Common use of General Responsibilities; Ownership of Regulatory Approvals Clause in Contracts

General Responsibilities; Ownership of Regulatory Approvals. Except with respect to the On-Going Studies, and subject to Section 3.4 and Section 4.4.3, Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product in the Licensed Field (including in connection with Patient Information Leaflets, labeling and packaging for Products) and Licensee shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities. For clarity, to the extent allowed by Applicable Law, all Regulatory Approvals for the Product in the Licensed Field shall be held and owned by Licensee in its name. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

General Responsibilities; Ownership of Regulatory Approvals. Except with respect to the On-Going Studies, and subject to Section 3.4 and Section 4.4.3, Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product in the Licensed Field (including in connection with the HHBB Study, Patient Information Leaflets, labeling and packaging for Products) and Licensee shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities. For clarity, to the extent allowed by Applicable Law, all Regulatory Approvals for the Product in the Licensed Field shall be held and owned by Licensee in its name. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.