IN GOOD FAITH
FROM TIME TO TIME WHETHER A SAFETY DATA EXCHANGE AGREEMENT IS REQUIRED.
3.7.4
MANUFACTURING OBLIGATIONS.
REGULUS SHALL [***] USE ITS DILIGENT
EFFORTS TO MANUFACTURE PRE-CLINICAL SUPPLIES AND CLINICAL SUPPLIES OF
COLLABORATION COMPOUNDS, INCLUDING ALL BULK DRUG SUBSTANCE, FOR ALL PRE-CLINICAL
STUDIES AND CLINICAL STUDIES, INCLUDING PROCESS DEVELOPMENT AND SCALE-UP,
CONDUCTED BY REGULUS UNDER SUCH PROGRAM DURING THE PROGRAM TERM FOR SUCH
PROGRAM.
AT GSK'S REQUEST, REGULUS SHALL ALSO SUPPLY TO GSK REASONABLE (AS
DETERMINED BY THE JOINT STEERING COMMITTEE) QUANTITIES OF BULK DRUG SUBSTANCE
FOR COLLABORATION COMPOUNDS AS REASONABLY REQUIRED BY GSK FOR CERTAIN
SUPPLEMENTAL ENABLING STUDIES WHICH GSK MAY FROM TIME TO TIME UNDERTAKE PURSUANT
TO SECTION 3.8, UNLESS REGULUS IS UNABLE TO DO SO DUE TO [***], PROVIDED, THAT
THE DETERMINATION OF WHETHER [***] SHALL NOT TAKE INTO ACCOUNT [***].
REGULUS
SHALL CARRY OUT ITS MANUFACTURING OBLIGATIONS CONSISTENT WITH REGULUS'
REASONABLE INTERNAL PRACTICES, INDUSTRY STANDARDS, CGMP REQUIREMENTS, AND ALL
APPLICABLE LAWS AND REGULATIONS.
FOR PURPOSES OF CLARITY, UPON GSK'S EXERCISE
OF ITS PROGRAM OPTION FOR A PROGRAM, GSK WILL THEREAFTER BE RESPONSIBLE FOR
MANUFACTURING, [***] ALL PRE-CLINICAL, CLINICAL AND COMMERCIAL SUPPLIES OF THE
OPTION COMPOUNDS AND RELATED LICENSED PRODUCTS UNDER SUCH PROGRAM, AS SET FORTH
IN SECTION 4.4.2.
THE PARTIES SHALL DISCUSS IN GOOD FAITH AT THE JSC THE
MANUFACTURING PROCESS AS THEN BEING USED OR PLANNED TO BE USED BY REGULUS FOR
COLLABORATION COMPOUNDS UNDER EACH PROGRAM WELL IN ADVANCE OF THE PROGRAM
REACHING THE CANDIDATE SELECTION STAGE, IN ORDER THAT, WHEREVER PRACTICAL,
(A) THE PARTIES CAN PLAN TOGETHER TO MINIMIZE [***], AND (B) THE PARTIES CAN
[***] FOR COMMERCIALIZATION BY GSK IN THE EVENT THAT GSK EXERCISES ITS PROGRAM
OPTION.
3.8
GSK ENABLING STUDIES. GSK SHALL HAVE THE RIGHT AT ALL TIMES DURING THE
RESEARCH COLLABORATION TERM AND DURING ANY RELEVANT EARLY DEVELOPMENT PROGRAM
TERM, TO CONDUCT, AT ITS SOLE COST AND EXPENSE, CERTAIN REASONABLE SUPPLEMENTAL
ENABLING ACTIVITIES SUCH AS ADDITIONAL FORMULATION DEVELOPMENT, ADDITIONAL
PRE-CLINICAL ANIMAL STUDIES AND/OR COMPOUND SCALE-UP ("ENABLING STUDIES") WHICH
GSK REASONABLY DEEMS AS USEFUL FOR SUPPLEMENTING PRE-CLINICAL AND/OR CLINICAL
ACTIVITIES CONDUCTED BY REGULUS PURSUANT TO THE RESEARCH PROGRAM AND THE EARLY
DEVELOPMENT PROGRAM AND RELATING TO ONE OR MORE OF THE COLLABORATION COMPOUNDS.
AT GSK'S REQUEST, REGULUS SHALL OFFER GSK REASONABLE COOPERATION IN RELATION TO
SUCH ENABLING STUDIES, INCLUDING, SUBJECT TO AVAILABILITY AND SECTION 3.7.4, THE
TRANSFER OF REASONABLE QUANTITIES OF COLLABORATION COMPOUNDS, IF NECESSARY.
IT
IS UNDERSTOOD AND AGREED BY THE PARTIES THAT ANY SUCH SUPPLEMENTAL ENABLING
STUDIES ARE TO BE CONDUCTED BY GSK IN ITS REASONABLE DISCRETION AND NOT
43
AS PART OF ANY PROGRAM, PRE-CLINICAL STUDY, POC TRIAL OR OTHER CLINICAL STUDY
CONDUCTED BY REGULUS AND THAT REGULUS SHALL NOT BE PERMITTED OR REQUIRED TO
DELAY THE PROGRESS OF ANY RESEARCH PROGRAM OR EARLY DEVELOPMENT PROGRAM TO AWAIT
THE RESULTS OF ANY SUCH SUPPLEMENTAL ENABLING STUDIES OR TO TRANSFER ANY
RESPONSIBILITY TO GSK FOR THE CONDUCT OF ANY ACTIVITIES UNDER THE RESEARCH PLAN
OR EARLY DEVELOPMENT PLAN AND THAT GSK SHALL NOT BE PERMITTED (WITHOUT