Seller FDA Letters definition

Seller FDA Letters means letters to the FDA substantially in the form of Exhibit H, transferring the rights to the Purchased Regulatory Approvals to Purchaser.
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Seller FDA Letters means the letters to be delivered by Seller and/or certain of its Affiliates, as identified therein, to the FDA transferring to Purchaser the rights to the FDA Product Marketing Authorizations and INDs in the United States, in a form reasonably satisfactory to Purchaser and Seller.
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Seller FDA Letters means the letters from Seller to the FDA, duly executed by Seller, to be filed with the FDA pursuant to Section 5.7(a), with regard to the Regulatory Approvals, the form of which is attached hereto as Exhibit G, as such form may, in the case of the Seller FDA Letter for the BLA for the Product, be amended by Seller under the terms of the Transitional Services Agreement and its Schedule 2.1.
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Examples of Seller FDA Letters in a sentence

  • 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.


More Definitions of Seller FDA Letters

Seller FDA Letters means letters to the FDA substantially in the form of Exhibit H, transferring therights to the Purchased Regulatory Approvals to Purchaser.
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Seller FDA Letters has the meaning set forth in Section ‎2.4.2(a)(iv).
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Seller FDA Letters has the meaning set forth in Section 2.22(e).
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Seller FDA Letters means the letter from Seller to the FDA, duly executed by Seller, to be delivered to Buyer at the Closing, with regard to the Vasovist NDA and MS-325 IND 51,172, the forms of which are attached hereto as Exhibits F-1 and F-2, respectively.
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Related to Seller FDA Letters

  • 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 Ancillary Agreements means all agreements, instruments and documents being or to be executed and delivered by Buyer or an Affiliate of Buyer under this Agreement or in connection herewith, including the Escrow Agreement.

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

  • Seller Ancillary Documents means any agreement or other instrument, other than this Agreement, but including the Commercial Agreements, to be executed and delivered by a Seller or an Affiliate thereof in connection with the transactions contemplated hereby.

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

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

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

  • 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.

  • Pre-Closing Environmental Liabilities means (i) any violation of Environmental Law arising in connection with the ownership or operation of the Properties prior to the Effective Time, (ii) any Release of Hazardous Substances onto or from the Properties prior to the Effective Time or relating to or arising from any activities conducted on such properties or from operation of such assets prior to the Effective Time and (iii) any claim, action, cause of action, inquiry, investigation, remediation, removal or restoration with respect to the matters set forth in subsection (i) or (ii) above

  • Sellers has the meaning set forth in the preamble.

  • Seller Parties has the meaning set forth in the preamble to this Agreement.

  • 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.

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

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

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

  • 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.

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

  • Retained Contracts means all contracts, agreements, leases, software licenses, rights, obligations or other commitments of the Company that (a) arise out of or are related exclusively to any business or operation of the Company other than the Business, or (b) arise out of or are related in any way to the Business and which, in the case of both clauses (a) and (b) herein, are not Transferred Contracts.

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

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

  • Claims Made Policies has the meaning set forth in Section 5.01(b).

  • Sellers Disclosure Schedule means the disclosure schedule delivered by the Sellers to the Purchaser on the date hereof.

  • Seller Contracts means all Contracts (i) relating to the Business under which Seller has or may acquire any rights or benefits, (ii) relating to the Business under which Seller has or may become subject to any obligation or Liability or (iii) by which any of the Purchased Assets or Assumed Liabilities is or may become bound.

  • Business Contracts has the meaning ascribed to it in Section 1.01(a)(v).