Phase III Completion Date definition

Phase III Completion Date means sixty (60) days after the completion of statistical analyses of the final results of those Phase III clinical studies which Triangle considers reasonably necessary for inclusion in an NDA for a Licensed Product for HBV. As used in the preceding sentence, “Phase III clinical trials” shall mean those well-controlled clinical trials sponsored by Triangle the primary objective of which (as reasonably determined by Triangle) is to ascertain definitive safety data and efficacy data regarding such Licensed Product’s antiviral effects against HBV sufficient to support an NDA.
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Phase III Completion Date means the date that is sixty (60) days after the completion of statistical analyses of the final results of those Phase III Clinical Trials that are reasonably necessary for purposes of inclusion in an NDA or BLA, as applicable, for a Licensed Product and for which (a) statistical analyses reveal that the predetermined endpoints were met with statistically significant separation from placebo and (b) the safety profile is reasonably acceptable for effective commercialization of such Licensed Product.
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Phase III Completion Date means sixty (60) days after the completion of statistical analyses of the final results of those Phase III clinical studies which BUKWANG or its sublicensee considers reasonably necessary for the purpose of inclusion in an NDA, or other such application submitted to the regulatory authorities in a given country, requesting marketing approval for Licensed Product(s). As used in the preceding sentence, “Phase III clinical trials shall mean those well-controlled clinical trials sponsored by BUKWANG or its sublicensee, the primary objective of which (as reasonably determined by BUKWANG or its sublicensee) is to ascertain definitive safety data and efficacy data regarding such Licensed Product(s) antiviral effects sufficient to support an NDA.
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Examples of Phase III Completion Date in a sentence

  • Reduced Milestone Payments Aggregate Milestone Payment -------------------------------------------------- Start of Ragweed Phase Start of Ragweed Phase III Clinical Trial III Clinical Trial Delayed Until After Delayed Until After Event February 1, 2005 February 1, 2006 ----- ---------------------- ------------------- Phase III Completion Date for Ragweed Product .......


More Definitions of Phase III Completion Date

Phase III Completion Date means the date by which a Phase III Trial is completed with respect to a Product, and the results of that Phase III Trial are known, available and have been analyzed and, in Genentech's reasonable judgement, allow filing for a Biologics License Application or New Drug Application for that Product in the USA.
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Phase III Completion Date means the date that is sixty
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Phase III Completion Date means the date that is [***].
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Phase III Completion Date shall have the meaning set forth in Section 9.4(a).
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Related to Phase III Completion Date

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

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

  • 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;

  • Target Completion Date has the meaning given such term in Section 3.3(b).

  • The Completion Date means the date of completion of the Works as certified by the Employer’s Representative.

  • Scheduled Completion Date shall be the date set forth in Clause 10.3;

  • 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.

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

  • Completion Date means the date of completion of the Services by the Service Provider as certified by the Procuring Entity

  • Completion Period means the period starting from the date of issue of "Order" and required to complete the work in all respect.

  • 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.

  • 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;

  • Project Commencement Date means the commencement date notified to the Minister pursuant to clause 4(1);

  • 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.

  • Outside Completion Date shall have the meaning assigned to such term in Section 6.3(d).

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

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • 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:

  • Completion Rate means the percentage of an apprenticeship cohort who receives a certificate of apprenticeship completion within 1 year of the projected completion date. An apprenticeship cohort is the group of individual apprentices registered to a specific program during a 1 year time frame, except that a cohort does not include the apprentices whose apprenticeship agreement has been cancelled during the probationary period or who have transferred.

  • Successful Completion means that in the reasonable opinion of the Customer, Deliverables completed by the Supplier are fit for purpose, completed on time and otherwise meet all the criteria defined under this Contract;

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

  • Completion Deadline means the date by which the Arrangement is to be completed, which date shall be April 30, 2014 or such later date as may be agreed to in writing by the Parties;

  • Construction Period means the period commencing from the Appointed Date and ending on the date of the Completion Certificate;

  • 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).

  • Construction Commencement Date means the date set out in the Addendum, if applicable, by which you must commence construction of the Hotel. For the Hotel to be considered under construction, youmust have begun to pour concrete foundations for the Hotel or otherwise satisfied any site-specific criteria for “under construction” set out in the Addendum.