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

General Responsibilities; Ownership of Regulatory Approvals. Ono shall use Commercially Reasonable Efforts to obtain Regulatory Approval for Product, including Ono-Requested Configurations and any other configurations agreed in writing by both Parties to be Manufactured, in the Field in the Territory on the timelines described in the Development Plan subject to timely completion of Manufacturing Development Activities as reflected in the respective Manufacturing Development Plan. Subject to Section 5.2.5, Ono shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining Regulatory Approvals in the Territory (including in connection with patient information leaflets, and Packaging and Labeling for Product in the Field in the Territory) and [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Ono shall submit such Regulatory Materials, Regulatory Approvals and MAA’s, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Approvals for Product in the Territory (other than those related solely to the Manufacture of Compound in the Territory, if any) shall be in the name of Ono, and Ono shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials.

General Responsibilities; Ownership of Regulatory Approvals. Ono shall use Commercially Reasonable Efforts to obtain Regulatory Approval for Product, including Ono-Requested Configurations and any other configurations agreed in writing by both Parties to be Manufactured, Product in the Field in the Territory on the timelines described in the Development Plan subject to timely completion of Manufacturing Development Activities as reflected in the respective Manufacturing Development Plan. Subject to Section 5.2.5, Ono shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining Regulatory Approvals in the Territory (including in connection with patient information leaflets, and Packaging and Labeling for Product in the Field in the Territory) and [[ ** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. connection with Patient Information Leaflets, and labeling and packaging for Product in the Field in the Territory) and Ono shall submit such Regulatory Materials, Regulatory Approvals and MAA’s, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Approvals for Product in the Territory (other than those related solely to the Manufacture of Compound Product in the Territory, if any) shall be in the name of Ono, and Ono shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials.