Common use of FDA Compliance Clause in Contracts

FDA Compliance. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, the Company and its subsidiaries: (A) are and at all times have been in full compliance with all statutes, rules, regulations, or guidances applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, registrations, 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 the Company is not in violation of any term of any such Authorizations; (D) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge that any such Governmental 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 and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale Disclosure Package and Prospectus Supplement or otherwise in the ProspectusSEC Reports, the Company and its subsidiariesCompany: (Ai) are is and at all times have has been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the U.S. Food and Drug Administration (“FDA”) and other comparable governmental or regulatory agencies applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Regulatory Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (Bii) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Governmental Authority the FDA or other comparable governmental or regulatory agencies alleging or asserting noncompliance material non-compliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (Ciii) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (Div) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority other comparable governmental or regulatory agency or third party alleging that any product operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority other comparable governmental or regulatory agency or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Ev) have has not received notice that the FDA or any Governmental Authority other comparable governmental or regulatory agency 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 or any such Governmental Authority other comparable governmental or regulatory agency 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 Regulatory Laws or Authorizations 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).

FDA Compliance. Except in each case, as described would not, individually or in the Registration Statementaggregate, reasonably be expected to have a Material Adverse Effect, the Time of Sale Disclosure Package and the Prospectus, the Company and its subsidiariesCompany: (A) are is, and at all times have been has since February 1, 2020 been, in full compliance with all applicable statutes, rules, regulations, rules or guidances applicable regulations of the FDA relating to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority similar governmental entity in each case alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess possesses all material Authorizations required for the conduct of its business and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; except as described in the Registration Statement and the Prospectus, (D) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority governmental entity or third party is considering has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) have has not received written notice that the FDA or any Governmental Authority governmental entity 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 or any such Governmental Authority governmental entity 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 and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale General Disclosure Package and the ProspectusProspectus or as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiariesCompany: (A) are is and at all times have has been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the FDA and other comparable Governmental Entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, 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 the Company is not in material violation of any term of any such Authorizations; (D) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have no knowledge that and, to the Company’s knowledge, neither the FDA nor any such Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received notice that the FDA or any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and and, to the Company has no knowledge that Company’s knowledge, neither the FDA nor any such Governmental Authority is considering threatening to initiate 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 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale Disclosure Package Prospectus and the ProspectusProspectus or as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiariesCompany: (A) are is and at all times have has been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the FDA and other comparable Governmental Entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, 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 the Company is not in material violation of any term of any such Authorizations; (D) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have no knowledge that and, to the Company’s knowledge, neither the FDA nor any such Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received notice that the FDA or any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and and, to the Company has no knowledge that Company’s knowledge, neither the FDA nor any such Governmental Authority is considering threatening to initiate 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 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale Disclosure Package and Prospectus Supplement or otherwise in the ProspectusSEC Reports, or would not, singly or in the aggregate, result in a Material Adverse Effect, the Company and its subsidiariesCompany: (Ai) are is and at all times have has been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the U.S. Food and Drug Administration ("FDA") and other comparable governmental or regulatory agencies applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“"Applicable Regulatory Laws”"), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (Bii) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Governmental Authority the FDA or other comparable governmental or regulatory agencies alleging or asserting noncompliance material non-compliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“"Authorizations”"); (Ciii) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (Div) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority other comparable governmental or regulatory agency or third party alleging that any product operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority other comparable governmental or regulatory agency or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Ev) have has not received notice that the FDA or any Governmental Authority other comparable governmental or regulatory agency 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 or any such Governmental Authority other comparable governmental or regulatory agency 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 Regulatory Laws or Authorizations 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, the Company and its subsidiariesCompany: (A) are is and at all times have for the previous five (5) years has been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the FDA and other comparable Governmental Entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured under development, manufactured. marketed or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrationspermits, permits FDA’s letter stating the agency’s intent to exercise enforcement discretion for the Avance Nerve Graft assuming certain conditions are met, 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 the Company is not in material violation of any term of any such Authorizations; (D) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received notice that the FDA or any 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 or any 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 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).

FDA Compliance. Except as described in the each Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, the Company and its subsidiariesCompany: (A) are is and at all times have for the previous five (5) years has been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the FDA and other comparable Governmental Entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured under development, manufactured. marketed or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrationspermits, permits FDA’s letter stating the agency’s intent to exercise enforcement discretion for the Avance Nerve Graft assuming certain conditions are met, 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 the Company is not in material violation of any term of any such Authorizations; (D) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received notice that the FDA or any 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 or any 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 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, the Company and its subsidiariesCompany: (A) are and at all times have been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the FDA and other comparable Governmental Entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have not received any Form FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence from the FDA or notice from any other Governmental Authority Entity alleging or asserting material noncompliance with any Applicable Laws or the terms of any licenses, certificates, approvals, registrations, clearances, exemptions, authorizations, registrations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except in each case as would not, individually or in the aggregate have a Material Adverse Effect; (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not 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 or any other Governmental Authority Entity or third party alleging that any product operation operation, research program, or activity is in material violation of any Applicable Laws or Authorizations and have no knowledge that the FDA or any such other Governmental Authority Entity or third party is considering threatening any such claim, litigation, arbitration, action, suit, investigation or proceeding, except in each case as would not, individually or in the aggregate have a Material Adverse Effect; (E) have has not received written notice that the FDA or any other Governmental Authority Entity 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 or any such other Governmental Authority Entity is considering threatening such action, except in each case as would not, individually or in the aggregate have a Material Adverse Effect; 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 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, the Company and its subsidiariesCompany: (A) are is and at all times have has been in full compliance with all statutes, rules, regulations, rules or guidances regulations of the United Stated Food and Drug Administration (the “FDA”) and other comparable Governmental Entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), except as could where the failure so to comply would not, individually singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, registrations, permits and supplements or Governmental Licenses amendments thereto required by any such Applicable Laws (“Authorizations”), and to the knowledge of the Company, neither the FDA nor any other Governmental Entity is considering such action; (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, hearing, enforcement, audit, investigation or proceeding; (E) have has not received notice that the FDA or any 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 or any 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 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale Disclosure Package Prospectus and the ProspectusProspectus or as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiaries: (A) are and at all times have been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the FDA and other comparable Governmental Entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company or any of its subsidiaries (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, 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 of its subsidiaries is not in material violation of any term of any such Authorizations; (D) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have no knowledge that and, to the Company’s knowledge, neither the FDA nor any such Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received notice that the FDA or any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and and, to the Company has no knowledge that Company’s knowledge, neither the FDA nor any such Governmental Authority is considering threatening to initiate 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 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, the The Company and its subsidiariesSubsidiaries, since July 1, 2019: (Ai) are and at all times have been in full compliance with all statutes, rules, regulations, or guidances applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the FDA or any Governmental Authority other similar federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Health Care Laws (defined below) or any licenses, certificates, approvals, clearances, authorizations, registrationsexemptions, permits and supplements or amendments thereto required by any such Applicable Health Care Laws to conduct the Company’s business as described in Prospectus Supplement (“Authorizations”); (Cii) possess all material applicable Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor its Subsidiaries is not in violation of any term of any such AuthorizationsAuthorizations except where such violation would not, singly or in the aggregate, have a Material Adverse Effect; (Diii) have not received written notice of any pending or completed claim, actionAction, suit, proceedingProceeding, hearing, enforcement, investigation, arbitration or other action Action from the FDA or any Governmental Authority other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product candidate operation or activity is in material violation of any Applicable Health Care Laws or Authorizations and have the Company has no knowledge that the FDA or any such Governmental Authority other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, actionAction, suit, investigation or proceedingProceeding; (Eiv) have not received written notice that the FDA or any Governmental Authority other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action Action to limit, suspend, materially modify or revoke any material Authorizations and the Company has no knowledge that the FDA or any such Governmental Authority other federal, state, local or foreign governmental or regulatory authority is considering such actionAction; and (Fv) 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 Health Care Laws or Authorizations 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).

FDA Compliance. Except Since June 1, 2018, except as otherwise described in the Registration StatementDisclosure Documents or would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Time of Sale Disclosure Package and the Prospectus, the Company and its subsidiariesCompany: (A) are is and at all times have has been in full compliance with all applicable statutes, rules, regulations, rules or guidances regulations of the U.S. Food and Drug Administration (“FDA”) and other comparable governmental entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (collectively, “Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from the FDA or any Governmental Authority governmental entity alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, 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 the Company is not in 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 or any Governmental Authority or third party applicable governmental entity alleging that any product operation product, operation, or activity is in violation of any Applicable Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority or third party governmental entity is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received written notice that the FDA or any Governmental Authority governmental entity has taken, is taking or to the knowledge of the Company, intends to take action to limit, suspend, modify suspend or revoke any Authorizations and the Company has no knowledge that any such Governmental Authority is considering such actionAuthorizations; 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 and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in each of the Registration Statement, each of the Time of Sale Disclosure Package Information and the ProspectusOffering Memorandum, the Company and its subsidiariesCompany: (A) are is and at all times have has been in full material compliance with all statutes, rulesrules or regulations of the U.S. Food and Drug Administration (“FDA”) and other comparable federal, regulationsstate, local or guidances foreign governmental or regulatory authority (“Governmental Authority”) applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, registrations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would, individually or in the aggregate, result in a Material Adverse Effect; (C) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received notice that the FDA or any 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 or any 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 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale General Disclosure Package and the ProspectusFinal Prospectus or as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiariesCompany: (A) are is and at all times have has been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the FDA and other comparable Governmental Entities applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, 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 the Company is not in material violation of any term of any such Authorizations; (D) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and have no knowledge that and, to the Company’s knowledge, neither the FDA nor any such Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have has not received notice that the FDA or any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and and, to the Company has no knowledge that Company’s knowledge, neither the FDA nor any such Governmental Authority is considering threatening to initiate 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 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).

FDA Compliance. Except as described in the Registration Statement, the Time of Sale Disclosure Package and Statement or the Prospectus, or would not, singly or in the Company and its subsidiariesaggregate, result in a Material Adverse Effect, the Company: (Ai) are is and at all times have has been in full material compliance with all statutes, rules, regulations, rules or guidances regulations of the U.S. Food and Drug Administration (“FDA”) and other comparable governmental or regulatory agencies applicable to Company and its subsidiaries and the ownership, testing, research, design, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Regulatory Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (Bii) except as previously disclosed to the Underwriter, have has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Governmental Authority the FDA or other comparable governmental or regulatory agencies alleging or asserting noncompliance material non-compliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, registrations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (Ciii) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (Div) have has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority other comparable governmental or regulatory agency or third party alleging that any product operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and have has no knowledge that the FDA or any such Governmental Authority other comparable governmental or regulatory agency or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (Ev) have has not received notice that the FDA or any Governmental Authority other comparable governmental or regulatory agency 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 or any such Governmental Authority other comparable governmental or regulatory agency 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 Regulatory Laws or Authorizations 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).