Common use of Licenses and Permits; Compliance with Laws Clause in Contracts

Licenses and Permits; Compliance with Laws. The Company and its subsidiaries (i) possess, and are operating in compliance in all material respects with, all licenses, certificates, permits and other authorizations, registrations, approvals and clearances issued by the appropriate U.S. federal, state or non-U.S. regulatory authorities (including the United States Food and Drug Administration) necessary to conduct their respective businesses, except where the failure to operate in compliance with or possess such licenses, certificates, permits and other authorizations, registrations, approvals and clearances would not reasonably be expected to have a Material Adverse Effect, and none of the Company or its subsidiaries has received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit that, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to have a Material Adverse Effect, except as set forth in or contemplated in the Registration Statement, the Pricing Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto); and (ii) the Company and each of its subsidiaries is in compliance in all material respects with all applicable federal, state, local and foreign laws, regulations, orders and decrees, except where noncompliance with such laws, regulations, orders and decrees would not reasonably be expected to have a Material Adverse Effect, and has not received any communications from any United States Food and Drug Administration (the “FDA”) and such other federal, state, local or provincial governmental authorities having jurisdiction over the Company, its subsidiaries or any of their products or business operations (each a “Governmental Authority”) asserting noncompliance with any such laws, regulations, orders or decrees applicable to the manufacture, processing, storage, labeling, sale, marketing or transportation of the Company or its subsidiaries’ products, except where such noncompliance with such laws, regulations, orders or decrees would not reasonably be expected to have a Material Adverse Effect.

Licenses and Permits; Compliance with Laws. The Company and its subsidiaries Except (other than in the case of clauses (i) possessand (ii) below) as, individually or in the aggregate, has not had, and are operating in compliance in would not reasonably be expected to have, a Material Adverse Effect: (i) the Company or the Transferred Subsidiaries owns or possess all material respects withLicenses and Permits, and have made all licensesfilings, certificates, permits applications and other authorizations, registrations, approvals and clearances issued registrations with all Governmental Authorities (including all authorizations required by the appropriate U.S. federalDrug Enforcement Administration and under the Federal Food, state or non-U.S. regulatory authorities (including Drug and Cosmetic Act, the regulations of the United States Food and Drug AdministrationAdministration and Environmental Laws and all other similar Laws in other applicable jurisdictions) necessary to conduct their respective businesses, except where the failure to operate and all such Licenses and Permits are in compliance with or possess such licenses, certificates, permits full force and other authorizations, registrations, approvals and clearances would not reasonably be expected to have a Material Adverse Effect, and none of the Company or its subsidiaries has received any notice of proceedings relating to the revocation or modification effect; (ii) no loss of any such certificatematerial Licenses and Permits is pending in any Proceeding or, authorization or permit thatto the Knowledge of the Company, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to have has been threatened by a Material Adverse EffectGovernmental Authority, except as set forth for normal expirations in accordance with the terms thereof or contemplated in applicable Law and all such Licenses and Permits may be transferred to the Registration Statement, the Pricing Disclosure Package and the Prospectus Buyer or its Subsidiaries; (exclusive of any amendment or supplement thereto); and (iiiii) the Company and each of its subsidiaries is in compliance in the Transferred Subsidiaries have complied with (A) all material respects with terms and conditions of all Licenses and Permits and (B) all Laws applicable federal, state, local to the operation of each of the Consumables Business and foreign laws, regulations, orders the Process Business and decrees, except where noncompliance with such laws, regulations, orders and decrees would not reasonably be expected to have a Material Adverse Effectownership or use of the Transferred Assets, and it has not received any communications from written notice of any United States Food and Drug Administration pending Proceeding alleging facts which, if true, would constitute a failure to comply with either (A) or (B) of this Section 4.1(m)(iii); (iv) there are no (A) unresolved violations, criticisms or exceptions noted by any Governmental Authority in any report, comment letter or other written statement relating to or based on any examinations of the “FDA”) and such other federalConsumables Business, statethe Process Business, local or provincial governmental authorities having jurisdiction over the CompanyTransferred Subsidiaries or, its subsidiaries or any of their products or business operations (each a “Governmental Authority”) asserting noncompliance with any such laws, regulations, orders or decrees applicable respect to the manufactureConsumables Business, processingthe Process Business and the Transferred Assets, storage, labeling, sale, marketing or transportation of the Company or its subsidiaries’ productsSubsidiaries or (B) written agreements, except where memoranda of understanding, commitment letters or similar undertakings to which the Consumables Business, the Process Business, the Transferred Subsidiaries or, with respect to the Consumables Business, the Process Business and the Transferred Assets, the Company or its Subsidiaries is a party, or Orders from, or any resolution adopted at the request of, any Governmental Authority; and (v) to the Knowledge of the Company, each third party at any time engaged in the testing, manufacturing, storage, packaging, labeling, sale or distribution of a product on behalf of the Consumables Business, the Process Business, the Transferred Subsidiaries or, with respect to the Consumables Business, the Process Business and the Transferred Assets, the Company or its Subsidiaries has been, in compliance with all applicable Laws and Licenses and Permits which have jurisdiction over the products being tested, manufactured, stored, packaged, labeled, sold or distributed on behalf of the Consumables Business, the Process Business, the Transferred Subsidiaries or, with respect to the Consumables Business, the Process Business and the Transferred Assets, the Company or its Subsidiaries; provided, that with respect to this Section 4.1(m)(v), the term “Knowledge of the Company” shall mean, with respect to any such noncompliance with such lawsmatter, regulationsthe actual knowledge, orders or decrees would not reasonably be expected to have a Material Adverse Effectwithout due inquiry, of the individuals listed in Section 1.1(i) of the Company Disclosure Schedule.

Licenses and Permits; Compliance with Laws. The Company Issuer and each of its subsidiaries (i) possessSubsidiaries hold all governmental permits, licenses, authorizations, consents and approvals necessary for the Issuer and each of its Subsidiaries to own, lease, and are operating in compliance in all material respects with, all licenses, certificates, permits and other authorizations, registrations, approvals and clearances issued by the appropriate U.S. federal, state or non-U.S. regulatory authorities (including the United States Food and Drug Administration) necessary to conduct operate their respective businessesProperties and to operate their respective businesses as now being conducted (collectively, the "PERMITS"), except for Permits the failure of which to obtain is not reasonably likely to have a Material Adverse Effect. None of the Permits has been modified in any way that is reasonably likely to have a Material Adverse Effect. All Permits are in full force and effect, except where the failure to operate be in full force and effect would not be reasonably likely to have a Material Adverse Effect. Each of the Issuer and its Subsidiaries is in material compliance with all applicable statutes, laws, ordinances, rules, orders and regulations of any Governmental Authority in all jurisdictions in which it is presently doing business, and each of the Issuer and its Subsidiaries will comply with all such laws and regulations which may be imposed in the future in jurisdictions in which it may then be doing business, in each case other than those the noncompliance with which would not, individually or possess such licensesin the aggregate, certificates, permits and other authorizations, registrations, approvals and clearances would not reasonably be expected to have a Material Adverse Effect. There does not exist any judgment, and none order or injunction pro- hibiting or imposing material adverse conditions upon any of the Company Transactions or its subsidiaries has received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit that, singly or in performance by the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to have a Material Adverse Effect, except as set forth in or contemplated in the Registration Statement, the Pricing Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto); and (ii) the Company and each of its subsidiaries is in compliance in all material respects with all applicable federal, state, local and foreign laws, regulations, orders and decrees, except where noncompliance with such laws, regulations, orders and decrees would not reasonably be expected to have a Material Adverse Effect, and has not received any communications from any United States Food and Drug Administration (the “FDA”) and such other federal, state, local or provincial governmental authorities having jurisdiction over the Company, its subsidiaries Issuer or any of their products or business operations (each a “Governmental Authority”) asserting noncompliance with any such its Subsidiaries of its obligations under the Transaction Documents and all applicable laws, regulations, orders or decrees applicable to the manufacture, processing, storage, labeling, sale, marketing or transportation of the Company or its subsidiaries’ products, except where such noncompliance with such laws, regulations, orders or decrees would not reasonably be expected to have a Material Adverse Effect.