definiens: means any of the following : ( a ) any Clinical Study that is sponsored and conduc ted by a Cooperative Group as sponsor - investigator ( a ) that is supported or enabled by a Party or one o f its Affiliates ; ( b ) any Clinical Study that is sponsored and conduc ted by a Third Party as a sponsor - investigator, other than a Cooperative Grou p Study ( an or ) that is supported or enabled by a Party or one of i ts Affiliates ; or ( c ) any Clinical Study that : ( i ) is sponsored and c onducted by a Party or one of its Affiliates as a sponsor ; ( ii ) is not intended f or use as a basis for obtaining Marketing Approval ( e.g., for a further indication, label expansion or otherwise ) ; and ( iii ) is not being conducted as a commitment made to or a requirement imposed by a Regulatory Authori ty as a condition of, or in connection with obtaini ng or maintaining, a Marketing Approval ( a ), including any Real World Evidence ( RWE ) study that is intended to support commercial efforts to secure and retain reimbursement