IRB/IEC Approval. BioNTech as the sponsor and Regulatory Approval holder of the Clinical Trials shall ensure that the Clinical Trial is approved by and subject to continuing oversight by an appropriate Institutional Review Board (IRB) or Independent Ethics Committee (IEC), except that BioNTech shall delegate this responsibility to Pfizer for any Clinical Trial for which Pfizer is the Lead Development Party. The Lead Development Party shall provide documentation of both the initial IRB/IEC approval of the final protocol to the other Party and annual renewals of that approval if such renewals are required. To the extent a Party receives notice of any withdrawal or suspension of IRB/IEC approval during the term of this Agreement, it will promptly inform the other Party
IRB/IEC Approval. If required, Principal Investigator will ensure that the Study is approved by and subject to continuing oversight by an appropriate Institutional Review Board (“IRB”) or Independent Ethics Committee (“IEC”). As a condition of Pfizer support, Institution must provide Pfizer with documentation of both the initial IRB/IEC approval (or documentation of an exemption)of the final Protocol and annual renewals of that approval if such renewals are required(see Attachment B, Study Documentation Requirements). Institution will notify Pfizer promptly of any withdrawal or suspension of IRB/IEC approval during the term of this Agreement.
IRB/IEC Approval. If required, Grant Recipient will ensure that the Study/Registry is approved by and subject to continuing oversight by a duly- constituted Institutional Review Board (“IRB”) or Independent Ethics Committee (“IEC”). If IRB/IEC approval is required, Grant Recipient must provide Pfizer with documentation of the initial IRB/IEC approval of the Protocol/Registry Design, any annual renewals of that approval, and any IRB/IEC-approved amendments to the Protocol/Registry Design. Grant Recipient will notify Pfizer promptly of any withdrawal or suspension of IRB/IEC approval during the term of this Agreement. nichž xx Xxxxxx/Registr realizována.
IRB/IEC Approval. If required, Institution will ensure that the Study is approved by and subject to continuing oversight by a duly-constituted Institutional Review Board (“IRB”) or Independent Ethics Committee (“IEC”). If IRB/IEC approval is required, Institution must provide Pfizer with documentation of the initial IRB/IEC approval of the Protocol, any annual renewals of that approval, and any IRB/IEC-approved amendments to the Protocol. Institution will notify Pfizer promptly of any withdrawal or suspension of IRB/IEC approval during the term of this Agreement. DocuSign Envelope ID: 4774141B-6BA4-4042-BB26-8ACC4DDA3D57
