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. 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. 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. All Regulatory Costs incurred in connection with the preparation of Regulatory Materials and obtaining of Product Approvals in the Territory [***].
Cost of Regulatory Activities. The Parties will share equally (50:50) all External Costs solely relating to regulatory activities associated with the conduct of Clinical Trials for the Licensed Products included within the Eligible Global Development Costs, and otherwise, the applicable Regulatory Responsible Party will be responsible for the costs incurred by each Party and its Affiliates in connection with the preparation or maintenance of Regulatory Submissions and Regulatory Approvals with respect to the Licensed Products in a given jurisdiction, including any filing fees.
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 costs and expenses incurred by HanX (or its Affiliates) in connection with the preparation or maintenance of Regulatory Materials and Regulatory Approvals for sale of the Product in the Field in the Territory, including any filing fees shall be borne solely by HanX.
Cost of Regulatory Activities. Each Party will solely bear all costs and expenses incurred by such Party in connection with the preparation, filing, and maintenance of Regulatory Submissions, Reimbursement Submissions, Regulatory Approvals, and Reimbursement Approvals with respect to any Product, including any filing fees; except that Sobi shall reimburse Apellis for all reasonable Out-Of-Pocket costs and expenses mutually agreed in advance in good faith and incurred by Apellis in connection with the preparation, filing, and maintenance of the EMA PNH Regulatory Approval which, for the avoidance of doubt, shall not include any costs and expenses associated with any post-approval Development activities required in connection with such Regulatory Approval.
