Pre-Clinical Development definition

Pre-Clinical Development means 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 the Product in the Field in the Territory. This includes pre-clinical testing, pharmacokinetics, toxicology, documentary and medical writing directly related to Pre-clinical Development activities, and related regulatory affairs.

Pre-Clinical Development means pre-clinical safety and tolerance studies, including prototype design and development, process development, the collection of data, and the supply of materials (including fluid and blood samples or products).

Pre-Clinical Development means 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 the Product in the Field in the Territory. This includes pre-clinical testing, pharmacokinetics, toxicology, safety testing, test method development and stability testing, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control development, statistical analysis and report writing, clinical trial design and operations, preparing and filing documentary and medical writing directly related to Pre-clinical Development activities, and related regulatory affairs. * Portions of this exhibit, indicated by the xxxx “[ ]*,” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to an application requesting confidential treatment.

Examples of Pre-Clinical Development in a sentence

• The Parties, under the direction of the RMC shall conduct Pre-Clinical Development with respect to any designated Collaboration Lead Compound.

• The Cost of Goods (including qualification batches for FDA (or its foreign equivalent) approval) for Products actually used (and not sold) for all Pre-Clinical Development and Development studies shall be included in Development Costs.

• The costs of conducting such Pre-Clinical Development shall be shared by the Parties as set forth in Section 3(f).

• In addition, the RMC will be responsible for coordinating all aspects of all activities (including, but not limited to: [ * ] that will be undertaken with respect to a Collaboration Lead Compound that are necessary or desirable to enable the filing of an IND on Products based upon or incorporating such Collaboration Lead Compound, including the preparation and filing of an IND (collectively, "Pre-Clinical Development").

• On a Collaboration Lead Compound-by-Collaboration Lead Compound basis, either Party may elect (upon [ * ] written notice following receipt by the Party contemplating termination of its participation in the Pre-Clinical Development of any Collaboration Lead Compound or Development of any Product of Development Termination Documents) to terminate its participation in, or to not to participate in, the Pre-Clinical Development of any Collaboration Lead Compound or Development of any Product.

More Definitions of Pre-Clinical Development

Pre-Clinical Development means activities relating to the discovery and non-clinical development of a compound, product or diagnostic product, including toxicology, pharmacology, identification, characterization, modification, optimization, test method development and stability testing, formulation development, and delivery system development, but excluding Clinical Trials and Commercialization activities. When used as a verb, “Pre-Clinically Develop” means to engage in Pre-Clinical Development.

Pre-Clinical Development means all in vitro and in vivo animal testing, toxicology, or other studies or tests of a Product, including without limitations those studies, trials or tests necessary or useful to support an IND.

Pre-Clinical Development means any preclinical Development with respect to a product, including stability testing, toxicology, formulation, and process development, but specifically excluding GLP toxicology studies and IND-enabling manufacturing or regulatory activities.

Pre-Clinical Development has the meaning set forth in Section 1.93.

Pre-Clinical Development means all activities relating to the conduct of Pre-Clinical Studies specifically required to support Regulatory Approvals to market and sell Product in the USA or the Territory.

Pre-Clinical Development means drug development activities, including toxicology studies, bioanalytical test method development, pre-formulation and formulation, process development, manufacturing design and scale up, quality assurance/control and performance with respect to studies and materials.

Pre-Clinical Development means initiation of dosing of a Collaboration Compound in a GLP in vivo toxicology study.