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. (b) Neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any director, officer or employee of the Company or any of its Subsidiaries or any Company Clinical Trial Investigator is or has been excluded or suspended from a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or (b) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatened. (c) Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, (i) all Product Candidates under development by or on behalf of the Company or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of the Company or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Subsidiaries and (iv) neither the Company nor any of its Subsidiaries has received any written notice or communication alleging that the Company or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, neither the Company nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authority. (d) Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, the Company and its Subsidiaries have complied with, and have not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of the Company, any investigation with respect thereto) by the Company or any of its Subsidiaries or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect to any Product Candidates under development by or on behalf of the Company or any of its Subsidiaries.

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. (b) Neither the Company nor Parent or any of its Subsidiaries nor, to the Knowledge of the CompanyParent, any director, officer or employee of the Company Parent or any of its Subsidiaries or any Company Parent Clinical Trial Investigator is or has been excluded or suspended from a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or (b) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatened). (c) Except as would not, individually or in the aggregate, reasonably be expected to result in does not constitute a Company Parent Material Adverse Effect, (i) all Product Candidates under development by or on behalf of the Company Parent or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of the Company Parent or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company Parent or any of its Subsidiaries and (iv) neither the Company Parent nor any of its Subsidiaries has received any written notice or communication alleging that the Company Parent or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in does not constitute a Company Parent Material Adverse Effect, since the Applicable Date, neither the Company Parent nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authority. (d) Except as would not, individually or in the aggregate, reasonably be expected to result in does not constitute a Company Parent Material Adverse Effect, since the Applicable Date, the Company Parent and each of its Subsidiaries have has complied with, and have has not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of the CompanyParent, any investigation with respect thereto) by the Company Parent or any of its Subsidiaries or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect to any Product Candidates under development by or on behalf of the Company Parent or any of its Subsidiaries.

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. (b) Neither the Company nor Parent or any of its Subsidiaries nor, to the Knowledge of the CompanyParent, any director, officer or employee of the Company Parent or any of its Subsidiaries or any Company Parent Clinical Trial Investigator is or has been excluded or suspended from a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or (b) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatened. (c) Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Parent Material Adverse Effect, (i) all Product Candidates under development by or on behalf of the Company Parent or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of the Company Parent or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company Parent or any of its Subsidiaries and (iv) neither the Company Parent nor any of its Subsidiaries has received any written notice or communication alleging that the Company Parent or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Parent Material Adverse Effect, since the Applicable Date, neither the Company Parent nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authority. (d) Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Parent Material Adverse Effect, since the Applicable Date, the Company Parent and each of its Subsidiaries have complied with, and have not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of the CompanyParent, any investigation with respect thereto) by the Company Parent or any of its Subsidiaries or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect to any Product Candidates under development by or on behalf of the Company Parent or any of its Subsidiaries.

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 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. (b) Neither None of the Company nor any of its Subsidiaries noror, to the Knowledge of the Company, any director, officer or employee of the Company or any of its Subsidiaries or any Company Clinical Trial Investigator is or has been excluded or suspended from a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or (b) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatened). (c) Except as would not, individually or in the aggregate, reasonably be expected to result in does not constitute a Company Material Adverse Effect, (i) all Product Candidates under development by or on behalf of the Company or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of the Company or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Subsidiaries and (iv) neither the Company nor any of its Subsidiaries has not received any written notice or communication alleging that the Company or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in does not constitute a Company Material Adverse Effect, since the Applicable Date, neither the Company nor any of its Subsidiaries has not received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authority. (d) Except as would not, individually or in the aggregate, reasonably be expected to result in does not constitute a Company Material Adverse Effect, since the Applicable Date, the Company and its Subsidiaries have has complied with, and have has not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of the Company, any investigation with respect thereto) by the Company or any of its Subsidiaries or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect to any Product Candidates under development by or on behalf of the Company or any of its SubsidiariesCompany.

Healthcare Regulatory Matters. (a) Except asThe Company and its Subsidiaries currently conduct, individually or and since the Applicable Date have conducted, business in the aggregate, has not had material compliance with all applicable Healthcare Laws and would not reasonably be expected to result in a Company Material Adverse Effect, since Contracts. Since the Applicable Date, (i) all filingsneither the Company nor its Subsidiaries have received or been subject to any action, declarationswritten notice, listingscitation, registrationssuspension, reportsrevocation, submissionslimitation, applicationswarning or claim issued by a Governmental Entity, amendments, modifications, supplements, notices, correspondence and other documents required to be filed or maintained with or furnished to the FDA or allegation made by any other Healthcare Regulatory Authority (collectivelyPerson, “Health Care Submissions”) by that asserts that either the Company or any of its Subsidiaries have materially violated any Healthcare Law. Since the Applicable Date, there has been so filedno claim (including written, 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 noror, to the Knowledge of the Company, other notice of an intent to audit or investigate) by any officer, employee Person with respect to 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 business, other than customary health care claim reviews and corrections in the ordinary course of business, and there is no such pending, or to the Knowledge of the Company or any of its Subsidiaries thatCompany, at threatened action. Since the time such disclosure was madeApplicable Date, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraudno Person has sought, 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. (b) Neither the Company nor any of its Subsidiaries noror, to the Knowledge of the Company, any directoris reasonably expected to seek, officer or employee of indemnification from the Company (or any of equityholder or its Subsidiaries Subsidiaries, in connection with the Company) for any claims regarding noncompliance with, or any violations of, Healthcare Laws or Company Clinical Trial Investigator is or has been excluded or suspended from a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or Material Contracts. (b) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatened. (c) Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, (i) all Product Candidates under development by or on behalf of the Company or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of the Company or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Subsidiaries and (iv) neither the Company nor any of its Subsidiaries has received any written notice or communication alleging that the Company or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since Since the Applicable Date, neither the Company nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from of their respective directors, officers, or employees or, to the Knowledge of the Company, any other Healthcare Regulatory Authority contractors acting on behalf of the Company, has knowingly (as defined under the False Claims Act) submitted or (B) any other written notice of violations, inspectional observations, untitled letters caused to be submitted to a Governmental Health Program or other written administrativePayor a false or fraudulent claim for payment, regulatory or enforcement notice from and the FDA or billing, coding and claims review, audit and adjustment practices of the Company and its Subsidiaries, and any analogous Healthcare Regulatory Authority. (d) Except as would notPerson acting on the Company’s behalf, individually or are and since the Applicable Date have been, in the aggregate, reasonably be expected to result compliance in a all material respects with all applicable Laws and Company Material Adverse Effect, since Contracts to which the Company is bound or otherwise subject. Since the Applicable Date, the Company and its Subsidiaries have complied withundertaken good faith, reasonable efforts to identify and return any overpayments, as required under any applicable Laws or Company Material Contracts. (c) Except as would not be material to the Company or its Subsidiaries, the Company currently maintains, and since the Applicable Date has maintained, a compliance program reasonably designed to promote compliance with Healthcare Laws that includes applicable policies, procedures and training for all employees and workforce members and that meets requirements under Healthcare Laws. Since the Applicable Date, the Company and its Subsidiaries have operated in material compliance with such compliance program and has provided to Parent complete and accurate copies of all compliance program materials. (d) The Company and its Subsidiaries are, and since the Applicable Date, have been in compliance in all material respects with Healthcare Privacy Obligations, including HIPAA and all similar state applicable Laws governing the privacy, security or confidentiality of medical or health information of patients, to the extent applicable to the Company. Since the Applicable Date, the Company or its Subsidiaries have entered into Business Associate Agreements (as defined by HIPAA) with customers, contractors and other Persons, wherever required by applicable Law. The Company is not, and since January 1, 2023, has not been notified been, in writing by any Healthcare Regulatory Authority material breach of any failure (orBusiness Associate Agreements, and to the Knowledge of the Company, no counterparty has been in breach of any investigation with respect theretoBusiness Associate Agreements. With the exception of inadvertent disclosures of “Protected Health Information” (as defined by HIPAA) by involving fewer than one hundred (100) individuals that (i) the Company or any of its Subsidiaries disclosed to their customers and (ii) would not, individually or any licensorin the aggregate, licenseebe material to the Company and its Subsidiaries, partner or distributor to comply withtaken as a whole, since the Applicable Date, the Company has not otherwise experienced a “Breach” (as defined by HIPAA), successful “security incident” (as defined by HIPAA), or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case other reportable data incident with respect to any Product Candidates Protected Health Information in possession or under development by or on behalf the control of the Company or any its Business Associates (as defined by HIPAA). The Company maintains, and since the Applicable Date, has maintained, a HIPAA compliance program (including policies, procedures, training and security risk assessments) that materially complies with HIPAA and its Contracts, and has operated materially in compliance with such program. The Company maintains all PHI within the United States of America and only allows employees or contractors to access or view such PHI from outside the United States of America in compliance with applicable Healthcare Privacy Obligations. The Company currently maintains and since January 26, 2024, has maintained HITRUST certification in good standing, is in compliance with its SubsidiariesHITRUST certification, and to the Knowledge of the Company, there is no fact or circumstance that would jeopardize such certification.

Healthcare Regulatory Matters. (a) Except asThe Company and the Company Subsidiaries are, individually or and for the past three (3) years have been, in material compliance with all applicable Healthcare Laws. Since January 1, 2021, the aggregateCompany and the Company Subsidiaries have not received any written notice, 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 including any healthcare related Action from any Governmental Authority or any other Person regarding any material noncompliance of any applicable Healthcare Regulatory Authority (collectivelyLaw. No such notice or Action has been filed, “Health Care Submissions”) by commenced, or to the knowledge of the Company, threatened, against the Company or the Company Subsidiaries alleging that 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 Company Subsidiary is not in material 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 policyLaws. (b) Neither the Company nor the Company Subsidiaries nor any of its Subsidiaries northeir respective officers, directors, employees, or managing employees (as such term is defined in 42 U.S.C. § 1320a-5(b)), or, to the Knowledge knowledge of the Company, any directorcontractors, officer vendors, or employee of the Company or any of its Subsidiaries or any Company Clinical Trial Investigator agents is or has been excluded been: (i) convicted of or suspended from pled nolo contendere to sufficient facts regarding, any violation of a Government Healthcare Law, including any Law applicable to a Governmental Health Care Program or any other criminal offense that would result in mandatory exclusion from Governmental Health Programs; (ii) are or have been excluded, suspended, disqualified or debarred pursuant from participation in, or are otherwise ineligible to 21 U.S.C. § 335a participate in, any Governmental Health Program or listed on the General Services Administration-published list of parties excluded from procurement programs and non-procurement programs; (aiii) have entered into any corporate integrity agreement, deferred prosecution agreement, non-prosecution agreement, or similar agreement or settlement with any Governmental Authority with respect to any actual or alleged violation of any Healthcare Law; or (biv) have made, or disqualified from receiving investigational products are in the process of making, or conducting clinical research, and no such debarment are considering making a voluntary self-disclosure as may be required or disqualification proceedings are pending or threatenedpermitted under any Healthcare Law. (c) Except as would not, individually or in the aggregate, reasonably be expected to result in a The Company Material Adverse Effect, (i) all Product Candidates under development by or on behalf of and the Company Subsidiaries maintain, and have at all times maintained, a compliance program having the elements of an effective corporate compliance and ethics program identified in U.S.S.G. § 8B2.1. There are no material compliance complaints or any of its Subsidiaries have been researchedreports outstanding, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in ongoing internal compliance with all applicable Laws, (ii) all clinical trials conducted by investigations or on behalf of the Company or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Subsidiaries and (iv) neither the Company nor any of its Subsidiaries has received any written notice or communication alleging that the Company or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, neither the Company nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authoritycorrective actions outstanding. (d) Except as would not, individually or in the aggregate, reasonably be expected to result in a The Company Material Adverse Effect, since the Applicable Date, and the Company Subsidiaries are and its for the past three (3) years have been, in compliance in all material respects with HIPAA. The Company and the Company Subsidiaries have complied withnot received written notice of, and have not been notified in writing by any Healthcare Regulatory Authority of any failure (there is no Action or, to the Knowledge of the Company’s Knowledge, any investigation pending or threatened with respect theretoto any alleged “breach” (as defined in HIPAA) by the Company or any other members of its the Company Group or their respective “workforce”. Except as set forth on Schedule 4.22, for the past three (3) years, no “breach” by the Company or the Company Subsidiaries or, to the knowledge of the Company, their respective “workforce” or any licensorsuccessful “security incident” has occurred with respect to “protected health information” (as such terms are defined by HIPAA) in the possession or under the control of the Company and the Company Subsidiaries. The Company and the Company Subsidiaries have conducted a risk analysis as required by HIPAA and have implemented corrective actions to address all high-risk vulnerabilities identified through such analysis. The Company and the Company Subsidiaries have written, licenseesigned and HIPAA-compliant business associate agreements with each Person that is a “covered entity” or “business associate” (as such terms are defined in HIPAA) where required by HIPAA, partner or distributor to comply with, or maintain systems and programs to ensure have materially complied with such agreements. The Company and the Company Subsidiaries have maintained a HIPAA compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interestprogram, including current Good Manufacturing Practice Requirementswritten policies and procedures that address its HIPAA compliance efforts. (e) Except as set forth on Schedule 4.22(e), Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable prior to the debarment date hereof, the Company has provided to Parent a true, complete, and correct (i) listing of individualsactive or suspended, requirements applicable to but still ongoing (x) Targeted Probe and Educate (“TPE”) audits and (y) Unified Program Integrity Contractor (“UPIC”) audits, and (ii) letters of commencement and closure of the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirementssame, in each case with respect to any Product Candidates under development by or on behalf case, in existence as of the Company or any of its Subsidiariesdate hereof.

Healthcare Regulatory Matters. (ai) Except asThe Company, individually the Continuing Subsidiaries and the other Seller Parties (with respect to the Business) (A) are in material compliance with and have conducted the Business in and used or occupied its properties or assets in compliance with the aggregateFDC Act and applicable foreign equivalent Laws and applicable Healthcare Laws, and (B) have not received any written notice of any alleged violation of, or any citation for noncompliance with, any Healthcare Laws, in each of cases (A) and (B), that has not had and or 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)To Seller’s Knowledge, and (iii) neither the Company or any of its Subsidiaries nor, to the Knowledge none of the Company, any officer, employee or agent of the Company Continuing Subsidiary or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of other Seller Party (with respect to the Company or any of its Subsidiaries (a “Company Clinical Trial Investigator”Business) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority Governmental Authority, or committed any an act, made any statement a statement, or failed to make any statement, in each case, related to the business of the Company or any of its Subsidiaries a statement that, at the time such disclosure was made, would could reasonably be expected to provide a basis for the FDA or any other Governmental Authority 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. (biii) Neither the Company nor any of its Subsidiaries nor, to the Knowledge None of the Company, any directorContinuing Subsidiary, officer and any officer, employee or agent thereof, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law by a Governmental Authority. To Seller’s Knowledge, which is based on, among other things, screening the Company’s and the Continuing Subsidiaries’ officers, employees and agents against the Exclusions Database of the HHS Office of Inspector General, none of the Company nor any Continuing Subsidiary, and any officer, employee or agent thereof, has been convicted of any crime or engaged in any conduct for which such person or entity could be excluded from participating in the federal health care programs under Section 1128 or Section 1877 of the Social Security Act of 1935, as amended (the “Social Security Act”) or any similar Law. None of the Company, any Continuing Subsidiary, and any officer, employee or agent thereof, has engaged in any conduct that could subject such Person or entity to a civil money penalty or criminal penalty under Sections 1128A or 1128B of the Social Security Act or any similar Law. (iv) To Seller’s Knowledge, there are no facts, circumstances or conditions that would reasonably be expected to form the basis for any investigation, suit, claim, action, proceeding or imposition of any penalties against or affecting the Company or any of its Subsidiaries Continuing Subsidiary relating to or any Company Clinical Trial Investigator is arising under a Healthcare Law that has had or has been excluded or suspended from would reasonably be expected to have a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or (b) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatened. (c) Except as would notMaterial Adverse Effect, individually or in the aggregate. (v) None of Seller (with respect to the Business), reasonably be expected to result in a Company Material Adverse Effect, (i) all Product Candidates under development by or on behalf of the Company or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of the Company or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Continuing Subsidiaries and any other Seller Party (ivwith respect to the Business) neither the Company nor any of its Subsidiaries has received any written notice or communication alleging that the Company or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, neither the Company nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from other Governmental Authority has (A) commenced, or threatened to initiate, any other Healthcare Regulatory Authority or action to request the recall of any product, (B) commenced, or threatened to initiate, any other written notice action to enjoin reprocessing or distribution of violationsany product, inspectional observationsor (C) commenced, untitled letters or other written administrativethreatened to initiate, regulatory any action to enjoin the reprocessing or enforcement notice from the FDA distribution of any medical device produced at any facility where any product is reprocessed, tested, or any analogous Healthcare Regulatory Authorityheld. (dvi) Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, the The Company and its the Continuing Subsidiaries have complied withdo not possess any registrations, and have not been notified in writing by any Healthcare Regulatory Authority of any failure clearances or approvals issued under the FD&C Act (or, to the Knowledge of the Company, any investigation with respect thereto) by “FD&C Permits”). No FD&C Permits are required for the Company or the Company Subsidiaries to conduct the Business as presently conducted. As of the date hereof, neither the Company’s, any of its Subsidiaries the Continuing Subsidiaries’ or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case other Seller Party’s (with respect to any Product Candidates under development by or on behalf of the Company or Business) facilities nor any of their records have been inspected by the FDA. The Company, the Continuing Subsidiaries and the Seller Parties (with respect to the Business) have neither conducted any clinical studies in the United States nor sponsored the conduct of any clinical research in the United States that is subject to FDA regulation (i) since being owned or controlled by Seller and its SubsidiariesAffiliates, and (ii) to Seller’s Knowledge, prior to being owned or controlled by Seller and its Affiliates.

Healthcare Regulatory Matters. (a) Except asThe Company and the Company Subsidiaries are in compliance, individually or in the aggregateall material respects, has not had and would not reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, with (i) all filingsapplicable Laws (including, declarationsfor the avoidance of doubt, listingsgood manufacturing practices and good clinical practices) of the FDA, registrationsDEA, EMEA and applicable comparable Laws of each other Healthcare Regulatory Authority and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and the Company Subsidiaries, or by which any property, product or other asset of the Company and the Company Subsidiaries is bound or affected. Since January 1, 2011, neither the Company nor the Company Subsidiaries has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, Proceeding, enforcement, investigation or other action against the Company or any of the Company Subsidiaries from any Healthcare Regulatory Authority. (b) Except as described in Section 4.11(b) of the Disclosure Schedule, the Company and the Company Subsidiaries have not since January 1, 2011 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product manufactured, distributed or marketed by or on behalf of the Company and the Company Subsidiaries. Except as described in Section 4.11(b) of the Disclosure Schedule, neither the Company nor any of the Company Subsidiaries has received any written notice since January 1, 2011 that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke or withdraw a Product approval, or request the recall of any Product, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Product or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any Product produced at any facility where any Product is manufactured, tested, processed, packaged or held for sale. (c) All material reports, submissionsdocuments, applications, amendments, modifications, supplementsclaims, notices, correspondence licenses and other documents registrations relating to any of the Products that are 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 the Company Subsidiaries have been so filed, maintained or furnished, (ii) and all such Health Care Submissions reports, documents, licenses and registrations were complete and accurate and complete in compliance with all applicable Laws when material respects on the date filed (or were corrected in or supplemented by a subsequent filing). The Company and the Company Subsidiaries are and have been, since January 1, 2009, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse events related to the Products. (iiid) neither Neither the Company nor any of the Company Subsidiaries has received any material written information since January 1, 2011 from any Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its Products which would reasonably be expected to lead: (i) to the revocation, withdrawal, or denial of any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to be materially adverse to the Company and the Company Subsidiaries; or (ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to be materially adverse to the Company and the Company Subsidiaries. (e) There is no Proceeding pending or, to the Knowledge of the Company, threatened in writing against the Company or any Company Subsidiary that would reasonably be expected to result in the exclusion of its Subsidiaries northe Company or any Company Subsidiary from any third party payment program in which it participates. (f) Neither the Company nor any Company Subsidiary or, to the Knowledge of the Company, any officerof their respective current employees, employee or agent former employees, officers, agents, contractors or distributors during the time of their employment or service with such Person, has committed or been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a, any similar Law or authorized by 21 U.S.C. § 335a or any similar applicable Law. (g) Since January 1, 2011, the Company and the Company Subsidiaries have held all material Healthcare Regulatory Authorizations required for the conduct of their respective businesses and all such Healthcare Regulatory Authorizations are and have been in full force and effect. (h) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or the Company Subsidiaries, or in which the Company and the Company Subsidiaries or the Products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable Law, including good laboratory practice requirements in all material respects. The Company and the Company Subsidiaries have not received since January 1, 2011 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Company or any of its the Company Subsidiaries, or in which the Company or the any of the Company Subsidiaries acting on its behalf or have participated. (i) Except as described in Section 4.11(i) of the Disclosure Schedule, since January 1, 2011 the Company and the Company Subsidiaries have not engaged, and none of them is now engaging, in any clinical trial studies as sponsor, investigator conducting or monitor. (j) Except as described in Section 4.11(j) of the Disclosure Schedule, since January 1, 2011, neither the Company nor any clinical trial of a the Company Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Products, and there is no action or Proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of Law in any material respect with respect to, any Product Candidate manufactured, distributed or marketed by or on behalf of the Company or its Subsidiaries. (k) Neither the Company nor 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 Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, the Company Subsidiaries or any of its Subsidiaries thatthe Products, at the time such disclosure was made, would reasonably be expected to provide a basis for by the FDA pursuant to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the “Final Policy”), or for any other Healthcare Regulatory Authority to invoke any similar policy. (b) otherwise engaged in improper conduct contemplated by the Final Policy. Neither the Company nor any of its Subsidiaries the Company Subsidiaries, nor, to the Knowledge of the Company, any directorofficer, officer employee, agent, contractor or employee distributor of the Company or any of its Subsidiaries the Company Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any Company Clinical Trial Investigator is similar applicable Law. As of the date of this Agreement, no claims, actions, proceedings or has been excluded or suspended from a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or (b) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatened. (c) Except as investigations that would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effectmaterial debarment or exclusion are pending or, (i) all Product Candidates under development by or on behalf to the Knowledge of the Company or any of its Subsidiaries have been researchedCompany, developedthreatened, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of against the Company or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Subsidiaries and (iv) neither the Company nor any of its Subsidiaries has received any written notice or communication alleging that the Company or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, neither the Company nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authority. (d) Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, the Company and its Subsidiaries have complied with, and have not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of the Company, any investigation of its directors, officers, employees or agents. The Company has made available to Purchaser a true, correct and complete listing of fees, payments and reimbursements paid by the Company and the Company Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with respect theretothe subject matters thereof, and the Company and the Company Subsidiaries have been and are in compliance with the PhRMA Code on Interactions with Healthcare Professionals. (l) Neither the FDA nor any other Healthcare Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company or the Company Subsidiaries or, to the Knowledge of the Company, any Company Representatives to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Healthcare Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order. (m) To the Knowledge of the Company, no new drug applications (“NDAs”) or abbreviated new drug applications (“ANDAs”) submitted by the Company or any of its the Company Subsidiaries to any Healthcare Regulatory Authority for approval and which have been approved contain any untrue statement of a material fact or omit to state any licensor, licensee, partner or distributor material fact necessary in order to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to make the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirementsstatements made therein, in each case the light of the circumstances under which they were made, not misleading, but with respect to those NDAs and ANDAs that have been submitted for approval but which have not been approved, subject to the Company and the Company Subsidiaries having received or receiving ordinary course communications, inquiries and requests for information from Healthcare Regulatory Authorities with respect to the such NDAs or ANDAs. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any Product Candidates under development of the Company Subsidiaries for approval and which have been approved are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense, but with respect to NDAs and ANDAs that have been submitted for approval but which have not been approved, subject to the Company and the Company Subsidiaries having received or receiving ordinary course communications, inquiries and requests for information from Healthcare Regulatory Authorities with respect to such NDAs and ANDAs. (n) The Company and the Company Subsidiaries have made available to Purchaser true, correct and complete copies of all internal and third party facility audits completed at and on behalf of the Company during the past four (4) years. All facility registrations and product listings required of the Company and the Company Subsidiaries are timely, complete and correct. Section 4.11(n) of the Disclosure Schedule contains a complete list of the Company’s and the Company Subsidiaries’ registered facilities and Products, including an indication of any such Products’ identified status as “grandfathered”, “monograph”, abbreviated new drug application or new drug application. The Company and the Company Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2). (o) Neither the FDA nor any other Healthcare Regulatory Authority of its Subsidiariescompetent jurisdiction has requested, required, demanded or ordered the Company, the Company Subsidiaries to discontinue the Company’s Isotretinoin products (except with respect to Isotretinoin 30mg) and to the Knowledge of the Company, neither the FDA nor any other Healthcare Regulatory Authority of competent jurisdiction has taken any action that would reasonably be expected to lead to such a request, requirement, demand or order. (p) Each of the Company and the Company Subsidiaries has complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) HIPAA and (ii) any applicable privacy Laws.

Healthcare Regulatory Matters. (a) Except asThe Acquired Companies do not and are not required to hold any Healthcare Permit required to operate their businesses, individually provide services, or sell, distribute, manufacturer, test or use any of the Acquired Companies’ products or services. The Acquired Companies have not received any notice or been subject to any obligations under any adverse inspectional finding, penalty, fine, sanction, assessment, written request for corrective or remedial action, or other written compliance or enforcement notice alleging material non-compliance with any Healthcare Law or requirement to hold any Healthcare Permit. The Acquired Companies are not undergoing, and in the aggregatepast three (3) years have not undergone, has not had and would not reasonably be expected to result in a any inspection or investigation by any Governmental Entity with jurisdiction over any Healthcare Law. (b) Neither the Acquired Company Material Adverse Effectnor any of its respective directors, since the Applicable Datemanagers, officers, employees, or any other person acting on behalf thereof (i) all filingshave been convicted of any crime or engaged in any conduct for which they could be, declarationsexcluded or debarred from any healthcare program, listingsincluding a U.S. federal healthcare program (including Medicare, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence and other documents required to be filed TRICARE or maintained Medicaid); (ii) have been threatened with or furnished are currently subject to the FDA an investigation or proceeding that could result in suspension, exclusion or debarment from any U.S. federal healthcare program or inclusion in any other exclusion, debarment or sanction list or database; or (iii) have received notice from any Governmental Entity with respect to debarment or disqualification of any Person. No director, manager, officer, employee, 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 Person action on behalf of the Acquired Company, has (A) made 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, statement; (B) failed to disclose a material fact required to be disclosed to the FDA disclosed; or any other Healthcare Regulatory Authority or (C) committed any an act, made any statement a 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, a statement that would reasonably be expected to provide a the basis for the FDA Food and Drug Administration to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery▇▇▇▇▇▇▇, and Illegal Gratuities” set forth .” (c) The Acquired Company has, maintained a compliance program having the elements of an effective corporate compliance and ethics program identified in 56 FedU.S.S.G. §8B2.1. Reg. 46191 (September 10There are no outstanding compliance complaints or reports, 1991) ongoing internal investigations, or for any other Healthcare Regulatory Authority to invoke any similar policyoutstanding compliance corrective actions. (bd) Neither the Each Acquired Company is not and has not been subject to HIPAA as a “business associate” or “covered entity”, as defined under HIPAA, nor has any of its Subsidiaries nordirectors, officers managers, or employees, nor to the Knowledge of the Company, any directorindependent contractors, officer ever used, disclosed, created, received, maintained, accessed, or employee transmitted protected health information, as defined by HIPAA, to conduct the business of the Company or any of its Subsidiaries or any Company Clinical Trial Investigator is or has been excluded or suspended from a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or (b) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatenedAcquired Company. (ce) Except as would notThe Company has not engaged in any activity that involves the coding of medical claims, individually the submission of medical claims, or the receipt or sharing of professional medical collections to any governmental payors, third-party payors or patients. No Acquired Company has knowingly or willfully solicited, received, paid or offered to pay any remuneration, directly or indirectly, overtly or covertly, in cash or kind for the aggregate, reasonably be expected purpose of making or receiving any referrals or to result in a Company Material Adverse Effect, (i) all Product Candidates under development by induce business or on behalf of the Company otherwise illegally obtain business or payments from its customers or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of the Company or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Subsidiaries and (iv) neither the Company nor any of its Subsidiaries has received any written notice or communication alleging that the Company or any of its Subsidiaries has Person which violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as would not, individually or in the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, neither the Company nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory AuthorityLaws. (df) Except as would not, individually No Acquired Company has ever employed or in contracted with any licensed healthcare personnel for the aggregate, reasonably be expected to result in a Company Material Adverse Effect, since the Applicable Date, the Company and its Subsidiaries have complied with, and have not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of the Company, any investigation with respect thereto) by the Company or any of its Subsidiaries or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest provision of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect or clinical-related services delivered directly by such persons to any Product Candidates under development by or on behalf of the Company or any of its Subsidiariespatients.