EACH ANNUAL UPDATE TO THE DEVELOPMENT PLAN, THE
JSC SHALL REVIEW THE FTE COST, AND SHALL RECOMMEND TO THE PARTIES WHETHER ANY
AMENDMENT SHOULD BE MADE TO THE PROSPECTIVE FTE COST TO REFLECT UPDATED
BENCHMARKING INFORMATION OR ADJUSTMENTS TO ACCOUNT FOR FTE SKILL SETS THAT
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
30
WERE NOT INCLUDED IN THE ORIGINAL FTE COST CALCULATION.
NO CHANGE TO THE FTE
COST SHALL BE EFFECTIVE WITHOUT THE WRITTEN AGREEMENT OF BOTH PARTIES.
(C)
THE PARTIES ANTICIPATE THAT RESPONSIBILITIES FOR DEVELOPMENT
ACTIVITIES FOR THE PROFIT-SHARE TERRITORY WILL INITIALLY BE ALLOCATED BETWEEN
THE PARTIES SUBSTANTIALLY AS SET FORTH IN EXHIBIT E.
(D)
NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, CUBIST
SHALL NOT HAVE AN OBLIGATION TO SEEK JSC APPROVAL OF DEVELOPMENT PLANS AND
BUDGETS IN THE ROYALTY TERRITORY, BUT WILL KEEP THE JSC APPRISED OF SUCH PLANS.
SECTION 4.3
DEVELOPMENT EFFORTS; MANNER OF PERFORMANCE; RECORDS AND REPORTS.
(A)
EACH OF ALNYLAM AND CUBIST SHALL USE DILIGENT EFFORTS TO EXECUTE
AND TO PERFORM, OR CAUSE TO BE PERFORMED, THE ACTIVITIES ASSIGNED TO IT RELATING
TO THE DEVELOPMENT PLAN AND TO COOPERATE WITH THE OTHER IN CARRYING OUT THE
DEVELOPMENT PLAN, IN EACH CASE IN GOOD SCIENTIFIC MANNER AND IN COMPLIANCE WITH
APPLICABLE LAW, GOOD CLINICAL PRACTICE AND GOOD LABORATORY PRACTICE.
NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, NEITHER PARTY WILL
ENGAGE OR USE A THIRD PARTY TO PERFORM ANY OF THE DEVELOPMENT ACTIVITIES
ALLOCATED TO IT UNDER THE DEVELOPMENT PLAN OR PROVIDE ANY LICENSED PRODUCT TO
ANY THIRD PARTY IN THE PROFIT-SHARE TERRITORY UNLESS SUCH ACTION, AND THE FORM
OF AGREEMENT WITH SUCH THIRD PARTY, HAVE BEEN APPROVED IN ADVANCE BY THE JSC.
(B)
EACH PARTY WILL MAINTAIN SCIENTIFIC RECORDS, IN SUFFICIENT DETAIL
AND IN GOOD SCIENTIFIC MANNER APPROPRIATE FOR PATENT AND REGULATORY PURPOSES,
WHICH WILL FULLY AND PROPERLY REFLECT ALL WORK DONE AND RESULTS ACHIEVED IN THE
PERFORMANCE OF THE DEVELOPMENT ACTIVITIES WITH RESPECT TO LICENSED PRODUCT BY
SUCH PARTY AND ITS PERMITTED CONTRACTORS AND PERMITTED SUBLICENSEES.
EACH PARTY
WILL HAVE THE RIGHT, DURING NORMAL BUSINESS HOURS AND UPON REASONABLE NOTICE, TO
INSPECT AND COPY (OR REQUEST THE OTHER PARTY TO COPY) ALL RECORDS OF THE OTHER
PARTY MAINTAINED IN CONNECTION WITH THE WORK DONE AND RESULTS ACHIEVED IN THE
PERFORMANCE OF SUCH DEVELOPMENT ACTIVITIES, BUT SOLELY TO THE EXTENT SUCH
RECORDS RELATE TO LICENSED PRODUCT OR TO THE EXTENT ACCESS TO SUCH RECORDS IS
NECESSARY FOR A PARTY TO EXERCISE ITS RIGHTS UNDER THIS AGREEMENT.
ALL SUCH
RECORDS, AND THE INFORMATION DISCLOSED THEREIN, AS WELL AS ALL DISCLOSURES MADE
PURSUANT TO SECTIONS 4.3(C) AND 4.8, WILL BE MAINTAINED IN CONFIDENCE BY THE
RECIPIENT IN ACCORDANCE WITH ARTICLE IX AND WILL ONLY BE USED FOR PURPOSES OF
THE COLLABORATION; PROVIDED THAT ALNYLAM SHALL BE PERMITTED TO DISCLOSE ANY SUCH
INFORMATION OBTAINED FROM CUBIST TO ITS ASIAN PARTNER FOR THE PURPOSE OF
ASSISTING SUCH ASIAN PARTNER TO DEVELOP, MANUFACTURE AND COMMERCIALIZE LICENSED
PRODUCTS FOR ASIA, SUBJECT TO THE REQUIREMENT THAT,