AGREEMENT, IN PARTICULAR ENSURING THAT THE JRC MEETINGS OCCUR, AND THAT ANY
CONFLICT IS GIVEN PROMPT ATTENTION AS SET FORTH IN SECTION 13.4.
THE ALLIANCE MANAGERS SHALL BE ENTITLED TO ATTEND MEETINGS OF THE JRC, BUT SHALL
NOT HAVE, OR BE DEEMED TO HAVE, ANY RIGHTS OR RESPONSIBILITIES OF A MEMBER OF
THE JRC.
SIMILARLY, THE ALLIANCE MANAGERS MAY ATTEND MEETINGS OF THE WORKING
GROUP OR ANY SUBCOMMITTEES OF THE JRC.
8
EACH ALLIANCE MANAGER MAY BRING ANY MATTER TO THE ATTENTION THE JRC WHERE SUCH
ALLIANCE MANAGER REASONABLY BELIEVES THAT SUCH MATTER REQUIRES SUCH ATTENTION.
FOR PURPOSES OF CLARIFICATION, IN NO EVENT WILL THE ALLIANCE MANAGERS HAVE THE
POWER OR AUTHORITY TO AMEND ANY PROVISION OF THIS AGREEMENT.
SECTION 3.13
ANIMAL TESTING.
IN ORDER TO ASSURE THE APPROPRIATE CARE
AND USE OF ANIMALS USED IN THE PERFORMANCE OF THE RESEARCH PROGRAM BY ISIS, ISIS
AGREES TO THE FOLLOWING:
(A)
IF ISIS IS AAALAC ACCREDITED, IT WILL FOLLOW PROCEDURES
ESTABLISHED AS THE BASIS OF THAT ACCREDITATION.
ISIS REPRESENTS AND COVENANTS
THAT IT WILL USE ALL REASONABLE EFFORTS TO MAINTAIN SUCH AAALAC ACCREDITATION
DURING THE RESEARCH TERM.
FURTHER, UPON REQUEST BY BMS, ISIS WILL PROVIDE BMS
WITH A COPY OF THE MOST RECENT ACCREDITATION LETTER AND ANNUAL REPORT.
IF
DURING THE COURSE OF THE RESEARCH PROGRAM ISIS LOSES ITS ACCREDITATION OR
RECEIVES ANY NOTICE, WARNING OR REPRIMAND FROM AAALAC OR ANY GOVERNMENTAL OR
REGULATORY AGENCY RELATED TO ANIMAL CARE AND USE, ISIS WILL PROMPTLY NOTIFY BMS
IN WRITING.
(B)
IF ISIS IS NOT AAALAC ACCREDITED OR LOSES ITS AAALAC ACCREDITATION
AT ANY TIME DURING THE RESEARCH TERM, IT WILL, PRIOR TO THE COMMENCEMENT (OR
CONTINUATION) OF RESEARCH PROGRAM STUDIES USING ANIMALS PROVIDE BMS WITH
SUFFICIENT DOCUMENTATION IN SUCH MANNER, FORMAT AND FREQUENCY AS BMS MAY REQUIRE
IN ITS SOLE REASONABLE DISCRETION, TO ASSURE APPROPRIATE CARE AND USE OF
ANIMALS.
SUCH DOCUMENTATION MAY INCLUDE, WITHOUT LIMITATION, GOVERNMENT
INSPECTION REPORTS, ANIMAL TEST METHODS, ANIMAL USE PROTOCOLS AND ANY OTHER
WRITTEN DESCRIPTIONS OF ANIMAL CARE AND USE.
ISIS WILL ALSO COMPLY WITH ALL
APPLICABLE LAWS GOVERNING ANIMAL RESEARCH.
(C)
WHENEVER POSSIBLE, LIVE ANIMALS USED AS PART OF THE RESEARCH
PROGRAM SHOULD REMAIN THE PROPERTY OF THE APPLICABLE CONTRACT FACILITY.
UPON
REASONABLE ADVANCE NOTICE DURING THE RESEARCH TERM, REPRESENTATIVES OF BMS SHALL
HAVE THE RIGHT TO INSPECT THE RESEARCH FACILITIES AND TO AUDIT THE CARE,
TREATMENT AND USE OF THE ANIMALS USED IN THE RESEARCH PROGRAM.
THIS INCLUDES
THE RIGHT TO REVIEW ANY CORRESPONDENCE WITH OR REPORTS FROM GOVERNMENTAL
AGENCIES OR ACCREDITING ORGANIZATIONS RESPONSIBLE FOR ANIMAL WELFARE OR QUALITY
ASSURANCE.
ARTICLE 4 -
DEVELOPMENT, COMMERCIALIZATION & MANUFACTURING
SECTION 4.1
DEVELOPMENT, COMMERCIALIZATION AND REGULATORY
RESPONSIBILITIES.
OTHER THAN ISIS' RESPONSIBILITIES UNDER THE RESEARCH PROGRAM,
BMS SHALL HAVE SOLE RESPONSIBILITY, INCLUDING WITHOUT LIMITATION SOLE
RESPONSIBILITY FOR ALL FUNDING, RESOURCING AND DECISION-MAKING, FOR ALL FURTHER
DEVELOPMENT AND COMMERCIALIZATION WITH RESPECT TO THE COMPOUNDS AND PRODUCTS.
BMS HEREBY ASSUMES ALL REGULATORY RESPONSIBILITIES IN CONNECTION WITH COMPOUNDS
AND PRODUCTS, INCLUDING SOLE RESPONSIBILITY FOR ALL REGULATORY DOCUMENTATION AND
FOR OBTAINING ALL