Seller FDA Transfer Letters definition

Seller FDA Transfer Letters means the letters to the FDA in the form of Exhibit B, transferring the rights to the Product Approvals to Purchaser.
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Seller FDA Transfer Letters means the letters from Seller to the FDA, duly executed by Seller (and any Affiliate of Seller, as applicable), notifying the FDA of the transfer of the rights to the applicable Governmental Authorizations to Purchaser.
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Seller FDA Transfer Letters means the letters to the FDA in the form of Exhibit C, transferring the rights to the Purchased Regulatory Approvals to Buyer.
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Examples of Seller 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.

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

  • The Parties shall execute and deliver to the FDA and other appropriate Governmental Authorities such documents and instruments of conveyance (including the Seller FDA Transfer Letters and the Purchaser FDA Transfer Letters) as necessary and sufficient to effectuate the transfer of each Transferred Governmental Authorization to Purchaser under applicable Law on the Closing Date or as soon as possible if the Transferred Governmental Authorizations are assigned 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.


More Definitions of Seller FDA Transfer Letters

Seller FDA Transfer Letters means letters from Seller or any of its Subsidiaries, as applicable, to the FDA, transferring the rights to the Transferred Regulatory Approvals to Purchaser or any of the Purchaser Designees, in substantially the form set forth on Exhibit B hereto.
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Seller FDA Transfer Letters means the letter to the FDA in the form
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Seller FDA Transfer Letters means the letters to the FDA in the form of Exhibit B, transferring the rights to the Product Approvals to Purchaser. “Seller Indemnified Parties” has the meaning set forth in Section 9.3.
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Seller FDA Transfer Letters means the letters from the applicable holders of a New Drug Application or Abbreviated New Drug Application for human or animal drug products, premarket approval, or 510(k) clearance (each as defined by the FDA), duly executed, notifying the FDA of the transfer of the rights to the applicable Governmental Body New Drug Application, Abbreviated New Drug Application, premarket approval, or 510(k) clearance (each as defined by the FDA) to Purchaser. In the case of a premarket approval or 510(k) clearances, a “Seller FDA Transfer Letter” notification shall include the submission of electronic information to the FDA pursuant to 21 CFR §807.
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Related to Seller FDA Transfer 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 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 Ancillary Agreements means all agreements, instruments and documents being or to be executed and delivered by Seller under this Agreement or in connection herewith.

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

  • 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.

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

  • 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.

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

  • Transferred Contracts has the meaning ascribed to it in Section 2.1(c).

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

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

  • Acquisition Agreement Representations means the representations and warranties with respect to the Companies made by the Seller in the Acquisition Agreement to the extent a breach of such representations and warranties is material to the interests of the Lenders, but only to the extent that the Borrower or its Affiliates have the right to terminate its or their obligations under the Acquisition Agreement (or decline to consummate the Rockwood Acquisition) as a result of a breach of such representations in the Acquisition Agreement.

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

  • Training Agreement means an agreement registered under the provisions of the Industrial and Commercial Training Act 1985.

  • Reseller Agreement means the separate agreement between Customer and Reseller regarding the Services. The Reseller Agreement is independent of and outside the scope of 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.

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

  • Acquisition Agreements has the meaning specified in the Recitals.

  • 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.

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

  • Hospital purchaser/provider agreement (HPPA agreement) means a negotiated agreement entered between the fund and the hospital for the cost of hospital treatment.

  • IP License Agreement shall have the meaning set forth in Section 1.2.

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

  • Company IP Agreements means all licenses, sublicenses, consent to use agreements, settlements, coexistence agreements, covenants not to xxx, permissions and other Contracts (including any right to receive or obligation to pay royalties or any other consideration), whether written or oral, relating to Intellectual Property to which the Company is a party, beneficiary or otherwise bound.

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