AZASITE definition

AZASITE means AzaSite (ISV-401), a DuraSite formulation of azithromycin (1%).
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AZASITE has the meaning set forth in Section 1.107. 1.15 “▇▇▇▇ of Sale” means with respect to Purchased Assets, the ▇▇▇▇ of Sale for the Closing, substantially in the form of Exhibit C. 1.16 “Business Day” means any day other than Saturday, Sunday or a day on which banking institutions in the State of New York are permitted or obligated by Law to close. 1.17 “Buyer” has the meaning set forth in the preamble. 1.18 “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 Th...
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AZASITE has the meaning set forth in Section 1.107.
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Examples of AZASITE in a sentence

  • In the event that [***] (or its affiliate, as applicable) [***] has not supplied AZASITE (meeting applicable product specifications) under the Open Purchase Order by [***], 2014 (the “Anticipated Delivery Date”), then Merck shall make a payment to Buyer in the amount of [***] within sixty (60) days after such Anticipated Delivery Date.

  • For clarity, this provision shall be terminated and of no further force and effect from and after the time that [***] supplies AZASITE under the Open Purchase Order.

  • In the event that Merck was required to make a payment to Buyer pursuant to the foregoing provisions of this Article 13, but thereafter Buyer and/or any of its Affiliates thereafter manufactures, markets, sells or distributes AZASITE in the Territory prior to the [***] anniversary of the Closing Date, then, within (30) Business Days thereof, Buyer shall refund to Merck any and all amounts paid by Merck to Buyer pursuant to the foregoing provisions of this Article 13.

  • Notwithstanding the foregoing, the indemnification obligations of Merck with respect to damages, losses, Liabilities and expenses incurred by Buyer Parties and payable to [***] arising out of the [***] Action shall not be subject to the Indemnification Cap of Section 12.1. As used in this Section 12.4, the term “[***] Action” shall mean [***] AZASITE [***] License”) [***] occurring prior to the Closing Date.

Related to AZASITE

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • Licensed Territory means worldwide.

  • Territory means worldwide.

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all clinical studies and tests, including the manufacturing batch records, relating to the Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.