Phase 1 Data definition

Phase 1 Data has the meaning set forth in Section 8.8.2.
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Phase 1 Data has the meaning set forth in Section 5.1 (Right of First Negotiation). Portions of this exhibit have been omitted as the Registrant has determined that (i) the omitted information is not material and (ii) the omitted material is of the type that the Registrant treats as private or confidential. Omitted portions are indicated by [*].
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Phase 1 Data has the meaning set forth in Section 5.1 (Right of First Negotiation).
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Examples of Phase 1 Data in a sentence

  • Celltrion will have the right to terminate this Agreement if Rani fails to (a) Initiate a Phase 1 Trial with Product [*], or (b) deliver the Phase 1 Data to Celltrion [*], in each case commencing from delivery of the full amount of Initial Supply to Rani that complies with the terms of this Agreement.

  • For clarity, if such Phase 1 Trial has multiple parts (e.g., a part 2 repeat-dose portion), then for purposes of the preceding sentence the Phase 1 Data shall mean solely the data related to the single-dose or single-ascending dose portion of such trial, as applicable.

  • If Celgene designates a Third Party advisor to receive the Phase 1 Data Package, such Third Party advisor shall, prior to receiving such Phase 1 Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in Article 8.

  • Celgene shall have the right to exercise its Phase 1 Option with respect to such Program as set forth in Article 3 (including entering into a Global License Agreement for such Program with Prothena), with the date that Prothena so delivers the complete Phase 1 Data Package for such Program being deemed be the End of Phase 1 Date for such Program, and the provisions of Article 3 shall apply in connection therewith, mutatis mutandis.

  • If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program.

  • Celltrion will have thirty (30) days from delivery of the Phase 1 Data (the “ROFN Exercise Period”) to exercise its ROFN by giving Xxxx written notice thereof (a “ROFN Exercise Notice”), which will specify the country(ies) with respect to which the ROFN is being exercised (the “ROFN Territory”).

  • Exploration should proceed according to the following business plan: Phase 1 Data Evaluation and Prospecting Aeromagnetic data for the claim area should be researched for anomalies potentially caused by kimberlite.

  • Protagonist shall use Diligent Efforts to complete the clinical study report for the Phase 1 Clinical Trial of the first 2nd Generation Product set forth in the 2nd Generation Development Plan as promptly as is practicable following the delivery of the Phase 1 Data Package therefor, and shall deliver such clinical study report to Xxxxxxx promptly following its completion (and, in any event, no later than [*] after the Phase 1 Completion Date for such 2nd Generation Product).

  • X+1 Completion of Phase 1 Data center operations See Attachment A-4.

  • Duvelisib: iNHL iNHL: Indolent non-Hodgkin lymphoma Duvelisib Active in Relapsed/Refractory (R/R) iNHL Phase 1 Data CR FL 25mg BID 75mg BID PD prior to first assessment Best Perecent Change 72% (13/18) ORR, including 33% (6/18) CR, at 25 mg BID – 69% (9/13) ORR in follicular lymphoma patients, including 38% (5/13) CR Majority of adverse events Grade 1 or 2, reversible and clinically manageable Flinn et al., ASH 2014 Phase 1 data.


More Definitions of Phase 1 Data

Phase 1 Data. Package” 17
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Related to Phase 1 Data

  • Study Data shall have the meaning set forth in Section 8.1.

  • Development Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or Product.

  • Phase 1 Trial means a human clinical trial of a Product in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a), or its foreign equivalent.

  • 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).

  • Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Project Data means all proprietary data of the Project generated out of the Project operations and transactions, documents and related information including but not restricted to user data which the Bidder obtains, possesses or processes in the context of providing the Services to the users pursuant to this RFP including the SLA;

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • 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.

  • System Data means data and data elements collected by the SaaS Software, SaaS Service or Licensor’s computer systems regarding configuration, environment, usage, performance, vulnerabilities and security of the SaaS Software or SaaS Service that may be used to generate logs, statistics and reports regarding performance, availability, integrity and security of the SaaS Software.

  • 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 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.

  • Study Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • 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.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Phase 3 Study means a clinical study of a drug candidate in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety in order to obtain Regulatory Approval in any country, as further described in 21 C.F.R. 312.21(c) with respect to the United States, or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • 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.

  • Baseline data means information gathered at a selected point in time and used thereafter as a basis from which to monitor change.

  • 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).

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.