IF THE RESULTS OF ANY SUCH ACTIVITIES ARE INCLUDED BY THE OTHER PARTY IN A
FILING WITH A REGULATORY AUTHORITY (OTHER THAN A REQUIRED SUBMISSION FOR SAFETY
PURPOSES) TO SUPPORT A LABEL CLAIM OR A CHANGE IN AN APPROVED LABEL IN THAT
OTHER PARTY'S TERRITORY, THEN THE OTHER PARTY USING THAT DATA [***]
3.5.1
[***]
[***]
[***]
3.6
DEVELOPMENT EFFORTS; MANNER OF PERFORMANCE; REPORTS
3.6.1
STANDARDS FOR CONDUCT OF DEVELOPMENT PROGRAM. EACH OF VERTEX AND
JANSSEN SHALL USE DILIGENT EFFORTS TO EXECUTE AND TO PERFORM, OR CAUSE TO BE
PERFORMED, THE ACTIVITIES FOR WHICH IT IS RESPONSIBLE UNDER THE GLOBAL
DEVELOPMENT PLAN AND TO COOPERATE WITH AND COMPLY WITH ALL REASONABLE REQUESTS
OF THE OTHER PARTY IN CARRYING OUT THE GLOBAL DEVELOPMENT PLAN, IN EACH CASE IN
GOOD SCIENTIFIC MANNER AND IN COMPLIANCE WITH APPLICABLE LAW, GOOD CLINICAL
PRACTICE AND GOOD LABORATORY PRACTICE. JANSSEN SHALL USE DILIGENT EFFORTS TO
SEEK REGULATORY APPROVAL TO MARKET THE PRODUCT IN THE TERRITORY INCLUDING IN
EACH OF THE KEY COUNTRIES. [***]
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this exhibit has been filed separately with the
Commission.
17
3.6.2
DEVELOPMENT PROGRESS REPORTS. THE MINUTES OF THE COMMITTEES WILL
SERVE AS DEVELOPMENT PROGRESS REPORTS.
3.6.3
COORDINATION OF CERTAIN ACTIVITIES. THE PARTIES WILL USE REASONABLE
EFFORTS TO COORDINATE THEIR DEVELOPMENT ACTIVITIES TO EFFECT THE MOST EFFICIENT
AND REASONABLE CONTACTS AND [***]
3.6.4
DRUG SUPPLY FOR NON-CLINICAL AND CLINICAL TRIALS. DURING THE
DEVELOPMENT PROGRAM PRIOR TO THE FIRST COMMERCIAL SALE, VERTEX SHALL USE
DILIGENT EFFORTS TO SUPPLY CLINICAL TRIAL MATERIAL OF THE PRODUCT CANDIDATE FOR
USE IN CLINICAL STUDIES CONDUCTED IN ACCORDANCE WITH THE GLOBAL DEVELOPMENT PLAN
AND, IF APPLICABLE, FOR ADDITIONAL DEVELOPMENT ACTIVITIES. [***]
WITH RESPECT
TO SUPPLY FOR ANY ADDITIONAL DEVELOPMENT ACTIVITIES PRIOR TO THE FIRST
COMMERCIAL SALE, VERTEX SHALL USE DILIGENT EFFORTS TO PROVIDE CLINICAL TRIAL
MATERIAL, SUBJECT TO THE PRIMARY COMMITMENT TO SUPPLY CLINICAL TRIAL MATERIAL
FOR THE GLOBAL DEVELOPMENT PLAN. CLINICAL TRIAL MATERIAL FOR ADDITIONAL
DEVELOPMENT ACTIVITIES CONDUCTED BY JANSSEN SHALL BE SUPPLIED TO JANSSEN BY
VERTEX [***], AND OTHERWISE AS FURTHER DESCRIBED IN A DEVELOPMENT SUPPLY
AGREEMENT TO BE EXECUTED BY THE PARTIES IN ADVANCE OF JANSSEN'S NEED FOR SUCH
CLINICAL TRIAL MATERIAL. IN THE EVENT THAT JANSSEN CONDUCTS ONE OR MORE CLINICAL
TRIALS UNDER THE GLOBAL DEVELOPMENT PLAN, OR AS ADDITIONAL DEVELOPMENT
ACTIVITIES, VERTEX SHALL SUPPLY THE PRODUCT CANDIDATE IN BULK TABLET FORM, AND
JANSSEN WILL BE RESPONSIBLE FOR PACKAGING AND DISTRIBUTION, UNLESS VERTEX, AFTER
DISCUSSION AT THE JMC, ELECTS IN ITS SOLE DISCRETION TO TAKE ON THAT
RESPONSIBILITY. NOTWITHSTANDING THE FOREGOING, IN THE EVENT JANSSEN IS UNABLE TO
PERFORM PACKAGING DUE TO REGULATORY REQUIREMENTS, VERTEX WILL USE COMMERCIALLY
REASONABLE EFFORTS TO PERFORM PACKAGING, CONSISTENT WITH VERTEX'S CURRENT
CAPABILITIES, UPON JANSSEN REQUEST.
3.7
REGULATORY SUBMISSIONS AND REGULATORY APPROVALS
3.7.1
REGULATORY SUBMISSIONS. VERTEX SHALL BE SOLELY AND EXCLUSIVELY
RESPONSIBLE FOR OBTAINING ALL REGULATORY APPROVALS FOR PRODUCTS IN NORTH AMERICA
AND SHALL OWN ALL REGULATORY SUBMISSIONS, INCLUDING ALL APPLICATIONS FOR AND
DOSSIERS RELATING TO REGULATORY APPROVAL