VERTEX Development Activities definition

VERTEX Development Activities means all non-clinical and clinical activities performed by or on behalf of VERTEX or a VERTEX Licensee in the VERTEX Territory with respect to Bulk Drug Substance, a Compound, and/or Drug Product, including non-clinical studies, clinical trials, formulation research, formulation development, process research, process development, manufacturing scale-up, analytical method development and validation, and regulatory activities, in order to obtain Regulatory Approval from a Regulatory Authority for marketing the corresponding Drug Product in the VERTEX Territory for the Indications selected. For the avoidance of doubt, the Core Development Activities set forth in Section 1.11 shall be included in the VERTEX Development Activities.
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VERTEX Development Activities means all non-clinical and clinical activities performed by or on behalf of VERTEX or a VERTEX Licensee in the VERTEX Territory with respect to Bulk Drug Substance, a Compound, and/or Drug Product, including non-clinical studies, clinical trials, formulation research, formulation development, process research, process development, manufacturing scale-up, analytical method development and validation, and regulatory activities, in order to obtain Regulatory Approval from a Regulatory Authority for marketing the corresponding Drug Product in the VERTEX
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Examples of VERTEX Development Activities in a sentence

  • MITSUBISHI and VERTEX shall prepare and maintain, or have prepared and maintained, complete and accurate written records, data and information with respect to all clinical trials performed in the conduct of the MITSUBISHI Development Activities and the VERTEX Development Activities, respectively, as required by all applicable national, state, regional and local laws, guidelines, rules and regulations.

  • MITSUBISHI and VERTEX shall prepare and maintain, or have prepared and maintained, complete and accurate written records, accounts, notes, reports and data with respect to all laboratory work conducted in the performance of the MITSUBISHI Development Activities and the VERTEX Development Activities, respectively.

  • The VERTEX Development Plan will be updated by VERTEX annually thereafter to describe the VERTEX Development Activities (other than Core Development Activities) that VERTEX then intends will be conducted during the subsequent year and the remainder of the development period.

  • VERTEX shall enter into customary agreements with its agents and VERTEX Licensees that provide that all of such agents’ or VERTEX Licensees’ right, title and interest in, to and under any intellectual property invented, discovered or developed by such agents or VERTEX Licensees in the performance of the VERTEX Development Activities shall be assigned or licensed to VERTEX.

  • MITSUBISHI and VERTEX agree to perform the MITSUBISHI Development Activities and the VERTEX Development Activities, respectively, in accordance with the terms and conditions of this Agreement and in conformity with generally accepted standards of good laboratory practices and good clinical practices and with all applicable national, state, regional and local laws, guidelines, rules and regulations.

  • All employees of VERTEX who are expected to perform the VERTEX Development Activities have signed, or before any such performance will sign, agreements with VERTEX regarding proprietary information and inventions in a form reasonably considered by VERTEX and its counsel to assure VERTEX’s Control of any intellectual property invented, discovered or developed by such employees.

  • VERTEX shall provide to MITSUBISHI all relevant preclinical and non-clinical data, assays and associated materials, protocols, methods, processes, techniques, commercial assessments of potential Indications, and any other relevant information or materials with respect to a Compound, that are Controlled by and in the possession of VERTEX or its Affiliates and produced in the performance of the VERTEX Development Activities before and during the term of this Agreement.

  • VERTEX shall enter into customary agreements with the VERTEX Licensees that provide that the VERTEX Licensees shall supply VERTEX with relevant materials, data and regulatory information related to or generated in connection with any clinical trials of a Compound conducted, sponsored or funded by such VERTEX Licensees pursuant to the performance of the VERTEX Development Activities.

  • As soon as practicable after the Effective Date, VERTEX will prepare a development plan for the conduct of the VERTEX Development Activities in the VERTEX Territory, other than the Core Development Activities (the “VERTEX Development Plan”), and will provide a copy of such Plan to the JDC.

  • All employees of VERTEX who are expected to perform the VERTEX Development Activities have signed, or before any such performance will sign, agreements with VERTEX regarding proprietary information and inventions in a form reasonably considered by VERTEX and its counsel toassure VERTEX's Control of any intellectual property invented, discovered or developed by such employees.

Related to VERTEX Development Activities

  • 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.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Development Program means the implementation of the development plan.

  • 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.

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

  • Development Works means the external development works and internal development works on immovable property;

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

  • Research Program has the meaning set forth in Section 2.1.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • licensed activities means things authorised to be done by the licence

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

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

  • 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.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Project Activities means the activities to be undertaken or Works to be delivered or Property to be contributed or provided by you, your approved Sub-Grantees or your approved sub- contractors as summarised in the Particulars and more particularly described in the Agreed Proposal for which Xxxxx is payable under this Agreement;

  • 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)).

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Research Program Term has the meaning set forth in Section 2.2.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.