Common use of Clinical Protocol Clause in Contracts

Clinical Protocol. (a) NCI will facilitate the solicitation and receipt of ▇▇▇▇ for clinical research, contemplating the use of Collaborator’s Formulary Agents. NCI will require potential Sponsors to complete a “Letter of Intent” (“LOI”). NCI will provide Collaborator with a copy of any LOI submitted which requests use of Collaborator’s Formulary Agents, which contains a summary of the draft clinical protocol including the proposed statistical analysis plan for the Study and, estimated funding from the Collaborator to support the Study. (b) Within 60 days of receipt of a Letter of Intent from NCI, Collaborator shall provide a written notice to IC whether or not it approves the LOI. Acceptance of an LOI shall be Collaborator’s sole discretion. • If Collaborator notifies NCI of its rejection of the LOI within such 60-day period, then neither Party shall have any obligations to the other with respect to the proposed Study or any drug supply in respect of such Study. • If Collaborator notifies NCI within such 60-day period that it approves the LOI with a signed drug approval form, the Approved Investigator will draft and submit a full clinical Protocol(s) for approval by Collaborator. • Following the LOI approval, the Parties (or their respective designated Affiliate) will, as soon as reasonably practicable following such notification, arrange communications between PMB staff and Collaborator supply personnel to discuss logistics. • Any changes to the Protocol shall require Collaborator’s prior written consent. Any such proposed changes will be sent in writing to Collaborator by Approved Investigator.