WEIGHT, HEIGHT); (B) MEDICAL
HISTORY; (C) CONCURRENT MEDICATION USAGE; (D) PARTICULARS OF THE EVENT (VERBATIM
TERM, MEDDRA TERM & SYSTEM ORGAN CLASS, ONSET DATE, RESOLUTION DATE, RELATION TO
PRODUCT, SEVERITY AND CRITERIA MAKING EVENT SERIOUS, OUTCOME); (E) DOSING
HISTORY (DATES, QUANTITY OF PRODUCT ADMINISTERED, METHOD OF ADMINISTRATION); (F)
CHEMISTRY, URINALYSIS AND HEMATOLOGY LAB TESTS; AND (G) ANY COUNTERMEASURES
TAKEN FOR THE EVENT.
ALL SUCH INFORMATION DISCLOSED BY BMS TO ISIS IN
CONNECTION WITH THIS SECTION SHALL BE BMS CONFIDENTIAL INFORMATION; PROVIDED,
HOWEVER, THAT ISIS MAY DISCLOSE ANY BMS CONFIDENTIAL INFORMATION CONTAINED IN
THE ISIS DATABASE TO ANY THIRD PARTY SO LONG AS ISIS DOES NOT DISCLOSE TO ANY
THIRD PARTY THE IDENTITY OF THE APPLICABLE COMPOUND, THE PCSK9 TARGET OR BMS (OR
ANY INFORMATION THAT WOULD FORESEEABLY REVEAL THE IDENTITY OF THE APPLICABLE
COMPOUND, THE PCSK9 TARGET OR BMS) IN CONNECTION WITH ANY SUCH DISCLOSURE.
(B)
FROM TIME TO TIME, ISIS UTILIZES THE INFORMATION IN THE ISIS
DATABASE TO CONDUCT ANALYSES TO KEEP ISIS AND ITS PARTNERS INFORMED REGARDING
CLASS GENERIC PROPERTIES OF ASOS, INCLUDING WITH RESPECT TO SAFETY.
AS SUCH, IF
AND WHEN ISIS IDENTIFIES SAFETY OR OTHER RELATED ISSUES THAT MAY BE RELEVANT TO
A PRODUCT (INCLUDING POTENTIAL CLASS-RELATED TOXICITY LIABILITIES), IN
ACCORDANCE WITH AND SUBJECT TO THE PHARMACOVIGILANCE AGREEMENT, ISIS WILL
PROMPTLY INFORM BMS OF SUCH ISSUES, AND IF REQUESTED, PROVIDE THE DATA
SUPPORTING ISIS' CONCLUSIONS REGARDING SUCH ISSUES.
SECTION 4.8
PHARMACOVIGILANCE AGREEMENT.
SUBJECT TO THE TERMS OF
THIS AGREEMENT, AND WITHIN 3 MONTHS PRIOR TO THE EXPECTED DATE OF IND FILING FOR
A COMPOUND, BMS AND ISIS (UNDER THE GUIDANCE OF THEIR RESPECTIVE
PHARMACOVIGILANCE DEPARTMENTS, OR EQUIVALENT THEREOF) SHALL DEFINE AND FINALIZE
THE RESPONSIBILITIES THE PARTIES SHALL EMPLOY TO PROTECT PATIENTS AND PROMOTE
THEIR WELL-BEING IN A WRITTEN PHARMACOVIGILANCE AGREEMENT (HEREAFTER REFERRED TO
AS THE "PHARMACOVIGILANCE AGREEMENT").
THESE RESPONSIBILITIES SHALL INCLUDE
MUTUALLY ACCEPTABLE
13
GUIDELINES AND PROCEDURES FOR THE RECEIPT, INVESTIGATION, RECORDATION,
COMMUNICATION AND EXCHANGE (AS BETWEEN THE PARTIES) OF ADVERSE EVENT REPORTS AND
ANY OTHER INFORMATION CONCERNING THE SAFETY OF ANY COMPOUND OR PRODUCT.
SUCH
GUIDELINES AND PROCEDURES SHALL BE IN ACCORDANCE WITH, AND ENABLE THE PARTIES
AND THEIR AFFILIATES TO FULFILL, LOCAL AND NATIONAL REGULATORY REPORTING
OBLIGATIONS TO GOVERNMENT AUTHORITIES.
FURTHERMORE, SUCH AGREED PROCEDURES
SHALL BE CONSISTENT WITH RELEVANT INTERNATIONAL COUNCIL FOR HARMONIZATION (ICH)
GUIDELINES, EXCEPT WHERE SAID GUIDELINES MAY CONFLICT WITH EXISTING LOCAL
REGULATORY SAFETY REPORTING REQUIREMENTS, IN WHICH CASE LOCAL REPORTING
REQUIREMENTS SHALL PREVAIL.
EACH PARTY HEREBY AGREES TO COMPLY WITH ITS
RESPECTIVE OBLIGATIONS UNDER SUCH PHARMACOVIGILANCE AGREEMENT (AS IT MAY BE
MODIFIED FROM TIME TO TIME BY MUTUAL WRITTEN AGREEMENT OF THE PARTIES) AND TO
CAUSE ITS AFFILIATES TO COMPLY WITH SUCH OBLIGATIONS.
IN ACCORDANCE WITH AND
SUBJECT TO THE PHARMACOVIGILANCE AGREEMENT, EACH PARTY SHALL PROVIDE THE OTHER
PARTY WITH INFORMATION AVAILABLE TO SUCH PARTY THAT SUCH OTHER PARTY MAY
REASONABLY REQUIRE TO COMPLY WITH ITS PHARMACOVIGILANCE RESPONSIBILITIES UNDER
APPLICABLE LAW, INCLUDING NOTICE OF ANY ADVERSE DRUG EXPERIENCES FROM
PRE-CLINICAL OR CLINICAL LABORATORY, ANIMAL TOXICOLOGY AND PHARMACOLOGY STUDIES,
CLINICAL TRIALS