Development Costs

Development Costs. The fully-burdened costs to Mayfield and its Affiliates incurred or accrued in connection with the research, development, pre-clinical and clinical studies, production and regulatory approval through submission of the first NDA for Product

Development Costs. All internal and external costs incurred by Neuromed after the Effective Date for its conduct of Development of Products in accordance with the Development Plan, including any pre-clinical research or development activities, clinical trials, related regulatory activities (including preparing and making regulatory filings) and REMS activities, which Development activities are necessary or useful to seek or obtain regulatory approval by the FDA with respect to Product (or a specific indication... for Product) in the Territory. The costs and reasonable expenses of Neuromed employees to the extent actually engaged in Development shall be included in Development Costs at the applicable portion of the FTE Rate, based on the number of days or portion of any days spent by the applicable employee (during any particular time period) in conducting Development. View More

Development Costs. With respect to a particular Product the sum of all internal costs, including to the extent allocated to the foregoing directly related overhead (but not general or corporate overhead), and direct out-of-pocket costs, in each case incurred by a party and/or its Affiliates in connection with the conduct of the activities assigned to it by the JDC pursuant to the Development Plan, including, without limitation, FTE costs (which fairly reflect the actual FTE costs of each party for its personnel... in the applicable functional areas (but excluding senior executives), to be discussed and agreed upon by the parties respective finance departments), costs of preparation of regulatory filings, costs of clinical supply of Product, and any other activities conducted under the Development Plan that support obtaining or maintaining NDA Approval of Product in the Territory, such as surveillance studies and pharmacovigilance. Development Costs shall be determined in accordance with US GAAP and in accordance with the relevant party's accounting standards applied on a consistent basis View More

Development Costs. The costs incurred by the Parties in developing a Product, including but not limited to costs of formulation development, analytical development, scale-up, demo batches, bio-batch manufacturing, ICH Stability packaging and testing, bioequivalence studies, and ANDA filings.

Development Costs. In each case, that are incurred as an expense in accordance with such Party's accounting standards (consistently applied) and consistent with the applicable Study Plan and Budget for such Study; provided that in all cases, Development Costs.

Development Costs. Means expenses directly incurred by or on behalf of ProPhase in connection with any research and development (including without limitation costs and expenses incurred in connection with any market research, prosecution and maintenance of any intellectual property rights or any regulatory-related costs and expenses) relating to the Licensed Compound or a Licensed Product.