Initial Indication Development Plan definition

Initial Indication Development Plan means the plan for conducting Development of the Product for the Initial Indication for use in the Licensed Territory, as described in Section 3.2.
Initial Indication Development Plan has the meaning set forth in Section 3.4.2.
Initial Indication Development Plan means the plan for development of Product for the prevention or treatment of the Initial Indication in the United States as agreed to by the Parties.

Examples of Initial Indication Development Plan in a sentence

  • The JSC will review, discuss and approve the Initial Indication Development Plan and any amendments thereto in accordance with Section 2.2.2.1.

  • Article 17Article 14 Repeal of Regulation (EEC) No 1836/93 Committee 1.

  • ChemoCentryx shall provide VFMCRP with a statement setting forth all Third Party costs incurred or accrued for activities under the First-Phase Initial Indication Development Plan and for activities under the Subsequent-Phase Initial Indication Development Plan within ninety (90) days after completion of all such activities under the applicable Development Plan.

  • Upon JSC approval, such plan shall become effective as the then-current Initial Indication Development Plan.

  • From time to time, either Party may submit to the JSC for discussion any proposed modifications to the Initial Indication Development Plan, and the JSC shall discuss such proposed modifications at its next meeting, and any such modification will become effective only upon approval by the JSC as provided in Section 2.2.

  • First-Phase Initial Indication Development Plan (as initially approved by the JSC) Payable within ten (10) Business Days after the Amendment Effective Date [***] Payable on December 31, 2018 [***] Payable on June 15, 2019 [***] *** Certain information on this page has been omitted and filed separately with the Commission.

  • If the budget in the First-Phase Initial Indication Development Plan or the budget in the Subsequent-Phase Initial Indication Development Plan is increased pursuant to Section 4.4(b), then ChemoCentryx may invoice VFMCRP for its share of such increase as determined under Section 4.4(a), and VFMCRP shall pay such invoice within thirty (30) days after receipt thereof.

  • Within ninety (90) days after the Effective Date, the Parties shall prepare a comprehensive development plan, consistent in all material respects with the Initial Indication Development Plan, describing the activities to be conducted by the Parties to Develop and seek Regulatory Approval for the Product for the Initial Indication in the Licensed Territory under this Agreement, which plan the Parties shall submit to the JSC for review and approval.

  • Kaken will use Commercially Reasonable Efforts to perform and complete all the Development activities specified in the Initial Indication Development Plan on the timeline specified in such Plan, as it may be adjusted from time-to-time by the JSC consistent with the terms of this Agreement.

Related to Initial Indication Development Plan

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

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

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

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

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • 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).

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • 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).

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • 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. [***]

  • Development Program means the implementation of the development plan.

  • 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 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.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Global Development Plan has the meaning set forth in Section 3.1.

  • 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 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 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 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 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.

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

  • Additional Indication means any indication other than the Initial Indication.

  • 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.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.