FOLLOWING THE CONDUCT OF THE POC TRIAL BY
REGULUS FOR ANY DEVELOPMENT CANDIDATE, REGULUS SHALL PROMPTLY NOTIFY GSK IN
WRITING THEREOF AND PROVIDE TO THE JSC AND GSK THE POC TRIAL REPORT WHICH WILL
INITIATE THE [***] EXERCISE PERIOD.
REGULUS SHALL ENDEAVOR IN GOOD FAITH TO
PROVIDE GSK WITH A REASONABLY ACCURATE ESTIMATE OF THE TIME THAT THE POC TRIAL
REPORT WILL BE AVAILABLE AT LEAST [***] MONTHS IN ADVANCE.
IN THE EVENT THAT
SUCH ESTIMATE OF DELIVERY DATE IS FOUND TO BE MORE THAN [***] MONTHS PAST THE
ESTIMATED DATE, GSK SHALL HAVE A [***] EXTENSION FOR THE TIME ALLOWED HEREUNDER
TO EXERCISE THE POC OPTION.
3.5.5
CONDUCT OF POC TRIAL WITHIN POC FINANCIAL CAP.
IN THE EVENT THAT
(A) GSK, IN ACCORDANCE WITH SECTION 2.1.7, EXERCISES ITS FINAL DECISION-MAKING
AUTHORITY WITH RESPECT TO THE POC CRITERIA OR THE DESIGN, CONTENT AND END POINTS
OF ANY POC TRIAL, AND THE JSC AGREES
(SUCH AGREEMENT NOT TO BE UNREASONABLY
WITHHELD) THAT THE [***] OF SUCH POC TRIAL WOULD [***] OR (B) THE [***] OF SUCH
POC TRIAL ACTUALLY [***] EXCEPT TO THE EXTENT DUE TO [***], THEN, IN EACH CASE,
(I) REGULUS SHALL USE ITS DILIGENT EFFORTS TO CONDUCT SUCH POC TRIAL AND [***],
THE AMOUNT OF SUCH [***] TO BE AGREED PRIOR TO THE INITIATION OF THE POC TRIAL
(TO THE EXTENT POSSIBLE), AND IN SUCH EVENT ANY [***] ON ACCOUNT OF SUCH POC
TRIAL [***] SHALL BE [***] OF GSK ARISING UNDER THE RELEVANT PROGRAM HEREUNDER,
OR (II) IF REGULUS DOES NOT HAVE [***] TO CONDUCT SUCH POC TRIAL WHICH HAS BEEN
[***], THEN GSK SHALL EITHER, SUCH CHOICE TO BE MADE AT GSK'S SOLE DISCRETION,
39
(A) AGREE TO [***] SUCH AGREEMENT NOT SUBJECT TO [***] IN MAKING SUCH DECISION,
THE POC TRIAL, AND THEN [***] AS WOULD HAVE BEEN REQUIRED OF REGULUS HEREUNDER,
AND REGULUS SHALL BE REQUIRED TO [***] ATTRIBUTABLE TO THE POC TRIAL WHICH WOULD
HAVE BEEN EQUIVALENT TO [***] FOR CONDUCTING THE POC TRIAL IF A GOOD-FAITH
ESTIMATE OF SUCH [***] BASED ON THE POC TRIAL DESIGN, CONTENT AND END POINTS,
PLUS, THE FIRST [***] IN POC COSTS OF SUCH POC TRIAL, AND [***] ON ACCOUNT OF
SUCH POC TRIAL ABOVE [***] SHALL BE [***] OF GSK ARISING UNDER THE RELEVANT
PROGRAM HEREUNDER OR (B) REVISE THE POC CRITERIA OR THE DESIGN, CONTENT AND END
POINTS OF ANY POC TRIAL TO [***].
3.6
REGULUS DILIGENCE. THE COMMON OBJECTIVE OF THE PARTIES IS TO IDENTIFY AND
DEVELOP [***] COLLABORATION COMPOUND FOR EACH PROGRAM FOR DEVELOPMENT AND
COMMERCIALIZATION AS LICENSED PRODUCTS CONTAINING SUCH COLLABORATION
COMPOUND(S) IN THE FIELD IN THE TERRITORY UNDER THE TERMS OF THIS AGREEMENT.
REGULUS SHALL USE ITS DILIGENT EFFORTS TO CONDUCT THE IDENTIFICATION, SCREENING,
CHARACTERIZATION, OPTIMIZATION AND OTHER DISCOVERY AND RESEARCH ACTIVITIES IN
ACCORDANCE WITH THE INITIAL RESEARCH PLAN DURING THE TARGET SELECTION PERIOD,
AND TO CARRY OUT AND CONDUCT EACH RESEARCH PROGRAM AND DEVELOPMENT IN ACCORDANCE
WITH THE RESEARCH PLAN, AND, IF GSK HAS NOT EXERCISED ITS [***] OPTION