Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since December 31, 2016, have been, in compliance with all applicable Laws. To the knowledge of the Company, no investigation or review by any Governmental Authority with respect to any material violation of applicable Law by the Company or any of its Subsidiaries is pending or has been threatened in writing. Since December 31, 2016, neither the Company nor any of its Subsidiaries has received any written notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
Compliance with Laws; Regulatory Matters. (a) Each member of the Merger Partner Group is, and since the Regulatory Lookback Date has been, in compliance with all applicable Laws, including Laws relating to money transmission, virtual currency or other digital assets, consumer protection, credit reporting, data privacy, financial privacy, cybersecurity, securities Law matters, and payment services Law matters (including payment network rules) and Governmental Orders directly applicable to it, except where failure to so comply would not, individually or in the aggregate, reasonably be expected to be material to the Merger Partner Business or the Merger Partner Group, taken as a whole. Since the Regulatory Lookback Date, none of the members of the Merger Partner Group has received any written notice or other written communication from any Governmental Authority or any written notice from any other Person (a) regarding any actual or possible violation of, or failure to comply with, any Law or (b) that it is or has been the subject of any inspection, investigation, survey, audit, monitoring or other form of review by any Governmental Authority, except as would not, individually or in the aggregate, reasonably be expected to be material to the Merger Partner Business or the Merger Partner Group, taken as a whole. (b) Since the Regulatory Lookback Date, none of the members of the Merger Partner Group have been in violations of Money Services Laws, or, to the extent applicable, been denied a Money Services Permit or other Permit by any Governmental Authority or had any Money Services Permit or other Permit revoked or suspended. (c) Each member of the Merger Partner Group is, and at all times since the Regulatory Lookback Date has been, in compliance with all applicable Anti-Money Laundering Laws. None of the members of the Merger Partner Group or any of their respective directors,
Compliance with Laws; Regulatory Matters. The Company is in compliance in all material respects with all laws, rules and regulations, all orders, directives and supervisory letters of, and all agreements, memoranda of understanding or similar arrangements with, regulatory authorities and all other legal requirements applicable to the Company or the Company's businesses; and the Company is not subject to any order, directive or supervisory letter of, or agreement, memorandum or understanding or similar arrangement (including board resolutions adopted at the request of regulatory authority) with, any regulatory authority restricting its operations or, restricting it from taking any action or requiring that certain actions be taken, and the Company has no knowledge that any such order, directive, supervisory letter, agreement, memorandum or understanding or similar arrangement is threatened, contemplated or under consideration by any regulatory authority.
Compliance with Laws; Regulatory Matters. (a) The Company and each of its Subsidiaries is in compliance with, and since January 1, 2010 have been in compliance with, 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 written notice of any violation of, any Applicable Law, except to the extent that any non-compliance, investigation or violation would not reasonably be expected to be materially adverse to the Company and its Subsidiaries, taken as a whole.
Compliance with Laws; Regulatory Matters. Reliant has materially complied with all applicable Laws relating to the Product, the Product Line Operations and the Acquired Assets. The Registrations and all such other permits, government licenses, registrations, approvals, concessions, franchises and authorizations required for the manufacturing, marketing, sale and distribution of the Product in the Territory are in full force and effect. Without limiting the generality of the foregoing sentence, Reliant represents and warrants that, except as set forth in Schedule 5.9 of the Reliant Disclosure Schedule:
Compliance with Laws; Regulatory Matters. (a) Each member of the Remainco Group (to the extent related to the Spinco Business) is, and since the Regulatory Lookback Date has been, in compliance with all applicable Laws, including Laws relating to money transmission, virtual currency or other digital assets, consumer protection, credit reporting, data privacy, financial privacy, cybersecurity, securities Law matters, and payment services Law matters (including payment network rules) and Governmental Orders directly applicable to it, except where failure to so comply would not, individually or in the aggregate, reasonably be expected to be material to the Spinco Business or the Spinco Group, taken as a whole. Since the Regulatory Lookback Date, none of the members of the Remainco Group (to the extent related to the Spinco Business) have received any written notice or other written communication from any Governmental Authority or any written notice from any other Person (i) regarding any actual or possible violation of, or failure to comply with, any Law or (ii) that it is or has been the subject of any inspection, investigation, survey, audit, monitoring or other form of review by any Governmental Authority, except as would not, individually or in the aggregate, reasonably be expected to be material to the Spinco Business or the Spinco Group, taken as a whole. (b) Since the Regulatory Lookback Date, none of the members of the Spinco Group have been in violation of Money Services Laws, or, to the extent applicable, denied a Money
Compliance with Laws; Regulatory Matters. (c) The businesses of each Group Company is, and since January 1, 2016 has been, conducted in compliance in all material respects with all applicable Laws, including (i) the FDCA, (ii) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (iii) federal, state or provincial criminal or civil Laws (including the False Claims Act (42 U.S.C. §1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, EPA Good Laboratory Practices (Title 40 CFR Part 160 & 792), FDA Electronic Records requirements (Title 21 CFR Part 11) and any comparable federal, state, provincial or local Laws), (iv) state or provincial licensing, disclosure and reporting requirements and (v) applicable requirements relating to Good Laboratory Practices, Good Clinical Practices, adverse event reporting, recordkeeping, and filing of reports. Since January 1, 2016, neither the Company nor any of its Subsidiaries has received any written notification or communication (or to the Knowledge of the Company, any oral notification or communication) from any relevant Governmental Entity of noncompliance by, or liability of the Company or its Subsidiaries under, any applicable Law, and, to the Knowledge of the Company, no notification or communication of noncompliance or liability has been threatened by any Governmental Entity. Notwithstanding the foregoing and for the avoidance of doubt, this Section 3.16 shall not apply with respect to Taxes, which shall be covered exclusively by Section 3.13 and Section 3.17.
Compliance with Laws; Regulatory Matters. (i) Each of the WSI Entities is in compliance with and has conducted their business in compliance with all applicable Laws, including without limitation, the Foreign Corrupt Practices Act and any applicable foreign corrupt practice Law, and Orders, except for instances of non-compliance which, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect, and (ii) none of the WSI Entities has received any written communication during the past three years from a Governmental Authority that alleges that any of the WSI Entities is not in compliance in any material respect with any applicable Law or Order. None of the WSI Entities have received notice that any investigation or review of the WSI Entities or the WSI Business by any Governmental Authority is pending. This Section 3.16 does not relate to matters with respect to Taxes, or Environmental Requirements, which are subject of Sections 3.13 and 3.17 respectively.
Compliance with Laws; Regulatory Matters. (i) Each of the IESI-BFC Entities is in compliance with and has conducted its business in compliance with all applicable Laws, including without limitation, the Foreign Corrupt Practices Act and any applicable foreign corrupt practice Law, and Orders, except for instances of non-compliance which, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect, and (ii) none of the IESI-BFC Entities has received any written communication during the past three years from a Governmental Authority that alleges that any of the IESI-BFC Entities is not in compliance in any material respect with any applicable Law or Order. None of the IESI-BFC Entities have received notice that any investigation or review of the IESI-BFC Entities or the IESI-BFC Business by any Governmental Authority is pending. This Section 4.16 does not relate to matters with respect to Taxes, or Environmental Requirements, which are subject of Sections 4.13 and 4.17, respectively.
Compliance with Laws; Regulatory Matters. (a) The Company and each of the Company Subsidiaries is, and since January 1, 2018 has been, in compliance with all Laws and the terms of its Permits, except for failures to comply or violations or alleged violations that have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Without limiting the generality of the foregoing, each of the Company and the Company Subsidiaries and, to the Company’s Knowledge, their respective CROs, CMOs or other service vendors or other Persons acting on their behalf are, and have been since January 1, 2018, acting or operated in material compliance with Health Care Laws, including in connection with the conduct of all Clinical Trials and pre-clinical and non-clinical studies conducted by or on behalf of the Company or any Company Subsidiary with respect to a Product Candidate.
