definiens: means expenses and other costs incurred by or on behalf of a Party that are directly related to the development of the Lead Compound and corresponding Product in accordance with the Development Plan, including the costs of pre - clinical activities, DMPK, supply of clinical material, manufacturing scale - up, CMC and toxicology activities, clinical trials ( including Development Studies ), the preparation, collation and/or validation of data from clinical trials and the preparation of medical writing and publishing ; provided that Development Costs shall exclude the cost of Commercialization Studies . Without limitation of the generality of the foregoing, Development Costs include : ( a ) direct project related expenses paid by a Party or its Affiliates to Third Parties and specifically identifiable and incurred to develop such Product, such expenses to have been recorded as income statement items in accordance with the Party 's Accounting Standards and not including [ ... * * * ... ] amounts, [ ... * * * ... ] or [ ... * * * ... ] ; * * * Confidential Treatment Requested 4 < PAGE > ( b ) the direct and indirect costs of internal scientific, medical or technical personnel of a Party or its Affiliates ( including [ ... * * * ... ] and other [ ... * * * ... ] ( which are included in the [ ... * * * ... ] ), but for the avoidance of doubt, not including the costs of [ ... * * * ... ], [ ... * * * ... ], [ ... * * * ... ], [ ... * * * ... ], or [ ... * * * ... ] and [ ... * * * ... ] ) engaged in development of Product, which costs shall be determined based on the [ ... * * * ... ] ; ( c ) the cost of [ ... * * * ... ] and [ ... * * * ... ] of such Product, including costs for the [ ... * * * ... ] and/or [ ... * * * ... ] and [ ... * * * ... ] ( any [ ... * * * ... ] by [COMPANY] prior to the Effective Date will be [ .... * * * ... ] when [ ... * * * ... ] or [ ... * * * ... ], which costs shall not exceed $ [ ... * * * ... ] ) ; ( d ) the costs of filings to obtain Regulatory Approvals for such Product ; ( e ) the costs of [ ... * * * ... ], [ ... * * * ... ], [ ... * * * ... ] and/or [ ... * * * ... ] of such Product at [ ... * * * ... ] and [ ... * * * ... ] ; ( f ) the costs of [ ... * * * ... ], [ ... * * * ... ], [ ... * * * ... ] and/or [ ... * * * ... ] of [ ... * * * ... ], [COMPANY] Compounds to the extent required by Regulatory Authorities in connection with Regulatory Approval of Product ; and ( g ) the costs for prosecuting, obtaining and maintaining the [ ... * * * ... ] pursuant Clause [ ... * * * ... ] and [ ... * * * ... ] and [ ... * * * ... ] of the costs for [ ... * * * ... ], [ ... * * * ... ] and [ ... * * * ... ] the [ ... * * * ... ] and [ ... * * * ... ] pursuant Clause [ ... * * * ... ]