Common use of Required Time-Sensitive Notification Clause in Contracts

Required Time-Sensitive Notification. Under the contract, the Contractor must submit to the Contracting Officer’s representative (COR) as follows: 1. Expedited safety report of unexpected or life-threatening experience or death - A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted within 24 hours of knowledge of the event by the Contractor.