definiens: and means, with respect to any Licensed Product, all a ctivities with respect to such Licensed Product relating to r esearch and development in connection with seeking, obtaining or maintaining any Regulatory Approval fo r such Licensed Product in the Field in the Territo ry, including, without limitation, all preclinical rese arch and development activities, all human clinical studies ( including, without limitation, clinical trial desi gn and operations ), test method development and sta bility testing, regulatory toxicology studies, formulation, all act ivities relating to developing the ability to manuf acture any Licensed Product or any component thereof ( includin g, without limitation, process development, manufac turing scale - up, development - stage manufacturing and quali ty assurance / quality control development ), statisti cal analysis and report writing, preparing and filing D rug Approval Portions of this Exhibit, indicated by the mark were omitted and have been filed separately w ith the Securities and Exchange Commission pursuant to the Registrant ’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended