Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (a) Except as set forth in Part 2.11 of the Company Disclosure Schedule, (i) with respect to the Company Products and, to the extent applicable, any currently under development (A) the Company Entities have obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United States or foreign governments or government agencies, to permit the design, development, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where it currently conducts such activities (the "Activities to Date") with respect to each Company Product (collectively, the "Company Licenses"), except where the failure to hold such Company Licenses has not been material to the Company Entities and would not reasonably be expected to be material to the Company Entities; (B) the Company Entities are in material compliance with all terms and conditions of each Company License and with all applicable laws pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company Entities are in compliance in all material respects with all Legal Requirements regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company or, as applicable, a subsidiary of the Company exporting such Company Product, has exported such Company Product in compliance in all material respects with all Legal Requirements, and (ii) the Company Entities are in compliance in all material respects with all applicable reporting requirements for all Company Licenses or plant registrations described in clause (i) above.

FDA and Regulatory Matters. (aA) Except as set forth in Part 2.11 of the Company Disclosure Schedule, (i) with respect to the Company Products and, to the extent applicable, any currently under development (A) the Company Entities have obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United States or foreign governments or government agencies, to permit the design, development, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where it currently conducts such activities (the "Activities to DateACTIVITIES TO DATE") with respect to each Company Product (collectively, the "Company LicensesCOMPANY LICENSES"), except where the failure to hold such Company Licenses has not been material to the Company Entities and would not reasonably be expected to be material to the Company Entities; (B) the Company Entities are in material compliance with all terms and conditions of each Company License and with all applicable laws pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company Entities are in compliance in all material respects with all Legal Requirements regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company or, as applicable, a subsidiary of the Company exporting such Company Product, has exported such Company Product in compliance in all material respects with all Legal Requirements, and (ii) the Company Entities are in compliance in all material respects with all applicable reporting requirements for all Company Licenses or plant registrations described in clause (i) above.

FDA and Regulatory Matters. (a) Except as set forth in Part 2.11 3.7 of the Company Parent Disclosure Schedule, (i) with respect to the Company Parent Products and, to the extent applicable, any currently under development (A) the Company Parent Entities have obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United States or foreign governments or government agencies, to permit the design, development, manufacture, labeling, sale, distribution and promotion of the Company Parent Products in jurisdictions where it they currently conducts conduct such activities (the "Parent Activities to Date") with respect to each Company Parent Product (collectively, the "Company Parent Licenses"), except where the failure to hold such Company Parent Licenses has not been material to the Company Parent Entities and would not reasonably be expected to be material to the Company Parent Entities; (B) the Company Parent Entities are in material compliance with all terms and conditions of each Company Parent License and with all applicable laws pertaining to the Parent Activities to Date with respect to each Company Parent Product which is not required to be the subject of a Company Parent License; (C) the Company Parent Entities are in compliance in all material respects with all Legal Requirements regarding registration, license, certification for each site at which a Company Parent Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Parent Product has been exported from the United States, the Company Parent or, as applicable, a subsidiary of the Company Parent exporting such Company Parent Product, has exported such Company Parent Product in compliance in all material respects with all Legal Requirements, and (ii) the Company Parent Entities are in compliance in all material respects with all applicable reporting requirements for all Company Parent Licenses or plant registrations described in clause (i) above.

FDA and Regulatory Matters. (a) Except as set forth in Part 2.11 of the Company Disclosure Schedule, (i) with With respect to all of the Company Products Company’s existing products and, to the extent applicable, any products currently under development by the Company (collectively, the “Products”), (A) the Company Entities have and each of its Subsidiaries has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United States or foreign governments or government agencies, to permit the design, development, manufacture, labeling, sale, distribution development and promotion pre-clinical testing of the Company its Products in jurisdictions where it currently conducts such activities or contemplated conducting such activities (the "“Activities to To Date"”) with respect to each Company Product (collectively, the "Company “Regulatory Licenses"”), except where the failure to hold such Company Licenses has not been material to the Company Entities and would not reasonably be expected to be material to the Company Entities; (B) the Company Entities are and each of its Subsidiaries, as the case may be, is in material compliance with all terms and conditions of each Company Regulatory License and with all applicable laws Laws pertaining to the Activities to To Date with respect to each Company Product which is not required to be the subject of a Company Regulatory License; (C) the Company Entities are and each of its Subsidiaries, as the case may be, is in compliance in all material respects with all Legal Requirements applicable Laws regarding registration, license, and certification for each site at which a Company Product is manufactured, labeled, sold, manufactured or distributedused; and (D) to the extent any Company Product has been exported from the United States, the Company or, as applicable, a subsidiary Subsidiary of the Company exporting such Company Product, has exported such Company Product in compliance in all material respects with all Legal Requirements, applicable Law; and (E) the Company is licensed to export its Products in the respective jurisdictions set forth in the Company Disclosure Schedule; (ii) all manufacturing operations performed by or on behalf of the Company Entities or its Subsidiaries have been and are in compliance being conducted in all material respects in compliance with the applicable regulations of the U.S. Food and Drug Administration (the “FDA”) and, to the extent applicable to the Company or any of its Subsidiaries, counterpart regulations in all other countries where compliance is required; and (iii) the Company and each of its Subsidiaries is in compliance with all applicable reporting requirements for all Company Regulatory Licenses or plant registrations described describe in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside the United States under applicable Law.