definiens: means thos.c activities associated with creating and executing the Companion Diagnostic Validation Plan and eondllCting reglilatory activities involved in preparing and tiling a PMA for the Companion Oiagno ~ tic, including any · · · Confidntial Treatment Reqncstcd 2 and all such actnltles performed prior to the Effective Date . The Companion Diagnostic Activities shall concludc upon PMA ApprovaL 1.14 means those expenses that are included in the budget ( including any amendment thereto ) authorizeu by this Agreement or thc JCDC under Section 6.1(a ) for Companion Diagno ~ tic Activities, that are ineurred prior to P!l.1A Approval and that arc : ( al invoiced by a Third Party for Companion Diagnostic Activities ( including, without limitation, fees paid to FDA to submit the PIvlA., consultant foes, and reagent supplier . ;) ; ( b ) incllrred hy a Party, as calculated based upon certain pre - delined FTF