Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (A) Except as set forth in Part 3.7 of the Parent Disclosure Schedule, (i) with respect to the Parent Products and, to the extent applicable, any currently under development (A) the 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 Parent Products in jurisdictions where they currently conduct such activities (the "PARENT ACTIVITIES TO DATE") with respect to each Parent Product (collectively, the "PARENT LICENSES"), except where the failure to hold such Parent Licenses has not been material to the Parent Entities and would not reasonably be expected to be material to the Parent Entities; (B) the Parent Entities are in material compliance with all terms and conditions of each Parent License and with all applicable laws pertaining to the Parent Activities to Date with respect to each Parent Product which is not required to be the subject of a Parent License; (C) the Parent Entities are in compliance in all material respects with all Legal Requirements regarding registration, license, certification for each site at which a Parent Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Parent Product has been exported from the United States, Parent or, as applicable, a subsidiary of Parent exporting such Parent Product, has exported such Parent Product in compliance in all material respects with all Legal Requirements, and (ii) the Parent Entities are in compliance in all material respects with all applicable reporting requirements for all Parent Licenses or plant registrations described in clause (i) above.

FDA and Regulatory Matters. (A) Except as set forth in Part 3.7 The Company and each of the Parent Disclosure Schedule, (i) with respect to the Parent Products its Subsidiaries are and, to the extent applicableat all times since January 1, any currently under development (A) the Parent Entities 2021, have obtained all necessary and applicable approvalsbeen, 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 Parent Products in jurisdictions where they currently conduct such activities (the "PARENT ACTIVITIES TO DATE") with respect to each Parent Product (collectively, the "PARENT LICENSES"), except where the failure to hold such Parent Licenses has not been material to the Parent Entities and would not reasonably be expected to be material to the Parent Entities; (B) the Parent Entities are in material compliance with all terms and conditions of each Parent License and with all applicable laws pertaining to the Parent Activities to Date with respect to each Parent Product which is not required to be the subject of a Parent License; (C) the Parent Entities are in compliance in all material respects with all Legal Requirements regarding registration, license, certification for each site at which a Parent Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Parent Product has been exported from the United States, Parent or, as applicable, a subsidiary of Parent exporting such Parent Product, has exported such Parent Product in compliance in all material respects with all Legal Requirements, and (ii) the Parent Entities are in compliance in all material respects with all applicable reporting requirements for Healthcare Laws. To the knowledge of the Company, there are no facts or circumstances that reasonably would be expected to give rise to any material liability under any Healthcare Laws. The Company and its Subsidiaries have not received written notification of any pending action from the FDA or any other similar regulatory authority alleging that any operation or activity of the Company and its Subsidiaries is in material violation of any applicable Healthcare Law. All CVR Products are being, and since January 1, 2021, have been, developed, manufactured, packaged, labeled, stored, tested and distributed in material compliance with all Parent Licenses applicable Healthcare Laws. All regulatory filings made by the Company and its Subsidiaries with the FDA or plant registrations described any similar foreign Governmental Entity with respect to the CVR Products have complied in clause all material respects with all applicable Healthcare Laws. Neither the Company nor each of its Subsidiaries nor, to the knowledge of the Company, any officer, employee, agent or investigator of the Company and its Subsidiaries has (i) abovemade an untrue statement of a material fact or any fraudulent statement to the FDA or any other similar regulatory authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other similar regulatory authority or (iii) committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a reasonable basis for the FDA or any other similar regulatory authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46,191 (September 10, 1991) or any similar policy. The Company and its Subsidiaries have not, and, to the knowledge of the Company, no officer, employee, agent or investigator of the Company and its Subsidiaries has been, convicted of any crime or engaged in any conduct for which debarment is mandated under 21 U.S.C. § 335a(a) or (b) or any similar state or foreign Law. Neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any officer, employee, agent or investigator of the Company has been convicted of any crime or engaged in any conduct for which such person could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any other applicable Healthcare Law. No actions that would reasonably be expected to result in material debarment or exclusion are pending or, to the knowledge of the Company, threatened in writing against the Company and its Subsidiaries or any of their officers, employees, agents or investigators. The Company and its Subsidiaries are not party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. To the knowledge of the Company, all preclinical studies and clinical trials involving any CVR Products, including those conducted or sponsored by the Company and its Subsidiaries have been, and if still pending are being, conducted in compliance in all material respects with applicable research protocols and all applicable Healthcare Laws. To the knowledge of the Company, neither the FDA nor any similar applicable foreign Governmental Entity has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company and its Subsidiaries or to enjoin the manufacturing of the CVR Products.

FDA and Regulatory Matters. (Aa) Except as set forth in Part 3.7 of the Parent Disclosure Schedule, (i) with With respect to the Parent Company Products and, to the extent applicable, any other products currently under development by the Company (collectively, the “Products”), (i) (A) the Parent Entities have Company 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, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of Parent its Products in jurisdictions where they it currently conduct conducts such activities (the "PARENT ACTIVITIES TO DATE"“Activities to Date”) with respect to each Parent Product (collectively, the "PARENT LICENSES"“Company Licenses”), except where the failure to hold such Parent Licenses has not been material to the Parent Entities and would not reasonably be expected to be material to the Parent Entities; (B) the Parent Entities are Company and each of its Subsidiaries, as the case may be, is in material compliance with all terms and conditions of each Parent Company License and with all applicable laws pertaining to the Parent Activities to Date with respect to each Parent Product which is not required to be the subject of a Parent Company License; (C) the Parent Entities are Company 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, certification for each site at which a Parent Product is manufactured, labeled, sold, or distributed; and (D) to the extent that any Parent Product has been exported from the United States, Parent the Company or, as applicable, a subsidiary Subsidiary of Parent the Company exporting such Parent Product, has exported such Parent Product in compliance in all material respects with all Legal Requirements, and applicable law; (ii) all manufacturing operations performed by or on behalf of the Parent Entities Company or its Subsidiaries have been and are in compliance being conducted in all material respects in compliance with the Quality Systems regulations of the FDA and, to the extent applicable to the Company or any of its Subsidiaries, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Products under development, sponsored by the Company or any of its Subsidiaries and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance with the FDA’s Good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company or any of its Subsidiaries, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries is in compliance with all applicable reporting requirements for all Parent Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable law.

FDA and Regulatory Matters. (Aa) Except as set forth in Part 3.7 of the Parent Disclosure Schedule, (i) with With respect to the Parent Contingent Payment Products and, to the extent applicable, any other products currently under development by the Company (collectively, the “Products”), (i) (A) the Parent Entities have Company 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, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of Parent its Products in jurisdictions where they it currently conduct conducts such activities (the "PARENT ACTIVITIES TO DATE"“Activities to Date”) with respect to each Parent Product (collectively, the "PARENT LICENSES"“Company Licenses”), except where the failure to hold such Parent Licenses has not been material to the Parent Entities and would not reasonably be expected to be material to the Parent Entities; (B) the Parent Entities are Company and each of its Subsidiaries, as the case may be, is in compliance in all material compliance respects with all terms and conditions of each Parent Company License and with all applicable laws pertaining to the Parent Activities to Date with respect to each Parent Product which is not required to be the subject of a Parent Company License; (C) the Parent Entities are Company 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, license and/or certification for each site at which a Parent Product is manufactured, manufactured or labeled, sold, or distributedfrom which a Product is sold or distributed by the Company or its Subsidiaries; and (D) to the extent that any Parent Product has been exported from the United States, Parent the Company or, as applicable, a subsidiary Subsidiary of Parent the Company exporting such Parent Product, has exported such Parent Product in compliance in all material respects with all Legal Requirements, and applicable law; (ii) all manufacturing operations performed by or on behalf of the Parent Entities Company or its Subsidiaries have been and are being conducted in all material respects in compliance with the Quality Systems Regulations of the FDA and, to the extent applicable to the Company or any of its Subsidiaries, in all material respects with counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Products under development, sponsored by the Company or any of its Subsidiaries and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA’s Good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company or any of its Subsidiaries, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries is in compliance with all applicable reporting requirements for all Parent Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable law.

FDA and Regulatory Matters. (Aa) Except as set forth in Part 3.7 of the Parent Disclosure Schedule, (i) with With respect to the Parent Company Products and, to the extent applicable, any products currently under development by the Company (collectively, the “Products”), (A) except as set forth on Section 3.20 of the Parent Entities have Company Disclosure Schedule, the Company 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, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of Parent the Products in jurisdictions where they it currently conduct conducts such activities or contemplates conducting such activities (the "PARENT ACTIVITIES TO DATE"“Activities to Date”) with respect to each Parent Product (collectively, the "PARENT LICENSES"“Company Licenses”), except where the failure to hold such Parent Licenses has not been material to the Parent Entities and would not reasonably be expected to be material to the Parent Entities; (B) the Parent Entities are Company is in material compliance with all terms and conditions of each Parent Company License and with all applicable laws Laws pertaining to the Parent Activities to Date with respect to each Parent Product which is not required to be the subject of a Parent Company License; , (C) the Parent Entities are Company is in compliance in all material respects with all Legal Requirements applicable Laws regarding registration, license, certification for each site at which a Parent Product is manufactured, labeled, sold, sold or distributed; distributed and (D) to the extent any Parent Product has been exported from the United States, Parent or, as applicable, a subsidiary of Parent exporting such Parent Product, the Company has exported such Parent Product in compliance in all material respects with all Legal Requirements, and applicable Law; (ii) all manufacturing operations performed by or on behalf of the Parent Entities Company have been, and are in compliance being, conducted in all material respects in compliance with the Quality Systems regulations of the FDA and, to the extent applicable to the Company, counterpart regulations in the European Union, Canada and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance with the FDA’s Good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union, Canada and all other countries; and (iv) the Company is in compliance with all applicable reporting requirements for all Parent Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.

FDA and Regulatory Matters. (Aa) Except as set forth in Part 3.7 of the Parent Disclosure Schedule, (i) with With respect to the Parent Products andCompany Products, to the extent applicable, any currently under development (A1) the Parent Entities have Company 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, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of Parent its Products in jurisdictions where they it currently conduct conducts such activities (the "PARENT ACTIVITIES TO DATECompany Activities to Date") with respect to each Parent Product of its Products (collectively, the "PARENT LICENSESCompany Licenses"), except where the failure to hold such Parent Licenses has not been material to the Parent Entities and would not reasonably be expected to be material to the Parent Entities; (B2) the Parent Entities are Company is in compliance in all material compliance respects with all the terms and conditions of each Parent Company License and with all applicable laws Laws pertaining to the Parent Company Activities to Date with respect to each Parent Company Product which is not required to be the subject of a Parent Company License; (C3) the Parent Entities are Company is in compliance in all material respects with all Legal Requirements applicable Laws regarding registration, license, certification for each site at which a Parent Company Product is manufactured, labeled, sold, or distributed; and (D4) to the extent any Parent Company Product has been exported from the United States, Parent or, as applicable, a subsidiary of Parent exporting such Parent Product, the Company has exported such Parent Company Product in compliance in all material respects with all Legal Requirements, and applicable Law; (ii) all manufacturing operations performed by or on behalf of the Parent Entities Company have been and are being conducted in all material respects in compliance with the quality systems regulations of the FDA and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good laboratory practice for non-clinical studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company is in compliance in all material respects with all applicable reporting requirements for all Parent Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.

FDA and Regulatory Matters. (Aa) Except as set forth in Part 3.7 of the Parent Disclosure Schedule, (i) with With respect to the Parent Products andproducts of the Borrower that are currently marketed or sold by the Borrower (collectively, to the extent applicable"Borrower Products"), any currently under development (A) the Parent Entities have Borrower has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the United States Federal government or its agencies and all material approvals, clearances, authorizations, licenses and registrations required by foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of Parent the Borrower Products in jurisdictions where they the Borrower currently conduct conducts such activities or contemplates conducting such activities (the "PARENT ACTIVITIES TO DATEActivities to Date") with respect to each Parent Borrower Product (collectively, the "PARENT LICENSESBorrower Licenses"), except where the failure to hold such Parent Licenses has not been material to the Parent Entities and would not reasonably be expected to be material to the Parent Entities; (B) the Parent Entities are Borrower is in material compliance with all terms and conditions of each Parent Borrower License and with all applicable laws pertaining to the Parent Activities to Date with respect to each Parent Borrower Product which is not required to be the subject of a Parent Borrower License; (C) the Parent Entities are Borrower is in material compliance in all material respects with all Legal Requirements applicable laws regarding registration, license, certification for each site at which a Parent Borrower Product is manufactured, labeled, sold, sold or distributed; and (D) to the extent any Parent Borrower Product has been exported from the United States, Parent or, as applicable, a subsidiary of Parent exporting such Parent Product, the Borrower has exported such Parent Borrower Product in compliance in all material respects with all Legal Requirements, and applicable laws; (ii) all manufacturing operations performed by the Parent Entities Borrower have been and are in compliance being conducted in all material respects in compliance with the Quality Systems regulations of the U.S. Food and Drug Administration (the "FDA") (21 CFR Part 820) and, to the extent applicable to the Borrower, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Borrower Products under development, sponsored by the Borrower and intended to be used to support regulatory clearance or approval, have been and are being conducted in material compliance with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Borrower, counterpart regulations in the European Union and all other countries; and (iv) the Borrower is in material compliance with all applicable reporting requirements for all Parent Borrower Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable laws. The Borrower has not received any written notice or other written communication from the FDA or any other Governmental Entity (x) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Borrower Products or (y) otherwise alleging any violation of any laws by the Borrower. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Borrower threatened) by the FDA or any other Governmental Entity with respect to any of the Borrower Products.