End of Phase 1 Date definition

End of Phase 1 Date means, with respect to a given Program, the earlier of (a) (i) the date on which Prothena delivers to Celgene the first complete Phase 1 Data Package, if any, for such Program, in accordance with Section 2.2.3(b) or (ii) the date deemed the “End of Phase 1 Date” pursuant to Section 2.5.2 (as applicable), or (b) such other date as approved by the JSC with respect to such Program (this clause (b), an “Alternative End of Phase 1 Date” for a given Program).
Sample 1Sample 2Sample 3
End of Phase 1 Date means, with respect to an Available Target, the date that is forty-five (45) days after the delivery by EPIZYME to CELGENE of a complete Phase 1 Data Package for a Development Candidate directed to such Available Target, as such date may be extended pursuant to Section 2.8.4.
Sample 1Sample 2Sample 3
End of Phase 1 Date means, with respect to a given Program, the earlier of (a) (i) the date on which Prothena delivers to Celgene the first complete Phase 1 Data Package, if any, for such Program, in accordance with Section 2.2.3(b) or (ii) the date deemed the “End of Phase 1 Date” pursuant to Section 2.5.2 (as applicable), or (b) such other date as approved by the JSC with respect to such Program (this clause (b), an “ Alternative End of Phase 1 Date ” for a given Program).
Sample 1

Examples of End of Phase 1 Date 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).

  • 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.

  • 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 .

Related to End of Phase 1 Date

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

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

  • Project Commencement Date means the commencement date notified to the Minister pursuant to clause 4(1);

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

  • 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;

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

  • 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.

  • 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.

  • Commissioning Period means, with respect to each Subproject, the period commencing upon the first delivery of Feed Gas to the Subproject in accordance with Sections 4.8 and 11.1 of the Agreement continuing through achievement of RFSU, commissioning, Start Up, Performance Testing and achievement of Substantial Completion for such Subproject.

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

  • Completion Period means the period starting from the date of issue of "Order" and required to complete the work in all respect.

  • Construction Commencement Date means the date set out in the Addendum, if applicable, by which you must commence construction of the Hotel. For the Hotel to be considered under construction, youmust have begun to pour concrete foundations for the Hotel or otherwise satisfied any site-specific criteria for “under construction” set out in the Addendum.

  • 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.

  • Service Commencement Date in respect of a Service or a particular instance of a Service means the date on which that particular Service or particular instance of a Service is first provided to the Customer, or as otherwise explicitly set out in this Agreement;

  • Term Start Date has the meaning set forth in Section 1.01.

  • Project Start Date means the first Milestone Start Date specified in Schedule B;

  • Services Commencement Date means the date delivery of the Services shall commence as specified in the Key Provisions. If no date is specified in the Key Provisions this date shall be the Commencement Date;

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

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Framework Commencement Date means [insert date dd/mm/yyyy];

  • 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.

  • Date of commencement of the project means the date of the agreement.

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

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

  • Tests after Completion means the tests (if any) which are specified in the Contract and which are carried out in accordance with the Specification after the Works or a Section (as the case may be) are taken over by the Procuring Entity.