FDA Transfer Letters definition

FDA Transfer Letters means, (x) with respect to Seller, a letter or letters to the FDA transferring the rights to the Product Registrations to Buyer and a letter or letters to the FDA, notifying it of the transfer of the Product Registrations to Buyer, as well as any similar letters to any other applicable Regulatory Authority, in each case delivered to Buyer for further delivery on behalf of Seller; and (y), with respect to Buyer, a letter or letters to the FDA assuming responsibility for the Product Registrations from Seller and a letter or letters to the FDA from Buyer, notifying it of the transfer of the Product Registrations from Seller to Buyer, as well as any similar letters to any other applicable Regulatory Authority, in each case, copying Seller.
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FDA Transfer Letters has the meaning set forth in Section ------- 8.2(e). ------
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Examples of FDA Transfer Letters in a sentence

  • The Parties further acknowledge that Purchaser’s right to purchase, and Manufacturer’s obligation to supply, Products shall not commence unless and until the Parties fulfill their obligations under Section 6.08(a) of the Asset Purchase Agreement to execute and deliver to the FDA the Seller FDA Transfer Letters and the Purchaser FDA Transfer Letters.

  • Buyer and Sellers shall file the Buyer FDA Transfer Letters and the Sellers FDA Transfer Letters, respectively, with FDA on the date reasonably determined by Sellers that is no later than January 30, 2018.

  • Horizon and AstraZeneca shall file the Horizon FDA Transfer Letters and the AstraZeneca FDA Transfer Letters, respectively, with the FDA pursuant to the Transition Agreement.

  • Seller shall have duly executed and delivered to Buyer, dated as of the Closing Date, counterparts to each of the: (i) Ancillary Agreements; (ii) Seller Officer’s Certificate; (iii) Joint Written Instructions, duly executed by Seller, directing the Escrow Agent to deliver to Seller the Escrowed Funds in accordance with Section 3.1(a) and (iv) the FDA Transfer Letters.

  • Buyer shall have, and Buyer shall have caused its applicable Affiliates to have, duly executed and delivered to Seller, dated as of the Closing Date, counterparts to each of the: (i) Ancillary Agreements; (ii) Buyer Officer’s Certificate; (iii) Joint Written Instructions, duly executed by Buyer, directing the Escrow Agent to deliver to Seller the Escrowed Funds in accordance with Section 3.1(a); and (iv) the FDA Transfer Letters.

  • On or before [***] ([***])[***] after the Closing Date, Purchasers shall deliver the Purchaser FDA Transfer Letters to the FDA notifying the FDA of TJL Purchaser’s ownership of the Product Registrations and its acceptance of the regulatory responsibilities associated with the Product Registrations from Seller.

  • Seller shall have duly executed and delivered to Buyer, dated as of the Closing Date, counterparts to each of the: (i) Ancillary Agreements; (ii) Seller Officer’s Certificate; (iii) Joint Written Instructions, duly executed by Seller, directing the Escrow Agent to deliver to Buyer the Escrowed Funds in accordance with Section 3.1(a); and (iv) the FDA Transfer Letters.

  • The foregoing transfer and assignment shall be effected by the Seller submitting the FDA Transfer Letters to the FDA.

  • Seller shall file the Seller FDA Transfer Letters with the FDA within [***] after the Closing.

  • Buyer and Seller shall file the Buyer FDA Transfer Letters and the Seller FDA Transfer Letters, respectively, with the FDA within five Business Days after the Closing Date.

Related to FDA Transfer Letters

  • CMPPA Agreement means the CMPPA Agreement between the SSA and CHHS.

  • 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.

  • Definitive Acquisition Agreement means any definitive written agreement entered into by the Company that is conditioned on the approval by the holders of not less than a majority of the outstanding shares of Common Stock at a meeting of the stockholders of the Company with respect to (i) a merger, consolidation, recapitalization, reorganization, share exchange, business combination or similar transaction involving the Company or (ii) the acquisition in any manner, directly or indirectly, of more than 50% of the consolidated total assets (including, without limitation, equity securities of its subsidiaries) of the Company and its Subsidiaries.

  • Seller's Agreement An agreement for the origination and sale of Mortgage Loans generally in the form of the Seller Contract referred to or contained in the Program Guide, or in such other form as has been approved by the Master Servicer and the Company, each containing representations and warranties in respect of one or more Mortgage Loans consistent in all material respects with those set forth in the Program Guide.

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

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

  • Confidentiality Agreements shall have the meaning set forth in Section 6.7 hereof.

  • Retention Agreements has the meaning set forth in Section 5.11(e).

  • Offer Letter means the letter given to the Trainee providing him/her with an offer to join Infosys after the successful completion of the Program as a full-time employee in the capacity of a systems engineer, subject to terms and conditions contained in the offer letter.

  • Technology Transfer Agreement has the meaning given in Section 2.2(a).

  • SPS Agreement means the Agreement on the Application of Sanitary and Phytosanitary Measures which is a part of the WTO Agreement; Subheading means the first six digits in the tariff classification number under the HS; Territory means:

  • Lock-Up Agreements means the lock-up agreements that are delivered on the date hereof by each of the Company’s officers and directors, in the form of Exhibit A attached hereto.

  • Initial Agreement has the meaning set forth in the Recitals.

  • Confidentiality Agreement has the meaning set forth in Section 6.3.

  • Post-Closing Agreement shall have the meaning set forth in Section 8.9.

  • License Agreement means the agreement between SAP (or an SAP SE Affiliate, or an authorized reseller) under which Customer procured the rights to use SAP Software or a Cloud Service.

  • Master Separation Agreement has the meaning set forth in the recitals.

  • Transition Agreement has the meaning set forth in Section 12.8.1.

  • Mutual aid agreement means an agreement between the City and a town or other city for the City’s fire department to provide assistance to the fire department of a town or other city.

  • 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.

  • Subject Instruments shall nonetheless mean such instrument, agreement or other document, as the case may be, in its entirety, including any portions thereof which shall have been so redacted, deleted or otherwise not filed.

  • Collaboration Agreement has the meaning set forth in the Recitals.

  • 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.

  • Lock-Up Agreement means the Lock-Up Agreement, dated as of the date hereof, by and among the Company and the directors and officers of the Company, in the form of Exhibit B attached hereto.

  • Reciprocal agreement means an agreement between this state and a higher education compact or 1 or more other states that allows participating colleges to provide distance education to residents of this state and other member states under this act.

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