REASONABLY EXPECT
TO MAKE, SEEK OR ATTEMPT TO OBTAIN IN THE FOLLOWING * (*) MONTH PERIOD AND
(C) SUMMARIZE ALL CLINICAL AND OTHER DATA
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GENERATED BY DS WITH RESPECT TO LICENSED PRODUCTS.
IN ADDITION, DS SHALL
PROVIDE SUCH ADDITIONAL INFORMATION THAT IT HAS IN ITS POSSESSION AS MAY BE
REASONABLY REQUESTED BY ARQULE REGARDING THE COMMERCIALIZATION OF ANY LICENSED
PRODUCT, WHICH REQUEST SHALL NOT BE MADE MORE THAN * EACH CALENDAR YEAR.
3.10.3
RIGHT OF ACCESS.
EACH PARTY SHALL PROVIDE THE OTHER
PARTY WITH ACCESS TO ALL CLINICAL PROJECT PLANS AND CLINICAL DATA, RESULTS AND
INFORMATION DERIVED FROM OR RELATING TO ALL CLINICAL TRIALS CONDUCTED, AND ALL
REGULATORY FILINGS PREPARED, WITH RESPECT TO COLLABORATION COMPOUNDS AND/OR
LICENSED PRODUCTS (COLLECTIVELY, "PRODUCT-RELATED DATA") IN ENGLISH AND AT NO
ADDITIONAL COST OR EXPENSE.
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS
AGREEMENT, ARQULE (A) MAY USE, AND PROVIDE TO ITS THIRD PARTY LICENSEES AND
COLLABORATORS, SUCH PRODUCT-RELATED DATA; PROVIDED, THAT, (I) ARQULE SHALL ONLY
HAVE THE RIGHT TO SHARE SUCH PRODUCT-RELATED DATA TO ITS THIRD PARTY
COLLABORATORS AND LICENSEES THAT HAVE GRANTED ARQULE THE RECIPROCAL RIGHT TO
SHARE WITH DS CLINICAL DATA, RESULTS AND INFORMATION, AND INFORMATION DERIVED
FROM OR RELATED TO REGULATORY FILINGS CONTROLLED BY SUCH THIRD PARTY
COLLABORATORS AND LICENSEES FOR USE WITH LICENSED PRODUCTS UNDER THIS AGREEMENT
AND (II) ARQULE SHALL, UPON DS'S REQUEST, USE COMMERCIALLY REASONABLE EFFORTS TO
COORDINATE A GLOBAL CLINICAL TRIAL TARGETING BOTH WITHIN THE TERRITORY AND THE
ASIAN TERRITORY INVOLVING ITS THIRD PARTY COLLABORATORS AND DS; (B) MAY USE SUCH
PRODUCT-RELATED DATA FOR THE PERFORMANCE OF ITS OBLIGATIONS AND EXERCISE OF ITS
RIGHTS UNDER THIS AGREEMENT; AND (C) SHALL HAVE A RIGHT OF ACCESS, A RIGHT OF
REFERENCE AND A RIGHT TO USE AND INCORPORATE ALL SUCH PRODUCT-RELATED DATA IN
ANY REGULATORY FILINGS AND DRUG APPROVAL APPLICATIONS IT MAKES WITH RESPECT TO
LICENSED PRODUCTS.
THE PARTIES SHALL COOPERATE SO THAT SUCH PRODUCT-RELATED
DATA IS TRANSFERRED TO ARQULE AS EXPEDITIOUSLY AS POSSIBLE.
3.10.4
PHARMACOVIGILENCE; ADVERSE EVENT REPORTS.
(A)
ADVERSE EVENTS.
SUBJECT TO THE REGULATORY
TRANSITION PLAN, DS SHALL HAVE THE SOLE RIGHT AND RESPONSIBILITY FOR FURNISHING
TIMELY NOTICE TO THE APPLICABLE GOVERNMENTAL AGENCIES WITHIN THE TERRITORY OF
ALL SIDE EFFECTS, DRUG INTERACTIONS AND OTHER ADVERSE EFFECTS IDENTIFIED OR
SUSPECTED WITH RESPECT TO THE LICENSED PRODUCTS FOR THE TARGETED INDICATIONS
ADMINISTERED, DISTRIBUTED, MARKETED AND SOLD UNDER AUTHORITY OF ANY IND, NDA OR
REGULATORY APPROVALS ISSUED BY SUCH GOVERNMENTAL AGENCIES.
ARQULE SHALL PROVIDE
DS WITH ANY
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ASSISTANCE THAT MAY BE REASONABLY NECESSARY TO COMPLY WITH ALL ADVERSE REACTION
REPORTING REQUIREMENTS ESTABLISHED BY, OR REQUIRED UNDER, ANY APPLICABLE IND,
NDA OR REGULATORY APPROVALS AND/OR APPLICABLE LAWS WITHIN THE TERRITORY.
IN
ADDITION TO THE UPDATES DESCRIBED IN SECTIONS 3.10.1 AND 3.10.2, DS SHALL
PROVIDE ARQULE WITH ALL ADVERSE EVENT INFORMATION AND PRODUCT COMPLAINT
INFORMATION RELATING TO THE LICENSED PRODUCT AS SUCH INFORMATION IS COMPILED OR
PREPARED BY DS IN THE NORMAL COURSE OF BUSINESS IN CONNECTION WITH THE
DEVELOPMENT OR COMMERCIALIZATION OF THE LICENSED PRODUCT AND, IN ANY