End of Phase I definition

End of Phase I means completion of the last Phase I study.
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End of Phase I means the date that all Phase I clinical trials have been completed.
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End of Phase I means the successful completion of all patient dosing and the collection, review and analysis of all patient data as required under the applicable protocols adopted for the Phase I clinical trial, as determined by AVTAC in its sole discretion or the decision by AVTAC or an Affiliate of AVTAC or a sublicensee of AVTAC to proceed to a Phase U clinical trial, whichever occurs first.
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Examples of End of Phase I in a sentence

  • FDA does not hold an End of Phase I Meeting and does not respond to questions submitted by TMC in its request for an End of Phase I Meeting); provided that in no event shall the time determined under Section 9.2(i)-(iv) be earlier than January 1, 2007, if TMC decides to seek a partner for further development or Commercialization of the PTH Product, TMC will provide notice in writing to ALZA of such intention.

  • Rafael Pharmaceuticals’ vision is to be the premier cancer bioenergetics/metabolism firm designing drugs to attack the proteins and enzymes reconfigured, re-regulated, and repurposed in cancer and responsible for the unique metabolic features of tumors.In February 2017, Rafael Pharmaceuticals successfully completed an End of Phase I meeting with the FDA.

  • Following the End of Phase I, Roche, at its sole cost, shall be responsible for the preparation and filing of all regulatory applications and documentation for Regulatory Approvals with respect to such Compounds.

  • Adverse events related to the use of the Products or Compounds worldwide shall be in a single database, centralized, held and owned by Memory, through the End of Phase I with respect to each Compound.

  • To this end, AVTAC hereby agrees to (a) submit an IND to the FDA within one (1) year, (b) reach End of Phase I within two (2) years, and (c) reach End of Phase II within three and one-half (31/2) years after the Effective Date.

  • From and after the End of Phase I with respect to such Compound, and from and after Roche obtains a License with respect to 3454 Products, Roche shall be responsible for clinical development of the Compound, subject to the provisions of Section 3.1 and the oversight of the JSC (during its existence), and all related costs.

  • Draft and Final Regulatory Submission Documents to the FDA, including pre-IND, IND, and End of Phase I packages, as necessary.

Related to End of Phase I

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

  • 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.

  • 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.

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

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

  • 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.

  • 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;

  • Construction Completion means physical construction of a cleanup action component is complete.

  • Commissioning means the process for determining the need for and for obtaining the supply of healthcare and related services by the Trust within available resources.

  • Construction Phase means that Phase of the Project which shall commence after the Authority provides the Trade Contractor with written Notice to Proceed with the Construction Phase.

  • Tests after Completion means the tests (if any) which are specified in the Contract and which are carried out in accordance with the Specification after the Works or a Section (as the case may be) are taken over by the Procuring Entity.

  • 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.

  • Commissioning Tests means all of the procedures and tests which, in accordance with the Reasonable and Prudent Standard, and in compliance with industry guidelines, practices and standards, are:

  • Project Completion Schedule means the progressive Project Milestones set forth in Schedule-J for completion of the Project Highway on or before the Scheduled Completion Date;

  • Construction Completion Date means the date by which the overall development of the Project is completed in accordance with the provisions of this Agreement and when the Construction Completion Certificate is issued by the Independent Engineer as per Article 14.1.

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

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

  • Commissioning test means tests applied to the Generating Facility, after completion of the construction of the Generating Facility, in order to verify that the Generating Facility may be released for Operation.

  • Mechanical Completion means that (a) all components and systems of the Project have been properly constructed, installed and functionally tested according to EPC Contract requirements in a safe and prudent manner that does not void any equipment or system warranties or violate any permits, approvals or Laws; (b) the Project is ready for testing and commissioning, as applicable; (c) Seller has provided written acceptance to the EPC Contractor of mechanical completion as that term is specifically defined in the EPC Contract.

  • Commencement of Development means the date on which any material operation (as defined in Section 56(4) of the Act) forming part of the Development begins to be carried out other than (for the purposes of this Deed and for no other purpose) operations consisting of site clearance, demolition work, archaeological investigations, investigations for the purpose of assessing ground conditions, remedial work in respect of any contamination or other adverse ground conditions, diversion and laying of services, erection of any temporary means of enclosure, the temporary display of site notices or advertisements and “Commence Development” shall be construed accordingly.

  • Project Completion Date means the date on which the Completion Certificate is issued;

  • Final Completion means the date determined and certified by A/E and Owner on which the Work is fully and satisfactorily complete in accordance with the Contract.