Phase III Completion definition

Phase III Completion means the issuance of a study report upon completion of all Phase III Studies for a Licensed Product under the Development Plan.
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Phase III Completion means the completion of a data package for a Phase III study with respect to a Collaboration Product, which data package is sufficient to support the filing of an approvable BLA for such Collaboration Product in Japan, the United States, the United Kingdom, France, Germany or the European Union as a whole.
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Phase III Completion means, with respect to a Unilateral Target, the completion of a data package for a Phase III study with respect to the first Unilateral Product with respect to such Unilateral Target, which data package is sufficient to support the filing of an approvable BLA for such Unilateral Product in a Major Market.
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Examples of Phase III Completion in a sentence

  • If selected to receive funding, the applicant must submit a site-specific environmental cost estimate (or MCP Phase III Completion Report including a cost estimate) from a Massachusetts Licensed Site Professional (see http://public.dep.state.ma.us/LSP/lspsearch.htm for a list of LSPs).

  • 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.

  • Approved to seek approval to request Interim Finance Committee approval to increase the scope of work from $7 million to $10 million on the Mackay Mines, Phase III Completion at UNR.

  • A Phase III Completion Statement form, established by the Department for such purposes, shall be appended to and submitted with the Remedial Action Plan to the Department.

  • 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.

  • If selected to receive funding, the applicant must submit a site-specific environmental cost estimate (or MCP Phase III Completion Report including a cost estimate) from a Massachusetts Licensed Site Professional (see https://www.mass.gov/how-to/hiring-a-licensed-site-professional).

  • TheSubject to Section 5.4 of this Agreement, the Project will enable the creation of a total of forty (40) or more jobs during the a five (5) year period beginning October 1, 2012 and continuing until the completion of the five year period immediately following the Phase III Completion Dateending September 30, 2017.

  • 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.

  • The coral avoidance and minimization of injury efforts occurred in three phases.These include: • Phase I: Pre-Demonstration survey of corals and munitions, and assistance with development and review of BMP;• Phase II: Post-recovery survey to assess impacts to coral, loss of corals from munitions recovery, and recommend mitigation strategies for those impacts; and• Phase III: Completion of required coral mitigation activities by the Army.

Related to Phase III Completion

  • 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;

  • 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.

  • 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 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;

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

  • 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.

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

  • 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).

  • 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).

  • Tests on Completion means the tests which are specified in the Contract or agreed by both Parties or instructed as a Variation, and which are carried out under Clause 9 [Tests on Completion] before the Works or a Section (as the case may be) are taken over by the Procuring Entity.

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

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

  • 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 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 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 Date means the date on which Final Completion occurs.

  • 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:

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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 III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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.

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

  • 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 Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.