definiens: shall mean the following costs incurred, on a cash basis, by eith er Party for developing a Product : ( a ) Direct Costs for Development Activiti es for the Product, incurred, on a cash basis, by a Party or paid by a Party to Permitted Subcontractors, including, but not limited to, research, formulation developme nt and testing, clinical development activities, data mana gement, toxicology, and planning and execution of c linical trials required to procure data necessary for the a cceptance of filing of an NDA ; ( b ) Manufacturing Costs to satisfy Clinic al Supply Requirements ; ( c ) Direct Costs for regulatory filings p ursuant to the Development Activities ( specifically excluding any filing related to Non - NDA Trials ) for the Product ; 8 CONFIDENTIAL TREATMENT REQUESTED ( d ) Insurance premiums paid by either Par ty for commercial insurance to the extent such insu rance relates to Development Activities in accordance with Sectio n 10.4 hereof ( i.e., if insurance covers risks othe r than risks related to development of the Product, then only an appropriate portion of such premiums shall be incl uded ) ; ( e ) CDS Patent Costs paid from the Effect i ve Date up to the first Product Profitability Date that are not otherwise reimbursed by a Third Party ; provided, ho wever, that CDS Patent Costs in excess of [ * ] in an y calendar year shall not be included as Direct Devel opment Costs ; ( f ) Direct Costs of the activities conduc ted under Section 3.11, including, but not limited to, technology transfer assistance from CDS to Alimera to enable A limera to manufacture the Product for Commercializa tion ; ( g ) Direct Costs for capital expenditures to the extent attributable to the Product and part of Development Activities ; and ( h ) Other Direct Costs as mutually agreed upon by the Parties