Development

Development. Means the research and development of the Product, including all aspects of all activities that are necessary to enable the filing of an IND as well as those activities occurring from and after the filing of an IND, through and including obtaining Regulatory Approval of a BLA and any other Regulatory Approvals required for the Manufacture and Commercialization of the Product in a country. Development includes performance of clinical trials that are required by a Regulatory Authority as a... condition to obtaining or maintaining Regulatory Approvals for the Product. When used as a verb, Develop means to engage in Development. View More

Development. Or "Develop" means, with respect to the Licensed Compound and Licensed Product, those activities necessary or useful for research and development, including: preclinical and clinical drug development activities, the conduct of Clinical Trials, test method development and stability testing, toxicology, formulation, and delivery system development, process development, pre-clinical and clinical Licensed Compound and Licensed Product supply, manufacturing scale-up, development-stage manufacturing,... quality assurance/quality control procedure development, and performance with respect to clinical materials, statistical analysis, and report writing, and clinical studies, and regulatory affairs. When used as a verb, "Develop" means to engage in Development View More

Development. Shall mean all activities performed by or on behalf of Cardiokine, its Affiliates or sublicensees in a country or territory with respect to a Licensed Product from the Effective Date that are directly related to obtaining Regulatory Approval of such Licensed Product in such country or territory for the indication under study. When used as a verb, "Develop" shall mean to engage in Development.

Development. Non-clinical and clinical drug development activities pertaining to a pharmaceutical product, including toxicology, pharmacology, test method development and stability testing, process and manufacturing development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies (including pre- and post-approval studies), regulatory affairs, pharmacovigilance and Regulatory Approval and clinical study regulatory... activities (including regulatory activities directed to obtaining pricing and reimbursement approvals). View More

Development. The activities conducted by Piramal under this Agreement to develop, modify or improve all or any part of a Manufacturing Process.

Development. Any and all activities relating to preparing and conducting preclinical testing, toxicology testing, human clinical studies, and regulatory activities (e.g., regulatory applications) with respect to Licensee Product, together with the testing, analysis, expression, manufacture, production and storage of the Licensee Product solely for the purpose of conducting the foregoing activities