consent of the other Party,
subject to the exclusivity granted to OMI under Section 2.3.
4.7.4
DURING THE FIRST [***], IF REQUESTED BY A PARTY, THE
PARTIES WILL MEET ANNUALLY TO REVIEW MANUFACTURING IMPROVEMENTS DEVELOPED BY
EITHER OF THE PARTIES [***] OF THE COLLABORATION. AT SUCH TIME, THE PARTIES WILL
DISCLOSE ALL SUCH MANUFACTURING IMPROVEMENTS CONTROLLED BY SUCH PARTY IN
REASONABLE DETAIL AS TO ENABLE THE OTHER PARTY TO [***] WILL HAVE THE RIGHT TO
[***] WITH RESPECT TO THE COMMERCIALIZATION OF ONE OR MORE [***]
SECTION
4.8
ISIS REGULATORY INSPECTIONS. ISIS WILL COOPERATE IN GOOD FAITH WITH RESPECT TO
THE CONDUCT OF ANY INSPECTIONS BY ANY REGULATORY AUTHORITY OF AN ISIS SITE OR A
CONTRACTOR'S SITE AND FACILITIES IF SUCH INSPECTION CONCERNS WORK BEING
PERFORMED UNDER THE R&D PLAN AND THE CLINICAL MANUFACTURING AND SUPPLY
AGREEMENT. OMI SHALL BE GIVEN THE OPPORTUNITY TO ATTEND ANY INSPECTIONS BY ANY
REGULATORY AUTHORITY OF ISIS' OR ISIS' CONTRACTOR'S SITE AND FACILITIES IF SUCH
INSPECTIONS CONCERN WORK BEING PERFORMED UNDER THE R&D PLAN AND THE CLINICAL
MANUFACTURING AND SUPPLY AGREEMENT, AND THE SUMMARY (OR WRAP UP) MEETING WITH A
REGULATORY AUTHORITY AT THE CONCLUSION OF SUCH SITE INSPECTION. IN THE EVENT
THAT DURING AN INSPECTION OF THE ISIS FACILITIES, THE FACILITIES ARE FOUND BY A
REGULATORY AUTHORITY TO BE NON-COMPLIANT WITH ONE OR MORE GLP, GMP, GCP OR
CURRENT STANDARDS FOR PHARMACOVIGILANCE PRACTICE COMPLIANCE STANDARDS AND SUCH
FACILITIES ARE BEING USED TO CONDUCT WORK UNDER THE R&D PLAN AND THE CLINICAL
MANUFACTURING AND SUPPLY AGREEMENT, ISIS WILL PROMPTLY NOTIFY OMI OF SUCH
FINDING AND WILL SUBMIT A PROPOSED RECOVERY/CORRECTIVE ACTION PLAN, INCLUDING A
TIME LINE FOR IMPLEMENTATION OF THE PLAN, WITHIN [***] OF SUCH NOTIFICATION OF
NON-COMPLIANCE.
12
SECTION
4.9
QUALITY AGREEMENT. A QUALITY AGREEMENT (THE "QUALITY AGREEMENT") WILL BE
NEGOTIATED SIMULTANEOUSLY WITH THE PRESENT AGREEMENT AND IS ATTACHED HERETO AS
APPENDIX 9.
ARTICLE 5 -
DEVELOPMENT & COMMERCIALIZATION
SECTION
5.1
DEVELOPMENT, COMMERCIALIZATION AND REGULATORY RESPONSIBILITIES. OTHER THAN ISIS'
RESPONSIBILITIES UNDER THE R&D PLAN, OMI WILL 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. OMI HEREBY ASSUMES ALL REGULATORY
RESPONSIBILITIES IN CONNECTION WITH COMPOUNDS AND PRODUCTS, INCLUDING SOLE
RESPONSIBILITY FOR ALL REGULATORY DOCUMENTATION AND FOR OBTAINING ALL APPROVALS.
OMI WILL COMPLY WITH ALL APPLICABLE LAWS IN CONNECTION WITH THE DEVELOPMENT AND
COMMERCIALIZATION OF COMPOUNDS AND PRODUCTS. OMI (BY ITSELF OR THROUGH ITS
AFFILIATES, LICENSEES, (SUB)CONTRACTORS OR AGENTS, AS APPLICABLE) WILL USE
COMMERCIALLY REASONABLE EFFORTS TO DEVELOP AND COMMERCIALIZE AT LEAST ONE
COMPOUND OR PRODUCT FOR EACH COLLABORATION GENE PRODUCT. FOR CLARITY, IT IS
UNDERSTOOD AND ACKNOWLEDGED THAT COMMERCIALLY REASONABLE EFFORTS IN THE
DEVELOPMENT OF A PRODUCT IN A PARTICULAR COUNTRY MAY INCLUDE SEQUENTIAL
IMPLEMENTATION OF CLINICAL TRIALS AND/OR INTERVALS BETWEEN CLINICAL TRIALS FOR
DATA INTERPRETATION AND CLINICAL PROGRAM PLANNING AND APPROVAL, TO THE EXTENT
SUCH IMPLEMENTATION IS CONSISTENT WITH THE SCIENTIFIC, TECHNICAL AND COMMERCIAL
FACTORS RELEVANT TO DEVELOPMENT OF SUCH PRODUCT IN SUCH