AS SET FORTH IN SECTION 1.4.2 OF THIS AMENDMENT.
(E)
"STANFORD" MEANS THE BOARD OF TRUSTEES OF THE LELAND STANFORD
JUNIOR UNIVERSITY.
(F)
"STANFORD LICENSE AGREEMENT" MEANS THE CO-EXCLUSIVE LICENSE
AGREEMENT DATED AUGUST 31, 2005 AMONG STANFORD AND THE PARENT COMPANIES (AS
ASSIGNED BY ISIS TO REGULUS ON JULY 13, 2009).
(G)
"STANFORD PATENT(S)" MEANS ANY PATENT RIGHT LICENSED UNDER THE
STANFORD LICENSE AGREEMENT.
A LIST OF THE STANFORD PATENTS AS OF THE AMENDMENT
DATE IS ATTACHED HERETO UNDER EXHIBIT I.
1.1.3
AMENDMENT AND RESTATEMENT OF SECTION 1.59 OF AGREEMENT.
SECTION 1.59 (DEFINITION OF FIELD) OF THE AGREEMENT, IS HEREBY AMENDED, RESTATED
AND REPLACED IN ITS ENTIRETY BY THE FOLLOWING:
"1.59
"FIELD" SHALL MEAN (A) THE TREATMENT AND/OR PROPHYLAXIS OF ANY OR ALL
INDICATIONS AND (B) ALSO, TO THE EXTENT THAT REGULUS OR GSK, WHICHEVER IS THE
LICENSING PARTY HEREUNDER, CONTROLS DIAGNOSTIC RIGHTS, THE DIAGNOSIS OF ANY OR
ALL INDICATIONS, TO THE EXTENT SUCH DIAGNOSTIC RIGHTS ARE NECESSARY
2
OR IMPORTANT TO COMMERCIALIZE A LICENSED PRODUCT OR WHERE THE ABSENCE OF CONTROL
BY THE COMMERCIALIZING PARTY, OF DIAGNOSTIC RIGHTS COULD REASONABLY BE
CONSIDERED TO MATERIALLY ADVERSELY AFFECT THE SALES OF THE LICENSED PRODUCT;
PROVIDED, HOWEVER, THAT SOLELY WITH RESPECT TO [***], "FIELD" SHALL BE LIMITED
TO THE TREATMENT AND/OR PROPHYLAXIS OF HEPATITIS C VIRUS."
1.1.4
ALL REFERENCES TO "DOLLARS" MEAN U.S. DOLLARS.
THE USE OF THE
SINGULAR FORM OF A DEFINED TERM ALSO INCLUDES THE PLURAL FORM AND VICE VERSA,
EXCEPT WHERE EXPRESSLY NOTED. THE USE OF THE WORD "INCLUDING" SHALL MEAN
"INCLUDING WITHOUT LIMITATION".
THE USE OF THE WORDS "HEREIN," "HEREOF" OR
"HEREUNDER," AND WORDS OF SIMILAR IMPORT, REFER TO THIS AMENDMENT IN ITS
ENTIRETY AND NOT TO ANY PARTICULAR PROVISION HEREOF.
1.2
ADDITION OF MIR-122 AS COLLABORATION TARGET AND PROGRAM.
1.2.1
THE PARTIES HEREBY AGREE THAT, EFFECTIVE AS OF THE AMENDMENT DATE,
MIR-122 SHALL BE ADDED AS ONE OF THE FOUR COLLABORATION TARGETS AND THAT
REGULUS' MIR-122 PROGRAM WILL BE ADDED AS A PROGRAM UNDER THE AGREEMENT.
THE
PARTIES AGREE THAT FOR PURPOSES OF ADDING THE REGULUS MIR-122 PROGRAM TO THE
AGREEMENT, THE PROVISIONS OF SECTION 3.2.1 WILL BE DEEMED TO BE SATISFIED.
REGULUS WILL CONDUCT THE REGULUS MIR-122 PROGRAM IN ACCORDANCE WITH THE TERMS
AND CONDITIONS OF THE AGREEMENT, INCLUDING THE PROVISIONS OF ARTICLE 3 OF THE
AGREEMENT. REGULUS WILL PREPARE AND PRESENT A RESEARCH PLAN FOR THE REGULUS
MIR-122 PROGRAM TO THE MIR-122 JOINT PROGRAM SUBCOMMITTEE FOR APPROVAL WITHIN
SIXTY (60) DAYS OF THE AMENDMENT DATE. THE RESEARCH COLLABORATION TERM FOR THE
REGULUS MIR-122 PROGRAM WILL COMMENCE AS OF THE AMENDMENT DATE. GSK SHALL HAVE A
PROGRAM OPTION WITH RESPECT TO REGULUS' MIR-122 PROGRAM, IN ACCORDANCE WITH THE
TERMS AND CONDITIONS OF THE AGREEMENT; PROVIDED, HOWEVER, THE RESTRICTIONS SET
FORTH IN SECTION 4.1.3 AND ARTICLE 7 OF THE AGREEMENT WILL NOT RESTRICT OR
PREVENT REGULUS OR ITS PARENT COMPANIES FROM PRACTICING OUTSIDE THE FIELD WITH
RESPECT TO [***].
1.2.2
WITHIN THIRTY (30) DAYS OF THE AMENDMENT DATE, THE PARTIES WILL FORM
A JOINT PROGRAM SUBCOMMITTEE