Permitted Clinical Applications definition

Permitted Clinical Applications means all clinical applications described and not expressly excluded in Schedule W-2 of the Distribution Agreement.
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Permitted Clinical Applications as defined in the third Whereas clause.
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Examples of Permitted Clinical Applications in a sentence

  • CryoLife shall exert commercially reasonable best efforts to introduce, promote, sell, and distribute the Products for Permitted Clinical Applications within the Territory.

  • In support of the appointment in Section 1.1, SMI hereby grants to CryoLife the exclusive license to market, offer for sale, sell, have sold, distribute, have distributed, import and have imported (collectively, “Distribute” or “Distribution”) the Products for Permitted Clinical Applications within the Territory.

  • Each New Application shall be included within the Permitted Clinical Applications at the Transfer Prices applicable to the Product subtype.

  • During the term of this Agreement and provided SMI timely fulfills CryoLife’s orders for Products, CryoLife will not manufacture or Distribute for Permitted Clinical Applications within the Territory any Competitive Product except for products currently manufactured or Distributed by CryoLife, new and successor products related to products currently manufactured or Distributed by Cryolife and new and successor products that incorporate CryoLife’s protein hydrogel technology with any powdered product.

  • CryoLife will restrict its promotion and marketing of Products to activities reasonably calculated to sell the Products for Permitted Clinical Applications within the Territory and will not sell or distribute Products outside the Territory or sell or distribute Products knowingly to persons for the purpose of sale or distribution outside the Territory.

  • SMI agrees to promptly direct and cause all Other Parties to direct all sales inquiries respecting the Product for Permitted Clinical Applications within the Territory to CryoLife during the Term of this Agreement.

  • For the avoidance of doubt, nothing in this Section 1.3 shall be deemed to limit or prohibit any Party’s right to seek or obtain Regulatory Approval for the Permitted Clinical Applications in the Territory.

  • SMI represents and warrants that it has delivered to CryoLife the most current and complete copies of each and every agreement any of the Existing Distributors has respecting the Products or the right to Distribute any Products for Permitted Clinical Applications within the Territory.

  • SMI hereby appoints CryoLife as the exclusive distributor of the Products for Permitted Clinical Applications within the Territory.

  • Each Party agrees to notify the other Party in writing as and when it develops or obtains Regulatory Approval in the Territory for clinical applications for the Products that are not included within the Permitted Clinical Applications (each a “New Application,” collectively the “New Applications”).

Related to Permitted Clinical Applications

  • 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:

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • 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.

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

  • 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.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Phase 1 Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of Licensed Product or that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country in the Territory other than the United States.

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Drug Approval Application means an application for Regulatory Approval of a Licensed Product as a pharmaceutical product in a country in the Territory.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Marketing Authorization Application or “MAA” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.

  • Commercial applicator means any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.