Common use of Healthcare Regulatory Matters Clause in Contracts

Healthcare Regulatory Matters. (a) The Company and SpinCo are, and have been since their formation, in compliance with all applicable Healthcare Laws, except where such failure to so comply would not reasonably be expected to materially and adversely impact the SpinCo Business. Neither the Company nor SpinCo has received any written notice from any Regulatory Authority alleging any material violation of any applicable Healthcare Law. To the Knowledge of the SpinCo Group, there are no Actions pending or threatened against the Company or any of its Subsidiaries (excluding SpinCo) (in each case solely with respect to the SpinCo Business) or SpinCo or any of the SpinCo Products or alleging any material violation by the Company, SpinCo, the SpinCo Business or the SpinCo Products of any such applicable Healthcare Law. (b) Except as set forth in Section 5.24(b) of the SpinCo Disclosure Schedule, (i) SpinCo does not hold any Regulatory Authorization, and (ii) SpinCo does not have any application for a Regulatory Authorization pending with the FDA or any other applicable Regulatory Authority. (c) Except as set forth in Section 5.24(c) of the SpinCo Disclosure Schedule, (i) the Company does not hold any Regulatory Authorization in relation to the SpinCo Business, and (ii) the Company, in relation to the SpinCo Business, does not have any application for a Regulatory Authorization pending with the FDA or any other applicable Regulatory Authority. (d) None of the Company and its Subsidiaries or any person acting on behalf of any of the Company and its Subsidiaries has with respect to any SpinCo Product: (i) been subject to a shutdown or import or export prohibition imposed by any Regulatory Authority; or (ii) received any FDA Form 483, or other written notice of inspectional observations, “warning letters,” “untitled letters” or any similar written correspondence from any Regulatory Authority in respect of such Entity or its business operations, alleging or asserting material noncompliance with any applicable Healthcare Law or Regulatory Authorization. No Regulatory Authority has threatened such action. (e) To the Knowledge of the SpinCo Group, neither SpinCo nor the Company has (i) made an untrue statement of a material fact or a fraudulent claim or statement to any Regulatory Authority with respect to the SpinCo Business or the SpinCo Products, (ii) failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the SpinCo Business or the SpinCo Products or (iii) committed an act, made a disclosure, or failed to commit an act or make a disclosure, including with respect to any scientific data or information, that, at the time of such action, failure to act, disclosure or failure to disclose (as applicable), would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or for the FDA or any other Regulatory Authority to invoke any similar policy, in each case with respect to the SpinCo Business or the SpinCo Products. None of the Company, SpinCo nor, to the Knowledge of the SpinCo Group, any of their officers, employees or agents has been convicted of any crime or engaged in any conduct that has resulted in, or would reasonably be expected to result in, debarment from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) or (b) or exclusion from participation in any federal health care program.

Healthcare Regulatory Matters. (a) The Company SpinCo and SpinCo its Subsidiaries are, and for the past three (3) years have been since their formationbeen, in compliance with all applicable Healthcare Laws, except where such failure to so comply would not reasonably be expected expected, individually or in the aggregate, to materially and adversely have a material impact on the SpinCo Business. Neither the Company SpinCo nor SpinCo any of its Subsidiaries has received any written notice or other written communication from any Regulatory Authority alleging any material violation of any applicable Healthcare LawLaw that remains unresolved. To There are no investigations, suits, claims, actions or proceedings pending or, to the Knowledge of the SpinCo GroupCompany, there are no Actions pending or threatened against the Company SpinCo or any of its Subsidiaries (excluding SpinCo) (in each case solely with respect to the SpinCo Business) or SpinCo or any of the SpinCo Products or alleging any material violation by the Company, SpinCo, the SpinCo Business or the SpinCo Products of any such applicable Healthcare Law. (b) Except as set forth in Section 5.24(b) Neither SpinCo nor any of the SpinCo Disclosure Schedule, (i) SpinCo does not hold its Subsidiaries holds any Regulatory Authorization, and (ii) SpinCo does not have or has any such application for a Regulatory Authorization pending with the FDA or any other applicable Regulatory AuthorityAuthority or, to the Knowledge of the Company, has at any time in the past three (3) years has been required to hold a Regulatory Authorization in connection with the SpinCo Products or operations. (c) Except as set forth in Section 5.24(c) Neither SpinCo nor any of the SpinCo Disclosure Schedule, (i) the Company does not hold any Regulatory Authorization in relation to the SpinCo Businessits Subsidiaries is conducting or sponsoring, and during the past three (ii3) the Companyyears, has not conducted or sponsored, any pre-clinical studies or clinical trials that are or were required under any applicable Healthcare Laws to be conducted in relation to the SpinCo Business, does not have any application for a Regulatory Authorization pending compliance with the FDA Good Laboratory Practices or any other applicable Regulatory AuthorityGood Clinical Practices. (d) None of the Company and its Subsidiaries or SpinCo Entities or, to the Knowledge of the Company, any person acting on behalf of any of SpinCo Entity has during the Company and its Subsidiaries has past three (3) years, with respect to any SpinCo Product: (i) been subject to a shutdown or import or export prohibition imposed by any Regulatory Authority; or (ii) received any FDA Form 483, or other written notice of inspectional observations, “warning letters,” “untitled letters” or any similar written correspondence from any Regulatory Authority in respect of such SpinCo Entity or its business operations, alleging or asserting material noncompliance with any applicable Healthcare Law or Regulatory Authorization. No , and, to the Knowledge of the Company, no Regulatory Authority has threatened such action. (e) To the Knowledge None of the SpinCo Group, neither SpinCo nor the Company Entities has (i) made an untrue statement of a material fact or a fraudulent claim or statement to any Regulatory Authority with respect to the SpinCo Business or the SpinCo ProductsAuthority, (ii) failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the SpinCo Business or the SpinCo Products or (iii) committed an act, made a disclosure, or failed to commit an act or make a disclosure, including with respect to any scientific data or information, that, at the time of such action, failure to act, disclosure or failure to disclose (as applicable), would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or for the FDA or any other Regulatory Authority to invoke any similar policy, in each case with respect to the SpinCo Business or the SpinCo Products. None of the Company, SpinCo noror, to the Knowledge of the SpinCo GroupSpinCo, any of their its officers, employees or agents has been convicted of any crime or engaged in any conduct that has resulted in, or would reasonably be expected to result in, debarment from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) or (b) or exclusion from participation in any federal health care program.