Compliance with Law; Regulatory Matters. Except as set forth on Schedule 3.9:
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. 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. No written communication has been received by any of the Histogen Parties, and to the knowledge of the Histogen Parties no regulatory enforcement action or any related review or investigation by any Regulatory Authority or other governmental authority is pending or threatened with respect to any alleged or actual violation by any of the Histogen Parties of any Applicable Law or other requirement of any Regulatory Authority or other governmental authority relating to the development, clinical trials or other operations conducted by any of the Histogen Parties with respect to any of the Licensed Intellectual Property for any Product. All Technical Information has been developed by the Histogen Parties in accordance with Applicable Law.
Compliance with Law; Regulatory Matters. No written communication has been received by any of the Healeon Parties, and to the knowledge of the Healeon Parties no regulatory enforcement action or any related review or investigation by any Regulatory Authority or other governmental authority is pending or threatened with respect to any alleged or actual violation by any of the Healeon Parties of any Applicable Law or other requirement of any Regulatory Authority or other governmental authority relating to the development, clinical trials or other operations conducted by any of the Healeon Parties with respect to any of the Licensed Intellectual Property for any Product. To the knowledge of Healeon, all Technical Information has been developed in accordance with Applicable Law.
Compliance with Law; Regulatory Matters. (a) The Business and the Seller’s use of the Purchased Assets is currently being conducted in material compliance with the Acquired Regulatory Approvals and all applicable Laws. No loss, revocation, termination, suspension or expiration of any Acquired Regulatory Approval is pending, reasonably foreseeable, or to the Knowledge of the Seller, threatened, other than the expiration in accordance with the terms thereof.
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.
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.
