MAY BE USED BY NUVASIVE FOR FINAL RELEASE OF EACH LOT WITHOUT
ADDITIONAL TESTING BY NUVASIVE; PROVIDED, HOWEVER, THAT NUVASIVE MAY CONDUCT ITS
OWN RELEASE TESTING OF EACH LOT IN ITS DISCRETION. NUVASIVE (IN ITS SOLE
DISCRETION) SHALL DETERMINE THE FORM AND SUBSTANCE OF ANY RELEASE TESTING
INFORMATION THAT IS SUBMITTED TO ANY REGULATORY AUTHORITY.
AT THE TIME OF
DELIVERY OF EACH LOT, OSIRIS SHALL SEND TO NUVASIVE A SIGNED CERTIFICATE OF
ANALYSIS WITH RESPECT TO SUCH LOT. WITHIN THIRTY (30) DAYS FOLLOWING THE
DELIVERY OF EACH LOT, OSIRIS SHALL PROVIDE NUVASIVE WITH PROPERLY COMPLETED
COPIES OF LOT RECORDS FOR SUCH LOT PREPARED IN ACCORDANCE WITH THE
SPECIFICATIONS AND APPLICABLE LAWS.
3.6.
REJECTION AND CURE.
UPON RECEIPT OF EACH SHIPMENT OF PRODUCT,
NUVASIVE OR ITS CUSTOMERS SHALL PERFORM AN INITIAL PHYSICAL INSPECTION OF SUCH
PRODUCT AND REVIEW ANY RELATED DOCUMENTATION.
IF ANY PRODUCT (INCLUDING WITHOUT
LIMITATION ANY DOCUMENTATION RELATED THERETO) FAILS, IN WHOLE OR IN PART, TO
CONFORM TO THE APPLICABLE SPECIFICATIONS AND THE TERMS HEREOF, OR IF ANY PRODUCT
IS NOT PROCESSED IN ACCORDANCE WITH CGTP OR APPLICABLE LAWS, THEN NUVASIVE SHALL
HAVE THE RIGHT TO REJECT SUCH NONCONFORMING PRODUCT.
NUVASIVE SHALL GIVE
WRITTEN NOTICE TO OSIRIS OF ITS REJECTION HEREUNDER AS SOON AS POSSIBLE, BUT NO
MORE THAN THIRTY (30) DAYS AFTER NUVASIVE'S OR ITS CUSTOMER'S RECEIPT OF SUCH
SHIPMENT, SPECIFYING THE GROUNDS FOR SUCH REJECTION.
IF AT ANY TIME THEREAFTER
NUVASIVE DISCOVERS A LATENT DEFECT, NUVASIVE SHALL GIVE WRITTEN NOTICE TO OSIRIS
OF ITS REJECTION HEREUNDER AS SOON AS POSSIBLE, BUT NO MORE THAN NINETY (90)
DAYS AFTER NUVASIVE'S RECEIPT OF THE PRODUCT, SPECIFYING THE GROUNDS FOR SUCH
REJECTION.
THE NONCONFORMING PRODUCT SHALL BE HELD FOR OSIRIS'S DISPOSITION, OR
SHALL BE RETURNED TO OSIRIS, IN EACH CASE AT OSIRIS'S EXPENSE, AS DIRECTED BY
OSIRIS.
OSIRIS SHALL USE COMMERCIALLY REASONABLE BEST EFFORTS TO CORRECT THE
ROOT CAUSE OF THE NONCONFORMANCE IN ORDER TO COMPLY WITH THE REQUIREMENTS OF THE
APPLICABLE SPECIFICATION.
IN ADDITION, OSIRIS SHALL, AT ITS EXPENSE, PROMPTLY
REPLACE EACH NONCONFORMING PRODUCT WITH CONFORMING PRODUCT.
3.7.
WARRANTY.
WITH RESPECT TO PRODUCT SUPPLIED HEREUNDER, OSIRIS
WARRANTS ("OSIRIS PRODUCT WARRANTY") THAT THE (A) PRODUCT SHALL CONFORM WITH THE
APPLICABLE SPECIFICATIONS THEREFOR, SHALL BE FREE FROM DEFECTS IN MATERIALS OR
WORKMANSHIP, AND SHALL NOT BE ADULTERATED, MISBRANDED, CONTAMINATED, TAMPERED
WITH OR OTHERWISE ALTERED OR MISHANDLED WHILE IN THE CUSTODY AND CONTROL OF
OSIRIS; AND (B) PRODUCT SHALL BE PROCESSED IN ACCORDANCE WITH THE APPLICABLE
SPECIFICATIONS, AND IN COMPLIANCE WITH CGTP AND ALL APPLICABLE LAWS.
OSIRIS
HEREBY REPRESENTS, WARRANTS AND COVENANTS THAT IT WILL NOT, AND HAS NOT,
EMPLOYED OR OTHERWISE USED IN ANY CAPACITY THE SERVICES OF ANY PERSON DEBARRED
UNDER SECTION 21 U.S.C. 335A IN PERFORMING ANY PORTION OF THE PROCESSING OF
PRODUCT.
EXCEPT AS PROVIDED HEREIN, OSIRIS MAKES NO OTHER WARRANTIES, EXPRESS
OR IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY OR WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
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3.8.
PACKAGING; LABELING; MARKETING.
OSIRIS SHALL PACKAGE AND LABEL
THE PRODUCT ACCORDING