Phase 1 Data definition

Phase 1 Data has the meaning set forth in Section 8.8.2.
Sample 1Sample 2
Phase 1 Data has the meaning set forth in Section 5.1 (Right of First Negotiation).
Sample 1
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 [*].
Sample 1

Examples of Phase 1 Data in a sentence

  • Overhead Sign Structures Inspections Overhead Sign Structures Phase 1, Data Collection is expected to consist of performing a detailed structural inspection of all components of an overhead sign structure.

  • For the avoidance of doubt, if Celgene has exercised its IND Option for a given Program, the Phase 1 Development Portion of the Collaboration with respect to such Program may continue beyond the end of the Research Term until delivery of the Phase 1 Data Package for such Program.

  • High Mast Lighting TowerHigh Mast Tower Lighting Phase 1 Data Collection is expected to consist of performing a detailed structural inspection of all components of a High Mast Lighting Tower including foundation.

  • 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.

  • 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.

  • Overhead Sign Structures Phase 1, Data Collection is expected to consist of performing a detailed structural inspection of all components of an overhead sign structure.

  • High Mast Lighting Tower High Mast Tower Lighting Phase 1 Data Collection is expected to consist of performing a detailed structural inspection of all components of a High Mast Lighting Tower including foundation.

  • 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.

  • High Mast Tower Lighting Phase 1 Data Collection is expected to consist of performing a detailed structural inspection of all components of a High Mast Lighting Tower including foundation.

  • Phase 1 Data Gathering & Analysis The proponent shall collect the following information for presentation back to internal and external stakeholders.


More Definitions of Phase 1 Data

Phase 1 Data. Package” 17 1. 100 “Phase 1 Option Period” 18 1.101 “Phase 2 Clinical Trial” 18 1.102 “Phase 3 Clinical Trial” 18 1.103 “Pivotal Clinical Trial” 18 1.104 “Product Liability” 18 1.105 “Prosecution and Maintenance” or “Prosecute and Maintain” 19 1.106 “Regulatory Approval” 19 1.107 “Regulatory Authority” 19 1.108 “Regulatory-Based Exclusivity” 19 1.109 “Regulatory Materials” 19 1.110 “Related Compound” 20 1.111 “Research Plan” 20 1.112 “Selection Term” 20 1.113 “Shared Development Program” 20 1.114 “Sublicensee” 20 1.115 “[**]” 21 1.116 “[**]” 21 1.117 “Target” 21 1.118 “Territory-Specific Development Costs” 21 1.119 “Third Party” 21 1.120 “UNC” 21 1.121 “UNC Agreement” 21 1.122 “United States” or “U.S.” 21 1.123 “Valid Claim” 21 1.124 Additional Definitions. 22 ARTICLE 2 AMENDMENT AND RESTATEMENT; COLLABORATION; RESEARCH PLAN; OPT-OUTS 25 2.1 Amendment and Restatement. 25 2.2 Collaboration Overview. 26 2.3 Research Plan; Research Activities. 26
Sample 1

Related to Phase 1 Data

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

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • 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 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 phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and 000 xxxxx xx Xxxxxxxx Xxxx xx the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.

  • GLO Data means any data or information owned by the GLO, including PII or SPI as defined below, that Provider creates, obtains, accesses (via records, systems, or otherwise), receives (from the GLO or on behalf of the GLO), or uses in the performance of the Contract or any documents related thereto.

  • 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, 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 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).

  • 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, 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.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), 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 concerning the safety or performance that is generated from the use of a device and that are sourced from the following: