Common use of Permits; Compliance with Laws Clause in Contracts

Permits; Compliance with Laws. (a) Each of IVAX and the IVAX Subsidiaries is in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity, including, without limitation, the United States Food and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA"), and similar authorities in other jurisdictions, necessary for IVAX or any IVAX Subsidiary to own, lease and operate its properties or to produce, store, distribute and market its products or otherwise to carry on its business as it is now being conducted (the "IVAX Permits"), except where the failure to have, or the suspension or cancellation of, any of the IVAX Permits would not, individually or in the aggregate, have an IVAX Material Adverse Effect, and, as of the date of this Agreement, no suspension or cancellation of any of the IVAX Permits is pending or, to the knowledge of IVAX, threatened, except where the failure to have, or the suspension or cancellation of, any of the IVAX Permits would not, individually or in the aggregate, have an IVAX Material Adverse Effect. Neither IVAX nor any IVAX Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to IVAX or any IVAX Subsidiary or by which any property or asset of IVAX or any IVAX Subsidiary is bound or affected or (ii) any IVAX Permits, except in the case of clauses (i) and (ii) for any such conflicts, defaults or violations that would not, individually or in the aggregate, have an IVAX Material Adverse Effect. As used in this Agreement, "Law" means any federal, state or local statute, law, ordinance, regulation, rule, code, order, other requirement or rule of law of the United States or any other jurisdiction, including, without limitation, the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and any other similar act or law.

Permits; Compliance with Laws. (a) Each of IVAX Except as would not have a Company Material Adverse Effect, the Company and the IVAX Subsidiaries each Company Subsidiary is in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easementscertificates, variances, exceptionsexemptions, consentsapprovals, certificatesorders, approvals registrations and orders clearances of any Governmental EntityEntity (each, including, without limitation, the United States Food and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA"), and similar authorities in other jurisdictions, a “Permit”) necessary for IVAX or any IVAX the Company and each Company Subsidiary to own, lease and operate its properties or to produceand assets, store, distribute and market its products or otherwise to carry on and operate its business businesses as it is now being currently conducted (the "IVAX “Company Permits"”), except where and (i) all such Company Permits are in full force and effect, (ii) the failure Company and the Company Subsidiaries are, and have been since January 1, 2021, in compliance with the terms and requirements of such Company Permits, (iii) the Company and each Company Subsidiary is not in default under, and, to haveknowledge of the Company, no condition exists that, with or without notice, or the suspension lapse of time, or cancellation both, would constitute a default under, or would reasonably be expected to result in, any suspension, cancellation, modification, termination or revocation of, any such Company Permit, and (iv) neither the Company nor any of the IVAX Permits Company Subsidiaries has received any written notice from any Governmental Entity threatening to revoke, suspend, modify or cancel any Company Permit. (b) Since January 1, 2021 the Company and each of the Company Subsidiaries has been, and each currently is, in compliance with all Laws applicable to the Company, the Company Subsidiaries and their respective businesses and activities and properties or assets owned or used by them and with all Orders to which the Company or the Company Subsidiaries are subject, in each case, except for such noncompliance as would not, individually or in the aggregate, not have an IVAX a Company Material Adverse Effect. No investigation, and, as of review or audit by any Governmental Entity with respect to the date of this Agreement, no suspension Company or cancellation of any of the IVAX Permits Company Subsidiary is pending or, to the knowledge of IVAXthe Company, threatenedthreatened in writing against the Company or any Company Subsidiary, except where for such investigations, reviews and audits the failure to have, or the suspension or cancellation of, any outcomes of the IVAX Permits would notwhich, individually or in the aggregate, would not have an IVAX a Company Material Adverse Effect. Neither IVAX nor any IVAX Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to IVAX or any IVAX Subsidiary or by which any property or asset of IVAX or any IVAX Subsidiary is bound or affected or (ii) any IVAX Permits, except in the case of clauses (i) and (ii) for any such conflicts, defaults or violations that would not, individually or in the aggregate, have an IVAX Material Adverse Effect. As used in this Agreement, "Law" means any federal, state or local statute, law, ordinance, regulation, rule, code, order, other requirement or rule of law of the United States or any other jurisdiction, including, without limitation, the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and any other similar act or law.

Permits; Compliance with Laws. (a) Each of IVAX Parent and the IVAX its Subsidiaries is (i) are in possession of all authorizations, permits, franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exemptions, exceptions, consentspermissions, certificates, approvals Consents and orders certificates of any Governmental EntityAuthority, including(ii) have filed all tariffs, without limitationreports, notices and other documents with necessary for Parent and its Subsidiaries to operate their businesses as currently conducted (clauses (i) and (ii), collectively, the United States Food and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA"“Parent Permits”), and similar authorities all Parent Permits are in other jurisdictionsfull force and effect and no suspension, necessary for IVAX or any IVAX Subsidiary to ownmodification, lease and operate its properties or to produce, store, distribute and market its products or otherwise to carry on its business as it is now being conducted (the "IVAX Permits"), except where the failure to have, or the suspension or cancellation of, any of the IVAX Permits would not, individually or in the aggregate, have an IVAX Material Adverse Effect, and, as of the date of this Agreement, no suspension or cancellation of any of the IVAX Parent Permits is pending or, to the knowledge Knowledge of IVAXParent, threatened, except where the failure to havebe in possession of or be in full force and effect, or the suspension suspension, modification or cancellation of, any of the IVAX Parent Permits would notnot reasonably be expected to have, individually or in the aggregate, have an IVAX a Parent Material Adverse Effect. Neither IVAX Each of Parent and each of its Subsidiaries is in compliance with the terms and requirements of all Parent Permits, and neither Parent nor any IVAX Subsidiary is of its Subsidiaries has received any written notice regarding a default or violation in respect of any of the Parent Permits, except where the failure to be in compliance has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. (b) None of Parent nor any of its Subsidiaries is, and since January 1, 2022, has not been, in conflict with, in default under or in default or violation of, (i) of any Law applicable to IVAX Parent or any IVAX Subsidiary of its Subsidiaries or by which any property or asset of IVAX Parent or any IVAX Subsidiary of its Subsidiaries is bound or affected or (ii) any IVAX Permitsaffected, except in the case of clauses (i) and (ii) for any such conflicts, defaults or violations that would notnot have or would not reasonably be expected to have, individually or in the aggregate, have an IVAX a Parent Material Adverse Effect. As used in this AgreementSince January 1, "Law" means 2022, neither Parent nor any federalof its Subsidiaries has received any written notice or, state or local statute, law, ordinance, regulation, rule, code, orderto Parent’s Knowledge, other requirement communication from any Governmental Authority regarding any actual or rule of law of possible violation of, or failure to comply with, any Law, except as has not had and would not reasonably be expected to have, individually or in the United States or any other jurisdictionaggregate, including, without limitation, the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and any other similar act or lawa Parent Material Adverse Effect.

Permits; Compliance with Laws. (a) Each of IVAX The Company and the IVAX its Subsidiaries is (i) are in possession of all authorizations, permits, franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exemptions, exceptions, consentspermissions, certificatesqualifications, approvals registrations, clearances, Consents, waivers, approvals, orders, deviations, licenses and orders certificates of any Governmental Entity, including, without limitation, the United States Food and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA")Authority, and similar authorities in (ii) have filed all tariffs, reports, notices and other jurisdictions, documents with any Governmental Authority necessary for IVAX or any IVAX Subsidiary the Company and its Subsidiaries to own, lease and operate its their properties or to produceand assets, store, distribute and market its products or otherwise to carry on its business and operate their businesses as it is now being currently conducted (the "IVAX Permits"clauses (i) and (ii), except where collectively, the failure to have“Company Permits”), or the suspension or cancellation ofand all Company Permits are in full force and effect and no suspension, any of the IVAX Permits would notmodification, individually or in the aggregate, have an IVAX Material Adverse Effect, and, as of the date of this Agreement, no suspension or cancellation of any of the IVAX Company Permits is pending or, to the knowledge Knowledge of IVAXthe Company, threatened, except where the failure to havebe in possession of or be in full force and effect, or the suspension suspension, modification or cancellation of, any of the IVAX Company Permits would notnot reasonably be expected to have, individually or in the aggregate, have an IVAX a Company Material Adverse Effect. Neither IVAX Each of the Company and each of its Subsidiaries is in compliance with the terms and requirements of all Company Permits, and neither the Company nor any IVAX Subsidiary is of its Subsidiaries has received any written notice regarding a default or violation in respect of any of the Company Permits, except where the failure to be in compliance has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (b) None of the Company or any of its Subsidiaries is, and since July 21, 2021 has not been, in conflict with, in default under or in default or violation of, (i) of any Law applicable to IVAX the Company or any IVAX Subsidiary of its Subsidiaries or by which any property or asset of IVAX the Company or any IVAX Subsidiary of its Subsidiaries is bound or affected or (ii) any IVAX Permitsaffected, except in the case of clauses (i) and (ii) for any such conflicts, defaults or violations that would notnot have or would not reasonably be expected to have, individually or in the aggregate, have an IVAX a Company Material Adverse Effect. As used in this AgreementSince July 21, "Law" means 2021, neither the Company nor any federalof its Subsidiaries has received any written notice or, state or local statute, law, ordinance, regulation, rule, code, orderto the Knowledge of the Company, other requirement communication from any Governmental Authority regarding any actual or rule of law of possible violation of, or failure to comply with, any Law, except as has not had and would not reasonably be expected to have, individually or in the United States or any other jurisdictionaggregate, including, without limitation, the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and any other similar act or lawa Company Material Adverse Effect.

Permits; Compliance with Laws. (a) Each of IVAX (i) the Company and the IVAX Subsidiaries is each Company Subsidiary are in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exceptions, exemptions, consents, certificates, approvals approvals, product listings, registrations, Orders and orders of other authorizations, including any Governmental Entity, including, without limitation, the United States Food supplements and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA"), and similar authorities in other jurisdictionsamendments thereto, necessary for IVAX or any IVAX the Company and each Company Subsidiary to own, lease and operate its their respective properties and assets in accordance with all Laws or to produce, store, distribute and market its products or otherwise to carry on its business as it is now being conducted their respective businesses in accordance with all Laws (the "IVAX “Company Permits"), ”) except where the failure to have, obtain or the suspension or cancellation of, have any of the IVAX Permits such Company Permit would not, individually or in the aggregate, reasonably be expected to have an IVAX a Company Material Adverse Effect, and, as of the date of this Agreement, no suspension or cancellation of any of the IVAX (ii) all such Company Permits is pending or, to the knowledge of IVAX, threatenedare in full force and effect, except where the failure to have, or the suspension or cancellation of, any of the IVAX Permits as would not, individually or in the aggregate, reasonably be expected to have an IVAX a Company Material Adverse Effect. Neither IVAX nor any IVAX Subsidiary is in conflict with, or in default or (iii) there has occurred no 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 and (iv) no modification, suspension, cancellation, withdrawal or revocation thereof is pending or, to the Knowledge of the Company, threatened. The consummation of the transactions contemplated hereby will not cause the revocation or cancellation of any Company Permit that is material to the Company and its Subsidiaries, taken as a whole. (b) The Company and each Company Subsidiary are, and have been since January 1, 2020, in compliance with (i) any Law applicable to IVAX or any IVAX Subsidiary or by which any property or asset of IVAX or any IVAX Subsidiary is bound or affected or (ii) any IVAX Permits, except in the case of clauses (i) all Laws and (ii) for all Company Permits, except where any failure to be in such conflictscompliance (A) has not had, defaults or violations that and would notnot reasonably be expected to, individually or in the aggregate, have an IVAX a Company Material Adverse Effect. As used , and (B) would not reasonably be expected to, individually or in this Agreementthe aggregate, "Law" means impair in any federal, state or local statute, law, ordinance, regulation, rule, code, order, other requirement or rule of law material respect the ability of the United States Company to perform its obligations in accordance with this Agreement or to consummate the Merger, or prevent or materially delay the consummation of any of the Merger and the other transactions contemplated hereby. (c) Since January 1, 2020, neither the Company nor any Company Subsidiary or, to the Knowledge of the Company, any of their respective directors, officers or employees, has received any written or, to the Knowledge of the Company, oral notification from a Governmental Authority or other Person asserting that the Company or any other jurisdictionCompany Subsidiary is, includingor is suspected of, without limitationalleged to be or under investigation for being, the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and not in compliance in all material respects with any other similar act Laws or lawCompany Permits.

Permits; Compliance with Laws. (a) Each of IVAX CGI, Merger Sub and the IVAX Subsidiaries each other CGI Subsidiary is in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity, including, without limitation, the United States Food and Drug Administration (FDA, the "FDA"), United States Drug Enforcement Administration (the "DEA"), DEA and similar authorities in other jurisdictions, necessary for IVAX or any IVAX Subsidiary it to own, lease and operate its properties or to produce, store, distribute and market its products or otherwise to carry on its business as it is now being conducted (the "IVAX CGI Permits"), except where the failure to have, or the suspension or cancellation of, any of the IVAX CGI Permits would notcould not reasonably be expected to have, individually or in the aggregate, have an IVAX a CGI Material Adverse Effect, and, as of the date of this Agreement, no suspension or cancellation of any of the IVAX CGI Permits is pending or, to the knowledge of IVAXCGI, threatened, except where the failure to have, or the suspension or cancellation of, any of the IVAX CGI Permits would notcould not reasonably be expected to have, individually or in the aggregate, have an IVAX a CGI Material Adverse Effect. Neither IVAX nor None of CGI, Merger Sub or any IVAX other CGI Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to IVAX CGI, Merger Sub or any IVAX other CGI Subsidiary or by which any property or asset of IVAX CGI, Merger Sub or any IVAX other CGI Subsidiary is bound or affected or (ii) any IVAX CGI Permits, except in the case of clauses (i) and (ii) for any such conflicts, defaults or violations that would notcould not reasonably be expected to have, individually or in the aggregate, have an IVAX a CGI Material Adverse Effect. As used . (b) Except as disclosed in this Agreement, "Law" means any federal, state the CGI Reports or local statute, law, ordinance, regulation, rule, code, order, other requirement or rule of law in Section 5.06(b) of the United States CGI Disclosure Schedule or as could not reasonably be expected to have, individually or in the aggregate, a CGI Material Adverse Effect: (i) to the knowledge of CGI, all of the clinical studies which have been, or are being, conducted by or for CGI and the CGI Subsidiaries are being conducted in substantial compliance with generally accepted good clinical practices and all applicable government regulatory requirements; and (ii) to the knowledge of CGI, none of CGI, the CGI Subsidiaries or any other jurisdictionof their respective officers, includingemployees or agents (during the term of such person's employment by CGI or any CGI Subsidiary or while acting as an agent of CGI or any CGI Subsidiary, without limitationor, to CGI's knowledge, prior to such employment) has made any untrue statement of a material fact or fraudulent statement to the Federal FoodFDA or any similar Governmental Entity, Drugfailed to disclose a material fact required to be disclosed to the FDA or similar Governmental Entity, or committed an act, made a statement or failed to make a statement that could reasonably be expected to provide a basis for the FDA or similar Governmental Entity to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and any other Illegal Gratuities" or similar act governmental policy or lawLaw.

Permits; Compliance with Laws. (a) Each Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of IVAX it and the IVAX its Subsidiaries is is, and since January 1, 2012, has been, in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exceptions, consents, certificates, approvals and orders other permits of any Governmental Entity, including, without limitation, the United States Food and Drug Administration Entity (the "FDA"), United States Drug Enforcement Administration (the "DEA"), and similar authorities in other jurisdictions, “Permits”) necessary for IVAX or any IVAX Subsidiary it to own, lease and operate its properties and assets or to produce, store, distribute and market its products or otherwise to carry on its business as it is now currently being conducted (the "IVAX collectively, its “Required Permits"”), except where the failure to have, or the suspension or cancellation of, any of the IVAX and all such Required Permits are in full force and effect. Except as would not, individually or in the aggregate, reasonably be expected to have an IVAX a Material Adverse Effect, and, as of the date of this Agreement, no suspension or cancellation of any of the IVAX Required Permits is pending or, to the knowledge of IVAX, or threatened, except where the failure to have, or the and no such suspension or cancellation of, any will result from consummation of the IVAX Permits Transactions. (b) Except as would not, individually or in the aggregate, reasonably be expected to have an IVAX a Material Adverse Effect. Neither IVAX nor any IVAX Subsidiary is , it and each of its Subsidiaries is, and since January 1, 2012 has been, in conflict compliance with, or in default or violation of, : (i) any Law all Laws applicable to IVAX it or any IVAX such Subsidiary or by which any property its respective business or asset of IVAX or any IVAX Subsidiary is bound or affected or (ii) any IVAX Permits, except in the case of clauses (i) properties and (ii) for all its Required Permits. Neither it nor any such conflictsof its Subsidiaries is subject to any Order of, defaults or violations that any continuing, pending or threatened in writing formal investigation or formal inquiry by, any Governmental Entity except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (c) Without limiting the generality of the foregoing, except as would not, individually or in the aggregate, reasonably be expected to have an IVAX a Material Adverse Effect, it and each of its Subsidiaries is, and since January 1, 2012 has been, in compliance with: (i) the Foreign Corrupt Practices Act of 1977, as amended, and any rules and regulations promulgated thereunder, (ii) the Organization for Economic Cooperation and Development Convention Against Bribery of Foreign Public Officials in International Business Transactions and legislation implementing such Convention and (iii) the United Kingdom Bribery Act of 2010, as amended, and any rules and regulations promulgated thereunder. As used Except as would not, individually or in this Agreementthe aggregate, "Law" means reasonably be expected to have a Material Adverse Effect, neither it or any federalof its Subsidiaries nor, state to its Knowledge, any of their respective directors, officers, employees or local statuteagents, lawdoes any business with or involving the government of, ordinance, regulation, rule, code, order, other requirement any Person or rule project located in any country targeted by any of law the economic sanctions promulgated by any Executive Order issued by the President of the United States or administered by the United States Treasury Department’s Office of Foreign Assets Control, or knowingly supports or facilitates any such business or project, in each case other jurisdictionthan as permitted under such economic sanctions. Neither it nor any of its Subsidiaries has received any written notice of violation (or allegation of violation) of such sanctions from any Governmental Entity. This Section 3.23 does not relate to its SEC Reports, including, without limitation, financial statements or compliance with the Federal Food, Drug, and Cosmetic Xxxxxxxx-Xxxxx Act (the "FDCA"as associated rules and regulations), which are the Controlled Substances Actsubject of Section 3.10, Section 3.11 and any other similar act or lawSection 3.12.

Permits; Compliance with Laws. (ai) Each Except as set forth in Schedule 4.01(g)(i) and except for the authorizations, licenses, permits, certificates, approvals, variances, exemptions, orders, franchises, certifications and clearances that are the subject of IVAX and Section 4.01(k), which are addressed solely in that Section, Contributor or the IVAX Subsidiaries applicable Property Owner is in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Entity, including, without limitation, the United States Food and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA"), and similar authorities in other jurisdictions, Authority necessary for IVAX or any IVAX Subsidiary them to own, lease and, to the extent applicable, operate the Lighthouse Acquisition Properties and operate its properties or to produce, store, distribute and market its products or otherwise to carry on its business their businesses substantially as it is now they are being conducted as of the Effective Date (collectively, the "IVAX “Permits"”). All such Permits are valid and in full force and effect, except where the failure to havebe in full force and effect or to possess, obtain or maintain the Permits, or the suspension or cancellation of, any of the IVAX Permits would not, individually or in the aggregate, reasonably be expected to have an IVAX a Properties Material Adverse Effect, and, as . Neither Contributor nor any of its subsidiaries has taken any action that would reasonably be expected to result in the date revocation of this Agreement, any Permit and no suspension or cancellation of any of the IVAX Permits is pending or, to the knowledge of IVAX, threatenedpending, except where the failure to have, or the suspension or cancellation of, any of the IVAX Permits in each case as would not, individually or in the aggregate, reasonably be expected to have an IVAX a Properties Material Adverse Effect. Neither IVAX . (ii) Except as set forth in Schedule 4.01(g)(ii), neither Contributor nor any IVAX Subsidiary of its subsidiaries is in conflict with, or in default default, breach or violation of, (i) any Law Laws applicable to IVAX Contributor or any IVAX Subsidiary or its subsidiaries by which any property or asset of IVAX or any IVAX Subsidiary Lighthouse Acquisition Property is bound or affected or (ii) any IVAX PermitsPermit, except in the case of clauses (i) and (ii) for any such conflicts, defaults defaults, breaches or violations that which would not, individually or in the aggregate, reasonably be expected to have an IVAX a Properties Material Adverse Effect. As used in this Agreement, "Law" means any federal, state or local statute, law, ordinance, regulation, rule, code, order, other requirement or rule of law of the United States or any other jurisdiction, including, without limitation, the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and any other similar act or law.

Permits; Compliance with Laws. (a) Each of IVAX (i) Parent and the IVAX its Subsidiaries is are in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exceptions, exemptions, consents, certificates, approvals approvals, registrations, clearances, orders and orders of any Governmental Entity, including, without limitation, the United States Food and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA"), and similar authorities in other jurisdictions, authorizations necessary for IVAX or any IVAX Subsidiary Parent and its Subsidiaries to own, lease and operate its their respective properties and assets under and pursuant to all applicable Laws or to produce, store, distribute and market its products or otherwise to carry on its business their respective businesses as it is now being conducted under and pursuant to all applicable Laws (the "IVAX “Parent Permits"”), except where the failure to have, or the suspension or cancellation of, any of the IVAX (ii) all such Parent Permits would not, individually or are in the aggregate, have an IVAX Material Adverse Effect, and, full force and effect and (iii) as of the date of this Agreement, no suspension suspension, cancellation, withdrawal or cancellation of any of the IVAX Permits revocation thereof is pending or, to the knowledge Knowledge of IVAXParent, threatened, in each case, except where the failure to havebe in possession of, failure to be in full force and effect or the suspension suspension, cancellation, withdrawal or cancellation ofrevocation thereof (A) has not had, any of the IVAX Permits and would notnot reasonably be expected to have, individually or in the aggregate, have an IVAX a Parent Material Adverse Effect. Neither IVAX nor any IVAX Subsidiary is in conflict with, or in default or violation of, (i) any Law applicable to IVAX or any IVAX Subsidiary or by which any property or asset of IVAX or any IVAX Subsidiary is bound or affected or (ii) any IVAX Permits, except in the case of clauses (i) and (iiB) for any such conflicts, defaults or violations that would notnot reasonably be expected to, individually or in the aggregate, prevent or materially delay the consummation of any of the Merger and the other transactions contemplated by this Agreement. (b) Since December 31, 2015, Parent and its Subsidiaries have an IVAX been and are in compliance with (i) all applicable Laws and (ii) all Parent Permits, in each case, except where any failure to be in such compliance (A) has not had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. As used , and (B) would not reasonably be expected to, individually or in the aggregate, prevent or materially delay the consummation of any of the Merger and the other transactions contemplated by this Agreement. (c) Since December 31, 2015 through the date of this Agreement, "Law" means none of Parent or any federalof its Subsidiaries or, state to the Knowledge of Parent, any of their respective directors, officers or local statuteemployees, lawhas received any written or, ordinanceto the Knowledge of Parent, regulationoral notification from a Governmental Authority asserting that Parent or any of its Subsidiaries is not in compliance with, ruleor is under investigation with respect to any failure to comply with, codeany applicable Laws or Parent Permits or notifying Parent or any of its Subsidiaries regarding an investigation or possible non-compliance, orderexcept where any failure to be in such compliance or to be under such investigation (a) has not had, other requirement and would not reasonably be expected to have, individually or rule in the aggregate, a Parent Material Adverse Effect, and (B) would not reasonably be expected to, individually or in the aggregate, prevent or materially delay the consummation of law any of the United States or any Merger and the other jurisdiction, including, without limitation, the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and any other similar act or lawtransactions contemplated by this Agreement.

Permits; Compliance with Laws. (a) Each of IVAX (i) Parent and the IVAX its Subsidiaries is are in possession of all material franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easements, variances, exceptionsexemptions, consents, certificates, approvals approvals, registrations, clearances, orders and orders of any Governmental Entity, including, without limitation, the United States Food and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA"), and similar authorities in other jurisdictions, authorizations necessary for IVAX or any IVAX Subsidiary Parent and its Subsidiaries to own, lease and operate its their respective properties or to produce, store, distribute and market its products or otherwise assets and to carry on its business their respective businesses as it is now being conducted under and pursuant to all applicable Laws (the "IVAX “Parent Permits"”), except where the failure to have, or the suspension or cancellation of, any of the IVAX (ii) all such Parent Permits would not, individually or are in the aggregate, have an IVAX Material Adverse Effect, and, full force and effect and (iii) as of the date of this Agreement, no suspension suspension, cancellation, withdrawal or cancellation of any of the IVAX Permits revocation thereof is pending or, to the knowledge Knowledge of IVAXParent, threatened, except where the failure to havebe in possession of, failure to be in full force and effect or the suspension suspension, cancellation, withdrawal or cancellation ofrevocation thereof has not had, any of the IVAX Permits and would notnot reasonably be expected to have, individually or in the aggregate, have an IVAX a Parent Material Adverse Effect. Neither IVAX nor any IVAX Subsidiary is . (b) Since December 31, 2014, Parent and its Subsidiaries have been and are in conflict with, or in default or violation of, compliance with (i) any Law all applicable to IVAX or any IVAX Subsidiary or by which any property or asset of IVAX or any IVAX Subsidiary is bound or affected or (ii) any IVAX Permits, except in the case of clauses (i) Laws and (ii) for all Parent Permits, except where any failure to be in such conflictscompliance has not had, defaults or violations that and would notnot reasonably be expected to have, individually or in the aggregate, have an IVAX a Parent Material Adverse Effect. As used in . (c) Since December 31, 2014 through the date of this Agreement, "Law" means any federal, state or local statute, law, ordinance, regulation, rule, code, order, other requirement or rule none of law of the United States Parent or any other jurisdictionof its Subsidiaries or, includingto the Knowledge of Parent, without limitationany of their respective directors, officers or employees, has received any written or, to the Federal FoodKnowledge of Parent, Drugoral notification from a Governmental Authority asserting that Parent or any of its Subsidiaries is not in compliance with any Laws or Parent Permits, except where any failure to be in such compliance has not had, and Cosmetic Act (would not reasonably be expected to have, individually or in the "FDCA")aggregate, the Controlled Substances Act, and any other similar act or lawa Parent Material Adverse Effect.

Permits; Compliance with Laws. (a) Each of IVAX The REIT and the IVAX Subsidiaries each REIT Subsidiary is in possession of all franchises, grants, authorizations, licenses, establishment registrations, product listings, permits, easementscertificates, variances, exceptions, consents, certificatesexemptions, approvals and orders of any Governmental EntityEntity (each, including, without limitation, the United States Food and Drug Administration (the "FDA"), United States Drug Enforcement Administration (the "DEA"), and similar authorities in other jurisdictions, a “Permit”) necessary for IVAX or any IVAX the REIT and each REIT Subsidiary to own, lease and operate its properties or to produceand assets, store, distribute and market its products or otherwise to carry on and operate its business businesses as it is now being currently conducted as of the date hereof (the "IVAX “REIT Permits"”), and all such REIT Permits are in full force and effect, in each case except where the failure to have, or the suspension or cancellation of, any of the IVAX Permits as would not, individually or in the aggregate, reasonably be expected to have an IVAX a REIT Material Adverse Effect, and, as of the date of this Agreement, no . No suspension or cancellation of any of the IVAX REIT Permits is pending or, to the knowledge of IVAXthe REIT, threatened, except where the failure to have, or the threatened in writing and no such suspension or cancellation ofwill result from the transactions contemplated by this Agreement, any of the IVAX Permits in each case except as would not, individually or in the aggregate, reasonably be expected to have an IVAX a REIT Material Adverse Effect. Neither IVAX nor any IVAX Subsidiary Effect.‌ (b) The REIT and each of the REIT Subsidiaries is in conflict with, or in default or violation of, (i) any Law compliance with all Laws applicable to IVAX the REIT, the REIT Subsidiaries and their respective businesses and properties or any IVAX Subsidiary or by which any property or asset of IVAX or any IVAX Subsidiary is bound or affected or (ii) any IVAX Permitsassets, in each case except in the case of clauses (i) and (ii) for any such conflicts, defaults or violations that as would not, individually or in the aggregate, reasonably be expected to have an IVAX a REIT Material Adverse Effect. As used Except as would not, individually or in this Agreementthe aggregate, "Law" means reasonably be expected to have a REIT Material Adverse Effect, no investigation, review or proceeding by any federal, state Governmental Entity with respect to the REIT or local statute, law, ordinance, regulation, rule, code, order, other requirement or rule of law any of the United States REIT Subsidiaries or their operations is pending or, to the REIT’s (c) Except as would not, individually or in the aggregate, reasonably be expected to have a REIT Material Adverse Effect, neither the REIT nor any of the REIT Subsidiaries, nor, to the REIT’s knowledge, any director, trustee, officer or employee of the REIT or any of the REIT Subsidiaries, has (i) knowingly used any corporate funds for any unlawful contribution, gift, entertainment or other jurisdiction, including, without limitation, the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the Controlled Substances Act, and any other similar act or law.unlawful expense relating to political activity,