THE PRECEDING SENTENCE (INCLUDING EXTENSIONS, AMENDMENTS AND RENEWALS THEREOF),
IT SHALL NOT, FROM AND AFTER THE EFFECTIVE DATE AND THROUGHOUT THE TERM OF THIS
AGREEMENT, GRANT TO ANY THIRD PARTY ANY RIGHT OR LICENSE IN RESPECT OF THE BMS
PATENTS THAT WOULD CONFLICT WITH ANY GRANT TO GILEAD OR THE JV HEREUNDER.
(D)
THERE ARE NO JUDGMENTS OR SETTLEMENTS
AGAINST OR AMOUNTS WITH RESPECT THERETO OWED BY BMS RELATING TO THE BMS
PATENTS.
TO THE KNOWLEDGE OF BMS, IT HAS NOT RECEIVED WRITTEN NOTICE OF ANY
PROCEEDING IN WHICH IT IS ALLEGED THAT (I) THE BMS PATENTS ARE INVALID OR
UNENFORCEABLE OR (II) THE EXPLOITATION OF EFV, WHETHER ALONE OR IN COMBINATION
WITH EITHER OR BOTH OF TDF AND FTC, INFRINGES ANY THIRD PARTY PATENT.
(E)
TO THE KNOWLEDGE OF BMS, THE INFORMATION
CONTAINED IN BMS' SINGLE AGENT PRODUCT LABEL AND IN THE NDA FOR BMS' SINGLE
AGENT PRODUCT REPRESENTS, IN ALL MATERIAL RESPECTS, A COMPLETE AND ACCURATE
REFLECTION OF THE SAFETY AND EFFICACY PROFILE OF BMS' SINGLE AGENT PRODUCT AS OF
THE EFFECTIVE DATE.
BMS SHALL USE COMMERCIALLY REASONABLE EFFORTS TO MAINTAIN
ITS SINGLE AGENT PRODUCT LABEL AND THE BMS 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 AGENT PRODUCT.
IT IS UNDERSTOOD AND AGREED THAT
BMS MAKES THE REPRESENTATION AND COVENANT TO GILEAD SET FORTH IN THIS SECTION
13.2(E) SOLELY FOR PURPOSES OF THE MEMBER PARTIES' COLLABORATION PURSUANT TO
THIS AGREEMENT, AND FOR NO OTHER PURPOSE.
(F)
QUANTITIES OF EFV PROVIDED BY BMS
PURSUANT TO SECTION 4.1 WILL (I) BE MANUFACTURED USING REASONABLE CARE; (II)
CONFORM TO THE APPLICABLE EFV BULK SPECIFICATIONS (AS DEFINED IN THE BMS SUPPLY
AGREEMENT) AND WITH THE APPLICABLE CERTIFICATE OF ANALYSIS AT THE TIME OF
DELIVERY; (III) BE CONVEYED BY BMS WITH GOOD TITLE AND FREE FROM ANY LAWFUL
SECURITY INTEREST, LIEN OR ENCUMBRANCE; AND BMS (OR ANY AFFILIATES OR THIRD
PARTY SUPPLIERS AS APPLICABLE) WILL HAVE OBTAINED ALL APPROVALS REQUIRED BY ALL
APPLICABLE REGULATORY AUTHORITIES TO MANUFACTURE EFV FOR USE IN SUSTIVA.
13.3
ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF GILEAD.
GILEAD REPRESENTS, WARRANTS AND COVENANTS TO BMS THAT:
(A)
EACH OF GILEAD PARENT AND GILEAD SUB IS A
CORPORATION OR LIMITED LIABILITY COMPANY, AS THE CASE MAY BE, DULY ORGANIZED,
VALIDLY EXISTING AND IN GOOD STANDING UNDER THE LAWS OF THE STATE OF DELAWARE,
AND HAS FULL POWER AND AUTHORITY AND THE LEGAL RIGHT TO OWN AND OPERATE ITS
PROPERTY AND ASSETS AND TO CARRY ON ITS BUSINESS AS IT IS NOW BEING CONDUCTED
AND AS IS CONTEMPLATED TO BE CONDUCTED BY THIS AGREEMENT.
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(B)
NEITHER GILEAD NOR ANY OF ITS AFFILIATES HAS
BEEN DEBARRED OR IS SUBJECT TO DEBARMENT AND NEITHER GILEAD NOR ANY OF ITS
AFFILIATES SHALL USE IN ANY CAPACITY, IN CONNECTION WITH THE SERVICES TO BE
PERFORMED UNDER THIS AGREEMENT, ANY PERSON WHO HAS BEEN DEBARRED PURSUANT TO
SECTION 306 OF THE