Proposed Studies definition

Proposed Studies means the list of clinical studies proposed to be undertaken by ARIAD US in the Territory and the Reserved Territory, the name, protocol synopses for which are as set forth in Appendix 1.138.
Sample 1Sample 2Sample 3

Examples of Proposed Studies in a sentence

  • ARIAD US may in its sole discretion commence and conduct the Proposed Studies and the provisions of Sections 5.6 or 5.7.2 shall not apply to the Proposed Studies but otherwise all provisions of this ARTICLE 5 shall apply as appropriate to a Proposed Study.

  • The Proposed Studies and, if a Party does not veto a clinical study under Sections 5.6 or 5.7.2, the clinical studies the subject of (ii), in each case once initiated, shall be listed in a Development register (“Development Register”) maintained by the JSC.

  • ARIAD US shall report the results of each of the Proposed Studies to ARIAD SWISSCO by sending a substantially complete draft of the CSR as soon as practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within six (6) months of database lock for the applicable study.

  • ARIAD US and ARIAD SWISSCO shall use good faith efforts to coordinate and liaise, through the JSC, concerning continued Development of the Product with respect to (i) Development being Global Studies, Ongoing Studies and Proposed Studies and (ii) each Party’s separate plans for Development in its respective territory.

  • A Clinical Development Plan also may include information with respect to Proposed Studies, provided that the Parties shall not be obligated to conduct any such Proposed Studies and references in this Agreement to the Clinical Development Plan shall not be deemed to include any such Proposed Studies.

  • As between the Parties, subject to Section 4.2 (Xencor Proposed Studies), Genentech shall have sole decision-making authority over all Development matters for Collaboration Products.

  • For purposes of clarity, the payments under this Section 5.7.4 shall apply to any of the Proposed Studies that are Global Studies.

  • Any (a) material modifications to the GDP approved at a JDC meeting shall constitute an amendment to the GDP, and (b) decisions by the JDC related to any Proposed Studies shall be made, in each case upon approval by both Parties of the meeting minutes related thereto.

  • Milestone payments from Mundipharma to Allos in respect of any of the solid tumor and hematology Indications listed in Exhibit A will be discussed and agreed between the Parties at the time any Proposed Studies in respect of such solid tumor and hematology Indications are discussed.

  • If the Parties are unable to agree on the milestones payments at the time any such Proposed Studies are discussed, Mundipharma shall not file applications for such Regulatory Approvals in respect of any of the solid tumor and hematology Indications listed in Exhibit A, until such agreement on milestone payments is reached.

Related to Proposed Studies

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

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

  • Proposed Project SCHEDULE: (edit schedule below as appropriate) Project Event Completion Date Pre-bid Meeting Questions Due Proposals Due Begin Work Programming Phase Permitting Phase Schematic Design Phase Design Development Phase Construction Documents Phase Bidding or Negotiation Phase Construction Administration 1-Year Warranty

  • 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 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 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 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 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.

  • 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.

  • Proposed Plan As defined in Section 3.17(a)(iii).

  • 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 3 Study means a clinical study of an investigational product in 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 investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents [***]

  • 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 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.

  • Proposed decision means the presiding officer’s recommended findings of fact, conclusions of law, decision, and order in a contested case in which the administrator did not preside.

  • 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 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Proposed Works means the sewage works described in the Owner's application, this Certificate and in the supporting documentation referred to herein, to the extent approved by this Certificate;

  • 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.

  • 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.

  • 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 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.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

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

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • 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.