Common use of Compliance with Laws and Court Orders Clause in Contracts

Compliance with Laws and Court Orders. (a) The Company and each of its Subsidiaries is, and since March 31, 2011 has been, in compliance with, has not been charged with or given written notice by any Governmental Authority of any violation of and, to the knowledge of the Company, is not under investigation with respect to and has not been threatened to be charged with any violation of, Applicable Law or the terms of any of its Permits, except for failures to comply or violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company or any of its Subsidiaries, or any of their respective assets or properties, that has had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or that prevents, enjoins, alters or materially delays the Merger or any of the other transactions contemplated hereby. (b) None of the Company, any of its Subsidiaries, or any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalf, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment of any money, property, gift or anything of value, directly or indirectly (i) to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office to influence official action, or (ii) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has conducted its businesses in compliance in all material respects with the FCPA, the UK Bribery Act and any other anti-corruption or anti-bribery Applicable Law, and the Company has instituted and maintained policies and procedures designed to cause each such Person to comply with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons). (c) Neither the Company, any of its Subsidiaries or any of their respective directors, officers or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, is, or is owned or controlled by a Person that is (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and its Affiliates (i) have not engaged in, and are not now engaged in, directly or indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (d) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice of any violation of and, to the Company’s knowledge, are not under investigation with respect to and have not been threatened to be charged with any violation of, IT AR or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (e) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, (i) each product that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or on behalf of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdiction.

Compliance with Laws and Court Orders. (a) The Neither the Company and each of its Subsidiaries isnor any Subsidiary is in violation of, and has not since March December 31, 2011 has been2009 violated, in compliance with, has not been charged with or given written notice by any Governmental Authority of any violation of and, and to the knowledge of the Company, Seller is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of, any Applicable Law or the terms of any of its Permits, except for failures to comply or such violations that have not had and would not reasonably be expected to havenot, individually or in the aggregate, have a Company Material Adverse EffectEffect on the Company and the Subsidiaries taken as a whole. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company or any of its Subsidiaries, or any of their respective assets or properties, Subsidiaries that has had or would reasonably be expected to have, individually or in be material to the aggregate, Company and its Subsidiaries taken as a Company Material Adverse Effect whole or that preventsin any manner seeks to prevent, enjoinsenjoin, alters alter or materially delays delay the Merger or any consummation of the other transactions contemplated herebyby this Agreement. (b) None of Neither the Company, Company nor any of its SubsidiariesSubsidiaries or Affiliates, nor any director, officer, or employee, nor, to Seller’s knowledge, any agent or representative of the Company or of any of their respective directors, officers its Subsidiaries or employees, or any of their respective consultants, agents or other Persons acting for or on their behalfAffiliates, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment or giving of any money, property, gift gifts or anything else of value, directly or indirectly value to (i) to any “foreign government official” (as such term is defined in the FCPA) including any officer or employee of a government or government-owned or controlled entity or of a public international organization, or any foreign person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official thereof or any candidate for foreign political office office) in order to influence official action, or (ii) any person (whether or not a government official) to influence that person to act in breach of a duty of good faith, impartiality or trust (“acting improperly”), to reward the person for acting improperly, or in circumstances where the recipient would be acting improperly by receiving the thing of value; or (iii) any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign government official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has and its Subsidiaries and Affiliates have conducted its their businesses in compliance in with all material respects with the FCPA, the UK Bribery Act and any other applicable anti-corruption or anti-bribery Applicable Lawlaws, and including the Company has Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff),and have instituted and maintained maintain and will continue to maintain policies and procedures designed to cause each promote and achieve compliance with such Person to comply laws and with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons)representation and warranty contained herein. (c) Neither the Company, Company nor any of its Subsidiaries or Affiliates, nor any of their respective directorsdirectors or officers, officers is an individual or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, entity that is, or is owned or controlled by a Person that is is: (Ai) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State), the United Nations Security Council, the European Union Union, or other relevant sanctions authority (collectively, “Sanctions”), or (Bii) located, organized, a citizen of, organized or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The . (d) For the past five (5) years, neither the Company and nor any of its Subsidiaries or Affiliates (i) have not has engaged in, and are not or is now engaged in, directly or or, to the knowledge of the Company, indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, which such company is required to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectcomply. (de) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries and Affiliates are, and for the past five (5) years have been been, in compliance with and with, and, to Seller’s knowledge, have not been given notice of any violation of and, to the Company’s knowledge, are not penalized for or under investigation with respect to and have not been threatened to be charged with or given notice of any violation of, IT AR any applicable Sanctions or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectexport controls laws. (e) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, (i) each product that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or on behalf of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdiction.

Compliance with Laws and Court Orders. (a) The Company and each Neither Buyer nor any subsidiary of its Subsidiaries isBuyer is in violation of, and has not since March December 31, 2011 has been2009 violated, in compliance with, has not been charged with or given written notice by any Governmental Authority of any violation of and, and to the knowledge of the Company, Buyer is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of, any Applicable Law or the terms of any of its Permits, except for failures to comply or such violations that have not had and would not reasonably be expected to havenot, individually or in the aggregate, have a Company Material Adverse EffectEffect on Buyer and its subsidiaries taken as a whole. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company Buyer or any of its Subsidiaries, or any of their respective assets or properties, subsidiaries that has had or would reasonably be expected to have, individually or in the aggregate, be material to Buyer and its subsidiaries taken as a Company Material Adverse Effect whole or that preventsin any material manner seeks to prevent, enjoinsenjoin, alters alter or materially delays delay the Merger or any consummation of the other transactions contemplated herebyby this Agreement. (b) None of the Company, Neither Buyer nor any of its Subsidiariessubsidiaries, nor any director, officer, or employee, nor, to Buyer’s knowledge, any agent or representative of Buyer or of any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalfits subsidiaries, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment or giving of any money, property, gift gifts or anything else of value, directly or indirectly value to (iii) to any “foreign government official” (as such term is defined in the FCPA) including any officer or employee of a government or government-owned or controlled entity or of a public international organization, or any foreign person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official thereof or any candidate for foreign political office office) in order to influence official action, (iii) any person (whether or not a government official) to influence that person to act in breach of a duty of good faith, impartiality or trust (“acting improperly”), to reward the person for acting improperly, or in circumstances where the recipient would be acting improperly by receiving the thing of value; or (iiiv) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign government official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has Buyer and its subsidiaries have conducted its their businesses in compliance in with all material respects with the FCPA, the UK Bribery Act and any other applicable anti-corruption or anti-bribery Applicable Lawlaws, and including the Company has Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff),and have instituted and maintained maintain and will continue to maintain policies and procedures designed to cause each promote and achieve compliance with such Person to comply laws and with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons)representation and warranty contained herein. (c) Neither the Company, Buyer nor any of its Subsidiaries or subsidiaries, nor any of their respective directorsdirectors or officers, officers is an individual or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, entity that is, or is owned or controlled by a Person that is is: (Ai) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (Bii) located, organized, a citizen of, organized or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and . (d) For the past five (5) years, neither Buyer nor any of its Affiliates (i) have not subsidiaries has engaged in, and are not or is now engaged in, directly or to the knowledge of Buyer indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, which such company is required to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectcomply. (de) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company Buyer and its Subsidiaries subsidiaries and Affiliates are, and for the past five (5) years have been been, in compliance with with, and to Buyer’s knowledge have not been given notice of any violation of and, to the Company’s knowledge, are not penalized for or under investigation with respect to and have not been threatened to be charged with or given notice of any violation of, IT AR any applicable Sanctions or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectexport controls law. (e) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, (i) each product that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or on behalf of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdiction.

Compliance with Laws and Court Orders. (a) The Company and each of its Subsidiaries isSubsidiaries, and each of the assets and properties (including the Real Property) of the Company and each of the Subsidiaries, is and since March 31, 2011 the Applicable Date has been, been in compliance with, has not been charged with or given written notice by any Governmental Authority of any violation of and, and to the knowledge of the Company, Company is not under investigation with respect to and has not been threatened in writing to be charged with or given written notice of any violation of, any Applicable Law or the terms of any of its PermitsLaw, except for failures to comply comply, investigations or violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. There is no judgment. (b) Since the Applicable Date, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against neither the Company or nor any of its Subsidiaries, nor any director, officer, or any of their respective assets or propertiesemployee thereof, that has had or would reasonably be expected nor, to have, individually or in the aggregate, a Company Material Adverse Effect or that prevents, enjoins, alters or materially delays the Merger or any of the other transactions contemplated hereby. (b) None knowledge of the Company, any agent or representative of the Company or of any of its Subsidiaries, or any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalf, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment or giving of any money, property, gift gifts or anything else of value, value directly or indirectly (i) through an intermediary to any “foreign government official” (as such term is defined in the FCPA) including any officer or employee of a government or government-owned or controlled entity or of a public international organization, or any foreign person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official thereof or any candidate for foreign political office to influence official action, or (iioffice) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign official in order to influence or reward official action in violation of the Foreign Corrupt Practices Act, except as would not reasonably be expected to have, individually or to any person to influence such person to act improperly or reward in the person for doing soaggregate, a Company Material Adverse Effect. The Company has and its Subsidiaries and Affiliates have conducted its their businesses in compliance in with all material respects with the FCPA, the UK Bribery Act and any other applicable anti-corruption or anti-bribery Applicable Lawlaws, including, without limitation, the Foreign Corrupt Practices Act, and the Company has have instituted and maintained maintain and will continue to maintain policies and procedures that are designed to cause each provide reasonable assurance of compliance with such Person laws, except as would not reasonably be expected to comply with all such Applicable Law (buthave, individually or in each casethe aggregate, only to the extent such Applicable Law is applicable to the a Company or such Persons)Material Adverse Effect. (c) Neither the Company, Company nor any of its Subsidiaries or Subsidiaries, nor any of their respective directors, officers or employees, ornor, to the knowledge of the Company as Company, any agents or representatives of the date hereof, Company or any of their respective consultants, agents or other Persons acting for or on their behalfits Subsidiaries, is, or is 50% or more owned or controlled by a Person one or more Persons that is are: (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union Union, or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, organized or resident in a country or territory that is the subject of Sanctions (including including, without limitation, Crimea, Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The , except as would not reasonably be expected to have, individually or in the aggregate, a Company and Material Adverse Effect. (d) Since the Applicable Date, neither the Company nor any of its Affiliates (i) have not engaged in, and are not now Subsidiaries has engaged in, directly or indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (d) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice of any violation of and, to the Company’s knowledge, are not under investigation with respect to and have not been threatened to be charged with any violation of, IT AR or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (e) Except as would not reasonably be expected to beSince the Applicable Date, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, (i) each product that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or on behalf of the Company or its Subsidiaries, has Subsidiaries have been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Lawswith, (ii) none of the Company, any of its Subsidiaries orand, to the knowledge of the Company, any Person that manufactureshave not been penalized for, co-develops under investigation with respect to and have not been threatened in writing to be charged with or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received given written notice from of any Health Authority contesting the premarket clearance or approval violation of, the uses of any applicable Sanctions or the labeling and promotion of any such productexport controls laws, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that except as would not reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraudhave, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) individually or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdictionaggregate, a Company Material Adverse Effect.

Compliance with Laws and Court Orders. (a) The Each Group Company is not, and each of Seller Group and its Subsidiaries is, Affiliates with respect to the Group Company Assets and since March 31, 2011 has beenthe Business is not, in compliance withmaterial violation of, has not been charged with or given written notice by any Governmental Authority of any violation of andsince its incorporation violated, and to the best knowledge of the CompanySeller Group, is not under investigation with respect to and has not been threatened in writing to be charged with or given notice of any material violation of, any Applicable Law or the terms of any of its Permits, except for failures to comply or violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse EffectLaw. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the any Group Company or any of Seller Group or its Subsidiaries, Affiliates with respect to any Group Company Assets or any of their respective assets or properties, the Business that has had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or that prevents, enjoins, alters or materially delays the Merger or any of the other transactions contemplated hereby. (b) None of the Company, any of its Subsidiaries, or any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalf, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment of any money, property, gift or anything of value, directly or indirectly (i) to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office to influence official action, or (ii) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has conducted its businesses in compliance in all material respects with the FCPA, the UK Bribery Act and any other anti-corruption or anti-bribery Applicable Law, and the Company has instituted and maintained policies and procedures designed to cause each such Person to comply with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons). (c) Neither the Company, any of its Subsidiaries or any of their respective directors, officers or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, is, or is owned or controlled by a Person that is (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and its Affiliates (i) have not engaged in, and are not now engaged in, directly or indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (d) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice of any violation of and, to the Company’s knowledge, are not under investigation with respect to and have not been threatened to be charged with any violation of, IT AR or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (e) Except as would not reasonably be expected to be, individually or in the aggregate, material or that in any manner seeks to prevent, enjoin, alter or materially delay the consummation of the transactions contemplated by the Transaction Documents. (b) None of the Seller Group, their Affiliates and to the Company and its Subsidiariesbest knowledge of Seller Group, taken as a wholenone of their respective directors, (i) each product that is subject to officers, agents, employees, or any Health Lawother Persons, that is developed, manufactured, tested associated with or distributed or marketed by acting for or on behalf of such Person (“Covered Persons”), has, with respect to the Group Companies, the Group Company Assets or its Subsidiariesthe Business, has been and is being developeddirectly or indirectly (i) made or promised to make any contribution, manufacturedgift, testedbribe, distributed rebate, payoff, influence payment, kickback, or marketed other payment to any Person, regardless of form, whether in compliance with all applicable requirements under money, property, or services (A) to obtain favorable treatment in securing business, (B) to pay for favorable treatment for business secured or (C) to obtain special concessions or for special concessions already obtained, for or in respect of the Health LawsBusiness in violation of any Applicable Law, (ii) none of the Companymade or promised to make any direct or indirect unlawful payment to any official, any of its Subsidiaries or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (public official or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance other governmental official or approval of, the uses of employee or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31established or maintained any fund or asset that has not been recorded in the books and records. (c) No Covered Person has been the subject of any investigation, 2011inquiry or enforcement proceedings by any governmental, neither the Company nor administrative or regulatory body or any of its Subsidiaries have received customer regarding any notices of inspectional observations offence under any all Applicable Law relating to anti-bribery, anti-corruption, anti-money laundering, record keeping and internal control laws applicable to any such Person (including those reported on Form FDA 483“Anti-Corruption Laws”), warning lettersand no such investigation, action letters inquiry or untitled lettersproceedings have been threatened or are pending, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, there are no circumstances likely to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement give rise to any Health Authority such investigation, inquiry or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdictionproceedings.

Compliance with Laws and Court Orders. (a) The Neither the Company and each nor any Subsidiary of its Subsidiaries the Company is, and or since March 31January 1, 2011 2014 has been, in compliance conflict with, has not been charged with or given written notice by in default, breach or violation of any Applicable Law or any permit, license, or other authorization of any Governmental Authority used in the operation of any violation of and, to the knowledge of the Company, is not under investigation with respect to and has not been threatened to be charged with any violation of, Applicable Law or the terms of any of its Permitssuch Person’s business as currently conducted, except for failures to comply or violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company or any of its Subsidiaries, or any of their respective assets or properties, that has had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or that prevents, enjoins, alters or materially delays the Merger or any of the other transactions contemplated hereby. (b) None of on the Company, any of its Subsidiaries, or any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalf, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment of any money, property, gift or anything of value, directly or indirectly (i) to any “foreign official” (. Except as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office to influence official action, or (ii) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has conducted its businesses in compliance in all material respects with the FCPA, the UK Bribery Act and any other anti-corruption or anti-bribery Applicable Law, and the Company has instituted and maintained policies and procedures designed to cause each such Person to comply with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons). (c) Neither the Company, any of its Subsidiaries or any of their respective directors, officers or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, is, or is owned or controlled by a Person that is (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and its Affiliates (i) have not engaged in, and are not now engaged in, directly or indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, to the Company’s knowledge, is not under investigation with respect to had and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (d) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice of any violation of and, to Effect on the Company’s knowledge, are not under investigation with respect to and have not none of the Company or any Subsidiary of the Company has been threatened to be charged with or given notice by any Governmental Authority of, and to the knowledge of the Company, none of the Company or any Subsidiary of the Company is under investigation by any Governmental Authority with respect to, any violation of, IT AR or EARof any such Applicable Law. (b) Without limiting the foregoing, except where the failure to be in compliance as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Effect on the Company, neither the Company, any of its Subsidiaries nor any director or officer thereof nor, to the Company’s knowledge, any employee or agent of the Company or any of its Subsidiaries has (ei) directly or indirectly, used any funds for unlawful contributions, gifts, entertainment or other unlawful payments relating to political activity; (ii) directly or indirectly used, given, offered, promised or authorized to give, any money or thing of value to any foreign or domestic government official or to any foreign or domestic political party or campaign (collectively, “Government Official”), for the purpose of influencing an act or decision of the Government Official, or inducing the Government Official to use his or her influence or position to affect any government act or decision to obtain or retain business of the Company or any of its Subsidiaries, in each case of (i) or (ii) that would violate the Foreign Corrupt Practices Act of 1977, as amended or any other Applicable Law; or (iii) directly or indirectly made any unlawful payment. Except as has not had and would not reasonably be expected to behave, individually or in the aggregate, material to a Material Adverse Effect on the Company, all books and records of the Company and its SubsidiariesSubsidiaries accurately and fairly reflect, taken as a wholein reasonable detail, (i) each product that is subject to any Health Lawall transactions and dispositions of funds or assets, that is developed, manufactured, tested and there have been no false or distributed fictitious entries made in the books or marketed by or on behalf records of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries orrelating to any illegal payment or secret or unrecorded fund, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters has established or untitled letters, and (iv) none of the Company, any of its Subsidiaries maintained a secret or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdictionunrecorded fund.

Compliance with Laws and Court Orders. (a) The Company and each Neither Buyer nor any subsidiary of its Subsidiaries isBuyer is in violation of, and has not since March December 31, 2011 has been2009 violated, in compliance with, has not been charged with or given written notice by any Governmental Authority of any violation of and, and to the knowledge of the Company, Buyer is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of, any Applicable Law or the terms of any of its Permits, except for failures to comply or such violations that have not had and would not reasonably be expected to havenot, individually or in the aggregate, have a Company Material Adverse EffectEffect on Buyer and its subsidiaries taken as a whole. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company Buyer or any of its Subsidiaries, or any of their respective assets or properties, subsidiaries that has had or would reasonably be expected to have, individually or in the aggregate, be material to Buyer and its subsidiaries taken as a Company Material Adverse Effect whole or that preventsin any material manner seeks to prevent, enjoinsenjoin, alters alter or materially delays delay the Merger or any consummation of the other transactions contemplated herebyby this Agreement. (b) None of the Company, Neither Buyer nor any of its Subsidiariessubsidiaries, nor any director, officer, or employee, nor, to Buyer’s knowledge, any agent or representative of Buyer or of any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalfits subsidiaries, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment or giving of any money, property, gift gifts or anything else of value, directly or indirectly value to (i) to any “foreign government official” (as such term is defined in the FCPA) including any officer or employee of a government or government-owned or controlled entity or of a public international organization, or any foreign person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official thereof or any candidate for foreign political office office) in order to influence official action, or (ii) to any person while knowing (whether or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to not a foreign official in order government official) to influence or reward official action or to any person to influence such that person to act improperly in breach of a duty of good faith, impartiality or trust (“acting improperly”), to reward the person for doing so. The Company has conducted its businesses in compliance in all material respects with the FCPA, the UK Bribery Act and any other anti-corruption or anti-bribery Applicable Law, and the Company has instituted and maintained policies and procedures designed to cause each such Person to comply with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons). (c) Neither the Company, any of its Subsidiaries or any of their respective directors, officers or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, is, or is owned or controlled by a Person that is (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and its Affiliates (i) have not engaged in, and are not now engaged in, directly or indirectly, any dealings or transactions with any Personimproperly, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except circumstances where the failure to recipient would be in compliance would not reasonably be expected to have, individually or in acting improperly by receiving the aggregate, a Company Material Adverse Effect. (d) The Company is registered with DDTC as a manufacturer thing of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice of any violation of and, to the Company’s knowledge, are not under investigation with respect to and have not been threatened to be charged with any violation of, IT AR or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (e) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, (i) each product that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or on behalf of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries value; or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdiction.

Compliance with Laws and Court Orders. (a) The Company and each of its Subsidiaries isCompany, and since March 31April 11, 2011 2012, has been, been in compliance with, has not been charged with or given written notice by any Governmental Authority of any violation of and, to the knowledge Knowledge of the Company, is not under investigation with respect to and has not been threatened to be charged with any violation of, Applicable Law or the terms of any of its Permits, except for failures to comply or violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company or any of its Subsidiaries, or any of their respective assets or properties, that has had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or that prevents, enjoins, alters or materially delays the Merger or any of the other transactions contemplated hereby. (b) None of the Company, any of its Subsidiaries, or any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalf, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment of any money, property, gift or anything of value, directly or indirectly (i) to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office to influence official action, or (ii) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has conducted its businesses in compliance in all material respects with the FCPA, the UK Bribery Act and any other anti-corruption or anti-bribery Applicable Law, and the Company has instituted and maintained policies and procedures designed to cause each such Person to comply with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons). (c) Neither the Company, any of its Subsidiaries or any of their respective directors, officers or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, is, or is owned or controlled by a Person that is (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and its Affiliates (i) have not engaged in, and are not now engaged in, directly or indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, andany applicable Law or Order. The Company holds all governmental licenses, authorizations, permits, consents, approvals, variances, exemptions and orders necessary for the operation of the businesses of the Company, taken as a whole (the “Company Permits”). The Company is in compliance with the terms of the Company Permits. (b) Without limitation of Section 3.5(a), to the Knowledge of the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where (i) neither the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (d) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice controlled Affiliates (which, for all purposes of this Section 3.5(b), shall be deemed to include the entities, nor any violation of andits or their directors or officers is listed on the Specially Designated Nationals and Blocked Person list or other similar lists maintained by the Office of Foreign Assets Control, by the United States Department of the Treasury or pursuant to the Company’s knowledgeexecutive orders, are not under investigation with respect to and have not been threatened to be charged with any violation of, IT AR or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (eii) Except as would not reasonably be expected to be, individually or in the aggregate, material to neither the Company and its SubsidiariesSubsidiaries and controlled Affiliates, taken as a wholenor any of its or their directors, officers, employees, agents or other Persons acting on the Company’s or any Company Subsidiary’s behalf (iA) each product has taken, or caused to be taken, directly or indirectly, any action that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or on behalf of would cause the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material be in violation of any Health Anti-Corruption Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed corruptly made, promised, offered or authorized, or has caused or authorized any actconsultants, made joint venture partners or representatives corruptly to make, promise or offer, any statement payment or failed transfer of anything of value, directly or indirectly, to make any statement that would reasonably be expected to provide a basis official, employee or agent of any Governmental Entity for the FDA purpose of (1) influencing such Person to invoke take any action or decision or to omit to take any action, in his or her official capacity, (2) inducing such Person to use his or her influence with a Governmental Entity to affect any act or decision of a Governmental Entity, or (3) securing any improper advantage; and each of it and each of its policy controlled Affiliates complies with and implements internal compliance policies with respect to applicable Anti-Corruption Laws. As used in this Section 3.5(b), the term “FraudAnti-Corruption Laws” means each Law, Untrue Statements of Material Factsregulation, Briberytreaty or convention relating to anti-money laundering, and Illegal Gratuities”anti-terrorism financing, set forth in 56 Fed. Reg. 46191 (September 10anti-bribery, 1991) anti-corruption or for any other Governmental Authority to invoke any similar policymatters, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of including the Food, Drug and Cosmetic Foreign Corrupt Practices Act of 1938 (21 U.S.C. § 335a) or any other Health Law1977, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdictionas amended.

Compliance with Laws and Court Orders. (a) The Company and each of its Subsidiaries is, is and since March 31January 12, 2011 2005, has been, been in compliance with, has not been charged with or given written notice by any Governmental Authority of any violation of and, and to the knowledge of the Company, Company is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of, any Applicable Law or the terms of any of its PermitsLaw, except for failures to comply or violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company or any of its Subsidiaries, or any of their respective assets or properties, Subsidiaries that has had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or that preventsin any manner seeks to prevent, enjoinsenjoin, alters alter or materially delays delay the Merger Offer or any of the other transactions contemplated hereby. (b) (i) None of the Company, any of its Subsidiaries, or any of their respective the directors, officers employees or employees, agents of the Company or any of their respective consultants, agents or other Persons acting for or on their behalf, its Subsidiaries has taken made any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment of any money, propertyor offer, gift gift, promise to give, or authorization of the giving of anything of value, directly or indirectly (i) value to any “foreign official” (as such term is defined in the FCPA) Government Official or any foreign political party for purposes of influencing any act or decision of such official thereof or party in his or its official capacity, in order to obtain or retain business or secure any candidate for foreign political office to influence official action, or improper advantage. (ii) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has conducted its businesses in compliance in all material respects with the FCPA, the UK Bribery Act and any other anti-corruption or anti-bribery Applicable Law, and the Company has instituted and maintained policies and procedures designed to cause each such Person to comply with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons). (c) Neither the Company, any of its Subsidiaries or any of their respective directors, officers or employees, or, to the knowledge None of the Company Securities (excluding any publicly traded Company Securities held by any shareholder who beneficially holds less than 5% of the outstanding Shares as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, is, or is owned or controlled by a Person that is (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and its Affiliates (i) have not engaged in, and are not now engaged in, directly or indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, andSubsidiaries Securities are, to the Company’s knowledge, beneficially or legally owned or held by any Government Official who is not under investigation with respect in a position to and has not been threatened award or influence decisions favorable to be charged with the Company or any violation of its Subsidiaries or by any close family member of, or any applicable Sanctionsentity directly or indirectly owned by, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, such a Company Material Adverse Effect. (d) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITARPerson. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice of any violation of and, to To the Company’s knowledge, are not under investigation with respect to and have not been threatened to be charged with any violation of, IT AR none of the officers or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (e) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, (i) each product that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or on behalf directors of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries or, is a Government Official (or close family member of a Government Official) who is in a position to award or influence decisions favorable to the knowledge of the Company, any Person that manufactures, co-develops Company or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdictionSubsidiaries.

Compliance with Laws and Court Orders. (a) The Neither the Company and each nor any Subsidiary of its Subsidiaries the Company is, and or since March 31January 1, 2011 2014 has been, in compliance conflict with, has not been charged with or given written notice by in default, breach or violation of any Applicable Law or any permit, license, or other authorization of any Governmental Authority used in the operation of any violation of and, to the knowledge of the Company, is not under investigation with respect to and has not been threatened to be charged with any violation of, Applicable Law or the terms of any of its Permitssuch Person’s business as currently conducted, except for failures to comply or violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company or any of its Subsidiaries, or any of their respective assets or properties, that has had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or that prevents, enjoins, alters or materially delays the Merger or any of the other transactions contemplated hereby. (b) None of on the Company, any of its Subsidiaries, or any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalf, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment of any money, property, gift or anything of value, directly or indirectly (i) to any “foreign official” (. Except as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office to influence official action, or (ii) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has conducted its businesses in compliance in all material respects with the FCPA, the UK Bribery Act and any other anti-corruption or anti-bribery Applicable Law, and the Company has instituted and maintained policies and procedures designed to cause each such Person to comply with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons). (c) Neither the Company, any of its Subsidiaries or any of their respective directors, officers or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, is, or is owned or controlled by a Person that is (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and its Affiliates (i) have not engaged in, and are not now engaged in, directly or indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (d) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice of any violation of and, to Effect on the Company’s knowledge, are not under investigation with respect to and have not none of the Company or any Subsidiary of the Company has been threatened to be charged with or given notice by any Governmental Authority of, and to the knowledge of the Company none of the Company or any Subsidiary of the Company is under investigation by any Governmental Authority with respect to, any violation of, IT AR or EARof any such Applicable Law. (b) Without limiting the foregoing, except where the failure to be in compliance as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Effect on the Company, neither the Company, any of its Subsidiaries nor any director or officer thereof nor, to the Company’s knowledge, any employee or agent of the Company or any of its Subsidiaries has (ei) directly or indirectly, used any funds for unlawful contributions, gifts, entertainment or other unlawful payments relating to political activity, (ii) directly or indirectly, used, given, offered, promised, or authorized to give, any money or thing of value (except for payments permitted by 15 U.S.C. Section 78dd-2(b) or (c)) to any foreign or domestic government official or to any foreign or domestic political party or campaign (collectively, “Government Official”), for the purpose of influencing an act or decision of the Government Official, or inducing the Government Official to use his or her influence or position to affect any government act or decision to obtain or retain business of the Company or any of its Subsidiaries or (iii) directly or indirectly, made any unlawful payment. Except as would not reasonably be expected to behave, individually or in the aggregate, material to a Material Adverse Effect on the Company, all books and records of the Company and its SubsidiariesSubsidiaries accurately and fairly reflect, taken as a wholein reasonable detail, (i) each product that is subject to any Health Lawall transactions and dispositions of funds or assets, that is developed, manufactured, tested and there have been no false or distributed fictitious entries made in the books or marketed by or on behalf records of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries relating to any illegal payment or secret or unrecorded fund, and neither the Company nor any of its Subsidiaries has established or maintained a secret or unrecorded fund. (c) Without limiting the foregoing, except as would not reasonably be expected to have a Material Adverse Effect on the Company, the Company’s business is being and, since January 1, 2014, has been conducted in compliance in all material respects with, as applicable, the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq., and all regulations promulgated thereunder (the “FDCA”), and all FDA laws, including FDA regulations on clinical trials, establishment registration and device listing, medical device reporting, correction and removal reporting, good manufacturing practices, and device labeling, as well as comparable applicable foreign laws. There are no products that have been commercially distributed by the Company since January 1, 2014 that would require the CE marking of conformity or any approval or premarket clearance by the FDA or any comparable foreign Governmental Authority for the purpose for which they currently are being manufactured or sold (i) for which such CE marking of conformity, approval or premarket clearance has not been obtained, or (ii) for which such CE marking of conformity, approval or premarket clearance has been withdrawn, revoked or cancelled or is no longer in full force and effect or is wrongly affixed to such products, except where the failure to obtain such conformity, approval or premarket clearance, as applicable, would not reasonably be expected to have a Material Adverse Effect on the Company. The Company has not received since January 1, 2014, notice of any, and except as would not reasonably be expected to have a Material Adverse Effect on the Company, there is no, action, suit, proceeding or investigation by the FDA or any comparable foreign Governmental Authority, including but not limited to recall procedures or market withdrawals, pending or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither threatened against the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none alleging that products of the Company, or the manufacturing, marketing, advertising, promotion, labeling, distribution, or sale thereof, are in violation in any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge respect of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact FDCA or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any comparable applicable foreign jurisdictionlaws.

Compliance with Laws and Court Orders. (a) The Neither the Company and each of its Subsidiaries isnor any Subsidiary is in violation of, and has not since March December 31, 2011 has been2009 violated, in compliance with, has not been charged with or given written notice by any Governmental Authority of any violation of and, and to the knowledge of the Company, Seller is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of, any Applicable Law or the terms of any of its Permits, except for failures to comply or such violations that have not had and would not reasonably be expected to havenot, individually or in the aggregate, have a Company Material Adverse EffectEffect on the Company and the Subsidiaries taken as a whole. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company or any of its Subsidiaries, or any of their respective assets or properties, Subsidiaries that has had or would reasonably be expected to have, individually or in be material to the aggregate, Company and its Subsidiaries taken as a Company Material Adverse Effect whole or that preventsin any manner seeks to prevent, enjoinsenjoin, alters alter or materially delays delay the Merger or any consummation of the other transactions contemplated herebyby this Agreement. (b) None of Neither the Company, Company nor any of its SubsidiariesSubsidiaries or Affiliates, nor any director, officer, or employee, nor, to Seller’s knowledge, any agent or representative of the Company or of any of their respective directors, officers its Subsidiaries or employees, or any of their respective consultants, agents or other Persons acting for or on their behalfAffiliates, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment or giving of any money, property, gift gifts or anything else of value, directly or indirectly value to (i) to any “foreign government official” (as such term is defined in the FCPA) including any officer or employee of a government or government-owned or controlled entity or of a public international organization, or any foreign person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official thereof or any candidate for foreign political office office) in order to influence official action, or (ii) any person (whether or not a government official) to influence that person to act in breach of a duty of good faith, impartiality or trust (“acting improperly”), to reward the person for acting improperly, or in circumstances where the recipient would be acting improperly by receiving the thing of value; or (iii) any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign government official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has and its Subsidiaries and Affiliates have conducted its their businesses in compliance in with all material respects with the FCPA, the UK Bribery Act and any other applicable anti-corruption or anti-bribery Applicable Lawlaws, including the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff), and the Company has have instituted and maintained maintain and will continue to maintain policies and procedures designed to cause each promote and achieve compliance with such Person to comply laws and with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons)representation and warranty contained herein. (c) Neither the Company, Company nor any of its Subsidiaries or Affiliates, nor any of their respective directorsdirectors or officers, officers is an individual or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, entity that is, or is owned or controlled by a Person that is is: (Ai) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State), the United Nations Security Council, the European Union Union, or other relevant sanctions authority (collectively, “Sanctions”), or (Bii) located, organized, a citizen of, organized or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The . (d) For the past five (5) years, neither the Company and nor any of its Subsidiaries or Affiliates (i) have not has engaged in, and are not or is now engaged in, directly or or, to the knowledge of the Company, indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, which such company is required to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectcomply. (de) The Company is registered with DDTC as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries and Affiliates are, and for the past five (5) years have been been, in compliance with and with, and, to Seller’s knowledge, have not been given notice of any violation of and, to the Company’s knowledge, are not penalized for or under investigation with respect to and have not been threatened to be charged with or given notice of any violation of, IT AR any applicable Sanctions or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectexport controls laws. (e) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, (i) each product that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or on behalf of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483), warning letters, action letters or untitled letters, and (iv) none of the Company, any of its Subsidiaries or their respective officers, employees or agents or, to the knowledge of the Company, any Collaboration Partner, (A) has made any untrue statement of material fact or fraudulent statement to any Health Authority or failed to disclose a material fact required to be disclosed to any Health Authority, (B) has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdiction.

Compliance with Laws and Court Orders. (a) The Company and each of its Subsidiaries is, and since March 31January 1, 2011 2018 (the “Applicable Date”) has been, in compliance with, has and to the Knowledge of the Company is not been charged with or given written notice under investigation by any Governmental Authority of any violation of and, to the knowledge of the Company, is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of, any Applicable Law or the terms of any of its PermitsLaw, except for failures to comply or violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. There is no judgment, decree, injunction, rule or order of any arbitrator or Governmental Authority outstanding against the Company or any of its Subsidiaries, or any of their respective assets or properties, that has had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or that prevents, enjoins, alters or materially delays on the Merger or any of the other transactions contemplated herebyCompany. (b) None of the Company, any of its Subsidiaries, or any of their respective directors, officers or employees, or any of their respective consultants, agents or other Persons acting for or on their behalf, has taken any action that would result in a violation in any material respect by such Person of the Foreign Corrupt Practices Act (15 U.S.C. §§ 78m(b), 78dd-1, 78dd-2, 78ff) (the “FCPA”), The Bribery Act of 2010 of the United Kingdom (the “UK Bribery Act”) or any other anti-corruption or anti-bribery Applicable Law, including taking any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the payment of any money, property, gift or anything of value, directly or indirectly (i) to any “foreign official” (Except as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office to influence official action, or (ii) to any person while knowing or having reason to know that all or any portion of the money or other thing of value will be offered, promised or given to a foreign official in order to influence or reward official action or to any person to influence such person to act improperly or reward the person for doing so. The Company has conducted its businesses in compliance in all material respects with the FCPA, the UK Bribery Act and any other anti-corruption or anti-bribery Applicable Law, and the Company has instituted and maintained policies and procedures designed to cause each such Person to comply with all such Applicable Law (but, in each case, only to the extent such Applicable Law is applicable to the Company or such Persons). (c) Neither the Company, any of its Subsidiaries or any of their respective directors, officers or employees, or, to the knowledge of the Company as of the date hereof, any of their respective consultants, agents or other Persons acting for or on their behalf, is, or is owned or controlled by a Person that is (A) the subject of any sanctions administered by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) or the U.S. Department of State, the United Nations Security Council, the European Union or other relevant sanctions authority (collectively, “Sanctions”), or (B) located, organized, a citizen of, or resident in a country or territory that is the subject of Sanctions (including Cuba, Iran, Myanmar, North Korea, Sudan and Syria). The Company and its Affiliates (i) have not engaged in, and are not now engaged in, directly or indirectly, any dealings or transactions with any Person, or in any country or territory, that, at the time of the dealing or transaction, is or was the subject of Sanctions and (ii) have been in compliance with and has not been given notice of any violation of, and, to the Company’s knowledge, is not under investigation with respect to and has not been threatened to be charged with any violation of, any applicable Sanctions, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse EffectEffect on the Company, neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any director, officer, agent or employee of the Company or any of its Subsidiaries has (i) taken any action, directly or indirectly, that would result in a violation by any such Persons of the U.S. Foreign Corrupt Practices Act of 1977, the Anti-Kickback Act of 1986, the U.K. Bribery Act of 2010, or any other anti-bribery, anti-corruption, or anti-money laundering law or regulation promulgated by any Governmental Authority, (ii) used any funds (whether of the Company or otherwise) for unlawful contributions, gifts, entertainment or other unlawful expenses, or (iii) given, offered, promised or authorized the giving of money or anything of value, to any Person or Government Official, for the purpose of (A) influencing an act or decision of such Government Official or improperly inducing such Government Official to use his or her influence or position to affect any act or decision of a Governmental Authority, (B) obtaining an improper business advantage, or (C) obtaining or retaining business. (dc) The Company is registered with DDTC Except as a manufacturer of “defense articles” as that term is defined under Section 120.6 of ITAR. The Company produces and trades in U.S.-origin, dual-use goods and technology controlled under the Export Administration Regulations (“EAR”) and regulated by the U.S. Department of Commerce’s Bureau of Industry and Security. The Company and its Subsidiaries have been in compliance with and have not been given notice of any violation of and, to the Company’s knowledge, are not under investigation with respect to and have not been threatened to be charged with any violation of, IT AR or EAR, except where the failure to be in compliance would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (e) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, (i) each product that is subject to any Health Law, that is developed, manufactured, tested or distributed or marketed by or Effect on behalf of the Company or its Subsidiaries, has been and is being developed, manufactured, tested, distributed or marketed in compliance with all applicable requirements under the Health Laws, (ii) none of the Company, any of its Subsidiaries or, to the knowledge of the Company, any Person that manufactures, co-develops or co-markets (or has a license to develop, market or sell) any such product (or any component thereof) (each, a “Collaboration Partner”) has received written notice from any Health Authority contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any such product, or otherwise alleging any material violation of any Health Law, (iii) since March 31, 2011, neither the Company nor any of its Subsidiaries have received any notices of inspectional observations (including those reported on Form FDA 483)nor, warning letters, action letters or untitled letters, and (iv) none to the Knowledge of the Company, any of its Subsidiaries or their respective directors, officers, employees or agents or, to the knowledge of the Company, Company or any Collaboration Partnerof its Subsidiaries, (Ai) is or has been a Sanctions Target; (ii) has made engaged in or otherwise participated in, or assisted or facilitated any untrue statement of material fact direct or fraudulent statement to any Health Authority indirect dealing or failed to disclose transaction with, or for the benefit of, a material fact required to be disclosed to any Health Authority, Sanctions Target; or (Biii) has committed any actotherwise violated applicable sanctions including those administered by OFAC, made any statement the U.S. Department of State, the European Union, or failed to make any statement that would reasonably be expected to provide a basis for other relevant Governmental Authorities, export controls including the FDA to invoke its policy with respect to “FraudExport Administration Regulations, Untrue Statements of Material Facts, Briberyimport controls including those maintained by Customs and Border Protection, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy, (C) has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by Sec. 306 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C. § 335a) or any other Health anti-boycott Applicable Law, or (D) has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any similar Applicable Law in any foreign jurisdiction.