New Study Completion Date definition

New Study Completion Date means the date of Licensee’s receipt of a written certificate executed by a duly authorized officer of Licensor attesting that Licensee has received all results and data from Licensor resulting from the New Study, including, but not limited to, clinical study reports, Regulatory Materials, CMC Information, test data (including pharmacological, biological, chemical, biochemical, clinical test data and data resulting from non-clinical studies), stability data and other study data, procedures, analytical methods, formulations, formulae, techniques, processes, specifications, materials and any other data necessary for the continued Development of AST-005, in a reasonably organized and readable format.
Sample 1
New Study Completion Date means the date of Licensee’s receipt of a written certificate executed by a duly authorized officer of Licensor attesting that Licensee has received all results and data from Licensor resulting from the New Study, including, but not limited to, clinical study reports, Regulatory Materials, CMC Information, test data (including pharmacological, biological, chemical, biochemical, clinical test data and data resulting from non-clinical studies), stability data and other study data, procedures, analytical methods, formulations, formulae, techniques, processes, specifications, materials and any other data necessary for the continued Development of AST-005, in a reasonably organized and readable format. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
Sample 1

Examples of New Study Completion Date in a sentence

  • The AST-005 Option will be exercisable during the period commencing on ***** and ending ***** after the New Study Completion Date (“AST-005 Option Exercise Period”).

Related to New Study Completion Date

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

  • 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;

  • Substantial Completion Date means the date on which Substantial Completion occurs.

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

  • The Completion Date means the date of completion of the Works as certified by the Employer’s Representative.

  • Final Completion Date means the date on which Final Completion occurs.

  • 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.

  • 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.

  • 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;

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

  • 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 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).

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

  • 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.

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

  • Feasibility Study means a comprehensive study of a deposit in which all geological, engineering, operating, economic and other relevant factors are considered in sufficient detail that it could reasonably serve as the basis for a final decision by a financial institution to finance the development of the deposit for mineral production;

  • 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 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.

  • Scheduled Completion Date shall be the date set forth in Clause 10.3;

  • Study Period means the period commencing at 9:00 a.m. on the date hereof, and continuing through 5:00 p.m. on the Closing Date.

  • 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;

  • Completion Deadline means August 15, 2018, or such later date as may be agreed to in writing by the Parties;

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.