REGULUS'
CONSENT) TO TRANSFER ANY RESPONSIBILITY TO REGULUS FOR THE CONDUCT OF ANY
ENABLING STUDIES.
3.9
COOPERATION; EXCHANGE OF INFORMATION.
3.9.1
COOPERATION. THE PARTIES AGREE TO COOPERATE IN GOOD FAITH DURING THE
COLLABORATION TERM IN IDENTIFYING AND IMPLEMENTING OPPORTUNITIES TO REDUCE THE
COSTS INCURRED IN THE CONDUCT OF THE PROGRAMS, INCLUDING COSTS OF EQUIPMENT,
CONSUMABLES SUCH AS LABORATORY SUPPLIES, AND THIRD PARTY SERVICES SUCH AS
TOXICOLOGY, CLINICAL STUDIES, DRUG SUBSTANCE AND DRUG PRODUCT PROCESS
DEVELOPMENT, OR MANUFACTURING SERVICES, PROVIDED, THAT SUCH COOPERATION DOES NOT
DELAY OR HAMPER REGULUS IN THE PERFORMANCE OF ITS ACTIVITIES THEREUNDER AND IN
NO EVENT SHALL REGULUS BE OBLIGATED TO INCUR ADDITIONAL COSTS OR EXPENSES AS A
RESULT OF SUCH NEW OPPORTUNITIES.
THESE ATTEMPTS MAY INCLUDE EXPLORATION OF
[***].
3.9.2
EXCHANGE OF INFORMATION.
DURING THE RESEARCH COLLABORATION TERM AND
THE EARLY DEVELOPMENT TERM, REGULUS SHALL PROVIDE TO THE JSC REASONABLE PROGRESS
UPDATES AT EACH CALENDAR QUARTER MEETING OF THE JSC ON THE STATUS OF THE
RESEARCH PROGRAM FOR EACH COLLABORATION TARGET AND OF THE EARLY DEVELOPMENT
PROGRAMS, SUMMARIES OF DATA ASSOCIATED WITH REGULUS' RESEARCH AND DEVELOPMENT
EFFORTS AND THE LIKELIHOOD OF AND TIMETABLE FOR COMPLETION OF THE RESPECTIVE
PROGRAMS OR DEVELOPMENT ACTIVITIES AND ADVANCEMENT OF COLLABORATION COMPOUNDS TO
THE NEXT PHASE OF RESEARCH OR DEVELOPMENT, AS APPLICABLE.
ANY SUCH WRITTEN
SUMMARIES SHALL BE PROVIDED TO JSC MEMBERS AT LEAST [***] BUSINESS DAYS IN
ADVANCE OF THE UPCOMING JSC MEETING.
REGULUS WILL USE DILIGENT EFFORTS TO SHARE
ANY DATA OR INFORMATION, AS WELL AS ANY CORRESPONDENCE RECEIVED FROM OR
SUBMITTED TO ANY REGULATORY AUTHORITY, DIRECTLY RELATING TO COLLABORATION
COMPOUNDS THAT IS GENERATED IN THE COURSE OF REGULUS' ACTIVITIES HEREUNDER, WITH
THE JSC, ON AN ONGOING BASIS, REGARDLESS OF WHETHER SUCH DATA OR INFORMATION
WOULD HAVE A POSITIVE, NEUTRAL OR NEGATIVE IMPACT ON THE POTENTIAL COMMERCIAL,
SCIENTIFIC OR STRATEGIC VALUE OF SUCH COLLABORATION COMPOUNDS, IN ORDER TO
FACILITATE GSK'S DECISION-MAKING IN CONNECTION WITH THE EXERCISE OF AN
APPLICABLE PROGRAM OPTION AND TO MONITOR REGULUS' OBLIGATIONS DURING THE
APPLICABLE PROGRAM TERM.
THE PROVISION OF ALL SUCH DATA OR INFORMATION SHALL BE
PERFORMED IN A TIMELY MATTER TO ACCOMMODATE ALL REGULATORY DEADLINES AND ENSURE
COMPLIANCE WITH THE TIMELINES SET FORTH IN ANY AGREED PLAN.
44
3.9.3
PUBLICATION OF CLINICAL TRIALS RESULTS.
EACH OF GSK AND REGULUS
SHALL HAVE THE RIGHT TO PUBLISH SUMMARIES OF RESULTS FROM ANY HUMAN CLINICAL
TRIALS CONDUCTED BY SUCH PARTY UNDER THIS AGREEMENT, WITHOUT REQUIRING THE
CONSENT OF THE OTHER PARTY; PROVIDED HOWEVER THAT GSK SHALL HAVE NO RIGHT,
WITHOUT THE CONSENT OF REGULUS, TO SO PUBLISH DATA GENERATED BY REGULUS PRIOR TO
GSK'S EXERCISE OF ITS PROGRAM OPTION WITH RESPECT TO THE RELEVANT COLLABORATION
COMPOUNDS, AND, AFTER THE EXERCISE OF ITS PROGRAM OPTION, GSK SHALL HAVE THE
RIGHT TO SO PUBLISH ANY SUCH EXISTING AND FUTURE DATA GENERATED BY REGULUS OR
GSK WITH RESPECT TO THE RELEVANT COLLABORATION COMPOUND(S) WITHOUT OBTAINING THE
CONSENT OF REGULUS EXCEPT WITH RESPECT TO ANY REFUSED CANDIDATES, REFUSED
CANDIDATE PRODUCTS OR RETURNED LICENSED PRODUCTS.
IN ADDITION, AFTER THE
EXERCISE