Safety Study definition

Safety Study means [***].
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Examples of Safety Study in a sentence

  • Other than the first Phase 1 Safety Study for the Regional Antibody Candidates and Regional Licensed Products (subject to Section 8.2.3), Novartis has the sole responsibility to Manufacture (or have Manufactured) Regional Antibody Candidates and Regional Licensed Products for use in Development of such Regional Antibody Candidates and Regional Licensed Products in the Novartis Territory and the Surface Territory.

  • Subject to Section 8.2.3, Surface will be responsible for [***] of all Manufacturing Costs relating to Regional Antibody Candidates and Global Licensed Products incurred by or on behalf of Surface to support the first Phase 1 Safety Study for Regional Antibody Candidates and Regional Licensed Products.

  • Other than the first Phase 1 Safety Study for the Regional Antibody Candidates and Regional Licensed Products (subject to Section 8.2.3), Surface shall reimburse Novartis for [***] of all Manufacturing Costs relating to Regional Antibody Candidates and Regional Licensed Products incurred by or on behalf of Novartis for use in the Development of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory.

  • Subject to Section 8.2.3, and subject to the oversight of the JDC, Surface has the sole responsibility to Manufacture (or have Manufactured) Regional Antibody Candidates and Regional Licensed Products for use in the first Phase 1 Safety Study for the Regional Antibody Candidates and Regional Licensed Products in accordance with the RLP Development Plan.

  • Sections 1, 2.2(ii), 4.2.2 (to the extent of each Party’s right to use the Shell Safety Study Data thereunder) 5.5, 6.1, 8.1, 10, 11, 12, and all provisions of this Agreement necessary to give effect to the foregoing Sections, shall survive expiration or termination of this Agreement.

  • The CITY shall provide a Traffic Operations and Safety Study (“STUDY”) detailing the operations of the TRAFFIC SIGNAL and TRAFFIC CONTROL during and after the CLOSURE and provide an operational and safety summary that recommends restoration of pre-construction traffic control, retaining the new TRAFFIC SIGNAL and TRAFFIC CONTROL, or providing additional modifications.

  • The Mandatory Post-Approval Safety Study Costs in the Commercialization Budget shall be reasonably determined by FibroGen WFOE in light of the applicable requirements for the Mandatory Post-Approval Safety Studies.

  • It is anticipated that the Traffic Operations and Safety Study dated August 2020 may be referenced within the Project Concept Statement.

  • The researchers have data from the subset of heart failure patients from EXCLAIM (Extended Clinical Prophylaxis in Acutely Ill Medical Patients), MAGELLAN (Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Acutely Ill Medical Patients Comparing Rivaroxaban with Enoxaparin), and APEX (Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban) trials.

  • The Site will conduct the study entitled “A Phase 3 Randomized, Double-blind, Placebo- controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)” (the “Study”) at Institution in strict accordance with the Protocol, incorporated herein by reference, as may be further amended pursuant to the terms of this Agreement (the “Protocol”).