Buyer FDA Letters definition

Buyer FDA Letters means the letters from Buyer to the FDA, duly executed by Buyer, to be filed with the FDA pursuant to Section 5.7(a), with regard to Regulatory Approvals, the form of which is attached hereto as Exhibit C.
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Buyer FDA Letters shall have the meaning set forth in Section 7.3(a)(iv). (22) “Buyer Group” means Buyer Parent and each Subsidiary of Buyer Parent.
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Buyer FDA Letters means the letters from Buyer to the FDA, duly executed by Buyer, to be delivered to Seller at the Closing, with regard to the Vasovist NDA and MS-325 IND 51,172, the forms of which are attached hereto as Exhibits C-1 and C-2, respectively.
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Examples of Buyer FDA Letters in a sentence

  • The Buyer and the Company shall, on the Closing Date, have filed, or caused to be filed, through the electronic gateway, the Buyer FDA Letters and the Company FDA Letters, respectively, with the FDA.

  • Effective July 1, 2008, the Board adopted generally accepted accounting principles relating to accounting for fair value measurements and disclosures.

  • 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.


More Definitions of Buyer FDA Letters

Buyer FDA Letters means a letter or letters, in a standard and customary form and reasonably acceptable to Seller, to the FDA from Buyer accepting the transfer of rights to the Purchased Regulatory Approvals from Seller.
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Related to Buyer FDA Letters

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

  • 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).

  • 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.

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

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

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

  • Pre-Closing Statement has the meaning set forth in Section 2.4(a).

  • Closing Documents means the papers, instruments and documents required to be executed and delivered at the Closing pursuant to this Agreement;

  • 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.

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

  • Closing Checklist means the schedule, including all appendices, exhibits or schedules thereto, listing certain documents and information to be delivered in connection with the Agreement, the other Loan Documents and the transactions contemplated thereunder, substantially in the form attached hereto as Annex D.

  • Market Seller Offer Cap means a maximum offer price applicable to certain Market Sellers under certain conditions, as determined in accordance with Tariff, Attachment DD. section 6 and Tariff, Attachment M-Appendix, section II.E.

  • Closing Transactions has the meaning set forth in Section 11.8(a) of these Bylaws.

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

  • Private Letter Ruling has the meaning set forth in the recitals.

  • Buyer has the meaning set forth in the preamble.

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

  • Purchaser/ User means ultimate recipient of goods and services

  • Buyer Disclosure Letter means the letter, dated as of the date hereof, delivered by Buyer to Seller prior to the execution of this Agreement and identified as the Buyer Disclosure Letter.

  • Sellers has the meaning set forth in the preamble.

  • 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.