Withdrawal of Pre-Closing Notification. Without prejudice to Buyer’s discretion to withdraw a Notice of Intent to Use the Priority Review Voucher at any time by notice to the FDA, the Parties acknowledge and agree that Buyer may withdraw any Pre-Closing PRV Notice if Closing has not occurred by the date that is forty-five (45) days from the Effective Date.

Pre-Closing Notification. Buyer may, on or after the Effective Date and prior to Closing, submit a Notice of Intent to Use the Priority Review Voucher substantially in the form attached hereto as Exhibit F to the FDA of its intent to use the Priority Review Voucher to obtain Priority Review of a human drug application of Buyer’s choice in accordance with the applicable provisions of the FDC Act and the Priority Review Voucher (a “Pre-Closing PRV Notice”).