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. 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. • 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 5 business days of receipt. All documents shall be duly marked as either “Draft” or “Final.”
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).
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. Neurocrine shall provide Pfizer with notice of all meetings, conferences, and discussions (including without limitation, Advisory Committee meetings or any other meeting of experts convened by regulatory authorities concerning any topic relevant to the Products) scheduled with FDA concerning any pending NDA or other regulatory matters relating to the Products within forty-eight (48) hours after the scheduling of such meeting, conference, or discussion. Pfizer shall be entitled to have an equal number of representatives present at all such meetings. Neurocrine and Pfizer, through the RC, shall use all reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with FDA and other Governmental Authorities, and with respect to Advisory Committee Meetings, such items will agreed by the parties as a Consensus Matter as set forth in Section 4.1(c).
FDA Meetings. All meetings, conference calls, correspondences and other communications with the FDA concerning use of the Agent for the Indication will be discussed by Collaborator and the DCP in advance and will be held on mutually agreed upon dates. Collaborator may have the option to set the agenda for any such meeting. DCP will provide Collaborator with prompt notice of any communication (including without limitation a summary of telephone communications, email or written communications) it has or plans to have with the FDA regarding the Agent. Such notice will be provided a reasonable period in advance, to the extent possible, and Collaborator shall be permitted to participate in such communication, set the agenda for such communication to the extent applicable, and, with respect to email or written communications, comment thereon. In the event of any such communication where advance notice to Collaborator is not possible, DCP shall provide Collaborator notice of the communication, and a reasonably detailed description of the communication, as soon as possible following the communication. One of the missions of the DCP is to ensure that active investigational prevention and control agents are approved and made widely available in a timely fashion. Therefore, DCP 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, DCP 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 DCP should meet with FDA to discuss the development of Agent without the presence of a representative(s) from Collaborator, no unpublished data concerning the Agent will be discussed with the FDA without Collaborator’s permission, excepting safety data.
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 Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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 two subject matter experts). Contractor shall notify BARDA 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 BARDA within [***] of receipt. All documents shall be duly marked as either “Draft” or “Final.”
