information relating
to such development activities as necessary in order to comply with any
requirements of a Governmental Authority.
6.2
SUBCONTRACTING.
ALL AGREEMENTS BETWEEN ISIS AND THIRD PARTIES
(INCLUDING WITHOUT LIMITATION CLINICAL RESEARCH ORGANIZATIONS AND CONTRACT
MANUFACTURERS) FOR SUCH THIRD PARTIES TO PERFORM ANY ISIS OBLIGATIONS (EACH SUCH
THIRD PARTY, AN "ISIS SUBCONTRACTOR" AND EACH SUCH AGREEMENT, A "SUBCONTRACTING
AGREEMENT") ENTERED INTO BY ISIS PRIOR TO THE CLOSING DATE (EXCEPT FOR THOSE
MASTER SERVICE AGREEMENTS EXECUTED PRIOR TO THE CLOSING DATE THAT, ONLY THROUGH
THE SUBSEQUENT ADDITION OF A NEW WORK ORDER, CHANGE ORDER, PROJECT OR THE LIKE
AFTER THE CLOSING DATE, BECOME SUBCONTRACTING AGREEMENTS) SHALL BE DEEMED TO BE
ACCEPTABLE TO THE PARTIES IN ALL RESPECTS. FOLLOWING THE CLOSING DATE, ISIS
SHALL OBTAIN THE APPROVAL OF THE DEVELOPMENT COMMITTEE PRIOR TO ENTERING INTO
ANY SUBCONTRACTING AGREEMENT OR AMENDING OR TERMINATING ANY SUBCONTRACTING
AGREEMENT. ISIS SHALL PROVIDE THE DEVELOPMENT COMMITTEE WITH A COPY OF EACH
DRAFT SUBCONTRACTING AGREEMENT AT A MONTHLY DEVELOPMENT COMMITTEE MEETING, OR AT
SUCH OTHER TIME AS MAY BE AGREED AMONG THE PARTIES, PRIOR TO THE EXECUTION OF
SUCH SUBCONTRACTING AGREEMENT. THE TERMS OF ANY SUCH SUBCONTRACTING AGREEMENTS
SHALL BE DEEMED THE CONFIDENTIAL INFORMATION OF ISIS AND BE SUBJECT TO THE
RIGHTS AND OBLIGATIONS SET FORTH IN THE CONFIDENTIALITY AGREEMENT. ISIS SHALL
MONITOR THE PERFORMANCE OF ITS ISIS SUBCONTRACTORS AND SHALL PROMPTLY NOTIFY THE
DEVELOPMENT COMMITTEE WITH RESPECT TO ANY ISIS SUBCONTRACTOR PERFORMANCE ISSUES
THAT MAY HAVE A MATERIAL ADVERSE EFFECT ON THE PROGRAMS. THE DEVELOPMENT
COMMITTEE SHALL HAVE THE AUTHORITY TO DIRECT ISIS TO TERMINATE ANY
SUBCONTRACTING AGREEMENT PURSUANT TO THE TERMS THEREOF.
6.3
REPORTS.
ISIS SHALL KEEP THE DEVELOPMENT COMMITTEE INFORMED OF
ITS ACTIVITIES UNDER THE DEVELOPMENT PLAN THROUGH REGULAR REPORTS. AT EACH
SCHEDULED MEETING OF THE DEVELOPMENT COMMITTEE, ISIS SHALL, TO THE EXTENT
REASONABLY REQUIRED BY THE DEVELOPMENT COMMITTEE, PROVIDE THE DEVELOPMENT
COMMITTEE WITH A SUMMARY OF ISIS' ACTIVITIES AND DEVELOPMENTS WITH RESPECT TO
THE PROGRAMS FOR THE PERIOD FOLLOWING THE MOST RECENT PRECEDING SCHEDULED
MEETING. SUCH SUMMARY SHALL INCLUDE: (I) A COPY OF EACH NEW PROTOCOL FOR THE
PROGRAMS BEING DRAFTED BY ISIS; (II) A COPY OF EACH STANDARD CLINICAL STUDY
PROGRESS REPORT FOR THE PROGRAMS RECEIVED BY ISIS DURING THE PRECEDING MONTH
FROM ANY OF THE CLINICAL RESEARCH ORGANIZATIONS ENGAGED BY ISIS PURSUANT TO ANY
SUBCONTRACTING AGREEMENTS; (III) UPDATES REGARDING (A) CMC STATUS, NON-CLINICAL
PROGRAM STATUS, REGULATORY AND QUALITY PROGRAM STATUS, COMMUNICATIONS WITH
REGULATORY AGENCIES, RESULTS OF MEETINGS OF ISIS' CLINICAL ADVISORY BOARD FOR A
PARTICULAR PROGRAM, AND RESULTS OF MEETINGS WITH CONSULTANTS FOR THE PROGRAMS,
ALL TO THE EXTENT RELATED TO ISIS' ACTIVITIES UNDER THE DEVELOPMENT PLAN, AND
(B) PATIENT ENROLLMENT, ANY ADVERSE EVENTS (TO THE EXTENT ISIS HAS BEEN NOTIFIED
OF SUCH ADVERSE EVENTS) OR SERIOUS ADVERSE EVENTS, ANY ADDED OR TERMINATED
CLINICAL TRIAL SITES, ANY SIGNIFICANT PROTOCOL DEVIATION AND ANY INTERIM
7
ANALYSES OR STATISTICAL REPORTS, ALL TO THE EXTENT RELATING TO CLINICAL TRIALS
UNDER THE DEVELOPMENT PLAN; (IV) A FINANCIAL REPORT, IN A FORMAT AGREED UPON BY