NDA Submission and Acceptance Milestone Payment definition

NDA Submission and Acceptance Milestone Payment means the one-time, non-reimbursable and non-creditable payment of €[**] Euros) to be made to Faes by Marathon under Section 7.1 upon submission to, and acceptance, by the FDA of the first Marathon Suspension Product NDA filed by Marathon or its Affiliates, subsidiaries, designees or sublicensees with a ActiveUS 164142681 proposed label indication for the treatment in humans of duchenne muscular dystrophy or another indication.
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Related to NDA Submission and Acceptance Milestone Payment

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Sales Milestone Payment is defined in Section 5.3.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • Milestone Event has the meaning set forth in Section 8.4.

  • Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone Payments has the meaning set forth in Section 4.2.

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Additional Indication means any indication other than the Initial Indication.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Expiry Date (Data di Scadenza) means the "Expiry Date" as specified in § 1 of the Product and Underlying Data.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.