APPLICABLE, THE BOOKS AND RECORDS MAINTAINED BY
GILEAD ON BEHALF OF THE JV) PURSUANT TO SECTION 8.1 TO VERIFY ANY OR ALL OF THE
FOLLOWING: (A) THE ACCURACY OF THE AMOUNTS INVOICED BY THE OTHER MEMBER PARTY TO
THE JV PURSUANT TO SECTION 7.1 AND (B) THE AUTHORIZED COMMERCIALIZATION
EXPENSES, AUTHORIZED DEVELOPMENT EXPENSES AND AUTHORIZED OTHER EXPENSES CHARGED
BY THE OTHER MEMBER TO THE JV, IN EACH CASE ONLY AS TO ANY PERIOD ENDING NOT
MORE THAN THREE (3) YEARS PRIOR TO THE DATE OF SUCH REQUEST.
SUCH THIRD PARTY
ACCOUNTANT SHALL BE BOUND BY WRITTEN COMMERCIALLY REASONABLE CONFIDENTIALITY AND
NON-USE OBLIGATIONS TO THE MEMBER PARTIES.
EACH MEMBER PARTY SHALL RECEIVE A
COPY OF THE THIRD PARTY ACCOUNTANT'S REPORT OF ANY SUCH AUDIT, WHICH SHALL
DISCLOSE ONLY WHETHER SUCH AMOUNTS AS INVOICED OR CHARGED ARE CORRECT OR
INCORRECT, AND THE AMOUNTS OF ANY UNDERPAYMENTS OR OVERPAYMENTS; SUCH REPORT
SHALL BE CONFIDENTIAL INFORMATION OF BOTH MEMBER PARTIES.
ANY DISCREPANCY SHALL
BE RECTIFIED BY A RECONCILIATION PAYMENT MADE BY THE UNDERPAYING PARTY OR THE
OVERPAID PARTY, AS THE CASE MAY BE, WITHIN THIRTY (30) DAYS AFTER RECEIPT OF
NOTICE THEREOF.
IF SUCH AUDIT ESTABLISHES THAT EITHER THE NON-REQUESTING MEMBER
PARTY OR THE JV
66
MADE AN ERROR IN INVOICING OR PAYMENT TO THE DETRIMENT OF THE REQUESTING MEMBER
PARTY, IN AMOUNT EQUAL TO OR GREATER THAN [*] OF THE RELEVANT AMOUNTS FOR THE
PERIOD UNDER AUDIT, THEN THE OUT-OF-POCKET COSTS OF SUCH AUDIT SHALL QUALIFY AS
AN AUTHORIZED OTHER EXPENSE.
IN ALL OTHER CASES, THE COSTS OF SUCH AUDIT SHALL
BE BORNE SOLELY BY THE REQUESTING MEMBER PARTY AND SHALL NOT QUALIFY AS A JV
EXPENSE OR AN AUTHORIZED EXPENSE.
BMS AND GILEAD MAY EACH MAKE AUDIT REQUESTS
UNDER THIS SECTION 8.2 ON ITS OWN BEHALF OR ON BEHALF OF THE JV.
8.3
CERTAIN REPORTS.
SO THAT BMS MAY SATISFY ITS INTERNAL REPORTING
NEEDS, GILEAD SHALL PROVIDE TO BMS, AT THE APPLICABLE TIMES SET FORTH IN ANNEX
M, THE FINANCIAL DATA DESCRIBED IN THAT ANNEX.
SECTION 9.
ADVERSE EVENT AND OTHER INFORMATION EXCHANGE
9.1
PHARMACOVIGILANCE.
SUBJECT TO THE TERMS OF THIS AGREEMENT, BMS
AND GILEAD (UNDER THE GUIDANCE OF THEIR RESPECTIVE PHARMACOVIGILANCE
DEPARTMENTS, OR EQUIVALENT THEREOF) SHALL DEFINE AND FINALIZE MUTUALLY
ACCEPTABLE GUIDELINES AND PROCEDURES TO BE FOLLOWED BY THE MEMBER PARTIES WITH
RESPECT TO THE RECEIPT, INVESTIGATION, RECORDATION, COMMUNICATION, AND EXCHANGE
(AS BETWEEN THE MEMBER PARTIES) OF ADVERSE EVENT REPORTS, PREGNANCY REPORTS, AND
ANY OTHER INFORMATION, CONCERNING THE SAFETY OF THE COMBINATION PRODUCT OR EFV,
TDF OR FTC, AS APPROPRIATE.
SUCH GUIDELINES AND PROCEDURES SHALL BE INCLUDED IN
AN AGREEMENT (HEREAFTER REFERRED TO AS THE SAFETY DATA EXCHANGE AGREEMENT
("SDEA")), TO BE ENTERED INTO BY THE MEMBER PARTIES PRIOR TO THE EARLIER TO
OCCUR OF
(I) THE [*] ANNIVERSARY OF THE EFFECTIVE DATE AND (II) THE FIRST
DOSING OF THE COMBINATION PRODUCT IN PATIENTS, AND SHALL BE IN ACCORDANCE WITH,
AND ENABLE THE PARTIES AND THEIR AFFILIATES TO FULFILL, LOCAL AND INTERNATIONAL
REGULATORY REPORTING OBLIGATIONS TO GOVERNMENT AUTHORITIES.
FURTHERMORE, SUCH