DISCLOSURE; PROVIDED THAT INFORMATION SHALL NOT BE
DEEMED "CONFIDENTIAL INFORMATION" WHICH IS (A) PUBLICLY KNOWN, THROUGH NO FAULT
OF THE RECEIVING PARTY, (B) RECEIVED BY THE RECEIVING PARTY FROM A SOURCE HAVING
THE RIGHT TO
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DISCLOSE SUCH INFORMATION, (C) KNOWN BY THE RECEIVING PARTY PRIOR TO DISCLOSURE
OF SUCH INFORMATION, OR (D) INDEPENDENTLY DEVELOPED BY THE RECEIVING PARTY
WITHOUT USE OF THE DISCLOSING PARTY'S INFORMATION.
NOTWITHSTANDING THE
FOREGOING AND FOR THE AVOIDANCE OF DOUBT, THE CONFIDENTIAL INFORMATION OF
NUVASIVE INCLUDES ALL LICENSED TECHNOLOGY, WHETHER OR NOT MARKED, IDENTIFIED OR
OTHERWISE ACKNOWLEDGED TO BE CONFIDENTIAL AND WHETHER OR NOT KNOWN OR DEVELOPED
BY OSIRIS, AND THE USE AND DISCLOSURE OF LICENSED TECHNOLOGY BY OSIRIS (AS THE
RECEIVING PARTY HEREUNDER) SHALL BE SUBJECT TO SECTION 8.3.
1.7.
"CPI" SHALL MEAN THE "PRICE INDEX FOR ALL URBAN CONSUMERS, U.S.
CITY AVERAGE, ALL ITEMS, FOR THE THEN IMMEDIATELY PRECEDING 12-MONTH PERIOD" AS
PUBLISHED BY THE US GOVERNMENT.
1.8.
"DAMAGES" SHALL HAVE THE MEANING AS SUCH TERM IS DEFINED IN
SECTION 6.1 OF THIS AGREEMENT.
1.9.
"DELIVER" OR "DELIVERY" WITH RESPECT TO PRODUCT MEANS, AND SHALL
TAKE PLACE UPON, THE TRANSFER OF POSSESSION OF PRODUCT TO A CARRIER, FCA THE
FACILITY (INCOTERMS 2000).
1.10.
"DONOR" MEANS A HUMAN TISSUE DONOR.
1.11.
"DONOR TISSUE" MEANS HUMAN MUSCULOSKELETAL TISSUE, INCLUDING BONE
AND CONNECTIVE TISSUE.
1.12.
"EXCESS QUANTITIES" SHALL HAVE THE MEANING AS SUCH TERM IS DEFINED
IN SECTION 3.3 OF THIS AGREEMENT.
1.13.
"EXECUTIVES" SHALL HAVE THE MEANING AS SUCH TERM IS DEFINED IN
SECTION 9.8 OF THIS AGREEMENT.
1.14.
"FACILITY" MEANS THE FACILITY AT WHICH OSIRIS OR ITS SUBCONTRACTORS
SET FORTH ON SCHEDULE 3.11, OR OTHERWISE APPROVED BY NUVASIVE IN ACCORDANCE WITH
SECTION 3.11, WILL PROCESS PRODUCT UNDER THIS AGREEMENT.
1.15.
"FDA" MEANS THE U.S. FOOD AND DRUG ADMINISTRATION, AND ANY
SUCCESSOR OR REPLACEMENT AGENCY THERETO.
1.16.
"INVENTIONS" SHALL HAVE THE MEANING AS SUCH TERM IS DEFINED IN
SECTION 8.2 OF THIS AGREEMENT.
1.17.
"LATENT DEFECT" MEANS ANY DEFECT IN ANY LOT OR OTHER SHIPMENT OF
PRODUCT THAT COULD NOT REASONABLY BE FOUND BY THE EXERCISE OF ORDINARY CARE IN
AN INITIAL PHYSICAL INSPECTION BY NUVASIVE, SUCH AS, BUT NOT LIMITED TO, THE
PRESENCE OF A CONTAMINANT OR OSIRIS' FAILURE TO PROCESS PRODUCT IN ACCORDANCE
WITH CGTP.
1.18.
"LAWS" MEANS ALL LAWS, RULES, REGULATIONS, ORDINANCES, STANDARDS
AND GUIDELINES THAT APPLY TO THE PROCESSING OF PRODUCT OR THE PERFORMANCE OF
EITHER PARTY'S OBLIGATIONS UNDER THIS AGREEMENT, AS THE CONTEXT REQUIRES UNDER
THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, THE PUBLIC HEALTH SERVICE ACT, 42
U.S.C. §201 ET SEQ., THE UNITED STATES NATIONAL ORGAN TRANSPLANT ACT, TITLE 21
OF THE CODE OF FEDERAL REGULATIONS PARTS 1270 AND 1271, HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE BASED PRODUCTS, OTHER RULES, REGULATIONS OR STANDARDS
PROMULGATED BY THE FDA OR ANY OTHER APPLICABLE GOVERNMENTAL AGENCY, AND OF THE
AATB, AS EACH MAY BE AMENDED FROM TIME TO TIME.
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1.19.
"LICENSED TECHNOLOGY" MEANS THE INTELLECTUAL PROPERTY (INCLUDING
PATENTS AND PATENTS PENDING OF NUVASIVE), METHODS, TECHNOLOGY, AND KNOW-HOW
OWNED OR LICENSED