Common use of Health Care Law Compliance Clause in Contracts

Health Care Law Compliance. The Company’s business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign health care laws applicable to the Company and its business, and the Company is in compliance with such health care laws, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. Such health care laws include, without limitation: (i) the federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); (xx) the federal False Claims Act, 31 U.S.C. §§ 3729-3733; (iii) the federal criminal false claims law, 42 U.S.C. § 1320a-7b(a); (iv) the federal civil monetary penalties law, 42 U.S.C. § 1320a-7a; (v)18 U.S.C. §§286-287; (vi) the health care criminal fraud provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 42 U.S.C. 1320d et seq.; (vii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), 42 U.S.C. 17921 et seq.; (viii) the Xxxxx Law, 42 U.S.C. §1395nn; (ix) the exclusion laws, 42 U.S.C. §1320a-7; (x) the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act; (xi) Medicare, Title XVIII of the Social Security Act; (xii) Medicaid, Title XIX of the Social Security Act; and (xiii) the regulations promulgated pursuant to such laws (collectively, “Health Care Laws”). The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging a violation of any such Health Care Laws, nor to the Company’s knowledge has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. The Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws to operate its business, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where the failure to do so would not result in a Material Adverse Effect. The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor, to the Company’s knowledge, any of its employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Appears in 3 contracts

Samples: Underwriting Agreement (Ignyta, Inc.), Underwriting Agreement (Ignyta, Inc.), Underwriting Agreement (Ignyta, Inc.)

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Health Care Law Compliance. The Company’s business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign health care laws applicable to the Company and its business, and the Company is in compliance with such health care laws, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. Such health care laws include, without limitation: (i) the federal XxxxAxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); (xx) the federal civil False Claims Act, 31 U.S.C. §§ 3729-3733; (iii) all applicable federal, state, local and foreign criminal laws relating to health care fraud and abuse, including without limitation, the federal criminal false claims law, 42 U.S.C. § 1320a-7b(a); (iv) the federal civil monetary penalties law, 42 U.S.C. § 1320a-7a; (v)18 U.S.C. §§286-287; (vi) the health care criminal fraud provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 42 U.S.C. 1320d et seq.; (vii) HIPAA,, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), 42 U.S.C. 17921 et seq.; (vii) the federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.; (viii) the Xxxxx LawSxxxx Xxx, 42 U.S.C. 00 X.X.X. §1395nn0000xx; (ix) the exclusion laws, 42 U.S.C. §1320a-7; (x) the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act, Public Law 111-152; (xi) Medicare, Title XVIII of the Social Security Act; (xii) Medicaid, Title XIX of the Social Security Act; and (xiii) the regulations promulgated pursuant to such laws (collectively, “Health Care Laws”). The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging a violation of any such Health Care Laws, nor to the Company’s knowledge has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. The Company has filed, maintained or submitted all material and required reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws to operate its businesstheir respective businesses, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where the failure to do so would not result in a Material Adverse Effect. The Company is not a party to any corporate integrity agreements, plans of correction, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor, to the Company’s knowledge, nor any of its respective employees, officers, directors, officers or agents directors has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Appears in 3 contracts

Samples: Sales Agreement (Advaxis, Inc.), Placement Agency Agreement (Advaxis, Inc.), Underwriting Agreement (Advaxis, Inc.)

Health Care Law Compliance. The Company’s and each of its subsidiaries’ business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign health care laws applicable to the Company and its businesssubsidiaries respective businesses as currently operated, and the Company is in and its subsidiaries have taken reasonable actions to assure compliance with such health care laws, as may be applicable, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. Such health care laws laws, as may be applicable, include, without limitation: (i) the federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); (xx) the federal False Claims Act, 31 U.S.C. §§ 3729-3733; (iii) the federal criminal false claims law, law (42 U.S.C. § 1320a-7b(a); (iv) the federal civil monetary penalties law, 42 U.S.C. § 1320a-7a; (v)18 U.S.C. §§286-287; (vi) the health care criminal fraud provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 42 U.S.C. 1320d et seq.; (vii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), 42 U.S.C. 17921 et seq.; (viii) the Xxxxx Law, 42 U.S.C. §1395nn; (ix) the exclusion laws, 42 U.S.C. §1320a-7; (x) the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act; (xiviii) Medicare, Title XVIII of the Social Security Act; (xiiix) Medicaid, Title XIX of the Social Security Act; and (xiiix) the regulations promulgated pursuant to such laws (collectively, “Health Care Laws”). The To the Company’s knowledge, neither the Company nor any of its subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging a violation of any such Health Care Laws, nor to the Company’s knowledge has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. The Neither the Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws to operate nor any of its business, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where the failure to do so would not result in a Material Adverse Effect. The Company subsidiaries is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor, to the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers, directors, officers or agents directors has been excluded, suspended suspended, disqualified or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, disqualification or exclusion.

Appears in 1 contract

Samples: Underwriting Agreement (Ocata Therapeutics, Inc.)

Health Care Law Compliance. The Company’s and each of its Subsidiaries’ business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign health care laws applicable to the Company and its businessSubsidiaries respective businesses, and the Company is and its Subsidiaries are in compliance with such health care laws, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. Such health care laws include, without limitation: (i) the federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); (xx) the federal civil False Claims Act, 31 U.S.C. §§ 3729-3733; (iii) the federal criminal false claims law, 42 U.S.C. § 1320a-7b(a); (iv) the federal civil monetary penalties law, 42 U.S.C. § 1320a-7a; (v)18 U.S.C. §§286-287; (vi) the health care criminal fraud provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 42 U.S.C. 1320d et seq.; (vii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), 42 U.S.C. 17921 et seq.; (viii) the Xxxxx Law, 42 U.S.C. §1395nn; (ix) the exclusion laws, 42 U.S.C. §1320a-7; (x) the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act, Public Law 111-152; (xi) Medicare, Title XVIII of the Social Security Act; (xii) Medicaid, Title XIX of the Social Security Act; (xiii) the federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.; (xiv) the Public Health Service Act, 42 U.S.C. §262 et seq.; and (xiiixv) the regulations promulgated pursuant to such laws (collectively, “Health Care Laws”). The Neither the Company nor any of its Subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging a violation of any such Health Care Laws, nor to the Company’s knowledge has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. The Company has and its Subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws to operate its businesstheir respective businesses, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where . Neither the failure to do so would not result in a Material Adverse Effect. The Company nor any of its Subsidiaries is not a party to any corporate integrity agreements, monitoring agreements, plans of correction, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor, to the Company’s knowledge, any of its employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Appears in 1 contract

Samples: Underwriting Agreement (Agenus Inc)

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Health Care Law Compliance. The Company’s business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign health care laws applicable to the Company and its business, and the Company is in compliance with such health care laws, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. Such health care laws include, without limitation: (i) the federal XxxxAxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); (xx) the federal civil False Claims Act, 31 U.S.C. §§ 3729-3733; (iii) all applicable federal, state, local and foreign criminal laws relating to health care fraud and abuse, including, without limitation, the federal criminal false claims law, 42 U.S.C. § 1320a-7b(a); (iv) the federal civil monetary penalties law, 42 U.S.C. § 1320a-7a; (v)18 U.S.C. §§286-287; (vi) the health care criminal fraud provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 42 U.S.C. 1320d et seq.; (vii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), 42 U.S.C. 17921 et seq.; (vii) the federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.; (viii) the Xxxxx LawSxxxx Xxx, 42 U.S.C. 00 X.X.X. §1395nn0000xx; (ix) the exclusion laws, 42 U.S.C. §1320a-7; (x) the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act, Public Law 111-152; (xi) Medicare, Title XVIII of the Social Security Act; (xii) Medicaid, Title XIX of the Social Security Act; and (xiii) the regulations promulgated pursuant to such laws (collectively, “Health Care Laws”). The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging a violation of any such Health Care Laws, nor to the Company’s knowledge has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. The Company has filed, maintained or submitted all material and required reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws to operate its businesstheir respective businesses, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where the failure to do so would not result in a Material Adverse Effect. The Company is not a party to any corporate integrity agreements, plans of correction, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor, to the Company’s knowledge, nor any of its respective employees, officers, directors, officers or agents directors has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Appears in 1 contract

Samples: Underwriting Agreement (Advaxis, Inc.)

Health Care Law Compliance. The Company’s business practices have been structured in a manner reasonably designed to comply with the state, federal and foreign health care laws applicable to the Company and its business, and the Company is in compliance with such health care laws, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. Such health care laws include, without limitation: (i) the federal XxxxAxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); (xx) the federal civil False Claims Act, 31 U.S.C. §§ 3729-3733; (iii) all applicable federal, state, local and foreign criminal laws relating to health care fraud and abuse, including without limitation, the federal criminal false claims law, 42 U.S.C. § 1320a-7b(a); (iv) the federal civil monetary penalties law, 42 U.S.C. § 1320a-7a; (v)18 U.S.C. §§286-287; (vi) the health care criminal fraud provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 42 U.S.C. 1320d et seq.; (vii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), 42 U.S.C. 17921 et seq.; (vii) the federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.; (viii) the Xxxxx LawSxxxx Xxx, 42 U.S.C. 00 X.X.X. §1395nn0000xx; (ix) the exclusion laws, 42 U.S.C. §1320a-7; (x) the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act, Public Law 111-152; (xi) Medicare, Title XVIII of the Social Security Act; (xii) Medicaid, Title XIX of the Social Security Act; and (xiii) the regulations promulgated pursuant to such laws (collectively, “Health Care Laws”). The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging a violation of any such Health Care Laws, nor to the Company’s knowledge has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened. The Company has filed, maintained or submitted all material and required reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws to operate its businesstheir respective businesses, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments under Health Care Laws were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where the failure to do so would not result in a Material Adverse Effect. The Company is not a party to any corporate integrity agreements, plans of correction, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor, to the Company’s knowledge, nor any of its respective employees, officers, directors, officers or agents directors has not been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

Appears in 1 contract

Samples: Underwriting Agreement (Advaxis, Inc.)

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