Seller FDA Letters definition

Seller FDA Letters means letters to the FDA substantially in the form of Exhibit H, transferring the rights to the Purchased Regulatory Approvals to Purchaser.
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Seller FDA Letters means the letters to be delivered by Seller and/or certain of its Affiliates, as identified therein, to the FDA transferring to Purchaser the rights to the FDA Product Marketing Authorizations and INDs in the United States, in a form reasonably satisfactory to Purchaser and Seller.
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Seller FDA Letters means the letters from Seller to the FDA, duly executed by Seller, to be filed with the FDA pursuant to Section 5.7(a), with regard to the Regulatory Approvals, the form of which is attached hereto as Exhibit G, as such form may, in the case of the Seller FDA Letter for the BLA for the Product, be amended by Seller under the terms of the Transitional Services Agreement and its Schedule 2.1.
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Examples of Seller FDA Letters in a sentence

  • Pressure Lines VM, GWM, Interstitial, or SIR compliant: WAC 173-360-350(3)(c)YNN/A20.

  • Buyer and Sellers shall file the Buyer FDA Letter and the Seller FDA Letters, respectively, with the FDA within five(5) Business Days after the Closing Date.

  • Buyer and Seller shall file the Buyer FDA Letters and Seller FDA Letters, respectively, with FDA within [***] after the Closing Date; provided that Buyer's obligation shall be conditioned on it receiving from Seller not less than [***] prior to the Closing Date the complete regulatory file from Seller for all the relevant INDs and NDAs. Transfer of title to the NDA and the INDs for the Product shall be effective as of the Closing.

  • Promptly after the Closing (but in no event later than two (2) Business Days following the Closing), (a) Seller shall file, or cause to be filed, with the FDA the Seller FDA Letters and provide a copy of the as-filed Seller FDA Letters to Buyer, and (b) Buyer shall file, or cause to be filed, with the FDA the Buyer FDA Letters and provide a copy of the as-filed Buyer FDA Letters to Seller.

  • Buyer and Sellers shall file the Buyer FDA Letter and the Seller FDA Letters, respectively, with the FDA within five (5) Business Days after the Closing Date.


More Definitions of Seller FDA Letters

Seller FDA Letters means letters to the FDA substantially in the form of Exhibit H, transferring therights to the Purchased Regulatory Approvals to Purchaser.
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Seller FDA Letters means the letter from Seller to the FDA, duly executed by Seller, to be delivered to Buyer at the Closing, with regard to the Vasovist NDA and MS-325 IND 51,172, the forms of which are attached hereto as Exhibits F-1 and F-2, respectively.
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Seller FDA Letters has the meaning set forth in Section ‎2.4.2(a)(iv).
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Seller FDA Letters has the meaning set forth in Section 2.22(e).
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Seller FDA Letters means the letters from Seller or any of its Affiliates, as applicable, to the FDA or such other instrument as may be necessary to effectuate the transfer of Acquired Regulatory Approvals to Purchaser or its designated Affiliate in accordance with this Agreement, each in a form reasonably satisfactory to Purchaser, duly executed by Seller or its Affiliate, as applicable.
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Related to Seller FDA Letters

  • Seller Ancillary Agreements means all agreements, instruments and documents being or to be executed and delivered by Seller under this Agreement or in connection herewith.

  • Buyer Ancillary Agreements means all agreements, instruments and documents being or to be executed and delivered by Buyer under this Agreement or in connection herewith.

  • Seller’s Closing Documents as defined in Section 3.2(a).

  • Seller Use means fuel used for gas compression, LPG plants and LNG plants, other gas needed by Seller's facilities to furnish the requirements of Buyers, together with unaccounted for gas. This gas shall be considered Included In Priority of Service Category 1. Other vital uses of Seller, such as flame stabilization requirements, will be met as long as such uses do not jeopardize service to its firm service Buyers.

  • Seller Ancillary Documents means any certificate, agreement, document or other instrument, other than this Agreement, to be executed and delivered by the Seller or any Affiliate of the Seller in connection with the transactions contemplated hereby, including, but not limited to the Transaction Documents.

  • Seller Agreements means those agreements between Seller and third parties, including Artists and/or PRO, wherein Seller is entitled to receive the Percentage Interest of all Assets.

  • Seller's Closing Certificate means the certificate of Seller in the form of Exhibit C attached hereto.

  • Purchaser Plans shall have the meaning set forth in Section 6.6(a)(v).

  • Seller Closing Certificate has the meaning set forth in Section 7.02(d).

  • Closing Escrow Agreement means the Closing Escrow Agreement, dated as of the date hereof, between the Placement Agent, the Company and the Escrow Agent pursuant to which the Investors shall deposit their Investment Amounts with the Escrow Agent to be applied to the transactions contemplated hereunder, in the form of Exhibit B hereto.

  • Pre-Closing Environmental Liabilities means all environmental conditions at or arising from operations at the Owned Real Property at any time prior to the Closing Date, irrespective of the date of its discovery, including arising as a result of the presence or any Release of any Hazardous Substance on, at, under or migrating onto or from the Owned Real Property, including any environmental conditions on, at, under or migrating onto or from the Owned Real Property in Schedule 1.1(3).

  • Sellers has the meaning set forth in the preamble.

  • Seller Parties has the meaning set forth in the preamble to this Agreement.

  • Closing Statements has the meaning set forth in Section 3.3(b).

  • Draft Closing Statement means a draft closing statement as of the close of business of the fifth (5th) Business Day immediately preceding the Closing Date setting forth an estimate of the Purchase Price (including all adjustments and prorations thereto).

  • Seller’s Counsel has the meaning set forth in Section 10.13(a).

  • Closing Press Release has the meaning set forth in Section 5.4(b).

  • Assumed Contracts has the meaning set forth in Section 2.1(d).

  • Company Ancillary Agreements means, collectively, each certificate to be delivered on behalf of the Company by an officer or officers of the Company at the Closing pursuant to Article VII and each agreement or document (other than this Agreement) that the Company is to enter into as a party thereto pursuant to this Agreement.

  • Buyer Closing Certificate has the meaning set forth in Section 7.03(d).

  • Retained Contracts shall have the meaning set forth in Section 1.2(i).

  • Post Closing Letter is that certain Post Closing Letter dated as of the Effective Date by and between Collateral Agent and Borrower.

  • Assumed Agreements shall have the meaning as set forth in Section 2.2.

  • Claims Made Policies has the meaning set forth in Section 5.01(b).

  • Sellers Disclosure Schedule means the disclosure schedule delivered by the Sellers to the Purchaser on the date hereof.

  • Seller Contracts means all contracts, agreements and leases, other than those that are Governmental Permits, to which Seller is a party and pertain to the ownership, operation or maintenance of the Assets or the Business, including those described on Schedule 1.8.