definiens: means, for all studies or activities performed in accordance with a Development Plan for the Development of Product, ( a ) all out - of - pocket c osts and expenses incurred ( i.e., paid to Third Par ties or accrued and payable to Third Parties ) by USL or Ori on or their Affiliates, ( b ) the Party Internal Deve lopment Cost of such studies or activities, and ( c ) the Cli nical Supply Cost of such studies or activities . No twithstanding the foregoing, Development Costs shall not include any costs or expenses incurred in connection with manufacturing process development and validation, m anufacturing scale - up, stability testing, or qualit y assurance / quality control development for the Produ ct . Without limiting the foregoing, among the costs excluded from the definition of are the following ( which shall be borne by Orion ): ( 1 ) the costs for manufacture of three ( 3 ) NDA lots of each strength or dosage of the Product ; and ( 2 ) the costs for val idation, stability testing, and quality assurance and qualit y control development for the Product shall mean the pre - clinical, clinical and pharmac eutical development plan for Product, which sets forth the activities, timetable and budg et for the Development of Product in the Field, inc luding the Initial Development Plan attached to this Agreement, as such plan may be amended from time to time in accordance with the terms of this Agreement