SET
FORTH IN SECTION 4.5(A).
1.8
"COMMENCEMENT DATE" MEANS THE FIRST DATE
UPON WHICH A REGULATORY AUTHORITY APPROVES CARDINAL HEALTH AS A MANUFACTURER OF
ONE OF THE PRODUCTS.
1.9
"CONFIDENTIAL INFORMATION" IS AS DEFINED IN
SECTION 11.2.
1.10
"CONTRACT YEAR" MEANS EACH CONSECUTIVE TWELVE
(12) MONTH PERIOD BEGINNING ON THE COMMENCEMENT DATE.
1.11
"CLIENT MATERIALS" SHALL HAVE THE MEANING SET
FORTH IN ARTICLE 12.
1.12
"DEFECTIVE PRODUCT" SHALL HAVE THE MEANING SET
FORTH IN SECTION 5.2.
1.13
"DISPUTE" SHALL HAVE THE MEANING SET FORTH IN
SECTION 18.9.
1.14
"DOSAGE CONTAINER" MEANS ANY FINAL DOSAGE
FORM CONTAINER(S) THE PARTIES MAY AGREE UPON IN WRITING FROM TIME TO TIME.
1.15
"EFFECTIVE DATE" MEANS THE DATE THIS AGREEMENT
WAS FULLY EXECUTED.
1.16
"FACILITIES" MEANS CARDINAL HEALTH'S FACILITIES
LOCATED IN WINCHESTER, KENTUCKY, USA OR SUCH OTHER FACILITY AS AGREED BY THE
PARTIES.
1.17
"FDA" MEANS THE UNITED STATES FOOD AND DRUG
ADMINISTRATION.
1.18
"FIRM COMMITMENT" SHALL HAVE THE MEANING SET
FORTH IN SECTION 4.2.
1.19
"MINIMUM REQUIREMENT" SHALL HAVE THE MEANING SET
FORTH IN SECTION 4.1.
2
1.20
"PROCESS" OR "PROCESSING" MEANS THE MANUFACTURING
AND/OR PACKAGING OF THE API AND RAW MATERIALS INTO PRODUCT IN ACCORDANCE WITH
THE SPECIFICATIONS AND THE TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT.
1.21
"PROCESSING DATE," MEANS THE DAY ON WHICH THE
PRODUCT IS TO BE COMPOUNDED BY CARDINAL HEALTH.
1.22
"PRODUCT" MEANS THE FULLY COMPOUNDED BULK DRUG
PRODUCT PROCESSED AND PACKAGED IN ACCORDANCE WITH THE SPECIFICATIONS.
1.23
"PURCHASE ORDER" SHALL HAVE THE MEANING SET FORTH
IN SECTION 4.3.
1.24
"RAW MATERIALS" MEANS ALL RAW MATERIALS,
SUPPLIES, COMPONENTS AND PACKAGING NECESSARY TO MANUFACTURE AND SHIP THE PRODUCT
IN ACCORDANCE WITH THE SPECIFICATIONS, AS PROVIDED IN EXHIBIT A, BUT NOT
INCLUDING THE API.
1.25
"REGULATORY APPROVAL" SHALL HAVE THE MEANING SET
FORTH IN SECTION 7.4.
1.26
"REGULATORY AUTHORITY" MEANS ANY GOVERNMENTAL
REGULATORY AUTHORITY WITHIN A TERRITORY INVOLVED IN REGULATING ANY ASPECT OF THE
DEVELOPMENT, MANUFACTURE, MARKET APPROVAL, SALE, DISTRIBUTION, PACKAGING OR USE
OF THE PRODUCT.
1.27
"ROLLING FORECAST" SHALL HAVE THE MEANING SET
FORTH IN SECTION 4.2.
1.28
"SPECIFICATIONS" MEANS THE PROCEDURES,
REQUIREMENTS, STANDARDS, QUALITY CONTROL TESTING AND OTHER DATA AND THE SCOPE OF
SERVICES AS SET FORTH IN EXHIBIT A, WHICH ARE HEREBY INCORPORATED BY REFERENCE
INTO THIS AGREEMENT, ALONG WITH ANY VALID AMENDMENTS OR MODIFICATIONS THERETO,
SUBJECT TO THE TERMS AND CONDITIONS SET FORTH IN ARTICLE 8.
1.29
"TERM" SHALL HAVE THE MEANING SET FORTH IN
SECTION 15.1.
1.30
"TERRITORY" MEANS THE UNITED STATES OF AMERICA
AND ANY OTHER COUNTRY WHICH THE PARTIES AGREE IN WRITING TO ADD TO THIS
DEFINITION OF TERRITORY IN AN AMENDMENT TO THIS AGREEMENT.
1.31
"UNIT PRICING" SHALL HAVE THE MEANING SET FORTH
IN SECTION 7.1.
1.32
"VALIDATION BATCHES" SHALL MEAN EACH BATCH OF
PRODUCT MANUFACTURED BY CARDINAL HEALTH WHICH IS NECESSARY TO SUPPORT THE
VALIDATION PORTION OF CLIENT'S NDA OR ANDA SUBMISSION TO THE FDA.
ARTICLE 2
VALIDATION, PROCESSING & RELATED SERVICES
2.1
VALIDATION SERVICES. CARDINAL HEALTH SHALL
PERFORM THE QUALIFICATION, VALIDATION AND STABILITY SERVICES DESCRIBED IN
EXHIBIT A AND