Common use of FDA Compliance Clause in Contracts

FDA Compliance. Except as described in the Registration Statement, the Prospectus Supplement or otherwise in the SEC Reports, or would not, singly or in the aggregate, result in a Material Adverse Effect, the Company: (i) is and at all times has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") and other comparable governmental or regulatory agencies 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 under development, manufactured or distributed by the Company ("Applicable Regulatory Laws"); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or other comparable governmental or regulatory agencies alleging or asserting material non-compliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("Authorizations"); (iii) 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; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any 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 has no knowledge that the FDA or any other comparable governmental or regulatory agency or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that the FDA or any 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 has no knowledge that the FDA or any other comparable governmental or regulatory agency is considering such action; and (vi) 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, the Prospectus Supplement or otherwise in Time of Sale Disclosure Package and the SEC Reports, or would not, singly or in the aggregate, result in a Material Adverse EffectProspectus, the CompanyCompany and its subsidiaries: (iA) is are and at all times has have been in material full compliance with all statutes, rules rules, regulations, or regulations of the U.S. Food and Drug Administration ("FDA") and other comparable governmental or regulatory agencies 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 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; (iiB) has 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 the FDA or other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptionsauthorizations, authorizationsregistrations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”); (iiiC) possesses 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; (ivD) has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has have no knowledge that the FDA or any other comparable governmental or regulatory agency such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) has have not received notice that the FDA or any other comparable governmental or regulatory agency 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 other comparable governmental or regulatory agency such Governmental Authority is considering such action; and (viF) has 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 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 Prospectus Supplement and the Prospectus or otherwise in the SEC Reports, or as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the CompanyCompany and its subsidiaries: (iA) is are and at all times has have been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") FDA and other comparable governmental or regulatory agencies Governmental Entities 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 under development, manufactured or distributed by the Company or any of its subsidiaries ("“Applicable Regulatory Laws"”); (iiB) has 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 other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”); (iiiC) possesses 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; (ivD) has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental 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 and, to the Company’s knowledge, neither the FDA or nor any other comparable governmental or regulatory agency Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) has have not received notice that the FDA or any other comparable governmental or regulatory agency 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 and, to the Company’s knowledge, neither the FDA or nor any other comparable governmental or regulatory agency Governmental Authority is considering threatening to initiate such action; and (viF) has 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 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, the Prospectus Supplement or otherwise in General Disclosure Package and the SEC Reports, or would not, singly or in the aggregate, result in a Material Adverse EffectProspectus, the Company: (iA) is and at all times has been in material compliance with all statutes, rules or regulations of the U.S. United Stated Food and Drug Administration ("the “FDA"”) and other comparable governmental or regulatory agencies Governmental Entities 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 under development, manufactured or distributed by the Company ("“Applicable Regulatory Laws"”), except where the failure so to comply would not, singly or in the aggregate, result in a Material Adverse Effect; (iiB) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or Governmental Licenses amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”), and to the knowledge of the Company, neither the FDA nor any other Governmental Entity is considering such action; (iiiC) 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; (ivD) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental 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 or any other comparable governmental or regulatory agency Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, hearing, enforcement, audit, investigation or proceeding; (vE) has not received notice that the FDA or any other comparable governmental or regulatory agency 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 or any other comparable governmental or regulatory agency Governmental Authority is considering such action; and (viF) 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the each Registration Statement, the Prospectus Supplement or otherwise in General Disclosure Package and the SEC Reports, or would not, singly or in the aggregate, result in a Material Adverse EffectProspectus, the Company: (iA) is and at all times for the previous five (5) years has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") FDA and other comparable governmental or regulatory agencies Governmental Entities 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 under development, manufactured manufactured. marketed or distributed by the Company ("“Applicable Regulatory Laws"”); (iiB) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits 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 Regulatory Laws ("“Authorizations"”); (iiiC) 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; (ivD) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental 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 or any other comparable governmental or regulatory agency Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) has not received notice that the FDA or any other comparable governmental or regulatory agency 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 or any other comparable governmental or regulatory agency Governmental Authority is considering such action; and (viF) 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 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 Prospectus Supplement and the Prospectus or otherwise in the SEC Reports, or as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company: (iA) is and at all times has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") FDA and other comparable governmental or regulatory agencies Governmental Entities 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 under development, manufactured or distributed by the Company ("“Applicable Regulatory Laws"”); (iiB) 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 other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”); (iiiC) 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; (ivD) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental 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 and, to the Company’s knowledge, neither the FDA or nor any other comparable governmental or regulatory agency Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) has not received notice that the FDA or any other comparable governmental or regulatory agency 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 and, to the Company’s knowledge, neither the FDA or nor any other comparable governmental or regulatory agency Governmental Authority is considering threatening to initiate such action; and (viF) 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, Statement or the Prospectus Supplement or otherwise in the SEC ReportsProspectus, or would not, singly or in the aggregate, result in a Material Adverse Effect, the Company: (i) is and at all times has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("“FDA"”) and other comparable governmental or regulatory agencies 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 under development, manufactured or distributed by the Company ("“Applicable Regulatory Laws"”); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or other comparable governmental or regulatory agencies alleging or asserting material non-compliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”); (iii) 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; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any 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 has no knowledge that the FDA or any other comparable governmental or regulatory agency or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that the FDA or any 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 has no knowledge that the FDA or any other comparable governmental or regulatory agency is considering such action; and (vi) 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus Supplement or otherwise in the SEC Reports, or as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company: (iA) is and at all times has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") FDA and other comparable governmental or regulatory agencies Governmental Entities 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 under development, manufactured or distributed by the Company ("“Applicable Regulatory Laws"”); (iiB) 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 other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”); (iiiC) 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; (ivD) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental 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 and, to the Company’s knowledge, neither the FDA or nor any other comparable governmental or regulatory agency Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) has not received notice that the FDA or any other comparable governmental or regulatory agency 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 and, to the Company’s knowledge, neither the FDA or nor any other comparable governmental or regulatory agency Governmental Authority is considering threatening to initiate such action; and (viF) 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, the Prospectus Supplement or otherwise in General Disclosure Package and the SEC Reports, or would not, singly or in the aggregate, result in a Material Adverse EffectProspectus, the Company: (iA) is are and at all times has have been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") FDA and other comparable governmental or regulatory agencies Governmental Entities 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 under development, manufactured or distributed by or on behalf of the Company ("“Applicable Regulatory Laws"”); (iiB) has have not received any Form FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the FDA or any other comparable governmental or regulatory agencies Governmental Entity alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or the terms of any licenses, certificates, approvals, registrations, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”), except in each case as would not, individually or in the aggregate have a Material Adverse Effect; (iiiC) possesses 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; (ivD) has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental Entity or third party alleging that any product operation operation, research program, or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has have no knowledge that the FDA or any other comparable governmental or regulatory agency Governmental 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; (vE) has not received written notice that the FDA or any other comparable governmental or regulatory agency Governmental Entity 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 or any other comparable governmental or regulatory agency Governmental Entity is considering threatening such action, except in each case as would not, individually or in the aggregate have a Material Adverse Effect; and (viF) 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration StatementThe Company and its Subsidiaries, the Prospectus Supplement or otherwise in the SEC Reportssince July 1, or would not, singly or in the aggregate, result in a Material Adverse Effect, the Company2019: (i) is and at all times has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") and other comparable governmental or regulatory agencies 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 under development, manufactured or distributed by the Company ("Applicable Regulatory Laws"); (ii) has 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 other comparable similar federal, state, local or foreign governmental or regulatory agencies authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Health Care Laws (defined below) or any licenses, certificates, approvals, clearances, authorizations, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Health Care Laws to conduct the Company’s business as described in Prospectus Supplement ("“Authorizations"”); (iiiii) possesses 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 material violation of any term of any such AuthorizationsAuthorizations except where such violation would not, singly or in the aggregate, have a Material Adverse Effect; (iviii) has 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 other comparable federal, state, local or foreign governmental or regulatory agency authority or third party alleging that any product candidate operation or activity is in material violation of any Applicable Regulatory Health Care Laws or Authorizations and the Company has no knowledge that the FDA or any other comparable federal, state, local or foreign governmental or regulatory agency authority or third party is considering any such claim, litigation, arbitration, actionAction, suit, investigation or proceedingProceeding; (viv) has have not received written notice that the FDA or any other comparable federal, state, local or foreign governmental or regulatory agency authority has taken, is taking or intends to take action Action to limit, suspend, materially modify or revoke any material Authorizations and has no knowledge that the FDA or any other comparable federal, state, local or foreign governmental or regulatory agency authority is considering such actionAction; and (viv) has 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 Regulatory 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, the Prospectus Supplement or otherwise in General Disclosure Package and the SEC Reports, or would not, singly or in the aggregate, result in a Material Adverse EffectProspectus, the Company: (iA) is and at all times for the previous five (5) years has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") FDA and other comparable governmental or regulatory agencies Governmental Entities 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 under development, manufactured manufactured. marketed or distributed by the Company ("“Applicable Regulatory Laws"”); (iiB) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits 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 Regulatory Laws ("“Authorizations"”); (iiiC) 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; (ivD) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental 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 or any other comparable governmental or regulatory agency Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) has not received notice that the FDA or any other comparable governmental or regulatory agency 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 or any other comparable governmental or regulatory agency Governmental Authority is considering such action; and (viF) 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except in each case, as described in the Registration Statement, the Prospectus Supplement or otherwise in the SEC Reports, or would not, singly individually or in the aggregate, result in reasonably be expected to have a Material Adverse Effect, the Company: (iA) is is, and at all times has been since February 1, 2020 been, in material compliance with all applicable statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") and other comparable governmental or regulatory agencies applicable FDA relating 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 under development, manufactured or distributed by the Company ("“Applicable Regulatory Laws"”); (iiB) 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 other comparable any similar governmental or regulatory agencies entity in each case alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”); (iiiC) 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 material violation of any term of any such Authorizations; except as described in the Registration Statement and the Prospectus, (ivD) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency entity 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 or any other comparable governmental or regulatory agency entity or third party is considering has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (vE) has not received written notice that the FDA or any other comparable governmental or regulatory agency entity 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 or any other comparable governmental or regulatory agency entity is considering such action; and (vi) 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 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 Prospectus Supplement or otherwise in Time of Sale Information and the SEC Reports, or would not, singly or in the aggregate, result in a Material Adverse EffectOffering Memorandum, the Company: (iA) is and at all times has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("“FDA"”) and other comparable federal, state, local or foreign governmental or regulatory agencies authority (“Governmental Authority”) 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 under development, manufactured or distributed by the Company ("“Applicable Regulatory Laws"”); (iiB) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”), which would, individually or in the aggregate, result in a Material Adverse Effect; (iiiC) 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; (ivD) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental 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 or any other comparable governmental or regulatory agency Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) has not received notice that the FDA or any other comparable governmental or regulatory agency 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 or any other comparable governmental or regulatory agency Governmental Authority is considering such action; and (viF) 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 on the date filed (or were corrected or supplemented by a subsequent submission).

FDA Compliance. Except as described in the Registration Statement, the General Disclosure Package and the Final Prospectus Supplement or otherwise in the SEC Reports, or as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company: (iA) is and at all times has been in material compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration ("FDA") FDA and other comparable governmental or regulatory agencies Governmental Entities 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 under development, manufactured or distributed by the Company ("“Applicable Regulatory Laws"”); (iiB) 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 other comparable governmental or regulatory agencies any Governmental Authority alleging or asserting material non-compliance noncompliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws ("“Authorizations"”); (iiiC) 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; (ivD) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental or regulatory agency Governmental 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 and, to the Company’s knowledge, neither the FDA or nor any other comparable governmental or regulatory agency Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) has not received notice that the FDA or any other comparable governmental or regulatory agency 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 and, to the Company’s knowledge, neither the FDA or nor any other comparable governmental or regulatory agency Governmental Authority is considering threatening to initiate such action; and (viF) 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 on the date filed (or were corrected or supplemented by a subsequent submission).