BY THE
PURCHASER UNDER THIS SECTION SHALL OCCUR NO MORE FREQUENTLY THAN ONCE EACH
CALENDAR QUARTER (UNLESS OTHERWISE REQUIRED BY LAW, INCLUDING BY DIRECTION OF
THE REGULATORY AUTHORITY) AND SHALL BE DESIGNED TO CAUSE THE LEAST AMOUNT OF
DISRUPTION TO THE OPERATIONS OF THE SUPPLIER AS IS REASONABLY POSSIBLE.
SUCH
INSPECTIONS SHALL BE LIMITED TO THE MANUFACTURE OF PRODUCTS, AND SHALL NOT
INCLUDE ANY TRADE SECRETS OR OTHER CONFIDENTIAL INFORMATION UNLESS THE PURCHASER
AND ITS DESIGNEE (IF APPLICABLE) HAS SIGNED A CONFIDENTIALITY AGREEMENT
REASONABLY SATISFACTORY TO THE SUPPLIER.
5.2
REMEDYING DEFICIENCIES.
THE SUPPLIER SHALL BE RESPONSIBLE FOR
REMEDYING ANY DEFICIENCIES IDENTIFIED BY THE PURCHASER UNDER SECTION 5.1 AT
SUPPLIER'S COST AND EXPENSE WITHIN SIXTY (60) DAYS FOLLOWING WRITTEN NOTICE FROM
THE PURCHASER.
WITH RESPECT TO ANY SUCH INSPECTIONS FOR WHICH ANY DEFICIENCIES
ARE NOT CAPABLE OF BEING REMEDIED BY THE SUPPLIER WITHIN SIXTY (60) DAYS OF THE
NOTIFICATION THEREOF, THEN THE SUPPLIER AND THE PURCHASER SHALL DISCUSS IN GOOD
FAITH A CORRECTIVE ACTION PLAN WHICH WILL ENABLE THE PRODUCTS TO BE SUPPLIED IN
ACCORDANCE WITH THIS AGREEMENT UNTIL SUCH DEFICIENCIES ARE REMEDIED.
IF THE
PARTIES ARE UNABLE TO REACH AGREEMENT AFTER AN ADDITIONAL SIXTY (60) DAYS AS TO
SUCH ALTERNATIVE MANUFACTURING ARRANGEMENTS, THEN THE PURCHASER SHALL HAVE THE
RIGHT TO TERMINATE THIS AGREEMENT UPON WRITTEN NOTICE TO THE SUPPLIER.
8
CONFIDENTIAL
CERTAIN INFORMATION HAS BEEN REDACTED
CONFIDENTIAL TREATMENT REQUESTED
5.3
RECORDS.
THE SUPPLIER WILL MAINTAIN ITS RECORDS WITH RESPECT TO
THE MANUFACTURE OF THE PRODUCTS FOR TEN (10) YEARS AFTER THE DATE OF MANUFACTURE
OF THE LAST PRODUCT UNDER THIS AGREEMENT, AFTER WHICH SUPPLIER SHALL TRANSFER
SUCH RECORDS TO PURCHASER.
5.4
MEDICAL DEVICE REPORTING.
PURCHASER SHALL BE RESPONSIBLE TO
REPORT EVENTS IN COMPLIANCE WITH FDA MEDICAL DEVICE REPORTING REGULATION SET
FORTH IN 21 CFR PART 803 AND ANY APPLICABLE INTERNATIONAL REGULATIONS.
PURCHASER AGREES TO MAKE MEDICAL DEVICE REPORTS AVAILABLE TO SUPPLIER WITHIN
THREE (3) DAYS OF THE INITIAL RECEIPT OF ANY REPORT THAT REASONABLY SUGGESTS
THAT ONE OF THE PRODUCTS (I) MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR
SERIOUS INJURY OR (II) HAS MALFUNCTIONED.
5.5
NOTICES FROM REGULATORY AUTHORITIES.
A PARTY RECEIVING (THE
"REGULATORY RECEIVING PARTY") COMMUNICATIONS FROM ANY REGULATORY AUTHORITY,
INCLUDING ANY FDA FORM 483 REPORT ON INSPECTIONAL OBSERVATIONS OR EQUIVALENT
NOTICE, SHALL PROVIDE TO THE OTHER PARTY WITHIN TWENTY-FOUR (24) HOURS COPIES OF
ANY SUCH COMMUNICATIONS IT RECEIVES RELATED TO THE PRODUCTS.
5.6
PERMITS, ETC.
THE PURCHASER SHALL OBTAIN, AT THE PURCHASER'S SOLE
EXPENSE, ALL PERMITS, LICENSES, APPROVALS, CONSENTS, AND AUTHORIZATIONS FROM ALL
GOVERNMENTAL AUTHORITIES AS MAY BE NECESSARY OR APPROPRIATE TO MARKET, SOLICIT
ORDERS FOR, AND SELL THE PRODUCTS.
5.7
PRODUCT COMPLAINTS.
IN REVIEWING CUSTOMER COMPLAINTS CONCERNING
THE PRODUCTS, THE PURCHASER SHALL BE CONSIDERED THE "MANUFACTURER" FOR
REGULATORY PURPOSES, AND SHALL RECEIVE AND LOG ALL COMPLAINTS FROM CUSTOMERS
USING THE PRODUCTS.
IF AFTER EVALUATION BY THE PURCHASER OF THE COMPLAINTS, THE
PURCHASER REASONABLY BELIEVES THAT A COMPLAINT RELATES TO A BREACH BY THE
SUPPLIER OF THE WARRANTY CONTAINED IN SECTION 6.1, THE PURCHASER WILL