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, 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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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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Examples of Development Indication in a sentence

  • Dermira shall be responsible for all communications with the Investigators with respect to a Phase 3 Study, and any Post-Approval Study in relation to the Development of the Product in the Development Indication in the Development Territory.

  • 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.

  • During the Development Term, UCB shall communicate and interact with Regulatory Authorities in a manner that is consistent with such overall strategy, and shall consult with Dermira prior to any such communications and shall keep Dermira informed, through the JDT, of the progress, strategy and updates with respect to the regulatory activities for the Product in the Development Indication in the Development Territory.

  • All Medical Affairs activities for the Product for the Promotion Indication and, if applicable, the Development Indication in the Promotion Territory shall be coordinated through the JDT and subject to the oversight of the JDC.

  • In establishing business hours, PPM and PPM Physicians shall take into consideration the number and type of Members assigned to and/or receiving services at the office site.

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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 any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • 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 [***].

  • 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.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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 work of development to be performed on or with respect to the Land (including, without limitation, the installation of utilities, roads and all related on-site and off-site improvements) in connection with the development of the Land for the subsequent construction thereon of Homes, all of which work and construction shall be completed by or on behalf of the Borrower in accordance with the Plans and Specifications, but shall not include the Construction Improvements.

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

  • 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).