On November 29, 2022, bluebird bio, Inc. (the "Company") reported that it has entered into an asset purchase agreement (the "PRV Transfer Agreement") with argenx BV ("Buyer"), pursuant to which the Company agreed to sell a Rare Pediatric Disease Priority Review Voucher ("PRV") to Buyer (Press release, bluebird bio, NOV 30, 2022, View Source [SID1234624594]). The Company was awarded the voucher under a U.S. Food and Drug Administration ("FDA") program intended to encourage the development of certain rare pediatric disease product applications. The Company received the PRV when SKYSONA (elivaldogene autotemcel) received accelerated approval by the FDA for the treatment of early, active cerebral adrenoleukodystrophy. Pursuant to the PRV Transfer Agreement, Buyer agreed to pay the Company $102 million, payable in cash, upon the closing of the sale.
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The PRV Transfer Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
The foregoing description of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement, a copy of which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.