Revocation; Use of Purchased Assets. The Priority Review Voucher has been duly granted and issued and has not been revoked, and there are no facts or circumstances [*] or result in the redemption or transfer of the Priority Review Voucher (other than pursuant to the transactions contemplated by this Agreement), or that would reasonably be expected to preclude or interfere with the sale and transfer of the Purchased Assets to Buyer or Buyer’s use of the Purchased Assets following the Effective Date to obtain Priority Review or any other benefits associated with the Purchased Assets. Except for this Agreement, there is no Contract to which Seller or any Affiliate of Seller is a party that involves or affects the ownership of, licensing of, title to, sale or other transfer of, or use of any of the Purchased Assets. There is no term or condition imposed by the FDA as of the date hereof on the Priority Review Voucher that is not set forth in the Approval Letter or provided for under applicable Law. Seller has provided to Buyer true and complete copies of the Approval Letter and all other material written correspondence between Seller or any of its Affiliates and the FDA regarding the Priority Review Voucher, in each case, (a) with such redactions to any portion of the Approval Letter and such other material written correspondence that is not relevant to the Priority Review Voucher and (b) including any and all corrections with respect thereto. Neither Seller nor any of its Affiliates has notified the FDA, or permitted any Third Party to notify the FDA, of intent to use the Priority Review Voucher.
Revocation; Use of Purchased Assets. The Priority Review Voucher has not been terminated, canceled or revoked and to Seller’s Knowledge there are no facts or circumstances that could reasonably be expected to (with or without notice or lapse of time, or both) give rise to a right of FDA to terminate, cancel or revoke the Priority Review Voucher or that could reasonably be expected to preclude (a) the sale of the Purchased Assets to Buyer, or (b) Buyer’s use of the Purchased Assets to obtain Priority Review or any other benefit associated with the Purchased Assets. Neither Seller nor any of its Affiliates has notified FDA of its own intent to use the Priority Review Voucher.
Revocation; Use of Purchased Assets. The Priority Review Voucher has not been terminated, cancelled or revoked. None of Seller, BPI or any of their respective Affiliates have taken or refrained from taking any action that, and to Seller’s Knowledge there are no facts or circumstances that, could reasonably be expected to (with or without notice or lapse of time, or both) give rise to a right of FDA to revoke, cancel, suspend or terminate the Priority Review Voucher. There is nothing that would preclude or interfere with (i) the transfer of the Purchased Assets to Buyer or (ii) Buyer’s ability to use of the Purchased Assets to obtain Priority Review or any other benefit associated with the Purchased Assets following the Closing. There is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the FDA Approval Letter as of the date hereof. Seller and BPI have provided to Buyer true and complete copies of the FDA Approval Letter, the rare pediatric disease designation issued by the FDA for Brineura (cerliponase alfa) and all other correspondence received by Seller, BPI or any of their respective Affiliates from the FDA regarding the Priority Review Voucher.
Revocation; Use of Purchased Assets. The Priority Review Voucher has been duly granted and issued and has not been revoked, and there are no facts or circumstances that would reasonably be expected to result in the revocation of the Priority Review Voucher by a Governmental Entity, give rise to a right of the FDA to revoke the Priority Review Voucher, or result in the redemption or transfer of the Priority Review Voucher (other than pursuant to the 9
Revocation; Use of Purchased Assets. The Priority Review Voucher has not been redeemed, transferred, terminated, cancelled or revoked, and neither Seller nor any of its Affiliates or any of their respective Representatives has taken or omitted to take any action, and to Seller’s Knowledge there are no facts or circumstances, that would reasonably be expected to (with or without notice or lapse of time or both) result in the termination, cancellation or revocation of the Priority Review Voucher. Seller is not aware or in the possession of any information that would preclude or interfere with Buyer’s ability to use the Purchased Assets to obtain Priority Review or any other benefit associated with the Purchased Assets following the Closing. To Seller’s knowledge, there is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the NDA Approval Letter or Section 524 of the FDC Act, as interpreted by the FDA in the Tropical Disease Priority Review Vouchers, Guidance for Industry issued in October 2016. Seller has provided to Buyer true and complete copies of the NDA Approval Letter and all other written communications between Seller and the FDA regarding the Priority Review Voucher.
Revocation; Use of Purchased Assets. The Priority Review Voucher has not been terminated, cancelled or revoked, and neither Lumos nor any of its Affiliates or any of their respective Representatives has taken or omitted to take any action, and to Lumos’s Knowledge there are no facts or circumstances that would reasonably be expected to (with or without notice or lapse of time or both) result in the termination, cancellation or revocation of the Priority Review Voucher. There is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the BLA Approval Letter or Section 524 of the FDC Act. Lumos has provided to Merck true and complete copies of the BLA Approval Letter and any other material communications received by Lumos or any of its Affiliates from the FDA regarding the Priority Review Voucher.
Revocation; Use of Purchased Assets. The Priority Review Voucher has not been terminated, cancelled or revoked, and neither Seller nor any of its Affiliates or any of their respective Representatives has taken or omitted to take any action, and to Seller’s Knowledge there are no facts or circumstances that would reasonably be expected to (with or without notice or lapse of time or both) result in the termination, cancellation or revocation of the Priority Review Voucher. There is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the BLA Approval Letter or Section 529 of the FDC Act. Seller has provided to Buyer true and complete copies of the BLA Approval Letter and any other material communications between Seller or any of its Affiliates and the FDA regarding the Priority Review Voucher.
Revocation; Use of Purchased Assets. The Priority Review Voucher has not been revoked and there is nothing that would preclude (i) the transfer of the Purchased Assets to Buyer and, (ii) to Seller’s or BPI’s Knowledge, Buyer’s use of the Purchased Assets to obtain Priority Review or any other benefit associated with the Purchased Assets. BPI represents and warrants to Buyer, as of the Closing Date, as follows:
Revocation; Use of Purchased Assets. The Priority Review Voucher has not been terminated, cancelled or revoked, and neither Seller nor any of its Affiliates or any of their respective Representatives has taken or omitted to take any action, and to Seller’s Knowledge there are no facts or circumstances, that would reasonably be expected to (with or without notice or lapse of time or both) result in the termination, cancellation or revocation of the Priority Review Voucher or preclude Buyer’s use of the Purchased Assets to obtain Priority Review or any other benefit associated with the Purchased Assets. There is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the NDA Approval Letter or Section 565A of the FDC Act. Seller has provided to Buyer true and complete copies of the NDA Approval Letter and any other material communications between Seller or any of its Affiliates and the FDA regarding the Priority Review Voucher.
