FDA Meetings. The Contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up to a maximum of four people (COR, CO and up to 2 subject matter experts). • Contractor shall notify BARDA of upcoming FDA meeting within 24 hours of scheduling Type A, B or C meetings OR within 24 hours of meeting occurrence for ad hoc meetings. • The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to BARDA
FDA Meetings. All meetings with FDA concerning clinical studies for the development of Agent within the scope of the CRADA Research Plan will be discussed by Collaborator and NCI in advance and will be held on mutually agreed upon dates. Collaborator reserves the right to set jointly with NCI the agenda for any such meeting.
FDA Meetings. All meetings with FDA concerning clinical studies for the development of Agent within the scope of the Research Plan will be discussed by RPRP, Introgen and NCI in advance and will be held on mutually agreed upon dates. RPRP and Introgen each reserve the right to set, jointly with NCI, the agenda for and attend any such meeting.
FDA Meetings. All meetings with FDA concerning Agent will be discussed by Collaborator and DCTD in advance and will be held on mutually agreed upon dates. Collaborator will have the option to set the agenda for such a meeting. One of the missions of DCTD is to ensure that active investigational therapies are approved and made widely available in a timely fashion. Therefore, DCTD feels it is important to participate in the development plan for Agent and in discussions with the FDA regarding the design and endpoints of the pivotal trials. In addition, DCTD expects that Collaborator will actively pursue approval of Agent by the FDA and will take the initiative in arranging meetings with the FDA.
FDA Meetings. The Company agrees that between the date of this Agreement and the Effective Time the Company will use reasonable efforts to provide Parent and its representatives with a reasonable opportunity to review and confer with Company regarding any filing, correspondence, or other communications proposed to be submitted or transmitted to the FDA and to attend and participate in any meetings with any representatives of the FDA.
FDA Meetings i. The Contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for appropriate BARDA staff to attend the FDA meetings if requested by XXXXX. BARDA may include up to a maximum of four people (COR, CO and up to 2 subject matter experts).
ii. Contractor shall notify BARDA of upcoming FDA meetings within 24 hours of scheduling.
iii. The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to the CO and COR/ACOR within 5 business days of receipt. All documents shall be duly marked as either “Draft” or “Final.”
FDA Meetings. All meetings with FDA concerning Agent will be discussed by Collaborator and NIDA in advance and will be held on FDA determined dates. The parties agree that NIDA shall fully participate in market development plans for Agent and in discussions with FDA regarding the design and endpoints for the pivotal trials. NIDA will participate in meetings with the FDA only at the Collaborator’s request. However, Collaborator shall take the initiative in arranging meetings with the FDA and will be ultimately responsible for pursuing approval of the Agent by FDA.
FDA Meetings. The Contractor shall forward the dates and times of any meeting with the FDA to the CO and COR and make arrangements for appropriate Government staff to attend the FDA meetings. Government staff shall include up to a maximum of four people (COR, CO and up to 2 subject matter experts). • Contractor shall notify the Contracting Officer of upcoming FDA meeting within [**] of scheduling Type A, B or C meetings OR within [**] of meeting occurrence for ad hoc meetings. • The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to the CO and COR within [**] business days of receipt. All documents shall be duly marked as either “Draft” or “Final.”
FDA Meetings. All meetings with the FDA concerning Agent will be discussed by Collaborator and the DCPC in advance and will be held on mutually agreed upon dates. Collaborator will have the option to set the agenda for such a meeting. One of the missions of the DCPC is to ensure that active investigational prevention and control agents are approved and made widely available in a timely fashion. Therefore, DCPC feels it is important to participate in the development plan for Agent and in discussions with the FDA regarding the design and endpoints for the pivotal trials. In addition, DCPC expects that Collaborator will actively pursue approval of the Agent by FDA and will take the initiative in arranging meetings with the FDA. In the event DCPC should arrange to meet with FDA to discuss the development of Agent without the presence of a representative(s) from Collaborator, DCPC shall notify Collaborator in advance to afford Collaborator an opportunity to attend, no unpublished data concerning the agent will be discussed with the FDA without Collaborator's permission, and DCPC shall report to Collaborator concerning any meeting with the FDA at which Collaborator is not present.
FDA Meetings. Between the date of this Agreement and the Closing Date, each of the Company and the Parent will keep the other Party and its representatives reasonably informed of any filing, correspondence or other communications proposed to be submitted or transmitted to the FDA prior to the submission or transmittal of such communication, notify the Parent or Company, as applicable, in advance of any meetings with any representatives of the FDA, and promptly provide Parent or Company, as applicable, with a summary of such meetings.
