Common use of Regulatory Matters Clause in Contracts

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, and except as would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) neither the Company and each nor any of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not Subsidiaries has received any Form 483 from the FDA, written notice of adverse findingfiling, warning letter, untitled letter or other correspondence or written notice from the FDAU.S. Food and Drug Administration or other relevant regulatory authorities, the DEA, the EMA, the MHRA or any other court or arbitrator or federal, state, local, national local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FFDCA”), section 351 of the Public Health Service Act (42 U.S.C. § 262) ( “section 351 of the PHSA”) or similar state, federal or foreign law or regulation; (ii) the Company and any Applicable Laws Subsidiary, and to the Company’s knowledge, their respective directors, officers, employees or any licensesagents, certificatesare and have been in compliance in all material respects with applicable health care laws, approvalsincluding without limitation, clearancesthe FFDCA, authorizationssection 351 of the PHSA, permits each as amended, and supplements or amendments thereto required by any such Applicable Laws the regulations promulgated thereunder; and all other comparable local, state, federal, national, supranational and foreign laws, and the regulations promulgated thereunder, (collectively, “AuthorizationsHealth Care Laws”); (Ciii) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not Subsidiary has received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDAany U.S. or non-U.S. federal, the DEA, the EMA, the MHRA or any other federalnational, state, local, national local or foreign other governmental or regulatory authority authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product, product operation or activity is in material violation of any Applicable Health Care Laws or Authorizations and has no any knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Eiv) have not neither the Company nor any Subsidiary has received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and applicable Permit or has no any knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Authority is considering such action; (v) the Company and (F) have each Subsidiary has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Health Care Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vi) neither the Company nor any Subsidiary or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, and except as would not reasonably be expected to, singly or in the aggregate, have a Material Adverse Effect: (i) neither the Company and each of nor its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not subsidiaries has received any Form 483 from the FDA, written notice of adverse findingfiling, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEAEMA or other relevant regulatory authorities, the EMA, the MHRA or any other court or arbitrator or federal, state, local, national local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with any Applicable Laws the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FDCA”), or any licensessimilar state, certificatesfederal or foreign law or regulation (collectively, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“AuthorizationsHealth Care Laws”); (Cii) possess the Company and its subsidiaries are and have been in compliance in all material Authorizations and such Authorizations are valid and in full force and effect and respects with applicable Health Care Laws; (iii) neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) its subsidiaries have not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDAany U.S. or non-U.S. federal, the DEA, the EMA, the MHRA or any other federalnational, state, local, national local or foreign other governmental or regulatory authority authority, agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingHealth Care Laws; (Eiv) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations Company and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) its subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeapplicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); (v) neither the Company nor its subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime, engaged in any conduct or is subject to a governmental inquiry, investigation, proceeding or other similar action that would result in a debarment, suspension or exclusion from any federal or state government health care program or human research study trial; and (vi) the Company is not a party to and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by an Governmental Authority.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, and except as would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Change: (i) neither the Company and each of nor its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not Subsidiaries has received any Form 483 from the FDA, written notice of adverse findingfiling, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEAEMA or other relevant regulatory authorities, the EMA, the MHRA or any other court or arbitrator or federal, state, local, national local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with any Applicable Laws the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or any licensessimilar state, certificatesfederal or foreign law or regulation (collectively, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“AuthorizationsHealth Care Laws”); (Cii) possess the Company and its Subsidiaries are and have been in compliance in all material Authorizations and such Authorizations are valid and in full force and effect and respects with applicable Health Care Laws; (iii) neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not its Subsidiaries received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDAany U.S. or non-U.S. federal, the DEA, the EMA, the MHRA or any other federalnational, state, local, national local or foreign other governmental or regulatory authority authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingHealth Care Laws; (Eiv) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations Company and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) its Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeapplicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); (v) neither the Company nor its Subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) the Company is not a party to and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by an Governmental Authority.

Regulatory Matters. Except as described set forth in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, and except as would not reasonably be expected to have a Material Adverse Change, (i) the Company is and each of its subsidiaries: (A) are and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured by or distributed by on behalf of the Company including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of any national, federal, state, county, municipal, local or foreign government, or any subsidiary political subdivision, court, body, agency or regulatory authority thereof, and any Person exercising executive, legislative, judicial, regulatory, taxing or administrative functions of or pertaining to any of the foregoing (individually, a “Governmental Entity”) and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (Bii) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any Company possesses all licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as described in the Registration Statement and the Prospectus (collectively, “Authorizations”); (C) possess all material Authorizations and and, to its knowledge, such Authorizations are valid and in full force and effect and neither the Company; (iii) the Company nor and, to its knowledge, its contractors have not received any subsidiary is in material violation written notice of adverse finding, warning letter or other written correspondence or notice from the U.S. Food and Drug Administration (“FDA”) or any term of other Governmental Entity alleging or asserting noncompliance with any such Applicable Laws or Authorizations; (Div) have the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Entity or third party alleging that any product, operation or activity is in material violation of any Applicable Laws or Authorizations and or has no any knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company that would reasonably be expected to require the issuance of any such notice or result in an investigation, corrective action, or enforcement action by the FDA or similar Governmental Entity; (Ev) have the Company has not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and or has no any knowledge that the FDA, DEA, EMA, the MHRA any such Governmental Entity has threatened or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (Fvi) have the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the The Company and each of its subsidiaries: (A) are , and its and their respective directors, officers and employees, and, to the Company’s knowledge, its and their respective agents, affiliates and representatives, are, and at all times times: (i) have been operated and currently operate its business in compliance in all material compliance respects with all statutesapplicable provisions of the Health Care Laws (as defined below) of the FDA, rules the Department of Health and regulations Human Services (“HHS”) and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any of the Company's product sold, under development, candidates or any product manufactured or distributed by the Company or any subsidiary (“Applicable Laws”)Company; (Bii) have has not received any FDA Form 483 from the FDA483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA any court or any other federal, state, local, national arbitrator or foreign governmental or regulatory authority alleging or asserting material noncompliance non-compliance with (A) any Applicable Health Care Laws or (B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Health Care Laws (“Regulatory Authorizations”); (Ciii) possess possesses all material Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is of its subsidiaries are in violation, in any material violation respect, of any term of any such Regulatory Authorizations; (Div) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party Applicable Regulatory Authorities alleging that any product, product operation or activity is in material violation of any Applicable Health Care Laws or Regulatory Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party Applicable Regulatory Authorities is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Ev) have has not received written notice that any of the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Applicable Regulatory Authorities is considering such action; and (Fvi) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Health Care Laws or Regulatory Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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).; (vii) is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and (viii) has not been excluded, suspended or debarred from participation in any government health care program or

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Regulatory Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceedingProceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingProceeding; (E) have not received written notice that the FDA, DEA, ATGA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, ATGA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the The Company and each of its subsidiariesSubsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Regulatory Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceedingProceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingProceeding; (E) have not received written notice that the FDA, DEA, ATGA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, ATGA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect Material Adverse Effect on the Company and its subsidiaries, taken as a whole, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all applicable statutes, rules and regulations applicable to governing the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Regulatory Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceedingProceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingProceeding; (E) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering has threatened such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the ProspectusPPM, the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processingassembly, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Regulatory Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claimproceeding, litigationhearing, arbitrationenforcement, investigation, arbitration or other action, suit, investigation or proceeding; (E) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeMaterial Adverse Effect, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, and except as would not, singly or in the aggregate, have or reasonably be expected to have a Material Adverse Effect: (i) the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have has not received any Form 483 from the FDA, written notice of adverse findingfiling, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEAEMA or other relevant regulatory authorities, the EMA, the MHRA or any other court or arbitrator or federal, state, local, national local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with any Applicable Laws the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or any licensessimilar state, certificatesfederal or foreign law or regulation (collectively, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“AuthorizationsHealth Care Laws”); (Cii) possess the Company is and has been in compliance in all material Authorizations and such Authorizations are valid and in full force and effect and neither respects with applicable Health Care Laws; (iii) the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDAany U.S. or non-U.S. federal, the DEA, the EMA, the MHRA or any other federalnational, state, local, national local or foreign other governmental or regulatory authority authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingHealth Care Laws; (Eiv) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Company has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeapplicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); (v) neither the Company nor any of its directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) the Company is not a party to and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by an Governmental Authority.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, and except as would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect: (i) neither the Company and each of nor its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not Subsidiaries has received any Form 483 from the FDA, written notice of adverse findingfiling, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEAEMA or other relevant regulatory authorities, the EMA, the MHRA or any other court or arbitrator or federal, state, local, national local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with any Applicable Laws the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or any licensessimilar state, certificatesfederal or foreign law or regulation (collectively, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“AuthorizationsHealth Care Laws”); (Cii) possess the Company and its Subsidiaries are and have been in compliance in all material Authorizations and such Authorizations are valid and in full force and effect and respects with applicable Health Care Laws; (iii) neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not its Subsidiaries received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDAany U.S. or non-U.S. federal, the DEA, the EMA, the MHRA or any other federalnational, state, local, national local or foreign other governmental or regulatory authority authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingHealth Care Laws; (Eiv) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations Company and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) its Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeapplicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); (v) neither the Company nor its Subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) the Company is not a party to and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by an Governmental Authority.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity of the Company or its subsidiaries is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Regulatory Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceedingProceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingProceeding; (E) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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).

Regulatory Matters. Except as described set forth in the Registration StatementSEC Reports, the Time of Sale Prospectus and the Prospectusexcept as would not reasonably be expected to have a Material Adverse Change, (i) the Company is and each of its subsidiaries: (A) are and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured by or distributed by on behalf of the Company including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of any national, federal, state, county, municipal, local or foreign government, or any subsidiary political subdivision, court, body, agency or regulatory authority thereof, and any Person exercising executive, legislative, judicial, regulatory, taxing or administrative functions of or pertaining to any of the foregoing (individually, a “Governmental Entity”) and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (Bii) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any Company possesses all licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as described in the SEC Reports (collectively, “Authorizations”); (C) possess all material Authorizations and and, to its knowledge, such Authorizations are valid and in full force and effect and neither effect; (iii) the Company nor and, to its knowledge, its contractors have not received any subsidiary is in material violation written notice of adverse finding, warning letter or other written correspondence or notice from the U.S. Food and Drug Administration (“FDA”) or any term of other Governmental Entity alleging or asserting noncompliance with any such Applicable Laws or Authorizations; (Div) have the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Entity or third party alleging that any product, operation or activity is in material violation of any Applicable Laws or Authorizations and or has no any knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company that would reasonably be expected to require the issuance of any such notice or result in an investigation, corrective action, or enforcement action by the FDA or similar Governmental Entity; (Ev) have the Company has not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and or has no any knowledge that the FDA, DEA, EMA, the MHRA any such Governmental Entity has threatened or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (Fvi) have the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Regulatory Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceedingProceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA, the DEA, the ATGA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingProceeding; (E) have not received written notice that the FDA, DEA, ATGA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, ATGA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect Material Adverse Effect on the Company and its subsidiaries, taken as a whole, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, and except as would not, singly or in the aggregate, have or reasonably be expected to have a Material Adverse Effect: (i) neither the Company and each of nor its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not Subsidiaries has received any Form 483 from the FDA, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEAEMA or other relevant regulatory authorities, the EMA, the MHRA or any other court or arbitrator or federal, state, local, national local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with any Applicable Laws the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or any licensessimilar state, certificatesfederal or foreign law or regulation (collectively, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“AuthorizationsHealth Care Laws”); (Cii) possess the Company and its Subsidiaries are and have been in compliance in all material Authorizations and such Authorizations are valid and in full force and effect and respects with applicable Health Care Laws; (iii) neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not its Subsidiaries received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDAany U.S. or non-U.S. federal, the DEA, the EMA, the MHRA or any other federalnational, state, local, national local or foreign other governmental or regulatory authority authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingHealth Care Laws; (Eiv) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations Company and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) its Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeapplicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); (v) neither the Company nor its Subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) the Company is not a party to and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by an Governmental Authority.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and Pricing Disclosure Package or the Prospectus, the Company and each of its subsidiaries: (A) are is and at all times have has been in material compliance with all statutes, rules and rules, or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary of its subsidiaries (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (B) have has not received any FDA Form 483 from the FDA, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA U.S. Food and Drug Administration or any other federal, state, local, national state or foreign governmental authority having authority over the Company or regulatory authority any of its subsidiaries (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations Authorizations, and such Authorizations are valid and in full force and effect effect, and neither the Company nor any subsidiary is not in material violation of any term of any such Authorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus Information and the Prospectus, : (i) the Company and each of its subsidiaries: (A) are is and at all times have has been in material compliance with all statutes, rules and rules, regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“"Applicable Laws”"), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (Bii) have the Company has not received any FDA Form 483 from the FDA, notice of adverse finding483, warning letter, untitled letter or other correspondence or written notice from the U.S. Food and Drug Administration ("FDA, the DEA, the EMA, the MHRA ") or any other federal, state, local, national local or foreign governmental agency or regulatory authority having jurisdiction over the Company or any of its properties or assets alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“"Authorizations”"), except such FDA Forms 483 notices alleging or asserting noncompliance as would not, individually or in the aggregate, result in a Material Adverse Effect; (Ciii) possess the Company possesses all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is are not in material violation of any term of any such Authorizations; (Div) have the Company has not received written notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA FDA or any other federal, state, local, national local or foreign governmental agency or regulatory authority having jurisdiction over the Company or any of its properties or assets or third party alleging that any product, operation or activity is in material violation of any Applicable Laws or Authorizations and has no the Company does not have knowledge that the FDA, the DEA, the EMA, the MHRA FDA or any other federal, state, local, national local or foreign governmental agency or regulatory authority having jurisdiction over the Company or any of its properties or assets or any third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Ev) have the Company has not received written notice that the FDA, DEA, EMA, the MHRA FDA or any other federal, state, local, national local or foreign governmental agency or regulatory authority having jurisdiction over the Company or any of its properties or assets has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no the Company does not have knowledge that the FDA, DEA, EMA, the MHRA FDA or any other federal, state, local, national local or foreign governmental agency or regulatory authority having jurisdiction over the Company or any of its properties or assets is considering such action; and (Fvi) have the Company, or a third party on its behalf, has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations Authorizations, except that where the failure to file such reportsso file, documentsobtain, formsmaintain, noticesor submit would not, applicationsindividually or in the aggregate, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeMaterial Adverse Effect, and that 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) the Company has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall, 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, neither the FDA or any other federal, state, local or foreign governmental agency or regulatory authority having jurisdiction over the Company or any of its properties or assets has initiated, conducted or intends to initiate any such notice or action.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the ProspectusProspectus Supplement, and except as would not, singly or in the aggregate, have or reasonably be expected to have a Material Adverse Effect: (i) neither the Company and each nor any of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not subsidiaries has received any Form 483 from the FDA, written notice of adverse findingfiling, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEAEMA or other relevant regulatory authorities, the EMA, the MHRA or any other court or arbitrator or federal, state, local, national local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with any Applicable Laws the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or any licensessimilar state, certificatesfederal or foreign law or regulation (collectively, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“AuthorizationsHealth Care Laws”); (Cii) possess the Company and its subsidiaries are and have been in compliance in all material Authorizations and such Authorizations are valid and in full force and effect and respects with applicable Health Care Laws; (iii) neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not its subsidiaries has received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDAany U.S. or non-U.S. federal, the DEA, the EMA, the MHRA or any other federalnational, state, local, national local or foreign other governmental or regulatory authority authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingHealth Care Laws; (Eiv) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations Company and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) its subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeapplicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); (v) none of the Company, any of its subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) neither the Company nor any of its subsidiaries is a party to and the Company and its subsidiaries do not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by an Governmental Authority.

Regulatory Matters. Products and Product Candidates. Except as described in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Prospectus, the Company and each of its subsidiariesCompany: (A) are is and at all times have has been in compliance, in all material compliance respects, with all statutesapplicable provisions of the Health Care Laws (as defined below) of the FDA, rules and regulations or any comparable foreign regulatory authority to which they are subject (collectively, the “Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have has not received any FDA Form 483 from the FDA483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Regulatory Authorities alleging or asserting material noncompliance with any Applicable Health Care Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Health Care Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations 15 are valid and in full force and effect and neither the Company nor is not in violation, in any subsidiary is in material violation respect, of any term of any such Authorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA Regulatory Authorities or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, product operation or activity is in material violation of any Applicable Health Care Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA Regulatory Authorities or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received written notice that any of the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that any of the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Regulatory Authorities is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Health Care Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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 materially corrected or supplemented by a subsequent submission).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the The Company and each of its subsidiaries: (A) are , and its and their respective directors, officers and employees, and, to the Company’s knowledge, its and their respective agents, affiliates and representatives, are, and at all times times: (i) have been operated and currently operate its business in compliance in all material compliance respects with all statutesapplicable provisions of the Health Care Laws (as defined below) of the FDA, rules the Department of Health and regulations Human Services (“HHS”) and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any of the Company’s product sold, under development, candidates or any product manufactured or distributed by the Company or any subsidiary (“Applicable Laws”)Company; (Bii) have has not received any FDA Form 483 from the FDA483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA any court or any other federal, state, local, national arbitrator or foreign governmental or regulatory authority alleging or asserting material noncompliance non-compliance with (A) any Applicable Health Care Laws or (B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Health Care Laws (“Regulatory Authorizations”); (Ciii) possess possesses all material Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is of its subsidiaries are in violation, in any material violation respect, of any term of any such Regulatory Authorizations; (Div) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party Applicable Regulatory Authorities alleging that any product, product operation or activity is in material violation of any Applicable Health Care Laws or Regulatory Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party Applicable Regulatory Authorities is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Ev) have has not received written notice that any of the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Applicable Regulatory Authorities is considering such action; and (Fvi) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Health Care Laws or Regulatory Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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); (vii) is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and (viii) has not been excluded, suspended or debarred from participation in any government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. The term “Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under HIPAA, 42 U.S.C. §§ 1320d et seq.; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the The Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processingassembly, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Regulatory Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claimproceeding, litigationhearing, arbitrationenforcement, investigation, arbitration or other action, suit, investigation or proceeding; (E) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeMaterial Adverse Effect, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, and except as would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect: (i) neither the Company and each of nor its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”); (B) have not Subsidiaries has received any Form 483 from the FDA, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEAEMA or other relevant regulatory authorities, the EMA, the MHRA or any other court or arbitrator or federal, state, local, national local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with any Applicable Laws the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or any licensessimilar state, certificatesfederal or foreign law or regulation (collectively, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“AuthorizationsHealth Care Laws”); (Cii) possess the Company and its Subsidiaries are and have been in compliance in all material Authorizations and such Authorizations are valid and in full force and effect and respects with applicable Health Care Laws; (iii) neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not its Subsidiaries received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDAany U.S. or non-U.S. federal, the DEA, the EMA, the MHRA or any other federalnational, state, local, national local or foreign other governmental or regulatory authority authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingHealth Care Laws; (Eiv) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations Company and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) its Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a wholeapplicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); (v) neither the Company nor its Subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) the Company is not a party to and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by an Governmental Authority.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Final Prospectus, the Company and each of its subsidiariesCompany: (A) are is and at all times have has been in material full compliance with all statutes, rules and regulations rules, regulations, or guidances applicable to Company and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (B) have has not received any Form 483 from the FDA, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA U.S. Food and Drug Administration or any other federal, state, local, national state or foreign governmental or regulatory authority having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is are not in material violation of any term of any such Authorizations; (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority or third party alleging that any product, product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and the Company has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Authority is considering such action; and (F) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission).

Regulatory Matters. Except as described set forth in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, (i) the Company is and each of its subsidiaries: (A) are and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured by or distributed by on behalf of the Company including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of any national, federal, state, county, municipal, local or foreign government, or any subsidiary political subdivision, court, body, agency or regulatory authority thereof, and any Person exercising executive, legislative, judicial, regulatory, taxing or administrative functions of or pertaining to any of the foregoing (individually, a “Governmental Entity”) and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (Bii) have not received any Form 483 from the FDACompany and, notice of adverse findingto its knowledge, warning letterits collaborators and contractors, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any possess all licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as described in the Prospectus (collectively, “Authorizations”); (C) possess all material Authorizations and and, to its knowledge, such Authorizations are valid and in full force and effect and the Company; (iii) neither the Company nor nor, to its knowledge, its collaborators and contractors, have received any subsidiary is in material violation written notice of adverse finding, warning letter or other written correspondence or notice from the U.S. Food and Drug Administration (“FDA”) or any term of other Governmental Entity alleging or asserting noncompliance with any such Applicable Laws or Authorizations; (Div) have the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Entity or third party alleging that any product, operation or activity is in material violation of any Applicable Laws or Authorizations and or has no any knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company that would reasonably be expected to require the issuance of any such notice or result in an investigation, corrective action, or enforcement action by the FDA or similar Governmental Entity; (Ev) the Company and, to its knowledge, its collaborators and contractors have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and or has no any knowledge that the FDA, DEA, EMA, the MHRA any such Governmental Entity has threatened or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (Fvi) the Company and, to its knowledge, its collaborators and contractors have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission), except for, in each of the cases described in clauses (i), (ii), (iii), (iv), (v) and (vi), as would not reasonably be expected to result in a Material Adverse Change. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity.

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus Disclosure Package and the Prospectus, : (i) neither the Company nor any of its subsidiaries has received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other governmental entity alleging or asserting any material noncompliance with any Applicable Laws (as defined in clause (ii) below); (ii) to the knowledge of the Company, it and each of its subsidiaries: (A) are subsidiaries is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to the Company and its subsidiaries and their respective activities, including for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under developmentdeveloped, manufactured or distributed by the Company or any subsidiary Company, including without limitation, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.), the Public Health Service Act (42 U.S.C. § 201 et seq.), and similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (Biii) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not its subsidiaries has received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority entity or third party alleging that any product, operation or activity is in material violation of any Applicable Laws or Authorizations and Permits or has no any knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign such governmental or regulatory authority entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company or any of its subsidiaries; (Eiv) have not received written notice that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Company and each of its subsidiaries has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where Permits and, to the failure to file such reportsCompany’s knowledge, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company, any subsidiary nor, to the Company’s knowledge, any of their respective directors, officers, employees or agents has been convicted of any crime under any Applicable Laws or has been the subject of an FDA debarment proceeding. To the Company’s knowledge, neither the Company, any subsidiary nor any of its directors, officers, employees or agents, has made, or caused the making of, any material false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity. Neither the Company nor any of its subsidiaries nor, to the Company’s knowledge, any director, officer, employee, agent, employee or affiliate of the Company or any of 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 governmental or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law (as defined below).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the ProspectusPPM, the Company and each of its subsidiaries: (A) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processingassembly, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, under development, manufactured or distributed by the Company or any subsidiary (“Applicable Regulatory Laws”); (B) have not received any Form 483 from the FDA, notice of adverse finding, warning letter, or other correspondence or written notice from the FDADOT, the DEAFAA, the EMANHTSA, the MHRA PHMSA, EPA or any other federal, state, local, national or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDADOT, the DEAFAA, the EMANHTSA, the MHRA PHMSA, EPA or any other federal, state, local, national or foreign governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDADOT, the DEAFAA, the EMANHTSA, the MHRA PHMSA, EPA or any other federal, state, local, national or foreign governmental or regulatory authority or third party is considering any such claimproceeding, litigationhearing, arbitrationenforcement, investigation, arbitration or other action, suit, investigation or proceeding; (E) have not received written notice that the FDADOT, DEAFAA, EMANHTSA, the MHRA PHMSA, EPA or any other federal, state, local, national or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDADOT, DEAFAA, EMANHTSA, the MHRA PHMSA, EPA or any other federal, state, local, national or foreign governmental or regulatory authority is considering such action; and (F) have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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).

Regulatory Matters. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the The Company and each of its subsidiaries: (A) are , and its and their respective directors, officers and employees, and, to the Company’s knowledge, its and their respective agents, affiliates and representatives, are, and at all times times: (i) have been operated and currently operate its business in compliance in all material compliance respects with all statutesapplicable provisions of the Health Care Laws (as defined below) of the FDA, rules the Department of Health and regulations Human Services (“HHS”) and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any of the Company’s product sold, under development, candidates or any product manufactured or distributed by the Company or any subsidiary (“Applicable Laws”)Company; (Bii) have has not received any FDA Form 483 from the FDA483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA, the DEA, the EMA, the MHRA any court or any other federal, state, local, national arbitrator or foreign governmental or regulatory authority alleging or asserting material noncompliance non-compliance with (A) any Applicable Health Care Laws or (B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Health Care Laws (“Regulatory Authorizations”); (Ciii) possess possesses all material Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and neither the Company nor any subsidiary is of its subsidiaries are in violation, in any material violation respect, of any term of any such Regulatory Authorizations; (Div) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party Applicable Regulatory Authorities alleging that any product, product operation or activity is in material violation of any Applicable Health Care Laws or Regulatory Authorizations and has no knowledge that the FDA, the DEA, the EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority or third party Applicable Regulatory Authorities is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Ev) have has not received written notice that any of the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the FDA, DEA, EMA, the MHRA or any other federal, state, local, national or foreign governmental or regulatory authority Applicable Regulatory Authorities is considering such action; and (Fvi) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Health Care Laws or Regulatory Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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); (vii) is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and (viii) has not been excluded, suspended or debarred from participation in any government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. The term “Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under HIPAA, 42 U.S.C. §§ 1320d et seq.; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations.

Regulatory Matters. Except as described The Company and its Subsidiaries have operated and currently are in compliance in all material respects with all applicable laws, rules and regulations of the Registration Statement, the Time jurisdictions in which they are conducting business. Each of Sale Prospectus and the Prospectus, the Company and each of its subsidiaries: Subsidiaries (Ai) are is and at all times have has been in material compliance with all statutes, rules and or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product sold, candidate under development, manufactured or distributed by the Company or any subsidiary (“"Applicable Laws”"); (Bii) have has not received any FDA Form 483 from the FDA483, notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from the U.S. Food and Drug Administration (the "FDA, the DEA, the EMA, the MHRA ") or any other similar federal, state, local, national local or foreign governmental or regulatory authority (each a "Governmental Authority") alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws to conduct the Company’s business as described in Registration Statement (“"Authorizations”"); (Ciii) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any subsidiary its Subsidiaries is in material violation of any term of any such Authorizations; (Div) have has not received written notice of any pending or completed claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, the DEA, the EMA, the MHRA FDA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority or third party alleging that any product, product candidate operation or activity is in material violation of any Applicable Laws or Authorizations and the Company has no knowledge that the FDA, the DEA, the EMA, the MHRA FDA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Ev) have has not received written notice that the FDA, DEA, EMA, the MHRA FDA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority has taken, is taking or intends to take action to limit, suspend, materially modify or revoke any material Authorizations and has no knowledge that the FDA, DEA, EMA, the MHRA FDA or any other federal, state, local, national or foreign governmental or regulatory authority Governmental Authority is considering such action; and (Fvi) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations except where the failure to file such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments would not result in a material adverse effect on the Company and its subsidiaries, taken as a whole, and that 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). Neither the Company nor, to the knowledge of the Company, any of its officers, directors or managing employees (as defined in 42 U.S.C. x 0000x-0(x)) is or has been excluded, suspended or debarred from participation in any state or federal health care program, or made subject to any pending or, to the Company’s knowledge, threatened or contemplated action which could reasonably be expected to result in such exclusion, suspension or debarment.