definiens: means the following information owned or controlled by CPP as of the EffectiveDate and all Co - Owned Data ( excluding Data generated by Additional Studies funded solely by CPP ) thatmay contribute or be reasonably necessary to the Development, MA Approval or Sale of products based onor 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 otheraspects of treating Gastrointestinal Diseases with, the Licensed Formulation that may be useful to exercisethe rights granted under this Agreement 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 data contained, incorporated or referenced therein, to the extentissued, owned, controlled or registered in the name of CPP in any country of the Licensed Territory andrelating to the administration of the Licensed Formulation to treat or prevent an Indicated Disease ; and ( d)the Arizona Technical Information