Compliance with Law; Regulatory Matters. Licensee represents and warrants that it will comply, and will ensure that its Affiliates and Sublicensees comply, with all local, state, and international laws and regulations relating to its and their performance of their obligations and exercise of their rights under this Agreement, including without limitation, with respect to the manufacture, use, marketing and sale of Licensed Product. Without limiting the foregoing, Licensee represents and warrants that it will comply, and will ensure that its Affiliates and Sublicensees will comply, with all regulatory requirements of the FDA and the United States Federal Drug Enforcement Agency.
Compliance with Law; Regulatory Matters. No written communication has been received by Citius or any of its Affiliates, and no investigation, regulatory enforcement action or any related review by any Regulatory Authority or other governmental authority is or at any time prior to the Effective Date has been pending (or, to the knowledge of Citius and its Affiliates, is or at any time prior to the Effective Date has been threatened) by any Regulatory Authority or other governmental authority with respect to any alleged or actual violation by Citius, any of its Affiliates or any third party of any Applicable Law or other requirement of any Regulatory Authority or other governmental authority relating to the development, clinical trial and other operations conducted by Citius or any of its Affiliates or third party with respect to any of the Licensed Intellectual Property or any Product. To Citius’ knowledge, the Products, and all Licensed Intellectual Property and data and information included in the Citius Regulatory Filings and Approvals, have been developed in accordance with Applicable Law. As of the Effective Date, all Citius Regulatory Filings and Approvals are valid and in full force and effect. As of the Effective Date, there is no proceeding pending or, to the knowledge of Citius, threatened, to revoke, suspend, or modify any of the Citius Regulatory Filings and Approvals.
Compliance with Law; Regulatory Matters. Except as set forth on Schedule 3.9:
(a) each of the Purchased Companies is, and has been at all times since April 18, 2019, in compliance with all Laws applicable to it or its business, properties or assets, except for such noncompliance as would not, individually or in the aggregate, reasonably be expected to result in a material liability to the Purchased Companies, taken as a whole, or prevent or materially impair or delay either Seller’s ability to execute, deliver or perform this Agreement or any Ancillary Agreement, or to timely consummate the transactions contemplated hereby or thereby; and
(b) Griffon has heretofore made available to Buyer copies of all written notices received by any Purchased Company alleging any material violation under any applicable Law at any time since April 18, 2019.
Compliance with Law; Regulatory Matters. (a) Each of Parent and its Subsidiaries is in compliance with all Law, including Law enforced by the FDA and comparable foreign regulatory or governmental entities, except where the failure to so comply would not reasonably be expected to have a Parent Material Adverse Effect.
(b) Parent (i) is not and has not been Debarred, (ii) does not employ or use the services of any person or entity that is Debarred and (iii) to the knowledge of Parent has not employed or used the services of any person or entity that is or, during the time when such person or entity was employed by or providing services to Parent, was Debarred, except in the case of this clause (iii) as would not reasonably be expected to have a Parent Material Adverse Effect.
(c) Each of the products and product candidates of Parent and its Subsidiaries is being, and at all times has been, developed, tested, manufactured and stored, as applicable, in compliance with the FDA Act and applicable regulations and guidances issued by the FDA, including those requirements relating to good manufacturing practice, good laboratory practice and good clinical practice, except where the failure to so comply would not reasonably be expected to have a Parent Material Adverse Effect.
(d) Parent has made available to the Company each annual report filed by any of Parent and its Subsidiaries with the FDA and any similar state or foreign regulatory or governmental entity with respect to the products and product candidates listed on Section 3.8(d) of the Parent Disclosure Schedule (such products and product candidates, the “Identified Parent Products”).
(e) Parent has made available to the Company as of the date hereof (A) complete and correct copies of each NDA and each IND, made on behalf of any of Parent and its Subsidiaries with respect to the Identified Parent Products, including all material supplements and amendments thereto, (B) all correspondence, other than immaterial correspondence, sent to and received from the FDA and similar state Governmental Authorities that concerns or would reasonably be expected to impact any Identified Parent Product, and (C) all existing written records relating to all material discussions and all meetings between Parent or its Subsidiaries and the FDA relating to any Identified Parent Product.
(f) The clinical trials (including any post-marketing studies), animal studies and other preclinical tests conducted by Parent or its Subsidiaries with respect to each Identified Parent Pro...
Compliance with Law; Regulatory Matters. Suneva will act in accordance with Applicable Law with respect to the sales and marketing of any Products. No written communication has been received by Suneva, and no regulatory enforcement action or any related review, or to the knowledge of Suneva, investigation, by any Regulatory Authority or other governmental authority is or at any time prior to the Effective Date, has been, pending ( or, to the knowledge of Suneva, is or at any time prior to the Effective Date, has been, threatened by any Regulatory Authority or other governmental authority) with respect to any alleged or actual violation by Suneva of any Applicable Law or other requirement of any Regulatory Authority or other governmental authority relating to the development, clinical trials and other operations conducted by Suneva.
Compliance with Law; Regulatory Matters. (a) The Company is (and has been at all times during the past five (5) years) in compliance, in all material respects, with all applicable Laws. Except as set forth on Schedule 4.13(a), the Company has not been charged with, nor received any written notice that it is under investigation by a Governmental Entity with respect to, any violation of any applicable Law, and the Company has not received written notice that it has been charged with any violation of any applicable Law or other requirement of a Governmental Entity. The Company does not sell, nor has it ever sold, any product or provided any services directly to any Governmental Entity. The Company is not currently under any contract or agreement with any Governmental Entity. The Company has not received written notice from any Governmental Entity notifying the Company that it has been debarred or suspended from doing business with any Governmental Entity.
(b) The Company is (and has been at all times during the past five (5) years) in compliance, in all material respects, with all applicable Laws relating to the importation of merchandise into the United States. The Company’s origin declarations with respect to the conduct of the Business are (and during the past five (5) years have been) accurate in all material respects and based on the exercise of reasonable care. Except as set forth on Schedule 4.13(b), the Company has not received any written, or to the Knowledge of the Company, oral, communication with respect to the conduct of the Business during the past five (5) years from United States Customs and Border Protection, or its predecessor, the United States Customs Service, that: (i) alleges that the Company is not in compliance with any applicable Law; (ii) excludes merchandise; or (iii) asserts that the Company owes additional duties, liquidated damages, penalties, or fees.
(c) All products sold by the Company are (and have been at all times during the past five (5) years) in compliance in all material respects with the U.S. Consumer Product Safety Act, the Flammable Fabrics Act, the Hazardous Substances Act, and all rules and regulations of the U.S. Consumer Product Safety Commission as well as all state Laws relating to product safety and related matters.
(d) Neither the Company nor any director, agent, or employee of the Company, nor, to the Knowledge of the Company, any other Person associated with or acting for or on behalf of the Company, has ever (i) taken any action in furtherance of...
Compliance with Law; Regulatory Matters. Except as set forth on Schedule 3.9:
Compliance with Law; Regulatory Matters. The Company and the conduct of the Business are, and in the past five (5) years have been, in compliance in all material respects with any applicable foreign, federal or state law, regulation, ordinance, order, License, rule, judgment, injunction or other restriction or ruling of any Government (hereinafter collectively referred to as “Law” or “Laws”).
Compliance with Law; Regulatory Matters. No written communication has been received by CVTV or any of its Subsidiaries and Affiliates, and no investigation, regulatory enforcement action or any related review by any Regulatory Authority or other governmental authority is or at any time prior to the Effective Date has been pending (or, to the knowledge of CVTV and its Subsidiaries and Affiliates, is or at any time prior to the Effective Date has been threatened) by any Regulatory Authority or other governmental authority with respect to any alleged or actual violation by CVTV, any of its Subsidiaries and Affiliates or any third party of any Applicable Law or other requirement of any Regulatory Authority.
Compliance with Law; Regulatory Matters. CybEye represents and warrants that it shall comply, and shall ensure that its Affiliates comply, with all local, state and international laws and regulations relating to its and their performance of their obligations and exercise of their rights under this Agreement.
