SEC Filings

8-K
PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019
Entire Document
 

 

Sellers, are subject to any proceeding by any Governmental Authority that would reasonably be expected to result in such suspension, exclusion or debarment and to the Knowledge of the Sellers, there are no facts that would reasonably be expected to give rise to such suspension, exclusion or debarment. 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 not currently, and have not been, since January 1, 2017, (i) a party to any consent decree, judgment, order, or settlement, or any actual or potential settlement agreement, corporate integrity agreement or certification of compliance agreement, or (ii) a defendant or named party in any unsealed qui tam/False Claims Act litigation, in each case that relates to the Products.

 

(f)                  To the Knowledge of the Sellers, the Sellers have not received any notice or other correspondence from the FDA, any other Governmental Authority or any safety oversight board commencing, or threatening to initiate, any action to place a clinical hold order on, or to terminate, delay, suspend, or materially modify any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of the Sellers relating to any Product, except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole).

 

(g)                Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), all manufacturing operations conducted by or on behalf of the Sellers or that Sellers use in the Ordinary Course of Business to manufacture their Products related to the Products have been, since January 1, 2017, and are being conducted in accordance, in all material respects, with Good Manufacturing Practice requirements for the Products and there has not been any notice or other correspondence from the FDA or any other Governmental Authority to recall, suspend or otherwise restrict the manufacture of the Products since January 1, 2017. 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, the Sellers have not either voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, "dear doctor" letter, investigator notice, or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product, and to the Knowledge of the Sellers, there are no facts that are reasonably likely to cause the recall of any Product.

 

Section 3.15               Privacy and Data Security.

 

(a)                 The Sellers are, and since January 1, 2017 have been, in all material respects in compliance with all applicable Information Privacy and Security Laws with respect to the Business. With respect to the Business, the Sellers maintain policies and procedures regarding data security and privacy and maintain administrative, technical, organizational and physical security safeguards that are required in compliance with all applicable Information Privacy and Security Laws.

 

(b)                Since January 1, 2017, and solely to the extent required under applicable Information Privacy and Security Laws, the Sellers have had in place written data processing agreements with any key vendors acting as processors in material compliance with applicable Information Privacy and Security Laws in the case of processors.

 

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