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. Except as set forth in Section 5.3.5, [***] incurred in connection with applying for Regulatory Approval with respect to Global Licensed Products in the Novartis 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. 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. Except as provided in Section 2.3 (Responsibilities for Development Activities and Costs) and Section 3.1.1.2, each Party shall be responsible for all 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. The Parties shall share the Shared Development Costs associated with applying for Marketing Authorization with respect to Collaboration Products in the Beam Field in the Collaboration Territory, and related regulatory affairs activities in the Collaboration Territory as set forth in this Article 6. Beam shall be responsible for all costs and expenses incurred in connection with applying for Marketing Authorization with respect to Protected Products in the Beam Field in the Territory and Collaboration Products in the Beam Field outside the Collaboration Territory, and related regulatory affairs activities as set forth in this Article 6.
Costs of Regulatory Affairs. Novartis will be responsible for all costs and expenses incurred by either Party in connection with applying for Regulatory Approval with respect to Global Licensed Products, Optioned Licensed Products and Fc Licensed Products in the Novartis Territory, and related regulatory affairs activities, provided that Xencor shall not be reimbursed for any such costs or expenses that are not (i) contemplated by the Development Plan or this Agreement or (ii) without the prior written consent of Novartis.
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.
