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

  • UCB shall provide Dermira with drafts of material Regulatory Documentation and material correspondence with the Regulatory Authorities with respect to the Development Indication and/or the Promotion Indication for Dermira’s review and comment.

  • 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.

  • Meetings of the JDC shall take place during the Development Term until at least the date on which Regulatory Approval for the Product in the Development Indication has been granted by the FDA.

  • In all other cases, UCB shall have the right to deduct costs of Recall from the Gross Margin calculation to the extent such Recall results from the Development of the Product in the Development Indication, or the Dermira Commercial Activities for the Product in the Promotion Indication or the Development Indication.

  • UCB acknowledges that Institutions may require Dermira to include in Clinical Site Agreements representations and warranties regarding Product and/or Product Placebo supplied to Institutions or Investigators for use in a Phase 3 Study, or any Post-Approval Study in the Development Indication, and will require Dermira to include in such Clinical Site Agreements standard indemnities regarding the Product and/or Product Placebo.

  • Carrying out Post-Approval Studies (if any) for the Product in the Promotion Territory for the Promotion Indication and in the Reserved Territory for the Promotion Indication and the Development Indication.

  • In addition, UCB shall, to the extent practicable, provide Dermira with advance notification of any and all meetings with the FDA, EMA and Health Canada with respect to the Development Indication and/or the Promotion Indication, and allow Dermira to participate in such meetings as agreed by the JDC prior to such meetings.

  • 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.

  • UCB shall bear all costs of Recall to the extent such Recall results from the non-conformity of the Product to the Product Warranty or from UCB’s activities with respect to the Product outside the Development of the Product in the Development Indication or the Commercialisation of the Product by UCB in the Promotion Indication or the Development Indication.

  • Dermira (or the applicable CRO acting on Dermira’s behalf) shall monitor each Institution and any other site at which a Phase 3 Study, or any Post-Approval Study in relation to the Development of the Product in the Development Indication in the Development Territory is performed and collect Product Data therefrom, including CRFs, in compliance with Applicable Law, the Safety Agreement, and the applicable CRO Agreement.

Related to Development Indication

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • 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.

  • 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 any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • 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, repair, renovation, 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: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Second Indication means [***].

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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 any work carried out in relation to the physical construction of a mine;

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.