Clinical Trial Product definition

Clinical Trial Product means any pharmaceutical product, including all forms, presentations, doses and formulations, containing the Company’s compound, ACH-5228 or any salt, free-base, hydrate, solvate, polymorph, isomer, enantiomer, metabolite, prodrug or other derivative thereof, whether as the sole active ingredient or in combination with other active ingredients.
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Clinical Trial Product means the Product as used in the Clinical Trial.
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Clinical Trial Product means the product material as defined in the Protocol”]
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Examples of Clinical Trial Product in a sentence

  • The Institution/Principal Investigator shall administer the Clinical Trial Product only to Subjects from whom Informed Consent has been properly obtained by the Principal Investigator under Clause 4.1(g) and this Clause 6.

  • Final Payment: The final payment, which corresponds to the remaining 10% of costs, shall be made upon completion of the close-out visit and upon receipt of (i) all completed and corrected case report forms and queries, of (ii) all Clinical Trial documentation, of (iii) all unused Clinical Trial Product has been accounted for and (iv) all Clinical Trial equipment and supplies returned as specified by PPD and Sponsor.

  • Neither INSTITUTION nor INVESTIGATOR shall permit the Clinical Trial Product to be used for any purpose other than the conduct of the Clinical Trial and upon termination or expiration of this Agreement all unused Clinical Trial Product shall, at Sponsor’s option and expense, either be returned to Sponsor or disposed of in accordance with the Protocol or Sponsor’s instructions.

  • ERGOMED or Sponsor shall provide INSTITUTION with the required quantities of the Clinical Trial Product, at no charge, for the INSTITUTION to conduct the Clinical Trial.

  • Sponsor is and shall at all times remain the sole owner of the Clinical Trial Product.


More Definitions of Clinical Trial Product

Clinical Trial Product means Product purchased by Accentia hereunder for the limited purpose of conducting pre-clinical studies (consistent with applicable industry standards) and/or clinical trials for the purpose of securing a regulatory registration with the FDA, EMEA and/or other governmental authorities of similar scope and authority in the Clinical Field.
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Clinical Trial Product means a product, appropriate for use in clinical trials, containing a Licensed Compound or placebo (as applicable) in the formulation as determined by Tanabe but subject to reasonable prior approval by Lynx, for use in the clinical trials in the Field in the Territory, and including, if so elected by Tanabe at its reasonable discretion after good faith consultation with Lynx, such diluents and Delivery Means appropriate for such Licensed Compound for use in the Field as determined by Tanabe but subject to prior approval by Lynx, which approval shall not be unreasonably withheld, and provided further that such diluents and Delivery Means are available from Lynx.
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Clinical Trial Product shall have the meaning ascribed to such term in Section 3.1(hh).
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Clinical Trial Product means a product, appropriate for use in clinical trials, consisting of a Coronary Product or a Coronary Product wherein the Drug Substance has been replaced with a placebo, for use in clinical trials in the Field in the Territory. Unless changed by agreement of the Parties or by the FDA (or its equivalent in a country in the Territory), the Clinical Trial Product will be as described in Protocol 9501 dated March 5, 1996. [ * ] Confidential Treatment Requested.
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Clinical Trial Product. „Klinicky hodnocený přípravek“ with any conditions set by the IRB/EC; and (ii) in writing by ERGOMED or by the Sponsor. s platnými Předpisy a s veškerými podmínkami stanovenými IRB/EC; a (ii) písemně společností ERGOMED nebo Zadavatelem. The Informed Consent Form shall, among other things, document that each Clinical Trial Subject has consented to participate in the Clinical Trial after the Clinical Trial Subject has been duly informed, by a doctor, about the character, importance and scope of the Clinical Trial and by which the Clinical Trial Subject declares that he/she agrees to the collection of health data in the course of the Clinical Trial and to the examination of this data by the principals of the Sponsor or the competent authorities. Formulář informovaného souhlasu musí mimo jiné dokládat, že každý Subjekt Klinického hodnocení souhlasil s účastí v Klinickém hodnocení poté, co byl řádně informován lékařem o povaze, důležitosti a rozsahu Klinického hodnocení, a na základě nějž Subjekt Klinického hodnocení prohlašuje, že souhlasí se shromažďováním zdravotních údajů v průběhu Klinického hodnocení a s posouzením těchto údajů zástupci Zadavatele nebo příslušných orgánů. Any proposed modifications to any Informed Consent Form must be approved by both the IRB/EC and ERGOMED or the Sponsor before being used for the Clinical Trial. INSTITUTION/INVESTIGATOR shall ensure that all original signed consent forms are retained by the INVESTIGATOR and are available for the inspection by Sponsor, ERGOMED, their representatives and any agency or their designee. Všechny navrhované změny příslušného Formuláře informovaného souhlasu musí být schváleny IRB/EC a společností ERGOMED nebo Zadavatelem před použitím pro Klinické hodnocení. ÚSTAV / ŘEŠITEL zajistí, že všechny originální podepsané Formuláře souhlasů uschová ŘEŠITEL a budou k dispozici pro kontrolu ze strany Zadavatele, společnosti ERGOMED, jejich zástupců a jakéhokoli orgánu nebo jimi pověřených osob.
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Related to Clinical Trial Product

  • 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 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.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • 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 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 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.

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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.

  • 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.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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 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.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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.

  • 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.

  • 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).

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

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

  • 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.

  • 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:

  • 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.

  • 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;

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.