definiens: means, subject to the other terms of this Agreement and without duplication, ( a ) the direct out - of - pocket costs paid to Third Pa rty Providers or Third Party Suppliers by or on beh alf of a Party or any of its Affiliates, during the term of and pursuant to this Agreement, that ( i ) are specif ically identifiable or reasonably allocable to the Develop ment activities for a Licensed Product for the purp ose of obtaining Initial Regulatory Approval for such Lice nsed Product for one or more indications and any Po st Approval Studies required by the FDA with respect t o such Licensed Product, ( ii ) relate solely to Deve lopment activities performed on or after July 1, 2008, and, ( iii)(A ) with respect to Development activities pe rformed from July 1, 2008 through the Effective Date, are includ ed in the Development Plan and Budget and specifica lly listed on Schedule 1.34(a)(ii)(A ) or, ( B ) with respect to Development activities performed after the Effectiv e Date, are included in the Development Plan and Budget, ( b ) am ounts paid by Napo or [COMPANY] to Glenmark pursuant to the Glenmark Agreement or the Glenmark Supply Agreement in respect of capital acquisition costs for equipm ent to support the manufacturing activities contemplated b y the Glenmark Agreement or 5 the Glenmark Supply Agreement, to the extent such c apital acquisition costs are included in the Develo pment Plan and Budget, ( c ) the payments from [COMPANY] to Nap o contemplated by Section 3.1.2, ( d ) amounts paid t o Third Parties by either Party pursuant to Section 11.3, a nd ( e ) filing fees and other amounts paid to Regula tory Authorities in connection with applications for Ini tial Regulatory Approval for the Licensed Product ; provided, however, that if [COMPANY] takes ownership of an IND and the c orresponding program loses its small business waive r resulting in a PDUFA Fee being payable on filing of a Drug Approval Application in the United States, then payment of any resulting fee by [COMPANY] in respect of such Drug Approval Application shall constitute a Development Cost only if [COMPANY] provides written not ice to Napo that the chief executive officer of Sal ix has determined in good faith that due to concerns regar ding the financial condition and prospects of Napo it is appropriate in order to protect the rights of [COMPANY] hereunder that [COMPANY] take ownership of the IND and file the Drug Approval Application in its own name . Developm ent Costs shall include payments to Third Party Sup pliers for or in connection with the manufacture of Licens ed Product for use in Clinical Trials and Post Appr oval Studies . Third Party Payments shall not constitute Development Costs nor, for the avoidance of doubt, shall any cost of whatever kind or nature that is not reflect ed in and authorized by the Development Plan and Bu dget constitute Development Costs