Common use of Regulatory Matters; Compliance Clause in Contracts

Regulatory Matters; Compliance. (a) The Company or its subsidiaries hold all material licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearances, and have submitted notices to, all Governmental Authorities, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and any other Governmental Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the Company’s Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or any of its subsidiaries as currently conducted (the “Company Permits”), and as of the date hereof, all such Company Permits are valid and in full force and effect. There has not occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit. The Company and its subsidiaries are in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Permit. Since January 1, 2021, neither the Company nor its subsidiaries has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or other Company Regulatory Agency alleging that any operation or activity of the Company or any of its subsidiaries is in violation of any applicable Law.

Regulatory Matters; Compliance. (a) The Company Parent or its subsidiaries hold all material licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearances, and have submitted notices to, all Governmental Authorities, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) FDA promulgated thereunder, and any other Governmental Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the CompanyParent’s Products (any such Governmental Authority, a “Company Parent Regulatory Agency”) necessary for the lawful operation of the businesses of the Company Parent or any of its subsidiaries as currently conducted (the “Company Parent Permits”), and as of the date hereof, all such Company Parent Permits are valid and in full force and effect. There has not occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Parent Permit. The Company Parent and its subsidiaries are in compliance in all material respects with the terms of all Company Parent Permits, and no event has occurred that, to the Knowledge of the CompanyParent, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Parent Permit. Since January 1, 2021, neither the Company Parent nor its subsidiaries has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or other Company Parent Regulatory Agency alleging that any operation or activity of the Company Parent or any of its subsidiaries is in violation of any applicable Law.

Regulatory Matters; Compliance. Except as described in the Registration Statement and the Prospectus or as disclosed on Schedule 3.1(qq), as applicable, the Company and its Subsidiaries (ai) The Company are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or its subsidiaries hold all material arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consentscertificates, approvals, and clearances, authorizations, permits, registrations and have submitted notices to, all Governmental Authorities, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended supplements or amendments thereto required by any such Applicable Laws (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDAAuthorizations”) promulgated thereunder, except for a noncompliance that would not reasonably be expected to have a Material Adverse Effect; (iii) possess all material Authorizations and any other Governmental Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the Company’s Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or any of its subsidiaries as currently conducted (the “Company Permits”), and as of the date hereof, all such Company Permits Authorizations are valid and in full force and effect. There has effect and are not occurred any material in violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit. The Company and its subsidiaries are in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Permit. Since January 1, 2021, neither the Company nor its subsidiaries has term of any such Authorizations; (iv) have not received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, auditinvestigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA threatened except for a claim action, suit, proceeding, hearing, enforcement, investigation arbitration or other Company Regulatory Agency alleging action that would not reasonably be expected to have a Material Adverse Effect; (v) have not received any written notice that any operation court or activity of arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the Company date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any of its subsidiaries is in violation of material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any applicable Lawgovernmental or regulatory authority.

Regulatory Matters; Compliance. Except as described in the Registration Statement, the Preliminary Prospectus and the Prospectus or as disclosed on Schedule 3.1(qq), as applicable, the Company and its Subsidiaries (ai) The Company are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or its subsidiaries hold all material arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consentscertificates, approvals, and clearances, authorizations, permits, registrations and have submitted notices to, all Governmental Authorities, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended supplements or amendments thereto required by any such Applicable Laws (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDAAuthorizations”) promulgated thereunder, except for a noncompliance that would not reasonably be expected to have a Material Adverse Effect; (iii) possess all material Authorizations and any other Governmental Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the Company’s Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or any of its subsidiaries as currently conducted (the “Company Permits”), and as of the date hereof, all such Company Permits Authorizations are valid and in full force and effect. There has effect and are not occurred any material in violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit. The Company and its subsidiaries are in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Permit. Since January 1, 2021, neither the Company nor its subsidiaries has term of any such Authorizations; (iv) have not received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, auditinvestigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA threatened except for a claim action, suit, proceeding, hearing, enforcement, investigation arbitration or other Company Regulatory Agency alleging action that would not reasonably be expected to have a Material Adverse Effect; (v) have not received any written notice that any operation court or activity of arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the Company date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any of its subsidiaries is in violation of material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any applicable Lawgovernmental or regulatory authority.