Buyer FDA Letter definition

Buyer FDA Letter means the transfer of ownership letter from Buyer to the FDA as required by 21 CFR § 314.72, in a form mutually agreed between Seller and Buyer, to effectuate the transfer of the Regulatory Approvals from Seller to Buyer.
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Buyer FDA Letter means the letter substantially in the form of Exhibit A, with any changes thereto as may be mutually agreed by the Sellers and the Buyer Parties prior to the Closing.
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Buyer FDA Letter means a letter from Buyer to the FDA advising the FDA of the transfer of the NDAs and ANDA included in the Acquired Product Registrations to Buyer, which shall be in customary form reasonably acceptable to the Parties.
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Examples of Buyer FDA Letter in a sentence

  • Buyer shall send Buyer FDA Letter to the FDA, and Seller shall send Seller FDA Letter to the FDA, within ten (10) Business Days after Closing.

  • Buyer shall send the Buyer FDA Letter to the FDA, and Seller shall send the Seller FDA Letter to the FDA, within ten (10) Business Days of Closing.

  • Within seven (7) Business Days after receiving notice from the Seller of the filing of the Seller FDA Letter, Buyer shall file the Buyer FDA Letter with the FDA.

  • Except for the consents to be obtained by the Buyers’ shareholders, the Buyer FDA Letter, the Buyer Orphan Designation Letter and the consent of certain counterparties to the Assumed Contracts, 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 Buyers of the transactions contemplated by this Agreement.

  • If reasonably practicable, on the Closing Date, but in any event within one (1) Business Day of the Closing BPI shall duly submit to the FDA the Seller FDA Letter and Buyer shall duly submit to the FDA the Buyer FDA Letter.

  • Table of Contents in connection with the preparation and submission of the Buyer FDA Letter, the Seller FDA Letter and all other approvals, consents, registrations, Permits, FDA Permits, authorizations and other confirmations required to be obtained from any Governmental Authority that are necessary to transfer the Regulatory Approvals contemplated by Section 2.01(i).

  • 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.

  • Promptly after the Closing (but in no event later than two (2) Business Days following the Closing), Seller shall file, or cause to be filed, with the FDA the Seller FDA Letter, the Americas 92425100 Buyer FDA Letter, the Seller Orphan Designation Letter and the Buyer Orphan Designation Letter and shall provide an as‑filed copy of each such letter to Buyer.

  • Promptly after the Closing (but in no event later than two (2) Business Days following the Closing), Seller shall file, or cause to be filed, with the FDA the Seller FDA Letter, the Buyer FDA Letter, the Seller Orphan Designation Letter and the Buyer Orphan Designation Letter and shall provide an as-filed copy of each such letter to Buyer.


More Definitions of Buyer FDA Letter

Buyer FDA Letter means the letters from Buyer to the FDA notifying the FDA of the transfer of the applicable Health Registrations. 1.19 “Buyer Insurance” has the meaning set forth in Section 12.7. 1.20 “Buyer Parties” has the meaning set forth in Section 12.1. 1.21 “Calendar Quarter” means each three month period commencing on January 1, April 1, July 1, and October 1. 3 CONFIDENTIAL TREATMENT REQUESTED Portions of this exhibit indicated by “[***]” have been omitted, and such omitted portions have been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 1.22 “cGMP” means the then current good manufacturing practices and standards as required by applicable Governmental Authorities in the Territory. 1.23 “CIA” means the Corporate Integrity Agreement, effective as of November 22, 2011, by and between OIG and Merck & Co., Inc. 1.24 “Closing” has the meaning set forth in Section 4.1. 1.25 “Closing Date” has the meaning set forth in Section 4.1. 1.26 “Code” means the United States Internal Revenue Code of 1986, as amended. 1.27 “Compound” means each of (i) the chemical compound azithromycin, and (ii) the combination of the chemical compounds dorzolamide hydrochloride and timolol maleate, and “Compounds” means all of the foregoing collectively. For clarity, “Compound” shall not include dorzolamide hydrochloride alone or timolol maleate alone. 1.28 “Contract” means any legally binding agreement, contract, commitment or instrument, whether written or oral, together with any amendments or modifications thereto and restatements thereof. 1.29 “Control”, “Controls” or “Controlled by” means with respect to any intellectual property assets or rights, as applicable, the possession of (whether by ownership or license or other right, other than pursuant to a license under this Agreement) or the ability of a Person to grant access to, or a license or sublicense of, such items or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Person would be required hereunder to grant the other Person such access or license or sublicense. 1.30 “COSOPT” has the meaning set forth in Section 1.107. 1.31 “COSOPT PF” has the meaning set forth in Section 1.107. 1.32 “DEA” means the U.S. Drug Enforcement Administration. 1.33 “Deductible” has the meaning set forth in Section 12.1. 1.34 “Documents” means the following documents and rec...
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Buyer FDA Letter means the letters from Buyer to the FDA notifying the FDA of the transfer of the applicable Health Registrations.
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Buyer FDA Letter means the letter from Buyer to the FDA, duly executed by Buyer, to be delivered to Seller on the Closing Date, which shall be in customary form reasonably acceptable to both Parties.
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Related to Buyer FDA Letter

  • 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.

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

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

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

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

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

  • 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.

  • 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.

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

  • Buyer has the meaning set forth in the preamble.

  • Buyer Initial s/ PL Purchase Agreement for Tractor Supply-Maryville, TN Buyer shall be allowed five (5) days after receipt of said commitment for examination and the making of any objections to marketability thereto, said objections to be made in writing or deemed waived. If any objections are so made, the Seller shall be allowed eighty (80) days to make such title marketable or in the alternative to obtain a commitment for insurable title insuring over Buyer's objections. If Seller shall decide to make no efforts to make title marketable, or is unable to make title marketable or obtain insurable title, (after execution by Buyer of such documents reasonably requested by Seller to evidence the termination hereof) Buyer's First Payment shall be returned and this Agreement shall be null and void and of no further force and effect. Seller has no obligation to spend any funds or make any effort to satisfy Buyer's objections, if any. Pending satisfaction of Buyer's objections, the payments hereunder required shall be postponed, but upon satisfaction of Buyer's objections and within ten (10) days after written notice of satisfaction of Buyer's objections to the Buyer, the parties shall perform this Agreement according to its terms.

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

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

  • Purchaser/ User means ultimate recipient of goods and services

  • 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.

  • Transaction-Specific Hedge means any Transaction that is an interest rate cap, interest rate floor or interest rate swaption, or an interest rate swap if (x) the notional amount of the interest rate swap is “balance guaranteed” or (y) the notional amount of the interest rate swap for any Calculation Period otherwise is not a specific dollar amount that is fixed at the inception of the Transaction.

  • Closing Checklist means the schedule, including all appendices, exhibits or schedules thereto, listing certain documents and information to be delivered in connection with the Agreement, the other Loan Documents and the transactions contemplated thereunder, substantially in the form attached hereto as Annex D.

  • Pre-Closing Statement has the meaning set forth in Section 2.4(a).

  • 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.

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

  • Buyer Data means all data, records, files, information or content, including text, sound, video, images and software, that is (a) input or uploaded by Buyer or its Users to or collected, received, transmitted, processed, or stored by Buyer or its Users using the Software or SaaS Service in connection with this Agreement, or (b) derived from (a). Buyer Data is Confidential Information of Buyer.

  • Secondary Seller means the Seller whose Bid City selected as a back-up supplier in the event the Primary Seller is unable to provide all the Goods and/or Services required.

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Agent, desirable to perfect the security interests purported to be created by each Security Agreement, each Pledge Agreement and each Mortgage.

  • Medicare supplement policy means a group or individual policy of [accident and sickness] insurance or a subscriber contract [of hospital and medical service associations or health maintenance organizations], other than a policy issued pursuant to a contract under Section 1876 of the federal Social Security Act (42 U.S.C. Section 1395 et. seq.) or an issued policy under a demonstration project specified in 42 U.S.C. § 1395ss(g)(1), which is advertised, marketed or designed primarily as a supplement to reimbursements under Medicare for the hospital, medical or surgical expenses of persons eligible for Medicare. “Medicare supplement policy” does not include Medicare Advantage plans established under Medicare Part C, Outpatient Prescription Drug plans established under Medicare Part D, or any Health Care Prepayment Plan (HCPP) that provides benefits pursuant to an agreement under §1833(a)(1)(A) of the Social Security Act.

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