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.
Sample 1Sample 2
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.
Sample 1Sample 2
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.
Sample 1Sample 2

Examples of Phase III Completion Date in a sentence

  • If ROCHE has paid an Option Extension Fee for a Product, $5,000,000 shall be credited against the Development Costs reimbursable by ROCHE at the time of the exercise of the option following receipt of notice of the Phase III Completion Date.

  • If Roche exercises its option for a Product after notice of the Phase III Completion Date for that Product, no Global Development Costs will be shared for the completion of any clinical development or filing or preparation necessary for either Party's Registration for the indication which was the subject of the Phase III Trial related to the Phase III Completion Date.

  • Except for Genentech Products for which ROCHE exercises its option granted under Section 2(b) of Article II after the Phase III Completion Date, ROCHE shall pay GENENTECH a royalty of twelve and one-half percent (12.5%) on the first $100 million in aggregate Net Sales of each Genentech Product in the Roche Territory and a royalty of fifteen percent (15%) on aggregate Net Sales of such Genentech Product in excess of $100 million.

  • For Genentech Products for which ROCHE exercises its option granted under Section 2(b) of Article II after the Phase III Completion Date, ROCHE shall pay GENENTECH a royalty of fifteen percent (15%) on all Net Sales of such Genentech Product.

  • If ROCHE fails to exercise its option for a license for such Product within 60 days of the notice to ROCHE of the Phase III Completion Date, GENENTECH thereafter shall be free to develop, make, have made, use, sell and market (including the right to promote and detail) such Product in the Roche Territory in any manner it chooses, including by means of a license to one or more third parties, and free of any restrictions under Section 3.07 of the Governance Agreement.

  • 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 .......

  • If Buyer develops Phase III, then after the Phase III Completion Date, Buyer shall pay to ORA a sum equal to 20% of the Phase III Net Profit less any amounts paid to ORA pursuant to Section 9.2(c).


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.
Sample 1
Phase III Completion Date means the date that is sixty
Sample 1
Phase III Completion Date means the date that is [***].
Sample 1
Phase III Completion Date shall have the meaning set forth in Section 9.4(a).
Sample 1

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).

  • Scheduled Project Completion Date shall have the meaning specified in Section 6.3 (c);

  • 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 human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • 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 study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • 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 August 15, 2018, 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;

  • Quarterly Commencement Date means the 1st day of each of April, July, October and January in each year.