IRBs and Other Ethics Committees. 4.9.1. OPKO will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Trial at every Site.
IRBs and Other Ethics Committees. CRO will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Project at every Site. CRO will require that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law and CRO will provide all ethics committees, including all IRBs, and regulatory authorities, with all necessary documentation prior to, and during the course of, the Project as required by Applicable Law. CRO will be solely responsible for responding to all queries from the IRBs and other ethics committees; provided that (a) Sponsor will make itself reasonably available to assist with any such queries and (b) if such query relates solely to the CMC information, the manufacturing dossier, Sponsor will prepare the applicable response, with a copy to be provided to CRO.
IRBs and Other Ethics Committees. Opthea will use Commercially Reasonable Efforts to (a) obtain the approval of the IRBs and other ethics committees required prior to commencing, and during, the Product Clinical Trials at every Site, (b) ensure that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law, (c) provide all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, the Product Clinical Trials as required by Applicable Law, and (d) respond to all queries from the IRBs and other ethics committees, will prepare the applicable response and, if such query is material, will provide the JSC Representatives of Ocelot SPV LP with a copy thereof for review and comment reasonably prior to submission.
IRBs and Other Ethics Committees. 3.8.1 Each Party will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Clinical Trials at every Site in such Party’s Territory, except in the case of the European Clinical Trial Countries which SFJ will be responsible for.
IRBs and Other Ethics Committees. 3.8.1 SFJ will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the HNC Clinical Trials at every Site.
IRBs and Other Ethics Committees. Alnylam will be solely responsible for (a) obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Product Clinical Trials at every Site, and responding to all queries from all IRBs and other ethics committees, (b) ensuring that IRBs and such other relevant ethics committees have current registrations and accreditations, and (c) providing all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, the Product Clinical Trials.
IRBs and Other Ethics Committees. CymaBay will use Commercially Reasonable Efforts to (a) obtain the approval of the IRBs and other ethics committees required prior to commencing, and during, the Product Clinical Trials at every Site, and (b) ensure that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law. CymaBay will (a) provide all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, the Product Clinical Trials as required by Applicable Law, and (b) respond to all queries from the IRBs and other ethics committees, will prepare the applicable response.
