IND-Enabling Studies for Development Candidate Clause Samples
The "IND-Enabling Studies for Development Candidate" clause defines the requirements and procedures for conducting studies necessary to support the filing of an Investigational New Drug (IND) application for a selected development candidate. Typically, this clause outlines the types of preclinical studies that must be completed, such as toxicology, pharmacokinetics, and safety assessments, and may specify timelines, responsibilities, and reporting obligations between the parties involved. Its core function is to ensure that all essential data is generated and regulatory prerequisites are met, thereby facilitating a smooth and timely IND submission process.
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IND-Enabling Studies for Development Candidate. For each Development Candidate, the Parties (jointly or unilaterally) may conduct IND-enabling Non- Clinical Studies (such as pharmacokinetics studies, metabolism studies, toxicology studies and genotoxicity studies) to characterize such Development Candidate and to determine whether to further pursue Development of such Development Candidate in Phase I Clinical Studies. The plan for the initial undertaking to characterize the Development Candidates existing as of the Effective Date is set forth in the Joint Exploratory Development Plan. The Parties anticipate that the characterization of other Development Candidates, as they become designated as such during the course of this Agreement, will also be conducted, either jointly as part of an amended Joint Exploratory Development Plan in accordance with Section 4.3(a), or unilaterally as part of a Unilateral Exploratory Development Plan in accordance with Section 4.4.