Required Study definition

Required Study shall have the meaning assigned to such term in Section 4.1.
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Required Study has the meaning set forth in Section 4.4(e).
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Required Study means any study of the Product conducted prior to or after receipt of Regulatory Approval due to a request or requirement of a Regulatory Authority as a condition of receiving such Regulatory Approval. Required Study includes a study of the Product required to be conducted after obtaining Regulatory Approval on a conditional basis (such as post-marketing approval studies and observational studies if required as a condition of receiving such Regulatory Approval) and a study of the Product requested or required by a Regulatory Authority prior to and in order to obtain Regulatory Approval.
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Examples of Required Study in a sentence

  • Licensor shall, in a timely and responsive manner consistent with the requirements of applicable Regulatory Authorities, provide Licensee with any comments or questions concerning the Required Study.

  • Licensee shall have the right to proceed with the Required Study as outlined in the Required Study Notification and shall account for all internal and Third Party costs directly related to the performance of the Required Study, which costs shall be accounted for in accordance with Licensee’s accounting practices, standards and procedures (“Required Study Costs”).

  • Carcello, Chair, Investor as Owner Subcommittee, on behalf of Subcommittee members, of the SEC’s Investor Advisory Committee (November 22, 2016) (in response to FAST Act – SEC Required Study on Modernization and Simplification of Regulation S-K).

  • Notwithstanding anything in this Section 4.1 to the contrary, prior to making any decision to abandon or discontinue any of the Key Development Studies, any Replacement Study or any Replacement Indication Study (each a “Required Study”), or to change or modify any Required Study so as to effectively abandon same, Cubist shall have first provided its reasons in support of such decision to Chiron via the JCT and the JCT shall have met to discuss the merits of such decision.

  • Licensee shall pay for all Required Study Costs at the time necessary for completion of the Required Study.

  • At any time during the Term, if any Regulatory Authority requires additional clinical studies in connection with obtaining or maintaining Regulatory Approval for any Licensed Product in or for the Territory (each a “Required Study”), then Licensee shall notify Licensor of the need for and scope of such Required Study together with an estimated budget and timing for performing the Required Study (“Required Study Notification”).

  • Required Study Elements Scope of Service: Impact Fee Study Develop appropriate impact fee determination methodology and fee assessment schedules necessary for the City of Opa-locka to establish and defend its proposed impact fees.

  • In the event that [**] to undertake such Required Study, and Sepracor believes that the use of the results of any Required Study could be of material benefit to Sepracor in the Sepracor Territory, for example, if the Required Study were the development of a [**] of the Product, the Parties [**].

  • The final payment shall be contingent upon the following additional conditions: • All Required Study Subject visits have been completed • Idorsia has received all Study Subject Data in a form suitable for analysis inc- luding all source documentation required for event adjudication.

  • In the event that Sepracor believes that the use of the results of any Required Study could be of material benefit to Sepracor in the Sepracor Territory, for example, if the Required Study were the development of a [**] of the Product, the Parties shall [**], taking into account the costs of any assistance which may have been provided by Sepracor under this Section.


More Definitions of Required Study

Required Study means any study required as part of the minimum data package necessary for receipt of Marketing Approval in the relevant country. The Parties recognize that the application for Marketing Approval may include additional OUS Studies that are useful, but not required, and that any such additional study shall not be deemed a Required Study.
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Required Study means any studies, including any Clinical Trials and Other Studies, that are required to be conducted (including as a condition to maintain the applicable Regulatory Approval) pursuant to requirements imposed by a Regulatory Authority in the Territory with respect to the applicable indication for any Product in the Field.
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Related to Required Study

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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).

  • Study means the investigation to be conducted in accordance with the Protocol.

  • 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 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).

  • Mitigation Study Period means the duration of time extending six consecutive Capability Periods and beginning with the Starting Capability Period associated with a Class Year Study, Additional SDU Study, and/or Expedited Deliverability Study. For purposes of Section 23.4.5 of this Attachment H, “Mitigated UCAP” shall mean one or more megawatts of Unforced Capacity that are subject to Control by a Market Party that has been identified by the ISO as a Pivotal Supplier. For purposes of Section 23.4.5 of this Attachment H, “Mitigation Net CONE” shall mean the capacity price on the currently effective ICAP Demand Curve for the Mitigated Capacity Zone corresponding to the average amount of excess capacity above the Mitigated Capacity Zone Installed Capacity requirement, expressed as a percentage of that requirement, that formed the basis for the ICAP Demand Curve approved by the Commission.

  • 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 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.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study 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 clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • 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.

  • Clinical Trial means any human clinical trial of a Product.

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

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Independent study means a subject/program/activity that a person pursues autonomously that meets standards for approval criteria in the rules and includes a posttest.

  • 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.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.