SEC Filings

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

 

Governmental Authority with respect to any such filings or Product Approvals since January 1, 2017.

 

(c)                 All Product Regulatory Materials disclosed to Buyer are true, correct and complete in all material respects.

 

(d)                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 not received any written notice of adverse finding, written notice of violation, warning letter, untitled letter, regulatory letter, notice of inspectional observations (Form FDA 483), correspondence regarding the termination or suspension or delay or modification of any ongoing clinical or pre-clinical studies or tests, establishment inspection reports or other correspondence or notice from the FDA or any other applicable Governmental Authority that assert (i) any deficiency in the conduct of any research, formulation, pre-clinical or other testing, clinical trial, investigation, post-market research (including research required by a Governmental Authority) in connection with the Products, or the manufacture, processing, packaging, holding, distribution, marketing or selling of the Products, or (ii) any other lack of compliance with Health Care Laws in connection with the Products. 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 not received written notice of any pending or threatened civil, criminal, administrative or regulatory claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration, inquiry, search warrant, subpoena, or request for information by any Governmental Authority relating to any violation of Health Care Laws against the Sellers or, to the Knowledge of the Sellers, any person that has or is conducting or overseeing any research, development, pre-clinical or clinical testing of the Products, or that manufactures, packages, labels, imports, exports, stores, distributes or sells the Products pursuant to a manufacturing, supply or other arrangement with the Sellers, in each case since January 1, 2017.

 

(e)                 Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), neither the Sellers, nor, to the Knowledge of the Sellers, any member, officer, director, partner, employee, contractor or agent of any of the Sellers has made an untrue statement of fact or a fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities", set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy 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), neither the Sellers nor any member, officer, director, partner, employee, contractor or agent of the Sellers has been assessed or threatened with assessment of a civil monetary penalty, debarred or convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. Section 335a or any Health Care Laws or exclusion under 42 U.S.C. Section 1320a 7 or any Health Care Laws 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), neither the Sellers nor, to the Knowledge of the Sellers, any member, officer, director, partner, employee or agent of the

 

52