definiens: means the following information owned or controlled byCPP as of the Effective Date and all Co - Owned Data ( excluding Data generated by Additional Studies funded solelyby CPP ) that may contribute or be reasonably necessary to the Development, MA Approval or Sale of products basedon or containing the Licensed Formulation, including : ( a ) know - how owned or controlled by CPP relating to theformulation or administration of the Licensed Formulation and not included in any of the Licensed Patents ; ( b)technical, pre - clinical and clinical data owned or controlled by CPP relating to the safety, efficacy, dosing regimen, chemical and physical properties, biological effects, and contraindications of, and other aspects of treatingGastrointestinal Diseases with, the Licensed Formulation that may be useful to exercise the rights granted under thisAgreement or to obtain MA Approval in a country of the Licensed Territory, including any CPP - Owned Data and CPP - Owned Co - Development IP ; ( c ) regulatory filings and approvals, including the Regulatory Dossier, and the datacontained, incorporated or referenced therein, to the extent issued, owned, controlled or registered in the name of CPPin any country of the Licensed Territory and relating to the administration of the Licensed Formulation to treat orprevent an Indicated Disease ; and ( d ) the Arizona Technical Information