Clinical Trial Products definition

Clinical Trial Products means the formulations, and only such formulations as supplied by CTI, of Nitroglycerin Adhesive Mixture in such strengths as shall provide for delivery of * mg/hour to * mg/hour of GTN (glyceryl trinitrate) (and such other delivery strengths as the Parties may agree upon in writing) in patch form for transdermal administration to meet the Product Specifications.
Sample 1

Examples of Clinical Trial Products in a sentence

  • Clinical supplies of the Licensed Compound under Development shall be in the form of Clinical Trial Products.

  • At least [REDACT] prior to commencement of clinical trials of the Licensed Compounds in the Territory, Tanabe shall give Lynx a rolling [REDACT] forecast of its expected requirements for such Clinical Trial Products, including quantities, dosages and requested delivery dates.

  • Hercon shall provide CTI with such assistance as CTI shall reasonably request to obtain a right of reference to the Drug Master File of any third-party supplier of the Nitroglycerin Adhesive Mixture and other raw materials for the Clinical Trial Products designated from time to time by CTI.

  • Hercon will designate a primary project contact with respect to the Clinical Trial Products throughout the performance of the Processing of the Clinical Trial Products pursuant to this Section 2.1 to answer any reasonable questions from CTI.

  • All Clinical Trial Products shall be stored and packaged in accordance with the requirements of all applicable laws and the rules and regulations of the FDA or other regulatory authority promulgated thereunder.

  • Damian MRUGALSKI, “ Agnostos Theos: relacja między nieskończonością a niepoznawalnością Boga w doktrynach medio- platoników,” Roczniki Filozoficzne 67, no.

  • In addition, because the chemical composition and structure of steel slag is similar to cement, the heat required to convert a ton of steel slag to clinker is substantially lower than the heat required to convert a ton of raw materials to clinker.14 The costs associated with installing this process are primarily material handling equipment for the steel slag.

  • Hercon shall use its commercially reasonable efforts to replace each nonconforming shipment of Clinical Trial Products, or the nonconforming portion thereof, with conforming Clinical Trial Products as soon as reasonably practicable after receipt of notice of rejection thereof, and in any event shall do so within ninety (90) days after the receipt of replacement Nitroglycerin Adhesive Mixture which shall be ordered no later than thirty (30) days after receipt of notice of rejection thereof.

  • The net fair market value of nership,property is its fair market value (determined oning of section 1245 property that is placed in service in any tax year of the partnership or Sthe date the property is pledged) less any prior • Two S corporations if the same persons (or superior) claims to which it is subject.

  • In addition to its obligations pursuant to Sections 4.2 (d) and (e), Hercon will evaluate and inspect each batch of Clinical Trial Products in accordance with Packaging guidelines set forth in the Product Specifications and will provide CTI with a Clinical Trial Products lot release.

Related to Clinical Trial Products

  • 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.

  • 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.

  • 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.

  • 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.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

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

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

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

  • 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.

  • 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.

  • 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.

  • 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).

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • 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.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • 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.

  • 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.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • 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).