definiens: means ( a ) a Party ’s ( or its Affiliate ’s ) FTE costs at the applicable FTE Rates, and all costs and expenses paid to Third Parties ( or payable to Third Parties and accrued in accordance with GAAP)by a Party or any of its Affiliates, in each case, in conducting the clinical trials and other development work assignedto such Party in accordance with the applicable Development Plan and ( b ) Finished Product COGS with respect toclinical supply of the applicable Finished Product used in such clinical trials and other development work inaccordance with the applicable Development Plan . For clarity, costs of FTEs of a Party and its Affiliates, of ThirdParty experts, and of other Third Parties relating to or associated with ( w ) communicating ( including meetings ) withRegulatory Authorities, ( x ) filing fees for Regulatory Filings, ( y ) data analysis and preparation of Regulatory Filings, and ( z ) other activities to execute Regulatory Strategy are not included in Development Expenses