REMEDIES PROVIDED TO EITHER PARTY IN THIS
ARTICLE 13 SHALL NOT BE DEEMED THE EXCLUSIVE REMEDIES AVAILABLE TO THAT PARTY,
AND IN PARTICULAR SHALL NOT LIMIT ANY LEGAL OR EQUITABLE REMEDIES OTHERWISE
AVAILABLE TO THAT PARTY.
ARTICLE 14 -GOVERNING LAW AND DISPUTE RESOLUTION
14.1
GOVERNING LAW. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN
ACCORDANCE WITH THE LAWS OF THE COMMONWEALTH OF MASSACHUSETTS WITHOUT REFERENCE
TO ANY RULES OF CONFLICT OF LAWS. THE UNITED NATIONS CONVENTION ON THE SALE OF
GOODS SHALL NOT APPLY.
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this exhibit has been filed separately with the
Commission.
48
14.2
REFERRAL TO EXECUTIVE OFFICERS. IF FOR ANY REASON THE JSC CANNOT
RESOLVE ANY MATTER PROPERLY REFERRED TO IT FOR RESOLUTION, EITHER PARTY MAY
REFER THE MATTER TO THE EXECUTIVE OFFICERS FOR RESOLUTION. IF, AFTER DISCUSSING
THE MATTER IN GOOD FAITH AND ATTEMPTING TO FIND A MUTUALLY SATISFACTORY
RESOLUTION TO THE ISSUE, THE EXECUTIVE OFFICERS FAIL TO COME TO CONSENSUS WITHIN
[***] AFTER THE DATE ON WHICH THE MATTER IS REFERRED TO THE EXECUTIVE OFFICERS
(UNLESS A LONGER PERIOD IS AGREED TO IN WRITING BY THE PARTIES) THE PROVISIONS
OF SECTION 14.3 SHALL APPLY AND RESOLUTIONS REACHED THROUGH SUCH PROVISIONS
SHALL BE BINDING ON THE PARTIES; PROVIDED THAT [***]
14.3
FINAL DECISION-MAKING AUTHORITY. IF THE EXECUTIVE OFFICERS FAIL TO COME
TO CONSENSUS ON ANY MATTER PROPERLY REFERRED TO THE EXECUTIVE OFFICERS WITHIN
THE PERIOD FOR RESOLUTION SET FORTH IN SECTION 14.2 (AN "UNRESOLVED MATTER")
THEN THE FOLLOWING PROVISIONS SHALL APPLY:
14.3.1
SUBJECT TO THE PROVISIONS OF SUBSECTIONS 14.3.2 THROUGH 14.3.3,
VERTEX SHALL HAVE FINAL DECISION-MAKING AUTHORITY OVER ALL UNRESOLVED MATTERS;
14.3.2
JANSSEN SHALL HAVE FINAL DECISION-MAKING AUTHORITY WITH RESPECT TO
THE FOLLOWING:
[***]
[***]
[***]
[***]
14.3.3
NOTWITHSTANDING THE FOREGOING PROVISIONS OF THIS SECTION 14.3,
NEITHER PARTY SHALL HAVE FINAL DECISION-MAKING AUTHORITY PURSUANT TO THIS
SECTION 14.3 WITH RESPECT TO MATTERS OVER WHICH ONE OR THE OTHER OF THE PARTIES
IS EXPRESSLY ALLOCATED DECISION-MAKING AUTHORITY ELSEWHERE IN THIS AGREEMENT.
14.4
DECISION TO TERMINATE OR SUSPEND A STUDY BASED ON SAFETY CONCERNS. THE
PARTY SPONSORING OR CONTROLLING ANY CLINICAL STUDY OF A PRODUCT CANDIDATE MAY
TERMINATE OR SUSPEND SUCH CLINICAL STUDY IF (A) A REGULATORY AUTHORITY OR SAFETY
DATA REVIEW BOARD FOR SUCH CLINICAL STUDY HAS REQUIRED SUCH TERMINATION OR
SUSPENSION, OR (B) IF SUCH PARTY BELIEVES IN GOOD FAITH THAT SUCH TERMINATION OR
SUSPENSION IS WARRANTED BECAUSE OF SAFETY OR TOLERABILITY RISKS TO THE STUDY
SUBJECTS. IN EITHER CASE, SUCH PARTY SHALL PROMPTLY NOTIFY THE OTHER PARTY OF
SUCH TERMINATION OR SUSPENSION, AND SHALL USE ALL REASONABLE EFFORTS TO NOTIFY
AND CONSULT WITH THE OTHER PARTY PRIOR TO TAKING SUCH ACTION.
14.5
DISPUTE RESOLUTION.
14.5.1
THE PARTIES SHALL NEGOTIATE IN GOOD FAITH AND USE REASONABLE EFFORTS
TO SETTLE ANY DISPUTE, CONTROVERSY OR CLAIM ARISING FROM OR RELATED TO THIS
AGREEMENT OR THE BREACH THEREOF. IF THE PARTIES ARE UNABLE TO RESOLVE A DISPUTE
OTHER THAN A DISPUTE PROPERLY