WITHIN THREE (3) BUSINESS DAYS OF
DISTRIBUTOR'S REQUEST.
(C)
RETENTION SAMPLES SHALL ONLY BE DESTROYED AFTER THE REQUIRED
REGULATORY HOLDING PERIOD.
8.4.
STABILITY.
(A)
COMPANY SHALL ENSURE THAT STABILITY TESTING FOR THE PRODUCT AS
REQUIRED BY REGULATORY AUTHORITIES IN THE TERRITORY IS PERFORMED IN COMPLIANCE
THE REGISTRATION AND APPLICABLE LAWS.
COMPANY SHALL PERFORM STANDARD STABILITY
TESTING AS DEFINED IN COMPANY'S STANDARD OPERATING PROCEDURES OR AS SEPARATELY
AGREED TO IN ACCORDANCE WITH A DESIGN HISTORY
22
FILE (DHF) FOR THE PRODUCT.
DISTRIBUTOR SHALL RECEIVE A COPY OF COMPANY'S
ANNUAL REPORT FOR THE PRODUCT AS LONG AS COMPANY IS CONTINUING TO PRODUCE THE
PRODUCT FOR DISTRIBUTOR.
(B)
IF A CONFIRMED RESULT INDICATES THAT A PRODUCT HAS FAILED TO
REMAIN WITHIN STABILITY SPECIFICATIONS, THE COMPANY SHALL NOTIFY THE DISTRIBUTOR
WITHIN TWO (2) BUSINESS DAYS AFTER SUCH RESULT BECOMES AVAILABLE.
(C)
THE COMPANY SHALL PROVIDE STABILITY DATA RELATING TO THE PRODUCT
TO THE DISTRIBUTOR ON AN ONGOING BASIS AS REQUESTED.
(D)
IN THE EVENT THIS AGREEMENT IS TERMINATED, THE COMPANY SHALL, AS
REQUESTED, CONTINUE TO PROVIDE THE DISTRIBUTOR WITH STABILITY DATA SUPPORTING
THE ACCEPTABILITY OF THE PRODUCT UNTIL SUCH PRODUCT DISTRIBUTED BY THE
DISTRIBUTOR HAS REACHED THE END OF ITS SHELF LIFE.
9.
MEDICAL INFORMATION, COMPLAINTS ADVERSE
EVENTS AND POST-MARKETING SURVEILLANCE
9.1.
MEDICAL INFORMATION.
DISTRIBUTOR WILL PROVIDE A MEDICAL
INFORMATION SERVICE CONCERNING THE PRODUCT TO THE HEALTH PROFESSIONALS AND
PATIENTS IN THE TERRITORY.
9.2.
CUSTOMER COMPLAINTS; TECHNICAL/QUALITY RELATED ISSUES.
EACH PARTY
WILL REPORT TO THE OTHER ALL CUSTOMER COMPLAINTS, TECHNICAL OR QUALITY-RELATED
INCIDENTS AND/OR ISSUES, OF WHICH IT BECOMES AWARE.
DISTRIBUTOR SHALL BE
RESPONSIBLE FOR COMMUNICATING WITH THE CUSTOMER TO SUPPORT THE COMPLAINT
HANDLING PROCESS.
COMPANY SHALL PROVIDE ALL NECESSARY SUPPORT TO DISTRIBUTOR
INVESTIGATING AND ADDRESSING ALL SUCH CUSTOMER COMPLAINTS, TECHNICAL OR
QUALITY-RELATED INCIDENTS.
THE PARTIES AGREE TO REPORT ALL PRODUCT QUALITY
CUSTOMER COMPLAINTS, TECHNICAL OR QUALITY RELATED INCIDENTS AND/OR ISSUES TO
EACH OTHER WITHIN