Additional Indication Development Plan definition

Additional Indication Development Plan means the plan for development of Product for the prevention or treatment of one or more Additional Indication(s) for the Territory, as may be adopted and amended in accordance with this Agreement.
Sample 1

Examples of Additional Indication Development Plan in a sentence

  • Notwithstanding Section 4.2, Sucampo shall have the right to concur in the Development of the Product in an Additional Indication under the corresponding CPP Additional Indication Development Plan and Budget by delivery of written notice to CPP (“Concurrence Notice”).

  • Upon CPP’s receipt of the Concurrence Notice, (i) such Additional Indication shall automatically become a Sucampo-Approved Indication, and (ii) such CPP Additional Indication Development Plan and Budget shall automatically become a Sucampo-Approved Indication Development Plan and Budget.

  • Such additional development studies shall be conducted in accordance with an Additional Indication Development Plan prepared by BLS and presented to and discussed by the Collaboration Committee.

  • Budget, and (b) such Proposed Development Plan and Budget shall thereafter be a “CPP Additional Indication Development Plan and Budget”.

  • Each Additional Indication Development Plan shall set forth Development activities that are necessary or appropriate to obtain Regulatory Approval for Product for such Additional Indication in the Dyax Territory and the Defiante Territory, as well as allocation of such activities between the Parties, strategies and timelines for completing such activities, together with a reasonable forecast of the Development Costs and the annual budget for expenses related thereto.

  • If, after reviewing any such proposal and discussing it in good faith, the Parties agree to jointly Develop Product for such Additional Indication, then all further Development activities shall be carried out in accordance with an Additional Indication Development Plan referred to in Section 4.3(e) below.

  • Additional Indication Development Plan shall have the meaning given to that term under Section 4.3(e).

  • If the proposal submitted by the Proposing Party under Section 4.3(b) is accepted by the Non-Proposing Party or such Non-Proposing Party elects to exercise its opt-in rights under Section 4.3(d), then all further Development of Product in such Additional Indication shall be governed by a development plan jointly developed by Defiante and Dyax and approved by the JSC (each, an "Additional Indication Development Plan").

  • PROGRAM MANAGER Functional Responsibilities:a) Organizes, directs, and manages contract operation support functions, involving multiple, complex, and inter-related project tasks.(b) Manages teams of contract support personnel at multiple locations.(c) Maintains and manages the client interface at the senior levels of the client organization.(d) Meets with customer and contractor personnel to formulate andreview task plans and deliverable items.

Related to Additional Indication Development Plan

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

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

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

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

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

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

  • 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 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).

  • 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 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).

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • 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.

  • 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.

  • Development Program means the implementation of the development plan.

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

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

  • 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;

  • 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 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 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.

  • 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)).

  • 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 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).

  • 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.