Definition of Pre-clinical Development

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 mark "[ ]*," were omitted and have been filed separately with the Securities and Exchange Commission pursuant to an application requesting confidential treatment.