VARY DEPENDING ON THE STATE OF
PROGRESSION OF REGULUS' EFFORTS WITH REGARD TO SUCH COLLABORATION TARGET.
3.4
DEVELOPMENT CANDIDATE SELECTION; PRELIMINARY POC PLAN.
3.4.1
SELECTION OF DEVELOPMENT CANDIDATE.
DURING THE RELEVANT RESEARCH
COLLABORATION TERM, USING THE CANDIDATE SELECTION CRITERIA AND TARGET PRODUCT
PROFILE AS A GUIDE, REGULUS SHALL USE DILIGENT EFFORTS TO CONDUCT STUDIES UNDER
EACH RESEARCH PROGRAM THAT IT DETERMINES APPROPRIATE TO DEVELOP A DEVELOPMENT
CANDIDATE, AND TO SELECT [***] COLLABORATION COMPOUND THAT IT DETERMINES HAS MET
THE CANDIDATE SELECTION CRITERIA.
UPON SUCH DETERMINATION, REGULUS SHALL SEEK
CONFIRMATION BY THE JSC THAT SUCH COLLABORATION COMPOUND MEETS THE CANDIDATE
SELECTION CRITERIA.
THE JSC SHALL REVIEW ALL RELEVANT INFORMATION AND STUDY
RESULTS CONCERNING EACH SUCH PROPOSED DEVELOPMENT CANDIDATE, AND, IF THE JSC
UNANIMOUSLY CONFIRMS SUCH SELECTION, THEN (X) SUCH COLLABORATION COMPOUND SHALL
BE DESIGNATED A DEVELOPMENT CANDIDATE, (Y) THE PARTIES SHALL AGREE UPON AN EARLY
DEVELOPMENT PLAN FOR SUCH DEVELOPMENT CANDIDATE, AND (Z) FOLLOWING JSC APPROVAL
OF SUCH EARLY DEVELOPMENT PLAN, THE EARLY DEVELOPMENT PROGRAM FOR SUCH
DEVELOPMENT CANDIDATE SHALL COMMENCE IN ACCORDANCE WITH SECTION 3.5.
IF THE JSC
DOES NOT CONFIRM THAT SUCH COLLABORATION COMPOUND MEETS THE CANDIDATE SELECTION
CRITERIA, THEN THE PROCEDURES SET FORTH IN SECTION 3.4.3 SHALL APPLY.
3.4.2
IDENTIFICATION OF BACK-UP COMPOUNDS.
UPON JSC CONFIRMATION OF A
DEVELOPMENT CANDIDATE, REGULUS MAY ALSO IDENTIFY COLLABORATION COMPOUNDS AS
PRELIMINARY BACK-UP COMPOUNDS TO SUCH DEVELOPMENT CANDIDATE.
WITH RESPECT TO
ANY BACK-UP COMPOUND FOR SUCH PROGRAM, IF SUCH BACK-UP COMPOUND HAS NOT YET
REACHED THE [***] STAGE AS OF THE EXPIRATION OF THE [***] OPTION EXERCISE PERIOD
WITH RESPECT TO SUCH PROGRAM, REGULUS SHALL HAVE THE RIGHT, BUT NOT THE
OBLIGATION, TO CONDUCT DEVELOPMENT ACTIVITIES TO ADVANCE SUCH BACK-UP COMPOUND
TO THE [***] STAGE [***].
3.4.3
IF NO [***] IS SELECTED.
FOR CLARITY, IF NO COLLABORATION COMPOUND
UNDER A PROGRAM MEETS THE [***] CRITERIA, OR THE JSC DOES NOT CONFIRM REGULUS'
NOMINATION OF A COLLABORATION COMPOUND AS A [***] AFTER COMPLETION OF THE
ACTIVITIES OUTLINED IN THE APPLICABLE
37
RESEARCH PLAN OR OTHERWISE DECIDES TO TERMINATE THE PROGRAM BY THE END OF THE
RESEARCH COLLABORATION TERM, THE PROGRAM SHALL BE DEEMED TERMINATED BY THE JSC,
REGULUS SHALL NOT BE REQUIRED TO CONDUCT ANY ACTIVITIES UNDER ANY EARLY
DEVELOPMENT PROGRAM WITH RESPECT TO SUCH COLLABORATION TARGET, AND THE
COLLABORATION COMPOUNDS DIRECTED AGAINST SUCH COLLABORATION TARGET SHALL BE
DEEMED REFUSED CANDIDATES AND REVERT TO REGULUS, SUBJECT TO SECTION 4.2.7;
PROVIDED, HOWEVER, THAT GSK SHALL HAVE THE RIGHT TO EXERCISE ITS TERMINATED
PROGRAM OPTION FOR ANY PROGRAM IN ACCORDANCE WITH SECTION 4.2.3.
3.4.4
PRELIMINARY POC PLAN.
AT THE TIME OF, AND AS PART OF THE PROCESS OF
SELECTION OF THE DEVELOPMENT CANDIDATE AS PROVIDED IN SECTION 3.4.1, THE
PARTIES, THROUGH THE JSC AND/OR JPS, SHALL DISCUSS AND AGREE UPON THE
APPROPRIATE PRELIMINARY DEVELOPMENT STRATEGY AND A PRELIMINARY PLAN FOR
ESTABLISHING POC FOR SUCH DEVELOPMENT CANDIDATE, INCLUDING THE POSSIBLE TRIAL
DESIGN AND PROTOCOL FOR THE POC TRIAL, AND ESTIMATED ASSOCIATED COSTS AND
TIMELINES, IT BEING UNDERSTOOD THAT SUCH TRIAL DESIGN AND TIMELINES ARE MERELY