Completion of Phase II definition

Completion of Phase II means completion of the final statistical results of clinical trials that collectively evaluate the safety and efficacy of a Product’s specific dosage strength in an indication the Product is intended to treat, which data enables the Parties to proceed with pivotal registration Phase III studies, without any objection from the FDA, as documented by FDA contact reports. For the avoidance of doubt, the “Completion of Phase II” for each Product in the Collaboration shall be independent events.
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Completion of Phase II means the date on which the Food & Drug Administration and the Licensee agree that sufficient data and information have been submitted to the FDA to permit the Initiation of a Phase III Clinical Trial of a Licensed Product(s) without requiring the conduct of further Clinical Trials or the submission of additional data or information.
Sample 1
Completion of Phase II means, with respect to an Ophthalmic Product, the completion of data analysis for those Phase II Studies of such Ophthalmic Product that the Parties prospectively identify in the applicable Program Workplan as the studies the data from which would provide a sufficient basis to Initiate a Phase III Study.
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Examples of Completion of Phase II in a sentence

  • The anticipated date for achieving Substantial Completion of Phase II of the Project at the time this Agreement was executed is September 15, 2018.

  • Commencement and Completion of Phase II consistent with approved Construction Documents and approved Building Permit.

  • ACRES will be updated for each property when the following occur: • Completion of Phase I ESA • Completion of Phase II ESA • Completion of ABCA • Completion of the Project Period • As significant events occur at the site, but not later than the end of the quarter in which the event occurred TIMEFRAME: Throughout project performance period.

  • PHASE II (Upon Completion of Phase II (a) – (c), the Village will reimburse Developer $100,000.00.

  • If such Phase Completion of Phase II Block A shall not have occurred as of January 1, 2029, then the Incentive Payment based upon the Incremental TIF derived from Phase II Block A shall automatically shall be divested and shall terminate and be of no further force and effect and the Master Developer shall not be entitled to any Incremental TIF with respect to Phase II Block A.

  • If such Phase Completion of Phase II Block B shall not have occurred as of January 1, 2030, then the Incentive Payment based upon the Incremental TIF derived from Phase II Block B shall automatically shall be divested and shall terminate and be of no further force and effect and the Master Developer shall not be entitled to any Incremental TIF with respect to Phase II Block B.


More Definitions of Completion of Phase II

Completion of Phase II occurs for a Licensed Product in an Indication with the first administration of such Licensed Product to a patient in a Phase III Clinical Trial of such a Licensed Product for such Indication.
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Completion of Phase II means, with respect to an RNAi Therapeutic Product, the completion of data analysis for those Phase II Studies of such RNAi Therapeutic Product that the Parties prospectively identify in the applicable Program Workplan as the studies the data from which would provide a sufficient basis to Initiate a Phase III Study.
Sample 1
Completion of Phase II means completion of the final statistical results of clinical trials that collectively evaluate the safety and efficacy of a Product's specific dosage strength in an indication the Product is intended to treat, which data enables the Parties to proceed with pivotal registration Phase III studies, without any objection from the FDA, as documented by FDA contact reports. For the avoidance of doubt, the "Completion of Phase II" for each Product in the Collaboration shall be independent events.
Sample 1
Completion of Phase II. (or Phase III) Clinical Trials" means the delivery of a final report to the JPT on the outcome of the Phase II or Phase III Clinical Trial, as the case may be.
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Completion of Phase II means, with respect to a Product in the Field: (a) that one or more Phase II Trials of such Product have been conducted by or on behalf of Introgen and (b) [*] Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Introgen has met with the FDA to review plans to proceed to a Pivotal Trial of such Product, without receiving objection from the FDA that would prevent the commencement of a Pivotal Trial of such Product. For such purposes, an “objection” from the FDA will mean that the FDA makes clear to Introgen at the time of such meeting, as reflected in the minutes of such meeting (or the FDA otherwise notifies Introgen in writing within sixty (60) days after such meeting), that the Product would not be approvable based on the results of the proposed Pivotal Trial, or that the Product would not be approvable unless additional Phase II studies were undertaken before starting such Pivotal Trial. The “minutes” of such meeting shall be the version of the minutes distributed by the FDA within sixty (60) days after such meeting, or if the FDA does not distribute such meeting minutes (or such written notice) within such 60-day period, then as reflected in the minutes of the meeting prepared by Introgen and provided to the FDA as Introgen’s proposed draft of the minutes, provided that Introgen has received confirmation (by telephone or letter, for example) that the FDA does not disagree in a material way with such minutes.
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Related to Completion of Phase II

  • 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.

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

  • 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.

  • Substantial Completion means the stage in the progress of the work as determined and certified by the Contracting Officer in writing to the Contractor, on which the work (or a portion designated by the Government) is sufficiently complete and satisfactory. Substantial completion means that the property may be occupied or used for the purpose for which it is intended, and only minor items such as touch-up, adjustments, and minor replacements or installations remain to be completed or corrected which:

  • 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 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.

  • 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.

  • 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.

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

  • project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;

  • 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.

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

  • 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;

  • 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).

  • Construction Completion Certificate means a document:

  • Design Phase means the period during which the Transporter shall prepare a draft project proposal for publication in accordance with section 4.3;

  • Substantial Completion Date means the date on which Substantial Completion occurs.

  • Improvement completion assurance means a surety bond, letter of credit,

  • 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.

  • Pre-Construction Phase Services means the participation, documentation and execution of Contractor’s Pre-Construction Phase deliverables as required by this Agreement and further defined in Article 5.

  • Construction Work means any work in connection with⎯

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

  • 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.