DATA INTEGRITY.
(A)
REGULUS ACKNOWLEDGES THE IMPORTANCE TO GSK OF ENSURING THAT THE
ACTIVITIES UNDER THE INITIAL RESEARCH PLAN, RESEARCH PROGRAMS AND ANY EARLY
DEVELOPMENT PROGRAMS ARE UNDERTAKEN IN ACCORDANCE WITH THE FOLLOWING GOOD DATA
MANAGEMENT PRACTICES ("GOOD DATA MANAGEMENT PRACTICES"):
(I)
DATA ARE BEING GENERATED USING SOUND SCIENTIFIC TECHNIQUES AND
PROCESSES;
(II)
DATA ARE BEING ACCURATELY RECORDED IN ACCORDANCE WITH GOOD
SCIENTIFIC PRACTICES BY PERSONS CONDUCTING RESEARCH HEREUNDER;
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(III)
DATA ARE BEING ANALYZED APPROPRIATELY WITHOUT BIAS IN ACCORDANCE
WITH GOOD SCIENTIFIC PRACTICES;
(IV)
DATA AND RESULTS ARE BEING STORED SECURELY AND CAN BE EASILY
RETRIEVED, AND
(V)
WHERE, PURSUANT TO THEN-EXISTING POLICIES AND PROCEDURES, REGULUS'
SENIOR MANAGEMENT DOCUMENTS IN WRITING ITS KEY DECISIONS, IT WILL FOLLOW ITS
INTERNAL PROCEDURES AND POLICY, SO AS TO DEMONSTRATE AND/OR RECONSTRUCT KEY
DECISIONS MADE BY SUCH SENIOR MANAGEMENT DURING THE CONDUCT OF THE RESEARCH AND
DEVELOPMENT ACTIVITIES UNDER THIS AGREEMENT.
(B)
REGULUS AGREES THAT IT SHALL CARRY OUT THE RESEARCH PROGRAMS,
INITIAL RESEARCH PLAN, AND THE EARLY DEVELOPMENT PROGRAMS AND COLLECT AND RECORD
ANY DATA GENERATED THEREFROM IN A MANNER CONSISTENT WITH THE ABOVE REQUIREMENTS
AS SET FORTH IN (A) ABOVE, AND SHALL, UPON REASONABLE REQUEST BY GSK, PERMIT
REVIEW OF RELEVANT NOTEBOOKS AND RECORDS AS NEEDED AS A RESULT OF GSK
RESPONSIBILITIES UNDER ARTICLE 8 IN RELATION TO PROSECUTION AND MAINTENANCE.
3.7.3
REGULATORY MATTERS.
DURING THE COLLABORATION TERM, WITH RESPECT TO
ANY PROGRAM FOR WHICH THE PROGRAM OPTIONS HAVE NOT YET BEEN EXERCISED OR EXPIRED
AND WHICH PROGRAM HAS NOT OTHERWISE BEEN TERMINATED, AND THE COLLABORATION
COMPOUNDS THEREIN, REGULUS SHALL USE ITS DILIGENT EFFORTS TO:
(A)
OWN AND MAINTAIN ALL REGULATORY FILINGS FILED BY OR ON BEHALF
OF REGULUS FOR COLLABORATION COMPOUNDS DEVELOPED PURSUANT TO THIS AGREEMENT,
INCLUDING ALL INDS FILED BY REGULUS.
UPON EXERCISE BY GSK OF ITS PROGRAM OPTION
WITH RESPECT TO A PROGRAM, REGULUS SHALL TRANSFER TO GSK OWNERSHIP OF SUCH
REGULATORY FILINGS FOR ALL OPTION COMPOUNDS DEVELOPED UNDER SUCH PROGRAM, AS
FURTHER DESCRIBED IN SECTION 5.3;
(B)
REPORT ALL ADVERSE DRUG REACTION EXPERIENCES RELATED TO
COLLABORATION COMPOUNDS IN CONNECTION WITH THE ACTIVITIES OF REGULUS UNDER THIS
AGREEMENT TO THE APPROPRIATE REGULATORY AUTHORITIES IN THE COUNTRIES IN THE
TERRITORY IN WHICH SUCH COLLABORATION COMPOUNDS ARE BEING DEVELOPED, IN
ACCORDANCE WITH THE APPLICABLE LAWS AND REGULATIONS OF THE RELEVANT COUNTRIES
AND REGULATORY AUTHORITIES, AND TO PROVIDE GSK NOTICE OF SUCH EVENT AND PROVIDE
COPIES OF ALL REPORTS TO GSK AS PROMPTLY AS PRACTICABLE, WHICH GSK SHALL USE
SOLELY FOR PURPOSES OF FACILITATING GSK'S DECISION-MAKING WITH RESPECT TO ITS
EXERCISE OF ANY RELEVANT PROGRAM OPTION HEREUNDER, AND FOR NO OTHER PURPOSE
UNLESS AND UNTIL GSK EXERCISES SUCH PROGRAM OPTION.
THROUGH THE JSC, GSK SHALL
HAVE THE RIGHT, UPON REASONABLE REQUEST, TO REVIEW FROM TIME TO TIME REGULUS'
PHARMACOVIGILANCE POLICIES AND PROCEDURES.
GSK AND
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REGULUS AGREE TO COOPERATE AND USE GOOD FAITH EFFORTS TO ENSURE THAT REGULUS'
ADVERSE EVENT DATABASE IS ORGANIZED IN A FORMAT THAT IS REASONABLY COMPATIBLE
WITH GSK'S ADVERSE EVENT DATABASES.
THE PARTIES WILL CONSIDER