Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (a) The Company or its Subsidiary hold all material 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 Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the 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 the Company’s Products (any such Governmental Body, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or its Subsidiary as currently conducted (the “Company Permits”), and as of the date hereof, all such Company Permits are valid and in full force and effect. 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 Company Permit. The Company and its Subsidiary are in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Permit. Since December 31, 2020, neither the Company nor its Subsidiary 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 Company Regulatory Agency alleging that any operation or activity of the Company or its Subsidiary is in violation of any applicable Law.

FDA and Regulatory Matters. (a) The Company or and its Subsidiary Subsidiaries hold all material licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearances, and have submitted all required applications, notices or submissions to, all Governmental Bodies, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended 1938 (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), 1944 and the regulations of the 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 the Company’s Products (any such Governmental Body, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or and its Subsidiary Subsidiaries as currently conducted (the “Company Permits”), and as of the date hereofof this Agreement, all such Company Permits are valid and in full force and effect. 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 threat of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit. The Company and each of its Subsidiary Subsidiaries are in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to the Knowledge of the Company, would reasonably be expected to result in the revocation, suspension, cancellation, non-renewal or adverse material adverse modification of any material Company Permit. To the Knowledge of the Company, any third Person that is a manufacturer or contractor for the Company or any of its Subsidiaries is in material compliance with all Permits insofar as they pertain to the manufacture of product components or products for the Company or any of its Subsidiaries, as applicable. Since December 31January 1, 20202017, neither the Company nor any of its Subsidiary 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 Company Regulatory Agency any Governmental Body alleging that any operation or activity of the Company or any of its Subsidiary Subsidiaries is in violation of any applicable LawLaw that applies to a Company Permit. The Transactions, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit.

FDA and Regulatory Matters. Except in each case as set forth in the SEC Documents, the Company and its Subsidiaries (ai) The are and at all times have been in material compliance with all federal, state, local and foreign statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, handling, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of the Company or its Subsidiary hold all material licensesSubsidiaries, Permitsincluding, franchiseswithout limitation, 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 Drug, and Cosmetic Act of 1938, as amended and the Controlled Substances Act (the “FDCAIndustry Laws”); (ii) have not received any FDA Form 483, the Public Health Service Act notice of 1944adverse finding, as amended (the “PHSA”)warning letter, and the regulations of untitled letter or other similar correspondence or notice from the 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 the Company’s Products (any such Governmental Body, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or its Subsidiary as currently conducted Drug Enforcement Administration (the “Company DEA”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Industry Laws or any licenses, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Industry Laws (“Healthcare Permits”); (iii) possess all material Healthcare Permits, and as of the date hereof, all such Company Permits which are valid and in full force and effect. There has , and are not occurred any in material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right term of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company such Healthcare Permit. The Company and its Subsidiary are in compliance in all material respects with the terms of all Company Permits, and no event has occurred thatwhich allows, to the Knowledge or after notice or lapse of time would allow, revocation or termination of any Healthcare Permit or results in any other material impairment of the Company, would reasonably be expected to result in rights of the revocation, cancellation, non-renewal or material adverse modification holder of any Company Healthcare Permit. Since December 31, 2020, neither the Company nor its Subsidiary has ; (iv) have not received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA FDA, DEA or any other Company Regulatory Agency federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity of the Company or its Subsidiary is in material violation of any applicable LawIndustry Laws or Healthcare Permits, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) have not received notice that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Healthcare Permit, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Industry Laws or Healthcare Permits, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) have not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall, correction, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the Company, no third party has initiated, conducted or intends to initiate any such notice or action.

FDA and Regulatory Matters. (a) The Company or Except as would not have a material impact on Keryx, Keryx and its Subsidiary Subsidiaries hold all material 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 Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the 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 the CompanyKeryx’s Products (any such Governmental Body, a “Company Keryx Regulatory Agency”) necessary for the lawful operation of the businesses of the Company Keryx or any of its Subsidiary Subsidiaries as currently conducted (the “Company Keryx Permits”), and as of the date hereof, all such Company Keryx Permits are valid and in full force and effect. There Except as would not have a material impact on Keryx, 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 Company Keryx Permit. The Company Except as would not have a material impact on Keryx, Keryx and each of its Subsidiary Subsidiaries are in compliance in all material respects with the terms of all Company Keryx Permits, and no event has occurred that, to the Knowledge of the CompanyKeryx, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Keryx Permit. Since December 31January 1, 20202015, neither the Company Keryx nor any of its Subsidiary 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 Company Keryx Regulatory Agency alleging that any operation or activity of the Company Keryx or any of its Subsidiary Subsidiaries is in material violation of any applicable Law, except as would not have a Keryx Material Adverse Effect.

FDA and Regulatory Matters. (a) The Company Except as would not reasonably be expected to be, individually or in the aggregate, materially adverse to the business, assets, results of operations or condition (financial or otherwise) of CYTO and its Subsidiary Subsidiaries, taken as a whole, CYTO and its Subsidiaries hold all material 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 Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the 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 the CompanyCYTO’s Products (any such Governmental Body, a “Company CYTO Regulatory Agency”) necessary for the lawful operation of the businesses of the Company CYTO or any of its Subsidiary Subsidiaries as currently conducted (the “Company CYTO Permits”), and as of the date hereof, all such Company CYTO Permits are valid and in full force and effect. 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 Company CYTO Permit. The Company CYTO and each of its Subsidiary Subsidiaries are in compliance in all material respects with the terms of all Company CYTO Permits, and no event has occurred that, to the Knowledge of the CompanyCYTO, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company CYTO Permit. Since December 31January 1, 20202018, neither the Company CYTO nor any of its Subsidiary 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 Company CYTO Regulatory Agency alleging that any operation or activity of the Company CYTO or any of its Subsidiary Subsidiaries is in material violation of any applicable Law.

FDA and Regulatory Matters. (a) The Company or its Subsidiary hold holds all material licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearances, and have has submitted written notices to, all Governmental Bodies, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the 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 the Company’s Products (any such Governmental Body, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses business of the Company or its Subsidiary as currently conducted (the “Company FDA Permits”), and as of the date hereofof this Agreement, all such Company FDA Permits are valid and (i) in full force and effecteffect,(ii) in compliance with all material filing and maintenance requirements and (iii) in material good standing, valid and enforceable. There has not occurred any material violation of, or default (with or without written notice or lapse of time or both) under, or event giving to others under any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company FDA Permit. The Company has fulfilled and performed all of its Subsidiary are material obligations with respect to such FDA Permits, and is in compliance in all material respects with the terms of all Company FDA Permits, and no event has occurred that, to . To the Knowledge of the Company, no event has occurred which allows, or after written notice or lapse of time would reasonably be expected to result in the revocationallow, cancellation, non-renewal revocation or material adverse modification of any Company Permittermination thereof. Since December 31January 1, 20202019, neither the Company nor its Subsidiary has not received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or other Company Regulatory Agency any Governmental Body alleging that any operation or activity of the Company or its Subsidiary is in material violation of any applicable LawLaw that applies to a FDA Permit. The Contemplated Transactions, in and of themselves, will not cause the revocation or cancellation of any FDA Permit pursuant to the terms of any such FDA Permit.

FDA and Regulatory Matters. (a) The Company or and its Subsidiary hold all material licenses, Permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals, and clearancesSubsidiaries hold, and have submitted notices toheld at all times since January 1, 2019, all material Permits of all Governmental BodiesEntities required under applicable Healthcare Laws, including all authorizations such Permits required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the 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 the Company’s Products (any such Governmental Body, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or and its Subsidiary Subsidiaries as currently conducted or as have been conducted since January 1, 2019 (the “Company Permits”), and as of the date hereof, all such Company Permits required for the operation of the businesses as currently conducted are valid and in full force and effect. There Since January 1, 2019, 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 under any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any such Company Permit. The Company and each of its Subsidiary Subsidiaries are in compliance in all material respects with the terms of all such Company Permits, and no event has occurred that, to Permits required for the Knowledge operation of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Permitbusinesses as currently conducted. Since December 31January 1, 20202019, neither the Company nor any of its Subsidiary 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 Company Regulatory Agency any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiary Subsidiaries is in material violation of any applicable LawHealthcare Law or Company Permit.

FDA and Regulatory Matters. (a) The Company or and its Subsidiary hold Subsidiaries hold, and have held at all times since the Reference Date, all material 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 Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) or other Governmental Body promulgated thereunder, and any other Governmental Body that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the Company’s Products (any such Governmental Body, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company or and its Subsidiary Subsidiaries as currently conducted or have been conducted since the Reference Date (the “Company Permits”), and as of the date hereof, all such Company Permits are valid and in full force and effect. 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, under any Company Permit. The Company and each of its Subsidiary Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since the Reference Date, and no event neither the Company nor any of its Subsidiaries has occurred thatreceived written or, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Permit. Since December 31, 2020, neither the Company nor its Subsidiary has received written oral notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA or other Company Regulatory Agency any Governmental Body alleging that any operation or activity of the Company or any of its Subsidiary Subsidiaries is in material violation of any applicable LawLaw that applies to a Company Permit. The Contemplated Transactions, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit.

FDA and Regulatory Matters. (a) The Company or Except as would not have a material impact on Akebia, Akebia and its Subsidiary Subsidiaries hold all material 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 FoodFDCA, Drug and Cosmetic Act of 1938the PHSA, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”)amended, and the regulations of the U.S. Food and Drug Administration (the “FDA”) FDA promulgated thereunder, and any other Governmental Body that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the CompanyAkebia’s Products (any such Governmental Body, a an “Company Akebia Regulatory Agency”) necessary for the lawful operation of the businesses of the Company Akebia or any of its Subsidiary Subsidiaries as currently conducted (the “Company Akebia Permits”), and as of the date hereof, all such Company Akebia Permits are valid and in full force and effect. There Except as would not have a material impact on Akebia, 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 Company Akebia Permit. The Company Except as would not have a material impact on Akebia, Akebia and each of its Subsidiary Subsidiaries are in compliance in all material respects with the terms of all Company Akebia Permits, and no event has occurred that, to the Knowledge of the CompanyAkebia, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Akebia Permit. Since December 31January 1, 20202015, neither the Company Akebia nor any of its Subsidiary 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 Company Akebia Regulatory Agency alleging that any operation or activity of the Company Akebia or any of its Subsidiary Subsidiaries is in material violation of any applicable Law, except as would not have an Akebia Material Adverse Effect.