PDUFA Date

PDUFA Date. The first date on which the FDA accepts, rejects or provides a complete response letter with respect to the New Drug Application for VIAject, as the same may be accelerated or extended from time to time. For the avoidance of doubt, if the FDA issues a complete response letter on or about the PDUFA Date and, thereafter, a new FDA action date is set, any such new action date shall not be considered a PDUFA Date for purposes of this Warrant.