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.

  • GSK shall exclusively own all rights, title (“Rights”) in and to any invention, and interest in and to inventions (in any clinical specimens or samples obtained from the Subject), discoveries, know-how, patents (whether patentable or not), copyright, trade secrets and other intellectual rights, including but not limited to inventions, discoveries and technology relating to the Clinical Trial Product or otherwise generated by the Clinical Trial (collectively, “Inventions”).

  • Commencing ninety (90) days prior to the first order of Product from Baxter under this Agreement for commercial sale (excluding Clinical Trial Product) (the “Commencement Date for Annual Forecasts”), and prior to January 1 of each year thereafter, Accentia will provide to Baxter in writing an annual forecast for each calendar year during the remainder of the term of Accentia’s estimated requirements for each Product (the “Long Range Forecast”).

  • Client shall procure and maintain, from the Effective Date through the date that is one year after the expiration date of all Client Product Produced under this Agreement, Commercial General Liability Insurance, including without limitation, Clinical Trial Product Liability and Contractual Liability coverage (the “Client Insurance”).

  • In 1994, the Government of Uganda, through Uganda Wildlife Authority (UWA), and FACE Foundation started restoring forests as carbon offsets on formerly encroached areas (Fisher, Cavanagh, Sikor, & Mwayafu, 2018).

  • With respect to Clinical Trial Product, Baxter shall have no obligation to provide any amount of the Product in excess of the Clinical Trial Product Cap during the term of this Agreement.

  • Notwithstanding the foregoing, Parent shall have no obligation to develop the Clinical Trial Product in any indication other than paroxysmal nocturnal hemoglobinuria.

  • 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.

  • At a maximum dose of [REDACT] of the Licensed Compound, Lynx estimates that the cost per unit of Clinical Trial Product (including the Delivery Means) shall not be greater than [REDACT].

  • Parent agrees that its development and regulatory activities in connection with the Clinical Trial Product and Regulatory Approval Product will be carried out in compliance with all applicable Laws in all material respects.


More Definitions of Clinical Trial Product

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 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. „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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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 shall have the meaning ascribed to such term in Section 3.1(hh).
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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 any human clinical trial of a Product.

  • 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 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 the JDC 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 human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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 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 human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

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

  • 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 a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

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

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • 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;