Common use of Ownership and Maintenance of Governmental Approvals Clause in Contracts

Ownership and Maintenance of Governmental Approvals. 4.1.1 The Company will own all Marketing Authorizations for each country in the Territory for Licensed Products. Without limiting the generality of the foregoing, the Company shall prepare and submit in its own name and at its expense BLAs (or its equivalent) with the appropriate Competent Authorities in the Territory’ and any other equivalent application with the Competent Authorities in other countries in the Territory. 4.1.2 The Company shall secure and maintain in good standing, at its sole cost and expense, any and all Registrations and Governmental Approvals (including, Marketing Authorizations, licenses, permits and consents, facility licenses and permits required by Applicable Laws or by the applicable Competent Authorities) necessary and/or required for the Company to perform its obligations under this Agreement and use commercially reasonable efforts at its cost and expense to secure and maintain any variations and renewals thereof. The Company shall promptly notify the Licensor of any written or oral notices received from, or inspections by, any Competent Authority relating to any such Governmental Approvals.

Ownership and Maintenance of Governmental Approvals. 4.1.1 The Company will may obtain, in its own name, all Marketing Authorizations for each country in the Territory for Licensed Products. Without limiting the generality of the foregoing, the Company shall prepare and submit in its own name and at its expense BLAs (or its equivalent) PMAs with the appropriate Competent Authorities FDA in the Territory’ U.S. and any other equivalent application with the Competent Authorities in other countries in the Territory. 4.1.2 The Company shall secure and maintain in good standing, at its sole cost and expense, any and all Registrations and Governmental Approvals (including, Marketing Authorizations, licenses, permits and consents, facility licenses and permits required by Applicable Laws or by the applicable Competent Authorities) necessary and/or required for the Company to perform its obligations under this Agreement and use commercially reasonable efforts Commercially Reasonable Efforts at its cost and expense to secure and maintain any variations and renewals thereof. The Company Licensor shall promptly notify the Licensor Company of any written or oral notices received from, or inspections by, any Competent Authority relating to any such Governmental Approvals.