Trial Milestone Date definition

Trial Milestone Date means the later of (i) July 1, 2017 and (ii) the earlier of the date Borrower doses the first patient in (x) the Phase 3 portion of the ongoing Phase 2/3 trial of Bardoxolone Methyl in chronic kidney disease caused by Alport Syndrome, or (y) Part 2 of the ongoing two-part trial, or a separate Phase 3 trial which Collateral Agent and the Lenders agree would serve for registration and be used for FDA submission, of Omaveloxolone in Friedreich’s Ataxia; written evidence of which is provided, and is in form and substance reasonably acceptable, to Collateral Agent and the Lenders. WEST\275560994.6 368986-000139 38
Sample 1
Trial Milestone Date means the earlier of the date Borrower achieves (x) positive topline registrational data of Bardoxolone Methyl in chronic kidney disease caused by Alport Syndrome (the ongoing CARDINAL trial), or (y) positive topline registrational data of Omaveloxolone in Friedreich’s Ataxia (the ongoing MOXIe trial); written evidence of which is provided, and is in form and substance reasonably acceptable, to Collateral Agent and the Lenders. WEST\281916571.5 40 WEST\281916571.5 41
Sample 1

Related to Trial Milestone Date

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

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

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

  • 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.

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

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

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

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

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

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

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

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

  • Sales Milestone Payment is defined in Section 5.3.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

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

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

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • 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).

  • 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).

  • EBITDA Target means the Company's projected earnings before interest, taxes, one-time transition expenses, non-cash compensation expense charges, depreciation and amortization, as contained in the Company's budget for the Applicable Period and which is approved by the Board (without reference to any adjustments or revision, upwards or downwards, to such projected earnings which are subsequently approved by the Board as part of any subsequent revision to such budget), and (ii) the term "Financial Results" shall mean the Company's EBITDA calculated by reference to the Company's financial statements for the Applicable Period as filed with the Securities and Exchange Commission (the "SEC").

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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.