OPERATIONS
HEREUNDER AND OTHER LILLY MANUFACTURING OPERATIONS, SHALL BE DETERMINED IN A
MANNER CONSISTENT WITH THE INTERNAL METHODS USED BY LILLY FOR OTHER PRODUCTS AND
CONSISTENT WITH GENERALLY ACCEPTED ACCOUNTING PRACTICES IN THE U.S.
THE
FOREGOING DEFINITION OF ACTUAL MANUFACTURING COST ASSUMES THAT LILLY USES
DEDICATED CAPACITY FOR
PRIMARY EQUIPMENT FOR THE MANUFACTURE OF DEVICES.
IN
THE EVENT THAT LILLY DOES NOT USE DEDICATED CAPACITY FOR PRIMARY EQUIPMENT FOR
THE MANUFACTURE OF DEVICES, THE PARTIES SHALL AGREE IN GOOD FAITH UPON AN
APPROPRIATE ALLOCATION OF COSTS ASSOCIATED WITH THE MANUFACTURE OF DEVICES BASED
ON RELATIVE USAGE.
1.2
"APPLICABLE LAWS" MEANS ALL APPLICABLE
STATUTES, ORDINANCES, REGULATIONS, RULES OR ORDERS OF ANY KIND WHATSOEVER OF ANY
GOVERNMENTAL AUTHORITY, INCLUDING, WITHOUT LIMITATION, THE FD&C ACT, THE
REGULATORY LAW, PRESCRIPTION DRUG MARKETING ACT, GENERIC DRUG ENFORCEMENT ACT OF
1992 (21 U.S.C. §3359, ET. SEQ.), ANTI-KICKBACK STATUTE (42 U.S.C. §1320 A-7B,
ET. SEQ., RESOURCE CONSERVATION AND RECOVERY ACT, CLEAN WATER ACT, CLEAN AIR
ACT, THE DRUG ENFORCEMENT ACT, OCCUPATIONAL SAFETY AND HEALTH ACT, CGMP, CQSR
AND ANY COMPARABLE LAWS OF ANY FOREIGN JURISDICTION, ALL AS AMENDED FROM TIME TO
TIME.
1.3
"CQSR" MEANS THE THEN CURRENT QUALITY SYSTEM
REGULATIONS AS DEFINED IN THE UNITED STATES CODE OF FEDERAL REGULATIONS, 21 CFR
PART 820 AND, IN THE CASE OF FOREIGN JURISDICTIONS, COMPARABLE REGULATORY
STANDARDS.
2
1.4
"COLLABORATION AGREEMENT" MEANS THE
COLLABORATION AGREEMENT SET FORTH IN THE RECITALS OF THIS AGREEMENT, AS THE SAME
MAY BE AMENDED FROM TIME TO TIME.
1.5
"COMMENCEMENT DATE" MEANS THE EARLIER OF THE
FOLLOWING:
(I) THE DATE UPON WHICH ALL DEVELOPMENT ACTIVITIES WITH RESPECT TO
DEVICES HAVE BEEN COMPLETED AS REASONABLY DETERMINED BY THE DWT OR (II) THE DATE
UPON WHICH ANY REGULATORY AUTHORITY GRANTS EITHER PARTY MARKETING APPROVAL OF
PRODUCT IN THE U.S.
1.6
"COMMITTEE" MEANS (A) THE JDC FOR SO LONG AS
THE JDC HAS RESPONSIBILITY FOR MANUFACTURING MATTERS PURSUANT TO THE
COLLABORATION AGREEMENT AND (B) THE JCC FROM AND AFTER SUCH TIME AS
RESPONSIBILITY FOR MANUFACTURING MATTERS IS TRANSFERRED FROM THE JDC TO THE JCC
PURSUANT TO THE COLLABORATION AGREEMENT.
1.7
"DEDICATED CAPACITY" MEANS CAPACITY THAT IS
DESIGNATED TO BE USED SOLELY FOR THE DEVICE, INCLUDING ANY COMPONENT OR PART
USED SOLELY IN RELATION TO THE PRODUCT.
1.8
"DEVICE" MEANS A MECHANICAL INJECTION PEN FOR
DAILY USE, INCLUDING ANY COMPONENTS THEREOF AND ALL ASSOCIATED LABELING AND
PACKAGING COMPONENTS, INDIVIDUALLY OR INCORPORATED INTO SUB-ASSEMBLIES, WHICH
MEETS THE APPLICABLE SPECIFICATIONS, AND IS ASSEMBLED WITH A PRE-FILLED
CARTRIDGE CONTAINING COMPOUND AND USES LILLY'S INFINITY PEN PLATFORM, INCLUDING
IMPROVEMENTS THERETO AS FROM TIME TO TIME INCORPORATED INTO THE APPLICABLE
SPECIFICATIONS.
1.9
"DEVICE DEVELOPMENT" MEANS THE CONDUCT OF ALL
ACTIVITIES CONSISTENT WITH THE DEVICE DEVELOPMENT PLAN THAT ARE REASONABLY
REQUIRED TO COMPLETE DEVELOPMENT OF THE DEVICE INCLUDING: (I) REGULATORY
AFFAIRS, PRE-CLINICAL STUDIES AND CLINICAL TRIALS IN ACCORDANCE WITH THE CGLPS,
CGCPS, CGMPS, AND CQSRS OR OTHER DESIGNATED QUALITY STANDARDS AND APPLICABLE
LAWS; AND (II) ALL ACTIVITIES RELATING TO DEVELOPING THE ABILITY TO MANUFACTURE
DEVICES TO BE USED FOR THE DELIVERY OF COMPOUND,