ADDRESS SPECIFIC QUALITY PROBLEMS RELATING TO PRODUCT,
AS WELL AS IN PREPARATION FOR REGULATORY FILINGS AND IN RESPONSE TO REGULATORY
AUTHORITY REQUIREMENTS. ANY CORRECTIVE ACTION MUTUALLY AGREED UPON BY THE
PARTIES IN RESPONSE TO NUVASIVE'S AUDIT OR INSPECTION SHALL BE IMPLEMENTED BY
OSIRIS, AT OSIRIS' EXPENSE, PRIOR TO FILLING NEW OR OUTSTANDING ORDERS.
OSIRIS
HEREBY AGREES TO ADVISE NUVASIVE PROMPTLY (AND, IN ANY EVENT, WITHIN THIRTY-SIX
(36) HOURS) OF ANY PROPOSED OR UNANNOUNCED VISIT OR INSPECTION BY ANY AGENT OF A
REGULATORY AUTHORITY TO THE FACILITY WHERE SUCH VISIT OR INSPECTION IS
SPECIFICALLY RELATED TO THE PRODUCT OR ITS PROCESSING (A "PRODUCT-RELATED
INSPECTION").
OSIRIS AGREES TO PERMIT, TO THE EXTENT REASONABLY PRACTICAL, ONE
OR MORE QUALIFIED REPRESENTATIVE(S) OF NUVASIVE TO BE PRESENT DURING A
PRODUCT-RELATED INSPECTION IF REQUESTED BY NUVASIVE.
IF NUVASIVE IS NOT PRESENT
DURING A PRODUCT-RELATED INSPECTION, OSIRIS SHALL PROMPTLY PROVIDE A SUMMARY
REPORT OF THE RESULTS OF THE PRODUCT-RELATED INSPECTION TO NUVASIVE.
OSIRIS
SHALL PROMPTLY NOTIFY NUVASIVE OF THE RESULTS OF ANY INSPECTION, COMMENTS,
RESPONSES OR NOTICES RECEIVED FROM THE FDA, AATB, OR OTHER APPLICABLE REGULATORY
AUTHORITIES, WHICH RELATE TO THE PROCESSING OF PRODUCT HEREUNDER.
WITH RESPECT
TO THE
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FORGOING, EACH PARTY SHALL PROVIDE THE OTHER PARTY AT SUCH OTHER PARTY'S REQUEST
WITH COPIES OF ANY NOTICES OR CORRESPONDENCE FROM OR TO SUCH REGULATORY
AUTHORITIES THAT DIRECTLY RELATE TO PRODUCT.
SUCH NOTICES AND CORRESPONDENCE
ARE CONSIDERED CONFIDENTIAL INFORMATION IN ACCORDANCE WITH THIS AGREEMENT. THE
PARTIES WILL COOPERATE IN THE DEVELOPMENT AND REVIEW OF RESPONSES THAT ARE
REQUIRED TO BE SUBMITTED TO ANY REGULATORY AUTHORITY RELATING TO THE PROCESSING
OF PRODUCT PRIOR TO SUBMISSION TO THE REGULATORY AUTHORITY.
5.2.
RECORDS; SAFETY.
OSIRIS SHALL MAINTAIN ACCURATE AND COMPLETE
RECORDS OF ITS PROCUREMENT, PROCESSING AND SUPPLY OF PRODUCT HEREUNDER FOR THE
LONGER OF FIVE (5) YEARS AFTER SHIPMENT OF ANY SUCH PRODUCT, OR THE PERIOD OF
TIME REQUIRED BY APPLICABLE LAWS, REGULATIONS AND/OR STANDARDS, WHICHEVER IS
GREATER.
NO RECORDS REQUIRED BY THIS AGREEMENT SHALL BE DISCARDED BY OSIRIS
WITHOUT SPECIFIC PRIOR WRITTEN NOTIFICATION OF OSIRIS' INTENT TO DISCARD TO
NUVASIVE.
THOSE RECORDS (OR COPIES OF THOSE RECORDS) THAT OSIRIS IS UNWILLING
TO RETAIN WILL BE TRANSFERRED TO NUVASIVE FOR STORAGE.
OSIRIS SHALL PROMPTLY
(AND, IN ANY EVENT, WITHIN TWENTY FOUR (24) HOURS) NOTIFY NUVASIVE OF ANY
INFORMATION OF WHICH IT BECOMES AWARE CONCERNING PRODUCT SUPPLIED TO NUVASIVE.
ANY SUCH NOTIFICATION WILL INCLUDE ALL RELATED INFORMATION IN REASONABLE
DETAIL.
UPON SUCH NOTIFICATION, THE PARTIES SHALL CONSULT WITH EACH OTHER IN AN
EFFORT TO ARRIVE AT A MUTUALLY ACCEPTABLE PROCEDURE FOR TAKING APPROPRIATE
ACTION; PROVIDED, HOWEVER, THAT NOTHING CONTAINED HEREIN SHALL BE CONSTRUED AS
RESTRICTING THE RIGHT OF EITHER PARTY TO MAKE A TIMELY REPORT OF SUCH MATTER TO
ANY REGULATORY AUTHORITY OR TAKE OTHER ACTION THAT IT DEEMS TO BE APPROPRIATE OR
REQUIRED BY APPLICABLE LAWS.
5.3.
REGULATORY COMPLIANCE.
WITH RESPECT TO EACH PARTY'S PERFORMANCE
UNDER THIS AGREEMENT, OSIRIS AND NUVASIVE SHALL EACH COMPLY WITH ALL APPLICABLE
LAWS, REGULATIONS, AND STANDARDS.
5.4.
AATB ACCREDITATION.
THE PARTIES AGREE THAT OSIRIS