Common use of Healthcare Regulatory Matters Clause in Contracts

Healthcare Regulatory Matters. (a) Except as, individually or in the aggregate, has not had and would not reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, (i) all filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence and other documents required to be filed or maintained with or furnished to the FDA or any other Healthcare Regulatory Authority (collectively, “Health Care Submissions”) by the Company or any of its Subsidiaries have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither the Company or any of its Subsidiaries nor, to the Knowledge of the Company, any officer, employee or agent of the Company or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of the Company or any of its Subsidiaries (a “Company Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of the Company or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy.

Healthcare Regulatory Matters. (a) Except as, individually or in the aggregate, has not had and would not reasonably be expected to result in a Company Parent Material Adverse Effect, since the Applicable Date, (i) all filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence and other documents Health Care Submissions required to be filed or maintained with or furnished to the FDA or any other Healthcare Regulatory Authority (collectively, “Health Care Submissions”) by the Company Parent or any of its Subsidiaries have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither the Company Parent or any of its Subsidiaries nor, to the Knowledge of the CompanyParent, any officer, employee or agent of the Company Parent or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of the Company Parent or any of its Subsidiaries (a “Company Parent Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of the Company Parent or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy.

Healthcare Regulatory Matters. (a) Except as, individually or in the aggregate, has as does not had and would not reasonably be expected to result in constitute a Company Parent Material Adverse Effect, since the Applicable Date, (i) all filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence and other documents Health Care Submissions required to be filed or maintained with or furnished to the FDA or any other Healthcare Regulatory Authority (collectively, “Health Care Submissions”) by the Company Parent or any of its Subsidiaries have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither the Company Parent or any of its Subsidiaries nor, to the Knowledge of the CompanyParent, any officer, employee or agent of the Company Parent or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of the Company Parent or any of its Subsidiaries (a “Company Parent Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of the Company Parent or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy.

Healthcare Regulatory Matters. The Company (collectively with its Subsidiaries) (a) Except ashas operated and currently operates its business in compliance in all material respects with applicable provisions of the Health Care Laws of the Food and Drug Administration (“FDA”), the Department of Health and Human Services and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s or its Subsidiaries’ product candidates or any product manufactured or distributed by the Company, (b) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (i) any Health Care Laws or (ii) any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”), (c) possesses all Regulatory Authorizations required to conduct its business as currently conducted, except where the failure to possess the same would not, individually or in the aggregate, have a Material Adverse Effect, and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations, (d) has not had received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities or any other third party alleging that any product of the Company is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities or any other third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, (e) has not received written notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action, (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission), (g) is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority and (h) along with its employees, officers and directors, has not been excluded, suspended or debarred from participation in any government health care program or human clinical research and, to the Company’s Knowledge, is not subject to a governmental inquiry, investigation, proceeding or other similar action that would not reasonably be expected to result in a Company Material Adverse Effectdebarment, since the Applicable Date, (i) all filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence and other documents required to be filed suspension or maintained with or furnished to the FDA or any other Healthcare Regulatory Authority (collectively, “Health Care Submissions”) by the Company or any of its Subsidiaries have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither the Company or any of its Subsidiaries nor, to the Knowledge of the Company, any officer, employee or agent of the Company or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of the Company or any of its Subsidiaries (a “Company Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of the Company or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policyexclusion.

Healthcare Regulatory Matters. To the Knowledge of Fermat, (a) Except asFermat is, individually and at all times since January 1, 2015 has been, in compliance with all applicable Healthcare Laws with respect to the Acquired H&N Assets and the H&N Business, (b) Fermat and the H&N Business have obtained and are in compliance with all Permits pursuant to Healthcare Laws required for the operation of the Acquired H&N Assets and the H&N Business as presently conducted, and that such permits may be transferred or re-issued in the ordinary course to Descartes without any material adverse impact on the business, (c) there are no Proceedings pending against Fermat alleging a violation of Healthcare Laws with respect to the Acquired H&N Assets or the H&N Business nor are there any ongoing obligations required from the prior resolution of any alleged violation of Healthcare Laws, (d) Fermat has not received any written notification or communication from any Governmental Entity (including any inspection reports on Form 483, FDA warning letters or FDA untitled letters) of noncompliance with any Healthcare Law, (e) since January 1, 2015, Fermat has not received any written notice from any Person concerning any actual or alleged violation of Healthcare Law or of any Liabilities or potential Liabilities (including any investigatory, remedial, or corrective obligations) relating to the operation of the H&N Business arising under or in connection with Healthcare Law; (f) prior to the aggregatedate hereof, Fermat has not had made available to Descartes true and would not reasonably be expected accurate copies of all material reports, audits, data, investigations, correspondence or other documents related to result compliance with Healthcare Law that are in a Company Material Adverse Effect, since the Applicable DateFermat’s or its Affiliates’ possession or control, (ig) since January 1, 2015, all filings, declarations, listings, registrations, reports, submissionsdocuments, applications, amendments, modifications, supplements, notices, correspondence and other documents Permits or notices required to be filed or filed, maintained with or furnished to the FDA or any other Healthcare Regulatory Authority Governmental Entity (collectively, “Health Care SubmissionsHealthcare Regulatory Filings”) by the Company or any of its Subsidiaries have been so filed, maintained or furnishedfurnished in a timely manner, except where failure to file, maintain or furnish such reports, documents, Permits or notices would not constitute a H&N Business Material Adverse Effect, (iih) all such Health Care Submissions Healthcare Regulatory Filings were complete and accurate and in compliance with all applicable Laws when material respects on the date filed (or were corrected in or supplemented by a subsequent filing), ) and (iiii) neither the Company or Fermat nor any of its Subsidiaries nor, to the Knowledge of the Company, any Fermat officer, employee employee, agent or agent of the Company or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of the Company or any of its Subsidiaries (a “Company Clinical Trial Investigator”) distributor has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, Governmental Entity or failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of the Company or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 FedGovernmental Entity. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy.1414958.12A-NYCSR03A - MSW

Healthcare Regulatory Matters. To the Knowledge of Fermat, (a) Except asFermat is, individually and at all times since January 1, 2015 has been, in compliance with all applicable Healthcare Laws with respect to the Acquired H&N Assets and the H&N Business, (b) Fermat and the H&N Business have obtained and are in compliance with all Permits pursuant to Healthcare Laws required for the operation of the Acquired H&N Assets and the H&N Business as presently conducted, and that such permits may be transferred or re-issued in the ordinary course to Descartes without any material adverse impact on the business, (c) there are no Proceedings pending against Fermat alleging a violation of Healthcare Laws with respect to the Acquired H&N Assets or the H&N Business nor are there any ongoing obligations required from the prior resolution of any alleged violation of Healthcare Laws, (d) Fermat has not received any written notification or communication from any Governmental Entity (including any inspection reports on Form 483, FDA warning letters or FDA untitled letters) of noncompliance with any Healthcare Law, (e) since January 1, 2015, Fermat has not received any written notice from any Person concerning any actual or alleged violation of Healthcare Law or of any Liabilities or potential Liabilities (including any investigatory, remedial, or corrective obligations) relating to the operation of the H&N Business arising under or in connection with Healthcare Law; (f) prior to the aggregatedate hereof, Fermat has not had made available to Descartes true and would not reasonably be expected accurate copies of all material reports, audits, data, investigations, correspondence or other documents related to result compliance with Healthcare Law that are in a Company Material Adverse Effect, since the Applicable DateFermat’s or its Affiliates’ possession or control, (ig) since January 1, 2015, all filings, declarations, listings, registrations, reports, submissionsdocuments, applications, amendments, modifications, supplements, notices, correspondence and other documents Permits or notices required to be filed or filed, maintained with or furnished to the FDA or any other Healthcare Regulatory Authority Governmental Entity (collectively, “Health Care SubmissionsHealthcare Regulatory Filings”) by the Company or any of its Subsidiaries have been so filed, maintained or furnishedfurnished in a timely manner, except where failure to file, maintain or furnish such reports, documents, Permits or notices would not constitute a H&N Business Material Adverse Effect, (iih) all such Health Care Submissions Healthcare Regulatory Filings were complete and accurate and in compliance with all applicable Laws when material respects on the date filed (or were corrected in or supplemented by a subsequent filing), ) and (iiii) neither the Company or Fermat nor any of its Subsidiaries nor, to the Knowledge of the Company, any Fermat officer, employee employee, agent or agent of the Company or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of the Company or any of its Subsidiaries (a “Company Clinical Trial Investigator”) distributor has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, Governmental Entity or failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of the Company or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 FedGovernmental Entity. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy.Section 4.24