1.5
"ALLIANCE MANAGER" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 2.3.
1.6
"ALNYLAM" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN THE RECITALS.
1.7
"ANDA" SHALL MEAN AN ABBREVIATED NEW DRUG APPLICATION AND ALL AMENDMENTS
AND SUPPLEMENTS THERETO FILED WITH THE FDA, OR THE EQUIVALENT APPLICATION FILED
WITH ANY EQUIVALENT AGENCY OR GOVERNMENTAL AUTHORITY OUTSIDE THE U.S. (INCLUDING
ANY SUPRA-NATIONAL AGENCY SUCH AS THE EMEA IN THE EU).
1.8
"ANNUAL" OR "ANNUALLY" SHALL MEAN CALENDAR YEAR.
1.9
"BACK-UP COMPOUND" SHALL MEAN, WITH RESPECT TO A GIVEN LEADING COMPOUND FOR
A GIVEN PROGRAM, ANY OTHER COLLABORATION COMPOUND DEVELOPED UNDER SUCH PROGRAM
THAT IS DESIGNED TO INHIBIT (I.E. DIRECTED TO OR DIRECTED AGAINST) THE SAME
COLLABORATION TARGET AS THE LEADING COMPOUND AND [***] THE LEADING COMPOUND.
1.10
"BANKRUPTCY CODE" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 12.6.2.
1.11
"BLOCKED TARGET" SHALL MEAN A MIRNA FROM [***] THAT REGULUS ELECTS, BY
WRITTEN NOTICE TO GSK, [***] AND THAT GSK DOES NOT, IN ACCORDANCE WITH [***].
1.12
"BREACHING PARTY" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 12.2.1 OR SECTION 12.2.2, AS THE CASE MAY BE.
3
1.13
"BUSINESS DAY" SHALL MEAN ANY DAY OTHER THAN A SATURDAY OR SUNDAY ON WHICH
BANKING INSTITUTIONS IN BOTH NEW YORK, NEW YORK AND LONDON, ENGLAND ARE OPEN FOR
BUSINESS.
1.14
"CALENDAR QUARTER" SHALL MEAN A PERIOD OF THREE (3) CONSECUTIVE MONTHS
ENDING ON THE LAST DAY OF MARCH, JUNE, SEPTEMBER, OR DECEMBER, RESPECTIVELY AND
WILL ALSO INCLUDE THE PERIOD BEGINNING ON THE EFFECTIVE DATE AND ENDING ON THE
LAST DAY OF THE CALENDAR QUARTER IN WHICH THE EFFECTIVE DATE FALLS.
1.15
"CALENDAR YEAR" SHALL MEAN A YEAR OF 365 DAYS (OR 366 DAYS IN A LEAP YEAR)
BEGINNING ON JANUARY 1ST (OR, WITH RESPECT TO 2008, THE EFFECTIVE DATE) AND
ENDING DECEMBER 31ST, AND SO ON YEAR-BY-YEAR.
1.16
"CANDIDATE SELECTION CRITERIA" SHALL MEAN THE CRITERIA FOR ADVANCEMENT OF
A COLLABORATION COMPOUND [***], WHICH PROVISIONAL CRITERIA ARE INCLUDED IN THE
INITIAL RESEARCH PLAN WITH RESPECT TO PROGRAMS DIRECTED AGAINST THE INITIAL
COLLABORATION TARGETS (AS SUCH PROVISIONAL CRITERIA MAY BE [***] IN ACCORDANCE
WITH SECTION 2.1.6) AND, WITH RESPECT TO PROGRAMS DIRECTED AGAINST THE
SUBSEQUENT COLLABORATION TARGETS, AS CONFIRMED BY THE JSC WITH RESPECT TO EACH
SUCH PROGRAM IN ACCORDANCE WITH SECTION 2.1.6.
BY WAY OF GUIDELINE ONLY, THE
CANDIDATE SELECTION CRITERIA WILL TYPICALLY INCLUDE (A) DATA REGARDING THE [***]
OF THE COLLABORATION COMPOUND AND OTHER [***] OF THE COLLABORATION COMPOUND IN
[***] AS WELL AS A PRELIMINARY ASSESSMENT OF THE [***], AS WELL AS EVALUATION OF
[***] MODELS.
AN ASSESSMENT OF [***] SHOULD BE TYPICALLY INCLUDED WITH
PRELIMINARY [***], [***]; (B) THE PROPERTIES OF THE COLLABORATION COMPOUND
REGARDING [***]; (C) ASSESSMENT OF THE [***]; AND (D) A PRELIMINARY ASSESSMENT
OF [***], (PROVIDED, HOWEVER, THAT NOTHING HEREIN SHALL REQUIRE REGULUS TO
RESOLVE ANY SUCH ISSUES IF THEY ARE IDENTIFIED).
1.17
"[***]" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN SECTION 4.1.1.
1.18
"[***]" SHALL HAVE THE MEANING