(d) The development, manufacture, labeling and storage, as applicable, of any drugs or products by Impax and each of its Subsidiaries has been since January 1, 2014, and is being conducted, in compliance in all material respects with all applicable Laws of the FDA, U.S. Customs and Border Protection (“U.S. Customs”), DEA and other Healthcare Regulatory Authorities, including the FDA’s current Good Laboratory Practices, Good Manufacturing Practices and Good Clinical Practices. For the purposes of this Agreement, (i) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58, (ii) “Good Manufacturing Practices” means the current good manufacturing practices for drugs and medical devices, including the regulations for drugs and finished pharmaceutical products contained in 21 C.F.R. Parts 210 and 211, respectively, and medical devices contained in 21 C.F.R. 820, and (iii) “Good Clinical Practices” means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in 21 C.F.R. Parts 50, 54, 56 and 312, as applicable.
(e) Since January 1, 2014, neither Impax nor any of its Subsidiaries has (i) voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, or (ii) received any notices, information request letters, correspondence, orders or other communication from any Healthcare Regulatory Authority issuing, requiring or causing any recalls, seizures, detentions, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of, or enjoining manufacture or distribution of, any product or product candidate manufactured, distributed or marketed by or on behalf of Impax or any of its Subsidiaries and to Impax’s Knowledge no Healthcare Regulatory Authority and neither Impax nor any of its Subsidiaries is considering such action. Since January 1, 2014 until the date hereof, neither Impax nor any of its Subsidiaries has received any written or, to Impax’s Knowledge, oral notices, information request letters, correspondence, orders or other communications from any Healthcare Regulatory Authority regarding new safety information, postmarketing clinical trials or studies or risk evaluation and mitigation strategies asserting that labeling changes, postmarketing trials, studies, or other action will be required in order to ensure the safety of any products or product candidates.
(f) All studies, tests and clinical and pre-clinical trials conducted by or, the Knowledge of the Impax, on behalf of Impax or any of its Subsidiaries, or in which Impax or any of its Subsidiaries or their products or product candidates have participated were and, if still pending, have been and are being conducted in material compliance with all applicable Laws, including the applicable requirements of Good Laboratory Practices and Good Clinical Practices. Neither Impax nor any of its Subsidiaries has received any written or, to Impax’s Knowledge, oral notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any ongoing or planned clinical trials conducted by, or, to Impax’s Knowledge, on behalf of, Impax or any of its Subsidiaries or the business currently conducted by any of them, or in which Impax or any of its Subsidiaries or their products or product candidates have participated.
(g) Since January 1, 2014, neither Impax nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, letters of admonition, untitled letters or other written or, to Impax’s Knowledge, oral correspondence from any Healthcare Regulatory Authority alleging or asserting material noncompliance with any Laws applicable to, or a lack of safety regarding, Impax’s or any of its Subsidiaries’ manufacturing practices any product or product candidate manufactured, distributed or marketed by or on behalf of Impax or any of its Subsidiaries. Neither Impax nor any of its Subsidiaries is subject to any material order of, obligation or commitment to, or settlement with, any Healthcare Regulatory Authority. To Impax’s Knowledge, no event has occurred which would reasonably be expect to lead to any material claim, suit, proceeding, hearing, enforcement, audit, investigation, inspection by any Healthcare Regulatory Authority or any FDA warning letter, untitled letter, or request or requirement to make changes to the products or procedures of Impax or its Subsidiaries that, if not complied with, would reasonably be expected to have an Impax Material Adverse Effect.
(h) Neither Impax nor any of its Subsidiaries, nor any of their respective officers, directors, employees, nor, to Impax’s Knowledge, any of their respective contractors, suppliers, agents, or other company or individual performing research or product-related work on behalf of Impax or any of its Subsidiaries, nor any other person
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