definiens: means, with respect to a specific Licensed Produc t for a specific Indication, those Development costs actually incurred by TM fro m the Effective Date of this Agreement through the date of [COMPANY] ’s exercise of its Opt - in for such Licensed Prod uct for such Indication that are ( a ) either incurre d for such Licensed Product specifically for such Indication o r, subject to the terms at the end of this paragrap h, incurred for such Licensed Product, but which costs also hav e broader applicability to other Indications, Licen sed Products or other products, and ( b ) reimbursable, a s set forth below in this Section 1.14, in the even t of an Opt - in by [COMPANY] pursuant to Article IV . Reimbursable Develop ment Costs shall be limited to costs of studies on the toxicological, pharmacokinetic, metabolic or clinic al aspects of a Licensed Product necessary for the purpose of obtaining, maintaining and/or expanding FDA Approva l of a Licensed Product, and costs for preparing, submitting, reviewing or developing data or informa tion for the purpose of submission to the FDA to ob tain, maintain and/or expand FDA Approval of a Licensed P roduct and the costs deemed reimbursable as set for th below in this definition . Reimbursable Development Costs shall not include any pre - clinical or researc h costs