definiens: means with respect to a Pre - Candidate Product, a Candidate Product, or a Product, asappropriate and on a Targeted Indication and Targeted Territory basis, the activities, including the PreclinicalDevelopment 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 relevant Product, including without limitation : activitiesrelated to research, process development and manufacturing, pre- clinical and clinical drug development of suchCandidate 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 [ * * * ] CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE COMMISSION 4/44studies, data collection and management, clinical studies ( including research to design clinical studies ), regulatoryaffairs ( including all necessary steps to Develop the Candidate Product and/or Product as an orphan drug, obtainingscientific advices ), project management, drug safety surveillance activities related to clinical studies, validation ofmethods and tests