OR (VII) IN A MANNER
THAT WOULD REQUIRE THE OTHER PARTY TO PERFORM ANY ACT THAT IT REASONABLY
BELIEVES TO BE INCONSISTENT WITH ANY LAW OR ANY APPROVAL, ORDER, POLICY OR
GUIDELINES OF A REGULATORY AUTHORITY.
(D)
UNANIMOUS AGREEMENT.
IF THE
PROVISIONS OF THIS AGREEMENT (OTHER THAN SECTION 3.5(A)) SPECIFY THAT UNANIMOUS
AGREEMENT OF THE JSC OR ANY SUBCOMMITTEE IS REQUIRED FOR ANY MATTER, THEN
NEITHER PARTY MAY EXERCISE A DECIDING VOTE UNDER THE PROVISIONS OF
SECTION 3.5(B) WITH RESPECT TO SUCH MATTER.
3.6
Committee Membership.
(A)
APPOINTMENT IS A RIGHT.
THE
APPOINTMENT OF MEMBERS OF THE JSC AND ANY SUBCOMMITTEES OF THE JSC IS A RIGHT OF
EACH PARTY AND NOT AN OBLIGATION AND SHALL NOT BE A "DELIVERABLE" AS REFERENCED
IN ANY EXISTING AUTHORITATIVE ACCOUNTING LITERATURE.
EACH PARTY SHALL BE FREE
TO DETERMINE NOT TO APPOINT MEMBERS TO THE JSC OR ANY SUBCOMMITTEE OF THE JSC.
(B)
CONSEQUENCE OF NON-APPOINTMENT.
IF A PARTY DOES NOT APPOINT MEMBERS OF THE JSC OR ANY SUBCOMMITTEE OF THE JSC,
IT SHALL NOT BE A BREACH OF THIS AGREEMENT, NOR SHALL ANY CONSIDERATION BE
REQUIRED TO BE RETURNED, AND UNLESS AND UNTIL SUCH MEMBERS ARE APPOINTED, THE
PARTY THAT HAS MADE THE REQUISITE APPOINTMENTS MAY UNILATERALLY DISCHARGE THE
ROLES OF THE JSC OR ANY SUBCOMMITTEE THEREOF FOR WHICH MEMBERS WERE NOT
APPOINTED, PROVIDED THAT (I) NEITHER PARTY SHALL UNILATERALLY DISCHARGE THE
ROLES OF THE JSC OR ANY SUBCOMMITTEE THEREOF AS PERMITTED UNDER THIS
SECTION 3.6(B) UNLESS THE OTHER PARTY HAS NOT APPOINTED ANY MEMBERS WITHIN
THIRTY (30) DAYS AFTER THE FIRST PARTY HAS COMPLETED ITS APPOINTMENT OF ITS
MEMBERS, AND (II) THE RESPONSIBILITY OF THE JIPC SHALL BE CARRIED OUT THROUGH
BILATERAL MEETINGS OF REPRESENTATIVES OF INCYTE AND NOVARTIS, WITH ANY DISPUTED
MATTERS RESOLVED IN ACCORDANCE WITH SECTIONS 3.5(B)(I)(D) AND 3.5(B)(II)(D).
28
*** Confidential material redacted and filed separately with the Commission.
ARTICLE IV
DEVELOPMENT; REGULATORY MATTERS
4.1
Information Transfer.
(A)
INITIAL INFORMATION TRANSFER TO
NOVARTIS.
(I) WITHIN A REASONABLE PERIOD NOT TO EXCEED *** AFTER THE EFFECTIVE
DATE, INCYTE SHALL MAKE AVAILABLE TO NOVARTIS, IN A MUTUALLY-AGREED UPON FORMAT
AND WITHOUT FURTHER FINANCIAL CONSIDERATION, THE MATERIAL CLINICAL DATA AND
MANUFACTURING KNOW-HOW INCLUDED IN THE INCYTE KNOW-HOW AND THAT IS DESCRIBED IN
EXHIBIT B, AND (II) FROM THE EFFECTIVE DATE THROUGH ***, INCYTE SHALL MAKE ITS
RELEVANT SCIENTIFIC AND TECHNICAL PERSONNEL REASONABLY AVAILABLE TO NOVARTIS AT
INCYTE'S OFFICES, AT REASONABLE TIMES DURING INCYTE'S NORMAL BUSINESS HOURS AND
UPON REASONABLE PRIOR NOTICE, TO ANSWER ANY QUESTIONS OR PROVIDE INSTRUCTION AS
REASONABLY REQUESTED BY NOVARTIS CONCERNING THE INFORMATION DELIVERED PURSUANT
TO THIS SECTION 4.1.
(B)
CONTINUING INFORMATION
TRANSFER.
ON AN ONGOING BASIS DURING THE JAK PROGRAM TERM, ON A *** BASIS (OR
SUCH MORE FREQUENT BASIS AS DETERMINED BY THE JAK JDC), EACH PARTY SHALL MAKE
AVAILABLE TO THE OTHER PARTY, IN A MUTUALLY AGREED-UPON FORMAT, (I) MATERIAL
CLINICAL DATA, (II) MANUFACTURING KNOW-HOW INCLUDED IN THE INCYTE KNOW-HOW OR
NOVARTIS KNOW-HOW, AS APPLICABLE, (III) SOFTWARE TOOLS USED BY INCYTE OR
NOVARTIS, AS APPLICABLE,