Start of Phase III definition

Start of Phase III means the first administration of a Product in a Phase III Clinical Trial.
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Start of Phase III means with respect to a Pre-Development Compound selected during the Research Term, the initiation of the first Phase III Trial;
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Start of Phase III means the date that a patient is first dosed in a Phase III Clinical Trial for Target Product for an HPV Indication, as a result of activities under this Agreement.
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Examples of Start of Phase III in a sentence

  • For example, if Start of Phase III is achieved with respect to a particular Product but Start of Phase IIb has not been achieved by that Product or any other Product, the Development Milestones for both Start of Phase IIb and Start of Phase III shall be payable.

  • CLINICAL DEVELOPMENT MILESTONE PAYMENTS Start of Phase III for each product €**** the first grant of Marketing Authorization for each product in either (i) the USA, (ii) Japan, or (iii) each of France, Germany, Italy, Spain and the United Kingdom €**** first achievement of annual Net Sales in the Territory for each product > € **** €**** Royalty Payments : EVOTEC shall pay to BOEHRINGER a royalty of **** of Net Sales of each product covered by a valid claim.

  • Milestones under sub-section (iv) hereunder shall become due and payable within thirty (30) days of the Start of Phase III Clinical Trials.

  • If Roche is required by a relevant Regulatory Authority in a Major Market Country to divest rights to a Licensed Product with respect to which Roche has commenced the Start of Phase III trial prior to the order to divest, then Roche shall afford BioCryst a reasonable opportunity to acquire such rights on terms no less advantageous than those granted to other potential acquirers of such rights, including in bidding or other acquisition processes.

  • If the Second Royalty-Bearing Product reaches the Start of Phase III prior to the time that the First Royalty Bearing Product reaches the Start of Phase III, then the event payment would be *** dollars ($***) because the Second Royalty-Bearing Product is the first Autoimmune Indication to reach the Start of Phase III.

  • If after the Second Royalty-Bearing Product reaches the Start of Phase III, the First Royalty-Bearing Product reaches the Start of Phase III, then the event payment would be *** dollars ($***), because the First Royalty-Bearing Product is the second Autoimmune Indication to reach the Start of Phase III.

  • Start of IND enabling studies: [ *]% [ *]% Start of Phase I studies: [ *]% [ *]% Start of Phase II studies: [ *]% [ *]% Start of Phase III studies: [ *]% [ *]% Outside The Field: Neither party will have the right to develop Collaboration Targets or the corresponding antibodies outside the Field without the consent of the other party.

  • Tanzanian Gold announces end of Phase II Drilling and Start of Phase III Ultra-Deep Drilling; 50m @ 1.8 g/t Au including 5m @ 4.6 g/t Au, 7m @3.9 g/t Au and 1.0m @ 7.0 g/t Au Confirms Northeast Extension Still Open FOR IMMEDIATE RELEASE January 23, 2020 TORONTO, January 23, 2020, (GLOBE NEWSWIRE) - Tanzanian Gold Corporation’s, (TSX:TNX) (NYSE American:TRX) (the “Company’s”) Board of Directors is pleased to announce final results from Phase II of its ongoing drill program at the Buckreef Project.

  • If Roche is required by a relevant Regulatory Authority in a Major Market Country to divest rights to a Licensed Product with respect to which Roche has not commenced the Start of Phase III trial prior to the order to divest, then Roche shall use its commercially reasonable efforts to obtain authority to fulfill such requirements by returning rights to BioCryst in and to such Licensed Product in accordance with the procedures specified in Section 11.4(b).


More Definitions of Start of Phase III

Start of Phase III means the date that a patient is first dosed in a Phase III Clinical Trial for Target Product, as a result of activities under this Agreement
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Related to Start of Phase III

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

  • 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.

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

  • 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.

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

  • 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).

  • 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.

  • Phase 2 means the phase of the ATP comprised of: (1) improvements to the State Street Substation to receive Rebuilt Line 972; (2) the rebuilding of NYSEG’s existing Line 972 not performed in Phase 1; (3) construction of Relocated Line 15; (4) the construction of Bused Line 5; (5) improvements to the Elbridge Substation to receive Relocated Line 15; and (6) improvements to the Elbridge Substation to receive Bused Line 5.

  • Phase 1 means the phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and 000 xxxxx xx Xxxxxxxx Xxxx xx the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.

  • Maximum design heat input means the ability of a unit to combust a stated maximum amount of fuel per hour on a steady state basis, as determined by the physical design and physical characteristics of the unit.

  • 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.

  • Temporary clean coal technology demonstration project means a clean coal technology demonstration project that is operated for a period of five years or less and that complies with the SIP and other requirements necessary to attain and maintain the national ambient air quality standards during the project and after the project is terminated.

  • LWDA means the California Labor and Workforce Development Agency, the agency entitled, under Labor Code section 2699, subd. (i).

  • Supply Start Date means the date(s) specified in clause 2.8;

  • main phase employment and support allowance means an employment and support allowance where the calculation of the amount payable in respect of the applicant includes a component under section 2(1)(b) or 4(2)(b) of the Welfare Reform Act 2007 except in Part 1 of Schedule 1;

  • 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:

  • Basic Comprehensive User Guide means the Ministry document titled Basic Comprehensive Certificates of Approval (Air) User Guide” dated April 2004 as amended.

  • 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 test means tests applied to a distributed generation facility by the applicant after construction is completed to verify that the facility does not create adverse system impacts and performs to the submitted specifications. At a minimum, the scope of the commissioning tests performed shall include the commissioning test specified in Institute of Electrical and Electronics Engineers, Inc. (IEEE) Standard 1547 Section 5.4 "Commissioning tests".

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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.

  • Development Project means a project for the development of land within a project area.

  • 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.

  • Stage 2 means the construction of the second hotel and other developments facilities and amenities referred to in the Development Proposals;

  • LOCKHEED XXXXXX Procurement Representative means a person authorized by LOCKHEED XXXXXX'x cognizant procurement organization to administer and/or execute this Contract.

  • Implement of husbandry means a vehicle that is designed for agricultural purposes and