FDA Letters definition

FDA Letters means the Seller FDA Letter and the Purchaser FDA Letter.
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FDA Letters means the letters, in substantially the forms attached hereto as E xhibit D and signed by an authorized officer of: (a) the applicable Sellers notifying the FDA of the transfer of the Transferred Approvals or the Transferred INDs, as applicable, to Purchaser; and (b) Purchaser notifying the FDA of the assumption of the Transferred Approvals or the Transferred INDs, as applicable, from the applicable Sellers on the Closing Date.
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FDA Letters means the Buyer FDA Letters and the Cyclerion FDA Letters. (69) “Fully-Diluted Basis” shall mean, as of a specified date, the number of shares of common stock of Buyer Parent then-outstanding plus the number of shares of common stock of Buyer Parent issuable upon exercise or conversion of then-outstanding shares of preferred stock of Buyer Parent. (70) “Governmental Entity” means any nation or government, any state, municipality or other political subdivision thereof and any entity, body, agency, commission, department, board, bureau or court, whether domestic, foreign, multinational, or supranational exercising executive, legislative, judicial, regulatory, self-regulatory or administrative functions of or pertaining to government and any executive official thereof. (71) “Group” means (i) with respect to Buyer, the Buyer Group and (ii) with respect to Cyclerion, Cyclerion and its Subsidiary, as the context requires. (72) “Hydroxy-Compounds” shall have the meaning set forth in Section 6.13(c). (73) “Inactive Employee” shall have the meaning set forth in Section 6.5(a). (74) “IND” means an Investigational New Drug application required pursuant to 21 C.F.R. Part 312 or any comparable filings outside of the United States required to commence human clinical trials in such country or region, and all supplements or amendments that may be filed with respect to the foregoing. (75) “Indemnifiable Losses” means any and all Liabilities, including damages, losses, obligations, penalties, judgments, settlements, claims, payments, fines and other costs and expenses (but excluding consequential, punitive, incidental and similar damages except to the extent paid to a third party) of any and all Actions and demands, assessments, judgments, settlements and compromises relating thereto and the reasonable fees and expenses of attorneys, accountants, consultants and other professionals incurred in the investigation or defense thereof or the enforcement of rights hereunder.
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Examples of FDA Letters in a sentence

  • After the Closing, (i) Merck shall file the Merck FDA Letters with the FDA and the Merck Health Canada Letters with Health Canada no later than one (1) Business Day after the Closing Date and (ii) Buyer and Inspire shall file (A) the Buyer FDA Letters and the Inspire FDA Letters with the FDA and (B) the Inspire Health Canada Letters with Health Canada no later than one (1) Business Day after the Closing Date.

  • 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.

  • The Research Foundation consents to, and otherwise ratifies, the action previously taken by B&H pursuant to the Royalty Agreement in executing and delivering the FDA Letters.

  • 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.

  • Except for the Cyclerion FDA Letters and the Cyclerion Orphan Designation Letter, and as set forth on Section 4.4 of the Disclosure Schedules, no filing with, and no permit, authorization, consent or approval of, any third party, public body or governmental authority is necessary for the consummation by Cyclerion of the transactions contemplated by this Agreement.

  • For clarity, the Seller FDA Letters shall appear as a sequence in such Acquired Regulatory Approvals.

  • 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.


More Definitions of FDA Letters

FDA Letters means the letters to the FDA and any other Regulatory Authority, in United States or anywhere in the world, relating to the transfer of EUAs, substantially in the forms attached hereto as Exhibit 12.14 or in forms reasonably requested by Xxxxx.
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FDA Letters means the letters, in substantially the forms attached hereto as Exhibit D and signed by an authorized officer of: (a) the applicable Sellers notifying the FDA of the transfer of the Transferred Approvals or the Transferred INDs, as applicable, to Purchaser; and (b) Purchaser notifying the FDA of the assumption of the Transferred Approvals or the Transferred INDs, as applicable, from the applicable Sellers on the Closing Date.
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FDA Letters means the letters in the form attached hereto as Exhibit E and submitted via the FDA electronic gateway providing for the notification to the FDA of: (a) the transfer of ownership of the Transferred Approvals from Seller to Buyer; and (b) the assumption of responsibility for the Transferred Approvals by Buyer in place of Seller, in each case, as of the Closing Date.
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FDA Letters means the letters to the FDA and any other Regulatory Authority, in United States or anywhere in the world, relating to the transfer of EUAs, substantially in the forms attached hereto as Exhibit 12.14 or in forms reasonably requested by Buyer.
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Related to FDA Letters

  • Private Letter Ruling shall have the meaning set forth in the Recitals.

  • Payoff Letters has the meaning set forth in Section 6.6.

  • Representation Letters means the statements of facts and representations, officer’s certificates, representation letters and any other materials (including, without limitation, a Ruling Request and any related supplemental submissions to the IRS or other Tax Authority) delivered by EQT, SpinCo or any of their respective Affiliates or representatives in connection with the rendering by Tax Advisors, and/or the issuance by the IRS or other Tax Authority, of the Tax Opinions/Rulings.

  • Letters means that term as described in section 1105 of the estates and protected individuals code, 1998 PA 386, MCL 700.1105.

  • Commitment Letters has the meaning set forth in Section 4.5.

  • Regulatory Agreement means the regulatory agreement between HPD and the Owner establishing certain controls upon the operation of the Exemption Area during the term of the Exemption.

  • Supply Agreements has the meaning set forth in Section 7.1.

  • Letter of Intent means the intimation by a letter / email / fax to the bidder that the tender has been accepted in accordance with provision contained in that letter. The responsibility of the contractor commences from the date of issue of this letter and all the terms and conditions of contract are applicable from this date.

  • Undertaking Letter The letter in substantially the form set forth in Exhibit C of the Trust Agreement.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Contract Letter means the letter identifying those documents which form the Contract.

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.

  • Third Party Agreements means any Contract between or among a Party (or any member of its Group) and any other Persons (other than the Parties or any member of their respective Groups) (it being understood that to the extent that the rights and obligations of the Parties and the members of their respective Groups under any such Contracts constitute Versum Assets or Versum Liabilities, or Air Products Retained Assets or Air Products Retained Liabilities, such Contracts shall be assigned or retained pursuant to Article II).

  • Development Agreements means all development, utility or similar agreements included in the Permitted Encumbrances.

  • Letter of Intent (LOI means an intimation by a letter to Bidder that their Tender has been accepted in accordance with the provisions contained in the letter and hence to take preparatory steps and compliance of formalities to commence the work from the date desired by Owner.

  • Settlement Agreement means this agreement, including the recitals and schedules.

  • Ruling Documents means the Ruling and the Ruling Request.

  • 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.

  • Pay-Off Letters has the meaning set forth in Section 1.6.2.

  • Pending Litigation means a proceeding in a court of law whose activity is in progress but not yet completed.

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

  • Escrow Agreements means one or more of the agreements between the Company, the Partnership and one or more of the Performance Investors, dated as of the closing of the date of the initial public offering of the common stock of the General Partner, pursuant to which the Performance Investors have deposited their Performance Shares in escrow for possible transfer to the General Partner or the Partnership (as applicable).

  • License Agreements shall have the meaning set forth in Section 8.11 hereof.

  • Pharmacovigilance Agreement has the meaning set forth in Section 4.3.

  • Confidentiality Agreements has the meaning set forth in Section 5(d).

  • Supply Contracts means contracts having as their object the purchase, lease, rental or hire-purchase, with or without an option to buy, of products. A supply contract may include, as an incidental matter, siting and installation operations;