Gen 1 Product Development Plan definition

Gen 1 Product Development Plan means the written plan for the development of the Gen 1 Product attached in summary outline form as
Sample 1Sample 2
Gen 1 Product Development Plan means the written plan for the development of the Gen 1 Product attached in summary outline form as Exhibit A-1-1 to this Agreement, as the same may be amended from time to time in accordance with this Agreement.
Sample 1

Examples of Gen 1 Product Development Plan in a sentence

  • Such records shall fully and properly reflect all work done and results achieved in the performance of the Gen 1 Product Development Plan and the Gen 2 Product Development Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.

  • The Parties shall conduct joint research and develop the Gen 1 Product and the Gen 2 Product as provided in this Article 3 and in accordance with the Gen 1 Product Development Plan and the Gen 2 Product Development Plan.

  • Each Party shall maintain complete, current and accurate records of all work conducted by it under the Gen 1 Product Development Plan and the Gen 2 Product Development Plan and all data and other information resulting from such work.

  • Each Party shall provide reports to other Party on its activities under the Gen 1 Product Development Plan and the Gen 2 Product Development Plan at such times as reasonably requested by the other Party, at a level of detail reasonably sufficient to enable the other Party to determine the reporting Party’s progress against the tasks assigned to it under this Article 3.

  • Each Party shall use Commercially Reasonable Efforts to conduct the tasks assigned to such Party in the Gen 1 Product Development Plan and the Gen 2 Product Development Plan and to assist the other Party in the completion of the tasks assigned to the other Party in such plans.

  • In accordance with the Gen 1 Product Development Plan and the Gen 2 Product Development Plan, DexCom shall be responsible for assembling, submitting and maintaining Regulatory Materials for the Gen 1 Product in the United States; and, Xxxxxxx shall be responsible for assembling, submitting and maintaining Regulatory Materials for the Gen 1 Product outside the United States and the Gen 2 Product.

Related to Gen 1 Product Development Plan

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

  • 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 Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Development Program means the implementation of the development plan.

  • 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.

  • 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.

  • 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).

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

  • 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)).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

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

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

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

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • 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;

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • 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.

  • 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.

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

  • 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 I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

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

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.