Develop or Development means, with respect to a particular Product, engaging in preclinical, clinical and other pharmaceutical product development activities, including, in particular, scientific, technical data, work, development and manufacturing operations directed towards Regulatory Approval of a Product in the Territory such as the preparation and filing of an NDA with the FDA.
Develop or Development means to physically remove fine materials and sediment generated during construction of the well, by means including but not limited to surging, air surging or lifting, over pumping, backwashing, high velocity jetting or bailing of the completed well.
Develop or Development means all activities relating to preparing and conducting preclinical testing, toxicology testing, human clinical studies, regulatory affairs for obtaining the Regulatory Approvals, formulation development, process development for manufacture and associated validation, quality assurance and quality control activities (including qualification lots). Development shall exclude all Phase IV Clinical Trials.
Examples of Develop or Development in a sentence
Develop or Development shall mean research, discovery, modification and preclinical and clinical drug and/or biological development activities, including test method development and stability testing, toxicology, formulation, quality assurance/quality control development, statistical analysis, clinical studies and regulatory affairs, approval and registration in each case, of the Product for use in the Field.
More Definitions of Develop or Development
Develop or Development means to plan, design, develop, finance, lease, acquire, install, construct, or expand.
Develop or Development. : shall mean all activities relating to preparing and conducting preclinical testing, toxicology testing, human clinical studies, regulatory affairs for obtaining the Regulatory Approvals, formulation development, process development for manufacture and associated validation, quality assurance and quality control activities (including qualification lots). Development shall exclude all Phase IV Clinical Trials.
Develop or Development means all activities undertaken by or on behalf of a Party under this Agreement (whether inside or outside the Territory) to develop a Collaboration Product (including, without limitation, line extensions) in order to achieve Regulatory Approval or enhancements to product labeling of such Collaboration Product for the Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission. Territory, as approved by the CSC and in accordance with the applicable Development Program, including such clinical studies and other activities conducted by the Parties with the intent of, and as are necessary to, generate data for submission to regulatory authorities in support of an application for Regulatory Approval necessary to permit the Commercialization of the Collaboration Product (including, without limitation, line extensions) for the Territory. For clarity, Teva shall have the right to use any data generated from the Development of a Collaboration Product to support Regulatory Approval or enhancements to product labeling of such Collaboration Product outside of the Territory. When used as a verb, “Develop” means to engage in Development. For clarity, the term “Development” may include research on new formulations (such as extended-release formulations) and new indications, to the extent such work is included in a Development Program.
Develop or Development means the conduct of any and all non-clinical and clinical research and development, including, among other things: drug discovery, toxicology studies, DMPK studies and other non-clinical efforts, statistical analysis, the design and conduct of any Clinical Trials, formulation, regulatory activities including applying for and obtaining Marketing Authorization, with respect to the Licensed Compound and/or the Licensed Product in the Field, that are reasonably required or useful to obtain or maintain any Regulatory Approvals of the Licensed Compound and/or the Licensed Product in the Field in the Territory.
Develop or Development means the engagement of authors to write the content of the Product, and the giving of editorial direction to the writing of the authors;
Develop or Development means an activity that requires a building permit.
Develop or Development means any Improvement to a Parcel on which no previous Improvements have been constructed.