PROGRAM AND DEVELOPMENT PROGRAM. IN ADDITION, ON
REASONABLE REQUEST BY A PARTY, THE OTHER PARTY WILL MAKE PRESENTATIONS OF ITS
ACTIVITIES IN THE PERFORMANCE OF THE COLLABORATION TO INFORM SUCH PARTY OF THE
DETAILS OF THE WORK DONE IN THE PERFORMANCE OF THE COLLABORATION. THE RESULTS,
REPORTS, ANALYSES AND OTHER INFORMATION REGARDING THE COLLABORATION DISCLOSED BY
ONE PARTY TO THE OTHER PARTY PURSUANT HERETO MAY BE USED ONLY IN ACCORDANCE WITH
THE RIGHTS GRANTED AND OTHER TERMS AND CONDITIONS UNDER THIS AGREEMENT. UPON
REASONABLE REQUEST BY OMI, ISIS WILL PROVIDE OMI WITH ADDITIONAL DATA, RESULTS
AND OTHER INFORMATION WITH RESPECT TO THE WORK PERFORMED BY ISIS IN THE
PERFORMANCE OF THE COLLABORATION. ANY REPORTS REQUIRED, EXCLUDING REPORTS NEEDED
FOR SUBMISSION TO A REGULATORY AGENCY, UNDER THIS SECTION 3.8 MAY TAKE THE FORM
OF AND BE RECORDED IN MINUTES OF THE R&D COMMITTEE THAT WILL CONTAIN COPIES OF
ANY SLIDES RELATING TO THE RESULTS AND PRESENTED TO THE R&D COMMITTEE. REPORTS
NEEDED TO SUPPORT REGULATORY SUBMISSIONS AND UPDATES TO A REGULATORY AGENCY WILL
BE PROVIDED [***] AND IN A FORMAT AS AGREED UPON BY THE R&D COMMITTEE OR
DESIGNATED SUB COMMITTEE.
IN ADDITION, WITHIN [***] OF OMI'S REQUEST, ISIS WILL TRANSFER TO OMI COPIES OF
ALL DATA, RESULTS, AND INFORMATION RELATED TO TESTING AND STUDIES OF THE
COMPOUNDS (INCLUDING ANALYTICAL TEST RESULTS AND NON-CLINICAL PHARMACOLOGY AND
SAFETY DATA) IN THE POSSESSION OF ISIS TO THE EXTENT SUCH DATA, RESULTS AND/OR
INFORMATION IS NECESSARY OR USEFUL FOR THE CONTINUED
8
Development and Commercialization of Products, including but not limited to any
and all information directly relating to manufacturing methods (including
related analytical methods) of the Compounds or Products.
SECTION
3.9
RESEARCH EFFORTS; RESOURCES, SCIENTIFIC MANNER. EACH PARTY WILL USE COMMERCIALLY
REASONABLE EFFORTS TO PERFORM THE COLLABORATION, INCLUDING ITS RESPONSIBILITIES
UNDER THE R&D PLAN.
3.9.1
THROUGHOUT THE COLLABORATION TERM, ISIS WILL ASSIGN NO LESS THAN THE NUMBER OF
FTE QUALIFIED SCIENTISTS SPECIFIED IN THE R&D PLAN TO PERFORM THE WORK SET FORTH
IN THE THEN-APPLICABLE R&D PLAN. THE MIXTURE OF SKILLS AND LEVELS OF SUCH FTES
WILL BE APPROPRIATE TO THE SCIENTIFIC OBJECTIVES OF THE RESEARCH PROGRAM OR
DEVELOPMENT PROGRAM (AS APPLICABLE).
3.9.2
EACH PARTY WILL MAINTAIN LABORATORIES, OFFICES, ADMINISTRATIVE SUPPORT AND ALL
OTHER FACILITIES AT ITS OWN EXPENSE AND RISK NECESSARY TO CARRY OUT ITS
RESPONSIBILITIES UNDER THE COLLABORATION PURSUANT TO THE R&D PLAN. EACH PARTY
AGREES TO MAKE ITS EMPLOYEES REASONABLY AVAILABLE AT THEIR RESPECTIVE PLACES OF
EMPLOYMENT TO CONSULT WITH THE OTHER PARTY ON ISSUES ARISING DURING THE
PERFORMANCE OF THE COLLABORATION. OMI AND ISIS WILL COOPERATE WITH EACH OTHER IN
CARRYING OUT THE COLLABORATION, AND EACH PARTY WILL CONTRIBUTE ITS RELEVANT
KNOW-HOW AND EXPERIENCE NECESSARY TO CARRY OUT THE COLLABORATION.
3.9.3
THE COLLABORATION WILL BE CONDUCTED BY EACH PARTY IN GOOD SCIENTIFIC MANNER, AND
IN COMPLIANCE WITH ALL APPLICABLE GCP, GLP AND GMP, AND APPLICABLE LEGAL
REQUIREMENTS, TO ATTEMPT TO ACHIEVE EFFICIENTLY AND EXPEDITIOUSLY THE OBJECTIVES
OF THE COLLABORATION. EACH PARTY WILL COMPLY WITH ALL APPLICABLE LAWS, IN