Clinical Development Program means activities associated with the clinical development of a Drug Product Candidate which are conducted by or at the direction of CombinatoRx, its Affiliates, licensees or sublicensees, including but not limited to: (a) manufacture and formulation of Drug Product Candidates for use in clinical trials; (b) planning, implementation, evaluation and administration of human clinical trials; (c) manufacturing process development, scale-up and manufacture/analysis/ quality control/quality assurance of Drug Product Candidate for clinical trials; (d) preparation and submission of applications for Regulatory Approval; and (e) post-market monitoring of approved drug indications, as required or agreed as part of a marketing approval by any governmental regulatory authority.
Examples of Clinical Development Program in a sentence
During each Clinical Development Program, Athersys, after consulting with the JSC, shall direct all Clinical Development Program activities through the completion of Phase I Studies.
During each Clinical Development Program, Angiotech shall direct all Clinical Development Program activities after the completion of Phase I Studies.
For each Collaboration Antigen, during the Research Term for the applicable Research Candidates and following review of the data from activities under the applicable Research Plan, the JSC will select a Research Candidate that specifically targets such Collaboration Antigen to be a Development Candidate for Development pursuant to an Early Clinical Development Program in accordance with the terms and conditions of this Agreement.
Except as otherwise expressly provided in this Agreement, all matters regarding the Early Clinical Development Program and the Late Clinical Development Program will be decided by unanimous agreement by the JDC.
About the Opdivo Clinical Development Program Bristol-Myers Squibb’s global development program founded on scientific expertise in the field of Immuno-Oncology includes a broad range of clinical trials studying Opdivo, across all phases, including Phase 3, in a variety of tumor types.