provide to AZ in support of any AZ IND filings all relevant ARRY-142886
non-clinical data, including CMC, pharmacology and toxicology generated by
Array.
3.2
DEVELOPMENT COMMITTEE.
AS SOON AS
REASONABLY PRACTICABLE AFTER SELECTION OF THE FIRST CANDIDATE DRUG, AZ SHALL
FORM A COMMITTEE THAT WILL MANAGE THE CONDUCT AND PROGRESS OF THE FURTHER
DEVELOPMENT AND REGULATORY AFFAIRS WITH RESPECT TO THAT AND EACH SUBSEQUENT
CANDIDATE DRUG (THE "DEVELOPMENT COMMITTEE").
DAY TO DAY MANAGEMENT OF THE
DEVELOPMENT AND REGULATORY ACTIVITIES FOR THE CANDIDATE DRUGS SHALL BE CARRIED
OUT BY AN AZ GLOBAL PRODUCT TEAM WHICH SHALL REPORT TO THE DEVELOPMENT COMMITTEE
AT QUARTERLY MEETINGS.
DEVELOPMENT COMMITTEE MEETINGS SHALL BE HELD FACE TO
FACE OR BY TELECONFERENCE OR VIDEOCONFERENCE.
ARRAY SHALL BE NOTIFIED AT LEAST
TWO WEEKS IN ADVANCE OF THE DATE OF EACH DEVELOPMENT COMMITTEE MEETING AND SHALL
HAVE THE OPPORTUNITY TO SEND ONE ARRAY REPRESENTATIVE TO SUCH MEETING, WHO SHALL
HAVE OBSERVER STATUS.
AZ SHALL PROVIDE SUCH ARRAY REPRESENTATIVE WITH SCHEDULES
FOR ALL DEVELOPMENT COMMITTEE MEETINGS AND ALL OTHER INFORMATION DISTRIBUTED TO
AZ MEMBERS OF THE DEVELOPMENT COMMITTEE.
THE DEVELOPMENT COMMITTEE SHALL REVIEW
THE PLAN FOR THE DEVELOPMENT OF THE SUBJECT CANDIDATE DRUG (EACH, A "DEVELOPMENT
PLAN"), AND IN SO
13
DOING SHALL CONSIDER ALL REASONABLE SUGGESTIONS AND COMMENTS OF ARRAY IN
FORMULATING SUCH DEVELOPMENT PLAN.
SUCH DEVELOPMENT PLAN SHALL BE REASONABLY
COMPREHENSIVE AND SHALL DESCRIBE AT LEAST (I) THE PROPOSED ACTIVITIES RELATED TO
CLINICAL STUDIES AND REGULATORY PLANS, (II) CLINICAL GOALS AND OBJECTIVES AS
WELL AS CRITERIA FOR SUCCESSFUL COMPLETION OF CLINICAL TRIALS AND OTHER
DEVELOPMENT ACTIVITIES ("DEVELOPMENT CRITERIA") AND (III) OTHER ACTIVITIES AND
TIMELINES DIRECTED TO OBTAINING REGULATORY APPROVAL.
IN ANY EVENT, AZ AGREES TO
KEEP ARRAY INFORMED AS TO THE PROGRESS AND ACTIVITIES RELATING TO THE FURTHER
DEVELOPMENT AND REGULATORY MATTERS PERTAINING TO EACH CANDIDATE DRUG AND
LICENSED PRODUCT.
IN ADDITION, AZ SHALL PROVIDE ARRAY WITH SUCH INFORMATION AS
ARRAY MAY REASONABLY REQUEST FROM TIME TO TIME.
IT IS UNDERSTOOD THAT SUCH
INFORMATION WILL INCLUDE CORRESPONDENCE WITH REGULATORY AUTHORITIES WITH RESPECT
TO EACH LICENSED PRODUCT.
3.3
PHASE I SUCCESS CRITERIA.
AT ANY TIME
DURING OR AT THE COMPLETION OF THE PHASE I ACTIVITIES WITH RESPECT TO
ARRY-142886, THE DEVELOPMENT COMMITTEE SHALL ASSESS THAT LICENSED PRODUCT
AGAINST AGREED PHASE I SUCCESS CRITERIA SET OUT IN EXHIBIT 3.3 (THE "PHASE I
SUCCESS CRITERIA") AND SHALL CONFIRM WHETHER THE PHASE I SUCCESS CRITERIA HAVE
BEEN MET.
IF ARRY-142886 FAILS TO MEET THE PHASE I SUCCESS CRITERIA, AZ SHALL
HAVE THE RIGHT TO CEASE DEVELOPMENT OF ARRY-142886 PURSUANT TO THIS AGREEMENT,
AND IT SHALL BE DEEMED AN ABANDONED PRODUCT PURSUANT TO SECTION 11.3.2 BELOW.
3.4
PROCESS DEVELOPMENT; MANUFACTURING.
3.4.1
PROCESS PROGRAM.
ARRAY AND AZ AGREE TO CONDUCT A
PROGRAM ON A COLLABORATIVE BASIS WITH THE PRINCIPAL GOAL OF FURTHER DEVELOPING
PROCESSES AND RELATED ASSAYS FOR THE MANUFACTURE OF BULK QUANTITIES OF
ARRY-142886, OTHER CANDIDATE DRUGS AND LICENSED PRODUCTS.
(A)
PROCESS PLAN.
THE PROCESS PROGRAM SHALL BE
CARRIED OUT IN ACCORDANCE WITH A WRITTEN WORKPLAN AND BUDGET (THE "PROCESS
PLAN") AGREED