Subsequent Clinical Milestone - HEADWAY-DLB definition

Subsequent Clinical Milestone - HEADWAY-DLB means the HEADWAY-DLB study (as described in clinical study protocol RVT-101- 2001) has achieved statistically significant results on both co-primary endpoints and either (x) Borrower’s first patient has been dosed in a subsequent FDA-compliant Phase 3 clinical trial of intepirdine for the treatment of Dementia with Lewy bodies or (y) the filing of a New Drug Application with the FDA for intepirdine for the treatment of dementia with Lewy bodies, in each case subject to verification by Agent in its reasonable discretion (including supporting documentation requested by Agent).
Sample 1
Subsequent Clinical Milestone - HEADWAY-DLB means the HEADWAY-DLB study (as described in clinical study protocol RVT-101-2001) has achieved statistically significant results on both co-primary endpoints and either (x) Borrower’s first patient has been dosed in a subsequent FDA-compliant Phase 3 clinical trial of intepirdine for the treatment of Dementia with Lewy bodies or (y) the filing of a New Drug Application with the FDA for intepirdine for the treatment of dementia with Lewy bodies, in each case subject to verification by Agent in its reasonable discretion (including supporting documentation requested by Agent).
Sample 1

Related to Subsequent Clinical Milestone - HEADWAY-DLB

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

  • 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).

  • 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 Event has the meaning set forth in Section 8.4.

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

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

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

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

  • Sales Milestone Payment is defined in Section 5.3.

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

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

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

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

  • 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 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 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.

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

  • 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).

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

  • 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.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.