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.
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End of Phase 1 means ninety (90) days from the Closing Date or such earlier date as mutually agreed upon by the Parties.
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End of Phase 1 means the date of completion of a particular Phase 1 clinical trial.
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Examples of End of Phase 1 in a sentence

  • A joint research committee (the “JRC”) shall monitor the progress of the research program for Potential Licensed Compounds, and permit collaboration, wherever possible, during compound discovery through GLP Tox Completion or End of Phase 1, as applicable, for any given Potential Licensed Compound.

  • 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).

  • 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.

  • EXHIBIT 3 Buyer shall transition the sale and support of the Products from Seller’s sites to Buyer’s designated sites by the End of Phase 1.

  • Please revise the Summary to disclose your plan to conduct an End of Phase 1 meeting with the FDA.

  • Establishment and completion of its own product distribution chain (which shall be completed by no later than the End of Phase 1).

  • Schedule 1.320 Triple Combination End of Phase 1 Success Criteria [...***...] * Confidential information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission.

  • End of Phase 1: [****] Interim analysis of [****] [****] The JDC will assess the possibility and desirability of [****] for testing [****].

  • Maximum Term: Commencing on the Closing Date and for a period ending on the later of (a) ninety (90) days or (b) the End of Phase 1.

  • For clarity, AbbVie may elect to, but shall not be required to, proceed with the Development of a Triple Combination Product if such Triple Combination Product does not satisfy the Triple Combination End of Phase 1 Success Criteria, in which case, such failure to satisfy the Triple Combination End of Phase 1 Success Criteria shall not be a Combination POC Development Failure.

Related to End of Phase 1

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

  • 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.

  • Completion of work means completion of the entire contracted work. Exhaustion of quantity of any particular item mentioned in the bid document shall not imply completion of work or any component thereof.

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

  • 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.

  • 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.

  • 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 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.

  • 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.

  • 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;