Direct Development Costs definition

Direct Development Costs means all costs incurred by DURA or its Affiliates in respect of the Development, other than Indirect Development Costs, determined in accordance with generally accepted accounting principles consistent with DURA's internal accounting system, allocated on a reasonable and consistent basis. Direct Development Costs shall consist primarily of fully-burdened payroll costs (burdened to include benefits, payroll taxes and an allocation of facilities and overhead costs) and any other such costs generated internally by DURA in respect of the Development.

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Direct Development Costs means the costs incurred, on a cash basis, by Licensee with respect to the development of Licensed Products in accordance with the Development Plan, such as: 1.5.1 Costs for development activities conducted to procure data necessary for regulatory filings to obtain marketing approval from a Regulatory Authority, including, but not limited to, research, formulation development and testing, clinical development activities, data management, toxicology and planning and execution of clinical trials; 1.5.2 costs for regulatory filings necessary to obtain marketing approval from a Regulatory Authority; 1.5.3 insurance premiums paid for commercial insurance to the extent such insurance directly relates to development activities conducted pursuant to the Development Plan (i.e., if insurance covers risks other than risks related to development of the Licensed Product, then only an appropriate portion of such premiums shall be included); and 1.5.4 capital expenditures to the extent directly attributable to the development of Licensed Products. 1.5.5 the fully burdened costs of labor for the percentage of the individuals’ time spent on such development activities. To the extent a cost is associated with activities in addition to development of Licensed Products then only the appropriate portion of such costs devoted to the development of Licensed Products shall be included as Direct Development Costs.

Direct Development Costs means the following costs incurred, on a cash basis, by either Party for developing a Product: (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, 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 Activities (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 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; (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 and part of Development Activities; and (h) Other Direct Costs as mutually agreed upon by the Parties. Notwithstanding any other provisions in this Agreement, Direct Development Costs shall (1) with the exception of (e) and (f) above, include only Direct Costs incurred, on a cash basis, in connection with activities conducted to procure data necessary for the acceptance of filing of an NDA for the Product; and (2) include only the costs of labor for those individuals who spent greater than fifty percent (50%) of their time on Development Activities during any calendar month, and such costs shall be determined according to the percentage of the individuals’ time actually spent on such development activities; and (3) not include any Commercialization costs. Notwithstanding the foregoing, in the event that a person devotes time to both activities under the Comm...

Examples of Direct Development Costs in a sentence

Alimera shall be solely responsible for Alimera Patent Costs and such costs shall be neither Direct Development Costs nor Direct Commercialization Costs.
CDS will be reimbursed by Alimera for the costs associated with CDS Development Activities pursuant to this Section 3.1.2, and such payments shall be deemed Direct Development Costs, provided that all such reimbursed costs associated with the wet AMD trial, the vein occlusion trial and the additional marketing support trial shall be deemed Direct Commercialization Costs to the extent such trials are Non-NDA Trials.
Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera will be solely responsible for, and shall pay one hundred percent (100%) of, all development costs of a Product, including Direct Development Costs.
With respect to activities prior to the Amendment Effective Date, each Party was to pay [*] of the total Direct Development Costs of a Product incurred in accordance with the Development Budget (as defined in the Original Agreement).
The Manufacturing Costs for such supply shall be reimbursed by Alimera in accordance with Section 3.1.2 and shall be Direct Development Costs (except that the Manufacturing Costs associated with the wet AMD trial, the vein occlusion trial and the additional marketing support trial shall be deemed Direct Commercialization Costs to the extent such trials are Non-NDA Trials).

More Definitions of Direct Development Costs

Direct Development Costs means the costs, fees and expenses incurred for development of a Property, as listed in Exhibit 9.

Direct Development Costs has the meaning set out in Schedule 4.4.1.

Direct Development Costs means the costs incurred, on a cash basis, by Licensee with respect to the development of Licensed Products in accordance with the Development Plan, such as:

Direct Development Costs means, on a cash basis, the following costs incurred by either party with respect to an MD Product or a BT Product after such Product has been designated as an IND Candidate: (a) direct costs of labor (including only salaries, wages and current period employee benefits (but specifically excluding expenses associated with stock options or other equity-based or deferred compensation)), raw materials, supplies, services, fees, and other resources, directly and exclusively consumed or used in the conduct of the applicable activity, (b) payments required to be made by either party under a third party license agreement (e.g., the AGDG Agreement, the UNC License, the Isis CLA or a license entered into pursuant to Section 4.3); provided, however, that the following costs shall not be deemed Direct Development Costs: (i) corporate overhead expenses, including, but not limited to, general administration, business development, travel, entertainment, executive management, facilities, finance, information system and data management services, investor relations, human resources, legal, payroll, purchasing, and corporate supervisory services; (ii) amortization and depreciation expenses, interest expenses, taxes, extraordinary or nonrecurring losses customarily deducted by a party in calculating and reporting consolidated net income and capital expenditures (including, but not limited to, purchases of facilities, property or equipment), and inventory write-offs (to the extent not attributable to a Product); (iii) consulting (including legal) fees unless set forth in a mutually approved budget; (iv) costs to prosecute or maintain patent rights; and (v) payments made to any related party or Affiliates unless set forth in a mutually approved budget. For clarification, if a party incurs costs that are reimbursed or otherwise paid for by a third party (e.g., by a governmental grant), such costs shall not constitute Direct Development Costs. Ercole Invention has the meaning set forth in Section 4.1.2.

Direct Development Costs means the following costs incurred, on a cash basis, by either Party for developing a Product:

Direct Development Costs means 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: