definiens: shall mean the following costs incurred, on a cash basis, by either Party for developing a Product, to the extent set forth in the Development Budget approved by the Parties : ( a ) Direct Costs for development activities for the Product, incurred, on a cash basis, by a Party or paid by a Party to Permitted Subcontractors, conducted pursuant to the Development Plan, including, but not limited to, research, formulation development and testing, clinical development activities, data management, toxicology, and planning and execution of clinical trials required to procure data necessary for the acceptance of filing of an NDA ; ( b ) Manufacturing Costs to satisfy Clinical Supply Requirements ; ( c ) Direct Costs for regulatory filings pursuant to the Development Plan ( specifically excluding any filing related to Non‐NDA Trials ) for the Product ; ( d ) Insurance premiums paid by either Party for commercial insurance to the extent such insurance relates to development activities conducted pursuant to the Development Plan in accordance with Section 10.4 hereof ( i.e., if insurance covers risks other than risks related to development of the Product, then only an appropriate portion of such premiums shall be included ) ; ( e ) CDS Patent Costs paid from the Effective Date up to the first Product Profitability Date that are not otherwise reimbursed by a Third Party ; provided, however, that CDS Patent Costs in excess of [ * ] in any calendar year shall not be included as Direct Development Costs ; 7/15/2016 https://www.sec.gov/Archives/edgar/data/1314102/000095012306000446/y16393exv4w13.txthttps://www.sec.gov/Archives/edgar/data/1314102/000095012306000446/y16393exv4w13.txt 11/66 ( f ) Direct Costs of the activities conducted under Section 3.11, including, but not limited to, technology transfer assistance from CDS to Alimera to enable Alimera to manufacture the Product for Commercialization ; ( g ) Direct Costs for capital expenditures to the extent attributable to the Product as specifically approved in the Development Plan and set forth in the Development Budget ; and ( h ) Other Direct Costs as described in the Development Plan and set forth in the Development Budget