Clinical Studies definition

Clinical Studies means a Phase ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

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Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

Clinical Studies means ▇▇▇▇▇ ▇, ▇▇▇▇▇ ▇, ▇▇▇▇▇ ▇, ▇▇▇▇▇ 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

Examples of Clinical Studies in a sentence

• LICENSOR and LICENSEE shall jointly determine personnel, including without limitation investigators, principal investigators, study coordinators, research pharmacists, study physicians (“Clinical Study Personnel”) and sites for the conduct of Clinical Studies for the LICENSED PRODUCT within the Licensed Field.

• LICENSEE shall bear all costs and expenses reasonably incurred by LICENSOR in performance of the R&D Work (“R&D Costs”), including, but not limited to personnel costs, costs of purchasing research equipment, materials, clinical trial consultations, pre-review costs, and Clinical Studies.

• LICENSOR hereby agrees to use commercially reasonable efforts to conduct any and all research and development activities, including without limitation Clinical Studies (“R&D Work”) reasonably necessary to develop Licensed Product within the Territory for use within the Licensed Field, including, without limitation, to obtain Market Approval.

More Definitions of Clinical Studies

Clinical Studies means Phase 0, Phase I, Phase II, Phase III, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more Indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such Indication.

Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

Clinical Studies means all Clinical Phase I Studies, Clinical Phase II Studies and Clinical Phase III Studies, including pivotal studies.

Clinical Studies means any study in which human subjects are dosed with a drug, whether approved or investigational, including any Phase 1, 2, 3 or 4 study.

Clinical Studies means research studies in humans that are (a) designed in accordance with international ethical and scientific quality standards for designing, conducting, recording, and reporting research studies involving investigational medicinal products for human use and that involve the participation of human subjects, which standards are established through applicable Laws, and (b) designed to generate clinical data and results regarding a biological molecule in support of Marketing Approval, including any translational research studies. Clinical Studies include, but are not limited to, any ▇▇▇▇▇ ▇ Clinical Study, Phase 2 Clinical Study, or Pivotal Clinical Study.

Clinical Studies means collectively any Phase I Clinical Studies, Phase II Clinical Studies, Phase III Clinical Studies and Phase IV/Post-Approval Clinical Studies, and any other study in which human subjects are dosed with a drug, whether approved or investigational, in each case of a Licensed Product within the Field.

Clinical Studies means Phase I Clinical Studies, Phase II Clinical Studies, Phase III Clinical Studies, and/or Post-Registration Studies.