Marketing Trials definition

Marketing Trials shall have the meaning assigned to such term in the Financial Appendix.
Marketing Trials means all Phase IV studies other than those necessary to maintain the first Registration of a Product and other similar activities.
Marketing Trials means collectively the marketing trials under the Marketing Trials Plan or any additional marketing trials regarding the Product done by Distributor.

Examples of Marketing Trials in a sentence

  • Reserves actually recovered, and the timing of the production of those reserves, may differ substantially from original estimates.

  • Social Security Are you eligible for benefits based on your former spouse’s work history?22 Widow(er) Facts Widows and widowers are entitled to100 percent of the higher earner’s retirement benefit if the decedent spouse had reached full retirement age before death.

  • Distributor and Osiris shall share equally in the Marketing Trials Costs in accordance with the budget included in the Marketing Trials Plan.

  • CAPACITY BUILDING IN REGIONAL CENTRES OF REGULATORY EXCELLENCE (RCORES) AND OTHER TRAINING INSTITUTIONStherefore, phases I to III of a clinical trial could be combined for implementation and the course of the trial will seamlessly transition from one phase to the next Post Marketing Trials (Phase IV)• Phase IV studies relate to the stage after a drug has been approved and involves the long-term monitoring of the safety of the drug.

  • For the avoidance of doubt, SkyePharma shall not be required to pay the costs of any Marketing Trials.

  • WHEREAS, Operator has extensive experience in providing operation and maintenance services for the other projects and has agreed to provide those services for the Project on the terms and conditions set forth in this Agreement, NOW this Agreement witnesseth as follows: 1.

  • Therefore, Horton is inapplicable here where the Bureau did not use first class mail.

  • During the performance of the Marketing Trials, Distributor shall promptly notify Osiris if any Marketing Trial reveals any unexpected result.

  • In the event Distributor performs additional Marketing Trials with respect to the Product, Osiris shall have the right to co-sponsor any such Marketing Trial for fifty percent (50%) of the reasonable costs associated with such Marketing Trial.

  • This report presents the final results obtained by the CRIAA SA-DC team of consultants (Roger Gamond, Saskia den Adel and Michel Mallet) in implementing Phase-2 of the Indigenous Green Leafy Vegetable (IGLV) Processing and Marketing Trials.

Related to Marketing Trials

  • 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.

  • 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.

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

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

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • 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.

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

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

  • 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;

  • 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;

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Licensed Territory means worldwide.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • 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.

  • 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 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 Program means the implementation of the development plan.

  • 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.

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

  • 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.