Common use of Compliance with Laws; Governmental Authorizations Clause in Contracts

Compliance with Laws; Governmental Authorizations. Solely with respect to the Business, Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller Entities, except for such failures to comply as would not, individually or in the aggregate, reasonably be expected to be material to the Business. Seller and each other Asset Seller Entity hold all Governmental Authorizations necessary for the lawful conduct of the Business as presently conducted, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance would not, individually or in the aggregate, reasonably be expected to be material to the Business. Without limiting the generality of the foregoing, except as would not, individually or in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Seller, each of its and their other agents acting on its or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12.

Compliance with Laws; Governmental Authorizations. Solely with respect to the Triage Business, Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller Entities, except for such failures to comply as would not, individually or in the aggregate, reasonably be expected to be material to the Triage Business. Seller and each other Asset Seller Entity hold all Governmental Authorizations necessary for the lawful conduct of the Triage Business as presently conducted, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance would not, individually or in the aggregate, reasonably be expected to be material to the Triage Business. Without limiting the generality of the foregoing, except as would not, individually or in the aggregate, reasonably be expected to be material to the Triage Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Seller, each of its and their other agents acting on its or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Triage Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, employee benefits, which are the subject of Section 4.09, labor matters, which are the subject of Section 4.10, environmental matters, which are the subject of Section 4.11, Intellectual Property matters, which are the subject of Section 4.094.12, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.124.15.

Compliance with Laws; Governmental Authorizations. Solely with respect (a) Except as set forth in Attachment 3.14 to the Businessthis Agreement, Seller and each other Asset Seller Entity are, and have been since January 1, 2015, Acquired Company is in compliance with all stateLegal Requirements affecting the business or operations of such Acquired Company, including, without limitation, federal, local(if applicable) state and local (i) Environmental Laws; (ii) any kickback, nationalprocurement integrity, contingent fee, gratuities to government officials, customs, export control, foreign or multinational trade and foreign corrupt practices laws, statutessecurities (including all rules and regulations relating to protection of classified information and retention of facility and personnel security clearances), ordinancesor any order, codesdecree or judgment of any Governmental Entity having jurisdiction over any Acquired Company; (iii) Occupational Safety and Health Laws; (iv) securities laws, rules or regulations and regulations. Without prejudice to the above representation and warranty, except as set forth in Attachment 3.14 to this Agreement, SELLERS further represent and warrant that all the Acquired Companies have always and fully complied with all laws and regulations, both Italian and EU, in the matter of health and safety of workers and work site, including D. Lgs. 626/94 as amended and Law of August 3, 2007, n. 123, as well as any law and regulation, Italian and EU, for prevention of injuries and casualties (“Lawsantinfortunistica” and “prevenzionale”), for fire prevention (“antincendio”) or Judgments applicable to and in matter of the Asset Seller Entities, except for such failures to comply as would not, individually or specific processes carried out in the aggregatesite and in connection with the specific substances, reasonably be expected to be material to the Business. Seller materials and each other Asset Seller Entity hold all Governmental Authorizations necessary for the lawful conduct of the Business as presently conducted, and Seller and each other Asset Seller Entity areproducts processed, and have been since January 1, 2015, always and fully adopted all prevention measures and specific devices (misure di prevenzione e dispositivi individuali) required by any of the aforesaid laws and regulations (all such laws and regulations referred to as “Health and Safety Legislation”). SELLERS shall hold TOG and/or Acquired Companies harmless from any consequences which may derive from any proceeding in which non compliance with all such Governmental Authorizations, except where Health and Safety Legislation by any of the failure aforesaid companies might be alleged. It is however understood that TOG shall have the right to hold the same or be in compliance would not, individually or enforce this warranty only in the aggregateevent that any violation of any Health and Safety Legislation is assessed by any competent Authority. No Acquired Company has been charged with violating, reasonably be expected to be material or to the Business. Without limiting the generality Knowledge of the foregoingtwo major shareholders among the SELLERS, except as would notthreatened with a charge of violating, individually or in the aggregateor, reasonably be expected to be material to the BusinessKnowledge of the two major shareholders among the SELLERS, Selleris any Acquired Company under investigation with respect to a possible violation of, each other Asset Seller Entity and each any provision of its and any Legal Requirement relating to any of their directors, officers and employees assets or properties or any aspect of their business. (b) Each Acquired Company has obtained all material regulatory approvals from third parties and, to the Knowledge of Sellerthe two major shareholders among the SELLERS, each Acquired Company has obtained all necessary regulatory approvals, from any foreign regulatory bodies related to the products or services sold by such Acquired Company. (c) Attachment 3.14 (c) to this Agreement contains a complete and accurate list of each material governmental authorization, license or permit that is held by each Acquired Company and required for the conduct of its business or ownership of its assets. Each such governmental authorization is valid and their other agents acting on its in full force and effect, and will continue to be valid and in full force and effect after the Closing. (d) The execution, delivery and performance by SELLERS of this Agreement and the consummation of the transactions contemplated by this Agreement by SELLERS require no action by or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09of, or compliance with (i) the rules or regulations of the FDA or filing with, any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12Governmental Entity.

Compliance with Laws; Governmental Authorizations. Solely with respect to (a) During the Businessperiod of five (5) years ending on the date hereof, Seller and each other Asset Seller Entity are, and have been since January 1, 2015, of the Companies has complied in compliance all material respects with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller Entities, except for such failures to comply as would not, individually or in the aggregate, reasonably be expected to be material to the BusinessLaws and Governmental Orders. Seller and each other Asset Seller Entity hold all Governmental Authorizations necessary for the lawful conduct of the Business as presently conducted, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance would not, individually or in the aggregate, reasonably be expected to be material to the Business. Without limiting the generality of the foregoing, except as would not, individually or in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to To the Knowledge of Seller, none of the Companies is relying on any written exemption from or deferral of any Law, Governmental Order or Governmental Authorization that would not be available to them after the Closing. (b) Each of the Companies has in full force and effect all Governmental Authorizations necessary to conduct its business and own and operate its properties in the Ordinary Course of Business. Each of such Governmental Authorizations is listed in Schedule 3.17(b). Each of the Companies has complied in all material respects with all Governmental Authorizations applicable to it. (c) To the Knowledge of Seller, none of the Companies has offered, authorized, promised, made or agreed to make any gifts, payments or transfers of property of any kind (other than incidental gifts of nominal value) in connection with any actual or proposed transaction, except as required or permitted by the Laws of each of its applicable jurisdiction and their other agents acting on its or their behalf, is and in each such case has been since January 1, 2015 in compliance complied with (a) the US Foreign Corrupt Practices Act Act. (d) To the Knowledge of 1977 Seller, the Companies have complied with all applicable export control and trade embargo Laws in connection with any actual or proposed transaction. (be) To the Knowledge of Seller, during the period of five (5) years ending on the date hereof, each the Companies has complied with all applicable antiboycott Laws in connection with any rules and regulations promulgated thereunder with respect actual or proposed transaction. (f) All copyright levy payments that are applicable or may be applicable to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations sale of any products by the Companies have been paid to the extent relating relevant collecting society. (g) All anti-dumping and anti-subsidy duties that are applicable or may be applicable to Tax matters, which the sale of any products by the Companies have been paid to the relevant customs authority by the importers or suppliers of such products. (h) All products offered for sale by the Companies and their respective packaging are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance compliant in all material respects with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care all applicable Laws, which are the subject of Section 4.12.

Compliance with Laws; Governmental Authorizations. Solely (a) Except as set forth in Schedule 3.13, the Company has complied ------------- with respect to the Business, Seller and each other Asset Seller Entity are, and have been since January 1, 2015, is in compliance with all stateLaws applicable to it or any of its Assets or operations, federalincluding, localwithout limitation, nationalall applicable Laws relating to the regulation and protection of the Environment and all applicable Laws relating to the Company's employees, foreign and there does not exist any basis for any claim of default under, or multinational lawsviolation of, statutesany such Law. (b) Schedule 3.13 contains a complete and accurate list of each ------------- Governmental Authorization that is held by the Company or that otherwise relates to the business of, ordinancesor to any of the Assets owned or used by, codesthe Company. The Company has delivered to Buyer accurate and complete copies of all Governmental Authorizations identified in Schedule 3.13, rules including all renewals thereof and ------------- all amendments thereto. Each Governmental Authorization listed or regulations required to be listed in Schedule 3.13 of the Disclosure Schedules is valid and in full force and effect. The Governmental Authorizations listed in Schedule 3.13 ------------- collectively constitute all of the Governmental Authorizations necessary to permit the Company to lawfully conduct and operate its business in the manner it currently conducts and operates such business and to permit the Company to own and use the Assets in the manner in which it currently owns and uses such Assets. (“Laws”c) Each of the Company and Sellers has not been, or Judgments received any notice that it is, in violation of or in default under, any Law or Order applicable to the Asset Seller Entities, except for such failures to comply as would not, individually Company or in the aggregate, reasonably be expected to be material to the Business. Seller and each other Asset Seller Entity hold all Governmental Authorizations necessary for the lawful conduct of the Business as presently conducted, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance would not, individually or in the aggregate, reasonably be expected to be material to the Businessits Assets. Without limiting the generality of the foregoing, except as would not, individually or in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Sellerprevious sentence, each of its the Sellers and their other agents acting on its or their behalf, Company is and has been since January 1, 2015 in compliance familiar with (a) the terms of the U.S. Foreign Corrupt Practices Act of 1977 1977, as amended (the "FCPA"), and (b) any rules has ---- received and regulations promulgated thereunder reviewed a copy of a summary of the FCPA, which is attached to this Agreement as Exhibit D. None of Sellers is currently a government --------- representative, employee or officer of a political party. Each of Sellers and the Company will comply with respect all applicable Laws, including but not limited to the BusinessFCPA. This Section 4.07 does not relate None of Sellers or the Company has knowledge of any act that has been taken or contemplated by the Company or Sellers that would violate the FCPA without regard to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations applicability of the FDA FCPA to Sellers or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12Company.

Compliance with Laws; Governmental Authorizations. Solely (A) Neither the Company nor any Subsidiary: (i) is in default under or in violation of (and no event has occurred that has not been waived that, with respect notice or lapse of time or both, would result in a default by the Company or any Subsidiary under), nor has the Company or any Subsidiary received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to the Businesswhich it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived), Seller and each (ii) is in violation of any judgment, decree, or order of any court, arbitrator or other Asset Seller Entity aregovernmental authority or (iii) is or has been in violation of any statute, and have been since January 1rule, 2015ordinance or regulation of any governmental authority, in compliance with including without limitation all stateforeign, federal, localstate and local laws relating to taxes, nationalenvironmental protection, foreign or multinational lawsoccupational health and safety, statutesMaritime Guidelines, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller Entitiesproduct quality and safety and employment and labor matters, except for such failures to comply in each case as would not, individually could not have or in the aggregate, reasonably be expected to result in a Material Adverse Effect. Each of the Owned Vessels is operated in compliance with the. Maritime Guidelines and all applicable international, national, state and local conventions, laws, regulations, orders, governmental licenses and other requirements (including, without limitation, all Environmental Laws), in each case as in effect on the date hereof, except where such failure to be material in compliance is not resulting or would not reasonably be expected to result in a Material Adverse Effect. (B) The Company owns, holds, possesses or lawfully uses in the Business. Seller and each other Asset Seller Entity hold operation of its business all Governmental Authorizations (including those required by Maritime Guidelines) that are necessary for the lawful or required to conduct of the Business its business as presently now conducted, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold own, hold, possess or lawfully use such Governmental Authorization would not have a Material Adverse Effect. The Company and each applicable Subsidiary are qualified to own or lease, as the same case may be, and operate such Owned Vessels under all applicable international, national, state and local conventions, laws, regulations, orders, governmental licenses and other requirements (including, without limitation, all Environmental Laws) and Maritime Guidelines, including the laws, regulations and orders of each such vessel’s flag state, in each case as in effect on the date hereof, except where such failure to be so qualified is not resulting or be in compliance would not, individually or in the aggregate, not reasonably be expected expect to be material to the Business. Without limiting the generality of the foregoing, except as would not, individually or result in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Seller, each of its and their other agents acting on its or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12a Material Adverse Effect.

Compliance with Laws; Governmental Authorizations. Solely (a) The Company is, and has been since the Acquisition Date, in compliance in all material respects with all applicable Laws; (b) Since the Acquisition Date, the Company has filed all reports, statements, documents, registrations, filings or submissions required to be filed with any Governmental Entity, in connection with the operation of the Business. All such filings complied with applicable Law in all material respects when filed and no deficiencies have been asserted by any such Governmental Entity with respect to such filings and submissions; (c) The Company have not received, at any time within the Businesslast two years, Seller and each any written notice from any Governmental Entity or any other Asset Seller Entity arePerson regarding (i) any actual, alleged, possible, or potential violation of, or failure to comply with, any Law, or (ii) any actual, alleged, possible or potential obligation on the part of the Company to undertake, or to bear all or any portion of the cost of, any remedial action of any nature; (d) All applications required to have been filed for the renewal of all Consents required by any Governmental Entities have been duly filed on a timely basis with the appropriate Governmental Entity, and all other filings required to have been since January 1, 2015, in compliance made with respect to each Consent have been duly made on a timely basis with the appropriate Governmental Entity; and (e) The Company has obtained all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments necessary Consents and satisfied all Legal Requirements pursuant to all applicable Laws necessary to permit the Asset Seller Entities, except for such failures Company to comply as would not, individually or in the aggregate, reasonably be expected to be material to the Business. Seller lawfully conduct and each other Asset Seller Entity hold all Governmental Authorizations necessary for the lawful conduct of operate the Business as presently conducted. Except as set forth on Schedule 3.17(e), and Seller and each no other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where Consents are necessary to conduct the failure to hold the same or be in compliance would not, individually or in the aggregate, reasonably be expected to be material to the Business. Without limiting the generality of the foregoing, except Business as would not, individually or in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Seller, each of its and their other agents acting on its or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12presently conducted.

Compliance with Laws; Governmental Authorizations. Solely (a) Parent and each of its Subsidiaries is and, since December 31, 2013, has been in compliance with the Laws applicable to each of Parent and its Subsidiaries, in each case except to the extent that the failure to comply therewith would not reasonably be expected to have a Parent Material Adverse Effect. Parent and each of its Subsidiaries is and, since December 31, 2013, has been in material compliance with all Anti-Corruption Laws. Since December 31, 2013, neither Parent nor any of its Subsidiaries has received any written notices of violation with respect to the Business, Seller and each other Asset Seller Entity are, and have been since January 1, 2015any Laws applicable to it, in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller Entities, except for such failures to comply each case other than as would not, individually or in the aggregate, reasonably be expected to be material have a Parent Material Adverse Effect. (b) Without limiting the generality of Section 3.5(a), to the BusinessKnowledge of Parent, Parent, its Subsidiaries and their officers, directors, employees and agents are in compliance with and, since December 31, 2013, have complied in all material respects with: (i) the provisions of the FCPA, as if its foreign payments provisions were fully applicable to Parent, its Subsidiaries and such owners, officers, directors, employees, and agents, and (ii) Anti-Corruption Laws of each jurisdiction in which Parent and its Subsidiaries operate or have operated and in which any agent thereof is conducting or has conducted business involving Parent. Seller Since December 31, 2013, to the Knowledge of Parent, Parent, its Subsidiaries and/or their respective officers, directors, employees and agents have not paid, offered or promised to pay, or authorized or ratified the payment, directly or indirectly, of any monies or anything of value to any national, provincial, municipal or other Government Official or any political party or candidate for political office for the purpose of corruptly influencing any act or decision of such official or of the government to obtain or retain business, or direct business to any person or to secure any other improper benefit or advantage in each case in violation in any material respect of the FCPA and any laws described in clause (ii). (c) Parent and each other Asset Seller Entity hold of its Subsidiaries have all Governmental Authorizations necessary for the lawful to conduct of the Business their respective businesses as presently conducted, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance have any such Governmental Authorizations would not, individually or in the aggregate, reasonably be expected to be material have a Parent Material Adverse Effect. Within the three-year period prior to the Business. Without limiting the generality Agreement Date, Parent has not received any written notice from any Governmental Authority regarding (i) any actual or possible violation of the foregoingany Governmental Authorization, except or any failure to comply in any respect with any term or requirement of any Governmental Authorization or (ii) any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization, in each case other than as would not, individually or in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Seller, each of its and their other agents acting on its or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12have a Parent Material Adverse Effect.

Compliance with Laws; Governmental Authorizations. Solely with respect to the Business, Seller (a) Except as has not had and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller Entities, except for such failures to comply as would not, individually or in the aggregate, reasonably be expected to be material to have a Company Material Adverse Effect, neither the Business. Seller and each Company nor any of its Subsidiaries (i) is, or since December 31, 2011 has been, in violation of any applicable Law nor (ii) has received, at any time since December 31, 2011 any written notice from any Governmental Authority or any other Asset Seller Entity hold all Governmental Authorizations necessary for Person regarding any actual or alleged violation of, or failure on the lawful conduct part of the Business Company or any of its Subsidiaries to comply with, any applicable Law that has not been remedied. Except as presently conducted, has not had and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance would not, individually or in the aggregate, reasonably be expected to be material have a Company Material Adverse Effect, (A) the Company or one of its Subsidiaries holds and maintains in full force and effect all Governmental Authorizations, (B) each of the Company and its Subsidiaries, as applicable, is, and since December 31, 2011 has been, in compliance with all such Governmental Authorizations and (C) neither the Company nor any of its Subsidiaries has received, at any time since December 31, 2011, any written notice from any Governmental Authority or any other Person regarding any actual or alleged violation of, or failure on the part of the Company or its Subsidiaries to comply with, any term or requirement of any such Governmental Authorization that has not been remedied. (b) Neither the Company nor any of its Subsidiaries, nor, to the Business. Without limiting the generality Knowledge of the foregoingCompany, except as would not, individually any Representative of the Company or in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each any of its Subsidiaries, has, directly or indirectly, given, promised, offered or authorized the same, or paid anything of value to any recipient that was, is or would be prohibited under the Foreign Corrupt Practices Act of the United States, or any of the rules or regulations promulgated thereunder. Since December 31, 2011, the Company and its Subsidiaries have conducted their directors, officers and employees business in material compliance with the Foreign Corrupt Practices Act of the United States and, to the Knowledge of Sellerthe Company, each all contracts and arrangements between the Company or any of its Subsidiaries and their any other agents acting on its or their behalf, is and has been since January 1, 2015 Person are in material compliance with all such Laws. (ac) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 5.12 does not relate to compliance with Laws or Governmental Authorizations matters related to the extent relating to Tax Taxes, employee benefit matters, which are the subject of Section 4.08, Intellectual Property matters or environmental matters, which which, except for the representations and warranties in Section 5.6, are the subject of addressed exclusively by Section 4.095.10, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food Section 5.11, Section 5.13 and Drug Laws and Health Care LawsSection 5.16, which are the subject of Section 4.12respectively.

Compliance with Laws; Governmental Authorizations. Solely with respect to the Business4.19.1 Except as shown on Schedule 4.19.1, Seller each Company and each other Asset Seller Entity are, and have been since January 1, 2015, Subsidiary is in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments Laws applicable to the Asset Seller EntitiesCompany and the Subsidiaries or to the conduct of the business or operations of the Companies and the Subsidiaries or the use of their respective properties (including any leased property) and assets, except for such failures to comply non-compliances as would not, individually or in the aggregate, reasonably be expected have a material adverse effect on a Company or Subsidiary, and all Governmental Authorizations which are required for each of the Companies and the Subsidiaries to be operate its business have been issued, except for those the absence of which will not cause any Company or Subsidiary to cease or materially alter any operations presently conducted by such Company or Subsidiary. 4.19.2 Schedule 14.9.2 contains a complete and accurate list of each Governmental Authorization that is held by any Company or Subsidiary which is material to the Business. Seller and each other Asset Seller Entity hold all Governmental Authorizations necessary for the lawful conduct of the Business business of any Company or Subsidiary. Each Governmental Authorization listed in Schedule 4.19.2 is valid and in full force and effect. Except as presently conductedset forth in Schedule 4.19.2: (i) to the Knowledge of Sellers, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, Company or Subsidiary is in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance would not, individually or in the aggregate, reasonably be expected to be material to the Business. Without limiting the generality of the foregoing, except as would not, individually or terms and requirements of each Governmental Authorization identified in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, Schedule 4.19.2; (ii) to the Knowledge of SellerSellers, each no event has occurred that will (with or without notice or lapse of its time) (A) constitute or result directly or indirectly in a violation of or failure to comply with any term or requirement of any Governmental Authorization listed in Schedule 4.19.2, or (B) result directly or indirectly in the revocation, withdrawal, suspension, cancellation, or termination of, or any modification to, any Governmental Authorization listed in Schedule 4.19.2; and (iii) all applications required to have been filed for the renewal of the Governmental Authorizations listed in Schedule 4.19.2 have been duly filed with the appropriate Governmental Bodies, and their all other agents acting on its or their behalf, is and has filings required to have been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder made with respect to the Business. This Section 4.07 does not relate to compliance with Laws or such Governmental Authorizations to have been duly filed with the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12appropriate Governmental Bodies.

Compliance with Laws; Governmental Authorizations. Solely with (a) Except as set forth in Schedule 3.1(19) or where the effect of any such noncompliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: (i) the Corporation (and/or the Vendor, in respect to the Business, Seller and each other Asset Seller Entity are, and have been since January 1, 2015, of Seconded Employees) is in compliance with all stateApplicable Laws (including Environmental Law); and (ii) during the last three years, federalthe Corporation (and/or the Vendor, localin respect of Seconded Employees) has not, national(A) received any written notice from any Governmental Authority regarding any actual or possible violation of, foreign or multinational lawsfailure to comply with, statutesany Applicable Law (including Environmental Law), ordinancesor (B) provided any written notice to any Governmental Authority regarding any violation by Corporation (and/or the Vendor, codes, rules or regulations in respect of Seconded Employees) of any Applicable Law in any material respect (“Laws”including Environmental Law). (b) Except as set forth in Schedule 3.1(19)(b) or Judgments applicable to the Asset Seller Entities, except for such failures to comply as would not, individually or in the aggregate, reasonably be expected to be material to have a Material Adverse Effect: (i) the Business. Seller and each other Asset Seller Entity hold Corporation holds all Governmental Authorizations (including the Governmental Authorizations listed in Schedule 3.1(19)(b)) necessary for to enable the lawful Corporation to conduct of the Business as presently in the manner in which the Business is currently being conducted; (ii) all such Governmental Authorizations are valid and in full force and effect; and (iii) the Corporation is, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015has been, in compliance with all the terms and requirements of such Governmental Authorizations. To the Knowledge of the Vendor, except where no Governmental Authority has threatened to revoke, amend or impose any condition in respect of, or commenced Proceedings to revoke, amend or impose conditions in respect of, any such Governmental Authorizations. There are no outstanding Orders or material notices, deficiency letters, similar communications or requests relating to the failure to hold Corporation (and/or the same or be Vendor, in compliance would notrespect of Seconded Employees) issued by any Governmental Authority, individually or which have been received by the Corporation (and/or the Vendor, in respect of Seconded Employees) and to, the aggregateKnowledge of the Vendor, there are no matters under discussion with any such Governmental Authority, which could reasonably be expected to be material to result in such an Order. The Corporation has not adopted, in the Business. Without limiting last three years, any policies, procedures or board resolutions at the generality written request of any Governmental Authority that restricts the conduct of the foregoingCorporation (including with respect to its capital adequacy, credit or risk management policies or management), nor has the Corporation been advised by any Governmental Authority that such Governmental Authority is contemplating making any such requests, except as would not, individually or in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Seller, each of its and their other agents acting on its or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12have a Material Adverse Effect.

Compliance with Laws; Governmental Authorizations. Solely with respect to the Business, Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”a) or Judgments applicable to the Asset Seller Entities, except Except for such failures to comply as would notmatters that, individually or in the aggregate, have not had or would not reasonably be expected to be material to have a Company Material Adverse Effect, neither the Business. Seller and each other Asset Seller Entity hold all Company nor any of its Subsidiaries (i) is in violation of any applicable Law nor (ii) has received, at any time since December 31, 2010, any written notice from any Governmental Authorizations necessary for Authority regarding any actual or alleged violation of, or failure on the lawful conduct part of the Business as presently conductedCompany or any of its Subsidiaries to comply with, any applicable Law that has not been remedied. This Section 5.12 does not relate to matters related to Taxes, employee benefit matters, intellectual property matters or environmental matters, which are addressed exclusively by Section 5.10, Section 5.11, Section 5.13 and Seller and each other Asset Seller Entity areSection 5.16, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance would notrespectively. (b) Except for matters that, individually or in the aggregate, have not had or would not reasonably be expected to be material to have a Company Material Adverse Effect, (i) the Business. Without limiting the generality Company or one of its Subsidiaries holds and maintains in full force and effect all Governmental Authorizations, (ii) each of the foregoingCompany and its Subsidiaries, except as would notapplicable, individually is in compliance with all such Governmental Authorizations and (iii) neither the Company nor any of its Subsidiaries has received, at any time since December 31, 2010, any written notice from any Governmental Authority regarding any actual or alleged violation of, or failure on the part of the Company or its Subsidiaries to comply with, any term or requirement of any such Governmental Authorization that has not been remedied. (c) To the Knowledge of the Company, neither the Company nor any of its Subsidiaries, nor any of their respective employees (in each case, acting in their capacities as such), has, in the aggregatepast five (5) years, reasonably be expected directly or indirectly through its representatives or any Person authorized to be material act on its behalf, (i) violated any applicable Anti-corruption Laws or (ii) offered, paid, promised to pay, or authorized the Businesspayment of any money, Selleror offered, each gifted, promised to give, or authorized the giving of anything of value, to any Government Official or to any other Asset Seller Person: (A) for the purpose of (1) corruptly or improperly influencing any act or decision of any Government Official in his official capacity; (2) inducing any Government Official to do or omit to do any act in violation of their lawful duties; (3) securing any improper advantage; or (4) inducing any Government Official to use his respective influence with a Governmental Entity and to affect any act or decision of such Governmental Entity in order to, in the case of each of clause (1), (2), (3) or (4) assist the Company or any of its Subsidiaries in obtaining or retaining business for or with, or directing business to, the Company or any of its Subsidiaries; or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage. (d) To the Knowledge of the Company, (i) the Company and their directorsits Subsidiaries have maintained complete and accurate records of payments to any Government Officials, officers in accordance with GAAP, in all material respects, (ii) there have been no false or fictitious entries made in the books and employees andrecords of the Company or its Subsidiaries relating to any unlawful offer, payment, promise to pay, or authorization of the payment of any money, or unlawful offer, gift, promise to give, or authorization of the giving of anything of value, including any bribe, kickback or other illegal or improper payment, in each case to any Government Official, and (iii) the Company and its Subsidiaries have not established or maintained a secret or unrecorded fund with respect to payments to any Government Official. (e) None of the Company or any Company Subsidiaries or, to the Knowledge of Sellerthe Company, each any of its and their other agents acting on its or their behalf, is and respective employees (acting in their capacities as such) has been since January 1convicted of violating any Anti-corruption Laws or, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations Knowledge of the FDA Company, subjected to any investigation or proceeding by a Governmental Entity for, in each case, potential corruption, fraud or violation of any applicable Anti-corruption Laws. (f) To the Knowledge of the Company, neither the Company nor any of its Subsidiaries, nor any of their respective representatives (in each case, acting in their capacities as representatives of the Company or any comparable Healthcare Regulatory Authority having jurisdiction over of its Subsidiaries), have remained in material compliance for the Asset Seller Entities past five (5) years with the applicable export control Laws, trade or (ii) matters the subject of Food and Drug economic sanctions Laws and Health Care anti-boycott Laws, which are of the subject United States, including: The Arms Export Control Act (22 U.S.C.A. § 2278), the Export Administration Act (50 U.S.C. App. §§ 2401 – 420), the International Traffic in Arms Regulations (22 C.F.R. 120 – 30), the Export Administration Regulations (15 C.F.R. 730 et seq.), the Office of Section 4.12Foreign Assets Control Regulations (31 C.F.R. Chapter V), the Customs Laws of the United States (19 U.S.C. § 1 et seq.), the International Emergency Economic Powers Act (50 U.S.C. § 1701 – 706), the U.S. Commerce Department anti-boycott regulations (15 C.F.R. 560), the U.S. Treasury Department anti-boycott requirements (26 U.S.C. § 999) or any other export control regulations issued by the agencies listed in Part 730 of the Export Administration Regulations.

Compliance with Laws; Governmental Authorizations. Solely with respect to the Business, Seller (a) The Acquired Companies hold and each other Asset Seller Entity are, maintain in full force and have been since January 1, 2015, in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller Entities, except for such failures to comply as would not, individually or in the aggregate, reasonably be expected to be material to the Business. Seller and each other Asset Seller Entity hold effect all Governmental Authorizations (including, the insurance licenses from insurance regulatory authorities set forth on Section 3.14(a) of the Seller Disclosure Schedule) necessary for the lawful ownership and conduct of the Business as presently conducted, and Seller and respective businesses of the Acquired Companies in each other Asset Seller Entity are, and have been since January 1, 2015, of the jurisdictions in compliance with all such Governmental Authorizations, except where which the failure to hold the same Acquired Companies conduct or be in compliance would not, individually or operate their respective businesses substantially in the aggregate, reasonably be expected to be material to the Business. Without limiting the generality manner conducted as of the foregoingdate of this Agreement, except as would not, individually or in the aggregate, be expected to have a Material Adverse Effect. None of the Acquired Companies conducts any business or underwrites insurance or reinsurance in any non-U.S. jurisdiction that requires any license or approval for such business to be conducted, except as would not, individually or in the aggregate, be expected to have a Material Adverse Effect. (i) Each of the Acquired Companies, is, and at all times since January 1, 2009, has been, in material compliance with all of the terms and requirements of each such Governmental Authorization referred to in Section 3.14(a), (ii) to Seller’s Knowledge, with respect to the Governmental Authorizations of the Acquired Companies, neither the Acquired Companies nor its Affiliates, has received at any time since January 1, 2009, any written notice (except for notices that are subject to cure) from any Government Entity regarding (A) any actual or alleged violation of, or failure to comply with, any material term or material requirement of such material Governmental Authorization or (B) any actual or proposed revocation, withdrawal, suspension, cancellation, termination of, or modification to such material Governmental Authorization, and (iii) all material filings required to have been made with respect to each such material Governmental Authorization have been duly made on a timely basis with the appropriate Government Entity. (c) (i) Each of the Acquired Companies is, and at all times since January 1, 2009 has been, in compliance with all applicable Laws, except as would not, individually or in the aggregate, be expected to have a Material Adverse Effect, (ii) to Seller’s Knowledge, no event has occurred or circumstance exists that could reasonably be expected to be (with or without the giving of notice or the lapse of time or both) constitute or result in a material violation by any of the Acquired Companies, or a material failure on the part of any of the Acquired Companies to comply with, all applicable Laws and (iii) to Seller’s Knowledge, neither the BusinessAcquired Companies nor its Affiliates has received, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Seller, each of its and their other agents acting on its or their behalf, is and has been at any time since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) 2009, any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws written notice or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09other written communication from any Government Entity or any other Person regarding any actual or alleged violation of, or compliance with (i) failure on the rules or regulations part of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Acquired Companies to comply with, all applicable Laws, which are the subject of Section 4.12.

Compliance with Laws; Governmental Authorizations. Solely (a) The Company and each of its Subsidiaries is and, since July 31, 2013, has been in compliance with the Laws applicable to each of the Company and its Subsidiaries, in each case except to the extent that the failure to comply therewith would not reasonably be expected to have a Company Material Adverse Effect. The Company and each of its Subsidiaries is and, since July 31, 2013, has been in material compliance with all Anti-Corruption Laws. Since July 31, 2013, neither the Company nor any of its Subsidiaries has received any written notices of violation with respect to the Business, Seller and each other Asset Seller Entity are, and have been since January 1, 2015any Laws applicable to it, in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller Entities, except for such failures to comply each case other than as would not, individually or in the aggregate, reasonably be expected to be material have a Company Material Adverse Effect. (b) Without limiting the generality of Section 2.5(a), to the BusinessKnowledge of the Company, the Company, its Subsidiaries and/or their officers, directors, employees and agents are in compliance with and, since July 31, 2013, have complied in all material respects with: (i) the provisions of the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), as if its foreign payments provisions were fully applicable to the Company, its Subsidiaries and such owners, officers, directors, employees, and agents, and (ii) Anti-Corruption Laws of each jurisdiction in which the Company and its Subsidiaries operate or have operated and in which any agent thereof is conducting or has conducted business involving the Company. Seller Since July 31, 2013, to the Knowledge of the Company, the Company, its Subsidiaries and/or their respective officers, directors, employees and agents have not paid, offered or promised to pay, or authorized or ratified the payment, directly or indirectly, of any monies or anything of value to any national, provincial, municipal or other Government Official or any political party or candidate for political office for the purpose of corruptly influencing any act or decision of such official or of the government to obtain or retain business, or direct business to any person or to secure any other improper benefit or advantage in each case in violation in any material respect of the FCPA and any laws described in clause (ii). (c) The Company and its Subsidiaries (i) have instituted policies and procedures designed to ensure compliance with the FCPA and other Anti-Corruption Laws in each jurisdiction in which the Company and its Subsidiaries operate and (ii) have maintained and will maintain such policies and procedures in force. (d) Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any director, manager or employee of the Company or any of its Subsidiaries (in his or her capacity as a director, manager or employee of the Company or any of its Subsidiaries), are, and since July 31, 2013, have been, subject to any material, individually or in the aggregate, actual, pending, or, to the Knowledge of the Company, threatened civil, criminal, or administrative actions, suits, demands, claims, hearings, notices of violation, investigations, proceedings, demand letters, settlements, or enforcement actions, or made any voluntary disclosures to any Governmental Authority, involving the Company or any of its Subsidiaries relating to the FCPA, or any other anti-bribery, anti-corruption or anti-money laundering laws, except as would not reasonably be likely to have, individually or in the aggregate, a Company Material Adverse Effect. (e) The Company and each other Asset Seller Entity hold of its Subsidiaries have all Governmental Authorizations necessary for the lawful to conduct of the Business their respective businesses as presently conducted, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance have any such Governmental Authorizations would not, individually or in the aggregate, reasonably be expected to be material have a Company Material Adverse Effect. Since July 31, 2013, the Company has not received any written notice from any Governmental Authority regarding (i) any actual or possible violation of any Governmental Authorization, or any failure to the Business. Without limiting the generality comply in any respect with any term or requirement of the foregoingany Governmental Authorization or (ii) any actual or possible revocation, except withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization, in each case other than as would not, individually or in the aggregate, reasonably be expected to be material to the Business, Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Seller, each of its and their other agents acting on its or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12have a Company Material Adverse Effect.

Compliance with Laws; Governmental Authorizations. Solely with respect (a) The Company and each of its Subsidiaries is and, for the two years prior to the BusinessAgreement Date, Seller and each other Asset Seller Entity are, and have has been since January 1, 2015, in compliance with all state, federal, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments the Laws applicable to each of the Asset Seller EntitiesCompany and its Subsidiaries, (other than Anti-Corruption Laws, Sanctions and Laws of the United States relating to exports), in each case, except for such failures to the extent that the failure to comply as therewith have not had and would notnot reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Within the two-year period prior to the Agreement Date, neither the Company nor any of its Subsidiaries has received any written notices of violation with respect to any Laws applicable to it, in each case other than as have not had and would not reasonably be expected to be material to the Business. Seller and each other Asset Seller Entity hold all Governmental Authorizations necessary for the lawful conduct of the Business as presently conducted, and Seller and each other Asset Seller Entity are, and have been since January 1, 2015, in compliance with all such Governmental Authorizations, except where the failure to hold the same or be in compliance would nothave, individually or in the aggregate, a Company Material Adverse Effect. (b) Except as would not reasonably be expected to be material to the Business. Without limiting the generality of the foregoing, except as would nothave, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries is and, for the five years prior to the Agreement Date, has been in compliance with the Anti-Corruption Laws, Sanctions and all Laws of the United States relating to exports, in each case applicable to each of the Company and its Subsidiaries. Except as would not reasonably be expected to be material have, individually or in the aggregate, a Company Material Adverse Effect, within the five-year period prior to the BusinessAgreement Date, Sellerneither the Company nor any of its Subsidiaries has received any written notices of violations with respect to any Anti-Corruption Laws, each other Asset Seller Entity Sanctions or Laws of the United States relating to exports. (c) The Company and each of its Subsidiaries have all Governmental Authorizations necessary to conduct their respective businesses as presently conducted, except where the failure to have any such Governmental Authorizations have not had and their directorswould not reasonably be expected to have, officers and employees andindividually or in the aggregate, a Company Material Adverse Effect. Within the two-year period prior to the Knowledge of SellerAgreement Date, each of its and their other agents acting on its or their behalf, is and the Company has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) not received any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or written notice from any Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with Authority regarding (i) the rules any actual or regulations possible material violation of the FDA any Governmental Authorization, or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities failure to comply in any respect with any term or requirement of any Governmental Authorization or (ii) matters any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization, in each case other than as have not had and would not reasonably be expected to have, individually or in the subject aggregate, a Company Material Adverse Effect. The Company and its Subsidiaries comply with the terms of Food all Governmental Authorizations, and Drug Laws no suspension or cancellation of any of the Governmental Authorization is pending or, to the knowledge of the Company, threatened, except for such noncompliance, suspensions or cancellations that have not had and Health Care Lawswould not reasonably be expected to have, which are individually or in the subject of Section 4.12aggregate, a Company Material Adverse Effect.

Compliance with Laws; Governmental Authorizations. Solely (a) Except as set forth in Part 3.10(a) of the Disclosure Letter or where the effect of any such noncompliance would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect: (i) the Company and its Subsidiaries are in compliance with respect to the Business, Seller all applicable Laws; and each other Asset Seller Entity are, and have been (ii) since January 1, 20152021, in compliance with all stateneither the Company nor any of its Subsidiaries has, federal(A) received any written notice or, local, national, foreign or multinational laws, statutes, ordinances, codes, rules or regulations (“Laws”) or Judgments applicable to the Asset Seller EntitiesKnowledge of the Company, except for such failures other communication from any Governmental Authority regarding any actual or alleged violation of, or failure to comply with, any applicable Law, or (B) provided any written notice to any Governmental Authority regarding any violation by the Company or any of its Subsidiaries of any Law, and no such violation or failure to comply remains outstanding or unresolved as of the date of this Agreement. (b) Except as would not, individually or in the aggregate, reasonably be expected to be material to have a Company Material Adverse Effect: (i) the Business. Seller Company and each other Asset Seller Entity its Subsidiaries hold all Governmental Authorizations necessary for to enable the lawful Company and its Subsidiaries to conduct of their respective businesses in the Business as presently manner in which such businesses are currently being conducted, ; (ii) all such Governmental Authorizations are valid and Seller in full force and each other Asset Seller Entity effect; and (iii) the Company and its Subsidiaries are, and have been since January 1, 2015been, in compliance with all the terms and requirements of such Governmental Authorizations, except where . (c) With respect to the failure to hold the same or be in compliance would not, individually or Company’s Government Contracts: (i) in the aggregatepast six (6) years, reasonably be expected the Company has complied in all material respects with all applicable Laws pertaining to be material all Government Contracts (and proposals and quotations submitted that led to the Business. Without limiting formation of such Government Contracts), including but not limited to: the generality Truthful Cost and Pricing Data Statute, the Anti-Kickback Act of 1986, the foregoingProcurement Integrity Act, except as would notthe Buy American Act, individually or the Trade Agreements Act, the Wxxxx-Xxxxx Public Contracts Act; (ii) in the aggregatepast three (3) years, reasonably be expected the Company has not received a subpoena, search warrant, or civil investigative demand with respect to be material any Government Contract; and (iii) in the past three (3) years, the Company has not made a written disclosure with respect to any alleged, potential, or actual irregularity, misstatement, noncompliance, or omission arising under or relating to a Government Contract (or proposal or quotation that led to the Businessformation of a Government Contract), Seller, each other Asset Seller Entity and each of its and their directors, officers and employees and, to the Knowledge of Sellerthe Company, each no facts and circumstances exist that would require a mandatory disclosure pursuant to Section 52.203-13, Title 48, Code of its and their other agents acting on its or their behalf, is and has been since January 1, 2015 in compliance with (a) the Foreign Corrupt Practices Act of 1977 and (b) any rules and regulations promulgated thereunder with respect to the Business. This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12Federal Regulations.