Phase 0 definition

Phase 0 means an exploratory, first-in-human trial conducted in accordance with the FDA 2006 Guidance on Exploratory Investigational New Drug Studies (or the equivalent in any country or other jurisdiction outside of the United States) and designed to expedite the development of therapeutic or imaging agents by establishing very early on whether the agent behaves in human subjects as was anticipated from pre-clinical studies.
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Phase 0 means that portion of Development which starts after a candidate has been selected and approved by BI or a Third Party licensee thereof for start of development as a product as evidenced by the approval in writing of such start of development by BI's International Steering Committee or equivalent body. Phase 0 generally includes toxicological and pharmacological studies as well as drug substance and drug product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue human clinical testing.
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Phase 0 means the first stage of the Project as described in this Agreement;
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Examples of Phase 0 in a sentence

  • Phase 0 is a stand-alone effort and does not require a commitment to any follow-on phases (the bidding system development and implementation).

  • Activity Status Details Phase 0 Xxxxx Xxxxx 0 Xxxxx Xxxxx 0 Trial • Development Milestones Progress (as described in Section 5.2.1 of the Agreement) Development Milestones Status Comments [***] [***] [***] [***] [***] [***] Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission.

  • This Agreement and its exhibits, together with the Intellectual Property License Agreement, constitutes the complete agreement of the parties and supersedes any other agreements, written or oral (including all correspondence, emails, such as but not limited to the letter regarding Phase 0 dated February 20, 1998 concerning the subject matter hereof and such materials do not have any effect upon the rights and obligations of the Parties under this Agreement.

  • This Agreement, together with the Development Agreement and its Exhibits, constitutes the complete agreement of the parties and supersedes any other agreements, written or oral (including all correspondence, emails and the letter regarding Phase 0 dated February 20, 1998 concerning the subject matter hereof and such materials do not have any effect upon the rights and obligations of the Parties under this Agreement.

  • For denotation purposes, there is now a new and separate Phase 0 added to the proposed project.

  • All information in this is gleaned from the deliverable document (it can be thinned down) Discovery Installation Guide and Tools (Phase 0) Capacity Planner Checklist/requirements doc for Sales and Customers.

  • To begin both Phase 0 as well as Phase 1 of the Agreement, THE CONTRACTOR agrees to issue an insurance policy in favor of State entities within the ten (10) calendar days following the signing of the Agreement, to secure compliance of the initial obligations of the Agreement in an amount equivalent to one hundred thousand dollars (US$100,000.oo) and for a term of six (6) months starting on the date the Agreement is executed.

  • Xxxxxx will begin work on the Project within thirty (30) days of receipt of this Agreement executed by Client and will continue for a period of seven (7) months, from Phase 0 through Phase 4, subject to the terms and conditions of this Agreement.

  • Because of the Phase 0 schedule, the scheduling of any proposed follow-on phases would need to be determined later in June or early July.

  • No payment or obligation will be due to XXX during the performance of Phase 0.


More Definitions of Phase 0

Phase 0. The test implementation phase of the radio system, in which Vancouver Police Department and Vancouver Fire Department are the only participants.
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Phase 0 means the Phase of the Project during which Developer will develop, construct, operate, and maintain the Temporary Facility.
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Phase 0. “Temporary Facility”: Developer will construct a temporary casino gaming facility of approximately 70,000 square feet in a “Sprung Structure,” accessory modular/prefabricated structures, suitable on-site parking facilities, site circulation drives, curbing and gutters, landscaping, and signage on the Development Property as designated on the Site Plan Documents and operate the Temporary Facility therein. Developer’s investment in the Temporary Facility will be no less than $20 million. Phase 0 Commencement: Construction of Phase 0 will commence within 10 days of the earlier of (a) the execution of the Temporary Construction Easement; or (b) the Closing; provided, however, that in no event shall construction of Phase 0 commence prior to receipt of all required approvals of the IGB and the City. Developer will use commercially reasonable efforts to deconstruct and remove the Temporary Facility no later than 90 days after the opening of the Permanent Facility.
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Phase 0. Now until DAC 00/X0 00
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Related to Phase 0

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

  • Phase 2 means the second implementation phase of this section, beginning June 1, 2022 and continuing thereafter.

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

  • Development Phase means the period before a vehicle type is type approved.

  • 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).

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

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

  • Project Completion means completion of the Redevelopment in accordance with this Agreement to the state where the whole of the Morley Shopping Centre, as so redeveloped, is capable of occupation for its intended purpose;

  • Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.

  • Construction Phase Services means the coordination, implementation and execution of the Work required by this Agreement, which are further defined in Article 8.

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

  • 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.

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • System Impact Study means an assessment by the Transmission Provider of (i) the adequacy of the Transmission System to accommodate a Completed Application, an Interconnection Request or an Upgrade Request, (ii) whether any additional costs may be incurred in order to provide such transmission service or to accommodate an Interconnection Request, and (iii) with respect to an Interconnection Request, an estimated date that an Interconnection Customer’s Customer Facility can be interconnected with the Transmission System and an estimate of the Interconnection Customer’s cost responsibility for the interconnection; and (iv) with respect to an Upgrade Request, the estimated cost of the requested system upgrades or expansion, or of the cost of the system upgrades or expansion, necessary to provide the requested incremental rights. System Protection Facilities: “System Protection Facilities” shall refer to the equipment required to protect (i) the Transmission System, other delivery systems and/or other generating systems connected to the Transmission System from faults or other electrical disturbance occurring at or on the Customer Facility, and (ii) the Customer Facility from faults or other electrical system disturbance occurring on the Transmission System or on other delivery systems and/or other generating systems to which the Transmission System is directly or indirectly connected. System Protection Facilities shall include such protective and regulating devices as are identified in the Applicable Technical Requirements and Standards or that are required by Applicable Laws and Regulations or other Applicable Standards, or as are otherwise necessary to protect personnel and equipment and to minimize deleterious effects to the Transmission System arising from the Customer Facility. Transmission Facilities:

  • Phase 3 Study means a clinical study of an investigational product in 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 investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents [***]

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • 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.

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.2.

  • 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 or “Phases” in respect of the Project shall mean that the components of the Project are placed in service during more than one year during the Investment Period, and the word “Phase” shall therefore refer to the applicable portion of the Project placed in service in a given year during the Investment Period.

  • 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.

  • 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 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 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 I means the first part of the tuition incentive assistance program defined as the academic period of 80 semester or 120 term credits, or less, leading to an associate degree or certificate.