Clinical Trials Program definition

Clinical Trials Program means the series of clinical trials to be conducted involving the administration to humans of therapy for RA utilizing the Product, comprising the Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials, Phase IV Clinical Trials and post-marketing trials.
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Clinical Trials Program shall have the meaning set forth in Section 3.02 hereof.
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Examples of Clinical Trials Program in a sentence

  • The Fresenius Parties shall provide such personnel and services with respect to each phase of the Clinical Trials Program as shall be appropriate for such phase and shall use all reasonable efforts to implement and complete the Clinical Trials Program as soon as reasonably practicable in light of applicable regulatory requirements.

  • The Company shall take Commercially Reasonable Efforts to include sites in the Russian Federation in its global Clinical Trials Program.

  • Fresenius GmbH shall continue the development and planning of the Clinical Trials Program for the portion of Non-U.S. Territory comprising the European Union, including the necessity, location, timing, scope and nature of the trials to be conducted.

  • Such clinical trials shall hereinafter be referred to as the "Clinical Trials Program".

  • To the extent practicable, the Clinical Trials Program for the Non-U.S. Territory shall be conducted in a manner that is compatible with the clinical trials conducted in the U.S. Territory by Licensor and to be conducted after the Effective Date therein by Licensee; subject, nevertheless, to the overriding necessity to conduct such trials in a manner that will produce results acceptable to Territorial Regulators.

  • Notwithstanding anything to the contrary contained in this Article V, the results obtained in the course of the Pre-Clinical Development Program or the Clinical Trials Program may be submitted for publication by Vergemont, but only following notice to and approval by NexMed in its sole discretion.

  • Promptly after the execution and delivery of this Agreement, Fresenius AG shall commence the development and planning of the Clinical Trials Program for the portion of Non-U.S. Territory comprising the European Union, including the necessity, location, timing, scope and nature of the trials to be conducted.

  • The Clinical Trials Program in the Non-U.S. Territory shall be conducted exclusively by Fresenius AG, subject to the information exchange provisions of Article 8.

  • Fresenius AG shall provide such personnel and such advisory and support services with respect to each phase of the Clinical Trials Program as shall be appropriate for such phase and shall use all reasonable efforts to implement and complete the Clinical Trials Program as soon as reasonably practicable in light of applicable regulatory requirements.

  • To the extent practicable, the Clinical Trials Program for the Non-U.S. Territory shall be conducted in a manner that is compatible with the clinical trials conducted and to be conducted in the U.S. Territory by Licensor; subject, nevertheless, to the overriding necessity to conduct such trials in a manner that will produce results acceptable to Territorial Regulators.

Related to Clinical Trials Program

  • 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.

  • 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 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 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.

  • 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 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.

  • 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 IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • 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.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Development Plans has the meaning set forth in Section 3.2.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • 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).

  • Development Program means the implementation of the development plan.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Development Activities means those activities which are normally undertaken for the development, construction, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Development Plan has the meaning set forth in Section 3.2.