Development Indication definition

Development Indication means (a) with respect to Development, the treatment of psoriasis in adults, and, if applicable, children, as required by the FDA, EMA or Health Canada or otherwise provided in the Development Plan; and (b) with respect to the Commercialisation activities, the treatment of psoriasis in adults, and, if applicable, children, as further defined in each of the FDA, Health Canada and EMA approved product labels, as applicable, after the grant of the applicable Regulatory Approval.
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Development Indication means the Licensed Indication, or such other indication(s) as may be agreed to in writing between the Parties.
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Development Indication means, for a Collaboration Product, the Diabetes ------------------------ Indication and the Obesity Indication to the extent that the Collaboration Product is, at the time of determination, being jointly Developed and/or Commercialized pursuant to Articles IV, V or VII for such indication.
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Examples of Development Indication in a sentence

  • In accordance with all Applicable Law, Dermira shall be solely responsible for the payment of all amounts due to CROs, Institutions and Investigators under CRO Agreements and Clinical Site Agreements entered into by Dermira for the performance of any Phase 3 Study, and any Post-Approval Study in the Development Indication.

  • Subject to Section 5.10(a), Dermira shall use Commercially Reasonable Efforts to engage such number of Investigators and Institutions in order to satisfy the patient enrolment anticipated by and set forth in the Development Plan or the Phase 3 Protocol, or the Post-Approval Study Protocol * Confidential Treatment Requested in order to undertake the Development of the Product in the Development Indication in the Development Territory in accordance with the timelines set out in the Development Plan.

  • After such EMA Development Meeting, the JDT will review and amend, if appropriate, the Development Plan (including the * Confidential Treatment Requested 50 JDC-Approved Development Budget therein) for the recommendation by the JDC to seek approval from the JSC to reflect any requirement from the EMA for the Regulatory Approval by the EMA for the Product in the Development Indication.

  • Subject to the terms and conditions of this Agreement, UCB (or its designee) shall supply, in a timely manner in quantities and timing as agreed by the JDT to satisfy the Development activities set forth in the Development Plan in the manner set forth in the Development Responsibility Matrix, with required quantities of the Product in final packaged form, and Comparator Drugs and Placebo, to be used in a Phase 3 Study, and any Post-Approval Study in the Development Indication.

  • To the extent the FDA requires a Paediatric Plan to be undertaken as a condition for the Regulatory Approval of the Product in the Development Indication, such Paediatric Plan shall be included within the Development Plan.

  • Dermira shall diligently, in good scientific manner and in accordance with prevailing industry practices concerning the conduct of Clinical Studies, GCP, ICH Guidelines and Applicable Law, attempt to identify, or cause to be identified, and to resolve expeditiously, inconsistencies and deficiencies in Product Data from any Phase 3 Study, or any Post-Approval Study in the Development Indication, conducted by or on behalf of Dermira.

  • No admission or communication made by either Party to any Regulatory Authority in the absence of the other Party shall include any false or misleading information relating to the Development of the Product in the Development Indication in the Development Territory, the Product or the other Party.

  • For the avoidance of doubt, UCB shall be responsible for all Medical Affairs activities for the Product in the Promotion Indication and, if applicable, the * Confidential Treatment Requested Development Indication, in each case in the Reserved Territory, which activities shall not be subject to the oversight of the JSC or the terms of this Agreement.

  • Upon UCB’s written request, Dermira shall provide, or cause to be provided, to the relevant UCB Contact a copy of all Study Documentation and such other Information necessary or useful for UCB’s preparation of Regulatory Documentation, and any supplemental application or variation generated by or on behalf of Dermira during the Development Term or during the duration of any Post-Approval Study in relation to the Development of the Product in the Development Indication in the Development Territory.

  • The JDT shall endeavour to resolve any operational issues that arise from the conduct of the Development of the Product in the Development Indication in the Development Territory in accordance with the Development Plan, the conduct of the Medical Affairs activities under the Medical Affairs Plan, and the provisions of this Agreement in a fair, efficient and expeditious manner, and shall refer any unresolved issues to the JDC for resolution.

Related to Development Indication

  • 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.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • 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.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • 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.

  • Development Program means the implementation of the development plan.

  • 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)).

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

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

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • 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 Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Development Phase means the period before a vehicle type is type approved.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Second Indication means [***].

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Licensed Territory means worldwide.

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

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

  • 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.