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.
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.
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.
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.
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.
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.
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.
