Global Development Costs definition

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

• The non-requesting Party may agree to cover such portion of the of the requesting Party’s share of Global Development Costs in the non-requesting Party’s sole discretion.

• For clarity, Global Development Costs to be paid by Genzyme pursuant to this Section 5.3.4 (Global Development Costs) shall exclude any amounts paid after the Option Exercise Date for the SMA Licensed Product to Third Parties with respect to services rendered or services procured in connection with the conduct of any Clinical Study or Development activity that, in either case, is completed or performed prior to the Option Exercise Date for the SMA Licensed Product.

• Notwithstanding the foregoing, if following receipt of a Global Development Costs Report a Party (the “Disputing Party”) disputes any Global Development Costs under such Global Development Costs Report, it shall have [***] to notify the other Party (the “Non-Disputing Party”).

• 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”).

• Within [***] following January 1 of the Calendar Year subsequent to the Calendar Year during which the non-requesting Party covers any Global Development Costs for the requesting Party, the requesting Party shall pay to non-requesting Party [***] covered by the non-requesting Party for the requesting Party.

More Definitions of Global 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, with respect to a Split Product, all Development Costs other than Territory-Specific Development Costs.

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 shall have the meaning set forth in the Financial Appendix.

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, 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 shall have the meaning defined in Exhibit A.