definiens: or means all development activities for any Licensed Product in the Field, beginning with IMPD - enabling toxicology studies for such Licensed Product and including all clinical t esting and studies of such Licensed Product, manufacturing development, process development, toxicology studi es, distribution of Licensed Product for use in clinica l trials ( including placebos and comparators ), rese arch and development of a Companion Diagnostic, after select ion of the relevant Selected Biomarker(s ) pursuant to Section 3.5(d ), for use in connection with clinical trials of Licensed Product as well as approved Lic ensed Products, statistical analyses, and the preparation, filing and prosecution of any Marketing Approval Application for such Licensed Product, as well as all regulator y affairs related to any of the foregoing . Developm ent shall not include the discovery, design, identification, modi fication or derivatization of Licensed Oligos or th e non - clinical or preclinical testing of Licensed Product s prior to their selection as Selected Licensed Pro ducts pursuant to Section 3.5(c )