Protocol Approval Clause Samples

The Protocol Approval clause establishes the requirement that a specific protocol or plan must be reviewed and formally approved by designated parties before any related activities can commence. In practice, this means that all procedures, methodologies, or operational steps outlined in the protocol must be submitted for evaluation and receive written consent from relevant stakeholders, such as regulatory bodies, sponsors, or institutional committees. This clause ensures that all parties are aligned on the standards and expectations for the project, thereby reducing the risk of non-compliance, misunderstandings, or unauthorized actions.
Protocol Approval. Opthea will be responsible for obtaining any necessary approvals for the ShORe Protocol or the COAST Protocol, including any INDs, prior to commencing the ShORe Trial or the COAST Trial, respectively.
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Protocol Approval. Prior to the commencement of the Study, or if appropriate because of modifications during the Study, Institution and Principal Investigator shall ensure that the Protocol (or any amendments thereto) has been approved by the IRB or EC, with such IRB or EC approval being provided to CRO.
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Protocol Approval. The Contractor shall not commence any activity or work as described in any animal or clinical protocol unless the Contractor has received written approval of that activity or work from the NIAID Project Officer. The NIAID Project Officer will approve the protocol in consultation with an advisory group. It is understood that the protocol may be modified and may not be implemented as proposed. It is further understood that any costs incurred in the conduct of any animal or clinical protocol that has not received the written approval of the NIAID Project Officer shall not be reimbursed through this contract.
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Protocol Approval. Full [+] in parallel; AVI will answer any questions and amend protocol if necessary. The Amended protocol will be submitted to the [+] for approval prior to and notification of site(s) start study. All required information about the investigator, site, testing laboratories and CRO responsibilities will be submitted to the FDA prior to study start at any site.
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Protocol Approval. Alnylam will be responsible for obtaining all necessary approvals for the applicable Protocols prior to commencing a Product Clinical Trial. Each Party will reasonably cooperate with the other in such regard.
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Protocol Approval. SFJ will be responsible for obtaining all necessary approvals of each Protocol (including as required by Applicable Laws) within the SFJ Territory, and PB will be responsible for obtaining all necessary approvals of the Phase 3 Trial Protocol (including as required by Applicable Laws) within the PB Territory, in each case prior to commencing the applicable Clinical Trial in such Party’s Territory. Each Party will reasonably co-operate with the other in such regard.
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Protocol Approval. Nektar will be responsible for obtaining all necessary approvals of each HNC Clinical Trial Protocol (including as required by Applicable Laws) on a global basis, in each case prior to the commencement of the applicable HNC Clinical Trial. SFJ will reasonably co-operate with Nektar in such regard.
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Related to Protocol Approval

  • Final Approval After Acceptance, Engineer shall perform any required modifications, changes, alterations, corrections, redesigns, and additional work necessary to receive Final Approval by the County. "Final Approval" in this sense shall mean formal recognition that the Engineering Services have been fully carried out.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Project Approval The County may issue a Job Order Authorization for the Work, to include the firm-fixed-price of the Job Order and the project duration. Contractor agrees that all clauses of this Contract are applicable to any Job Order issued hereunder. The County reserves the right to reject a Contractor’s Quote based on unjustifiable quantities and/or methods, performance periods, inadequate documentation, or other inconsistencies or deficiencies on the Contractor’s part in the sole opinion of the County. The County reserves the right to issue a unilateral Job Order authorization for the Work if a Quote price cannot be mutually agreed upon. This is based upon unjustifiable quantities in the sole opinion of the County. The County also reserves the right to not issue a Job Order Authorization if the County’s requirement is no longer valid or the project is not funded. In these instances, the Contractor has no right of claim to recover Quote expenses. The County may pursue continuing valid requirements by other means where Contract was not reached with the Contractor.

  • Final Approval Hearing “Final Approval Hearing” shall mean the hearing at which the Court will consider and finally decide whether to enter the Final Judgment.