definiens: shall mean costs incurred ( i.e., paid or accrued ) after the Closing Date by either Party to the extent attributable to fulfilling such Party ’s responsibilities under the Development Pla n in accordance therewith and with this Agreement, inclu ding the costs of : ( A ) FTE Costs ; ( B ) Clinical Studies Costs ; ( C ) Out of Pocket Expenses incurred in relation to Clau ses 1.43(C)(1 ) – ( 4 ): ( 1 ) research and Development of the Product, including the Development of assays and test methods and studies of the toxicological, phar macokinetic, metabolic or clinical aspects of the Product ; ( 2 ) preparing and submitting INDs and New Product Appli cations to obtain, support or maintain Regulatory Approval for the Product ; ( 3 ) the receipt of Regulatory Approval for the Product, preparing and submitting filings to Regulatory Authorities, including filing or othe r fees paid to Regulatory Authorities, to obtain, support or maintain Price a nd Reimbursement Approvals for the Product ; and ( 4 ) communications and meetings with Regulatory Authori ties, exchange of information and assistance contemplated by Clause 4 ( but exclud ing associated travel and cost of living expenses ) ; but specifically excluding ( a ) Commercialisation Co sts, ( b ) Fully Burdened Manufacturing Costs ( other than those associated with the Manufacture of Clini cal Supplies ), ( c ) Patent Costs except as otherwise indicated in Clause 10.9, and ( d ) expenses relating to filing and maintenance of Product Tradenames or [COMPANY] Trademark registrations