COMMITTEE.
(A)
FORMATION; PURPOSES AND PRINCIPLES.
WITHIN TEN DAYS AFTER THE
EFFECTIVE DATE, DYAX AND FOVEA SHALL ESTABLISH A JOINT STEERING COMMITTEE (THE
"JSC"), WHICH SHALL HAVE OVERALL RESPONSIBILITY FOR THE OVERSIGHT OF THE
PARTIES' ACTIVITIES UNDER THIS AGREEMENT.
(B)
SPECIFIC RESPONSIBILITIES.
IN ADDITION TO ITS OVERALL
RESPONSIBILITY FOR SUCH OVERSIGHT AS IS ESTABLISHED BY THIS AGREEMENT, THE JSC
SHALL IN PARTICULAR:
(I)
REVIEW AND MONITOR THE CLINICAL AND REGULATORY PROGRAM OF FOVEA
UNDER THE CORE DEVELOPMENT PLAN;
(II)
ANNUALLY REVIEW AND APPROVE UPDATES BY FOVEA TO THE CORE
DEVELOPMENT PLAN, INCLUDING WITHOUT LIMITATION, THE CLINICAL STUDY ENDPOINTS,
CLINICAL METHODOLOGY AND MONITORING REQUIREMENTS FOR THE CLINICAL STUDIES
DESCRIBED IN THE CORE DEVELOPMENT PLAN;
(III)
REVIEW, DISCUSS AND COMMENT ON THE PARTIES' ANNUAL
COMMERCIALIZATION PLANS PURSUANT TO, AND IN ACCORDANCE WITH, SECTION 5.2 HEREOF;
(IV)
REVIEW, DISCUSS AND COMMENT ON THE CLINICAL AND REGULATORY PROGRAM
OF DYAX UNDER ANY SUPPLEMENTAL DEVELOPMENT PLAN PROVIDED BY DYAX;
(V)
ANNUALLY REVIEW, DISCUSS AND COMMENT ON UPDATES BY DYAX TO ANY
SUPPLEMENTAL DEVELOPMENT PLAN;
(VI)
REVIEW, DISCUSS AND COMMENT ON EACH PARTY'S STRATEGY TO SEEK AND
OBTAIN REGULATORY APPROVAL OF THE PRODUCT, AS WELL AS, TO THE EXTENT CONSISTENT
WITH APPLICABLE LAW, RELATED PRICING AND REIMBURSEMENT APPROVALS, IN THE
TERRITORY OF SUCH PARTY;
(VII)
REVIEW AND MONITOR EACH PARTY'S PROGRESS IN SEEKING AND OBTAINING
REGULATORY APPROVAL OF THE PRODUCT, AS WELL AS RELATED PRICING AND REIMBURSEMENT
APPROVALS, IN THE TERRITORY OF SUCH PARTY;
(VIII)
REVIEW, DISCUSS AND COMMENT ON EACH PARTY'S ANNUAL
COMMERCIALIZATION PLAN AND BUDGET AND THE COMMERCIALIZATION PROGRAM AND
ACTIVITIES OF SUCH PARTY; AND
* Confidential Treatment Requested.
Omitted portions filed with the Commission.
11
(IX)
PERFORM SUCH OTHER FUNCTIONS AS ARE EXPRESSLY PROVIDED FOR
ELSEWHERE IN THIS AGREEMENT OR AS ARE APPROPRIATE TO FURTHER THE PURPOSES OF
THIS AGREEMENT AS DETERMINED BY THE PARTIES, INCLUDING PERIODIC EVALUATIONS OF
PERFORMANCE AGAINST GOALS.
SECTION 2.2
WORKING GROUPS.
FROM TIME TO TIME, THE JSC MAY
ESTABLISH WORKING GROUPS (EACH, A "WORKING GROUP") TO OVERSEE PARTICULAR
PROJECTS OR ACTIVITIES, AND EACH SUCH WORKING GROUP SHALL BE CONSTITUTED AND
SHALL OPERATE AS THE JSC DETERMINES.
SECTION 2.3
MEMBERSHIP.
EACH OF THE JSC AND ANY WORKING GROUPS
SHALL BE COMPOSED OF AN EQUAL NUMBER OF REPRESENTATIVES APPOINTED BY EACH OF
DYAX AND FOVEA.
THE JSC SHALL INITIALLY HAVE THREE (3) REPRESENTATIVES OF EACH
PARTY, BUT THE JSC MAY CHANGE THE SIZE OF THE JSC FROM TIME TO TIME BY MUTUAL
CONSENT OF THE MEMBERS OF THE JSC.
EACH PARTY MAY REPLACE ITS JSC AND WORKING
GROUP REPRESENTATIVES AT ANY TIME UPON WRITTEN NOTICE TO THE OTHER PARTY. THE
JSC SHALL BE CHAIRED FIRST BY A REPRESENTATIVE OF [*****] FOR THE PERIOD FROM
THE EFFECTIVE DATE [*****], AND THEREAFTER THE CHAIRPERSON POSITION SHALL ROTATE
[*****] ON EVERY OTHER [*****], WITH FOVEA TO APPOINT THE CHAIRPERSONS FOR THE
SECOND TWO-YEAR TERM, AND SO FORTH THEREAFTER.
THE CHAIRPERSON SHALL BE
RESPONSIBLE FOR CALLING MEETINGS, PREPARING AND CIRCULATING AN AGENDA IN ADVANCE
OF EACH MEETING, AND PREPARING AND ISSUING MINUTES