WILL NOTIFY GSK WHEN IT HAS COMPLETED A
POC TRIAL WITH RESPECT TO A DEVELOPMENT CANDIDATE, AND SHALL PROVIDE TO GSK,
WITHIN [***] DAYS OF SUCH OCCURRENCE (TO BE REASONABLY EXTENDED IF IMPRACTICAL
DEPENDING ON THE NATURE OF THE CLINICAL STUDIES, PRE-CLINICAL STUDIES AND THE
OTHER DATA GENERATED THEREUNDER), A REASONABLY COMPLETE DATA PACKAGE CONTAINING
ALL MATERIAL ANALYSIS, RESULTS AND CLINICAL DATA OR ANY RELATED MATERIAL
CORRESPONDENCE OR INFORMATION RECEIVED FROM OR SENT TO ANY REGULATORY AUTHORITY
RELATING TO THE DEVELOPMENT CANDIDATE AT ISSUE (WHICH DATA PACKAGE NEED NOT
INCLUDE ANY INFORMATION OR DATA GENERATED IN THE COURSE OF GSK'S CONDUCT OF THE
POC TRIAL, OR PORTION THEREOF, UNDER SECTION 3.5.5) (THE "[***] REPORT", AND
REFERRED TO COLLECTIVELY WITH THE [***] REPORT AS THE "REPORTS"), 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 [***] 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.
48
(B)
GSK MAY EXERCISE ITS [***] 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 POC TRIAL REPORT (SUCH [***]-DAY
PERIOD, AS IT MAY BE EXTENDED, THE "[***] EXERCISE PERIOD"), WITH RESPECT TO THE
APPLICABLE DEVELOPMENT CANDIDATE AT ISSUE (SUCH DATE OF RECEIPT BY GSK, THE
"[***] DATE"), SPECIFYING THE PROGRAM FOR WHICH THE PROGRAM OPTION IS BEING
EXERCISED, SUBJECT TO THE TOLLING OF SUCH PAYMENT OBLIGATION PURSUANT TO
SECTION 4.2.6.
AFTER PROVIDING TO REGULUS SUCH WRITTEN NOTICE OF ITS ELECTION
TO EXERCISE THE [***], GSK SHALL, WITHIN [***] DAYS OF RECEIPT OF AN INVOICE
THEREFORE FROM REGULUS, PAY THE [***] EXERCISE FEE AS DESCRIBED IN SECTION 6.4.
NOTWITHSTANDING THE FOREGOING, IN GSK'S SOLE DISCRETION, IT SHALL HAVE THE RIGHT
TO EXERCISE A PROGRAM OPTION PRIOR TO THE [***] DATE BY PROVIDING REGULUS
WRITTEN NOTICE THEREOF.
4.2.3
TERMINATED PROGRAM OPTION. SUBJECT TO GSK'S OBLIGATION TO PAY
MILESTONES AND ROYALTIES PURSUANT TO SECTION 6.4, SUBJECT TO SECTION 6.5.3,
SECTION 6.6.1(D) AND SECTION 6.6.2, GSK SHALL HAVE THE RIGHT TO EXERCISE ITS
TERMINATED PROGRAM OPTION FOR A PROGRAM BY PROVIDING REGULUS WRITTEN NOTICE
WITHIN AN EXERCISE PERIOD OF [***] DAYS (EXTENDABLE TO [***] DAYS AT GSK'S
REQUEST IF MADE WITHIN SUCH INITIAL [***] DAY PERIOD) AFTER THE PROVISION OF A
DATA PACKAGE TO GSK BY REGULUS (COMPARABLE TO THE [***] REPORT) FOR A TERMINATED
PROGRAM IN ACCORDANCE WITH GSK'S TERMINATED PROGRAM OPTIONS AS DESCRIBED UNDER
SECTION 4.1.1 (THE "TERMINATED PROGRAM OPTION REPORT"); PROVIDED, THAT GSK'S
OBLIGATION TO PAY REGULUS MILESTONES AND ROYALTIES SHALL VARY, AS SET FORTH IN
SECTION 6.4, SUBJECT