Clinical Trial Milestone definition

Clinical Trial Milestone means, and will be deemed to occur upon, the earlier of (a) first dosing of the first patient with the Clinical Trial Product in the first Phase III Clinical Trial, (b) the Conversion Date for the first Converted Trial of the Clinical Trial Product (and, for clarity, the first dosing of the first patient in an Adaptive Trial prior to the Conversion Date shall not constitute dosing of a first patient in a Phase III Clinical Trial), and (c) the first submission of a new drug application to market and sell the Clinical Trial Product in the United States.
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Clinical Trial Milestone means Borrower’s achievement of both of the following milestones, concerning Borrower’s Phase 2b epilepsy trial, on or before June 30, 2014:
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Clinical Trial Milestone means Borrower’s achievement, on or before December 31, 2015, of 80% enrollment of Borrower’s ongoing Phase 3 trial for focal onset epilepsy.
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Examples of Clinical Trial Milestone in a sentence

  • Notwithstanding the foregoing, in no event shall Parent be required to pay the Clinical Trial Milestone Payment more than once, and Parent shall not be required to pay the Clinical Trial Milestone Payment if the Clinical Trial Milestone occurs after the expiration of the Clinical Trial Milestone Period.

  • The Rights Agent shall hold the Aggregate Clinical Trial Milestone Payment in a non-interest bearing account until such payment is made in accordance with the foregoing sentence.

  • In its First Cause of Action, Plaintiff claims that Shire breached its obligation to make the Initiation of Phase III Clinical Trial Milestone payment under Sections 258 Id. ¶ 81.259 Dkts.

  • Borrower may request Term Loans B at any time after the achievement of the Clinical Trial Milestone but on or before the Availability End Date.

  • The first five Milestone Events above (the “Clinical Trial Milestones”) are intended to be successive; if any of the Clinical Trial Milestones is reached without achieving a preceding Clinical Trial Milestone, then the amount which would have been payable on achievement of the preceding Clinical Trial Milestone shall be payable upon achievement of the next successive Clinical Trial Milestone.

  • In the latter scenario—which is the scenario here—Section 2.9(b) has no application, and Shire would be required to pay the full amount of the Initiation of Phase III Clinical Trial Milestone payment.

  • Thus, even if it were to somehow conflict with Section 2.9(b)—it does not— Section 2.9(f) would prevail.Circumstance,” Shire must make the $45 million Initiation of Phase III Clinical Trial Milestone payment pursuant to Section 2.9(a) of the Merger Agreement.Plaintiff is also entitled to interest on the First Milestone Payment calculated in accordance with Section 2.9(a) of the Merger Agreement.

  • Section 2.9(f) then provides that if the Phase III trials have not been initiated “on or before December 31, 2015,” other than as a result of a Fundamental Circumstance, the “Initiation of Phase III Clinical Trial Milestone shall be deemed to have been achieved on such date.” A492.

  • Borrower may request Term Loans D at any time after the achievement of the Clinical Trial Milestone but on or before the Term Loan D Availability End Date.

  • Thus, the Milestone Trigger Event5 for the Initiation of Phase III Clinical Trial Milestone for $45 million was deemed to have occurred on December 31, 2015 pursuant to Section 2.9(f), unless Shire's failure to initiate a Phase III trial by that date was “as a result of a Fundamental Circumstance,” which Section 1.1 defines as “the existence of material safety or efficacy concerns related to [deferitazole ] .


More Definitions of Clinical Trial Milestone

Clinical Trial Milestone means the publication by the Company of top-line results from the EVOGUARD clinical trial.
Sample 1
Clinical Trial Milestone means, with respect to any of the Company’s products, compounds or solutions, the first human dosing in a phase II clinical trial approved by the U.S. Food and Drug Administration or an analogous human clinical trial in
Sample 1

Related to Clinical Trial Milestone

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

  • 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.

  • 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 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 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 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

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

  • 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.

  • 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).

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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 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. [***]

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

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

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

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

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

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

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

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