Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. Except in each case as set forth in the SEC Documents, the Company and its Subsidiaries (i) 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 Subsidiaries, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other similar correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), the Drug Enforcement Administration (the “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, which are valid and in full force and effect, and are not in material violation of any term of any such Healthcare Permit, and no event has occurred which allows, 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 rights of the holder of any Healthcare Permit; (iv) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Industry 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. Except in each case as set forth in the SEC Documents, the (a) The Company and its Subsidiaries (i) are hold all material Permits, and at have submitted all times have been in material compliance with required applications, notices or submissions to, all federalGovernmental Bodies, 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 including all authorizations under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of the Company or its Subsidiaries, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act of 1938 (the “FDCA”), the Public Health Service Act of 1944 and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice regulations of adverse finding, warning letter, untitled letter or other similar correspondence or notice from the U.S. Food and Drug Administration (the “FDA”)) promulgated thereunder, necessary for the Drug Enforcement Administration lawful operation of the businesses of the Company and its Subsidiaries as currently conducted (the “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 Company Permits”); (iii) possess , and as of the date of this Agreement, all material Healthcare Permits, which such Company Permits are valid and in full force and effect, and are . There has not in occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any term threat of termination, amendment or cancellation of, with or without notice or lapse of time or both, any such Healthcare Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits, and no event has occurred which allowsthat, to the Knowledge of the Company, would reasonably be expected to result in the revocation, suspension, cancellation, non-renewal or after notice or lapse of time would allow, revocation or termination adverse material modification of any Healthcare Permit or results in any other material impairment Company Permit. To the Knowledge of the rights 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 holder manufacture of product components or products for the Company or any Healthcare Permit; (iv) have not of its Subsidiaries, as applicable. Since January 1, 2017, neither the Company nor any of its Subsidiaries has received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party Governmental Body alleging that any product operation or activity of the Company or any of its Subsidiaries is in material violation of any Industry Laws Law that applies to a Company Permit. The Transactions, in and of themselves, will not cause the revocation or Healthcare Permits, and have no knowledge that cancellation of any Company Permit pursuant to the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering terms of 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 Company 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. Except in each case as set forth in the SEC Documents, the Company and its Subsidiaries (ia) 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 The Company or its SubsidiariesSubsidiary hold all material licenses, includingPermits, without limitationfranchises, 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 (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice regulations of adverse finding, warning letter, 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 Drug Enforcement Administration 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 “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 Company Permits”); (iii) possess , and as of the date hereof, all material Healthcare Permits, which such Company Permits are valid and in full force and effect, and are . There has not in occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any term right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any such Healthcare 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 which allowsthat, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or after notice or lapse of time would allow, revocation or termination material adverse modification of any Healthcare Permit or results in any other material impairment of Company Permit. Since December 31, 2020, neither the rights of the holder of any Healthcare Permit; (iv) have not Company nor its Subsidiary has received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, DEA FDA or any other federal, state, local or foreign governmental or regulatory authority or third party Company Regulatory Agency alleging that any product operation or activity of the Company or its Subsidiary is in material violation of any Industry 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 actionapplicable Law.

FDA and Regulatory Matters. (a) Except in each case as set forth in the SEC Documentswould not have a material impact on Keryx, the Company Keryx and its Subsidiaries (i) are hold all licenses, Permits, franchises, variances, registrations, exemptions, orders and at other governmental authorizations, consents, approvals, and clearances, and have submitted notices to, all times have been in material compliance with Governmental Bodies, including 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 authorizations under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of the Company or its Subsidiaries, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice regulations of adverse finding, warning letter, 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 Drug Enforcement Administration quality, identity, strength, purity, safety, efficacy or manufacturing of Keryx’s Products (any such Governmental Body, a “Keryx Regulatory Agency”) necessary for the lawful operation of the businesses of Keryx or any of its Subsidiaries as currently conducted (the “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 Keryx Permits”); (iii) possess , and as of the date hereof, all material Healthcare Permits, which such Keryx Permits are valid and in full force and effect. Except as would not have a material impact on Keryx, 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 Keryx Permit. Except as would not have a material impact on Keryx, Keryx and each of its Subsidiaries are not in material violation compliance with the terms of any term of any such Healthcare Permitall Keryx Permits, and no event has occurred which allowsthat, to the Knowledge of Keryx, would reasonably be expected to result in the revocation, cancellation, non-renewal or after notice or lapse of time would allow, revocation or termination material adverse modification of any Healthcare Permit or results in Keryx Permit. Since January 1, 2015, neither Keryx nor any other material impairment of the rights of the holder of any Healthcare Permit; (iv) have not its Subsidiaries has received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, DEA FDA or any other federal, state, local or foreign governmental or regulatory authority or third party Keryx Regulatory Agency alleging that any product operation or activity of Keryx or any of its Subsidiaries is in material violation of any Industry Laws or Healthcare Permitsapplicable Law, and except as would not 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 actionKeryx Material Adverse Effect.

FDA and Regulatory Matters. (a) Except in each case as set forth in the SEC Documentswould not have a material impact on Akebia, the Company Akebia and its Subsidiaries (i) are hold all licenses, Permits, franchises, variances, registrations, exemptions, orders and at other governmental authorizations, consents, approvals, and clearances, and have submitted notices to, all times have been in material compliance with Governmental Bodies, including all federalauthorizations under the FDCA, statethe PHSA, local as amended, and foreign statutes, rules and the 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 Subsidiaries, including, without limitation, the Federal Food, DrugFDA promulgated thereunder, and Cosmetic Act and any other Governmental Body that regulates the Controlled Substances Act quality, identity, strength, purity, safety, efficacy or manufacturing of Akebia’s Products (any such Governmental Body, an “Industry LawsAkebia Regulatory Agency”); (ii) have not received necessary for the lawful operation of the businesses of Akebia or any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other similar correspondence or notice from the U.S. Food and Drug Administration its Subsidiaries as currently conducted (the “FDAAkebia Permits”), and as of the Drug Enforcement Administration (the “DEA”) or any other federaldate hereof, 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 all such Industry Laws (“Healthcare Permits”); (iii) possess all material Healthcare Permits, which 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 not in material violation compliance with the terms of any term of any such Healthcare Permitall Akebia Permits, and no event has occurred which allowsthat, to the Knowledge of Akebia, would reasonably be expected to result in the revocation, cancellation, non-renewal or after notice or lapse of time would allow, revocation or termination material adverse modification of any Healthcare Permit or results in Akebia Permit. Since January 1, 2015, neither Akebia nor any other material impairment of the rights of the holder of any Healthcare Permit; (iv) have not its Subsidiaries has received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, DEA FDA or any other federal, state, local or foreign governmental or regulatory authority or third party Akebia Regulatory Agency alleging that any product operation or activity of Akebia or any of its Subsidiaries is in material violation of any Industry Laws or Healthcare Permitsapplicable Law, and except as would not 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 actionan Akebia Material Adverse Effect.

FDA and Regulatory Matters. Except in each case as set forth in the SEC Documents(a) The Company holds all material Permits, the Company and its Subsidiaries (i) are and at has submitted written notices to, all times have been in material compliance with Governmental Bodies, including 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 authorizations under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of the Company or its Subsidiaries, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice regulations of adverse finding, warning letter, untitled letter or other similar correspondence or notice from the U.S. Food and Drug Administration (the “FDA”)) promulgated thereunder, necessary for the Drug Enforcement Administration lawful operation of the business of the Company as currently conducted (the “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 FDA Permits”); , and as of the date of this Agreement, all such FDA Permits are (iiii) possess all material Healthcare Permits, which are valid and 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 any FDA Permit. The Company has fulfilled and performed all of its material obligations with respect to such FDA Permits, and are not is in compliance in all material violation respects with the terms of any term all FDA Permits. To the Knowledge of any such Healthcare Permitthe Company, and no event has occurred which allows, or after written notice or lapse of time would allow, revocation or termination of any Healthcare Permit or results in any other material impairment of thereof. Since January 1, 2019, the rights of the holder of any Healthcare Permit; (iv) have Company has not received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party Governmental Body alleging that any product operation or activity of the Company is in material violation of any Industry Laws Law that applies to a FDA Permit. The Contemplated Transactions, in and of themselves, will not cause the revocation or Healthcare Permits, and have no knowledge that cancellation of any FDA Permit pursuant to the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering terms of 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 FDA 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. Except in each case as set forth in the SEC Documents, the (a) The Company and its Subsidiaries (i) are hold, and have held at all times since the Reference Date, all material Permits, and have been in material compliance with submitted notices to, all federalGovernmental Bodies, 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 including all authorizations under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of the Company or its Subsidiaries, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice regulations of adverse finding, warning letter, untitled letter or other similar correspondence or notice from the U.S. Food and Drug Administration (the “FDA”)) or other Governmental Body promulgated thereunder, necessary for the Drug Enforcement Administration lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since the Reference Date (the “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 Company Permits”); (iii) possess , and all material Healthcare Permits, which such Company Permits are valid and in full force and effect, and are . There has not in occurred any material violation of any term of any such Healthcare Permitof, and no event has occurred which allows, default (with or after without notice or lapse of time would allowor both) under any Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since the Reference Date, revocation or termination neither the Company nor any of any Healthcare Permit or results in any other material impairment its Subsidiaries has received written or, the Knowledge of the rights of the holder of any Healthcare Permit; (iv) have not received Company, oral notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party Governmental Body alleging that any product operation or activity of the Company or any of its Subsidiaries is in material violation of any Industry Laws Law that applies to a Company Permit. The Contemplated Transactions, in and of themselves, will not cause the revocation or Healthcare Permits, and have no knowledge that cancellation of any Company Permit pursuant to the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering terms of 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 Company 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. Except in each case as set forth in the SEC Documents, the (a) The Company and its Subsidiaries (i) are hold, and have held at all times have been in since January 1, 2019, all material compliance with Permits of all federalGovernmental Entities required under applicable Healthcare Laws, 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 including all such Permits required under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of the Company or its Subsidiaries, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice regulations of adverse finding, warning letter, untitled letter or other similar correspondence or notice from the U.S. Food and Drug Administration (the “FDA”)) promulgated thereunder, necessary for the Drug Enforcement Administration lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or as have been conducted since January 1, 2019 (the “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 Company Permits”); (iii) possess , and all material Healthcare Permits, which such Company Permits required for the operation of the businesses as currently conducted are valid and in full force and effect. Since January 1, and are 2019, there has not in occurred any material violation of any term of any such Healthcare Permitof, and no event has occurred which allows, default (with or after without notice or lapse of time would allow, revocation or termination both) under any such Company Permit. The Company and each of any Healthcare Permit or results its Subsidiaries are in any other compliance in all material impairment respects with the terms of all such Company Permits required for the operation of the rights businesses as currently conducted. Since January 1, 2019, neither the Company nor any of the holder of any Healthcare Permit; (iv) have not its Subsidiaries has received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party Governmental Entity alleging that any product operation or activity of the Company or any of its Subsidiaries is in material violation of any Industry Laws Healthcare Law 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 Company 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) Except in each case as set forth would not reasonably be expected to be, individually or in the SEC Documentsaggregate, materially adverse to the Company business, assets, results of operations or condition (financial or otherwise) of CYTO and its Subsidiaries, taken as a whole, CYTO and its Subsidiaries (i) are hold all Permits and at have submitted notices to, all times have been in material compliance with Governmental Bodies, including 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 authorizations under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of the Company or its Subsidiaries, including, without limitation, the Federal Food, Drug, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice regulations of adverse finding, warning letter, 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 Drug Enforcement Administration quality, identity, strength, purity, safety, efficacy or manufacturing of CYTO’s Products (any such Governmental Body, a “CYTO Regulatory Agency”) necessary for the lawful operation of the businesses of CYTO or any of its Subsidiaries as currently conducted (the “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 CYTO Permits”); (iii) possess , and as of the date hereof, all material Healthcare Permits, which such CYTO Permits are valid and in full force and effect, and are . There has not in occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any term right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any such Healthcare CYTO Permit. CYTO and each of its Subsidiaries are in compliance in all material respects with the terms of all CYTO Permits, and no event has occurred which allowsthat, to the Knowledge of CYTO, would reasonably be expected to result in the revocation, cancellation, non-renewal or after notice or lapse of time would allow, revocation or termination material adverse modification of any Healthcare Permit or results in CYTO Permit. Since January 1, 2018, neither CYTO nor any other material impairment of the rights of the holder of any Healthcare Permit; (iv) have not its Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration pending or threatened Action from the FDA or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party CYTO Regulatory Agency alleging that any product operation or activity of CYTO or any of its Subsidiaries is in material violation of any Industry 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 actionapplicable Law.