Clinical Development definition

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.

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Clinical Development means Clinical Studies, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval.

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

The Clinical Research Plan will include: (a) a description of the Research Program Activities and each Party’s obligations in connection therewith; (b) the projected timelines for completion of the Research Program Activities; (c) an estimated budget for the Clinical Development activities (the “Clinical Development Budget”); and (d) a clinical trial synopsis with respect to the Clinical Study.
Moderna may terminate this Project Agreement in the event that Immatics’ has given notice to Moderna pursuant to Section 8.2.2 that the anticipated Clinical Development Costs for a given Calendar Year are [***], and the Parties are unable to agree on a mitigation strategy within [***] of such notice.
The Parties will execute a pharmacovigilance agreement (the “Pharmacovigilance Agreement”) by the earlier of: (a) [***] following the Effective Date; and (b) [***] prior to the initiation of Clinical Development activities under the Clinical Research Plan, to ensure the exchange of relevant safety data within appropriate timeframes and in an appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews.
Subject to Section 8.2.2, Moderna shall be responsible for all Clinical Development Research Program Costs incurred by either Party in connection with Clinical Development Research Program Activities under the Clinical Research Plan.
For clarity, In no event shall Immatics be required to incur any Clinical Development Research Program Costs that are not reimbursed by Moderna, and in no event shall Moderna be required to reimburse Immatics for any Clinical Development Research Program Costs that [***].

More Definitions of Clinical Development

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 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 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 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 means the trials conducted in human subjects to determine the safety, efficacy and pharmacokinetics of a compound as required by the US FDA. Clinical Development includes Phase I, Phase II, Phase III (and IV if required), and the New Drug Application (NDA) for Regulatory Approval by the FDA .

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.