definiens: means all research and development activities, withrespect to a Licensed Antibody or Licensed Product, other than ( i ) the conduct of a Clinical Trial with respect tosuch Licensed Antibody or Licensed Product in any disease, Indication and/or combination and ( ii ) regulatoryactivities directed at utilizing the results of such Clinical Trial to obtain or maintain Marketing Approval for theLicensed Antibody or Licensed Product in such disease, Indication and/or combination . Preclinical Developmentincludes : research ; non - clinical and preclinical testing ; all non - human in vivo and in vitro studies, includingefficacy, toxicity, pharmacodynamic and pharmacokinetic testing ; biomarker development ; drug - drug interactiontesting ; formulation ; manufacturing process development for drug product ; and regulatory affairs and submissionof an IND filing to the appropriate Regulatory Authority(ies ) . For clarity, Preclinical Development activities shallcontinue to be defined as Preclinical Development if the * * * INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED . ALL SUCHOMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED