Combination Trial definition

Combination Trial means a Clinical Study that is designed to provide safety, dose ranging, dose selection or efficacy data for a Combination.
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Combination Trial means a Clinical Trial of the Licensed Product [***].
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Combination Trial has the meaning set forth in Schedule 1.
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Examples of Combination Trial in a sentence

  • At BMS’s request, Five Prime’s shall continue to obtain supply of FPA008 for the Current Combination Trial or the Current Five Prime Non-I-O Studies after the Effective Date from CMOs engaged by Five Prime prior to the Effective Date pursuant to agreements, statements of work or scopes of work entered into prior to the Effective Date.

  • Continuous supply and non-supply Idenix will supply IDX HCV Product to Novartis for the relevant HCV Combination Trial pursuant to Novartis’ firm orders.

  • The initial draft Development Plan (including for the Current Combination Trial) as of the Execution Date is attached to this Agreement as Exhibit E.

  • The Borrower shall not (a) become a Blocked Person or (b) have any investments in or engage in any dealings or transactions with any Blocked Person if such investments, dealings or transactions would cause any Lender to be in violation of any laws or regulations that are applicable to such Lender.

  • Whereas, Rxxxxx Xxxxxxx, M.D., an employee of Institution, (“Principal Investigator”) is the Principal Investigator for a clinical research study (“the Study”) entitled “A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Scleroses” (“the Protocol”), and has received funding for the Study from the National Institutes of Health (“NIH”) and the National Multiple Sclerosis Society (“NMSS”).

  • Except as otherwise expressly provided herein or in the Combination Trial Agreement, all inventions and discoveries invented, conceived or developed by or on behalf of a Party or its Affiliates, whether alone or with the other Party or a Third Party, in conducting activities pursuant to this Agreement shall be owned by ImmunoGen.

  • CytoDyn Announces Positive Results from Completed Pivotal PRO 140 HIV Combination Trial [Internet].

  • In the event that Five Prime does not meet the deadlines in Section 4.3(b)(i)(A) or 4.3(b)(i)(B), after taking into account any tolling described above, BMS may upon notice to Five Prime, assume operational control of the Current Combination Trial.

  • RP2D + PembroCohort 1CompleteCohort 2Cohort 3Phase 1bRP2D Mono Lead-in + Pembro Combination* Trial design dosing is by mbIL-2 in CD45+ cells/kg body weight.

  • A factorial study of combination hypertension treatment with metoprolol succinate extended release and felodipine extended release results of the Metoprolol Succinate- Felodipine Antihypertension Combination Trial (M-FACT).


More Definitions of Combination Trial

Combination Trial means a clinical trial (or set of clinical trials) of [ * ] an Amgen Product, conducted by or on behalf of Amgen or a Development Collaborator (solely to the extent within the scope of a collaboration described in Section 1.50). B. The following shall be added to the Original Agreement as new Sections 2.2(e) and (f):
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Combination Trial means a clinical trial (or set of clinical trials) of [***] an Amgen Product, conducted by or on behalf of Amgen or a Development Collaborator (solely to the extent within the scope of a collaboration described in Section 1.50). B. The following shall be added to the Original Agreement as new Sections 2.2(e) and (f):
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Related to Combination Trial

  • Combination means an event in which the Company consolidates with, merges with or into, or sells all or substantially all its property and assets to another Person.

  • Combination carrier means a ship designed to carry either oil or solid cargoes in bulk.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • UNE Combination means a combination of two (2) or more Unbundled Network Elements that were or were not previously combined or connected in Qwest's network, as required by the FCC, the Commission or this Agreement.

  • 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.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • 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)).

  • 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 Trial means any human clinical trial of a Product.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • 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 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.

  • 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.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Step therapy protocol means a protocol or program that establishes the specific

  • 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 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.

  • 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.

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