Buyer FDA Transfer Letters definition

Buyer FDA Transfer Letters means the letters to the FDA, substantially in the form attached hereto as Exhibit C, accepting the transfer of rights to the Product IND and the Product NDA from Mallinckrodt and specifying that such transfer shall become effective on January 1, 2015.
Sample 1Sample 2
Buyer FDA Transfer Letters means the letters to the FDA in the form of Exhibit B, indicating Buyer’s acceptance of the rights to the Purchased Regulatory Approvals from Seller.
Sample 1Sample 2
Buyer FDA Transfer Letters means the letter to FDA in substantially
Sample 1

Examples of Buyer FDA Transfer Letters in a sentence

  • 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.

  • Except for the Buyer FDA Intent Letters, the Buyer FDA Transfer Letters, the Mallinckrodt FDA Intent Letters and the Mallinckrodt FDA Transfer Letters, no notice to, filing with, permit of, authorization of, exemption by or consent of any Governmental Authority or other Person is required for Seller to consummate the Transactions.

  • Seller shall cause Mallinckrodt to file the Mallinckrodt FDA Transfer Letters, and Buyer shall file the Buyer FDA Transfer Letters, with the FDA on the date selected by Buyer by written notice to Seller, which date shall not be later than December 31, 2014.

  • Buyer shall file the Buyer FDA Transfer Letters within one Business Day after receiving the complete copies of the Regulatory Approvals as required under 21 CFR §314.72(a)(2)(iii).

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

  • 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.

  • 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.

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

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

  • Closing Transactions has the meaning set forth in Section 11.8(a) of these Bylaws.

  • 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.

  • 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.

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

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

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

  • 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.

  • 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.

  • Shareholder Agreements has the meaning set forth in the recitals to this Agreement.

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

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

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

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

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

  • Acquisition Agreements has the meaning specified in the Recitals.

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

  • Draft Closing Statement means a draft closing statement as of the close of business of the fifth (5th) Business Day immediately preceding the Closing Date setting forth an estimate of the Purchase Price (including all adjustments and prorations thereto).

  • New Services Queue Closing Date means each April 30 and October 31 shall be the Queue Closing Date for the New Services Queue comprised of Interconnection Requests, Completed Applications, and Upgrade Requests received during the six-month period ending on such date. “New York ISO” or “NYISO” shall mean the New York Independent System Operator, Inc. or any successor thereto.

  • 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.