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. Means the direct and indirect costs incurred by Pozen in any country in the Territory after the Effective Date in order to obtain marketing approval in a country in the Territory that are specifically attributable to the development of Products and are consistent with activities as set out in the Development Plan. Development Costs include Direct Costs and Indirect Costs incurred to obtain the authorization to manufacture, formulate, fill,... ship and/or sell a Product in commercial quantities in the Territory and include but are not limited to costs of: (i) studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of a Product, whether conducted internally or by individual investigators or consultants; (ii) manufacturing process development and scale up, (iii) qualification lots; (iv) preparing, submitting, reviewing or developing data or information necessary for the purpose of submission to the FDA in order to obtain and/or maintain approval of a Product in the Territory; (v) data management; (vi) statistical designs and studies; (vii) document preparation and other administration expenses associated with the clinical testing program. Development Costs shall not include patent costs, pricing costs, reimbursement costs, pre-registration marketing costs (e.g. trademark costs, advertising agency selection costs, pre-marketing studies), post-registration clinical and marketing studies (except for Phase IV Studies required for registration) that are not conducted as part of the Development Plan. In determining Development Costs, Pozen will use its applicable project cost system with the purpose of tracking costs as much as possible on a product indication-by-product indication basis. Pozen shall maintain, and cause the Third Parties acting for its account to maintain, books of account and complete and accurate records pertaining to the Development Costs in sufficient detail to permit Roche to confirm the correct calculation of Development Costs. View More

Development Costs. Shall mean all reasonable costs and expenses incurred by Omrix in connection with the Project (including, without limitation, all costs and expenses relating to clinical studies and regulatory filing fees and costs of subcontractors and consultants, provided that such subcontractors or consultants do not replace full-time, permanent Omrix personnel positions) in a manner consistent with parameters set forth in a budget approved by the DAB, except for Labor Costs.

Development Costs. Shall mean the costs of the Program incurred by ALZA pursuant to this Agreement and determined in accordance with Exhibit A hereto.

Development Costs. Shall have the meaning set forth in the Development Agreement and Amendment and, for the avoidance of any doubt, shall include the fully loaded costs incurred by either party in connection with maintaining FDA Approvals, including, without limitation, any Phase IV post-marketing clinical trials *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the commission. 2 performed in connection... with any Agreement Product(s) or Improved Agreement Products. For the purposes of this definition, "fully loaded costs" shall mean (a) all direct costs of labor, raw materials, supplies, services, fees (including external costs incurred by third parties) and other resources consumed or used in the conduct of the applicable activity, and (b) all indirect costs of rent, utilities, insurance, facility and equipment depreciation, administrative support and other overhead charges related to the applicable activity. Indirect costs shall be allocated based upon the portion of such costs directly attributable to the support of the applicable activity. All cost determinations made hereunder shall be made in accordance with generally accepted accounting principles consistently applied. View More

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.