FDA and Regulatory Matters. (a) Except as would not have a material impact on Akebia, Akebia and its Subsidiaries hold all licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearances, and have submitted notices to, all Governmental Bodies, including all authorizations under the FDCA, the PHSA, as amended, and the regulations of the FDA promulgated thereunder, and any other Governmental Body that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of Akebia’s Products (any such Governmental Body, an “Akebia Regulatory Agency”) necessary for the lawful operation of the businesses of Akebia or any of its Subsidiaries as currently conducted (the “Akebia Permits”), and as of the date hereof, all such Akebia Permits are valid and in full force and effect. Except as would not have a material impact on Akebia, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Akebia Permit. Except as would not have a material impact on Akebia, Akebia and each of its Subsidiaries are in compliance with the terms of all Akebia Permits, and no event has occurred that, to the Knowledge of Akebia, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Akebia Permit. Since January 1, 2015, neither Akebia nor any of its Subsidiaries has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or other Akebia Regulatory Agency alleging that any operation or activity of Akebia or any of its Subsidiaries is in material violation of any applicable Law, except as would not have an Akebia Material Adverse Effect. (b) Except as would not have a material impact on Akebia, since January 1, 2015, all of Akebia’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Akebia Regulatory Agencies have been manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of Akebia or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Permit or Law, including applicable statutes and implementing regulations administered or enforced by the FDA or other Akebia Regulatory Agency. Except as would not have a material impact on Akebia, since January 1, 2015, all applications, submissions, notifications, information and data utilized by Akebia or its Subsidiaries as the basis for, or submitted by or, to the Knowledge of Akebia, on behalf of Akebia or its Subsidiaries in connection with, any and all requests for the Akebia Permits relating to Akebia or any of its Subsidiaries when submitted to the FDA or other Akebia Regulatory Agency, were true, complete and correct as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, notifications, information and data required under applicable Laws have been submitted to the FDA or other Akebia Regulatory Agency. (c) Except as would not have a material impact on Akebia, since January 1, 2015, neither Akebia, nor its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Akebia Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Except as would not have a material impact on Akebia, neither Akebia nor or any of its Subsidiaries nor, to the Knowledge of Akebia, any of their respective officers, employees, contractors, suppliers or other entities or individuals performing research or work on behalf of Akebia or any of its Subsidiaries has been subject to any kind of consent decree, individual integrity agreement, deferred prosecution agreement, or other similar form of agreement with any Governmental Body or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in a material debarment or exclusion under applicable Law, including, without limitation, 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the Knowledge of Akebia, threatened against Akebia or any of its Subsidiaries or, to the Knowledge of Akebia, any of their respective officers, employees, contractors, suppliers, or other entities or individuals performing research or work on behalf of Akebia or any of its Subsidiaries. (d) To the Knowledge of Akebia, since January 1, 2015, the manufacture of Products by or on behalf of Akebia and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws including the FDA’s current Good Manufacturing Practices. Since January 1, 2015, none of Akebia, any of its Subsidiaries, or, to the Knowledge of Akebia, any of their respective contract manufacturers for Products, has received any FDA Form 483, warning letter, untitled letter, or other similar correspondence or written notice from the FDA or any other Akebia Regulatory Agency alleging or asserting material noncompliance with any applicable Laws or Akebia Permits with respect to any Product of Akebia or its Subsidiaries. Since January 1, 2015, no manufacturing site owned by Akebia, its Subsidiaries, or, to the Knowledge of Akebia, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Akebia Regulatory Agency. Except as would not have a material impact on Akebia, to the Knowledge of Akebia, no event has occurred which would reasonably be expected to lead to any claim, suit, proceeding, investigation, enforcement, inspection or other action by any Akebia Regulatory Agency or any FDA warning letter, untitled letter, or request or requirement to make material changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (e) Since January 1, 2015, all studies, tests and preclinical and clinical trials being conducted by Akebia or its Subsidiaries, or in which Akebia, its Subsidiaries or any Product or Product candidate has participated, have been and are being conducted in material compliance with applicable Laws, including the applicable requirements of Good Laboratory Practices or Good Clinical Practices. Since January 1, 2015, Akebia and its Subsidiaries have not received any written notices, correspondence or other communication from any institutional review board, the FDA or any other Akebia Regulatory Agency, recommending or requiring the termination, suspension, or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, Akebia or its Subsidiaries. (f) Except as would not have a material impact on Akebia, since January 1, 2015, Akebia and its Subsidiaries have not either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notification, field correction, market withdrawal, or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action, in each case relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product candidate (“Akebia Safety Notices”). Except as would not have an Akebia Material Adverse Effect, as of the date hereof, Akebia has no Knowledge of any facts which would cause (i) an Akebia Safety Notice with respect to any Product sold or intended to be sold by Akebia or its Subsidiaries, (ii) a change in the marketing classification or a material change in labeling of any such Products, (iii) a termination or suspension of marketing or testing of any such Products, or (iv) the imposition of a postmarketing study or risk evaluation and mitigation strategy by the FDA or other Akebia Regulatory Agency. (g) Except as would not have an Akebia Material Adverse Effect, Akebia and its Subsidiaries are, and at all times since January 1, 2015 have been, in compliance with all applicable Healthcare Laws. There is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, proceeding, notice or demand pending, received by or filed since January 1, 2015, or to the Knowledge of Akebia, threatened in writing, against Akebia or any Akebia Subsidiary alleging any material violation by Akebia or its Subsidiaries of any applicable Healthcare Laws. (h) Neither Akebia nor any of its Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, deferred prosecution agreements, settlement orders or similar agreements with or imposed by any Governmental Body. (i) Except as would not have a material impact on Akebia, neither Akebia, its Subsidiaries nor any of their respective directors, officers, or employees, nor, to the Knowledge of Akebia, any of its agents or distributors or any other person while acting on behalf of Akebia or any of its Subsidiaries has at any time since January 1, 2015, (i) violated or is in violation of any provision of the FCPA, (ii) violated or is in violation of any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention, (iii) violated or is in violation of any provision of the UK Bribery Act, (iv) violated any anti-bribery or anti-corruption Law in any foreign jurisdiction, (v) made, offered to make, promised to make, or authorized the payment or giving of, directly or indirectly, any Prohibited Payment, (vi) been subject to any investigation by any Governmental Body with regard to any Prohibited Payment or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. (j) Since January 1, 2015, and except as would not have a material impact on Akebia, Akebia has: (x) distributed Product samples in accordance with applicable Healthcare Laws, and the provision of such samples has been appropriately documented in accordance with requirements of the Prescription Drug Marketing Act of 1987; and (y) filed complete and accurate reports as required under the federal Sunshine/Open Payments Law and all applicable state transparency Laws, including Laws requiring certifications of compliance with the PhRMA Code and other compliance program certifications. (k) Except as disclosed in Section 3.20(k) of the Akebia Disclosure Letter or as would not have an Akebia Material Adverse Effect, as of the date hereof, neither Akebia nor its Subsidiaries has received written notice that it is subject to any pending or threatened investigation, claim, or enforcement action by FDA, HHS-OIG, private whistleblowers, CMS, VA, VA OIG, or DOJ, or any other state or non-U.S. equivalent Governmental Bodies pursuant to the Healthcare Laws. Akebia has no Knowledge of any fact that would require Akebia to restate or resubmit to the government any data reported under the Medicaid Rebate Statute, Medicare Part B Drug Pricing requirements, 340B Program requirements, Veterans Health Care Act of 1992, or the Medicare Part D Coverage Gap Discount Program to comply with such Price Reporting Laws, or refund any monies owed due to a resubmission or restatement.
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FDA and Regulatory Matters. (a) Except as would not have a material impact on AkebiaKeryx, Akebia Keryx and its Subsidiaries hold all licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearances, and have submitted notices to, all Governmental Bodies, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the PHSAPublic Health Service Act of 1944, as amendedamended (the “PHSA”), and the regulations of the FDA U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and any other Governmental Body that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of AkebiaKeryx’s Products (any such Governmental Body, an a “Akebia Keryx Regulatory Agency”) necessary for the lawful operation of the businesses of Akebia Keryx or any of its Subsidiaries as currently conducted (the “Akebia Keryx Permits”), and as of the date hereof, all such Akebia Keryx Permits are valid and in full force and effect. Except as would not have a material impact on AkebiaKeryx, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Akebia Keryx Permit. Except as would not have a material impact on AkebiaKeryx, Akebia Keryx and each of its Subsidiaries are in compliance with the terms of all Akebia Keryx Permits, and no event has occurred that, to the Knowledge of AkebiaKeryx, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Akebia Keryx Permit. Since January 1, 2015, neither Akebia Keryx nor any of its Subsidiaries has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or other Akebia Keryx Regulatory Agency alleging that any operation or activity of Akebia Keryx or any of its Subsidiaries is in material violation of any applicable Law, except as would not have an Akebia a Keryx Material Adverse Effect.
(b) Except as would not have a material impact on AkebiaKeryx, since January 1, 2015, all of AkebiaKeryx’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Akebia Keryx Regulatory Agencies have been manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of Akebia Keryx or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Permit or Law, including applicable statutes and implementing regulations administered or enforced by the FDA or other Akebia Keryx Regulatory Agency. Except as would not have a material impact on AkebiaKeryx, since January 1, 2015, all applications, submissions, notifications, information and data utilized by Akebia Keryx or its Subsidiaries as the basis for, or submitted by or, to the Knowledge of AkebiaKeryx, on behalf of Akebia Keryx or its Subsidiaries in connection with, any and all requests for the Akebia Keryx Permits relating to Akebia Keryx or any of its Subsidiaries when submitted to the FDA or other Akebia Keryx Regulatory Agency, were true, complete and correct as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, notifications, information and data required under applicable Laws have been submitted to the FDA or other Akebia Keryx Regulatory Agency.
(c) Except as would not have a material impact on AkebiaKeryx, since January 1, 2015, neither AkebiaKeryx, nor its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Akebia Keryx Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Except as would not have a material impact on AkebiaKeryx, neither Akebia Keryx nor or any of its Subsidiaries nor, to the Knowledge of AkebiaKeryx, any of their respective officers, employees, contractors, suppliers or other entities or individuals performing research or work on behalf of Akebia Keryx or any of its Subsidiaries has been subject to any kind of consent decree, individual integrity agreement, deferred prosecution agreement, or other similar form of agreement with any Governmental Body or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in a material debarment or exclusion under applicable Law, including, without limitation, 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the Knowledge of AkebiaKeryx, threatened against Akebia Keryx or any of its Subsidiaries or, to the Knowledge of AkebiaKeryx, any of their respective officers, employees, contractors, suppliers, suppliers or other entities or individuals performing research or work on behalf of Akebia Keryx or any of its Subsidiaries.
(d) To the Knowledge of AkebiaKeryx, since January 1, 2015, the manufacture of Products by or on behalf of Akebia Keryx and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws including the FDA’s current Good Manufacturing Practices. Since January 1, 2015, none of AkebiaKeryx, any of its Subsidiaries, or, to the Knowledge of AkebiaKeryx, any of their respective contract manufacturers for Products, has received any FDA Form 483, warning letter, untitled letter, or other similar correspondence or written notice from the FDA or any other Akebia Keryx Regulatory Agency alleging or asserting material noncompliance with any applicable Laws or Akebia Keryx Permits with respect to any Product of Akebia Keryx or its Subsidiaries. Since January 1, 2015, no manufacturing site owned by AkebiaKeryx, its Subsidiaries, or, to the Knowledge of AkebiaKeryx, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Akebia Keryx Regulatory Agency. Except as would not have a material impact on AkebiaKeryx, to the Knowledge of AkebiaKeryx, no event has occurred which would reasonably be expected to lead to any claim, suit, proceeding, investigation, enforcement, inspection or other action by any Akebia Keryx Regulatory Agency or any FDA warning letter, untitled letter, or request or requirement to make material changes to the Products or the manner in which the Products are manufactured, distributed or marketed.
(e) Since January 1, 2015, all studies, tests and preclinical and clinical trials being conducted by Akebia Keryx or its Subsidiaries, or in which AkebiaKeryx, its Subsidiaries or any Product or Product candidate has participated, have been and are being conducted in material compliance with applicable Laws, including the applicable requirements of Good Laboratory Practices or Good Clinical Practices. Since January 1, 2015, Akebia Keryx and its Subsidiaries have not received any written notices, correspondence or other communication from any institutional review board, the FDA or any other Akebia Keryx Regulatory Agency, recommending or requiring the termination, suspension, or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, Akebia Keryx or its Subsidiaries.
(f) Except as would not have a material impact on AkebiaKeryx, since January 1, 2015, Akebia Keryx and its Subsidiaries have not either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notification, field correction, market withdrawal, or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action, in each case relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product candidate (“Akebia Keryx Safety Notices”). Except as would not have an Akebia a Keryx Material Adverse Effect, as of the date hereof, Akebia Keryx has no Knowledge of any facts which would cause (i) an Akebia a Keryx Safety Notice with respect to any Product sold or intended to be sold by Akebia Keryx or its Subsidiaries, ; (ii) a change in the marketing classification or a material change in labeling of any such Products, ; (iii) a termination or suspension of marketing or testing of any such Products, ; or (iv) the imposition of a postmarketing study or risk evaluation and mitigation strategy by the FDA or other Akebia Keryx Regulatory Agency.
(g) Except as would not have an Akebia a Keryx Material Adverse Effect, Akebia Keryx and its Subsidiaries are, and at all times since January 1, 2015 have been, in compliance with all applicable Healthcare Laws. There is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, proceeding, notice or demand pending, received by or filed since January 1, 2015, or to the Knowledge of AkebiaKeryx, threatened in writing, against Akebia Keryx or any Akebia Keryx Subsidiary alleging any material violation by Akebia Keryx or its Subsidiaries Subsidiary of any applicable Healthcare Laws.
(h) Neither Akebia Keryx nor any of its Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, deferred prosecution agreements, settlement orders or similar agreements with or imposed by any Governmental Body.
(i) Except as would not have a material impact on AkebiaKeryx, neither AkebiaKeryx, its Subsidiaries nor any of their respective directors, officers, or employees, nor, to the Knowledge of AkebiaKeryx, any of its agents or distributors or any other person while acting on behalf of Akebia Keryx or any of its Subsidiaries has has, at any time since January 1, 2015, (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”), (ii) violated or is in violation of any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions (the “OECD Convention”), (iii) violated or is in violation of any provision of the UK Bribery Act of 2010 (the “UK Bribery Act”), (iv) violated any anti-bribery or anti-corruption Law in any foreign jurisdiction, (v) made, offered to make, promised to make, or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful payment or gift of money or anything of value prohibited under any applicable Law addressing matters comparable to those addressed by the FCPA, the UK Bribery Act, or the OECD Convention implementing legislation concerning such payments or gifts in any jurisdiction (any such payment, a “Prohibited Payment”), (vi) been subject to any investigation by any Governmental Body with regard to any Prohibited Payment or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery.
(j) Since January 1, 2015, and except as would not have a material impact on AkebiaKeryx, Akebia Keryx has: (x) distributed Product samples in accordance with applicable Healthcare Laws, and the provision of such samples has been appropriately documented in accordance with requirements of the Prescription Drug Marketing Act of 1987; and (y) filed complete and accurate reports as required under the federal Sunshine/Open Payments Law and all applicable state transparency Laws, including Laws requiring certifications of compliance with the PhRMA Code and other compliance program certifications.
(k) Except as disclosed in Section 3.20(k2.20(k) of the Akebia Keryx Disclosure Letter or as would not have an Akebia a Keryx Material Adverse Effect, as of the date hereof, neither Akebia Keryx nor its Subsidiaries has received written notice that it is subject to any pending or threatened investigation, claim, or enforcement action by FDA, HHS-OIG, private whistleblowers, CMS, VA, VA OIG, or DOJ, or any other state or non-U.S. equivalent Governmental Bodies pursuant to the Healthcare Laws. Akebia Keryx has no Knowledge of any fact that would require Akebia Keryx to restate or resubmit to the government any data reported under the Medicaid Rebate Statute, Medicare Part B Drug Pricing requirements, 340B Program requirements, Veterans Health Care Act of 1992, or the Medicare Part D Coverage Gap Discount Program to comply with such Price Reporting Laws, or refund any monies owed due to a resubmission or restatement.
Appears in 1 contract
FDA and Regulatory Matters. (a) Except as would not have a material impact on Akebiareasonably be expected to be, Akebia individually or in the aggregate, materially adverse to the business, assets, results of operations or condition (financial or otherwise) of CBLI and its Subsidiaries CBLI and its Subsidiaries hold all licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearances, Permits and have submitted notices to, all Governmental Bodies, including all authorizations under the FDCA, the PHSA, as amended, and the regulations of the FDA promulgated thereunder, and any other Governmental Body that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of AkebiaCBLI’s Products (any such Governmental Body, an “Akebia CBLI Regulatory Agency”) necessary for the lawful operation of the businesses of Akebia CBLI or any of its Subsidiaries as currently conducted (the “Akebia CBLI Permits”), and as of the date hereof, all such Akebia CBLI Permits are valid and in full force and effect. Except as would not have a material impact on Akebia, there There has not occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Akebia CBLI Permit. Except as would not have a material impact on Akebia, Akebia CBLI and each of its Subsidiaries are in compliance in all material respects with the terms of all Akebia CBLI Permits, and no event has occurred that, to the Knowledge of AkebiaCBLI, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Akebia CBLI Permit. Since January 1, 20152018, neither Akebia CBLI nor any of its Subsidiaries has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action Action from the FDA or other Akebia CBLI Regulatory Agency alleging that any operation or activity of Akebia CBLI or any of its Subsidiaries is in material violation of any applicable Law, except as would not have an Akebia Material Adverse Effect.
(b) Except as would not have a material impact on Akebia, since Since January 1, 20152018, all of AkebiaCBLI’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Akebia CBLI Regulatory Agencies have been manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of Akebia CBLI or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Permit or Law, including applicable statutes and implementing regulations administered or enforced by the FDA or other Akebia CBLI Regulatory Agency. Except as would not have a material impact on Akebia, since Since January 1, 20152018, all applications, submissions, notifications, information and data utilized by Akebia CBLI or its Subsidiaries as the basis for, or submitted by or, to the Knowledge of AkebiaCBLI, on behalf of Akebia CBLI or its Subsidiaries in connection with, any and all requests for the Akebia CBLI Permits relating to Akebia CBLI or any of its Subsidiaries when submitted to the FDA or other Akebia CBLI Regulatory Agency, were true, complete and correct correct, in all material respects, as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, notifications, information and data required under applicable Laws have been submitted to the FDA or other Akebia CBLI Regulatory Agency.
(c) Except as would not have a material impact on Akebia, since January 1, 2015, neither AkebiaNeither CBLI, nor its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Akebia CBLI Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Except as would not have a material impact on Akebiaset forth in the CBLI Disclosure Letter, neither Akebia CBLI nor or any of its Subsidiaries Subsidiaries, any of their respective officers or employees nor, to the Knowledge of AkebiaCBLI, any of their respective officers, employees, contractors, suppliers or other entities or individuals performing research or work on behalf of Akebia CBLI or any of its Subsidiaries has been subject to any kind of consent decree, individual integrity agreement, deferred prosecution agreement, or other similar form of agreement with any Governmental Body or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in a material debarment or exclusion under applicable Law, including, without limitation, 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations Actions that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the Knowledge of AkebiaCBLI, threatened against Akebia CBLI or any of its Subsidiaries or, to the Knowledge of Akebia, or any of their respective officers, or to the Knowledge of CBLI, their employees, contractors, suppliers, or other entities or individuals performing research or work on behalf of Akebia CBLI or any of its Subsidiaries.
(d) To the Knowledge of Akebia, since Since January 1, 20152018, the manufacture of Products by or on behalf of Akebia CBLI and its Subsidiaries has been and is being conducted in compliance in all material compliance respects with all applicable Laws including the FDA’s current Good Manufacturing Practices. Since January 1, 20152018, none of AkebiaCBLI, any of its Subsidiaries, or, to the Knowledge of AkebiaCBLI, any of their respective contract manufacturers for Products, has received any FDA Form 483, warning letter, untitled letter, or other similar correspondence or written notice from the FDA or any other Akebia CBLI Regulatory Agency alleging or asserting material noncompliance with any applicable Laws or Akebia CBLI Permits with respect to any Product of Akebia CBLI or its Subsidiaries. Since January 1, 20152018, no manufacturing site owned or operated by AkebiaCBLI, its Subsidiaries, or, to the Knowledge of AkebiaCBLI, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Akebia CBLI Regulatory Agency. Except as would not have a material impact on Akebiaset forth in the CBLI Disclosure Letter, to the Knowledge of AkebiaCBLI, no event has occurred which would reasonably be expected to lead to any claim, suit, proceeding, investigation, enforcement, inspection or other action Action by any Akebia CBLI Regulatory Agency or any FDA warning letter, untitled letter, or request or requirement to make material changes to the Products or the manner in which the Products are manufactured, distributed or marketed.
(e) Since January 1, 20152018, all studies, tests and preclinical and clinical trials being conducted by Akebia CBLI or its Subsidiaries, or in which AkebiaCBLI, its Subsidiaries or any Product or Product candidate has participated, have been and are being conducted in compliance in all material compliance respects with applicable Laws, including the applicable requirements of Good Laboratory Practices or Good Clinical Practices. Since January 1, 20152018, Akebia and neither CBLI nor any of its Subsidiaries have not received any written notices, correspondence or other communication from any institutional review board, the FDA or any other Akebia CBLI Regulatory Agency, recommending or requiring the termination, suspension, or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, Akebia CBLI or any of its Subsidiaries.
(f) Except as would not have a material impact on Akebiaset forth in the CBLI Disclosure Letter, since January 1, 2015, Akebia and neither CBLI nor any of its Subsidiaries have not either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notification, field correction, market withdrawal, or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action, in each case relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product candidate (“Akebia CBLI Safety Notices”). Except as would not have an Akebia Material Adverse Effectset forth in the CBLI Disclosure Letter, as of the date hereof, Akebia CBLI has no Knowledge of any facts which would cause (i) an Akebia a CBLI Safety Notice with respect to any Product sold or intended to be sold by Akebia CBLI or its Subsidiaries, (ii) a change in the marketing classification or a material change in labeling of any such Products, (iii) a termination or suspension of marketing or testing of any such Products, or (iv) the imposition of a postmarketing study or risk evaluation and mitigation strategy by the FDA or other Akebia CBLI Regulatory Agency.
(g) Except as would not have an Akebia Material Adverse Effectset forth in the CBLI Disclosure Letter, Akebia CBLI and its Subsidiaries are, and at all times since January 1, 2015 2018 have been, in compliance in all material respects with all applicable Healthcare Laws. There is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, proceeding, notice or demand Action pending, received by or filed since January 1, 20152018, or to the Knowledge of AkebiaCBLI, threatened in writing, Action against Akebia CBLI or any Akebia Subsidiary of its Subsidiaries alleging any material violation by Akebia CBLI or its Subsidiaries of any applicable Healthcare Laws.
(h) Neither Akebia CBLI nor any of its Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, deferred prosecution agreements, settlement orders Orders or similar agreements with or imposed by any Governmental Body.
(i) Except as would not have a material impact on Akebia, neither Akebia, Neither CBLI nor its Subsidiaries nor any of their respective directors, officers, or employees, nor, to the Knowledge of AkebiaCBLI, any of its agents or distributors or any other person Person while acting on behalf of Akebia CBLI or any of its Subsidiaries has at any time since January 1, 20152018, (i) violated or is in material violation of any provision of the FCPA, (ii) violated or is in material violation of any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention, (iii) violated or is in violation of any provision of the UK Bribery Act, (iv) materially violated any anti-bribery or anti-corruption Law in any foreign jurisdiction, (v) made, offered to make, promised to make, or authorized the payment or giving of, directly or indirectly, any Prohibited Payment, (vi) been subject to any investigation by any Governmental Body with regard to any Prohibited Payment to the Knowledge of CBLI or (vii) violated or is in material violation of any other Laws regarding use of funds for political activity or commercial bribery.
(j) Since January 1, 20152018, and except as would not have a material impact on Akebia, Akebia CBLI has: (x) distributed Product samples in accordance compliance in all material respects with applicable Healthcare Laws, and the provision of such samples has been appropriately documented in accordance with requirements of the Prescription Drug Marketing Act of 1987; and (y) filed complete and accurate reports reports, in all material respects, as required under the federal Sunshine/Open Payments Law Physician Payment Sunshine Act and all applicable state transparency Laws, including Laws requiring certifications of compliance with the PhRMA Code and other compliance program certifications.
(k) Except as disclosed in Section 3.20(k4.20(k) of the Akebia CBLI Disclosure Letter or as would not have an Akebia Material Adverse EffectLetter, as of the date hereof, neither Akebia CBLI nor its Subsidiaries has received written notice that it is subject to any pending or threatened investigation, claim, or enforcement action Action by FDA, HHS-OIG, private whistleblowers, CMS, VA, VA OIG, or DOJ, or any other state or non-U.S. equivalent Governmental Bodies pursuant to the Healthcare Laws. Akebia CBLI has no Knowledge of any fact that would require Akebia CBLI to restate or resubmit to the government any data reported under the Medicaid Rebate Statute, Medicare Part B Drug Pricing requirements, 340B Program requirements, Veterans Health Care Act of 1992, or the Medicare Part D Coverage Gap Discount Program to comply with such Price Pricing Reporting Laws, or refund any monies owed due to a resubmission or restatement.
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FDA and Regulatory Matters. (a) Except as disclosed in the Registration Statement, the Prospectus and the Prospectus Supplement, the Company has made all filings, applications and submissions required by, possesses and is operating in compliance with, all approvals, licenses, certificates, certifications, clearances, consents, grants, exemptions, marks, notifications, orders, permits and other authorizations issued by, the appropriate federal, state or foreign Governmental Authority (including, without limitation, the FDA, the United States Drug Enforcement Administration, applicable state departments of health and state boards of pharmacy, or any other foreign, federal, state, provincial, court or local Government Authorities engaged in the regulation of clinical trials, pharmaceuticals, biologics or biohazardous substances or materials, or the sale, promotion or distribution thereof) necessary for the ownership or lease of its properties or to conduct its business as described in the Registration Statement, the Prospectus and the Prospectus Supplement (collectively, “Permits”), except for such Permits the failure of which to possess, obtain or make the same would not have a material impact on Akebia, Akebia Material Adverse Effect; the Company is in compliance with the terms and its Subsidiaries hold conditions of all licenses, such Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearances, and except where the failure to be in compliance would not have submitted notices to, a Material Adverse Effect; all Governmental Bodies, including all authorizations under the FDCA, the PHSA, as amended, and the regulations of the FDA promulgated thereunder, and any other Governmental Body that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of Akebia’s Products (any such Governmental Body, an “Akebia Regulatory Agency”) necessary for the lawful operation of the businesses of Akebia or any of its Subsidiaries as currently conducted (the “Akebia Permits”), and as of the date hereof, all such Akebia Permits are valid and in full force and effect. Except , except where any invalidity, individually or in the aggregate, would not be reasonably expected to have a Material Adverse Effect; and the Company has not received any written notice relating to the limitation, revocation, cancellation, suspension, modification or non-renewal of any such Permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would have a Material Adverse Effect, or has any reason to believe that any such license, certificate, permit or authorization will not be renewed in the ordinary course, except as would not reasonably be expected to have a Material Adverse Effect. To the extent required by applicable laws of the FDA, the Company or a third party on its behalf has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material impact on Akebiacompliance with applicable laws when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions. The Company possesses such valid and current certificates, there authorizations or permits issued by the appropriate state, federal or foreign regulatory agencies or bodies necessary to conduct its business, and the Company has not occurred received, or has any violation reason to believe that it will receive, any notice of proceedings relating to the revocation or modification of, default (or non-compliance with, any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could result in a Material Adverse Effect. To the extent required in connection with its business, the Company has the requisite provider number or without notice other authorization to bill the Medicare program and the respective Medicaid program in the state or lapse states in which the Company operates unless failure to maintain such provider number or other authorization would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of time or both) underits officers, directors, employees, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or boththe Company’s knowledge, any Akebia Permit. Except as would not have a material impact on Akebia, Akebia and each of its Subsidiaries are independent contractors has been suspended, excluded or debarred from participation in compliance with any U.S. federal health care program, including Medicare or any state Medicaid program; the terms of all Akebia Permits, and no event has occurred thatCompany is not subject to any pending or, to the Knowledge of AkebiaCompany’s knowledge, threatened or contemplated action which would reasonably be expected to result either in a revocation of any provider number or authorization or in the revocationCompany’s suspension, cancellation, non-renewal exclusion or material adverse modification of any Akebia Permit. Since January 1, 2015, neither Akebia nor any of its Subsidiaries has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action debarment from the FDA or other Akebia Regulatory Agency alleging that any operation or activity of Akebia Medicare or any of its Subsidiaries is in material violation of any applicable Law, except as would not have an Akebia Material Adverse Effect.
(b) Except as would not have a material impact on Akebia, since January 1, 2015, all of Akebiastate Medicaid programs; the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Akebia Regulatory Agencies business practices have been manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of Akebia or any of its Subsidiaries structured in all material respects in compliance a manner reasonably designed to comply with all applicable requirements under any Permit federal or Law, including applicable statutes state laws governing Medicare and implementing regulations administered or enforced by the FDA or other Akebia Regulatory Agency. Except as would not have a material impact on Akebia, since January 1, 2015, all applications, submissions, notifications, information and data utilized by Akebia or its Subsidiaries as the basis for, or submitted by or, to the Knowledge of Akebia, on behalf of Akebia or its Subsidiaries in connection with, any and all requests for the Akebia Permits relating to Akebia or any of its Subsidiaries when submitted to the FDA or other Akebia Regulatory Agency, were true, complete and correct as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, notifications, information and data required under applicable Laws have been submitted to the FDA or other Akebia Regulatory Agency.
(c) Except as would not have a material impact on Akebia, since January 1, 2015, neither Akebia, nor its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Akebia Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Except as would not have a material impact on Akebia, neither Akebia nor or any of its Subsidiaries nor, to the Knowledge of Akebia, any of their respective officers, employees, contractors, suppliers or other entities or individuals performing research or work on behalf of Akebia or any of its Subsidiaries has been subject to any kind of consent decree, individual integrity agreement, deferred prosecution agreement, or other similar form of agreement with any Governmental Body or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in a material debarment or exclusion under applicable Lawstate Medicaid programs, including, without limitation, 21 Sections 1320a-7a, 1320a-7b, and 1320a-7h of Title 42 of the United States Code, and the health care fraud provisions under the Health Insurance Portability and Accountability Act of 1996 and the Company reasonably believes that it is in compliance with such laws; the Company has taken reasonable actions designed to ensure that it does not: (i) violate the False Claims Act, 31 U.S.C. Section 335a§§ 3729-3733 or (ii) allow any individual with an ownership or control interest (as defined in 42 U.S.C. § 1320a-3(a)(3)) in the Company or have any officer, director or managing employee (as defined in 42 U.S.C. § 1320a-5(b)) of the Company who would be a person excluded from participation in any federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) as described in 42 U.S.C. § 1320a-7(b)(8); and the Company has structured its business practices in a manner reasonably designed to comply with the federal and state laws regarding physician ownership of (or financial relationship with), and referral to, entities providing healthcare-related goods or services, and with laws requiring disclosure of financial interests held by physicians in entities to which they may refer patients for the provisions of healthcare-related goods or services and the Company reasonably believes that it is in material compliance with such laws. No claimsExcept as disclosed in the Registration Statement, actionsthe Prospectus and the Prospectus Supplement, proceedings the Company has not failed to file with the applicable Governmental Authority (including, without limitation, the FDA, or investigations that any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to result have a Material Adverse Effect; except as disclosed in such a material debarment or exclusion are pending or, to the Knowledge of Akebia, threatened against Akebia or any of its Subsidiaries or, to the Knowledge of Akebia, any of their respective officers, employees, contractors, suppliers, or other entities or individuals performing research or work on behalf of Akebia or any of its Subsidiaries.
(d) To the Knowledge of Akebia, since January 1, 2015Registration Statement, the manufacture of Products by Prospectus and the Prospectus Supplement, all such filings, declarations, listings, registrations, reports or on behalf of Akebia and its Subsidiaries has been and is being conducted submissions were in material compliance with all applicable Laws including the FDA’s current Good Manufacturing Practices. Since January 1, 2015, none of Akebia, any of its Subsidiaries, or, to the Knowledge of Akebia, any of their respective contract manufacturers for Products, has received any FDA Form 483, warning letter, untitled letter, or other similar correspondence or written notice from the FDA or any other Akebia Regulatory Agency alleging or asserting material noncompliance with laws when filed and no deficiencies have been asserted by any applicable Laws or Akebia Permits regulatory authority with respect to any Product of Akebia such filings, declarations, listings, registrations, reports or its Subsidiaries. Since January 1submissions, 2015except for any failure to comply or deficiencies that, no manufacturing site owned by Akebiaindividually or in the aggregate, its Subsidiaries, or, to the Knowledge of Akebia, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Akebia Regulatory Agency. Except as would not have a material impact on Akebia, to the Knowledge of Akebia, no event has occurred which would reasonably be expected to lead to any claim, suit, proceeding, investigation, enforcement, inspection or other action by any Akebia Regulatory Agency or any FDA warning letter, untitled letter, or request or requirement to make material changes to the Products or the manner in which the Products are manufactured, distributed or marketed.
(e) Since January 1, 2015, all studies, tests and preclinical and clinical trials being conducted by Akebia or its Subsidiaries, or in which Akebia, its Subsidiaries or any Product or Product candidate has participated, have been and are being conducted in material compliance with applicable Laws, including the applicable requirements of Good Laboratory Practices or Good Clinical Practices. Since January 1, 2015, Akebia and its Subsidiaries have not received any written notices, correspondence or other communication from any institutional review board, the FDA or any other Akebia Regulatory Agency, recommending or requiring the termination, suspension, or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, Akebia or its Subsidiaries.
(f) Except as would not have a material impact on Akebia, since January 1, 2015, Akebia and its Subsidiaries have not either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notification, field correction, market withdrawal, or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action, in each case relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product candidate (“Akebia Safety Notices”). Except as would not have an Akebia Material Adverse Effect. The Company has operated and currently is, as of the date hereof, Akebia has no Knowledge of any facts which would cause (i) an Akebia Safety Notice with respect to any Product sold or intended to be sold by Akebia or its Subsidiaries, (ii) a change in the marketing classification or a all material change in labeling of any such Products, (iii) a termination or suspension of marketing or testing of any such Products, or (iv) the imposition of a postmarketing study or risk evaluation and mitigation strategy by the FDA or other Akebia Regulatory Agency.
(g) Except as would not have an Akebia Material Adverse Effect, Akebia and its Subsidiaries are, and at all times since January 1, 2015 have beenrespects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable Healthcare Laws. There is no civil, criminal, administrative, or other action, subpoena, suit, demand, claim, hearing, proceeding, notice or demand pending, received by or filed since January 1, 2015, or to the Knowledge of Akebia, threatened in writing, against Akebia or any Akebia Subsidiary alleging any material violation by Akebia or its Subsidiaries of any applicable Healthcare Laws.
(h) Neither Akebia nor any of its Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, deferred prosecution agreements, settlement orders or similar agreements with or imposed by any Governmental Body.
(i) Except as would not have a material impact on Akebia, neither Akebia, its Subsidiaries nor any of their respective directors, officers, or employees, nor, to the Knowledge of Akebia, any of its agents or distributors or any other person while acting on behalf of Akebia or any of its Subsidiaries has at any time since January 1, 2015, (i) violated or is in violation of any provision rules and regulations of the FCPA, (ii) violated or is in violation of any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention, (iii) violated or is in violation of any provision of the UK Bribery Act, (iv) violated any anti-bribery or anti-corruption Law in any foreign jurisdiction, (v) made, offered to make, promised to make, or authorized the payment or giving of, directly or indirectly, any Prohibited Payment, (vi) been subject to any investigation by any Governmental Body with regard to any Prohibited Payment or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery.
(j) Since January 1, 2015, and except as would not have a material impact on Akebia, Akebia has: (x) distributed Product samples in accordance with applicable Healthcare Laws, and the provision of such samples has been appropriately documented in accordance with requirements of the Prescription Drug Marketing Act of 1987; and (y) filed complete and accurate reports as required under the federal Sunshine/Open Payments Law and all applicable state transparency Laws, including Laws requiring certifications of compliance with the PhRMA Code FDA and other compliance program certificationsfederal, state, local and foreign Governmental Authority exercising comparable authority.
(k) Except as disclosed in Section 3.20(k) of the Akebia Disclosure Letter or as would not have an Akebia Material Adverse Effect, as of the date hereof, neither Akebia nor its Subsidiaries has received written notice that it is subject to any pending or threatened investigation, claim, or enforcement action by FDA, HHS-OIG, private whistleblowers, CMS, VA, VA OIG, or DOJ, or any other state or non-U.S. equivalent Governmental Bodies pursuant to the Healthcare Laws. Akebia has no Knowledge of any fact that would require Akebia to restate or resubmit to the government any data reported under the Medicaid Rebate Statute, Medicare Part B Drug Pricing requirements, 340B Program requirements, Veterans Health Care Act of 1992, or the Medicare Part D Coverage Gap Discount Program to comply with such Price Reporting Laws, or refund any monies owed due to a resubmission or restatement.
Appears in 1 contract
