Clinical Development Costs definition

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, 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 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.

Examples of Clinical Development Costs in a sentence

• 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.

• 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.

• 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.

• The Auditing Party shall pay the full cost of the review unless the underpayment of milestones, royalties, FTE Costs, MacroGenics out-of-pocket expenses under Section 6.3(b)(i) and/or Clinical Development Costs is greater than *** of the amount due for the applicable period, in which case the Audited Party shall pay the reasonable costs charged by such accounting firm for such review.

• The report of such accounting firm shall be limited to a certificate stating whether any report made or invoice or payment submitted by the Audited Party during such period is accurate or inaccurate and the actual amounts of Clinical Development Costs, FTE Costs, MacroGenics out-of-pocket expenses under Section 6.3(b)(i), and any payments under Section 3.7, and the amount of any Net Sales, milestone or royalty discrepancy.

More Definitions of Clinical Development Costs

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):

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 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.

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 activities that are specifically identified in the applicable Clinical Development Plan and (ii) those costs contained in the budget therein. Subject to the foregoing, Clinical Development Costs shall include such costs in connection with the following activities, as applicable: