Health Regulatory Clause Samples

A Health Regulatory clause sets out the obligations and requirements for compliance with health-related laws and regulations relevant to the agreement. It typically requires the parties to adhere to all applicable healthcare statutes, rules, and industry standards, such as those governing medical devices, pharmaceuticals, or patient data privacy. This clause ensures that both parties operate within the legal framework of the healthcare sector, thereby reducing the risk of regulatory violations and associated penalties.
Health Regulatory. (a) The Company has not engaged, and no other Person (i) who has a direct or indirect ownership interest (as defined in 42 C.F.R. § 1001.1001(a)(2)) in the Company, or (ii) who has an ownership or control interest (as defined in 42 C.F.R. § 420.201) in the Company, or (iii) who is an officer, director, agent (as defined in 42 C.F.R. § 1001.1001(a)(2)), or managing employee (as defined in 42 C.F.R. § 420.201) of the Company, has engaged on behalf of the Company in any activities which are prohibited by, or are cause for civil penalties or mandatory or permissive exclusion from any Federal Health Care Program under, any applicable Law, including, without limitation, 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b, 1395nn or 31 U.S.C. § 3729, or the regulations promulgated pursuant to such statutes, in each case to the extent applicable to the Company. (b) Neither the Company, nor any officer, director, managing employee, or, to Seller’s Knowledge, agent of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other similar formal agreement with any Governmental Authority resulting from a failure, or alleged failure, to comply with applicable Laws. (c) To Seller’s Knowledge, no person has filed or has threatened to file a whistleblower action against the Company under any Law, including under the False Claims Act of 1863 (31 U.S.C. 3729 et seq.). (d) The Company has an operational healthcare compliance program, including a code of ethics or has adopted a code of ethics that governs all employees, including sales representatives, which interact with physician and hospital customers, and such employees’ interactions with their physician and hospital customers. (e) The Company is not a “covered entity,” nor a “Business Associate” as those terms are defined under the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder, as each is amended from time to time (“HIPAA”). (f) The Company has not engaged in any activities, or otherwise acted in a manner, prohibited by or in violation of any Law governing the maintenance, use, disclosure, privacy, and/or security of, and standard transactions related to, Personal Information, including, but not limited to, the ▇▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Act and its implementing regulations (“GLBA”), HIPAA, as amended by HITECH, state health information privacy laws, and state data breach notification laws (collectively, “Privacy and Security...
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Health Regulatory. (a) Except as set forth in Section 4.07(a) of the Company Disclosure Schedule, to the knowledge of the Company, the Company and any Company Subsidiary and each manager, director, officer, employee and independent contractor of the Company and any Subsidiary, and any other persons acting on behalf of the Company or any Subsidiary, are, and since January 1, 2017, have been, in material compliance with all Healthcare Laws and all Laws and orders of any Governmental Authority applicable to the operation of the business of the Company and any Subsidiary. Except as set forth in Section 4.07(a) of the Company Disclosure Schedule, (i) the Company has not received any notice, subpoena, charges, orders, or any other request from any Governmental Authority regarding any violation or alleged violation of any applicable Healthcare Laws, or any obligation on the part of the Company to undertake, or to bear all or any portion of the cost of, any remedial, corrective or response action of any nature, and (ii) to the Company’s knowledge, the Company and any Subsidiary have, and are in material compliance with, all Healthcare Permits necessary to conduct their respective businesses as presently conducted, and all such Healthcare Permits are in full force and effect and no cancellation, revocation or suspension of any such Healthcare Permit is pending or to the Company’s knowledge, threatened, that would individually or in the aggregate have or reasonably be expected to have a Company Material Adverse Effect. (b) Except as set forth in Section 4.07(b) of the Company Disclosure Schedule, to Company’s knowledge, the Company, any Subsidiary, and all products sold by the Company or any Subsidiary (i) are, and since January 1, 2017, have been, in material compliance with all Healthcare Laws, and (ii) since January 1, 2017, have not received an FDA-483, untitled letter, warning letter, notice of adverse finding, or notice of deficiency, search warrant, subpoena or civil investigative demand from the FDA or any other Governmental Authority. To the Company’s knowledge, each of the agents, independent contractors, health care provider consultants and distributors of the Company and any Subsidiary, and any other persons acting on behalf of the Company or any Subsidiary, are in material compliance with all Healthcare Laws relative to the business of the Company and/or any Subsidiary. (c) As applicable, and except as would not have or be reasonably likely to have, individually or in the...
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Health Regulatory. (a) The Company has not engaged, and no other Person (i) who has a direct or indirect ownership interest (as defined in 42 C.F.R. § 1001.1001(a)(2)) in the Company, or (ii) who has an ownership or control interest (as defined in 42 C.F.R. § 420.201) in the Company, or (iii) who is an officer, director, agent (as defined in 42 C.F.R. § 1001.1001(a)(2)), or managing employee (as defined in 42 C.F.R. § 420.201) of the Company, has engaged on behalf of the Company in any activities which are prohibited by, or are cause for civil penalties or mandatory or permissive exclusion from any Federal Health Care Program under, any applicable Law, including, without limitation, 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b, 1395nn or 31 U.S.C. § 3729, or the regulations promulgated pursuant to such statutes, in each case to the extent applicable to the Company. (b) The Company is not a “covered entity,” as defined under the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder (“HIPAA”). (c) None of the Company or any of the Employee Plans that meet the definition of a “group health plan” under HIPAA (each, a “Group Health Plan”) has engaged in any activities, or otherwise acted in a manner, prohibited by or in violation of any Law governing the maintenance, use, disclosure, privacy, and/or security of, and standard transactions related to, Personal Information, including, but not limited to, the ▇▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Act and its implementing regulations (“GLBA”), HIPAA, state health information privacy laws, and state data breach notification laws (collectively, “Privacy and Security Laws”); there is no charge, proceeding or, to the Knowledge of the Company, investigation by any Governmental Authority with respect to a violation of any applicable Privacy and Security Laws that is now pending or, to the Knowledge of the Company, threatened with respect to the Company; and the Company has not received any requests or demands from a Governmental Authority or any other party to make available its internal practices, books, and/or records relating to its use and disclosure of health information for purposes of determining a covered entity’s or the Company’s compliance with HIPAA or with other applicable privacy laws. (d) There are no facts, circumstances or conditions that would reasonably be expected to form the basis for any Action against or affecting the Company relating to or arising under Privacy and Security Laws; and none of ...
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Health Regulatory. Except as disclosed in the SEC Documents, each of the Company and its Subsidiaries: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the FDA, the Department of Health and Human Services (“HHS”) and any comparable foreign or other regulatory authority or Governmental Entity to which they are subject, in Europe or elsewhere (collectively, the “Applicable Regulatory Authorities”); (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted, except where the failure to possess the same would not, individually or in the aggregate, have a Material Adverse Effect, and such Regulatory Authorizations are valid and in full force and effect and neither the Company nor any of its Subsidiaries are in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received written notice of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities or any other third party alleging that any product of the Company is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities or any other third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received written notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizati...
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Health Regulatory. (a) Except as set forth on Section 4.27 of the Company Disclosure Schedule, neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company any other Person (i) who has a direct or indirect ownership interest (as defined in 42 C.F.R. § 1001.1001(a)(2)) in the Company or any Subsidiary, or (ii) who has an ownership or control interest (as defined in 42 C.F.R. § 420.201) in the Company or any Subsidiary, or (iii) who is an officer, director, agent (as defined in 42 C.F.R. § 1001.1001(a)(2)), or managing employee (as defined in 42 C.F.R. § 420.201) of the Company or any Subsidiary thereof, has engaged in any activities which are prohibited by, or are cause for civil penalties or mandatory or permissive exclusion from any Federal Health Care Program under, any applicable Law, including, without limitation, 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b, 1395nn or 31 U.S.C. § 3729, or the regulations promulgated pursuant to such statutes. (b) Except as set forth on Section 4.27 of the Company Disclosure Schedule, neither the Company nor any of its Subsidiaries is a “covered entity,” as defined under the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder (“HIPAA”), and neither the Company nor any of its Subsidiaries has received any requests or demands from a covered entity or Governmental Authority to make available its internal practices, books, and/or records relating to its use and disclosure of health information for purposes of determining a covered entity’s or the Company’s compliance with HIPAA or with other applicable privacy laws.
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Health Regulatory. (a) To the Company’s knowledge, the Company and any Subsidiary are, and since the Formation Date, have been, in material compliance with all applicable Healthcare Laws. The Company has not received any notice, subpoena, charges, orders, or any other request from any Governmental Authority regarding any violation or alleged violation of any applicable Healthcare Laws, or any obligation on the part of the Company to undertake, or to bear all or any portion of the cost of, any remedial, corrective or response action of any nature. The Company and any Subsidiary have, and are in material compliance with, all applicable Healthcare Permits necessary to conduct their respective businesses as presently conducted, and all such Healthcare Permits are in full force and effect and no cancellation, revocation or suspension of any such Healthcare Permit is pending or to the Company’s knowledge, threatened. (b) To the Company’s knowledge, neither the Company nor any Subsidiary has submitted, nor caused to be submitted, any claim for payment to any Governmental Healthcare Program, that was false or fraudulent, or in violation of any false claim or fraud Law, including the federal False Claims Act or any other applicable federal or state false claim or fraud Law. (c) To the Company’s knowledge, neither the Company nor any Subsidiary, nor any officer, director, or employee of the Company or any Subsidiary have been (i) debarred under 21 U.S.C. § 335a or suspended, excluded or debarred from contracting with any Governmental Authority or from participating in any Governmental Healthcare Program, or any federal or state governmental procurement or non-procurement program; (ii) the subject of any investigation conducted by or on behalf of any Governmental Authority; (iii) subject to any criminal, civil or administrative fine, assessment or penalty imposed by any Governmental Authority, or any order, writ, judgment, verdict, injunction, decree, stipulation, ruling, determination or award entered into or issued by or with any Governmental Authority, with respect to any Governmental Healthcare Program or other Payor plan or program, nor is any of the foregoing pending or, to the Company’s knowledge, threatened; (iv) convicted of a criminal or civil offense under any Healthcare Law or is or has been under indictment for the same; (v) a defendant in any qui tam, False Claims Act or similar litigation, (vi) a party to an individual integrity agreement or corporate integrity agreement...
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Related to Health Regulatory

  • Health Requirements This is an active trip that requires you to make a realistic assessment of your health. To enjoy the trips as intended, a minimum level of fitness is required. All Participants are expected to be in active good health, to be comfortable traveling as part of a group, and to be ready to experience cultural differences with grace. Air Journey will require prior notice if any participant has any physical or other condition or disability that would prevent them from participating in active elements of any trip and/or could create a hazard to him or herself or to other members of the group. Air Journey may require guests to produce a doctor’s certificate certifying that they are fit to participate. Any physical condition requiring special attention, diet, or treatment should be reported in writing when the reservation is made. We will make reasonable efforts to accommodate Participants with special needs; however, we cannot accommodate wheelchairs. . Walking and climbing stairs are required in many hotels and airports, and are part of many excursions. If you require a slower pace, extra assistance, or the use of a cane or walking stick, arrangements will be made for private touring at each destination, if necessary, at the discretion of our Journey staff. Any extra cost for such arrangements will be the responsibility of the Participant. If you would like to forego some of the scheduled sightseeing to rejuvenate and relax, please feel free to do so at any time. Acting reasonably, if Air Journey is unable to properly accommodate the need of the person(s) concerned or believes that health and safety may be compromised, Air Journey reserves the right to refuse participation. Air Journey also reserves the right to remove from the trip, at the participant’s own expense, anyone whose physical condition or conduct negatively impacts the enjoyment of the other guests or disrupts the tour. Malaria and other diseases may be present in some of the countries featured in this itinerary; proof of yellow fever inoculation may be required. For the latest recommendations on specific health precautions for the areas you will visit, consult your physician and the Centers for Disease Control. The participant represents that neither he nor she nor anyone traveling with him or her has any physical or other condition or disability that could create a hazard to himself or herself or other members of the tour. The itinerary and Journey leaders are subject to modification and change by Air Journey. Every reasonable effort will be made to operate the Journey as planned; however, should unforeseen world events and conditions require our itinerary to be altered, Air Journey reserves the right to do so for the safety and best interest of the group without prior notification or consultation. The operation of these flights is subject to the foreign governments involved granting landing rights for the flight. If the air carrier cannot obtain these rights for any particular flight leg of the Journey, that flight leg will be canceled and alternative arrangements may be made, at the discretion of Air Journey. Every effort will be made to operate tours as planned but alterations may occur after the final itinerary has been issued.

  • Regulatory Except as described in the Registration Statement and the Prospectus, as applicable, the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are 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.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • Health and Safety Standards Contractor shall abide by all health and safety standards set forth by the State of California and/or the County of ▇▇▇▇▇▇ pursuant to the Injury and Illness Prevention Program. If applicable, Contractor must receive all health and safety information and training from County.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.