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 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 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 purpose of this Amendment is to change certain terms of the Letter of Intent (LOI) for the proposed Cooperative Research and Development Agreement (CRADA) entitled “Preclinical and Clinical Development of 1-Methyl [d]-Tryptophan as an Anticancer Agent.” These changes are reflected below, and except for these changes, all other provisions of the original CRADA LOI remain in full force and effect.

• If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then such matter shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement.

• Any dispute between the Parties with respect to the conduct of such Development activities shall be referred to the Vice President, Clinical Development and Medical Affairs of Infinity and the Head of Development of Novartis Oncology for good faith resolution.

• Said written reports shall be complete and accurate and, where appropriate, will contain raw data from the Clinical Development of the Product carried out by or on behalf of Licensee.

• Connetics shall notify Genentech in writing when it achieves a Clinical Development Milestone.

More Definitions of Clinical Development

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 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 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 activities in the Field relating to developing, preparing and conducting clinical trials.

Clinical Development means any and all Development activities performed by a Party following the achievement of animal in vivo proof of concept Milestone.