Revocation; Use of Purchased Assets Sample Clauses

Revocation; Use of Purchased Assets. The Priority Review Voucher was awarded to Seller by the FDA in respect of Seller’s sponsorship of a Rare Pediatric Disease product application pursuant to Section 529(b)(1) of the FFDCA. The Priority Review Voucher has been duly granted and issued and has not been terminated, redeemed, transferred, suspended, cancelled 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) result in the termination, suspension, cancellation or revocation of the Priority Review Voucher by a Governmental Entity, give rise to a right of FDA to revoke the Priority Review Voucher, result in the redemption or transfer of the Priority Review Voucher (other than pursuant to the transactions contemplated by this Agreement), or that could 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 Closing to obtain Priority Review or any other benefits associated with the Purchased Assets. There is no term or condition imposed by the FDA on the Priority Review Voucher as of the date hereof that is not set forth in the Approval Letter. Seller has provided to Buyer true and complete copies of the Approval Letter and all other correspondence submitted or received by Seller or any of its respective Affiliates regarding the Priority Review Voucher. Neither Seller nor any of its Affiliates has notified FDA of intent to use the Priority Review Voucher.
AutoNDA by SimpleDocs
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, suspended, cancelled or revoked and to Sellers’ 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, suspend, cancel or revoke the Priority Review Voucher. There is nothing that could reasonably be expected to preclude or interfere with (a) the sale and transfer 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 following the Closing. There is no term or condition imposed by the FDA on the Priority Review Voucher as of the date hereof that is not set forth in the Approval Letter. Sellers have provided to Buyer true and complete copies of the Approval Letter and all other correspondence received by Sellers or any of their respective Affiliates regarding the Priority Review Voucher. Neither Sellers nor any of their Affiliates have notified FDA of their own intent to use the Priority Review Voucher.
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:
AutoNDA by SimpleDocs
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.

Related to Revocation; Use of Purchased Assets

  • Condition of Purchased Assets All of the tangible property included in the Purchased Assets is in good operating condition and repair, ordinary wear and tear excepted, and in the state of maintenance, repair and operating condition required for the proper operation and use thereof in the ordinary and usual course of business by Seller.

  • Sale of Purchased Assets Sell, transfer, assign, lease, encumber or otherwise dispose of any of the Purchased Assets other than in the ordinary course of Seller's business consistent with past practices;

  • Transfer of Purchased Assets At each exercise of the Asset Purchase Option by Party A:

  • Purchase and Sale of Purchased Assets On the terms and subject to the conditions set forth in this Agreement, at the Closing, the Purchaser will purchase from the Seller, and the Seller will sell, transfer, assign, convey and deliver to the Purchaser the Purchased Assets pursuant to the Xxxx of Sale.

  • Delivery of Purchased Assets The Seller shall have delivered possession of the Purchased Assets to the Purchaser, and shall have made all intangible Purchased Assets available to the Purchaser.

  • Seller's Assignment of Purchased Receivables With respect to all Receivables repurchased by the Seller pursuant to this Agreement, the Purchaser shall assign, without recourse, representation or warranty, to the Seller all the Purchaser's right, title and interest in and to such Receivables, and all security and documents relating thereto.

  • Release of Encumbrances The Company shall have filed or recorded (where necessary) and delivered to Buyer all documents necessary to release the Shares and assets of the Company from all Encumbrances (except for Encumbrances permitted under Section 4.9), which documents shall be in a form reasonably satisfactory to Buyer's counsel.

  • EXECUTION OF PURCHASE AND SALE ORDERS In connection with purchases or sales of portfolio securities for the account of the Fund, it is understood that you will arrange for the placing of all orders for the purchase and sale of portfolio securities for the account with brokers or dealers selected by you, subject to review of this selection by the Board from time to time. You will be responsible for the negotiation and the allocation of principal business and portfolio brokerage. In the selection of such brokers or dealers and the placing of such orders, you are directed at all times to seek for the Fund the best qualitative execution, taking into account such factors as price (including the applicable brokerage commission or dealer spread), the execution capability, financial responsibility and responsiveness of the broker or dealer and the brokerage and research services provided by the broker or dealer. You should generally seek favorable prices and commission rates that are reasonable in relation to the benefits received. In seeking best qualitative execution, you are authorized to select brokers or dealers who also provide brokerage and research services to the Fund and/or the other accounts over which you exercise investment discretion. You are authorized to pay a broker or dealer who provides such brokerage and research services a commission for executing a Fund portfolio transaction which is in excess of the amount of commission another broker or dealer would have charged for effecting that transaction if you determine in good faith that the amount of the commission is reasonable in relation to the value of the brokerage and research services provided by the executing broker or dealer. The determination may be viewed in terms of either a particular transaction or your overall responsibilities with respect to the Fund and to accounts over which you exercise investment discretion. The Fund and you understand and acknowledge that, although the information may be useful to the Fund and you, it is not possible to place a dollar value on such information. The Board shall periodically review the commissions paid by the Fund to determine if the commissions paid over representative periods of time were reasonable in relation to the benefits to the Fund. Consistent with the Rules of Fair Practice of the National Association of Securities Dealers, Inc., and subject to seeking best qualitative execution as described above, you may give consideration to sales of shares of the Fund as a factor in the selection of brokers and dealers to execute Fund portfolio transactions. Subject to the provisions of the 1940 Act, and other applicable law, you, any of your affiliates or any affiliates of your affiliates may retain compensation in connection with effecting the Fund's portfolio transactions, including transactions effected through others. If any occasion should arise in which you give any advice to clients of yours concerning the shares of the Fund, you will act solely as investment counsel for such client and not in any way on behalf of the Fund. Your services to the Fund pursuant to this Agreement are not to be deemed to be exclusive and it is understood that you may render investment advice, management and other services to others, including other registered investment companies.

  • Rights of Purchaser The Capital Securities shall be offered and sold by the Trust directly to the Purchaser without registration of any of the Capital Securities, the Debentures or the Guarantee under the Securities Act of 1933, as amended (the "Securities Act"), or any other applicable securities laws in reliance upon exemptions from the registration requirements of the Securities Act and other applicable securities laws. The Offerors agree that this Agreement shall be incorporated by reference into the Subscription Agreement and the Purchaser shall be entitled to each of the benefits of the Placement Agents and the Purchaser under this Agreement and shall be entitled to enforce obligations of the Offerors under this Agreement as fully as if the Purchaser were a party to this Agreement. The Offerors and the Placement Agents have entered into this Agreement to set forth their understanding as to their relationship and their respective rights, duties and obligations.

  • Valid Issuance of Purchased Shares The Purchased Shares, when issued, sold, delivered, and paid for by the Investor in accordance with the terms of this Agreement, will be duly and validly issued, fully paid, and non-assessable

Time is Money Join Law Insider Premium to draft better contracts faster.