Common use of FDA Meetings Clause in Contracts

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. 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 meetingsscheduling. • ● The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to BARDAthe CO and COR within 5 business days of receipt. All documents shall be duly marked as either “Draft” or “Final.”

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 meetingsscheduling. • The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to BARDAthe 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 meetingsmeetings if requested by XXXXX. BARDA staff shall 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 meeting meetings within 24 hours of scheduling Type A, B or C meetings OR within 24 hours of meeting occurrence for ad hoc meetingsscheduling. iii. • The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to BARDAthe CO and COR within 5 business days of receipt.

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 observe 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 meetingsscheduling. • The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to BARDAthe CO and COR within [***] of receipt. All documents shall be duly marked as either “Draft” or “Final.”