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.

  • 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.

  • At least five (5) Business Days prior to the Closing Date, the Buyer and the Company shall (or shall cause their applicable Subsidiary or Affiliate to) deliver to the other party the Buyer FDA Letters and the Company FDA Letters, respectively.

  • As a result, when a fingerprint is in their possession, they can retrieve information concerning that fingerprint from Eurodac, for instance a person‟s reference number, sex, member state of origin, the date on which the fingerprints were taken, etc.

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


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, prepared by Seller, as of the close of business of the third (3rd) business day preceding the Closing Date setting forth an estimated calculation of both the Purchase Price and the Estimated Payment Amount.

  • Closing Escrow Agreement means the Closing Escrow Agreement, dated as of the date hereof, between the Company, Xxxx Capital Partners, LLC and the escrow agent (the “Escrow Agent”) identified therein, 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 all agreements, instruments and documents being or to be executed and delivered by Seller or any of its Affiliates under this Agreement or in connection herewith.

  • 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 all agreements, instruments and documents being or to be executed and delivered by the Company under this Agreement or in connection herewith.

  • 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)(i) of these Bylaws.

  • Private Letter Ruling shall have 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 the Sale and Servicing Agreement, the Purchase Agreement, the Trust Agreement, [the Insurance Agreement, the Indemnification Agreement] and this Agreement. The Notes are being purchased by the Underwriters named in Schedule 1 hereto, and the Underwriters are purchasing, severally, only the Notes set forth opposite their names in Schedule 1, except that the amounts purchased by the Underwriters may change in accordance with Section 10 of this Agreement. [Name of representative of underwriters] is acting as representative of the Underwriters and in such capacity, is hereinafter referred to as the "Representative." The offering of the Notes will be made by the Underwriters and the Companies understand that the Underwriters propose to make a public offering of the Notes for settlement on _____________, 20__ as the Underwriters deem advisable. The Certificate will be retained by the Seller. Defined terms used herein shall have their respective meanings as set forth in the Sale and Servicing Agreement.

  • Transaction-Specific Hedge means any Transaction that is an interest rate cap, interest rate floor or interest rate swaption, or an interest rate swap if (x) the notional amount of the interest rate swap is “balance guaranteed” or (y) the notional amount of the interest rate swap for any Calculation Period otherwise is not a specific dollar amount that is fixed at the inception of the Transaction.