Voluntary Phase 4 Clinical Trial definition

Voluntary Phase 4 Clinical Trial means a Phase 4 Clinical Trial that is not a Required Phase 4 Clinical Trial.
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Voluntary Phase 4 Clinical Trial means a Phase 4 Clinical Trial that is not a Requested or Required Phase 4 Clinical Trial.
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Voluntary Phase 4 Clinical Trial means a Phase 4 Clinical Trial that is not a Required Phase 4 Clinical Trial.* Confidential Information, indicated by […***…], has been omitted from this filing and filed separately with the Securities and Exchange Commission.ARTICLE 2 PROGRAM; GOVERNANCE
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More Definitions of Voluntary Phase 4 Clinical Trial

Voluntary Phase 4 Clinical Trial means a Phase 4 Clinical Trial that is not a Requested or Required Phase 4 Clinical Trial. Each of the following terms is defined in the Section set forth opposite such term: Term Section Active Galapagos Target Schedule 8.10 Agreement Preamble Alliance Manager 1.9 Anti-Corruption Laws 11.1(e) Antitrust Clearance Date 16.1(b) […***…] 2.3(c)(iii) Bankrupt Party 14.9 Bankruptcy Code 14.5 Bribery Act 11.1(e) Clinical Supply Agreement 6.2(e) Combination Product Activities Agreement 2.6(c)(iii) Commercial Supply Agreement 6.2(f) Committee Dispute 15.1(c) Confidential Information 13.1(a) Dispute 15.1(b) DOJ 8.2(d)(ii) FCPA 11.1(e) FTC 8.2(d)(ii) Galapagos Preamble Galapagos Acquirer 17.6(b) Galapagos Collaboration IP 10.1(a) Galapagos Collaboration Know-How 10.1(a) Galapagos Collaboration Patents 10.1(a) Galapagos Indemnitees 12.2 Galapagos Program Period 8.2(a) Galapagos R&D Activities 2.1 Galapagos Schedule of Exceptions 11.2 Enforcing Party 10.4(f) Execution Date Preamble Gilead Preamble Gilead Collaboration IP 10.1(b) Gilead Contributions 2.2 Gilead Indemnitees 12.1 Gilead Reversion Patents 14.7(c)(i) Global Commercialization Plan and Budget 5.2(a) Global Manufacturing Plan and Budget 6.2(a) Term Section Global Optioned Product Trademarks 10.9(a) Global Promotional Materials 5.2(c) ICC Rules 15.2(c) Indemnified Party 12.3 Indemnifying Party 12.3 Independent Activities 7.1 Independent Activities Costs 7.5 Independent Activities Data 7.4(a) Independent Activities Party 7.2(a) Independent Activities Plan 7.2(a) Independent Activities Regulatory Documentation 7.4(b) Independent Post-Option In-License 9.6(a)(ii) Infringing Activity 10.6(a) Initial Option Closing 8.2(c)(i) Joint Collaboration IP 10.1(c) Joint Commercialization Committee or JCC 1.3(a) Joint Communication Review Committee” or “JCRC 1.4(a) Joint Development Committee or JDC 1.2(a) Joint Post-Option In-License 9.6(a)(i) Joint Steering Committee or JSC 1.1(a) Lead Molecule “Galapagos Program” definition Lead Patent “Related Molecules” definition Losses 12.1 Market Abuse Regulation 11.2(q) Material Adverse Effect 11.2(r) Non-Committee Dispute 15.1(b) Non-Enforcing Party 10.4(f) Option 8.2(a) Option Bringdown Date 8.2(c)(ii) Option Exercise Closing 8.2(c)(i) Option Exercise Notice 8.2(b)(i) Option Exercise Period 8.2(b)(i) Option Payment 9.2 Optioned Product Orange Book Listing 10.3(a) Optioned Program R&D Activities 3.2 Opt-Out Notice 3.7(a) Outside Date 14.2 Term Section Party Indemnitees 12.4(a) Party...
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Related to Voluntary Phase 4 Clinical Trial

  • 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 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 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.

  • 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 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.

  • 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 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.

  • 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 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 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 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).

  • 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.

  • 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.

  • 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.

  • 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:

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • 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.

  • 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 Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

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

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • 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).

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.