GSK Development Compound definition

GSK Development Compound means any Collaboration Compound within a Program for which GSK exercises a GSK Program Option and with respect to which GSK, after such exercise, is conducting Development and/or Commercialization.
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GSK Development Compound means [***].
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GSK Development Compound means any Compound, including Back-up Compounds, within a Dynavax Program that has become a GSK Development Program upon GSK’s exercise of the Option.
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Examples of GSK Development Compound in a sentence

  • If GSK exercises the GSK Program Option with respect to such Candidate Selection Compound, GSK shall thereafter further Develop such Candidate Selection Compound as a GSK Development Compound, subject to the terms of this Agreement, including without limitation GSK’s obligations under Section 9.2 and GSK’s obligation to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

  • The royalties due under Section 6.5.1 or 6.5.2 with respect to a Product, even if reduced as provided in Section 6.5.3(b) or (c), shall commence upon the First Commercial Sale of such Product in a particular country in the Territory and will expire on a country-by-country basis upon the expiration in such country of the last to expire Valid Claim of an issued Patent Controlled by Anacor or Controlled jointly by GSK and Anacor [***] the GSK Development Compound included in such Product.

  • Promptly after GSK’s exercise of a GSK Program Option, OncoMed shall assign to GSK any Regulatory Filings for the relevant GSK Development Compound.

  • Subject to Article 6, however, all decisions with respect to the Development and Commercialization of any such GSK Development Compound shall be made at the sole discretion of GSK.

  • The milestones in Section 6.3.2(a) and 6.3.2(b) above assume that the Collaboration Compound, GSK Development Compound or Product that incorporates a GSK Development Compound has a [***].

  • In accordance with its obligations under Section 9.2, within [***] following the exercise by GSK of a GSK Program Option, for each GSK Development Compound, GSK will prepare and provide to the JSC for review and consideration pursuant to Section 2.2.1(k), a draft Development Plan for such GSK Development Compound.

  • If a Third Party asserts that a Patent or other right owned by it is infringed by the manufacture, use, sale or importation of any GSK Development Compound, GSK shall have the primary right but not the obligation to defend against any such assertions at its cost and expense.

  • Not later than [***] after the exercise by GSK of a GSK Program Option, GSK will prepare and provide to the JSC for review and consideration a draft global commercialization plan (to include, but not be limited to, the United States) with respect to the relevant GSK Development Compound (the “Global Commercialization Plan”).

  • Subject to Section 7.2.2, during [***] the Effective Date, GSK shall not, either alone or with or for any Third Party, research, optimize, develop, or commercialize (a) any Collaboration Compound from Project 2 that is not a GSK Development Compound or any product that incorporates such a Collaboration Compound, or (b) [***].

  • Upon exercise of a GSK Program Option, subject to Section 16.1, the relevant Candidate Selection Compound shall be designated as a GSK Development Compound, unless and until GSK terminates its Development and/or Commercialization activities with respect to such GSK Development Compound pursuant to Section 4.2.7 or this Agreement is terminated, whether in its entirety or with respect to such GSK Development Compound and such Program (alone or with other Programs).


More Definitions of GSK Development Compound

GSK Development Compound means any Compound, arising out of (i) the exclusively licensed Exon 51 Program, pursuant to Section 4 or (ii) a PROSENSA Collaboration Program that has become a GSK Development Program upon GSK’s exercise of the applicable Option.
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GSK Development Compound means a Candidate Selection Compound or Proof-of-Concept Compound that is selected by GSK for further development and commercialization by GSK and exclusively licensed to GSK pursuant to any one of the Options defined in Article 4 of this Agreement. A “GSK Development Compound” shall be **.
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Related to GSK Development Compound

  • 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 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.

  • 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”).

  • Licensed Compound means [***].

  • 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 Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • 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.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • 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).

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Exempt compound means the same as defined in Rule 2.

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

  • Development Program means the implementation of the development plan.

  • 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.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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.

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

  • 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.

  • 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).

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

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

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.