OF ITS PROGRAM OPTION BY GSK, REGULUS SHALL NOT HAVE THE RIGHT TO
PUBLISH ANY OF SUCH DATA, WITHOUT THE PRIOR CONSENT OF GSK, FOR ANY DATA
PERTAINING TO THE RELEVANT COLLABORATION COMPOUNDS, EXCEPT (A) WITH RESPECT TO
ANY REFUSED CANDIDATES, REFUSED CANDIDATE PRODUCTS OR RETURNED LICENSED PRODUCTS
AND (B) AS DESCRIBED IN SECTION 9.2(II).
THE PARTIES SHALL DISCUSS AND
REASONABLY COOPERATE IN ORDER TO FACILITATE THE PROCESS TO BE EMPLOYED IN ORDER
TO ENSURE THE PUBLICATION OF ANY SUCH SUMMARIES OF HUMAN CLINICAL TRIALS DATA
AND RESULTS AS REQUIRED ON THE CLINICAL TRIAL REGISTRY OF EACH RESPECTIVE PARTY,
AND SHALL PROVIDE THE OTHER PARTY VIA SUBMISSION TO THE JOINT PATENT
SUBCOMMITTEE ESTABLISHED UNDER SECTION 2.2.2, AT LEAST [***] DAYS PRIOR NOTICE
TO REVIEW THE CLINICAL TRIALS RESULTS TO BE PUBLISHED FOR THE PURPOSES OF
PREPARING ANY NECESSARY PATENT RIGHT FILINGS.
3.10
SUBCONTRACTING.
EACH PARTY SHALL HAVE THE RIGHT TO ENGAGE THIRD PARTY
SUBCONTRACTORS AND, IN THE CASE OF REGULUS, ITS PARENT COMPANIES, TO PERFORM
CERTAIN OF ITS OBLIGATIONS UNDER THIS AGREEMENT; PROVIDED THAT REGULUS SHALL NOT
HAVE THE RIGHT TO SUBCONTRACT, IN WHOLE OR IN PART, THE DISCOVERY, RESEARCH OR
OPTIMIZATION OF MIRNA ANTAGONISTS AGAINST COLLABORATION TARGETS EXCEPT TO ITS
PARENT COMPANIES PURSUANT TO THE SERVICES AGREEMENT.
ANY SUBCONTRACTOR TO BE
ENGAGED BY A PARTY TO PERFORM A PARTY'S OBLIGATIONS SET FORTH IN THE AGREEMENT
SHALL MEET THE QUALIFICATIONS TYPICALLY REQUIRED BY SUCH PARTY FOR THE
PERFORMANCE OF WORK SIMILAR IN SCOPE AND COMPLEXITY TO THE SUBCONTRACTED
ACTIVITY.
NOTWITHSTANDING THE PRECEDING, ANY PARTY ENGAGING A SUBCONTRACTOR
HEREUNDER (INCLUDING, WITHOUT LIMITATION, FOR THE PERFORMANCE OF CLINICAL
TRIALS) SHALL REMAIN RESPONSIBLE AND OBLIGATED FOR SUCH ACTIVITIES AND SHALL IN
ALL CASES RETAIN OR OBTAIN EXCLUSIVE [***], AT THE SOLE COST AND EXPENSE OF THE
PARTY ENGAGING SUCH SUBCONTRACTOR, AND ANY SUCH COSTS AND EXPENSES [***], UNLESS
THE JSC AGREES, IN ADVANCE AS DOCUMENTED IN THE RELEVANT MEETING MINUTES, TO
ENGAGE SUCH SUBCONTRACTOR AND TO ASSUME THE PROPOSED FINANCIAL OBLIGATIONS THAT
WOULD RESULT UNDER ANY AGREEMENT WITH SUCH SUBCONTRACTOR, IN WHICH CASE THE
ALLOCATION OF SUCH COSTS AND EXPENSES BETWEEN THE PARTIES SHALL BE GOVERNED BY
[***].
TO THE EXTENT THAT SUCH EXCLUSIVE [***] CANNOT BE OBTAINED BY REGULUS
WITH RESPECT TO
45
[***] OF REGULUS, PRIOR TO ENTERING INTO ANY SUCH ARRANGEMENT WITH ANY SUCH
SUBCONTRACTOR, REGULUS SHALL BRING SUCH MATTER TO GSK IN WRITING IN A TIMELY
FASHION IN ORDER TO SEEK THE PRIOR WRITTEN CONSENT FROM GSK TO ENTER INTO SUCH
AN ARRANGEMENT, SUCH CONSENT NOT TO BE UNREASONABLY WITHHELD.
FOR CLARITY, THIS
SECTION 3.10 SHALL NOT APPLY TO RESTRICT OR OTHERWISE LIMIT THE RIGHTS OF GSK TO
USE A SUBCONTRACTOR AFTER THE EXERCISE OF ITS PROGRAM OPTION OR THE ACQUISITION
OF EXCLUSIVE RIGHTS TO THE COLLABORATION COMPOUNDS OF A PROGRAM PURSUANT TO THE
EXPRESS PROVISIONS OF ARTICLE 12 FOR THE RELEVANT PROGRAM BEYOND THE
RESTRICTIONS AND LIMITATIONS EXPRESSLY STATED IN SECTION 5.2.2.
ARTICLE 4
GSK'S PROGRAM OPTION RIGHTS; EXERCISE OF PROGRAM OPTIONS;
GSK DILIGENCE
4.1
PROGRAM OPTIONS.