Initiation of Phase III Clinical Trial definition

Initiation of Phase III Clinical Trial means the administration of the respective Licensed Product to the first patient in such Phase.
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Initiation of Phase III Clinical Trial means the first administration of an Aminoglycoside Product to the first patient in a human clinical trial of such Aminoglycoside Product which is designed to be of a size and statistical power to support an NDA filing alone or in combination with other similar studies. If it is unclear whether or not a particular study will be sufficient to support an NDA filing (other than by virtue of the uncertainty of safety and efficacy data from that trial) the clinical trial will be deemed to be a Phase III Clinical Trial upon the initiation of activities to prepare an N DA filing for such Aminoglycoside Product.
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Initiation of Phase III Clinical Trial means the date of First Dosing in a Phase III Clinical Trial.
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Examples of Initiation of Phase III Clinical Trial in a 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.

  • 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.

  • In particular, Section 2.9 of the Merger Agreement provided for five milestone payments with respect to deferitazole: (1) a $45 million Initiation of Phase III Clinical Trial Milestone4; (2) a $50 million US Approval Milestone; (3) a $30 million EU Approval Milestone; (4) a $50 million First Net Sales Milestone; and (5) a $50 million Second Net Sales Milestone.

  • The Parties agree further that, in the event that, for a particular non-Section 5.2 Product, the "Initiation of Phase III Clinical Trial" milestone is achieved prior to the achievement of the "Initiation of Phase IIb Clinical Trial" milestone for the same Product, then at such time as the "Initiation of Phase III Clinical Trial" milestone is achieved, the milestone payments for both milestones shall become payable.

  • Section 2.9(f) provides: Notwithstanding anything else in this Agreement to the contrary, in the event that [Shire] has not achieved the Initiation of the Phase III Clinical Trial Milestone on or before December 31, 2015, other than as a result of a Fundamental Circumstance, then the Initiation of Phase III Clinical Trial Milestone shall be deemed to have been achieved on such 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 ] .

  • Initiation of Phase III Clinical Trial Six months after an end of Phase II meeting with FDA, provided, however, that if the FDA recommends in writing that additional non-clinical studies be performed prior to the initiation of the Phase III Clinical Trial, such target date shall be extended by the amount of the time needed to complete such non-clinical studies plus an additional two (2) months.

Related to Initiation of Phase III Clinical Trial

  • 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 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 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 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.

  • 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 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 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 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 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.

  • 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 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).

  • 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.

  • 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).

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • 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 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 III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • 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.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

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

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

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

  • 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).

  • Pivotal Trial means a controlled pivotal clinical trial of Licensed Technology that is prospectively designed to demonstrate statistically whether such Licensed Technology is effective and safe for use in a particular indication in a manner sufficient to obtain regulatory approval to market such product in the United States, European Union, or other foreign jurisdiction.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.