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).
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End of Phase 1 Date means the earlier of (a) (i) the date on which Prothena delivers to Celgene the first complete Phase 1 Data Package in accordance with Section 2.2.1(b), (ii) the date[***], or (iii) the date [***], or (b) such other date as approved by the JDC (this clause (b), an “Alternative End of Phase 1 Date”).
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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.
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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.

  • As may be necessary from time to time prior to the End of Phase 1 Date, each Party may propose an update to the PRX019 Clinical Development Plan and will submit each such updated PRX019 Clinical Development Plan to the JDC to review, discuss, and determine whether to approve.

  • 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 .

  • For the avoidance of doubt, during the period from the end of the End of Phase 1 Date until the end of the Celgene Decision Term, no further activities shall be conducted by or on behalf of Prothena with respect to the Licensed Program (including the Licensed Target, Licensed Antibodies or Licensed Products thereunder), unless agreed to by Celgene in writing (such agreement not to be unreasonably withheld).

  • If EPIZYME does not materially provide such requested additional information to CELGENE (or its designee) within such [**] day period, the End of Phase 1 Date with respect to such Available Target shall be extended by a period of time equal to the number of days after such [**] day period during which EPIZYME fails to materially provide such requested additional information.

  • Clinical Trial (including publications in journals, posters, presentations at conferences and abstracts submitted in advance of conferences) for communications prior to the Celgene Decision Date; (v) discuss and attempt to resolve any JDC disputes; (vi) determine the Alternative End of Phase 1 Date, if any; and (vii) perform such other responsibilities as may be mutually agreed by the Parties from time to time.

Related to End of Phase 1 Date

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

  • 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.

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

  • 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.

  • Commissioning Period has the meaning set forth in Attachment T.

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

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • 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 means the date the Transmission Provider begins to provide service pursuant to the terms of an executed Service Agreement, or the date the Transmission Provider begins to provide service in accordance with Tariff, Part II, section 15.3 or Tariff, Part III, section 29.1.

  • 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, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory 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.