Clinical Development Costs. Clinical Development Costs means the costs and expenses incurred by or on behalf of a Party that are specific to the conduct of *** for a Product. Clinical Development Costs shall include ***
Clinical Development Costs means the costs incurred by the Parties in connection with their respective activities under a Clinical Development Plan, as such costs are more fully described on Schedule 1.13.
Clinical Development Costs means, with respect to each Clinical Development Plan, all of the external and internal costs and expenses (including applicable overhead costs and expenses, including applicable general and administrative expenses, but excluding any Commercialization Costs and Commercial Manufacturing Costs) incurred or paid by a Party and its Affiliates in connection with the clinical development of Clinical Development Candidates or Cell Therapy Products, including, without limitation, the following costs to the extent such costs are actually incurred by a Party, accounted for in accordance with U.S. GAAP as consistently applied by such Party and attributable to the activities assigned to it under the Clinical Development Plan (except to the extent such costs constitute Commercialization Costs or Commercial Manufacturing Costs):
(a) All direct costs of preparing and conducting clinical trials that is/are subject of the Clinical Development Plan, including all direct costs related to site recruitment, enrollment, project management, site management and monitoring, biostatistics, clinical event classification, medical communication, data management, outcome studies, regulatory submissions and compliance, safety surveillance, clinical monitoring and all Clinical Manufacturing Costs; and
(b) A reasonable allocation of indirect costs associated with the foregoing.
Examples of Clinical Development Costs in a sentence
Accrued Clinical Development Costs Outside research costs are a component of research and development expense.
Notwithstanding the foregoing, if a Party is unable to pay any or all of its portion of Clinical Development Costs when due, such Party shall be deemed to have delivered an Opt-Out Notice on the date such payment was due.
During the Term and for seven (7) years thereafter, each Party shall keep complete and accurate records of its Clinical Development Costs, Manufacturing Costs, Commercialization Costs, Net Sales and other business and financial data and information underlying the reconciliations, cost reports, calculation of costs and Profits, and payments that are the subject of the Transaction Agreements.
The Parties shall share equally all (a) income received from such Third Party(ies) and (b) Clinical Development Costs, Commercialization Costs and Manufacturing Costs (as applicable) associated with the wind-down of activities related to the applicable Clinical Development Candidate or Cell Therapy Product.
MacroGenics shall have the option, exercisable with respect to *** Products, to co-fund up to *** of BI’s Clinical Development Costs which are incurred after the date of such written notice and *** for such Product.
More Definitions of Clinical Development Costs
Clinical Development Costs means costs, including direct overhead directly attributable to the Collaboration but excluding other overhead, incurred by a Party or for its account, specifically identifiable to the development of a Product, which is aimed at achieving regulatory approval to market such Product or an expanded or significantly modified label for a Product as to which regulatory approval to market such Product has been previously obtained, including Cost of Goods for Product for use in clinical trials and costs incurred with regulatory submissions, wages and benefits to the extent employees work on clinical trials or regulatory submissions (calculated on a full-time equivalent basis) and investigator grants and laboratory materials.
Clinical Development Costs means, unless otherwise provided in writing between the Parties, costs incurred in connection with Clinical Studies, whether such Clinical Studies are conducted by Servier or by Pieris, and determined in accordance with a cost per patient methodology using study drivers defined by both Parties or alternative methodologies agreed by the Parties. These costs per patient exclude CMC, translational activities and transversal activities (finance, human resources, project and alliance management).
Clinical Development Costs means, in relation to a Collaboration Development Candidate, the FTE Costs and Out-of-Pocket Expenses incurred by or on behalf of a Party or its Affiliates that are directly attributable or reasonably allocable to Clinical Development activities for that Collaboration Development Candidate.
Clinical Development Costs means, with respect to each Clinical IRD Product [***] all costs and expenses incurred on or after the Effective Date in connection with the performance of any Clinical Development Plan Activities for such Clinical IRD Product in accordance with the applicable Clinical Development Plan, including FTE Costs and fees charged by Third Party service providers, but excluding (a) overhead costs and capital expenditures and (b) all Clinical Development Manufacturing Costs.
Clinical Development Costs means for all studies or activities performed in accordance with a Clinical Development Plan for any Product in the Territory, the following: (a) All out-of-pocket costs and expenses incurred (i. e., paid to Third Parties or accrued therefor) by the applicable Party or Parties or any of their permitted designees including, without limitation, the costs of clinical trial insurance, (b) the costs of internal personnel engaged in the performance of such studies or activities, which costs shall be determined based on FTE costing or such other basis as may be agreed by the Parties, if relevant, and (c) the costs of Clinical Supplies for such studies or activities, which costs shall include (i) the Clinical Supply Price, (ii) out-of-pocket costs and expenses incurred in purchasing comparator drug and in packaging comparator drug and/or such Product, as applicable, shipping Clinical Supplies to centers, or disposal of Clinical Supplies, and (iii) actual costs of packaging Clinical Samples and comparator drug, as applicable, if done by a Party. Notwithstanding the foregoing, Clinical Development Costs shall not include any costs or expenses incurred in connection with manufacturing process development and validation, manufacturing scale-up, stability testing, or quality assurance/quality control development.
Clinical Development Costs means, with respect to a Product, the costs and expenses for Developing such Product under a Clinical Development Plan, which shall include FTE Costs incurred (at the FTE Costs), and the direct Third Party costs, in each case without xxxx-up or administrative fee, recorded as an expense, by or on behalf of a Party or any of its Affiliates that are specifically identifiable or reasonably and directly allocable to those activities conducted in accordance with the applicable Clinical Development Plan. Except for costs in clause (d) below, Clinical Development Costs shall be limited to (i) those CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT between CUREVAC and ARCTURUS Confidential
(a) clinical trials (including Required Phase 4 Studies) for a Product, including (i) the preparation for and conduct of clinical trials; (ii) data collection and analysis and report writing; (iii) clinical laboratory work; (iv) regulatory activities in direct connection with such studies, including adverse event recordation and reporting, but not including regulatory activities relating generally to a Product and not directly related to such studies, such as regulatory activities relating to Marketing Authorization Applications, other than as set forth in clause (b); and (v) advisory meetings in connection with a Product.
(b) the preparation of a regulatory dossier to the extent necessary to obtain any Regulatory Approval for a Product and filing fees in connection with the filing of applications for Regulatory Approvals;
(c) (i) Manufacture or purchase of a Product for use in clinical trials or other activities for such Product; (ii) the manufacture, purchase or packaging of comparators or placebo for use in clinical trials for a Product (with the manufacturing costs for comparators or placebo to be determined in the same manner as manufacturing costs are determined for such Product); and (iii) costs and expenses of disposal of drugs and other supplies used in such clinical trials or other activities (in each case ((i) through (iii)) determined based on the definition of Manufacturing Costs), but excluding the costs for scale-up, qualification and validation; and
(d) Recall or withdrawal expenses to be treated as Clinical Development Costs pursuant to Section 5.5(b); and Damages from Third Party Claims to be treated as Clinical Development Costs pursuant to Section 13.4.
Clinical Development Costs means, with respect to any Pfizer Quarter, the aggregate of all costs incurred in performing the activities under a Clinical Development Plan (including clinical Manufacturing Costs) for a Licensed Product, excluding corporate overhead.
(a) out-of-pocket costs and expenses incurred internally or to a Third Party in connection with all development activities performed in accordance with a Clinical Development Plan, including personnel costs, study costs, clinical supply costs, costs in connection with regulatory submissions, and costs for process development of the manufacturing process for the Licensed Product;
(b) Manufacturing Costs of products for clinical trials;
(c) such other out-of-pocket costs and expenses as the parties may agree upon in writing from time to time; and
(d) a reasonable allocation of indirect costs associated with such direct costs not to exceed [*] per cent ([*%]) thereof.