Global Development Costs means, with respect to any Licensed Product, any costs included in the Global Development Plan for such Licensed Product, including (i) [***], (ii) [***], (iii) [***], (iv) [***] and (vi) [***].
Global Development Costs means any Development Costs incurred by a Party (or for its account by an Affiliate or a Third Party) that are intended to support approval both in the Co-Development Territory and outside of the Co-Development Territory, regardless of where those costs are physically incurred. For purposes of clarity, Global Development Costs do not include (a) any filing fees required for, and other costs associated with, any Regulatory Filings for a particular country or (b) clinical studies conducted solely to support approval in a specific country or countries (i.e., U.S. Development Costs or Ex-U.S. Development Costs as defined below).
Global Development Costs means all of the following expenses related to Global Development Activities incurred by Company or its Affiliates (or by MacroGenics or its Affiliates pursuant to Section 4.2(c)), regardless of whether such expenses are incurred before or during the Co-Funding Term:
Examples of Global Development Costs in a sentence
Each Party shall calculate and maintain records of Global Development Costs incurred by it and its Affiliates with respect to a Split Territory Licensed Product and, within [***] following the end of each Calendar Quarter, each Party shall submit to the other a report detailing the Global Development Costs incurred by it and its Affiliates during such Calendar Quarter, and, if requested, shall provide reasonable supporting documentation to the other Party (an “Global Development Costs Report”).
The Party that incurs more than its share of the total actual Global Development Costs with respect to a Split Territory Licensed Product during any Calendar Quarter shall be paid by the other Party an amount of cash sufficient to reconcile to its agreed percentage of Global Development Costs for such Split Territory Licensed Product, which payment shall be made within [***] after delivery of the Global Development Costs Reports for such Calendar Quarter.
With respect to any SMA Licensed Product, Genzyme shall be responsible for one-hundred percent (100%) of all Global Development Costs that occur after the Option Exercise Date for such SMA Licensed Product.
The Parties shall use reasonable efforts to resolve any such dispute as soon as reasonably practicable, and any undisputed portion of Global Development Costs in such Global Development Costs Report shall be paid within [***] after delivery of such Global Development Costs Report.
Please note that in many cases a written request, submitted for approval before leave begins, is required.Employees on extended leave who plan to return the next fiscal year must notify the Executive Director/designee in writing of their intention to return to work by April 1.For complete information regarding leaves of absence, refer to the NKCES Policy Manual.
More Definitions of Global Development Costs
Global Development Costs means, with respect to a Split Product, all Development Costs other than Territory-Specific Development Costs.
Global Development Costs shall have the meaning set forth in the Financial Appendix.
Global Development Costs means, with respect to a Profit-Share Product, the sum of the FTE Costs and Out-of-Pocket Development Costs incurred by or on behalf of Seagen and its Affiliates for the Development of the applicable Profit-Share Product that is necessary or reasonably useful for obtaining, maintaining, or supporting Regulatory Approval in [*] (including, for the avoidance of doubt, (a) to the extent obtaining, maintaining, or supporting such Regulatory Approval is necessary or reasonably useful for Development or Commercialization in [*], and (b) whether such activities are conducted before or after receipt of such Regulatory Approval), in each case, excluding those Development costs reasonably allocable to Clinical Trials conducted solely to obtain Regulatory Approval in a jurisdiction outside [*] (and not for purposes of obtaining Regulatory Approval in [*]). By way of example, the Development costs of a [*] study would not be included in “Global Development Costs.” The Parties shall mutually agree in each Profit-Share Product Agreement on the applicable FTE rate for determination of FTE Costs and a mechanism for adjustments thereto; provided, that such rate and mechanism shall be in accordance with then-current industry practice. For purposes of this Section 1.122 (“Global Development Costs”): (i) “FTE Costs” means [*]; provided, that the FTE Costs shall be calculated in accordance with accounting and reimbursement principles consistent with Xxxxxx’s then-current Accounting Standard (such calculation methodology will be discussed and agreed by the applicable Committee in connection with Nurix’s exercise of the relevant Profit-Share Option); (ii) “FTE” means a full-time equivalent person year as further defined and mutually agreed by the Parties in good faith in the relevant Profit-Share Product Agreement (which definition shall be consistent with Seagen’s then-current policies and Accounting Standard); and (iii) “Out-of-Pocket Development Costs” means all costs incurred by or on behalf of Seagen and its Affiliates for payments made to Third Parties in the Development of the applicable Profit-Share Product (including CMC Development and the Manufacture of clinical material for Clinical Trials for such Profit-Share Product).
Global Development Costs means all Development Costs incurred by the Parties in accordance with the applicable budget approved by the JDC, other than the Territory-Specific Development Costs.
Global Development Costs means all Development Costs incurred by the Parties with respect to a Shared Development Program in accordance with the applicable budget approved by the JDC, other than the Territory-Specific Development Costs.
Global Development Costs means those certain Development Costs incurred on or after [***] in connection with either Party’s conduct of the Global Phase 3 Study in accordance with the Global Phase 3 Study Plan. For clarity, Global Development Costs excludes (i) any costs or expenses incurred by Advaccine in connection with its activities under the Global Phase 3 Study in Greater China, and (ii) any costs or expenses incurred by Inovio, its Affiliates, Sublicensees or Third Parties that are solely related to its activities in connection with the performance of the Clinical Trial in the US under the Global Phase 3 Study. For clarity, Global Development Costs shall include costs incurred by Inovio in the US in connection with the conduct of Global Phase 3 Study that are not specific to the dosing of patients in the Clinical Trial in the US, such as trial management and operations costs, pharmacovigilance costs, on-going stability costs, regulatory costs, and analytical testing costs.
Global Development Costs means the costs specifically attributable to the development of a Product and actually incurred after the date of ROCHE's decision to exercise its option for a GENENTECH or an In-Licensed Product through the date of marketing approval or termination of development efforts of the final indication or formulation or dosing for which marketing approval is sought in the USA and/or the Collaborative Countries. Such costs shall comprise those costs, both direct and indirect including Allocable Overhead (i.e. fully burdened costs), required to obtain the authorization to manufacture, formulate, fill, ship and/or sell a Product in commercial quantities in the USA and/or the Collaborative Countries to third parties. Such Global Development Costs shall include but are not limited to costs of development including cost of studies on the toxicological, pharmacokinetical, metabolical or clinical aspects of a Product conducted internally or by individual investigators or consultants, manufacturing process development and scale up costs, qualification lots, costs for preparing, submitting, reviewing or developing data or information necessary for the purpose of submission to the FDA, EMEA or other governmental authority in order to obtain and/or maintain approval of a Product in the USA and/or the Collaborative Countries. These costs shall include expenses for data management, statistical designs and studies, document preparation, and other administration expenses associated with the clinical testing program. These costs shall include costs incurred in geographical areas other than USA and/or the Collaborative Countries (e.g.: Canada, South Africa and Brazil) only to the extent that the activities related with such costs are specifically planned (and specifically included in the mutually approved global development plan and budget) to be incurred in such geographical areas for the purpose of generating data or information required to obtain the above mentioned authorization in the USA and/or the Collaborative Countries. These costs shall not include Patent costs, pre-registration marketing costs (e.g. trademark costs, advertising agency selection costs, pre- marketing studies), post-registration clinical and marketing studies which are not conducted as part of the global development plan. In determining Global Development Costs, each Party will use its applicable project cost system with the purpose of tracking costs as much as possible on a product indication-by-product ...