hazardous substance, toxic chemical, toxic substance, toxic waste, hazardous waste, special handling waste, industrial waste, residual waste, solid waste, municipal waste, mixed waste, infectious waste, chemotherapeutic waste, medical waste, or regulated substance or any other material, substance or waste, regardless of its form or nature, which otherwise is regulated by Environmental Laws.
(xvii) SOX Compliance. The Company has taken all actions it deems reasonably necessary or advisable to take on or prior to the date of this Agreement to assure that, upon and at all times after the date hereof, it will be in compliance in all material respects with all provisions of the Sarbanes-Oxley Act of 2002 and all rules and regulations promulgated thereunder or implementing the provisions thereof (the Sarbanes-Oxley Act) that are then in effect and applicable to the Company.
(xviii) Compliance with Health Care Laws. The Company and each of its subsidiaries and, to the Companys knowledge, the directors, officers, employees, and agents (while acting in such capacity) of the Company and each of its subsidiaries are, and at all times since August 1, 2018 have been, in compliance with, all health care laws and regulations applicable to the Company or its subsidiaries, including all such health care laws and regulations pertaining to development and testing of health care products or medical devices, fraud and abuse, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by health care laws), quality, safety, privacy, security, licensure, ownership, manufacturing, packaging, labeling, processing, use, distribution, storage, import, export, advertising, promotion, marketing or disposal of health care products or medical devices (collectively, Health Care Laws), except where such noncompliance would not, individually or in the aggregate, have a Material Adverse Effect. Except as set forth in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, neither the Company nor any of its subsidiaries has received any written notification, correspondence or any other written communication for non-compliance of Health Care Laws, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority, including, without limitation, the United States Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, where such alleged noncompliance would, individually or in the aggregate, have a Material Adverse Effect. To the Companys knowledge, there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company or any of its subsidiaries under any Health Care Laws, except that would not individually or in the aggregate have a Material Adverse Effect Except as set forth in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, the manufacture of products by or on behalf of the Company and its subsidiaries is being conducted in compliance in all material respects with all Health Care Laws applicable to the Company or its subsidiaries or any of its products or activities, including, without limitation, the FDAs current good manufacturing practice regulations at 21 C.F.R. Part 820 for products sold in the United States, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package, the Prospectus and any Permitted Free Writing Prospectus (as defined below) or as would not reasonably be expected to have a Material Adverse Effect, during the three year period ended on December 31, 2019 and through the date hereof, neither Company nor any of its subsidiaries has had any product or Company- or subsidiary-owned manufacturing site subject to