definiens: means with respect to a Pre - Candidate Product, a Candidate Product, or a Product, as appropriate and on aTargeted Indication and Targeted Territory basis, the activities, including the Preclinical Development as well as the Clinical Development, performed by a Party as from the beginning of the work on a Pre - Candidate Product until and including the MAA filing for the relevantProduct, including without limitation : activities related to research, process development and manufacturing, pre - clinical and clinical drugdevelopment of such Candidate Product and/or Product in its Targeted Indication in the Field and in its Targeted Territory, including withoutlimitation, test method development and stability testing, assay development, toxicology, pharmacology, formulation, quality assurance, quality development, technology transfer, statistical analysis, process development, and scale - up, pharmakocinetic studies, data collectionand management, clinical studies ( including research to design clinical studies ), regulatory affairs ( including all necessary steps to Developthe Candidate Product and/or Product as an orphan drug, obtaining scientific advices ), project management, drug safety surveillanceactivities related to clinical studies, validation of methods and tests