IS ACTIVELY
PURSUING AATB ACCREDITATION, AND THAT NUVASIVE SHALL CONTINUE TO PERFORM ITS
OBLIGATIONS UNDER THIS AGREEMENT DESPITE THE PENDENCY OF SUCH AATB ACCREDITATION
FOR SO LONG AS OSIRIS IS USING REASONABLE COMMERCIAL EFFORTS TO OBTAIN SUCH
ACCREDITATION.
ONCE OBTAINED, OSIRIS AGREES TO MAINTAIN ITS ACCREDITATION WITH
THE AATB AND SHOULD OSIRIS' ACCREDITATION LAPSE AT ANY TIME OR FOR ANY REASON,
IT SHALL PROMPTLY COMMUNICATE TO THE NUVASIVE THE REASONS FOR SUCH LAPSE AND THE
ACTIONS TAKEN TO CURE THE LOSS OF AATB ACCREDITATION. IN THE EVENT THAT OSIRIS
FAILS TO CURE SUCH LOSS WITHIN SIX MONTHS, NOTWITHSTANDING ANY PROVISION TO THE
CONTRARY CONTAINED IN THIS AGREEMENT, NUVASIVE SHALL BE IMMEDIATELY AND FOREVER
RELIEVED OF ANY OBLIGATION TO ORDER PRODUCT OR TO PAY ANY FEES WITH RESPECT
THERETO AND SHALL HAVE THE RIGHT TO CANCEL OR AMEND, WITHOUT LIABILITY, ANY
ORDERS THEN PENDING; PROVIDED, HOWEVER, NUVASIVE SHALL PAY THE PRODUCT FEES FOR
ALL ORDERS SHIPPED AS LONG AS SUCH ORDERS ARE FILLED WITH PRODUCT PROCESSED
WHILE OSIRIS WAS ACCREDITED.
5.5.
COMPLAINTS.
OSIRIS HEREBY AGREES TO ADVISE NUVASIVE PROMPTLY
(AND, IN ANY EVENT, WITHIN THIRTY-SIX (36) HOURS) OF ANY COMPLAINT INFORMATION
(INCLUDING ADVERSE EVENT INFORMATION) OSIRIS RECEIVES RELATING TO PRODUCT.
OSIRIS WILL ASSIST NUVASIVE IN INVESTIGATING AND RESOLVING ALL COMPLAINTS AND
ADVERSE EVENTS RELATED TO THE PROCESSING OF PRODUCT.
NUVASIVE WILL BE
RESPONSIBLE FOR EVALUATING AND INVESTIGATING COMPLAINTS AND THE PARTIES WILL
COOPERATE IN PREPARING
COMMUNICATIONS TO ANY REGULATORY AUTHORITIES REGARDING
PRODUCT COMPLAINTS OR ADVERSE EVENTS.
OSIRIS WILL TAKE ANY CORRECTIVE ACTIONS
AGREED TO BY THE PARTIES TO AVOID FUTURE OCCURRENCES OF PRODUCT COMPLAINTS OR
ADVERSE EVENTS RELATED TO THE PROCESSING OF THE PRODUCT.
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5.6.
PRODUCT TRACKING.
NUVASIVE SHALL BE RESPONSIBLE FOR MAINTAINING
TRACKABILITY FOR ALL PRODUCTS PROVIDED BY OSIRIS. TRACKING RECORDS SHALL BE
MAINTAINED BY NUVASIVE IN ACCORDANCE WITH ALL APPLICABLE LAWS.
5.7.
PRODUCT WITHDRAWAL.
IN THE EVENT OSIRIS OR NUVASIVE BELIEVES IT
MAY BE NECESSARY TO CONDUCT A RECALL, FIELD CORRECTION, MARKET WITHDRAWAL, STOCK
RECOVERY, OR OTHER SIMILAR ACTION WITH RESPECT TO PRODUCT (A "PRODUCT
WITHDRAWAL"), NUVASIVE SHALL MAKE ALL DECISIONS AS TO SUCH PRODUCT WITHDRAWAL
AND OSIRIS SHALL COOPERATE WITH NUVASIVE IN ANY PRODUCT WITHDRAWAL. NUVASIVE
SHALL BEAR ALL COSTS IN CONNECTION WITH ANY SUCH PRODUCT WITHDRAWAL AND NUVASIVE
SHALL REIMBURSE OSIRIS FOR ALL REASONABLE OUT-OF-POCKET EXPENSES INCURRED BY
OSIRIS IN CONNECTION WITH ANY SUCH PRODUCT WITHDRAWAL; PROVIDED, HOWEVER, THAT
IF SUCH PRODUCT WITHDRAWAL IS ATTRIBUTABLE TO ANY BREACH, MISREPRESENTATION OR
NON-FULFILLMENT OF ANY COVENANT, AGREEMENT, REPRESENTATION OR WARRANTY MADE OR
TO BE PERFORMED BY OSIRIS UNDER THE ASSET PURCHASE AGREEMENT OR THIS AGREEMENT
(INCLUDING, WITHOUT LIMITATION, THE FAILURE OF ANY PRODUCT SUPPLIED HEREUNDER TO
MEET THE OSIRIS PRODUCT WARRANTY) OR TO THE NEGLIGENT ACT OR OMISSION OR WILLFUL
MISCONDUCT OF OSIRIS, OSIRIS SHALL REIMBURSE NUVASIVE FOR ALL COSTS REASONABLY
INCURRED BY NUVASIVE IN CONNECTION WITH ANY SUCH PRODUCT WITHDRAWAL.
ARTICLE 6
INDEMNIFICATION AND INSURANCE
6.1.
OSIRIS'S INDEMNITY OBLIGATIONS.
OSIRIS SHALL DEFEND, INDEMNIFY
AND HOLD HARMLESS NUVASIVE, ITS AFFILIATES AND THEIR RESPECTIVE SUCCESSORS AND
PERMITTED ASSIGNS