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

Ownership and Maintenance of Governmental Approvals. (a) Strata will own all Marketing Authorizations for each country in the Territory for use in the Field. Without limiting the generality of the foregoing, Strata shall prepare and submit in its own name and at its expense the NDA with the FDA in the U.S. and any other equivalent application with the Competent Authorities in other countries in the Territory. Without acting as a limitation to any other provision under this Agreement, Strata shall maintain a current and valid DMF on the Compound and the Product, whether as an independent document or as part of the NDA, which it shall keep up to date at all times during the Term and shall cause any Subcontractor to similarly maintain the same or grant the Subcontractor reference rights to Strata’s DMF for the Product. (b) Other than those required to be maintained by Micrologix under Section 6.7(b), Strata shall secure and maintain in good standing, at its sole cost and expense, any and all 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 Strata 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. (c) Excluding Marketing Authorizations and subject to Section 6.7(b), Micrologix shall secure and maintain, at its sole cost and expense, any and all Governmental Approvals (including, licenses, permits and consents, facility licenses and permits required by Applicable Laws or by the applicable Competent Authorities) necessary and/or required for Micrologix to perform its obligations under this Agreement and any Development Subcontract and use Commercially Reasonable Efforts, at its cost and expense to secure and maintain any variations or renewals thereof.

Ownership and Maintenance of Governmental Approvals. (a) Strata will own all Marketing Authorizations for each country in the Territory for use in the Field. Without limiting the generality of the foregoing, Strata shall prepare and submit in its own name and at its expense the NDA with the FDA in the U.S. and any other equivalent application with the Competent Authorities in other countries in the Territory. Without acting as a limitation to any other provision under this Agreement, Strata shall maintain a current and valid DMF on the Compound and the Product, whether as an independent document or as part of the NDA, which it shall keep up to date at all times during the Term and shall cause any Subcontractor to similarly maintain the same or grant the Subcontractor reference rights to Strata’s 's DMF for the Product. (b) . Other than those required to be maintained by Micrologix under Section 6.7(b), Strata shall secure and maintain in good standing, at its sole cost and expense, any and all 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 Strata 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. (c) . Excluding Marketing Authorizations and subject to Section 6.7(b), Micrologix shall secure and maintain, at its sole cost and expense, any and all Governmental Approvals (including, licenses, permits and consents, facility licenses and permits required by Applicable Laws or by the applicable Competent Authorities) necessary and/or required for Micrologix to perform its obligations under this Agreement and any Development Subcontract and use Commercially Reasonable Efforts, at its cost and expense to secure and maintain any variations or renewals thereof.

Ownership and Maintenance of Governmental Approvals. (a) Strata Fujisawa will own all Marketing Authorizations for each country in the Territory for use in the Field. Without limiting the generality of the foregoing, Strata Fujisawa shall prepare and submit in its own name and at its expense the NDA with the FDA in the U.S. and any other equivalent application with the Competent Authorities in other countries in the Territory. Without acting as a limitation to any other provision under this Agreement, Strata Fujisawa shall maintain a current and valid DMF on the Compound and the Product, whether as an independent document or as part of the NDA, which it shall keep up to date at all times during the Term and or shall cause any Subcontractor a Representative to similarly maintain the same or grant the Subcontractor Representative reference rights to StrataFujisawa’s DMF for the Product. (b) Other than those required to be maintained by Micrologix Cardiome under Section 6.7(b6.5(b), Strata Fujisawa shall secure and maintain in good standingmaintain, at its sole cost and expenseexpense (except for those expenses specifically included as Development Costs under this Agreement), any and all Governmental Approvals (including, including Marketing Authorizations, licenses, permits and consents, facility licenses and permits required by Applicable Laws or by the applicable Competent Authorities) necessary and/or or required for Strata Fujisawa to perform its obligations under this Agreement and use Commercially Reasonable Efforts at its cost and expense (except for those expenses specifically included as Development Costs under this Agreement) to secure and maintain any variations and renewals thereof. (c) Excluding Marketing Authorizations and subject to Section 6.7(b6.5(b), Micrologix Cardiome shall secure and maintain, at its sole cost and expenseexpense (except for those expenses specifically included as Development Costs under this Agreement), any and all Governmental Approvals (including, including licenses, permits and consents, facility licenses and permits required by Applicable Laws or by the applicable Competent Authorities) necessary and/or or required for Micrologix Cardiome to perform its obligations under this Agreement and any Development Subcontract and use Commercially Reasonable Efforts, at its cost and expense (except for those expenses specifically included as Development Costs under this Agreement) to secure and maintain any variations or renewals thereof.

Ownership and Maintenance of Governmental Approvals. (a) Strata Fujisawa will own all Marketing Authorizations for each country in the Territory for use in the Field. Without limiting the generality of the foregoing, Strata Fujisawa shall prepare and submit in its own name and at its expense the NDA with the FDA in the U.S. and any other equivalent application with the Competent Authorities in other countries in the Territory. Without acting as a limitation to any other provision under this Agreement, Strata Fujisawa shall maintain a current and valid DMF on the Compound and the Product, whether as an independent document or as part of the NDA, which it shall keep up to date at all times during the Term and or shall cause any Subcontractor a Representative to similarly maintain the same or grant the Subcontractor Representative reference rights to Strata’s Fujisawa's DMF for the Product. (b) Other than those required to be maintained by Micrologix Cardiome under Section 6.7(b6.5(b), Strata Fujisawa shall secure and maintain in good standingmaintain, at its sole cost and expenseexpense (except for those expenses specifically included as Development Costs under this Agreement), any and all Governmental Approvals (including, including Marketing Authorizations, licenses, permits and consents, facility licenses and permits required by Applicable Laws or by the applicable Competent Authorities) necessary and/or or required for Strata Fujisawa to perform its obligations under this Agreement and use Commercially Reasonable Efforts at its cost and expense (except for those expenses specifically included as Development Costs under this Agreement) to secure and maintain any variations and renewals thereof. (c) Excluding Marketing Authorizations and subject to Section 6.7(b6.5(b), Micrologix Cardiome shall secure and maintain, at its sole cost and expenseexpense (except for those expenses specifically included as Development Costs under this Agreement), any and all Governmental Approvals (including, including licenses, permits and consents, facility licenses and permits required by Applicable Laws or by the applicable Competent Authorities) necessary and/or or required for Micrologix Cardiome to perform its obligations under this Agreement and any Development Subcontract and use Commercially Reasonable Efforts, at its cost and expense (except for those expenses specifically included as Development Costs under this Agreement) to secure and maintain any variations or renewals thereof.