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 (collectively, the "COMPANY PERMITS") (but not including, however, Company Permits relating to compliance with Safety and Environmental Laws (as of the date hereof (the “Company Permits”defined herein), and all such Company Permits which are valid, and addressed in full force and effectSection 3.11), 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 3.11) 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) 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”"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 except in the case of clauses (i) and (ii), for ) any such conflicts, defaults or violations that would notwhich, 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 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 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) 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 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. (a) Each of the Company and the Company Subsidiary is in possession of all, and each of the Former Subsidiaries is in possession of all material, 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, the Company Subsidiary and each of the Former Subsidiaries 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 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 . (b) Except as disclosed in full force and effect of, any Section 3.06(b) of the Company Permits would notDisclosure Schedule, individually or in none of the aggregateCompany, reasonably be expected to have a Company Material Adverse Effect. Neither the Company nor Subsidiary or any Company Former Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to the Company, the Company Subsidiary or any Company Former Subsidiary or by which any property or asset of the Company, the Company Subsidiary or any Former Subsidiary is bound or affected, (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which the Company, the Company Subsidiary, or any Former Subsidiary is a party or by which the Company, the Company Subsidiary or any Former Subsidiary, or any property or asset of the Company, the Company Subsidiary or any Former Subsidiary, is bound or affected or (iiiii) any Company Permits, except, with respect to clauses (i) and (ii), except in each case for any such conflicts, defaults or violations that would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse EffectEffect or prevent or materially delay the consummation of the transactions contemplated by this Agreement.

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 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”"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 Except for permits respecting the business of insurance, which are the subject solely of Section 3.19, each of the Company and the each Company Subsidiaries Subsidiary is in possession of all authorizations, licenses, permits, certificates, approvals approvals, consents 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 Authority (the “FDCACompany Permits”), 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 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”)hereof, and all such Company Permits are valid, valid and in full force and effect, and there is no pending, or, to the Company’s knowledge, threatened action or proceeding to terminate, suspend, limit or adversely modify any Company Permit, 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 has not or would not, individually or in the aggregate, not reasonably be expected to have a Company Material Adverse Effect. Neither Except as disclosed in Section 3.6 of the Company Disclosure Schedule, the Company and each Company Subsidiary has at all times since January 1, 2009 been and is in compliance with all applicable Laws, regulations and orders and neither the Company nor any Company Subsidiary is in conflict with, or in default or violation of, or, with the giving of notice or the passage of time, would be in conflict with, or in default or violation of, (ia) 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 affected, (iib) any of the Company Permits, except, with respect to clauses or (ic) and any of the provisions of its certificate of incorporation or By-laws (iior other organizational or governing instruments), for any other than such conflictsnon-compliance, defaults conflict, default or violations that violation as would not, individually or in not materially and adversely impact the aggregate, reasonably be expected to have Company and the Company Subsidiaries considered as a Company Material Adverse Effectwhole.

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, a) Except 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 , (i) each of the Company nor and its Subsidiaries is in possession of all franchises, grants, authorizations, licenses, easements, variances, exceptions, consents, certificates, permanent certificates of occupancy, approvals and other permits of any Governmental Authority (“Permits”) necessary for it to own, lease and operate its properties and assets or to carry on its business as it is now being conducted (collectively, the “Company Subsidiary Permits”) and (ii) all such Company Permits are in full force and effect. No suspension or cancellation of any of the Company Permits is pending or, to the Knowledge of the Company, threatened. (b) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole, since January 1, 2018, none of the Company or any of its Subsidiaries is or has been in conflict with, or in default or violation of, (i) any Law applicable to the Company or any such Subsidiary of the Company Subsidiary or by which any property or asset of the Company or any Company Subsidiary Assets is bound or affected or (ii) any Company Permits. To the Knowledge of the Company, except, neither the Company nor any of its Subsidiaries is under investigation with respect to clauses (i) and (ii)or has been threatened to be charged with or given written notice of, nor has any Governmental Authority notified the Company in writing of its intent to conduct an investigation of, any violation of any applicable Law, except for any such conflicts, defaults investigations or violations that charges which would not, individually or in the aggregate, not reasonably be expected to have be material to the business, financial condition or results of operations of the Company and its Subsidiaries, taken as a Company Material Adverse Effectwhole.

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.