End of Phase 1 definition

End of Phase 1 means, for a given Potential Licensed Compound, the completion of all the criteria listed in Schedule 5 during the Collaboration Period.
End of Phase 1 means the date of completion of a particular Phase 1 clinical trial.
End of Phase 1 means ninety (90) days from the Closing Date or such earlier date as mutually agreed upon by the Parties.

Examples of End of Phase 1 in a sentence

  • For the avoidance of doubt, with respect to a given Program, during the period from the end of the End of Phase 1 Date until the end of the Phase 1 Option Period for such Program, no further activities shall be conducted by or on behalf of Prothena with respect to such Program (including the Collaboration Target, Collaboration Candidates or Collaboration Product thereunder), unless agreed to by Celgene in writing (such agreement not to be unreasonably withheld).

  • Increasing the use of community pharmacy also forms part of the future vision for urgent care set out in NHS England (2013b) Urgent and Emergency Care Review, End of Phase 1 report.

  • Celgene shall have the right to exercise its Phase 1 Option with respect to such Program as set forth in Article 3 (including entering into a Global License Agreement for such Program with Prothena), with the date that Prothena so delivers the complete Phase 1 Data Package for such Program being deemed be the End of Phase 1 Date for such Program, and the provisions of Article 3 shall apply in connection therewith, mutatis mutandis.

  • Betty faced resistance at first from colleagues as she started the project; however, the collaborative approach adopted allowed her to gain the respect and collaboration of colleagues for the initiative.

  • Our strategy has been strongly influenced by the vision from NHS England’s (November 2013) End of Phase 1 report, Transforming urgent and emergency care services in England - Urgent and Emergency Care Review, which defines five key elements for future urgent and emergency care services in England.

  • For clarity, once delivered an End of Phase 1 Opt-Out Notice will be irreversible.

  • Under the conditions ZS=0.03-j19 Ω and ZL=14.9-j370 Ω, a large value of τ =-14.7 dB was obtained at the lowest frequency of 200 MHz. This phenomenon is caused by the strong magnetic-coupling between two loop anten- nas in the near-field region, while this phenomenon was not appeared between two dipole antennas.

  • Table 3.12 Between Treatment Comparisons for the Change from the End of Phase 1 in msSBP (mmHg) at the End of Phase 2 (FAS 2) N is the number of FAS2 patients with non-missing measurement at Week 8 or LOCF value.

  • Table 3-14 Between Treatment Comparisons for Change from Baseline in msDBP (mmHg) at the End of Phase 1 (FAS1) * For change from baseline to end of Phase 1 in msDBP, the ANCOVA model is fitted with weight, age, region and hypertension etiology as factors and baseline msDBP and dose ratio as covariates.

  • Such payment obligations will be based on the Parties’ respective contributions as of the date of the applicable effective of End of Phase 1 Opt-Out Notice ([***]) and risks assumed.

Related to End of Phase 1

  • 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.

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

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

  • 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.

  • 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.

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

  • 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.

  • Project Completion means the date, as determined by the Division after consultation with the Recipient, that operation of the Project is initiated or is capable of being initiated, whichever comes first.

  • 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.

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

  • 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.

  • The Project Plan means the document to be developed by the Supplier and approved by the Purchaser, pursuant to GCC Clause 19, based on the requirements of the Contract and the Preliminary Project Plan included in the Supplier’s bid. The “Agreed and Finalized Project Plan” is the version of the Project Plan approved by the Purchaser, in accordance with GCC Clause 19.2. Should the Project Plan conflict with the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Single Phase Aerosol Air Freshener means an aerosol air freshener with the liquid contents in a single homogeneous phase and which does not require that the product container be shaken before use.

  • Backflow Prevention Assembly means any mechanical assembly installed at a water service line or at a plumbing fixture to prevent a backflow contamination event, provided that the mechanical assembly is appropriate for the identified contaminant at the cross connection and is an in-line field-testable assembly.

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

  • Program of study means a curriculum that requires a candidate to demonstrate and document competency in the specific knowledge, skills, and dispositions for a particular endorsement to an educator’s license, a licensure content area, or level of licensure, and is:

  • Construction Completion Date means the Completion Date of the Construction as specified in the Statutory Declaration of Completion for the Project;

  • Project Commissioning means the Project will be considered as commissioned if all equipment as per rated project capacity has been installed and energy has flown into grid, in line with the Commissioning procedures defined in the RfS/PPA.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Statement of Work means the description of activities performed in completing the Project, as specified in the Contract and as may be amended.

  • Project Description means the document that describes the Project's Reduction activities and that uses either the VCS Project Description Template or the project description template specified by the relevant Approved GHG Program;

  • Project Schedule means a document that, with respect to each Phase of the Project, identifies, coordinates and integrates the anticipated design and construction schedules, the Contracting Authority’s and Owner's responsibilities, government authority reviews and other activities as are necessary for the timely completion of the Work.

  • service delivery and budget implementation plan means a detailed plan approved by the mayor of a municipality in terms of section 53(1) (c) (ii) for implementing the municipality’s delivery of municipal services and its annual budget.

  • Work Plan means a plan that describes each individual activity to be conducted to complete eligible activities and the associated costs of each individual activity.

  • 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;

  • Stage 1 means the area at Port Xxxxxxx which is the subject of this Agreement and of the ERMP and which is shown bordered in purple as “stage 1” on Department of Land Administration 4 Miscellaneous Plan No. 1743;