Preclinical Development definition

Preclinical Development means the conduct of studies of the Product, in vitro or in animals, to assess the pharmacokinetics and safety (i.e., toxicology, carcinogenicity and mutagenicity) of the Product.

Preclinical Development shall refer to all activities relating to the planning and execution of non-human studies conducted in in vitro or in relevant in vivo animal models directed toward obtaining Regulatory Approval of a Product in each regulatory jurisdiction in the Territory. This includes preclinical testing, pharmacokinetics, toxicology, documentary and medical writing directly related to Preclinical Development activities, and related regulatory affairs and outside counsel regulatory legal services.

Preclinical Development means all pre-clinical and non-clinical Development activities for a Candidate or Product undertaken prior to the commencement of the first Clinical Trial for such Candidate or Product, including non-clinical studies and other material Development activities to be undertaken to generate data sufficient to enable the filing of an IND.

Examples of Preclinical Development in a sentence

• The purpose of the Preclinical Plan is to detail the responsibilities and activities of CytomX and BMS with respect to carrying out the Preclinical Development Program.

• The Preclinical Plan will include a description of the specific activities to be performed by CytomX in support of the Preclinical Development Program, the number of qualified CytomX FTEs to perform the activities in support of the Preclinical Development Program, projected timelines for completion of such activities and, as applicable, provisions for the supply of Compound by CytomX to BMS.

• If BMS has concerns regarding any specific scientist assigned to the Preclinical Development Program, such concerns shall be communicated to the JRC for its consideration.

• If CytomX develops any assays, that are not Tools, used in the Preclinical Development Program, upon request by BMS, CytomX shall transfer to BMS the CytomX Materials and Information to enable BMS to use such assays in support of BMS’ research and development activities under this Agreement.

• Any BMS Materials provided by BMS to CytomX (including, as applicable, any progeny, expression products, mutants, replicates, derivatives and modifications thereof) shall be used by CytomX solely for purposes of conducting the Preclinical Development Program and will be returned to BMS (or destroyed as may be requested by BMS in writing) promptly following the end of the Research Term or earlier upon request by BMS.

More Definitions of Preclinical Development

Preclinical Development means those preclinical studies with respect to the Compounds and/or Products that are specifically required for an IND, including without limitation ADME and GLP toxicology studies, or studies required for the CMC section of an IND or an NDA. It is understood that “preclinical” testing will continue after the filing of an IND in support of the clinical development of a Compound or Product, including ongoing toxicology, metabolic, PK and other non-clinical testing of such Compound or Product, and that “Preclinical Development” as used herein shall include such ongoing non-clinical testing.

Preclinical Development means any and all non-clinical Development activities performed by a Party until and including animal in vivo Proof of Concept Milestone.

Preclinical Development means the commencement of potency and efficacy testing of a compound in animal models.

Preclinical Development means those Development activities performed before the filing of an IND.

Preclinical Development shall refer to all activities relating to the planning and execution of non-human studies conducted in IN VITRO or in relevant IN VIVO animal models directed toward obtaining Regulatory Approval of a Product in each regulatory jurisdiction in the Territory. This includes preclinical testing, pharmacokinetics, toxicology, documentary and medical writing directly related to Preclinical Development activities, and related regulatory affairs and outside counsel regulatory legal services.

Preclinical Development means all internal and external non-clinical or preclinical activities related to pharmaceutical products, including non-clinical testing and research, toxicology testing and studies, preclinical studies.

Preclinical Development means, with respect to a particular Program, any research, preclinical and process development activities relating to such particular Program, up to the delivery of a Final Report.