Bioanalysis Plan definition
Examples of Bioanalysis Plan in a sentence
No amendment, modification, release or discharge to this Agreement, the Quality Agreement or any material amendment, modification, release or discharge to a Bioanalysis Plan, a Statistical Analysis Plan, or a CRO Agreement (to the extent provided in Section 2.4(o)) shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.
Except as may be required under this Agreement, a Bioanalysis Plan, or a Protocol, BioXcel shall not perform, and shall not allow any Third Parties to perform, any analytical testing of the quantities of Nektar Compound supplied to it under this Agreement.
Except as may be required under this Agreement, a Bioanalysis Plan, or a Protocol, Nektar shall not perform, and shall not allow any Third Parties to perform, any analytical testing of the quantities of BMS Compound supplied to it under this Agreement.
Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2 Protocol, Statistical Analysis and Bioanalysis Plan (the “Term”); provided that if termination language in Sections 2.1(e) applies, then the Term shall expire.
Amendments to this Agreement, the Pharmacogivilance Agreement, and Quality Agreement shall be executed in the form of a written amendment in accordance with Section 14.1. Amendments to a Protocol, Bioanalysis Plan or Statistical Analysis Plan may be made in writing by approval of a JPT (without a formal amendment to this Agreement pursuant to Section 14.1).
Study Costs shall also include the out-of-pocket costs of the PD-L1 Expression Testing (and any exploratory biomarker analysis to be conducted by BMS as specified in the Bioanalysis Plan), and the out-of-pocket costs of the Biomarker Testing (and any exploratory biomarker analysis to be conducted by the Company as specified in the Bioanalysis Plan).
Except as may be required under this Agreement, a Bioanalysis Plan, or a Protocol, Nektar shall not perform, and shall not allow any Third Parties to perform, any analytical testing of the quantities of BMS Assets supplied to it under this Agreement.
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ Title: President and CEO Title: President Date: January 25, 2013 Date: 1/25/13 Exhibit A: 2-DAA Drug-Drug Interaction Clinical Trial Protocol Synopsis Exhibit B: ▇▇▇▇▇ ▇ Clinical Trial Protocol Synopsis Exhibit C: Study Design from December 2012 meeting Exhibit D: Bioanalysis Plan Exhibit E: Collaboration Budget Exhibit F: Initial Press Release Exhibit G: Compliance with Laws Author(s): ▇▇▇▇▇ D, ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇ JZ, ▇▇▇▇ XJ Sponsor: Idenix Pharmaceuticals, Inc.
Study Costs shall also include (1) the out-of-pocket costs of the [***] (and any exploratory biomarker analysis to be conducted by BMS as specified in the Bioanalysis Plan) in accordance with the Study protocol and (2) the out-of-pocket costs of the [***] (and any exploratory biomarker analysis to be conducted by Checkmate as specified in the Bioanalysis Plan) in accordance with the Study protocol.
Except as may be required under this Agreement, a Bioanalysis Plan, or a Protocol, BMS shall not perform, and shall not allow any Third Parties to perform, any analytical testing of the quantities of Exelixis Compound supplied to it under this Agreement.