Approved CRO definition
Examples of Approved CRO in a sentence
Each Party will promptly notify the JDC upon learning of any investigations by any Governmental Authority involving any Third Party conducting activities with respect to the Development Plan, including any Approved CRO or Approved Vendor.
For clarity, OPKO will remain responsible for all its obligations under this Agreement, including if it has delegated such to an Approved CRO and/or contracted with an Approved Vendor (except to the extent any Vendor Agreement has been assigned to Pfizer or a Third Party designee of Pfizer), as if OPKO had not so delegated and/or contracted with respect to such responsibilities.
Subject to the terms hereof, for future Trials, OPKO will conduct, or ensure that each Approved CRO conducts, all Trials in accordance with standard operating procedures (the “SOPs”), access to electronic copies of which will be provided by OPKO to the JDC for review prior to the initiation of each Trial at a time to be determined by the JDC.
Opthea will oversee the services of its Affiliates and any Approved CRO or Approved Vendor utilized by such Party to provide services hereunder.
CROs determined by the JDC (an “Approved CRO”) pursuant to a written agreement between OPKO and such Approved CRO (a “CRO Agreement”).
Opthea will enter, and, to the extent applicable, will ensure that its Affiliates and each Approved CRO likewise enter, into an agreement with each study site (the “Clinical Trial Agreement” and upon execution of such Clinical Trial Agreement, such study site will be deemed a “Site”) on commercially reasonable and customary terms, consistent with industry standards for similar agreements.
If any Governmental Authority, including any Regulatory Authority, notifies Phio or AgonOx (or Approved CRO) that it intends to inspect, audit, or investigate Phio or AgonOx (or Approved CRO) or take any regulatory action relating to the Phase I/II Clinical Trial, or such Party’s obligations hereunder, the relevant Party will notify the other Party within one (1) Business Day following receipt of such notice.
AgonOx (or Approved CRO), will inform the JSC of any other Governmental Authorities’ inspections of any of the Sites where they intend to review the Phase I /II Clinical Trial, and at the request of the JSC, will provide the JSC with copies of all relevant correspondence from such Governmental Authorities (including any Regulatory Authorities) relating to the Sites.
Subject to the terms hereof, SFJ will, within the SFJ Territory, use Commercially Reasonable Efforts to conduct, or ensure that the Approved CRO conducts, the Clinical Trials in accordance with the standard operating procedures (the “SFJ SOPs”) that will be provided to PB within [***] following the later of (i) the Effective Date or (ii) the selection of such Approved CRO for PB’s review and comment.
Each Party shall use Commercially Reasonable Efforts to oversee the services of its Affiliates and any Approved CRO or Approved Vendor utilized by such Party to provide services hereunder.