Pediatric Study definition

Pediatric Study means the pediatric clinical study of the Licensed Product that, as of the effective date of the ex-US Agreement, was being designed and prepared by Protalix, to be conducted in accordance with Section 3.2(d).
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Pediatric Study shall have the meaning set forth in Section 5.1(b).
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Pediatric Study means the ongoing Clinical Trial entitled “An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus.”
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Examples of Pediatric Study in a sentence

  • FDA is announcing the availability of a draft guidance for industry entitled ‘‘Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.’’ The purpose of this draft guidance is to assist sponsors in the submission of an initial PSP and any amendments to the PSP.

  • Promptly after the Amendment Effective Date, the Parties will designate Liaisons to receive communications and to communicate regarding (a) the conduct of Clinical Trials by a Party during the Term in which Product containing VX-950 is administered, including for the Pediatric Study, and (b) the Agreement.

  • Notwithstanding anything to the contrary in this Agreement or the Ex-US Agreement, the Parties shall agree, through the Steering Committee, and in accordance with Section 3.3, on which Party will conduct the Pediatric Study.

  • The Parties shall as promptly as practicable wind down all “other” activities, if any, contemplated by the Global Development Plan as of the Amendment Effective Date (“other” meaning other than the Pediatric Study, the conduct of which shall be governed by Section 3.4 of this 2013 Amendment, the Extend Study, the conduct of which shall be governed by Section 3.5 of this 2013 Amendment, and the Specific Studies).

  • Except with respect to the Immunization Study and the Pediatric Study, which shall be conducted by ZARS at ZARS’ expense to the extent provided above, ENDO shall be responsible for conducting any and all additional clinical studies with respect to the Licensed Product in the Territory during the term of this Agreement, which studies shall be conducted at ENDO’s sole reasonable discretion.

  • The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the respective Pediatric Study Plan and Pediatric Investigation Plan (PIP) enabling us to initiate clinical trials in children.

  • AMAG shall promptly provide Takeda with copies of all data and reports with respect to the conduct of each Initial Study, U.S. Study, Pediatric Study and Future Required Study as such data and reports become available.

  • The Parties’ Liaisons shall review any proposed amendments to the Pediatric Study presented by either Party and may approve or disapprove any such proposed amendments; provided that such Pediatric Study shall be amended by the Parties to the extent required by any relevant Regulatory Authority.

  • Disagreements regarding the Pediatric Study that cannot be resolved by the Liaisons shall be submitted for resolution as Unresolved Matters under the provisions of Section 14.2 of the Parent Agreement.