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 no event shall any Product or Comparator Drugs or Placebos supplied for use in such Phase 3 Study, or a Post-Approval Study in the Development Indication, be used by or on behalf of Dermira for any purpose other than as contemplated by the Development Plan in relation to the Development of the Product in the Development Indication in the Development Territory.

  • If an award for damages and costs is made against UCB as a result of such action, claim or proceeding, to the extent that such damages and costs are attributable to the alleged infringement activities in the Promotion Territory in the Promotion Indication or the Development Indication, UCB shall be entitled to deduct an appropriate proportion of such damages and costs from Royalty Bearing Sales.

  • 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.

  • 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.

  • 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.

  • After such EMA Development Meeting, the JDT will review and amend, if appropriate, the Development Plan (including the 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.

  • 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 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.

  • 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 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 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, [***].