definiens: means ( a ) the research, ( b ) all non - clinical, preclinical and post - IND filing development activitiesfor any product in the Field, including all clinical testing and studies of any product, toxicology studies, distribution ofproduct for use in clinical trials ( including placebos and comparators ), statistical analyses, and the preparation, filingand prosecution of any marketing authorization application for any product, as well as all regulatory affairs related toany of the foregoing ; and ( c ) all activities directed to using, making or having made, manufacturing, marketing, holdingor keeping ( whether for disposal or otherwise ) or otherwise disposing of, distributing, detailing offering for sale orselling a product in the Field ( as well as importing and exporting activities in connection therewith ), all activitiesdirected to obtaining Pricing Approvals, and all activities directed to Phase 4 Studies ; all of ( a ), ( b ) and ( c ) withrespect to Out - of - Scope Products in each case not inconsistent with the license granted herein under Article 2