Common use of Permits; Compliance with Law Clause in Contracts

Permits; Compliance with Law. Each of the Company and the Company Subsidiaries is in possession of all authorizations, licenses, permits, certificates, approvals and clearances, and has submitted notices to, all Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) necessary for the Company or any such Company Subsidiary to own, lease and operate its properties or other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is being conducted as of the date hereof (the “Company Permits”), and all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. Neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), for any such conflicts, defaults or violations that would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.

Permits; Compliance with Law. Each of the Company and the Company Subsidiaries is in possession of all franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and clearances, and has submitted notices to, all orders of any Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) Entity necessary for the Company or any such Company Subsidiary to own, lease and operate its properties or other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is now being conducted as of (collectively, the date hereof (the “"Company Permits”"), and all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would notPermits, individually or in the aggregate, has not resulted and could not reasonably be expected to have result in a Company Material Adverse EffectEffect on the Company, and, as of the date of this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Company Permits, individually or in the aggregate, has not resulted and could not reasonably be expected to result in a Material Adverse Effect on the Company. Neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is or may be bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), except for any such conflicts, defaults or violations that would notthat, individually or in the aggregate, have not resulted and could not reasonably be expected to have result in a Company Material Adverse EffectEffect on the Company.

Permits; Compliance with Law. Each of the The Company and the Company each of its Subsidiaries is in possession of all authorizations, licenses, permits, certificates, approvals and clearancesclearances of any Governmental Entity (collectively, and has submitted notices to, all Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCACompany Permits”), including all Company Permits under the FDCA and the regulations of the United States Food FDA promulgated thereunder and Drug Administration (the “FDA”) promulgated thereunder) regulations of the EMEA, necessary for the Company or any such Company Subsidiary it to own, lease and or operate its properties or and other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and operations as it is being presently conducted as of the date hereof (the “Company Permits”), and all such Company Permits are valid, and in full force and effect, except where the failure to have, have or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. Neither No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the knowledge of the Company, threatened, which seeks to revoke or limit any Company Permit. None of the Company nor or any Company Subsidiary of its Subsidiaries is in conflict with, or in default or violation of, (ix) any Law applicable to the Company or any Company Subsidiary it or by which any property of its properties or asset of the Company or any Company Subsidiary assets is bound or affected or (iiy) any Company Permits, except, with respect to clauses (i) and (ii)in each case, for any such conflicts, defaults or violations that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. No investigation, review or other Legal Proceeding by any Governmental Entity is pending or, to the knowledge of the Company, threatened against the Company, nor has any Governmental Entity indicated to the Company or any of its Subsidiaries an intention to conduct the same that would, individually or in the aggregate, have a Material Adverse Effect.

Permits; Compliance with Law. Each of the Company and the Company Subsidiaries is in possession of all franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and clearances, and has submitted notices to, all orders of any Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) Authority necessary for the Company or any such Company Subsidiary to own, lease and operate its properties or other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is now being conducted as of (collectively, the date hereof (the “Company Permits”"COMPANY PERMITS"), and all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would notPermits, individually or in the aggregate, has not resulted and could not reasonably be expected to have result in a Company Material Adverse EffectEffect on the Company, and, as of the date of this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of Parent or the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Company Permits, individually or in the aggregate, has not resulted and could not reasonably be expected to result in a Material Adverse Effect on the Company. Neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is or may be bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), except for any such conflicts, defaults or violations that would notthat, individually or in the aggregate, have not resulted and could not reasonably be expected to have result in a Company Material Adverse EffectEffect on the Company.

Permits; Compliance with Law. Each of the Company and the each Company Subsidiaries Subsidiary is in possession of all material authorizations, licenses, permits, certificates, registrations, approvals and clearancesclearances of any Governmental Entity, and has submitted notices tomade all material filings, all applications and registrations with any Governmental Entities (including all authorizations under the Federal FoodEntity, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) in each case that are necessary for the Company or any such and each Company Subsidiary to own, lease and and/or operate its properties or other assets and assets, or to carry on its respective business businesses substantially in substantially the manner described in the Company SEC Filings Reports (as defined in Section 4.7) filed prior to the date hereof and substantially as it is being conducted as of the date hereof (the “Company Permits”), and all such Company Permits are valid, valid and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would not, individually or in the aggregate, reasonably be expected to (i) prevent or materially delay consummation of the Merger or any other transactions contemplated by this Agreement, (ii) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement, or (iii) have a Company Material Adverse EffectEffect on the Company. Neither None of the Company nor or any Company Subsidiary is in conflict with, or in default or violation of, (iA) in any material respect, any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is bound or affected or (iiB) any Company PermitsPermit, except, with respect to clauses clause (i) and (iiB), for any such conflicts, defaults or violations that would not, individually or in the aggregate, reasonably be expected to (a) prevent or materially delay consummation of the Merger or any other transactions contemplated by this Agreement, (b) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement, or (c) have a Company Material Adverse EffectEffect on the Company. None of the Company Permits will be terminated or impaired or will become terminable, in whole or in part, as a result of the transactions contemplated by this Agreement. Neither the Company nor any Company Subsidiary has, within the last three years, received any warning, notice, notice of violation or probable violation, notice of revocation or other communication from or on behalf of any Governmental Entity, alleging (x) any violation of any Company Permit or (y) that the Company or any Company Subsidiary requires any Company Permit for its business as currently conducted that is not currently held by it. Except as set forth in Section 4.6 of the Company Disclosure Schedule, to the Company’s knowledge, no investigation or inquiry by any Governmental Entity with respect to the Company or any Company Subsidiary is pending or threatened, in each case with respect to any alleged or claimed violation of Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is bound or affected. Neither the Company nor any of the Company Subsidiaries, nor to the Company’s knowledge, any director, officer, Affiliate or employee thereof, has on behalf of or with respect to the Company engaged in any conduct constituting a violation of the Foreign Corrupt Practices Act of 1977, as amended.

Permits; Compliance with Law. Each of the Company and the Company Subsidiaries is in possession of all authorizations, licenses, permits, certificates, approvals and clearances, and has submitted notices to, all Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “"FDCA”), ") and the regulations of the United States Food and Drug Administration (the “"FDA”") promulgated thereunder) necessary for the Company or any such Company Subsidiary to own, lease and operate its properties or other assets and to carry on its their respective business businesses in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is being conducted as of the date hereof (the “"Company Permits”"), and all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. Neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), for any such conflicts, defaults or violations that would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.

Permits; Compliance with Law. Each (a) Except for the authorizations, licenses, permits, certificates, approvals, variances, exemptions, orders, franchises, certifications and clearances that are the subject of the Section 4.16 or Section 4.17, which are addressed solely in those Sections, Company and the each Company Subsidiaries Subsidiary is in possession of all authorizations, licenses, permits, certificates, approvals approvals, variances, exemptions, orders, franchises, certifications and clearancesclearances of any Governmental Authority, and has submitted notices to, all Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) necessary for the Company or any such and each Company Subsidiary to own, lease and, to the extent applicable, operate its properties and assets or to carry on and operate its properties or other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is being conducted as of the date hereof (the “Company Permits”), and all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, possession of any of the Company Permits as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. Neither All such Company Permits are valid and in full force and effect, except where the Company nor any Company Subsidiary is in conflict with, failure to be valid or in default or violation of, (i) full force and effect of any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), for any such conflicts, defaults or violations that would not, individually or in the aggregate, would not reasonably be expected to have a Company Material Adverse Effect. Neither Company nor any Company Subsidiary has received any written claim or written notice indicating that Company or any Company Subsidiary is currently not in compliance with the terms of any such Company Permits, or that suspension or cancellation of any Company Permits is pending threatened in writing, and no such suspension or cancellation will result from the transactions contemplated by this Agreement, except where the failure to be in compliance with the terms of any such Company Permits, individually or in the aggregate, would not reasonably be expected to have a Company Material Adverse Effect.

Permits; Compliance with Law. Each of the Company and the Company Subsidiaries is in possession of all franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and clearances, and has submitted notices to, all orders of any Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) Entity necessary for the Company or any such Company Subsidiary to own, lease and operate its properties or other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is now being conducted as of (collectively, the date hereof (the “"Company Permits”") (but not including, however, Company Permits relating to compliance with Safety and Environmental Laws (as defined herein), and all such Company Permits which are valid, and addressed in full force and effectSection 3.14), except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would notPermits, individually or in the aggregate, has not resulted and could not reasonably be expected to have result in a Company Material Adverse Effect, and, as of the date of this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Company Permits, individually or in the aggregate, has not resulted and could not reasonably be expected to result in a Company Material Adverse Effect. Neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law (but not including, however, any Safety and Environmental Laws, which is addressed in Section 3.14) applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is or may be bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), except for any such conflicts, defaults or violations that would notthat, individually or in the aggregate, have not resulted and could not reasonably be expected to have result in a Company Material Adverse Effect.

Permits; Compliance with Law. Each of the Company and the Company Subsidiaries is in possession of all franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and clearances, and has submitted notices to, all orders of any Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) Authority necessary for the Company or any such Company Subsidiary to own, lease and operate its properties or other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is now being conducted as of (collectively, the date hereof (the “"Company Permits”"), and all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would notPermits, individually or in the aggregate, has not resulted and could not reasonably be expected to have result in a Company Material Adverse EffectEffect on the Company, and, as of the date of this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of Parent or the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Company Permits, individually or in the aggregate, has not resulted and could not reasonably be expected to result in a Material Adverse Effect on the Company. Neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is or may be bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), except for any such conflicts, defaults or violations that would notthat, individually or in the aggregate, have not resulted and could not reasonably be expected to have result in a Company Material Adverse EffectEffect on the Company.

Permits; Compliance with Law. Each of the Company and the ---------------------------- Company Subsidiaries is in possession of all authorizations, licenses, permits, certificates, approvals and clearances, and has submitted notices to, all Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “"FDCA”), ") and the regulations of the ---- United States Food and Drug Administration (the “"FDA”") promulgated thereunder) --- necessary for the Company or any such Company Subsidiary to own, lease and operate its properties or other assets and to carry on its their respective business businesses in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is being conducted as of the date hereof (the “"Company Permits”"), and --------------- all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. Neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), for any such conflicts, defaults or violations that would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.

Permits; Compliance with Law. Each of the Company and the Company Subsidiaries is in possession of all franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and clearances, and has submitted notices to, all orders of any Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) Entity necessary for the Company or any such Company Subsidiary to own, lease and operate its properties or other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is now being conducted (collectively, the "Company Permits"), except where the failure to have, or the suspension or --------------- cancellation of, any of the Company Permits, individually or in the aggregate, has not resulted and could not reasonably be expected to result in a Material Adverse Effect on the Company, and, as of the date hereof (of this Agreement, no suspension or cancellation of any of the “Company Permits”), and all such Company Permits are validis pending or, and in full force and effectto the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would notPermits, individually or in the aggregate, has not resulted and could not reasonably be expected to have result in a Company Material Adverse EffectEffect on the Company. Neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary is or may be bound or affected or (ii) any Company Permits, except, with respect to clauses (i) and (ii), except for any such conflicts, defaults or violations that would notthat, individually or in the aggregate, have not resulted and could not reasonably be expected to have result in a Company Material Adverse EffectEffect on the Company.

Permits; Compliance with Law. Each (a) Except for the authorizations, licenses, permits, certificates, approvals, variances, exemptions, orders, franchises, certifications and clearances that are the subject of Section 4.11, Section 4.15 and Section 4.16, which are addressed solely in those Sections, each of the Company Parties and the each other Company Subsidiaries Subsidiary is in possession of all authorizations, licenses, permits, certificates, approvals approvals, variances, exemptions, orders, franchises, certifications and clearances, and has submitted notices to, all clearances of any Governmental Entities (including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder) Authority necessary for the Company or any such and each Company Subsidiary to own, lease and and, to the extent applicable, operate its properties or other assets and to carry on its respective business in substantially the manner described in the Company SEC Filings filed prior to the date hereof and as it is they are being conducted as of the date hereof (the “Company Permits”), and all such Company Permits are valid, valid and in full force and effect, except where the failure to havebe in possession of, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Company Permits would notPermits, individually or in the aggregate, would not reasonably be expected to have a Company Material Adverse Effect. Neither the Company nor No event has occurred with respect to any Company Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company or any Company Subsidiary or by which any property or asset of the Company Permits which permits, or after notice or lapse of time or both would permit, revocation or termination thereof or would result in any other material impairment of the rights of the holder of any such Company Permits. To the Knowledge of Company, there is not pending any applicable petition, objection or other pleading with any Governmental Authority having jurisdiction or authority over the operations of Company or the Company Subsidiaries that impairs the validity of any Company Subsidiary is bound Permit or affected which would reasonably be expected, if accepted or (ii) granted, to result in the revocation of any Company Permits, except, with respect to clauses (i) and (ii), for any such conflicts, defaults or violations that would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse EffectPermit.