THE PRODUCT IN COMPLIANCE WITH
APPLICABLE LAW AND THE SPECIFICATIONS.
8.3
QUALITY AGREEMENT. PRIOR TO THE FIRST SHIPMENT
OF THE PRODUCT, THE PARTIES SHALL ENTER INTO AN AGREEMENT THAT DESCRIBES CERTAIN
QUALITY AND REGULATORY RESPONSIBILITIES RELATING TO THE MANUFACTURE AND RELEASE
FOR SALE OF THE PRODUCT BY LILLY (THE "QUALITY AGREEMENT").
THE QUALITY
AGREEMENT SHALL BE SUBJECT TO AND NOT INCONSISTENT WITH THE TERMS OF THIS
AGREEMENT AND THE LICENSE AGREEMENT, AND IN THE EVENT OF CONFLICT BETWEEN THE
TERMS OF THIS AGREEMENT OR THE LICENSE AGREEMENT, AS APPLICABLE, ON ONE HAND,
AND THE QUALITY AGREEMENT ON THE OTHER, THIS AGREEMENT OR THE LICENSE AGREEMENT,
AS APPLICABLE, SHALL GOVERN.
SECTIONS OF THE QUALITY AGREEMENT MAY BE MODIFIED
FROM TIME TO TIME THROUGH THE ISSUANCE OF A REVISED QUALITY AGREEMENT SIGNED ON
BEHALF OF EACH OF THE PARTIES BY AN AUTHORIZED REPRESENTATIVE INCORPORATING THE
MODIFICATION AND STATING THE EFFECTIVE DATE AND REVISION NUMBER OF THE
MODIFICATION.
8.4
SHELF LIFE. AT THE TIME OF DELIVERY OF THE
PRODUCT TO THE WHOLESALER BY LILLY, THE PRODUCT SHALL HAVE A MINIMUM OF [***]
([***]) MONTHS SHELF LIFE REMAINING; PROVIDED THAT [***] ([***]) YEAR DATING IS
GRANTED BY THE FDA AT THE TIME REGULATORY APPROVAL IS OBTAINED FOR THE PRODUCT
IN THE FIELD IN THE TERRITORY. LILLY WILL USE COMMERCIALLY REASONABLE EFFORTS TO
SUPPLY PRODUCT WITH A MINIMUM SHELF LIFE AT DELIVERY EQUAL TO AT LEAST
TWO-THIRDS OF THE SHELF LIFE FOR THE PRODUCT APPROVED BY THE REGULATORY
AUTHORITY.
LILLY MAY DELIVER THE PRODUCT WITH A SHELF LIFE SHORTER THAN NOTED
ABOVE IF AGREED BY PARTIES UPON THE WRITTEN REQUEST OF UNITED THERAPEUTICS.
8.5
LOT NUMBERING. LILLY'S LOT NUMBERS SHALL BE
AFFIXED ON THE CONTAINERS FOR THE PRODUCT AND ON EACH SHIPPING CARTON IN
ACCORDANCE WITH APPLICABLE LAWS.
8.6
LILLY OBLIGATIONS TO MEET SPECIFICATIONS.
(A)
ALL PRODUCT SOLD TO UNITED THERAPEUTICS
SHALL MEET THE SPECIFICATIONS AS OF THE DATE OF DELIVERY TO THE WHOLESALER.
LILLY SHALL TEST OR CAUSE TO BE TESTED, IN ACCORDANCE WITH THE TEST METHODS AND
PROCEDURES IN THE SPECIFICATIONS AS SET FORTH IN EXHIBIT 1.8, EACH LOT OF
PRODUCT BEFORE SHIPMENT TO A LILLY DISTRIBUTION CENTER.
LILLY SHALL ENSURE THAT
ITS QUALITY CONTROL DEPARTMENT APPROVES EACH LOT OF THE PRODUCT FOR RELEASE
PROMPTLY FOLLOWING SUCCESSFUL COMPLETION OF RELEASE TESTING AND DOES NOT RELEASE
ANY LOT OF THE PRODUCT THAT DOES NOT MEET THE REQUIREMENTS SET OUT IN THE
SPECIFICATIONS.
(B)
IF ANY PRODUCT IS REJECTED PRIOR TO
ENTERING UNITED THERAPEUTICS' INVENTORY FOR ANY REASON, LILLY SHALL REPLACE
REJECTED PRODUCT WITH PRODUCT THAT MEETS THE SPECIFICATIONS WITHIN A
COMMERCIALLY REASONABLE TIME.
ARTICLE 9
REPRESENTATIONS, WARRANTIES AND INDEMNIFICATION
9.1
INCORPORATION BY REFERENCE OF WARRANTIES AND
INDEMNIFICATION.
THE TERMS OF ARTICLE 10 (REPRESENTATIONS, WARRANTIES, AND
COVENANTS) (EXCLUDING SECTION 10.3) AND ARTICLE 12 (INDEMNIFICATION) (EXCLUDING
SECTION 12.4) OF THE LICENSE AGREEMENT ARE HEREBY INCORPORATED
20
HEREIN AND MADE PART OF THIS AGREEMENT. THE DISCLAIMER IN SECTION 10.4
(DISCLAIMER) OF THE LICENSE AGREEMENT SHALL APPLY TO THE WARRANTIES IN
ARTICLE 10 OF THE LICENSE AGREEMENT