Commercial Launch Plan definition

Commercial Launch Plan means any good faith projections as to Harrow’s intended launch plan for Product in each country of the Territory, provided by Harrow to Sintetica in a timely manner with the purpose of facilitating Sintetica’s supply of launch quantities of Product as set forth in this Agreement, including any projected approval dates, forecasting of quantities required and timing for the supply of such quantities and other information useful for such purpose, and, including, in particular, all dates, quantities and other information to be provided by Harrow concerning Product launch, whether in forecasts, the Launch Order, or otherwise, pursuant to Sections 6.5 and 6.6(b), as may be amended from time to time, provided, however, that such amendments do not reduce the terms currently set forth in connection with forecasting and Launch Order leadtime in 6.5 and 6.6.
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Commercial Launch Plan means the plan for launching and initial marketing and promotion of the Product in the Territory as provided in Section 8.3.
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Commercial Launch Plan means the plan providing the estimated timeline for the registration of the Product (in countries in the Territory where the Product is not yet registered) and for the First Commercial Sale Date by Cardiome of the Product, the template for which is set out in Schedule 4.
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Examples of Commercial Launch Plan in a sentence

  • Cardiome shall undertake such activities pursuant to the regulatory timelines and plans included in the Commercial Launch Plan and in the Commercialization Plans.

  • Commercial Launch Plan (for each Licensed Product): The initial Licensed Product shall be positioned for regulatory market approval and launch in peripheral artery disease (PAD).

  • Cardiome will provide Basilea with the country-specific Commercialization Plans for the Product to Basilea for its review and comment within one (1) month of the Effective Date, including the information listed in Schedule 1 and shall provide the Commercial Launch Plan in the format provided in the template set forth in Schedule 4.

  • The JSC will facilitate communications between the Parties with respect to the obligations and responsibilities set out in this Agreement, including but not limited to reviewing, sharing and discussing the implementation of the Commercial Launch Plan, the Commercialization Plan, as well as commercialization strategies, such as brand strategies and Product positioning and life cycle management, and any other topics the Parties consider useful for the optimisation of this Agreement.

  • Basilea will discuss with Cardiome through the JSC the outcome of the Phase 3 program and its plan to update the core harmonized Dossier for the Product as soon as reasonably possible upon completion of the studies, and Cardiome shall thereafter update the Commercial Launch Plan and/or the Commercialization Plan.

  • For any countries in the Core European Territory in which the Product is not yet registered, Cardiome shall notify Basilea of its intent to register the Product in such countries in line with the Commercial Launch Plan.


More Definitions of Commercial Launch Plan

Commercial Launch Plan means the plan for launching and initial
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Related to Commercial Launch Plan

  • Commercial Launch means on a country-by-country basis, the first sale of a Product to a Third Party following Regulatory Approval of the Product in such country.

  • Launch means the intentional ignition of the first-stage motor(s) of the Launch Vehicle intended to place or try to place a Launch Vehicle (which may or may not include any Transfer Vehicle, Payload or crew) from Earth:

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

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

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

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

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • 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.

  • Commercial Sale means for a given product and country the sale for value of that product by a Party (or, as the case may be, by an Affiliate or permitted sublicensee of a Party), to a Third Party after regulatory approval (if necessary) has been obtained for such product in such country.

  • 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.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • 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.

  • System Impact Study means an assessment by the Transmission Provider of (i) the adequacy of the Transmission System to accommodate a Completed Application, an Interconnection Request or an Upgrade Request, (ii) whether any additional costs may be incurred in order to provide such transmission service or to accommodate an Interconnection Request, and (iii) with respect to an Interconnection Request, an estimated date that an Interconnection Customer’s Customer Facility can be interconnected with the Transmission System and an estimate of the Interconnection Customer’s cost responsibility for the interconnection; and (iv) with respect to an Upgrade Request, the estimated cost of the requested system upgrades or expansion, or of the cost of the system upgrades or expansion, necessary to provide the requested incremental rights. System Protection Facilities: “System Protection Facilities” shall refer to the equipment required to protect (i) the Transmission System, other delivery systems and/or other generating systems connected to the Transmission System from faults or other electrical disturbance occurring at or on the Customer Facility, and (ii) the Customer Facility from faults or other electrical system disturbance occurring on the Transmission System or on other delivery systems and/or other generating systems to which the Transmission System is directly or indirectly connected. System Protection Facilities shall include such protective and regulating devices as are identified in the Applicable Technical Requirements and Standards or that are required by Applicable Laws and Regulations or other Applicable Standards, or as are otherwise necessary to protect personnel and equipment and to minimize deleterious effects to the Transmission System arising from the Customer Facility. Transmission Facilities:

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Commercial Product means any such product as defined in FAR 2.101.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • 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.

  • Development Program means the implementation of the development plan.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Commercial Item means a commercial item as defined in FAR 2.101.

  • 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).

  • 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.