TO THE SPECIFICATIONS AND IN COMPLIANCE WITH CGTP AND ALL
APPLICABLE LAWS, RULES, REGULATIONS, AND/OR STANDARDS. PRODUCT SUPPLIED TO
NUVASIVE SHALL BE LABELED AS DETERMINED BY NUVASIVE, PROVIDED THAT NUVASIVE
SHALL PROVIDE OSIRIS WITH AT LEAST THIRTY (30) DAYS PRIOR WRITTEN NOTICE OF ANY
LABELING CHANGES (INCLUDING, BUT NOT LIMITED TO, BRAND NAMES), AND OSIRIS SHALL
BE ENTITLED TO RECOVER, AND NUVASIVE SHALL BE RESPONSIBLE TO PAY TO OSIRIS, ALL
REASONABLE OUT OF POCKET COSTS THAT OSIRIS INCURS ASSOCIATED WITH SUCH LABELING
CHANGE. EACH UNIT OF PRODUCT SHALL HAVE A UNIQUE IDENTIFICATION NUMBER.
3.9.
REGULATORY APPROVALS.
PRODUCT IS CURRENTLY REGULATED UNDER 21 CFR
PARTS 1270 AND 1271 AS A HUMAN CELLULAR AND TISSUE BASED TISSUE PRODUCT.
NUVASIVE SHALL OBTAIN AT ITS EXPENSE ALL REGULATORY APPROVAL BY THE FDA OR OTHER
REGULATORY AUTHORITY NECESSARY OR REQUIRED FOR THE DISTRIBUTION, SALE AND
MARKETING OF PRODUCT UNDER CURRENT LAWS AS OF THE EFFECTIVE DATE.
AT NUVASIVE'S
REQUEST DURING THE TERM, OSIRIS WILL ASSIST NUVASIVE IN PREPARING THE PORTIONS
OF NUVASIVE'S REGULATORY FILINGS THAT PERTAIN TO PROCESSING AND WILL MAKE
APPROPRIATE OSIRIS PERSONNEL REASONABLY AVAILABLE FOR MEETINGS WITH REGULATORY
AUTHORITIES RELATING TO PROCESSING, PROVIDED THAT ALL SUCH REGULATORY FILINGS
SHALL BE THE SOLE AND EXCLUSIVE PROPERTY OF NUVASIVE AND NUVASIVE SHALL HAVE
SOLE AUTHORITY AND RESPONSIBILITY WITH RESPECT TO CONTACTS AND COMMUNICATIONS
WITH REGULATORY AUTHORITIES RELATING TO THE PRODUCT. IN THE EVENT OF CHANGES IN
APPLICABLE LAWS, OR SIGNIFICANT REGULATORY DIFFERENCES IN FOREIGN COUNTRIES
WHERE NUVASIVE DISTRIBUTES PRODUCT, THE PARTIES SHALL COOPERATE TO DETERMINE
WHAT ACTIONS, IF ANY, ARE REQUIRED TO MEET ANY NEW OR FOREIGN REGULATIONS AND
SHALL NEGOTIATE IN GOOD FAITH CHANGES TO THIS AGREEMENT INCLUDING BUT NOT
LIMITED TO, CHANGES TO ORDERS, PRODUCT FEES AND MINIMUM PERFORMANCE LEVELS TO
REFLECT ANY CHANGE IN PRODUCT MANUFACTURING COSTS. NO CHANGE IN PRODUCT-SPECIFIC
MANUFACTURING PROCESSES, TEST METHODS, OR OTHER PROCEDURES OR DOCUMENTATION
RELATING TO PROCESSING SHALL BE IMPLEMENTED BY OSIRIS UNLESS AND UNTIL THE
PARTIES HAVE AGREED IN WRITING TO SUCH CHANGE.
3.10.
TECHNOLOGY LICENSE. NUVASIVE HEREBY GRANTS TO OSIRIS DURING THE
TERM, FOR THE SOLE PURPOSE OF PERFORMING ITS DUTIES AND FULFILLING ITS
OBLIGATIONS UNDER THIS ARTICLE 3, A NON-EXCLUSIVE AND NON-TRANSFERABLE LICENSE,
WITHOUT A RIGHT TO SUBLICENSE, TO USE THE LICENSED TECHNOLOGY SOLELY TO THE
EXTENT NECESSARY TO PROCESS THE PRODUCT UNDER THE TERMS AND CONDITIONS OF THIS
AGREEMENT. NOTWITHSTANDING THE FOREGOING, NUVASIVE HEREBY CONSENTS TO THE
SUBLICENSE BY OSIRIS OF THE LICENSED TECHNOLOGY TO THE PERSONS LISTED ON
SCHEDULE 3.11 SOLELY TO THE EXTENT NECESSARY FOR SUCH SUBCONTRACTOR TO PROVIDE
PROCESSING SERVICES TO OSIRIS, PROVIDED THAT THE TERMS OF ANY SUCH SUBLICENSE
ARRANGEMENT SHALL EITHER BE PURSUANT TO (I) THE TERMS OF THOSE CONTRACTS BETWEEN
SELLER AND SUCH PERSONS WHICH ARE IDENTIFIED ON SCHEDULE 3.11 HERETO AS SUCH
CONTRACTS ARE IN EFFECT ON THE DATE HEREOF OR (II) REQUIRE THE PRIOR WRITTEN
CONSENT OF NUVASIVE, WHICH CONSENT SHALL NOT BE UNREASONABLY WITHHELD.
3.11.
SUBCONTRACTING.
EXCEPT AS PROVIDED ON SCHEDULE 3.11, OSIRIS SHALL
NOT ASSIGN, SUBCONTRACT, OR DELEGATE ANY OF ITS RESPONSIBILITIES