AGREEMENT
IS EXPRESSLY CONDITIONED UPON NUVASIVE'S ABILITY TO REGULARLY INSPECT THE
FACILITY, NUVASIVE'S ABILITY TO REGULARLY REVIEW BTC'S PROCESSING PRACTICES, AND
NUVASIVE'S BEING REASONABLY SATISFIED THAT THE FACILITY AND BTC'S PROCESSING
PRACTICES CONFORM TO ALL OF REQUIREMENTS SET FORTH IN THIS AGREEMENT AND IMPOSED
BY GOVERNING LAW (AS DEFINED IN SECTION 12) AND ALL APPLICABLE REGULATIONS.
BTC
SHALL REQUEST AN AUDIT OF THE DISTRIBUTION FACILITY (S) FOR NUVASIVE AT LEAST
ONCE EVERY 2 YEARS ACCORDING TO AATB STANDARDS.
(E)
NUVASIVE INSTRUMENTATION.
NUVASIVE MAY PROVIDE BTC WITH CERTAIN
INSTRUMENTATION FOR PROCESSING, CUTTING, PACKAGING AND/OR OTHERWISE PROVIDING
TISSUES TO NUVASIVE UNDER THIS AGREEMENT, INCLUDING BUT NOT LIMITED TO PACKAGING
EQUIPMENT FOR PROVIDING THE TISSUES IN STERILE SALINE UNDER US PATENT NO.
6,739,112 OWNED BY NUVASIVE, AND STAMPING, CUTTING, HOLDING AND/OR MILLING
EQUIPMENT FOR MANUFACTURING THE TISSUES ACCORDING TO THIS AGREEMENT ("NUVASIVE
INSTRUMENTATION").
BTC AGREES THAT THE NUVASIVE INSTRUMENTATION (ALONG WITH ANY
AND ALL PROPRIETARY RIGHTS PERTAINING THERETO, INCLUDING ANY IMPROVEMENTS MADE
BY BTC) SHALL BE THE SOLE AND EXCLUSIVE PROPERTY OF NUVASIVE.
BTC SHALL HAVE A
LIMITED LICENSE TO USE NUVASIVE INSTRUMENTATION (AND THE PROPRIETARY RIGHTS
THERETO) SOLELY FOR USE IN PROVIDING TISSUES TO NUVASIVE DURING THE TERM OF THIS
AGREEMENT.
BTC AGREES THAT BTC SHALL BE STRICTLY PROHIBITED FROM PROCESSING,
CUTTING, PACKAGING AND/OR OTHERWISE PROVIDING TISSUES TO THIRD PARTIES USING
NUVASIVE INSTRUMENTATION AND/OR THE PROPRIETARY RIGHTS THERETO.
BTC SHALL
MAINTAIN THE NUVASIVE INSTRUMENTATION IN GOOD WORKING CONDITION WHILE IN BTC'S
USE, CARE OR POSSESSION, SHALL PERFORM ALL MAINTENANCE AND REPAIRS REQUIRED TO
KEEP THE NUVASIVE INSTRUMENTATION IN SUCH CONDITION, AND HEREBY ASSUMES ALL
RESPONSIBILITY AND LIABILITY FOR ANY LOSS, THEFT OR DESTRUCTION OF THE NUVASIVE
INSTRUMENTATION PRIOR TO ITS RETURN TO NUVASIVE, AS WELL AS ANY DAMAGE, INJURY
OR HARM CAUSED BY THE NUVASIVE INSTRUMENTATION OR BTC'S USE THEREOF PRIOR TO ITS
RETURN TO NUVASIVE.
UPON ANY TERMINATION OF THIS AGREEMENT, BTC'S LIMITED
LICENSE TO USE THE NUVASIVE INSTRUMENTATION (AND THE PROPRIETARY RIGHTS THERETO)
SHALL IMMEDIATELY CEASE AND BTC SHALL PROMPTLY RETURN THE NUVASIVE
INSTRUMENTATION TO NUVASIVE IN GOOD WORKING CONDITION.
3
2.
RESPONSIBILITIES OF NUVASIVE.
(A)
PAYMENTS.
NUVASIVE SHALL PROMPTLY PAY FOR THE TISSUES SHIPPED TO
IT AS PER THE TERMS OF SECTION 3 BELOW.
(B)
SPECIFICATIONS.
NUVASIVE SHALL PROVIDE THE WRITTEN SPECIFICATIONS
TO BTC IN SUFFICIENT DETAIL TO ENABLE BTC TO PROCESS THE TISSUES AS EFFICIENTLY
AS POSSIBLE.
(C)
INSPECTION OF FACILITIES.
BTC SHALL HAVE THE RIGHT TO INSPECT THE
HANDLING AND STORAGE FACILITY WHERE THE TISSUES ARE TO BE STORED BY NUVASIVE
PENDING FURTHER SHIPMENT BY NUVASIVE (THE "NUVASIVE FACILITY") BETWEEN THE HOURS
OF 9:00 A.M. AND 5:00 P.M. ON ANY BUSINESS DAY UPON GIVING NO LESS THAN 24 HOURS
WRITTEN NOTICE DURING THE TERM OF THIS AGREEMENT IN ORDER TO ENSURE NUVASIVE'S
CONTINUING COMPLIANCE WITH THE TERMS AND CONDITIONS OF THIS AGREEMENT.
THE
PERFORMANCE OF BTC'S OBLIGATIONS UNDER THIS AGREEMENT IS EXPRESSLY CONDITIONED
UPON BTC'S ABILITY TO REGULARLY INSPECT THE NUVASIVE FACILITY, BTC'S ABILITY TO
REGULARLY REVIEW NUVASIVE'S HANDLING AND STORING PRACTICES, AND BTC'S BEING
REASONABLY