AND
THE GILEAD REGULATORY DOCUMENTATION THROUGH UPDATES AS NEEDED TO ENSURE THAT
SUCH INFORMATION CONTINUES TO REPRESENT A COMPLETE AND ACCURATE REFLECTION IN
ALL MATERIAL RESPECTS OF THE SAFETY AND EFFICACY PROFILE OF ITS SINGLE AND
DOUBLE AGENT PRODUCTS.
IT IS UNDERSTOOD AND AGREED THAT GILEAD MAKES THE
REPRESENTATION AND COVENANT TO BMS SET FORTH IN THIS SECTION 13.3(E) SOLELY FOR
PURPOSES OF THE MEMBER PARTIES' COLLABORATION PURSUANT TO THIS AGREEMENT, AND
FOR NO OTHER PURPOSE.
(F)
QUANTITIES OF FTC AND TDF PROVIDED BY
GILEAD PURSUANT TO SECTION 4.1 WILL (I) BE MANUFACTURED USING REASONABLE CARE;
(II) CONFORM TO THE APPLICABLE
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PRODUCT SPECIFICATIONS (AS DEFINED IN THE GILEAD SUPPLY AGREEMENT) AND WITH THE
APPLICABLE CERTIFICATE OF ANALYSIS AT THE TIME OF DELIVERY; (III) BE CONVEYED BY
GILEAD WITH GOOD TITLE AND FREE FROM ANY LAWFUL SECURITY INTEREST, LIEN OR
ENCUMBRANCE; AND GILEAD (OR ANY AFFILIATES OR THIRD PARTY SUPPLIERS AS
APPLICABLE) WILL HAVE OBTAINED ALL APPROVALS REQUIRED BY ALL APPLICABLE
REGULATORY AUTHORITIES TO MANUFACTURE FTC AND TDF FOR USE IN VIREAD, EMTRIVA AND
TRUVADA AS APPLICABLE.
13.4
DISCLAIMER.
EXCEPT AS SET FORTH IN SECTIONS
13.1, 13.2 AND 13.3, EACH PARTY HEREBY DISCLAIMS ANY AND ALL WARRANTIES, WHETHER
WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WITH
RESPECT TO THE SINGLE AGENT PRODUCTS, THE DOUBLE AGENT PRODUCT, THE COMBINATION
PRODUCT OR ANY ACTIVE PHARMACEUTICAL INGREDIENTS FOR THE COMBINATION PRODUCT
SUPPLIED UNDER THIS AGREEMENT, OR ANY TECHNOLOGY LICENSED UNDER THIS AGREEMENT,
INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF QUALITY, PERFORMANCE,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE.
FOR THE AVOIDANCE
OF DOUBT, NOTHING CONTAINED IN THIS SECTION 13.4 SHALL OPERATE TO LIMIT OR
INVALIDATE ANY WARRANTY CONTAINED IN ANY ANCILLARY AGREEMENT.
13.5
INDEMNIFICATION BY THE JV.
THE JV SHALL
INDEMNIFY EACH OF THE MEMBER PARTIES AND THEIR AFFILIATES AND THEIR RESPECTIVE
OFFICERS, DIRECTORS AND EMPLOYEES FROM AND AGAINST (A) (I) ALL PROCEEDINGS IN
WHICH SUCH MEMBER PARTY (OR ITS AFFILIATE) IS INVOLVED OR THREATENED TO BE
INVOLVED AND WHICH ARISES OUT OF THE EXPLOITATION OF THE COMBINATION PRODUCT OR
EITHER MEMBER PARTY'S (OR ITS AFFILIATE'S) PERFORMANCE OF ITS OBLIGATIONS UNDER
AND IN COMPLIANCE WITH THIS AGREEMENT, THE OPERATING AGREEMENT, THE SDEA OR THE
MTTA
AND (II) ALL LOSSES INCURRED BY THE INDEMNITEE RESULTING FROM SUCH
PROCEEDINGS, AND (B) WITHOUT LIMITATION OF THE FOREGOING CLAUSE (A), (I) ALL
PROCEEDINGS IN WHICH SUCH MEMBER PARTY (OR ITS AFFILIATE) IS INVOLVED OR
THREATENED TO BE INVOLVED AND WHICH ARISES OUT OF (A) THE CONTENT OF ANY
APPROVED MARKETING MATERIALS, TO THE EXTENT THAT SUCH APPROVED MARKETING
MATERIALS ARE USED BY BOTH MEMBER PARTIES, (B) THE PERFORMANCE OF SUCH MEMBER
PARTY'S DUTIES UNDER SECTION 3.3 (WITH RESPECT TO FORMULATION AND MANUFACTURING
PROCESS DEVELOPMENT RELATED ACTIVITIES), 5.2, 5.3, 5.4, 7.1 OR 8.1 OF THIS
AGREEMENT, (C) THE PERFORMANCE BY THE TAX MATTERS MEMBER OF ITS DUTIES UNDER THE
OPERATING AGREEMENT, OR (D) THE JV'S USE OF THE COMBINATION PRODUCT TRADEMARKS,
THE GILEAD LICENSED TRADEMARKS, AND/OR THE BMS LICENSED TRADEMARKS, AND (II) ALL