Section 4.14 Compliance with Laws; Permits; Regulatory Matters.
(a) Each Company is, and since January 1, 2015 such Company has been, and conducts and has conducted its business, in material compliance with all Laws applicable to it, the Products, the Business and its properties or assets, including those of the FDA, DEA, FTC, CMS and other Regulatory Authorities. As required under Law, or pursuant to regulation, the Companies have maintained, filed, or furnished to the applicable Regulatory Authority, Governmental Authority, or Person all material registrations, listings, filings, documents, claims, reports, notices, and other submissions (collectively Reports) required to be maintained, filed, or furnished on a timely basis. At the time of maintenance, filing, or furnishing, all such Reports were complete and accurate in all material respects, or were subsequently updated, changed, corrected, or modified.
(b) Section 4.14(b) of the Disclosure Schedules sets forth a complete and correct list of all material Permits, except Environmental Permits, held by the Companies, which constitute all material Permits, except Environmental Permits, that are required under all applicable Laws to own, operate and lease the properties and assets that each purports to own, operate or lease, to manufacture or market any Product and to conduct their business as currently conducted. All such Permits held by the Companies are valid and in full force and effect and will continue in full force and effect immediately following the Closing and no Company is in material default under or in material violation of (and, to Sellers Knowledge, no event has occurred that, with notice or the lapse of time or both, would constitute a material default under or material violation of) any Permit held by it. There are no Proceedings pending or, to Sellers Knowledge, threatened against either Company that could reasonably be expected to result in the revocation, cancellation, suspension or limitation of any Permit held by such Company.
(c) Except as set forth on Section 4.14(c) of the Disclosure Schedules, the Companies have not, since January 1, 2015, voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals, removals or replacements, warnings, dear doctor letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, stability or regulatory compliance of any Product developed, manufactured, tested, processed, packaged, labeled, repackaged, relabeled, imported, stored or held for sale, distributed, sold, used or marketed by or on behalf of the Companies. None of the Companies have received any written notice since January 1, 2015 through the date hereof, that the FDA, DEA, FTC, CMS, National Institutes of Health, Office of the Inspector General for the Department of Health and Human Services, Department of Justice, or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke, deny or withdraw any Regulatory Approval or other marketing authority of a Product, or request the recall, market withdrawal, removal or replacement of any Product, (ii) commenced, or threatened to initiate, any action to seize any Product or enjoin the development, manufacture, testing, processing, packaging, labeling, repackaging, relabeling, import, storage, sale, use, marketing, promotion or distribution of any Product, or (iii) commenced, or threatened to initiate, any action to seize any Product or enjoin the development, manufacture, testing, processing, packaging, labeling, repackaging, relabeling, import, storage, sale, use, marketing, promotion or distribution of any Product produced at any facility where any Product is developed, manufactured, tested, processed, packaged, labeled or held for sale, distributed, sold, or used.