Cost of Regulatory Activities. All regulatory costs incurred in connection with the preparation of Regulatory Materials for, and obtaining of Product Approvals in, the Field in the Territory for the Product shall be borne solely by Licensee, and Licensee shall be responsible for all regulatory costs involved in the maintenance of all Regulatory Approvals for the Product in the Field in the Territory.
Cost of Regulatory Activities. All regulatory costs incurred on or after the Effective Date in connection with the preparation of Regulatory Materials for, and obtaining of Regulatory Approvals in, the Licensed Field for the Product shall be borne solely by Licensee. Licensee shall be responsible for all regulatory costs involved in the maintenance of all Regulatory Approvals for the Product in the Licensed Field, and Lilly shall be responsible for all regulatory costs involved in the maintenance of all Regulatory Approvals for the Lilly Products in the Reserved Field.
Cost of Regulatory Activities. Subject to Section 4.4.3, all Regulatory Costs incurred in connection with the preparation by or on behalf of Ono of Regulatory Materials for, and obtaining of Product Approvals in the Field in the Territory for Product shall be borne solely by Ono. Ono shall be responsible for all Regulatory Costs involved in the maintenance of all Regulatory Approvals for Product in the Field in the Territory.
Cost of Regulatory Activities. All Regulatory Costs incurred in connection with the preparation of Regulatory Materials and obtaining of Product Approvals in the Territory (a) for the Product for Dupuytren’s Contracture shall be included in the Development Budget and shall be borne by Pfizer (other than those costs related to matters described in Section 5.2.2(b) which shall be borne by Auxilium); provided, that, Pfizer may recoup fifty percent (50%) of such Regulatory Costs for the Product for Dupuytren’s Contracture in the Territory by means of an off-set against the milestone payment due upon First Commercial Sale of the Product for such indication up to an amount equal to Two Million Five Hundred Thousand Dollars ($2,500,000); and (b) for all other indications in the Field shall be included in the Development Budget and shall be borne solely by Pfizer. Pfizer shall be responsible for all Regulatory Costs involved in the maintenance of all Regulatory Approvals (other than Bulk Product Manufacturing-related Regulatory Approvals) for the Product in the Field in the Territory.
Cost of Regulatory Activities. Except to the extent specified otherwise in this Article 5 (Regulatory Affairs), each Party will be responsible for all costs and expenses incurred in connection with its activities under this Article 5 (Regulatory Affairs), including the preparation or maintenance of Regulatory Submissions and Regulatory Approvals with respect to the Licensed Products for which it is responsible, including any filing fees and, with respect to Ionis, including all costs and expenses of Ionis Regulatory Activities and all costs and expenses related to the ASMF (if filed) and other regulatory affairs related to Manufacturing of Licensed Products, which in each case will be borne solely by Ionis.
Cost of Regulatory Activities. The Parties will share equally (50:50) all actual Internal Costs and actual External Costs relating to regulatory activities included within the Eligible Global Development Costs, and otherwise, the applicable Regulatory Responsible Party will be responsible for the costs and expenses incurred by each Party and its Affiliates in connection with the preparation or maintenance of Regulatory Submissions and Regulatory Approvals with respect to a Licensed Product and corresponding Sarepta Diagnostic Products in a given jurisdiction, including any filing fees.
Cost of Regulatory Activities. All Regulatory Costs incurred in connection with the preparation of Regulatory Materials and obtaining of Product Approvals in the Territory [***].
Cost of Regulatory Activities. All regulatory costs incurred by a Party or its Affiliates in connection with the preparation, submission and maintenance of any Regulatory Materials for, and obtaining of Regulatory Approvals of, the Licensed Products in the Field in the Territory as set forth in Section 5.1.1 (Immatics Pre-Clinical Studies, Immatics CMC Activities and Immatics GDP Trial) or 5.1.2 (BMS Responsibility for Other Regulatory Materials), as applicable, will be borne by such Party.
Cost of Regulatory Activities. All Regulatory Costs incurred by Sobi, or Auxilium, in connection with the transfer, preparation, filing, and maintenance of Regulatory Materials for the Product, and obtaining of Regulatory Approvals for the Finished Product, in the Field in the Territory shall be borne solely by Sobi. Sobi shall be responsible for all Regulatory Costs involved in the maintenance of all Regulatory Approvals (other than Bulk Product Manufacturing-related Regulatory Approvals) for the Finished Product in the Field in the Territory. Auxilium shall invoice Sobi for: (i) all Regulatory Costs it incurs in connection with the preparation of Regulatory Materials for, and obtaining of Regulatory Approvals in the Field in the Territory for the Finished Product and (ii) all Regulatory Costs it incurs in connection with the maintenance of Regulatory Approvals in the Field in the Territory for the Finished Product, which invoices Sobi shall pay within thirty (30) days of receipt thereof.
Cost of Regulatory Activities. All regulatory costs incurred in connection with the preparation of Regulatory Materials, and obtaining of Product Approvals, for the Product shall be borne solely by Aimmune. Aimmune shall be responsible for all regulatory costs involved in the maintenance of all Regulatory Approvals for the Product.
