Development Expense definition

Development Expense means, with respect to any Project, cash expenditures made by Company or any of its Subsidiaries to fund (i) engineering, permitting, legal, environmental and other similar expenses and (ii) fees and expenses of consultants and advisers with respect to engineering, permitting, legal and environmental issues, in each case to the extent such expenses are payable to Persons other than Company and its Subsidiaries in connection with any Expansion permitted under this Agreement, prior to the date of financial closing for such Expansion; provided, that Development Expenses shall exclude payroll expense and reasonable travel expenses of employees of Company and its Subsidiaries.

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Development Expense means Existing Trial Expenses, Preclinical Development Expenses, Clinical Development Expenses and CMC/Manufacturing Expenses.

Development Expense shall have the meaning assigned to it in Section 2.3.

Examples of Development Expense in a sentence

• The University shall inform staff members of their rights and obligations under the University’s policy for Professional Development Expense Accounts and the Central Pro-D fund.

• Wyeth shall keep accurate records of its activities under this Agreement that relate to the events with respect to which Additional Research and Development Expense Payments may be made under Section 5.3 hereof.

• The rate of reimbursement shall be as per BCIT’s Travel and Professional Development Expense Reimbursement Policy No. 2005 and Procedure as amended.

• In the event Forest informs Microbia that it does not intend to continue specific Development or Commercialization activities then in progress, costs incurred in closing out such activities shall be allocated in accordance with the allocation of the applicable Development Expense or Commercialization Expense responsibilities provided hereunder.

• In further consideration of Trubion's contributions under the Research Program and the Development Program, as provided in Articles 3 and 4 above, Wyeth shall pay to Trubion the payments specified in Exhibit 5.3 attached hereto (each an "Additional Research and Development Expense Payment") in the amounts and at such times as specified in Exhibit 5.

• Such individual funding shall be made available for professional development purposes as outlined on the Professional Development Expense Claim Form.

• Costs and expenses of filing, prosecuting, maintaining, and extending the Collaboration Patent Rights will be included as Development Expense.

• In the event that Microbia informs Forest that it does not intend to continue specific development activities then in progress, costs incurred in closing out such activities shall be allocated in accordance with the allocation of the applicable Development Expense responsibilities provided hereunder.

• All costs to maintain such databases (including internal FTE costs) will be included as Development Expense.

• Within [****] following the end of a Calendar Quarter, each Party shall submit to the other Party its report of actual results as outlined above (including a summary of charges and credits allocated to its Development Expense Project Account).

More Definitions of Development Expense

Development Expense means the costs incurred by a Party in connection with studies or activities performed under the Development Plan in order to obtain, maintain or expand the relevant Regulatory Approval to manufacture, use or sell Product in the Field in the Territory to the extent included in the Development Budget. Development Expense shall include, without limitation, (a) all out-of-pocket costs and expenses actually incurred by Forest or Microbia in conducting such studies or activities including without limitation costs of studies on the toxicological, pharmacological, metabolic or clinical aspects of a Product conducted internally or by individual investigators or consultants and necessary for the purpose of obtaining, maintaining and/or expanding Regulatory Approval of the Product, process development, process improvement and scale-up costs, validation costs, including qualification lots, (b) the costs of internal personnel engaged in the performance of such studies or activities, including the activities described below in this Section (such costs shall be included in the Development Budget [**]), (c) all costs of developing data for Regulatory Submissions and all costs associated with making such submissions, (d) all costs related to pharmacovigilance activities, and (e) any other costs that are designated as Development Expenses herein, in each case as included in the Development Plan and the Development Budget.

Development Expense means the fully-burdened internal and external costs (except as otherwise expressly provided in the Development Budget, which provision explicitly acknowledges a deviation from this Section 1.54) incurred by a Party in connection with studies or activities performed pursuant to the Development Plan in order to obtain, maintain or expand the relevant Regulatory Approval to Manufacture, use or sell Product in the Field in the Territory to the extent included in the Development Budget. Development Expense will include, in each case to the extent relating to the Development of the Product and set forth in the Development Plan and Development Budget (or constituting a permitted overage thereto under Section 4.2.6), (a) all out-of-pocket costs and expenses actually incurred by AstraZeneca or Ironwood in conducting such studies or activities including without limitation costs of studies on the toxicological, pharmacological, metabolic or clinical aspects of the Licensed Compound or Product [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. conducted internally or by individual investigators or consultants and necessary for the purpose of obtaining, maintaining or expanding Regulatory Approval of the Product, including Post-Approval Research, process development, process improvement and scale-up costs (including validation, qualification lots, technology transfer and analytical transfer for supply of Licensed Compound or Product to AstraZeneca), [**], (b) the costs of internal personnel engaged in the performance of such studies or activities, including the activities described below in this Section 1.54 (such costs will be included in the Development Budget [**]), (c) all costs of developing data for Regulatory Submissions and all costs associated with making such submissions, (d) all costs related to pharmacovigilance activities (unless included in Commercialization Expenses), (e) all costs of Clinical Trial Materials, (f) all irrevocable, Indirect Taxes and duties, and (g) any other costs that are designated as Development Expenses herein. For clarity, any import duties or non-recoverable VAT incurred due to shipping the Product into the Territory for Development purposes shall be considered a Development Expense. Notwithstanding any other provision of this Agreement to the contrary, [**].

Development Expense is defined in Exhibit F.

Development Expense. Costs and expenses incurred by Landlord (other than Project Costs) as described on Exhibit “D” hereto. Landlord shall have no obligation, duty or requirement to fund more than nine million dollars ($9,000,000) of Development Expense.

Development Expense means expenses incurred by a Party or for its account on or after January 1, 2006, which are specifically attributable to the Development of Licensed Product, including, without limitation: (a) costs of non-clinical design and evaluation of Licensed Product, and costs of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of Licensed Product (such costs include the costs of any consultants or other Third Parties engaged by a Party to conduct such design or evaluation); (b) costs of manufacturing clinical supplies of Licensed Product and, to the extent included in an approved budget for a Global Development Program or otherwise approved by the JSC, costs of process development, CMC activities and scale up of Licensed Product manufacturing; provided, that such costs shall not be included in the transfer price charged pursuant to the Manufacturing Agreement; (c) costs of conducting Clinical Trials on Licensed Product including the manufacturing cost of clinical supplies of the Licensed Product, regulatory compliance, quality control, medical affairs, clinical operations and study subject recruitment; (d) costs of preparing, submitting, reviewing or developing data or information for the purpose of submission to a Regulatory Authority to obtain approval to commence Clinical Trials or to obtain Regulatory Approval for Licensed Product; (e) fees, including FDA user fees, associated with Regulatory Submissions and Regulatory Filings in the United States or the Bayer Territory or other U.S. and foreign governmental requirements related to Licensed Product; (f) costs of Third Party licenses under Patents or other intellectual property rights reasonably necessary to develop Licensed Product, but excluding any payments to Amgen Inc. under the Amgen-Nuvelo Agreement; and (g) such other costs directly related to Development that are included in or contemplated by Development plans or annual Development budgets approved by the JSC; (h) direct project expenses incurred by third parties being invoiced for services or materials for use in Development of Licensed Products; (i) Licensed Product related FTEs; and (j) excludes the Parties’ overhead expenses to the extent not included in FTE Costs. For purposes of calculating a Party’s internal Development Expenses, the cost of each Party’s FTEs shall be calculated using an FTE rate of $[ * ] for a U.S. based FTE and using an FTE rate of €[ * ] for a Bayer Territory based FTE, which shall include the co...