ON A PROGRAM-BY-PROGRAM BASIS, REGULUS WILL NOTIFY GSK, THROUGH
THE JSC, WHEN IT HAS DEVELOPED A COLLABORATION COMPOUND THAT MEETS THE [***]
CRITERIA FOR NOMINATION AS A DEVELOPMENT CANDIDATE, AND SHALL PROVIDE TO GSK,
THROUGH THE JSC, WITHIN [***] DAYS OF SUCH OCCURRENCE (TO BE REASONABLY EXTENDED
IF IMPRACTICAL DEPENDING ON THE NATURE OF THE PRE-CLINICAL STUDIES AND THE DATA
GENERATED THEREUNDER), A COMPLETE DATA PACKAGE CONTAINING ALL MATERIAL ANALYSIS,
RESULTS AND PRECLINICAL DATA OR ANY RELATED MATERIAL CORRESPONDENCE OR
INFORMATION RECEIVED FROM OR SENT TO ANY REGULATORY AUTHORITY RELATING TO THE
COLLABORATION COMPOUNDS AT ISSUE (THE "CANDIDATE SELECTION REPORT"), IN EACH
CASE AS WOULD BE REASONABLY EXPECTED TO BE MATERIAL TO ASSIST AND ENABLE GSK TO
MAKE ITS DECISION ON WHETHER TO ELECT TO EXERCISE ITS [***] OPTION WITH RESPECT
TO THE PROGRAM UNDER WHICH SUCH DEVELOPMENT CANDIDATE IS DEVELOPED.
IN
ADDITION, GSK SHALL HAVE THE RIGHT TO REVIEW, TO THE EXTENT PRACTICAL AND
REASONABLE, THE ORIGINAL RECORDS AND DOCUMENTATION CONTAINING SUCH MATERIAL
DATA, RESULTS AND INFORMATION. THE JSC SHALL CONFIRM WHETHER THE [***] CRITERIA
HAVE BEEN MET.
(B)
GSK MAY EXERCISE ITS [***] OPTION WITH RESPECT TO A PROGRAM BY
DELIVERING TO REGULUS A WRITTEN NOTICE OF EXERCISE NOT LATER THAN [***] DAYS
(UNLESS EXTENDED BY THE MUTUAL WRITTEN AGREEMENT OF THE PARTIES OR AS PERMITTED
HEREIN PENDING HSR CLEARANCE BY THE FTC AS SET FORTH IN SECTION 4.2.6) AFTER THE
DATE OF RECEIPT BY GSK FROM REGULUS OF THE
47
COMPLETED [***] REPORT (SUCH [***]-DAY PERIOD, AS IT MAY BE EXTENDED, THE "[***]
OPTION EXERCISE PERIOD"), WITH RESPECT TO THE COLLABORATION COMPOUND AT ISSUE
(SUCH DATE OF RECEIPT BY GSK, THE "[***] REPORT DATE"), SPECIFYING THE PROGRAM
FOR WHICH THE PROGRAM OPTION IS BEING EXERCISED.
AFTER PROVIDING TO REGULUS
SUCH WRITTEN NOTICE OF ITS ELECTION TO EXERCISE THE [***] OPTION, GSK SHALL,
WITHIN [***] DAYS OF RECEIPT OF AN INVOICE THEREFORE FROM REGULUS, PAY THE [***]
OPTION EXERCISE FEE.
NOTWITHSTANDING THE FOREGOING, IN GSK'S SOLE DISCRETION,
IT SHALL HAVE THE RIGHT TO EXERCISE A PROGRAM OPTION PRIOR TO THE [***] REPORT
DATE BUT DURING THE [***] OPTION EXERCISE PERIOD BY PROVIDING REGULUS WRITTEN
NOTICE THEREOF, IN WHICH CASE THE TABLE 1 RATES WILL STILL APPLY TO THE
MILESTONE PAYMENTS AND ROYALTIES OWED BY GSK TO REGULUS HEREUNDER.
(C)
NOTWITHSTANDING ANY OF THE FOREGOING, IF, AT ANY TIME DURING
THE RESEARCH COLLABORATION TERM FOR A RESEARCH PROGRAM, THE JSC (BY MUTUAL
AGREEMENT) OR GSK REQUESTS THAT REGULUS BEGIN A [***] OF A COLLABORATION
COMPOUND UNDER SUCH RESEARCH PROGRAM PRIOR TO REGULUS' NOTIFICATION TO GSK OF A
COLLABORATION COMPOUND THAT MEETS THE [***] CRITERIA, THE [***] CRITERIA SHALL
BE DEEMED TO HAVE BEEN MET AND, UPON SUCH REQUEST, THE [***] OPTION EXERCISE
PERIOD SHALL BEGIN.
4.2.2
POC OPTION.
(A)
IF GSK DOES NOT EXERCISE THE [***] OPTION WITHIN THE [***]
OPTION EXERCISE PERIOD, THEN, ON A PROGRAM-BY-PROGRAM BASIS, REGULUS WILL
CONTINUE TO USE DILIGENT EFFORTS TO PROGRESS THE PROGRAM THROUGH TO THE [***].
ON A PROGRAM-BY-PROGRAM BASIS, REGULUS