INCLUDING, WITHOUT LIMITATION,
DELIVERY TECHNOLOGIES RELATED TO DEVICES AND COMPONENTS THEREOF, INDUSTRIAL AND
MECHANICAL DESIGN, AND MANUFACTURING AND QUALITY ASSURANCE TECHNICAL SUPPORT,
UNTIL SUCH TIME AS MANUFACTURING OF DEVICES INTENDED FOR COMMERCIAL SALE OF
PRODUCT COMMENCES AND THEREAFTER TO THE EXTENT REQUIRED UNDER APPLICABLE LAW FOR
CONTINUED COMMERCIAL SALE OF PRODUCT.
1.10
"DEVICE DEVELOPMENT COSTS" MEANS THOSE COSTS AND
EXPENSES INCURRED BY A PARTY OR FOR ITS ACCOUNT FOR DEVICE DEVELOPMENT
CALCULATED IN ACCORDANCE WITH SECTION 4.3 OF THE COLLABORATION AGREEMENT TO THE
EXTENT CONSISTENT WITH THE DEVICE DEVELOPMENT PLAN, AND
3
ANY COSTS INCURRED FOR DEVICE DEVELOPMENT PURSUANT TO THE COLLABORATION
AGREEMENT PRIOR TO THE EFFECTIVE DATE OF THIS AGREEMENT TO THE EXTENT CONSISTENT
WITH THE DEVELOPMENT PLAN.
DEVICE DEVELOPMENT COSTS INCLUDE THOSE COSTS
INCURRED FOR FTES (AS DEFINED IN THE COLLABORATION AGREEMENT), PRODUCT SPECIFIC
THIRD PARTY COSTS, DEPRECIATION OF DEVICE SPECIFIC CAPITAL INVESTMENTS, AND
DEPRECIATION OF AN ALLOCATION OF GENERAL DEVICE DEVELOPMENT EQUIPMENT DIRECTLY
ASSOCIATED WITH THE DEVICE DEVELOPMENT.
PRODUCT SPECIFIC THIRD PARTY COSTS
INCLUDE, BUT ARE NOT LIMITED TO, [...***...].
1.11
"DEVICE DEVELOPMENT PLAN" WILL HAVE THE MEANING SET
FORTH IN SECTION 2.2.
1.12
"DHF" MEANS THE DESIGN HISTORY FILE THAT LILLY WILL
ESTABLISH AND MAINTAIN FOR THE DEVICE THAT WILL CONTAIN OR REFERENCE ALL RECORDS
AND SUBMISSIONS NECESSARY TO DEMONSTRATE THAT THE DESIGN WAS DEVELOPED IN
ACCORDANCE WITH THE APPROVED DEVICE DEVELOPMENT PLAN.
1.13
"EFFECTIVE DATE" WILL HAVE THE MEANING SET FORTH IN
THE FIRST PARAGRAPH OF THIS AGREEMENT.
1.14
"FIVE-YEAR FORECAST" WILL HAVE THE MEANING SET FORTH
IN SECTION 5.1(A).
1.15
"FORECAST" WILL HAVE THE MEANING SET FORTH IN
SECTION 5.1 OF THIS AGREEMENT.
1.16
"FORCE MAJEURE" WILL HAVE THE MEANING SET FORTH IN
SECTION 16.14 OF THIS AGREEMENT.
1.17
"INSPECTION PERIOD" WILL HAVE THE MEANING SET FORTH
IN SECTION 5.6(A) OF THIS AGREEMENT.
1.18
"LATENT DEFECT" MEANS DEFECTS THAT CAUSE THE DEVICES
TO FAIL TO CONFORM TO THE SPECIFICATIONS OR OTHERWISE FAIL TO CONFORM TO THE
WARRANTIES PROVIDED PURSUANT TO SECTION 9.7 HEREOF, WHICH DEFECTS ARE NOT
DISCOVERABLE UPON REASONABLE PHYSICAL INSPECTION AS PROVIDED IN SECTION 5.6(A).
1.19
"MANUFACTURE", "MANUFACTURING" OR "MANUFACTURED"
MEANS ALL OPERATIONS INVOLVED IN THE MANUFACTURING, QUALITY CONTROL TESTING
(INCLUDING IN-PROCESS, RELEASE AND STABILITY TESTING), ASSEMBLING, RELEASING,
LABELING, PACKAGING AND SHIPPING OF THE DEVICES AS MORE FULLY DESCRIBED IN THE
MRD.
*Confidential Treatment Request(ed)
4
1.20
"MRD" MEANS THE MANUFACTURING RESPONSIBILITIES
DOCUMENT, WHICH SETS FORTH WRITTEN INSTRUCTIONS REGARDING THE MANUFACTURE AND
OTHER TECHNICAL MATTERS INCLUDING, WITHOUT LIMITATION, TESTING PROCEDURES AND
SUPPLY OF THE DEVICES UNDER THIS AGREEMENT.
THE TABLE OF CONTENTS OF A SAMPLE
MRD IS ATTACHED FOR REFERENCE ONLY AS EXHIBIT B.
1.21
"PARTY" OR "PARTIES" WILL HAVE THE MEANING SET FORTH
IN THE FIRST PARAGRAPH OF THIS AGREEMENT.
1.22
"QA" MEANS THE QUALITY AGREEMENT BETWEEN THE PARTIES
WHICH DESCRIBES CERTAIN QUALITY EXPECTATIONS AND RESPONSIBILITIES RELATING TO
THE DEVELOPMENT, MANUFACTURE, RELEASE TESTING AND SUPPLY OF THE DEVICES AND
FINAL ASSEMBLED PRODUCTS (ASSEMBLED PEN AND CARTRIDGE CONTAINING COMPOUND) TO
AMYLIN.
IF THE PARTIES SO SELECT, THERE MAY BE SEPARATE