definiens: shall mean, with respect to a Development Candidate and Drug Products derived therefrom, expenses and other costs, including Regulatory Expenses ( except for the maintenance of Regulatory Approvals ), incurred byor on behalf of a party in connection with the worldwide development of such Development Candidate and Drug Productsderived therefrom in accordance with the Development Program in the Cardiac Field, including without limitation the costs ofclinical trials, the preparation, collation and/or validation of data from such clinical trials and the preparation of medicalwriting as will make the results of such clinical trials an element of one or more Registration Filings in the Cardiac Field;provided, that Development Costs shall include : ( a ) the cost of any preclinical or clinical studies conducted by [ .. * * .. ] CONFIDENTIAL TREATMENT REQUESTED4 NIBRI or its Affiliates in connection with a Development Program outside the Cardiac Field ( and not reimbursed or paid by aThird Party ), to the extent the results of such studies are required to be performed under applicable regulatory guidelinesspecific to the indication being studied in the Cardiac Field and incorporated as part of any Registration Filings submitted tosupport a Regulatory Approval for an indication in the Cardiac Field ; and ( b ) the cost of Phase IIIB clinical trials and Phase IVclinical trials only if and to the extent they are intended to support indications in the Cardiac Field beyond the respectiveinitial indications ( as agreed upon by the parties ) for the Drug Products, to support expanded labeling for the Drug Products, or to satisfy requirements imposed by governmental regulatory authorities in connection with Regulatory Approvals for theProducts in the Cardiac Field . Development Costs consist of : ( a ) all out - of - pocket costs incurred by the parties or their Affiliates, including payments made to Third Parties withrespect to any of the foregoing ; ( b ) the fully allocated costs of internal scientific or technical personnel engaged in such efforts, which costs shall bedetermined based on the FTE annual rate or such other basis as may otherwise be agreed by the parties ; ( c ) the costs of clinical supplies for such efforts as agreed in the applicable approved Development Program in theCardiac Field, including : ( i ) the fully allocated cost or out - of - pocket costs, as applicable, incurred in purchasing and / orpackaging comparator drugs ; and ( ii ) disposal of clinical samples ; ( d ) the costs and expenses incurred in connection with technical development and with other manufacturingdevelopment activities ; ( e ) all amounts paid by NIBRI or its Affiliates to a Third Party to license, purchase or otherwise acquire HDAC InhibitorCompounds ; and ( f ) any other costs or expenses explicitly included in the Development Program in the Cardiac Field