PDUFA Date definition

PDUFA Date means the user fee goal date that is set forth in a filing communication or other written correspondence from FDA.

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PDUFA Date means the earlier of (i) the date immediately following the date upon which the Corporation first publicly announces the outcome of the review by the U.S. Food and Drug Administration of the Corporation’s new drug application of its product candidate known as KP415, and (ii) March 2, 2021.

PDUFA Date means October 21, 2015.

Examples of PDUFA Date in a sentence

• For Grünenthal: [ * ] VP Portfolio Development For AcelRx: [ * ] VP Clinical Operations ZALVISO PDUFA Date Conference Call at 8:30 a.m. Eastern time on Monday, December 16, 2013 About ZALVISO About AcelRx Pharmaceuticals, Inc.

• Either Party shall have the right to terminate this Agreement (i) [***] ([***]) days after the PDUFA Date if Relypsa receives a [***] from the FDA that is [***] within [***] ([***]) months from the PDUFA Date, or (ii) if Relypsa has not obtained regulatory approval from the FDA to sell the Product in the Territory on or before [***].

• Subject to the last sentence of subsection 2.1(b), the Tranche 2 Funding Date shall occur on (x) if Regulatory Approval shall have been received on the PDUFA Date, the fifth Business Day following the date on which notice of Regulatory Approval is delivered to the Administrative Agent or (y) if Regulatory Approval shall have been received on any other date, the tenth Business Day following the date on which notice of Regulatory Approval is delivered to the Agent.

More Definitions of PDUFA Date

PDUFA Date means the date as set by the FDA for response to the NDA pursuant to the Prescription Drug User Fee Act of 1992, as amended.

PDUFA Date means October 21, 2015. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. EXECUTION VERSION

PDUFA Date means the deadline established by the FDA pursuant to the Prescription Drug User Fee Act.”

PDUFA Date means the date that the FDA is expected to deliver its decision on the Customer's New Drug Application for the Product. • "Price" means the price for Product referred to in Section 4.1. • "Product - Bulk Tablets" means the Recorlev (levoketoconazole) 150 mg tablets in accordance with the Specifications. • "Product - Britestock" means the Recorlev (levoketoconazole) 150 mg tablets in unlabeled primary packaging in accordance with the Specifications. • "Product" shall mean both Product - Bulk Tablets and Product - Britestock. • "Quality Agreement" means the Quality Agreement referred to in Section 8.1. • "Raw Materials" means all materials used in connection with the manufacture and supply of Product hereunder, other than the API, as specified in the Specifications attached to this Agreement as Exhibit B. • "Regulatory Approval" means the receipt of all approvals, licenses, registrations or authorizations from the FDA necessary to market and sell the Product in the Territory. • "Services" means the commercial manufacturing services and related services to be performed by Lonza under this Agreement as required to manufacture and supply Customer with Product as set forth herein, the particulars of which are set out in in the Specifications and each Purchase Order. • "Specifications" means the release specifications for the manufacture, processing, bulk packaging, testing and testing procedures, shipping, storage and supply of the Product, any Raw Material requirements, analytical procedures and standards of quality control and quality assurance, established by the Parties for the Product. The Specifications are attached to this Agreement as Exhibit B. • "Territory" means the United States of America, its territories and possessions, the United Kingdom, Canada, the European Union and its member countries and any other countries or jurisdictions that are mutually agreed to by the Parties in writing.

PDUFA Date means the date by which the FDA will review the Pacritinib NDA and render a decision thereon.

PDUFA Date means the first date on which the FDA accepts, rejects or provides a complete response letter with respect to the New Drug Application for VIAject, as the same may be accelerated or extended from time to time. For the avoidance of doubt, if the FDA issues a complete response letter on or about the PDUFA Date and, thereafter, a new FDA action date is set, any such new action date shall not be considered a PDUFA Date for purposes of this Warrant.

PDUFA Date means the date by which the FDA will review the Pacritinib NDA and render a decision