definiens: means all ( a ) clinical development and regulatory a ctivities regarding a pharmaceutical compound or product, as the case m ay be, including ( i ) clinical trials of such pharma ceutical compound or product ; ( ii ) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain a uthorization to conduct clinical trials or obtain R egulatory Approval of such pharmaceutical product ; and ( iii ) Medical Affairs with respect to such pharmaceutical compound or product, and ( b ) with respect to the activities of Licensee, solely ( i ) to the extent agreed upon with in the JSC or required by a relevant Regulatory Authority in the Territory to obtain or maintain a Regulatory Approval contem plated by this Agreement, and ( ii ) on a non - exclusive basis unless otherwise agreed by the Parties, non - clinical or p re - clinical activities conducted in support of the foregoing, t he Development Plan, the Launch Plan or the Commerc ialization Plan