|PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019|
2017, all Taxes relating to the Business or the Transferred Assets (i) that were due and payable have been duly and timely paid and (ii) that are incurred in or attributable to the Pre-Closing Tax Period and are not yet due and payable, have had adequate provision in accordance with GAAP made for their payment.
(b) There is no action, suit, claim, assessment, or audit, pending, proposed in writing, or, to the Sellers' Knowledge, threatened in writing with respect to Taxes relating to the Business or the Transferred Assets. Since January 1, 2017, no Governmental Authority has made a claim in writing that the Business and/or the Transferred Assets may be subject to material Tax, or that a material Tax Return relating to the Business and/or the Transferred Assets may be required to be filed, in a jurisdiction where no such Tax Returns have been filed.
(c) There are no Encumbrances for Taxes upon the Transferred Assets other than Permitted Encumbrances described in clause (a) of the definition thereof.
Section 3.14 Regulatory Matters.
(a) Since January 1, 2017, the Products have been and are being researched, developed, tested, investigated, produced, manufactured, labeled, distributed, stored, sold, imported and exported, and all business operations of the Sellers relating to pre-clinical and clinical investigations sponsored by the Sellers or involving Products, or to the marketing, advertising, medical information and medical affairs activities and communications, sale and pricing of the Products (including by means of the outsourcing by Sellers of any of the foregoing activities) have been and are being conducted in all material respects in compliance with Health Care Laws.
(b) Except as set forth on Section 3.14(b) of the Disclosure Letter and as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), the Sellers have all Regulatory Approvals and have all the applicable documentation related to such Regulatory Approvals as provided for in the definition of Product Approvals. Each Product Approval is valid and in full force and effect except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole). The Sellers are in compliance in all material respects with, and since January 1, 2017, have fulfilled and performed in all material respects their respective obligations under, each such Regulatory Approval. There is no action or proceeding by any Governmental Authority pending or, to the Knowledge of the Sellers, threatened seeking the revocation or suspension of any of the Product Approvals, and since January 1, 2017, no event has occurred or condition or state of facts exists that would constitute a breach or default, or would reasonably be expected to cause revocation, termination, or modification of any of the Product Approvals, in each case except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole). Since January 1, 2017, Sellers have filed with the FDA and any other applicable Governmental Authority all material filings, notices, registrations, reports or submissions which are required under any Product Approval or by any Health Care Law to have been filed or obtained as of the date hereof. All such documents were when filed or submitted, and continue to be, in material compliance with applicable Health Care Laws and to the Knowledge of the Sellers, no material deficiencies have been asserted by any applicable