OF THE INDIVIDUAL(S)
PERFORMING THE MANUFACTURING OPERATIONS, IDENTIFICATION OF THE INDIVIDUAL(S)
PERFORMING THE QUALITY TESTING PROCEDURES, ACCEPTANCE RECORDS INCLUDING RESULTS
OF THE QUALITY TESTING PROCEDURES, THE QUANTITY RELEASED FOR DISTRIBUTION, A
SAMPLE OF THE LABELING, AND IDENTIFICATION OF THE INDIVIDUAL(S) RESPONSIBLE FOR
VERIFICATION OF THE DHR AND FINAL RELEASE OF THE PRODUCT. THE MANUFACTURING
OPERATIONS AND QUALITY TESTING PROCEDURES SHALL BE CARRIED OUT IN ACCORDANCE
WITH THE WRITTEN PROCEDURES PREPARED BY THE PARTIES, AS AFORESAID. FOR EACH
PRODUCT LOT, THE MANUFACTURER SHALL PROVIDE THE COMPANY WITH A HARD-COPY OF THE
DHR, APPROPRIATELY SIGNED BY ALL MANUFACTURING AND QUALITY PERSONNEL.
ALL
RECORDS GENERATED BY THE MANUFACTURER AND RELATED TO THE MANUFACTURE OF THE
PRODUCT, SHALL BE MAINTAINED FOR A PERIOD OF AT LEAST 2 YEARS FOLLOWING THE
EXPIRATION OF THE SHELF LIFE OF EACH LOT OF THE PRODUCT. IN THE EVENT THAT THE
COMPANY RECEIVES INFORMATION OF ANY FAILURE OF A PRODUCT PURCHASED FROM THE
MANUFACTURER, THE MANUFACTURER SHALL, WITHIN 72 HOURS OF RECEIVING ANY REQUEST
FROM THE COMPANY, FURNISH THE COMPANY WITH A COPY OF THE DHR PERTAINING TO SUCH
PRODUCT.
7.6.
THE MANUFACTURER SHALL CERTIFY THAT ALL OF THE
MANUFACTURER'S PERSONNEL, AND ANY SUB-CONTRACTOR, WHO ENGAGE IN THE MANUFACTURE
HEREUNDER, SHALL RECEIVE ALL NECESSARY AND APPROPRIATE TRAINING.
7.7.
THE MANUFACTURER AGREES AT NO ADDITIONAL COST
TO THE COMPANY, TO FULLY COOPERATE AS REQUIRED TO PREPARE FOR AND PARTICIPATE IN
QUALITY AUDITS OF THE MANUFACTURER'S FACILITY BY ALL APPLICABLE REGULATORY
AGENCIES.
THE MANUFACTURER AGREES TO MAKE ALL APPROPRIATE PERSONNEL AVAILABLE
AS NECESSARY FOR THIS PURPOSE. THE MANUFACTURER AGREES TO NOTIFY THE COMPANY OF
ALL OBSERVATIONS MADE BY REGULATORY AGENCIES, WHICH PERFORM AUDITS OF THE
MANUFACTURER'S FACILITY FROM TIME TO TIME IN RELATION TO THE PRODUCTS AS WELL AS
TO ANY PRODUCTS OTHER THAN THE PRODUCTS. FOR THE SAKE OF CLARITY, THE
MANUFACTURER SHALL NOT CHARGE THE COMPANY FOR SAID AUDITS. TO FURTHER CLARIFY,
THE MANUFACTURER SHALL NOT BE RESPONSIBLE TO PAY THE OUT-OF-POCKET COST,
INCLUDING TRAVEL RELATED EXPENSES, FOR AUDITS OF THE MANUFACTURER PERFORMED BY
AN AGENT OF THE COMPANY AS PART OF THE AGENT'S AUDIT OF THE COMPANY.
7.8.
THE MANUFACTURER SHALL IMMEDIATELY REPORT TO
THE COMPANY ANY PROBLEMS, DIFFICULTIES OR DEVIATIONS FROM THE SPECIFICATIONS,
WHICH IT ENCOUNTERS DURING THE MANUFACTURE OF THE PRODUCTS.
6
7.9.
THE MANUFACTURER SHALL SUPPLY TO THE COMPANY,
FREE OF CHARGE, AT LEAST ONE COMPLETE SET OF DOCUMENTATION FOR EACH PRODUCT,
INCLUDING THE DOCUMENTATION DETAILED IN APPENDIX "7.9" ATTACHED HERETO.
8.
ORDERS AND DELIVERY
8.1.
WITHIN 30 DAYS OF THE EFFECTIVE DATE, THE
COMPANY SHALL FURNISH THE MANUFACTURER WITH A NON-BINDING FORECAST, ESTIMATING
THE QUANTITY OF EACH PRODUCT THAT THE COMPANY INTENDS TO PURCHASE FROM THE
MANUFACTURER DURING THE FOLLOWING 6-MONTH PERIOD (THE "FORECAST"). THE FORECAST
WILL BE REVOLVING AND UPDATED, FROM TIME TO TIME, BY THE COMPANY PRIOR TO THE
EXPIRATION OF EACH MONTH COVERED BY THE FORECAST, SO THAT THE FORECAST SHALL AT
ANY GIVEN TIME COVER A PERIOD OF 6 MONTHS.
8.2.
UPON SUBMISSION OF THE FORECAST TO THE
MANUFACTURER,