Clinical Development definition

Clinical Development means the conduct of studies of the Product in humans in the Field to assess the dosing, safety and/or efficacy of the Product, including but not limited to Xxxxx 0 Clinical Trials, Phase 2 Clinical Trials and Phase 3 Clinical Trials, or as required by the applicable Regulatory Authority.

Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

Clinical Development means all activities required for MARKET APPROVAL of PRODUCT in the TERRITORY (including without limitation clinical trials and toxicology studies), as well as all clinical activities desirable for optimized marketing of PRODUCT in the TERRITORY (including without limitation phase IIIb and phase IV studies). This term does not include any activities necessary for manufacture and/or supply of PRODUCT;

Examples of Clinical Development in a sentence

• ATAI shall pay to the Company $[***] upon the certification by the Board (as confirmed by ATAI, which confirmation not to be unreasonably withheld) of an update to the Initial Clinical Development Plan, which update will include go/no-go decisions governing the conduct of the POC Study.

• Subject to the terms and conditions of this Agreement, as between the Parties, Licensee will be solely responsible for and will conduct all activities under the Japanese Clinical Development Plan (“Development Activities”) at its sole cost.

• As between the Parties, Licensor or its designee will maintain a global safety database for Clinical Trials for the Licensed Products, including those Clinical Trials conducted under a Japanese Clinical Development Plan.

• Licensee will be responsible for reporting and responding to all quality complaints, adverse events, and safety data related to such Licensed Product for all Clinical Trials conducted under a Japanese Clinical Development Plan.

• The initial high-level Japanese Clinical Development Plan for each Licensed Product is set forth on Schedule 4.2 (Japanese Clinical Development Plans) attached hereto.

More Definitions of Clinical Development

Clinical Development means any and all Development activities to be conducted in humans related to or in furtherance of Regulatory Approval, including all clinical trials and any such post-approval regulatory commitments, or Post-Approval Clinical Trials. The Clinical Development activities to be performed as part of the Collaboration shall be as described in the applicable Product Work Plan.

Clinical Development means all clinical development activities relating to obtaining Regulatory Approval to market and sell Licensed Product for a particular indication, dose or formulation (but not including post-Regulatory Approval activities required by the relevant regulatory authority to support such Regulatory Approval in a country or other post-approval product support clinical trials undertaken by the Parties, including any Phase IV Trials).

Clinical Development means the conduct of studies of a medicinal product in human subjects in order to—

Clinical Development means those pre-clinical and clinical activities, including post Regulatory Approval studies that are necessary or reasonably useful to obtain or maintain Regulatory Approval for a product for an indication, including testing in animals for purposes of obtaining or maintaining a Regulatory Approval.

Clinical Development or “Clinically Develop” means all Development activities which are directed to the preparation for, conduct of, and analysis of a clinical trial or study of the Product, including, without limitation, as applicable, preclinical testing, toxicology, the examination of particular patient sub-populations within a given indication, and regulatory affairs which do not relate specifically to manufacturing of the Product (including preparation and submission of Regulatory Materials but excluding the Chemistry Manufacturing and Controls related portions of an such Regulatory Materials).

Clinical Development means all Development activities in humans for a Candidate or Product undertaken from and after Initiation of the first Phase I Clinical Trial for such Candidate or Product, including conduct of each Clinical Trial.

Clinical Development means, with respect to a Licensed Product or Combination Product, [***] as the case may be, [***].