MEANS MEASURING,
EXAMINING, AND TESTING THAT GAUGES ONE OR MORE CHARACTERISTICS OF A PRODUCT
COMPONENT AND THE COMPARISON OF SUCH COMPONENT WITH THE SPECIFIED REQUIREMENTS
TO DETERMINE SUCH COMPONENT'S CONFORMITY TO THE SPECIFICATIONS.
1.14
INTELLECTUAL PROPERTY.
"INTELLECTUAL PROPERTY" HAS THE MEANING
GIVEN IN SECTION 10.1.
1.15
INTELLECTUAL PROPERTY RIGHTS.
"INTELLECTUAL PROPERTY RIGHTS" HAS
THE MEANING GIVEN IN SECTION 10.1.
1.16
PROCEDURES.
"PROCEDURES" HAS THE MEANING GIVEN IN SECTION 2.1.
1.17
PROCESS.
"PROCESS" MEANS THE METHODS AND ALL REFERENCED PROCEDURES
USED IN THE MANUFACTURE OF THE PRODUCT.
1.18
PRODUCT.
"PRODUCTS" SHALL MEAN THE PURCHASER PRODUCTS LISTED ON
EXHIBIT A ATTACHED TO THIS AGREEMENT.
NEW PRODUCTS SHALL BE ADDED TO EXHIBIT A
IN ACCORDANCE WITH SECTION 2.2 AND SUCH PRODUCTS WILL THEREAFTER BE DEEMED
INCLUDED WITHIN THE DEFINITION OF PRODUCTS.
1.19
PRODUCT DEVICE MASTER RECORD.
"PRODUCT DEVICE MASTER RECORD" MEANS
THE PRODUCT DEVICE MASTER RECORD FOR THE PRODUCT REQUIRED BY THE REGULATORY
AUTHORITIES, AS IT MAY BE REVISED AND IN EFFECT FROM TIME TO TIME.
1.20
PURCHASE ORDER.
"PURCHASE ORDER" MEANS A PURCHASE ORDER FOR
PRODUCTS IN A FORM PROVIDED BY PURCHASER.
1.21
PURCHASE PRICE.
"PURCHASE PRICE" HAS THE MEANING GIVEN IN
SECTION 3.1.
1.22
QUALIFIED TRAINER.
"QUALIFIED TRAINER" SHALL MEAN MANUFACTURER'S
DESIGNATED INDIVIDUAL(S) WHO CAN PERFORM TRAINING ON MANUFACTURING PROCESSES,
TEST METHODS AND/OR STANDARD OPERATING PROCEDURES AS DEVELOPED AND APPROVED BY
PURCHASER.
1.23
REGULATORY AUTHORITY.
"REGULATORY AUTHORITY" MEANS THE FOOD AND
DRUG ADMINISTRATION OF THE UNITED STATES (THE "FDA") OR, ANY SUCCESSOR AGENCY
OR, IF APPLICABLE IN THE
2
CONFIDENTIAL
CERTAIN INFORMATION HAS BEEN REDACTED
CONFIDENTIAL TREATMENT REQUESTED
CONTEXT, THE GOVERNMENT AGENCY PERFORMING THE SAME REGULATORY FUNCTION AS THE
FDA IN ANOTHER COUNTRY.
1.24
SPECIFICATIONS.
"SPECIFICATIONS" MEANS THE SPECIFICATIONS FOR THE
PRODUCT AS PROVIDED IN THE PRODUCT DEVICE MASTER RECORD.
1.25
TERM.
"TERM" HAS THE MEANING GIVEN IN SECTION 12.1.
2.
SUPPLY RIGHTS.
2.1
MANUFACTURE AND SUPPLY.
SUPPLIER AGREES, PURSUANT TO THE DELIVERY
SCHEDULE, TO PROCURE INVENTORY, WHICH INCLUDES RAW MATERIALS, COMPONENTS AND
OTHER SUPPLIES, AND TO MANUFACTURE, TEST, ASSEMBLE, INSPECT AND DELIVER THE
PRODUCTS PURSUANT TO THE SPECIFICATIONS FOR EACH SUCH PRODUCT.
SUPPLIER
RECOGNIZES AND AGREES THAT THE SPECIFIC MANUFACTURING SITE EMPLOYED FOR THE
PRODUCTION OF THE PRODUCTS MUST BE APPROVED AND ACCEPTED BY THE PURCHASER.
SUPPLIER AGREES TO PROVIDE ADEQUATE CAPACITY TO MEET THE VOLUMES AGREED BY THE
PARTIES IN ACCORDANCE WITH SECTION 3.4.
ALL MATERIALS FOR USE IN PRODUCTS,
INCLUDING BUT NOT LIMITED TO RAW MATERIALS, SUPPLIES, AND COMPLETED PRODUCT WILL
BE STORED BY SUPPLIER IN A SECURE, SEGREGATED, AND CONTROLLED AREA TO PREVENT
THEFT, LOSS, DEGRADATION OR DAMAGE OF SUCH MATERIALS.
SUPPLIER SHALL MAINTAIN
LOT TRACEABILITY OF RAW MATERIALS, WORK IN PROCESS AND FINISHED PRODUCT.
ALL
COMPONENTS USED IN THE PRODUCTS SHALL BE PROCESSED THROUGH INCOMING INSPECTION.
ALL MATERIALS AND COMPONENTS THAT DO NOT MEET THE APPLICABLE SPECIFICATIONS
SHALL BE QUARANTINED AND INVESTIGATED THROUGH THE SUPPLIER'S NON-CONFORMANCE
PROCEDURE.
SUPPLIER'S PERSONNEL RESPONSIBLE FOR MANUFACTURING, TESTING, AND
INSPECTING PRODUCT SHALL BE TRAINED IN THE PROCEDURES (AS DEFINED BELOW) BY A
QUALIFIED TRAINER.
SUPPLIER'S QUALITY ASSURANCE PERSONNEL SHALL ENSURE