Costs of Regulatory Affairs. Except as provided in Section 5.3.5, [***] costs and expenses incurred in connection with applying for, obtaining and maintaining Regulatory Approval with respect to Regional Licensed Products in its Territory, and related regulatory affairs activities.
Costs of Regulatory Affairs. Each Party shall be responsible for all costs incurred by or on behalf of it in connection with applying for Regulatory Approval with respect to each Licensed Product in the Field in each country in its own Territory and related regulatory affairs activities.
Costs of Regulatory Affairs. [***] costs and expenses incurred in connection with applying for Regulatory Approval with respect to T1 Licensed Products in the Novartis Territory, and related regulatory affairs activities.
Costs of Regulatory Affairs. Except as provided in Sections 2.3 (Joint Responsibilities for Development Activities and Costs) and 3.1.1.2 (Ownership of Regulatory Filings), each Party shall be responsible for all costs and expenses incurred in connection with applying for, obtaining and maintaining Regulatory Approval with respect to Co-Co Licensed Products, and related regulatory affairs activities.
Costs of Regulatory Affairs. The Parties will share as Joint Development Costs the FTE Costs and Out-of-Pocket Costs incurred in the performance of regulatory activities for Licensed Products in the Profit-Share Territory to the extent in accordance with the applicable Joint Development Budget. Biogen will be solely responsible for all costs and expenses incurred in connection with the performance of regulatory activities solely related to applying for and maintaining Regulatory Approval for the Licensed Products in the Biogen Territory.
Costs of Regulatory Affairs. After expiration of the Transition Period, Genzyme shall be responsible for all costs and expenses incurred in connection with applying for Regulatory Approval with respect to Global AT3 Licensed Products in the Licensed Territory, and related regulatory affairs activities.
Costs of Regulatory Affairs. With respect to costs and expenses incurred following the Effective Date in connection with applying for Regulatory Approval with respect to Licensed Products in the Territory, and related regulatory affairs activities (excluding any costs expressly set out hereunder as being at one Party’s cost), such costs and expenses shall be treated as Development Costs and Gilead shall be responsible for […***…] percent ([…***…]%) and Galapagos shall be responsible for […***…] percent ([…***…]%). Gilead shall be solely responsible for all costs and expenses incurred for regulatory affairs activities following Regulatory Approval with respect to the Licensed Product or Gilead Combination Product in a particular indication, provided that, any costs and expenses incurred in connection with regulatory activities with respect to any Phase 4 Clinical Trial and any other fees paid to Regulatory Authorities following Regulatory Approval, in each case with respect to Licensed Products and not Gilead Combination Products, shall be shared by the Parties as Development Costs in accordance with Section 3.4. Within […***…] Business Days after the end of the second (2nd) month of each calendar quarter, Galapagos shall provide to Gilead a report in reasonable detail of any such costs, expenses and fees incurred by Galapagos in the last calendar month of the preceding quarter and the first two calendar months of the current quarter for each Licensed Product. The costs, expenses and fees so reported will be used for the calculation of the […***…] split for Development Costs and will be included in the reconciliation, invoicing and payment made pursuant to Section 3.4.
Costs of Regulatory Affairs. After expiration of the Transition Period, Alnylam shall be responsible for [***] in connection with applying for Regulatory Approval with respect to Licensed Products in the Licensed Territory, and related regulatory affairs activities.
Costs of Regulatory Affairs. Except as otherwise expressly provided in this Article 5 (Regulatory Matters), (a) during the period of a PSP P&L Share for a Profit-Share Product, the Parties will share the applicable Eligible Development Expenses associated with obtaining and maintaining Regulatory Approval in the Territory, and related regulatory affairs activities as set forth in this Article 5 (Regulatory Matters) for such Profit-Share Product in accordance with Section 9.2.1 (Profit and Loss Share) and (b) outside the period of a PSP P&L Share, for a Royalty-Bearing Product, Neurocrine will bear all such costs and expenses for such Royalty-Bearing Product, except as otherwise expressly set forth in this Agreement.
Costs of Regulatory Affairs. Subject to Section 5.1.1, [***] will be responsible for all costs and expenses incurred in connection with applying for, obtaining and maintaining Regulatory Approval with respect to Licensed Products in its Territory, and related regulatory affairs activities.
