Permits; Regulatory Matters Sample Clauses

Permits; Regulatory Matters. (a) The Company and each of its Subsidiaries has and has maintained all authorizations, permits, licenses and franchises from Governmental Entities required to conduct their businesses as now being conducted and as conducted since January 1, 2021, including those required by the FDA, such as allowance of an Investigational New Drug application (“IND”), approval of a New Drug Application (“NDA”) or NDA supplement, medical device listings and clearances, and any other federal, state or foreign agencies or bodies engaged in the regulation of drug products, medical devices and combination products (together with the FDA, the “Regulating Authorities”) (the “Company Permits”), except for such authorizations, permits, licenses and franchises the absence of which, individually or in the aggregate, would not reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole. Except for matters that, individually or in the aggregate, would not reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole: (i) all Company Permits are and have been, since January 1, 2021, in full force and effect and (ii) the Company and its Subsidiaries are and have been, since January 1, 2021, in compliance with the terms of all Company Permits. (b) Except for matters that, individually or in the aggregate, would not reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole, since January 1, 2021: (i) all applications, reports, notices and other documents required to be filed by the Company and its Subsidiaries with all Regulating Authorities have been filed and were complete and accurate on the date filed (or were corrected in or supplemented by a subsequent filing) and (ii) neither the Company nor any of its Subsidiaries, nor, to the Company’s Knowledge, any director, officer or employee of the Company or any of its Subsidiaries or any agent or other Representative of the Company or any of its Subsidiaries, has made an untrue statement of a material fact or fraudulent statement to any Regulating Authority, failed to disclose a material fact required to be disclosed to any Regulating Authority, or committed any act, made any statement, or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or ...

Permits; Regulatory Matters. (a) The Group Companies have obtained, and maintain, all Permits required to permit the Group Companies to construct, develop, own, operate, use and maintain their assets in the manner in which they are now operated and maintained and to conduct the business of the Group Companies as currently conducted in all material respects. (b) Each material Permit held by a Group Company is valid, binding and in full force and effect. None of the Group Companies (i) is in default or violation (and no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation) in any material respect of any term, condition or provision of any material Permit to which it is a party, (ii) is or has been the subject of any pending or, to the knowledge of the Company, threatened Action by a Governmental Authority seeking the revocation, suspension, termination, modification, non-renewal or impairment of any Permit, or (iii) has received any written notice that any Governmental Authority that has issued any Permit intends to cancel, terminate, or not renew any such Permit, except to the extent such Permit may be amended, replaced, or reissued as a result of and as necessary to reflect the transactions contemplated hereby.

Permits; Regulatory Matters. (a) The Company and its Subsidiaries have obtained, and maintain, all Permits required to permit the Company and its Subsidiaries to own, operate, use and maintain their assets in the manner in which they are now operated and maintained and to conduct the business of the Company and its Subsidiaries as currently conducted in all material respects. (b) Section 4.18(b) of the Company Disclosure Letter sets forth a true, correct and complete list of material Permits held by the Company or its Subsidiaries. (c) Each material Permit held by the Company or any of the Company’s Subsidiaries is valid, binding and in full force and effect. Neither the Company nor any of its Subsidiaries (i) is in default or violation (and no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation) in any material respect of any term, condition or provision of any material Permit to which it is a party, (ii) is or has been the subject of any pending or, to the knowledge of the Company threatened Action by a Governmental Authority seeking the revocation, suspension, termination, modification, or impairment of any Permit, or (iii) has received any written notice that any Governmental Authority that has issued any Permit intends to cancel, terminate, or not renew any such Permit, except to the extent such Permit may be amended, replaced, or reissued as a result of and as necessary to reflect the transactions contemplated hereby.

Permits; Regulatory Matters. The Company and its Subsidiaries have, and since January 1, 2018 have had, all authorizations, permits, licenses and franchises from Governmental Entities required to conduct their businesses as now being conducted, except for such authorizations, permits, licenses and franchises the absence of which, individually or in the aggregate, are not reasonably likely to have a Company Material Adverse Effect (the “Company Permits”). The Company Permits are, and since January 1, 2018 have been, in full force and effect, except for any failures to be in full force and effect that, individually or in the aggregate, are not reasonably likely to have a Company Material Adverse Effect. The Company and each of its Subsidiaries are, and since January 1, 2018 have been, in compliance with the terms of the Company Permits, except for such failures to comply that, individually or in the aggregate, are not reasonably likely to have a Company Material Adverse Effect.

Permits; Regulatory Matters. (a) The Company and its Subsidiaries have all authorizations, permits, licenses and franchises from Governmental Entities required to conduct their businesses as now being conducted, except for such permits, licenses and franchises the absence of which, individually or in the aggregate, have not had, and would not reasonably be expected to have, a Company Material Adverse Effect (the “Company Permits”). (b) The Company Permits are in full force and effect, except for any failures to be in full force and effect that, individually or in the aggregate, have not had, and would not reasonably be expected to have, a Company Material Adverse Effect. The Company and each of its Subsidiaries is in compliance with the terms of each Company Permit and no suspension or cancellation of any of the Governmental Authorizations is pending or, to the Knowledge of the Company, threatened, except for such failures to comply, suspensions or cancellations that, individually or in the aggregate, have not had, and would not reasonably be expected to have, a Company Material Adverse Effect.

Permits; Regulatory Matters. (a) As of the date of this Agreement, the Company has all Permits required to permit the Company to conduct the Business, except for such failures to have such Permits, when taken together with all other such failures by the Company to have such Permits, would not have a Material Adverse Effect. As of the date of this Agreement, all of the Permits held by or issued to the Company are in full force and effect, and the Company is in compliance with each such Permit held by or issued to it, except for such failures to so comply, when taken together with all other such failures by the Company to so comply, as would not have a Material Adverse Effect. Except to the extent that any such Permit were to expire prior to the exercise of the Option or the consummation of the Merger or as would not have a Material Adverse Effect, each such Permit will continue in full force and effect after the date hereof and after the exercise of the Option and the consummation of the Merger, in each case without (x) the occurrence of any breach, default or forfeiture of rights thereunder or (y) the consent, approval, or act of, or the making of any filing with, any Governmental Body. This Section 3.9(a) does not apply to regulatory compliance, which is addressed in Sections 3.9(b) –(h). (b) The Company is in compliance with applicable Laws of all Governmental Bodies with jurisdiction over its operation, including but not limited to the Laws enforced by the United States Department of Health and Human Services (HHS) and its constituent agencies (such as the FDA, the Centers for Medicare & Medicaid Services, and the Office of Inspector General), and the Laws enforced by the United States Department of Justice, including: the Food, Drug & Cosmetic Act, as amended, and Title 21 of the Code of Federal Regulations; the anti-kickback law (Social Security Act §1128B(b)); the drug price reporting requirements of titles XVIII and XIX of the Social Security Act; the federal Social Security Act, the federal False Claims Act (31 U.S.C. § 3729 et seq.); the federal Program Fraud Civil Penalties Act; the federal Health Insurance Portability and Accountability Act of 1996, and its implementing regulations; the FCPA; the Laws precluding the off-label sale or pre-approval marketing of pharmaceuticals; and all similar local, state, federal and foreign Governmental Body requirements, except where the failure to so comply, when taken together with all other such failures by the Company to so comply, wo...

Permits; Regulatory Matters. (a) The Company and each of its Subsidiaries have all permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) required to conduct its business as currently conducted, including all such Permits required by the FDA or foreign equivalent Regulating Authorities (as defined herein), such as allowance of an Investigational New Drug application or foreign equivalent application (“IND”) and approval of a New Drug Application or foreign equivalent application (“NDA”), and any other federal, state or foreign agencies or bodies engaged in the regulation of drug products (together with the FDA, the “Regulating Authorities”), except for such Permits the absence of which, individually or in the aggregate, are not material to the Company and its Subsidiaries, taken as a whole (the “Company Authorizations”). (b) The Company Authorizations are in full force and effect. The Company and each of its Subsidiaries is in compliance in all material respects under such Company Authorizations. Except for matters that, individually or in the aggregate, are not material to the Company and its Subsidiaries, taken as a whole, since January 1, 2019, all applications, reports, notices and other documents required to be filed by the Company and its Subsidiaries with all Regulating Authorities have been filed and were complete and accurate on the date filed (or were corrected in or supplemented by a subsequent filing). None of the Company, any Subsidiary of the Company, and to the Company’s Knowledge, any officer, employee or agent of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (i) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other Regulating Authority, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any Regulating Authority. (c) Except for matters that, individually or in the aggregate, are not material to the Company and its Subsidiaries, taken as a whole, since January 1, 2019, the Company and each of its Subsidiaries: (i) is and at all times has been in compliance, to the extent applicable, with all statutes, rules, regulations (including all applicable requirements relating to Good Manuf...

Permits; Regulatory Matters. The Company and its Subsidiaries have all authorizations, permits, licenses and franchises from Governmental Entities required to conduct their businesses as now being conducted, except for such authorizations, permits, licenses and franchises the absence of which, individually or in the aggregate, have not had and would not reasonably be expected to have a Company Material Adverse Effect (the “Company Permits”). The Company Permits are in full force and effect, except for any failures to be in full force and effect that, individually or in the aggregate, have not had and would not reasonably be expected to have a Company Material Adverse Effect. The Company and each of its Subsidiaries are in compliance with the terms of the Company Permits, except for such failures to comply that, individually or in the aggregate, have not had and would not reasonably be expected to have a Company Material Adverse Effect.

Permits; Regulatory Matters. 5.13.1 Seller and, to the extent required, each officer and employee of the Seller, holds all Permits necessary for the operation of the Business and the Acquired Assets as conducted as of the date hereof or the Acquired Assets. Part 5.13.1 of the Disclosure Schedule sets forth a list of the Permits, including without limitation Permits issued or granted to Seller by any Governmental Entity regulating food businesses, products, or services authorizing Seller in connection with the operation of the Business or the Acquired Assets. 5.13.2 Such Permits shall continue to be in full force and effect and in good standing immediately following the consummation of the transactions contemplated by this Agreement. 5.13.3 The Seller has not received any notice or communication from any Governmental Entity alleging noncompliance of the Business with any FDA/OSHA Law. There are no Legal Proceedings pending or, to Knowledge of the Seller, threatened against Seller or any of its directors, officers or employees, that involves any violation of any FDA/OSHA Law with respect to the Business. 5.13.4 With respect to the Business, neither the Seller nor any of its respective directors, officers or employees, is or has been: (i) convicted of, charged with, or under investigation for or related to any criminal offense in respect of any FDA/OSHA Law, (ii) debarred or disqualified from participation in regulated activities for any violation or alleged violation of any FDA/OSHA Law, or (iii) assessed a civil money penalty 21 U.S.C. §§ 333 or 307 or any Legal Provisions promulgated thereunder. Neither the Seller nor any of its respective directors, officers or employees, has received any written requests for information or subpoenas claiming or raising concerns with respect to violations or potential violations of any FDA/OSHA Law with respect to the Business. 5.13.5 With respect to the Business, the Seller is in compliance with all applicable FDA/OSHA Law governing advertising, marketing or promotional activities. 5.13.6 Seller is not, and shall not become, a Person or entity with whom Buyer is restricted from doing business with under regulations of the Office of Foreign Asset Control (“OFAC”) of the Department of the Treasury (including, but not limited to, those named on OFAC’s Specially Designated and Blocked Persons list) or under any statute, executive order (including, but not limited to, Executive Order 13224 Blocking Property and Prohibiting Transactions With Persons Who C...