Common use of Healthcare Regulatory Matters Clause in Contracts

Healthcare Regulatory Matters. (a) Each of Parent and its Subsidiaries and, to the Knowledge of Parent, their respective directors, officers, employees and agents are, and at all times within the last three (3) years have been, in compliance with all applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to the Parent, taken as a whole. In the past three (3) years, neither Parent nor any of its Subsidiaries has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority asserting non-compliance by, or liability of, Parent or any of its Subsidiaries under any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. (b) All clinical or preclinical studies, tests or trials that have been or are being conducted by or on behalf of, or sponsored by, Parent and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed with or submitted to the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of 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 the FDA or any other Governmental Authority to invoke any similar policy. Neither Parent nor any of its Subsidiaries, nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiaries.

Healthcare Regulatory Matters. (a) Each The Loan Parties and their Subsidiaries hold or license, and are operating in material compliance with, such material permits, registrations, licenses, franchises, approvals, authorizations and clearances of Parent the U.S. Food and its Drug Administration (“FDA”) required for the conduct of their business as currently conducted (collectively, the “FDA Permits”), and such other material Governmental Authorizations required for the conduct of their business as currently conducted. All such material FDA Permits and material Governmental Authorizations are in full force and effect. The Loan Parties and their Subsidiaries have fulfilled and performed, in all material respects, all of their obligations with respect to the material FDA Permits and material Governmental Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any material FDA Permit or material Governmental Authorization. (b) The Loan Parties and their Subsidiaries hold, and are operating in material compliance with, such material registrations, permits, licenses, approvals, authorizations, certifications, and declarations of conformity, required for the conduct of their business as currently conducted in the EEA (collectively, the “EEA Permits”), and all such material EEA Permits are in full force and effect. The Loan Parties and their Subsidiaries have fulfilled and performed in all material respects all of their obligations with respect to the material EEA Permits, and no event has occurred that would reasonably be expected to allow, or after notice or lapse of time that would reasonably be expected to allow, revocation or termination thereof. (c) Except as would not, individually or in the aggregate, reasonably expected to have a Material Adverse Effect, the Loan Parties and their Subsidiaries, each of their licensed employees and, and to the Knowledge knowledge of Parentthe Loan Parties and their Subsidiaries, each of their respective directorscontractors, officers, employees and agents are, and at all times within the last three (3) years have been, are in compliance with all applicable Healthcare Laws. Except as would not, except where individually or in the aggregate, reasonably expected to have a Material Adverse Effect, none of the Loan Parties or their Subsidiaries has received notice of, or is party to, any pending claim, suit, proceeding, hearing, enforcement action, audit, inquiry, inspection, investigation, arbitration or other action from the U.S. Department of Health and Human Services (“HHS”), the FDA, the Centers for Medicare and Medicaid Services, the HHS Office of Inspector General, the U.S. Department of Justice, any State Attorneys General or Medicaid Agency, or any other applicable Governmental Authority or applicable foreign regulatory agency or any qui tam plaintiff, alleging that any operation or activity of any Loan Party or any of its Subsidiaries is in material violation of any applicable Healthcare Law. (d) To the knowledge of the Loan Parties and their Subsidiaries, all applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a FDA Permit from the FDA or other Governmental Authority relating to the Loan Parties and their Subsidiaries, their business and their products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such nonapplications, submissions, information and data have been timely submitted to the FDA or other Governmental Authority. (e) Except as set forth in Schedule 3.20, between December 3, 2013 and the Closing Date, the Loan Parties and their Subsidiaries have not had any product or manufacturing site, and to the knowledge of the Loan Parties and their Subsidiaries, no contract manufacturer of the Loan Parties or any of their Subsidiaries has had any manufacturing site, subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, “warning letters,” “untitled letters” or requests or requirements to make material changes to any of the Loan Parties’ or their Subsidiaries’ products, or similar correspondence or notice from the FDA or other Governmental Authority in respect of the Loan Parties’ and their Subsidiaries’ business and alleging or asserting material noncompliance with any applicable law, permit or such requests or requirements of a Governmental Authority. (f) Schedule 3.20 sets forth a list of (i) all recalls, field notifications, field corrections, field safety corrective actions, market withdrawals or replacements, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Loan Parties’ and their Subsidiaries’ products (“Safety Notices”) between December 3, 2013 and the Closing Date, and (ii) the status of such Safety Notices, if any. (g) To the Loan Parties’ and their Subsidiaries’ knowledge, the clinical, pre-compliance clinical and other studies and tests conducted by or on behalf of or sponsored by the Loan Parties or their Subsidiaries or in which the Loan Parties or their Subsidiaries or their products or product candidates have participated were and, if still pending, are being conducted in all material respect in accordance with standard medical and scientific research procedures and all applicable laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812. Except as would not, individually or in the aggregate, reasonably be expected to be material have a Material Adverse Effect or to the Parentextent disclosed in Schedule 3.20, taken no investigational new drug application or, as a whole. In of the past three (3) yearsClosing Date, neither Parent nor any of its Subsidiaries has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority asserting non-compliance by, or liability of, Parent or any of its Subsidiaries under any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. (b) All clinical or preclinical studies, tests or trials that have been or are being conducted no investigational device exemption filed by or on behalf of, of the Loan Parties or sponsored by, Parent and its Subsidiaries, their Subsidiaries with the FDA has been terminated or in which Parent’s or its Subsidiaries’ products or product candidates have participatedsuspended by the FDA, and which have been submitted to neither the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed with or submitted to the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board foreign regulatory agency has commenced, or or, to the Knowledge knowledge of Parentthe Loan Parties or their Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent the Loan Parties or any of its their Subsidiaries. (ch) To None of the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee Loan Parties or agent their Subsidiaries is the subject of any of Parent or any of its Subsidiariespending or, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA Loan Parties’ or any other Governmental Authoritytheir Subsidiaries’ knowledge, (ii) failed to disclose a material fact required to be disclosed to threatened investigation in respect of the Loan Parties or their Subsidiaries or their products, by the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed pursuant to make a statement, in each such case, related to the business of 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,” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or and any other Governmental Authority to invoke any similar policyamendments thereto. Neither Parent the Loan Parties nor their Subsidiaries nor any of its Subsidiariestheir officers, noremployees or, to the Knowledge of ParentLoan Parties’ and their Subsidiaries’ knowledge, any director, officer, employee or agent of any of Parent or any of its Subsidiariesagents, has been debarred or convicted of any crime or engaged in any conduct for which that could result in a material debarment is mandated by or exclusion (i) under 21 U.S.C. Section 335a(a335a, or (ii) or any similar applicable Law law. As of the date hereof, no claims, actions, proceedings or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding investigations that would reasonably be expected to result in such a material debarment is or exclusion are pending or, to the Knowledge of ParentLoan Parties’ and their Subsidiaries’ knowledge, threatened in writing against any of Parent the Loan Parties, their Subsidiaries or any of its Subsidiaries their officers, employees or agents. (i) None of the Loan Parties or their Subsidiaries, or their respective equity holders, officers, directors, managing employees, or to the Knowledge of ParentLoan Parties’ and their Subsidiaries’ knowledge, any director, officer, employee agents or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiariescontractors, has been debarred, suspended or is currently excluded from participation in Federal Health Care Programs as defined at 42 U.S.C. § 1320a-7b(f), and none of the Loan Parties or their Subsidiaries is a party to a corporate integrity agreement or has any federal health care program reporting obligations pursuant to a settlement agreement, plan or convicted correction or other remedial measure entered into with any Governmental Authority. (j) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Loan Parties and their Subsidiaries are in compliance with the applicable requirements of any crime orHIPAA, as amended by HITECH, and their implementing regulations codified at 45 C.F.R. Parts 160 through 164, as amended from time to time (“HIPAA Regulations”). The Loan Parties and their Subsidiaries have implemented appropriate security procedures in accordance with the applicable requirements of HIPAA, HITECH and the HIPAA Regulations, including, without limitation, administrative, physical and technical safeguards, to protect the Knowledge confidentiality, integrity and availability of Parentall electronic protected health information (as defined under the HIPAA Regulations) that they create, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935receive, as amended, maintain or any similar Law or programtransmit. Further, except as would not not, individually or in the aggregate, reasonably be expected to be material have a Material Adverse Effect, in each contractual arrangement that is subject to Parent HIPAA, each of the Loan Parties and their Subsidiaries has: (i) to the extent required by Applicable Law, entered into a written Business Associate Agreement (as such term is defined under the HIPAA Regulations) that meets the requirements of HIPAA, HITECH and the HIPAA Regulations; (ii) complied with such Business Associate Agreements; and (iii) at no time experienced or any had a use or disclosure of its SubsidiariesProtected Health Information (as defined in the HIPAA Regulations) in violation of HIPAA, taken HITECH or the HIPAA Regulations, or a Breach of Unsecured Protected Health Information as a wholesuch terms are defined at 45 C.F.R. § 164.402. No legal proceeding that Except as would not, individually or in the aggregate, reasonably be expected to result have a Material Adverse Effect, the Loan Parties and their Subsidiaries are in such an exclusion is pending orcompliance with applicable state health information privacy and security laws and have experienced no privacy violations or security incidents as defined under applicable state laws. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Knowledge Loan Parties and their Subsidiaries are in compliance with the EU Data Protection Directive (Directive 95/46/EC), and any EEA Member State laws implementing the provisions of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiariesthis directive.

Healthcare Regulatory Matters. (a) Each of Parent and its Subsidiaries and, to the Knowledge of Parent, their respective directors, officers, employees and agents are, and at all times within the last three (3) years have been, in compliance with all applicable Healthcare Laws, except where such non-compliance would notExcept as, individually or in the aggregate, has not had and would not reasonably be expected to be material to result in a Company Material Adverse Effect, since the ParentApplicable Date, taken as a whole. In the past three (3i) yearsall filings, neither Parent nor any of its Subsidiaries has received any written notificationdeclarations, listings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence and other documents required to be filed or any other communication from maintained with or furnished to the FDA or any other Governmental Healthcare Regulatory Authority asserting non-compliance by(collectively, or liability of, Parent “Health Care Submissions”) by the Company or any of its Subsidiaries under any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. (b) All clinical or preclinical studies, tests or trials that have been so filed, maintained or are being conducted by or on behalf offurnished, or sponsored by, Parent (ii) all such Health Care Submissions were complete and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, accurate and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application Laws when filed with (or submitted to were corrected in or supplemented by a subsequent filing), and (iii) neither the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent Company or any of its Subsidiaries has been terminated or suspendednor, and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiatethe Company, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent the Company or any of its Subsidiaries, 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 (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Healthcare Regulatory Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, Healthcare Regulatory Authority or (iii) committed an any act, made a statement, any statement or failed to make a any statement, in each such case, related to the business of Parent 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 the FDA or any other Governmental Healthcare Regulatory Authority to invoke any similar policy. . (b) Neither Parent nor any of its Subsidiaries, nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent Company nor any of its Subsidiaries nor, to the Knowledge of Parentthe Company, any director, officer, officer or employee or agent of any of Parent the Company or any of its Subsidiaries, Subsidiaries or any Company Clinical Trial Investigator is or has been debarredexcluded 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, suspended and no such debarment or excluded 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 participation 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 federal health care program or convicted Healthcare Regulatory Authority of any crime failure (or, to the Knowledge of Parentthe Company, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of investigation with respect thereto) by the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent 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 Knowledge debarment of Parentindividuals, 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 director, officer, employee Product Candidates under development by or agent on behalf of Parent the Company or any of its Subsidiaries.

Healthcare Regulatory Matters. (a) Each of Parent The Seller and its Subsidiaries and, to the Knowledge of Parent, their respective directors, officers, employees and agents Affiliates are, and at all times within the last three (3) years since January 1, 2014 have been, in compliance with all applicable Healthcare Laws, except where such non-compliance would not, individually or in conducting the aggregate, reasonably be expected to be material to the Parent, taken as a whole. In the past three (3) years, neither Parent nor any of its Subsidiaries has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority asserting non-compliance by, or liability of, Parent or any of its Subsidiaries under any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. (b) All clinical or preclinical studies, tests or trials that have been or are being conducted by or on behalf of, or sponsored by, Parent and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted Business in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed To the Knowledge of the Seller, the Products have been researched, developed and manufactured on behalf of the Seller and its Affiliates in compliance in all material respects with applicable Healthcare Laws. With respect to the Business, neither the Seller nor any of its Affiliates is a party to, and the Business is not subject to, any corporate integrity agreements, monitoring agreements, consent decrees, deferred prosecution agreements, settlement orders or similar Contracts with or submitted imposed by any Governmental Authority related to any Healthcare Law, and no such Contract is currently pending or, to the Knowledge of the Seller, threatened. (b) All material reports, documents, claims, permits, adverse event reports, recalls, removals and corrections, notices, registrations and applications relating to the Products that are required to be filed, maintained or furnished to a Governmental Authority by the Seller have been so filed, maintained, or furnished. (c) With respect to the Business, neither the Seller nor any of its Affiliates has received from the FDA or comparable application submitted to any other Governmental Authority by since January 1, 2014, any inspection reports, notices of adverse findings, warning or on behalf of Parent untitled letters, or other correspondence concerning the Products or Business in which any Governmental Authority alleges or asserts a failure to comply with applicable Healthcare Laws, or that Products may not be safe, effective or approvable other than in either case any reports, notices, warnings, letters or other correspondence that would not reasonably be expected to result in material Liabilities or material damages to the Business. (d) With respect to the Business, neither the Seller nor any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board has commencedAffiliates, or to the Knowledge of Parent, threatened to initiatethe Seller, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent or any of its SubsidiariesSeller Partner, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental AuthorityAuthority responsible for enforcement or oversight with respect to Healthcare Laws, (ii) or failed to disclose a material fact required to be disclosed to the FDA or any other such Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of its Subsidiaries Products, 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 the FDA or any other Governmental Authority to invoke any a similar policy. . (e) Neither Parent nor any of the Seller, its SubsidiariesAffiliates, their respective employees and agents, nor, to the Knowledge of Parentthe Seller, any directorSeller Partner, officerhas, employee under any Healthcare Law, been debarred, excluded, suspended or agent otherwise determined to be ineligible to participate in any health care programs of any of Parent or any of its SubsidiariesGovernmental Authority, has been debarred or convicted of any crime or crime, or, to the Knowledge of the Seller, engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) that has resulted, or would reasonably be expected to result, in any similar applicable Law such debarment, exclusion, suspension, ineligibility or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding conviction in a manner that would reasonably be expected to result in such a debarment is pending or, to adversely affect the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its SubsidiariesBusiness.

Healthcare Regulatory Matters. 107 (a) Each The Loan Parties and their Subsidiaries hold or license, and are operating in material compliance with, such material permits, registrations, licenses, franchises, approvals, authorizations and clearances of Parent the U.S. Food and its Drug Administration (“FDA”) required for the conduct of their business as currently conducted (collectively, the “FDA Permits”), and such other material Governmental Authorizations required for the conduct of their business as currently conducted. All such material FDA Permits and material Governmental Authorizations are in full force and effect. The Loan Parties and their Subsidiaries have fulfilled and performed, in all material respects, all of their obligations with respect to the material FDA Permits and material Governmental Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any material FDA Permit or material Governmental Authorization. (b) The Loan Parties and their Subsidiaries hold, and are operating in material compliance with, such material registrations, permits, licenses, approvals, authorizations, certifications, and declarations of conformity, required for the conduct of their business as currently conducted in the EEA (collectively, the “EEA Permits”), and all such material EEA Permits are in full force and effect. The Loan Parties and their Subsidiaries have fulfilled and performed in all material respects all of their obligations with respect to the material EEA Permits, and no event has occurred that would reasonably be expected to allow, or after notice or lapse of time that would reasonably be expected to allow, revocation or termination thereof. (c) Except as would not, individually or in the aggregate, reasonably expected to have a Material Adverse Effect, the Loan Parties and their Subsidiaries, each of their licensed employees and, and to the Knowledge knowledge of Parentthe Loan Parties and their Subsidiaries, each of their respective directorscontractors, officers, employees and agents are, and at all times within the last three (3) years have been, are in compliance with all applicable Healthcare Laws. Except as would not, except where individually or in the aggregate, reasonably expected to have a Material Adverse Effect, none of the Loan Parties or their Subsidiaries has received notice of, or is party to, any pending claim, suit, proceeding, hearing, enforcement action, audit, inquiry, inspection, investigation, arbitration or other action from the U.S. Department of Health and Human Services (“HHS”), the FDA, the Centers for Medicare and Medicaid Services, the HHS Office of Inspector General, the U.S. Department of Justice, any State Attorneys General or Medicaid Agency, or any other applicable Governmental Authority or applicable foreign regulatory agency or any qui tam plaintiff, alleging that any operation or activity of any Loan Party or any of its Subsidiaries is in material violation of any applicable Healthcare Law. (d) To the knowledge of the Loan Parties and their Subsidiaries, all applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a FDA Permit from the FDA or other Governmental Authority relating to the Loan Parties and their Subsidiaries, their business and their products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such nonapplications, submissions, information and data have been timely submitted to the FDA or other Governmental Authority. (e) Except as set forth in Schedule 3.20, between December 3, 2013 and the Closing Date, the Loan Parties and their Subsidiaries have not had any product or manufacturing site, and to the knowledge of the Loan Parties and their Subsidiaries, no contract manufacturer of the Loan Parties or any of their Subsidiaries has had any manufacturing site, subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, “warning letters,” “untitled letters” or requests or requirements to make material changes to any of the Loan Parties’ or their Subsidiaries’ products, or similar correspondence or notice from the FDA or other Governmental Authority in respect of the Loan Parties’ and their Subsidiaries’ business and alleging or asserting material noncompliance with any applicable law, permit or such requests or requirements of a Governmental Authority. (f) Schedule 3.20 sets forth a list of (i) all recalls, field notifications, field corrections, field safety corrective actions, market withdrawals or replacements, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Loan Parties’ and their Subsidiaries’ products (“Safety Notices”) between December 3, 2013 and the Closing Date, and (ii) the status of such Safety Notices, if any. (g) To the Loan Parties’ and their Subsidiaries’ knowledge, the clinical, pre-compliance clinical and other studies and tests conducted by or on behalf of or sponsored by the Loan Parties or their Subsidiaries or in which the Loan Parties or their Subsidiaries or their products or product candidates have participated were and, if still pending, are being conducted in all material respect in accordance with standard medical and scientific research procedures and all applicable laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812. Except as would not, individually or in the aggregate, reasonably be expected to be material have a Material Adverse Effect or to the Parentextent disclosed in Schedule 3.20, taken no investigational new drug application or, as a whole. In of the past three (3) yearsClosing Date, neither Parent nor any of its Subsidiaries has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority asserting non-compliance by, or liability of, Parent or any of its Subsidiaries under any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. (b) All clinical or preclinical studies, tests or trials that have been or are being conducted no investigational device exemption filed by or on behalf of, of the Loan Parties or sponsored by, Parent and its Subsidiaries, their Subsidiaries with the FDA has been terminated or in which Parent’s or its Subsidiaries’ products or product candidates have participatedsuspended by the FDA, and which have been submitted to neither the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed with or submitted to the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board foreign regulatory agency has commenced, or or, to the Knowledge knowledge of Parentthe Loan Parties or their Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent the Loan Parties or any of its their Subsidiaries. (ch) To None of the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee Loan Parties or agent their Subsidiaries is the subject of any of Parent or any of its Subsidiariespending or, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA Loan Parties’ or any other Governmental Authoritytheir Subsidiaries’ knowledge, (ii) failed to disclose a material fact required to be disclosed to threatened investigation in respect of the Loan Parties or their Subsidiaries or their products, by the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed pursuant to make a statement, in each such case, related to the business of 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,” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or and any other Governmental Authority to invoke any similar policyamendments thereto. Neither Parent the Loan Parties nor their Subsidiaries nor any of its Subsidiariestheir officers, noremployees or, to the Knowledge of ParentLoan Parties’ and their Subsidiaries’ knowledge, any director, officer, employee or agent of any of Parent or any of its Subsidiariesagents, has been debarred or convicted of any crime or engaged in any conduct for which that could result in a material debarment is mandated by or exclusion (i) under 21 U.S.C. Section 335a(a335a, or (ii) or any similar applicable Law law. As of the date hereof, no claims, actions, proceedings or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding investigations that would reasonably be expected to result in such a material debarment is or exclusion are pending or, to the Knowledge of ParentLoan Parties’ and their Subsidiaries’ knowledge, threatened in writing against any of Parent the Loan Parties, their Subsidiaries or any of its Subsidiaries their officers, employees or agents. (i) None of the Loan Parties or their Subsidiaries, or their respective equity holders, officers, directors, managing employees, or to the Knowledge of ParentLoan Parties’ and their Subsidiaries’ knowledge, any director, officer, employee agents or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiariescontractors, has been debarred, suspended or is currently excluded from participation in Federal Health Care Programs as defined at 42 U.S.C. § 1320a-7b(f), and none of the Loan Parties or their Subsidiaries is a party to a corporate integrity agreement or has any federal health care program reporting obligations pursuant to a settlement agreement, plan or convicted correction or other remedial measure entered into with any Governmental Authority. (j) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Loan Parties and their Subsidiaries are in compliance with the applicable requirements of any crime orHIPAA, as amended by HITECH, and their implementing regulations codified at 45 C.F.R. Parts 160 through 164, as amended from time to time (“HIPAA Regulations”). The Loan Parties and their Subsidiaries have implemented appropriate security procedures in accordance with the applicable requirements of HIPAA, HITECH and the HIPAA Regulations, including, without limitation, administrative, physical and technical safeguards, to protect the Knowledge confidentiality, integrity and availability of Parentall electronic protected health information (as defined under the HIPAA Regulations) that they create, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935receive, as amended, maintain or any similar Law or programtransmit. Further, except as would not not, individually or in the aggregate, reasonably be expected to be material have a Material Adverse Effect, in each contractual arrangement that is subject to Parent HIPAA, each of the Loan Parties and their Subsidiaries has: (i) to the extent required by Applicable Law, entered into a written Business Associate Agreement (as such term is defined under the HIPAA Regulations) that meets the requirements of HIPAA, HITECH and the HIPAA Regulations; (ii) complied with such Business Associate Agreements; and (iii) at no time experienced or any had a use or disclosure of its SubsidiariesProtected Health Information (as defined in the HIPAA Regulations) in violation of HIPAA, taken HITECH or the HIPAA Regulations, or a Breach of Unsecured Protected Health Information as a wholesuch terms are defined at 45 C.F.R. § 164.402. No legal proceeding that Except as would not, individually or in the aggregate, reasonably be expected to result have a Material Adverse Effect, the Loan Parties and their Subsidiaries are in such an exclusion is pending orcompliance with applicable state health information privacy and security laws and have experienced no privacy violations or security incidents as defined under applicable state laws. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Knowledge Loan Parties and their Subsidiaries are in compliance with the EU Data Protection Directive (Directive 95/46/EC), and any EEA Member State laws implementing the provisions of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiariesthis directive.

Healthcare Regulatory Matters. (a) Each Except as set forth on Section 3.23(a) of Parent the Disclosure Schedules, the Company is and its Subsidiaries andhas been in compliance in all respects with all Healthcare Laws in connection with the conduct, ownership, use, occupancy or operation of the Business, and the Company has not received any written (or, to the Knowledge Company’s Knowledge, other) notice during the past six (6) years of Parentany actual or alleged violation of any Healthcare Law. The Company has not been subject to any adverse inspection, finding, penalty assessment or other investigation or non-routine audit by any Governmental Authority that has not been fully and finally resolved. (b) The Company has obtained and currently holds, and at all times has held, in good standing all appropriate Permits required by any Governmental Authority or under any Healthcare Laws for the operation of the Business in all relevant jurisdictions (“Healthcare Permits”). All Healthcare Permits (i) are valid and in full force and effect, (ii) have not been reversed, stayed, set aside, annulled, or suspended, and are not subject to any investigation by a Governmental Authority or Accreditation Organization to revoke, stay, set aside, annul or suspend any such Permits and (iii) are not subject to any adverse conditions or requirements that are not generally imposed on the holders thereof. The Company has at all times been and is in compliance with the terms of each Healthcare Permit. All applications required to have been filed for the renewal of such Healthcare Permits have been duly filed with the appropriate Governmental Authority or Accreditation Organization, and all other filings required to have been made with respect to such Healthcare Permits or otherwise in accordance with any Healthcare Law have been duly made on a timely basis with the appropriate Governmental Authority or Accreditation Organization. A complete and accurate list of such Healthcare Permits is set forth on Section 3.23(b) of the Disclosure Schedules. (c) The Company has not submitted, or caused to be submitted, any claim for payment to any Government Healthcare Program or third-party payor. (d) The Company has not made a voluntary self-disclosure of any possible violation of any Healthcare Law under a federal or state voluntary self-disclosure program. (e) The Company has not engaged in or authorized any activities that constitute the commission of fraud under applicable Healthcare Laws. (f) Neither the Company, nor any of their respective directors, officers, employees, or agents has offered or paid any remuneration (including any kickback, bribe, rebate, payoff, influence payment or inducement) directly or indirectly, overtly or covertly, in cash or in kind, to any Person to induce such Person (i) to refer an individual to a Person for the furnishing or arranging for the furnishing of any item or service in violation of any Healthcare Law, or (ii) to purchase, lease, order, arrange for or recommend purchasing, leasing or ordering any good, facility, service or item in violation of any Healthcare Law or to obtain or maintain favorable treatment in securing business in violation of any applicable Healthcare Law. The Company and its officers, directors, managers, employees and agents arehave complied in all respects with all other applicable Healthcare Laws with respect to direct and indirect compensation arrangements, ownership interests or other relationships between such Person and any past, present or potential patient, physician, supplier, contractor, customer, payor or other Person in a position to refer, recommend or arrange for the referral of patients or other health care business or to whom such Person refers, recommends or arranges for the referral of patients or other health care business. (g) The legal and financial relationships of the Company do not violate, and at all times within have not violated, any applicable Healthcare Laws in any respect, including those regarding: (i) the last three organization or ownership of Persons that employ or otherwise engage physicians and other healthcare professionals to provide professional services, including with respect to licensure and active practice requirements; (3ii) the manner in which physicians and other healthcare professionals may split or share with non-physicians fees generated from the provision of professional services; (iii) the unauthorized or unlicensed practice of medicine; and (iv) the enforcement of non-competition covenants entered into by physicians and other healthcare professionals (collectively, the “Medical Practice Rules”). There is and during the past five (5) years there have beenbeen no pending, or to the Knowledge of Sellers, threatened, Proceeding alleging that the legal and financial relationships of the Company, violates the Medical Practice Rules. (h) All Contracts with the Company’s referral sources, including the terms, methodology, amount and payment of any compensation, benefits or other remuneration provided, paid or made available to (directly or indirectly), is and has been in compliance with all applicable Healthcare Laws. (i) Except as set forth on Section 3.23(i) of the Disclosure Schedules, except where such non-the Company’s marketing and advertising materials are, and have been, truthful, accurate, and in compliance would not, individually or in the aggregate, reasonably be expected to be material to the Parent, taken as a whole. In the past three (3) years, neither Parent nor any of its Subsidiaries has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority asserting non-compliance by, or liability of, Parent or any of its Subsidiaries under any with all applicable Healthcare Laws. (j) To the Sellers’ Knowledge, except where such non-compliance would notno person has commenced or threatened against the Company any Proceeding relating to any Healthcare Law under any federal or state whistleblower statute, individually or in including under the aggregateFalse Claims Act (31 U.S.C. § 3729 et seq.). (k) Neither the Company, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any Company officer, director, employee, nor, to the Sellers’ Knowledge, agent of its Subsidiaries the Company, is a party to nor has to, or bound by, any ongoing reporting obligations pursuant to order, individual integrity agreement, corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement agreement or under other formal or informal agreement with any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements concerning compliance with or imposed by any Governmental AuthorityHealthcare Laws. (bl) All clinical To the extent the Company is a “Covered Entity” or preclinical studies“Business Associate” as such terms are defined under HIPAA, tests and collected, stored or trials otherwise processed “Personal Health Information” as that have been or are being conducted by term is defined under HIPAA, the Company has taken appropriate measures to protect the privacy and security of, and to maintain in confidence, the Personal Health Information collected by, or on behalf of, or sponsored by, Parent and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted Company in compliance in all material respects with all HIPAA and other applicable Healthcare Laws. No investigational new drug application filed with or submitted to the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of 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 the FDA or any other Governmental Authority to invoke any similar policy. Neither Parent nor any of its Subsidiaries, nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiaries.

Healthcare Regulatory Matters. (a) Each of Parent and its Subsidiaries Company and, to the Knowledge of Parent, their respective directors, officers, employees and agents are, and at all times within the last three (3) years have been, in compliance with all applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to the ParentParent Companies, taken as a whole. In the past three (3) years, neither no Parent nor any of its Subsidiaries Company has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority Body asserting non-compliance by, or liability of, any Parent or any of its Subsidiaries Company under any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to the Parent and its SubsidiariesCompanies, taken as a whole. Neither No Parent nor any of its Subsidiaries Company is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority Body or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental AuthorityBody. (b) All clinical or preclinical studies, tests or trials that have been or are being conducted by or on behalf of, or sponsored by, any Parent and its SubsidiariesCompany, or in which Parentany Parent Company’s or its Subsidiaries’ products or product candidates have participated, and which have been or will be submitted to the FDA or other Governmental Authority Body in connection with applications for authorizations from any Governmental AuthorityAuthorizations, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed with or submitted to the FDA or comparable application submitted to any other Governmental Authority Body by or on behalf of any Parent or any of its Subsidiaries Company has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority Body or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of any Parent or any of its SubsidiariesCompany. (c) To No Parent Company, nor, to the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of the Parent or any of its SubsidiariesCompanies, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental AuthorityBody, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental AuthorityBody, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of its Subsidiaries the Parent Companies 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 the FDA or any other Governmental Authority Body to invoke any similar policy. Neither None of the Parent nor any of its SubsidiariesCompanies, nor, to the Knowledge of Parent, any director, officer, employee or agent of any of the Parent or any of its SubsidiariesCompanies, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding Legal Proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parent, threatened against any of the Parent or any of its Subsidiaries Companies or to the Knowledge of Parent, any director, officer, employee or agent of any of the Parent or any Companies. None of its Subsidiaries. Neither the Parent nor any of its Subsidiaries Companies nor, to the Knowledge of Parent, any director, officer, employee or agent of any of the Parent or any of its SubsidiariesCompanies, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to the Parent or any of its SubsidiariesCompanies, taken as a whole. No legal proceeding Legal Proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of the Parent or any of its Subsidiaries Companies or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiariesthe Parent Companies.

Healthcare Regulatory Matters. (a) Each of Parent The Company and its Subsidiaries and, to the Knowledge of Parent, their respective directors, officers, employees and agents are, and at all times within the last three (3) years have been, in compliance with all applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to the Parent, taken as a whole. In the past three (3) years, neither Parent nor any each of its Subsidiaries has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority asserting non-compliance by, or liability of, Parent or any have implemented procedures and programs reasonably designed to assure that each of its Subsidiaries under any applicable Healthcare Laws, except where such non-compliance would not, individually managed independent or in the aggregate, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. (b) All clinical or preclinical studies, tests or trials that have been or assisted living facilities are being conducted by or on behalf of, or sponsored by, Parent and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted operated in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed with For the two (2) years preceding the Initial Signing Date, none of the Company or submitted to the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of 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 the FDA or any other Governmental Authority to invoke any similar policy. Neither Parent nor any of its Subsidiaries, nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parentthe Company, any director, officer, employee of the Company or agent of any of Parent its Subsidiaries (acting in their capacity as such) has given, received, offered to pay or solicited any remuneration from, in cash or kind, directly or indirectly, any past or present resident, physician, other healthcare provider, supplier, contractor or other Person in connection with the operation of the business of the Company in violation of applicable Laws, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as whole. For the two (2) years preceding the Initial Signing Date, none of the Company or any of its Subsidiaries: (i) is or has been a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlements, orders, or similar agreements with or imposed by any Governmental Entity with respect to its managed independent or assisted living facilities, (ii) has been assessed a material civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder or any other fine or penalty by any other Governmental Entity with respect to its managed independent or assisted living facilities, (iii) has been charged with, convicted of or entered a plea of guilty or nolo contendere to any criminal or civil offense relating to the delivery of any item or service or any other violation of Laws or (iv) is or has been debarred, excluded or suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except in each case as would not individually or in the aggregate reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent or any of Company and its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiariestake as whole.

Healthcare Regulatory Matters. To the Knowledge of Fermat, (a) Each of Parent and its Subsidiaries and, to the Knowledge of Parent, their respective directors, officers, employees and agents areFermat is, and at all times within the last three (3) years have 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, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to the Parent, taken as a whole. In the past three (3d) years, neither Parent nor any of its Subsidiaries Fermat has not received any written notificationnotification 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 date hereof, Fermat has made available to Descartes true and accurate copies of all material reports, audits, data, investigations, correspondence or any other communication from documents related to compliance with Healthcare Law that are in Fermat’s or its Affiliates’ possession or control, (g) since January 1, 2015, all reports, documents, Permits or notices required to be filed, maintained or furnished to the FDA or any other Governmental Authority asserting non-compliance byEntity (collectively, “Healthcare Regulatory Filings”) have been so filed, maintained or liability of, Parent or any of its Subsidiaries under any applicable Healthcare Lawsfurnished in a timely manner, except where failure to file, maintain or furnish such non-compliance reports, documents, Permits or notices would notnot constitute a H&N Business Material Adverse Effect, individually or in the aggregate, reasonably be expected to be material to Parent (h) all such Healthcare Regulatory Filings were complete and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. (b) All clinical or preclinical studies, tests or trials that have been or are being conducted by or on behalf of, or sponsored by, Parent and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted in compliance accurate in all material respects with all applicable Healthcare Laws. No investigational new drug application on the date filed with (or submitted to the FDA were corrected in or comparable application submitted to any other Governmental Authority supplemented by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, a subsequent filing) and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has (i) neither Fermat nor any Fermat officer, employee, agent or distributor has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Authority, (ii) Entity or failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of 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 the FDA or any other Governmental Authority to invoke any similar policy. Neither Parent nor any of its Subsidiaries, nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its SubsidiariesEntity.

Healthcare Regulatory Matters. To the Knowledge of Fermat, (a) Each of Parent and its Subsidiaries and, to the Knowledge of Parent, their respective directors, officers, employees and agents areFermat is, and at all times within the last three (3) years have 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, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to the Parent, taken as a whole. In the past three (3d) years, neither Parent nor any of its Subsidiaries Fermat has not received any written notificationnotification 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 date hereof, Fermat has made available to Descartes true and accurate copies of all material reports, audits, data, investigations, correspondence or any other communication from documents related to compliance with Healthcare Law that are in Fermat’s or its Affiliates’ possession or control, (g) since January 1, 2015, all reports, documents, Permits or notices required to be filed, maintained or furnished to the FDA or any other Governmental Authority asserting non-compliance byEntity (collectively, “Healthcare Regulatory Filings”) have been so filed, maintained or liability of, Parent or any of its Subsidiaries under any applicable Healthcare Lawsfurnished in a timely manner, except where failure to file, maintain or furnish such non-compliance reports, documents, Permits or notices would notnot constitute a H&N Business Material Adverse Effect, individually or in the aggregate, reasonably be expected to be material to Parent (h) all such Healthcare Regulatory Filings were complete and its Subsidiaries, taken as a whole. Neither Parent nor any of its Subsidiaries is a party to nor has any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. (b) All clinical or preclinical studies, tests or trials that have been or are being conducted by or on behalf of, or sponsored by, Parent and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted in compliance accurate in all material respects with all applicable Healthcare Laws. No investigational new drug application on the date filed with (or submitted to the FDA were corrected in or comparable application submitted to any other Governmental Authority supplemented by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, a subsequent filing) and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has (i) neither Fermat nor any Fermat officer, employee, agent or distributor has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Authority, (ii) Entity or failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of 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 FedEntity. Reg. 46191 (September 10, 1991) or for the FDA or any other Governmental Authority to invoke any similar policy. Neither Parent nor any of its Subsidiaries, nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiaries.1414958.12A-NYCSR03A - MSW

Healthcare Regulatory Matters. (a) Each Except as set forth on Section 3.23(a) of Parent the Disclosure Schedules, the Company is and its Subsidiaries andhas been in compliance in all respects with all Healthcare Laws in connection with the conduct, ownership, use, occupancy or operation of the Business, and the Company has not received any written (or, to the Knowledge Company’s Knowledge, other) notice during the past six (6) years of Parentany actual or alleged violation of any Healthcare Law. The Company has not been subject to any adverse inspection, finding, penalty assessment or other investigation or non-routine audit by any Governmental Authority that has not been fully and finally resolved. (b) The Company has obtained and currently holds, and at all times has held, in good standing all appropriate Permits required by any Governmental Authority or under any Healthcare Laws for the operation of the Business in all relevant jurisdictions (“Healthcare Permits”). All Healthcare Permits (i) are valid and in full force and effect, (ii) have not been reversed, stayed, set aside, annulled, or suspended, and are not subject to any investigation by a Governmental Authority or Accreditation Organization to revoke, stay, set aside, annul or suspend any such Permits and (iii) are not subject to any adverse conditions or requirements that are not generally imposed on the holders thereof. The Company has at all times been and is in compliance with the terms of each Healthcare Permit. All applications required to have been filed for the renewal of such Healthcare Permits have been duly filed with the appropriate Governmental Authority or Accreditation Organization, and all other filings required to have been made with respect to such Healthcare Permits or otherwise in accordance with any Healthcare Law have been duly made on a timely basis with the appropriate Governmental Authority or Accreditation Organization. A complete and accurate list of such Healthcare Permits is set forth on Section 3.23(b) of the Disclosure Schedules. (c) The Company has not submitted, or caused to be submitted, any claim for payment to any Government Healthcare Program or third-party payor. (d) The Company has not made a voluntary self-disclosure of any possible violation of any Healthcare Law under a federal or state voluntary self-disclosure program. (e) The Company has not engaged in or authorized any activities that constitute the commission of fraud under applicable Healthcare Laws. (f) Neither the Company, nor any of their respective directors, officers, employees, or agents has offered or paid any remuneration (including any kickback, bribe, rebate, payoff, influence payment or inducement) directly or indirectly, overtly or covertly, in cash or in kind, to any Person to induce such Person (i) to refer an individual to a Person for the furnishing or arranging for the furnishing of any item or service in violation of any Healthcare Law, or (ii) to purchase, lease, order, arrange for or recommend purchasing, leasing or ordering any good, facility, service or item in violation of any Healthcare Law or to obtain or maintain favorable treatment in securing business in violation of any applicable Healthcare Law. The Company and its officers, directors, managers, employees and agents arehave complied in all respects with all other applicable Healthcare Laws with respect to direct and indirect compensation arrangements, ownership interests or other relationships between such Person and any past, present or potential patient, physician, supplier, contractor, customer, payor or other Person in a position to refer, recommend or arrange for the referral of patients or other health care business or to whom such Person refers, recommends or arranges for the referral of patients or other health care business. (g) The legal and financial relationships of the Company do not violate, and at all times within have not violated, any applicable Healthcare Laws in any respect, including those regarding: (i) the last three organization or ownership of Persons that employ or otherwise engage physicians and other healthcare professionals to provide professional services, including with respect to licensure and active practice requirements; (3ii) the manner in which physicians and other healthcare professionals may split or share with non-physicians fees generated from the provision of professional services; (iii) the unauthorized or unlicensed practice of medicine; and (iv) the enforcement of non-competition covenants entered into by physicians and other healthcare professionals (collectively, the “Medical Practice Rules”). There is and during the past five (5) years there have beenbeen no pending, or to the Knowledge of Seller, threatened, Proceeding alleging that the legal and financial relationships of the Company, violates the Medical Practice Rules. (h) All Contracts with the Company’s referral sources, including the terms, methodology, amount and payment of any compensation, benefits or other remuneration provided, paid or made available to (directly or indirectly), is and has been in compliance with all applicable Healthcare Laws. (i) Except as set forth on Section 3.23(i) of the Disclosure Schedules, except where such non-the Company’s marketing and advertising materials are, and have been, truthful, accurate, and in compliance would not, individually or in the aggregate, reasonably be expected to be material to the Parent, taken as a whole. In the past three (3) years, neither Parent nor any of its Subsidiaries has received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority asserting non-compliance by, or liability of, Parent or any of its Subsidiaries under any with all applicable Healthcare Laws. (j) To the Seller’s Knowledge, except where such non-compliance would notno person has commenced or threatened against the Company any Proceeding relating to any Healthcare Law under any federal or state whistleblower statute, individually or in including under the aggregateFalse Claims Act (31 U.S.C. § 3729 et seq.). (k) Neither the Company, reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. Neither Parent nor any Company officer, director, employee, nor, to the Seller’s Knowledge, agent of its Subsidiaries the Company, is a party to nor has to, or bound by, any ongoing reporting obligations pursuant to order, individual integrity agreement, corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement agreement or under other formal or informal agreement with any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements concerning compliance with or imposed by any Governmental AuthorityHealthcare Laws. (bl) All clinical To the extent the Company is a “Covered Entity” or preclinical studies“Business Associate” as such terms are defined under HIPAA, tests and collected, stored or trials otherwise processed “Personal Health Information” as that have been or are being conducted by term is defined under HIPAA, the Company has taken appropriate measures to protect the privacy and security of, and to maintain in confidence, the Personal Health Information collected by, or on behalf of, or sponsored by, Parent and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted Company in compliance in all material respects with all HIPAA and other applicable Healthcare Laws. No investigational new drug application filed with or submitted to the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of 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 the FDA or any other Governmental Authority to invoke any similar policy. Neither Parent nor any of its Subsidiaries, nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiaries.

Healthcare Regulatory Matters. (a) Each of Parent and its Subsidiaries The Acquired Companies, and, to the Knowledge of Parentthe Company, their respective directors, officers, employees and agents are, and at all times within the last three (3) years have been, in compliance with all applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to the ParentAcquired Companies, taken as a whole. In the past three (3) years, neither Parent nor any of its Subsidiaries the Company has not received any written notification, correspondence or any other communication from the FDA or any other Governmental Authority Body asserting non-compliance by, or liability of, Parent or any of its Subsidiaries the Acquired Companies under any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to Parent and its Subsidiariesthe Acquired Companies, taken as a whole. Neither Parent nor any of its Subsidiaries The Company is not a party to nor or has any ongoing reporting obligations pursuant to or under any Order order by a Governmental Authority Body or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental AuthorityBody. (b) All clinical or preclinical studies, tests or trials that have been or are being conducted by or on behalf of, or sponsored by, Parent and its Subsidiariesany of the Acquired Companies, or in which Parent’s or its Subsidiariesany of the Acquired Companies’ products or product candidates have participated, and which have been or will be submitted to the FDA or other Governmental Authority Body in connection with applications for authorizations from any Governmental AuthorityAuthorizations, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed with All material reports, documents, claims and notices required to be filed, maintained or submitted to the FDA or comparable application submitted furnished to any other Governmental Authority Body by or on behalf of Parent or any of its Subsidiaries has the Acquired Companies have been terminated so filed, maintained or suspendedfurnished, and neither all such reports, documents, claims and notices, if any, were true, complete and correct on the FDA nor any applicable Governmental Authority date filed (or institutional review board has commenced, were corrected in or to the Knowledge of Parent, threatened to initiate, any action to place supplemented by a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiariessubsequent filing). (c) To None of the Acquired Companies nor, to the Knowledge of Parent, neither Parent nor any of its Subsidiaries, northe Company, any director, officer, employee or agent of any of Parent or any of its Subsidiariesthe Acquired Companies, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental AuthorityBody, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental AuthorityBody, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of its Subsidiaries the Acquired Companies 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 the FDA or any other Governmental Authority Body to invoke any similar policy. Neither Parent nor any None of its Subsidiaries, the Acquired Companies nor, to the Knowledge of Parentthe Company, any director, officer, employee or agent of any of Parent or any of its Subsidiariesthe Acquired Companies, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding Legal Proceeding that would reasonably be expected to result in such a debarment is pending or, to the Knowledge of Parentthe Company, threatened against any of Parent or any of its Subsidiaries the Acquired Companies or to the Knowledge of Parentthe Company, any director, officer, employee or agent of any of Parent or any the Acquired Companies. None of its Subsidiaries. Neither Parent nor any of its Subsidiaries the Acquired Companies nor, to the Knowledge of Parentthe Company, any director, officer, employee or agent of any of Parent or any of its Subsidiariesthe Acquired Companies, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parentthe Company, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiariesthe Acquired Companies, taken as a whole. No legal proceeding Legal Proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parentthe Company, threatened against any of Parent or any of its Subsidiaries the Acquired Companies or to the Knowledge of Parentthe Company, any director, officer, employee or agent of Parent or any of its Subsidiariesthe Acquired Companies.

Healthcare Regulatory Matters. The Company (collectively with its Subsidiaries) (a) Each has operated and currently operates its business in compliance in all material respects with applicable provisions of Parent the Health Care Laws of the Food and its Subsidiaries andDrug 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 Knowledge ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of Parentany of the Company’s or its Subsidiaries’ product candidates or any product manufactured or distributed by the Company, their respective directors(b) has not received any FDA Form 483, officerswritten notice of adverse finding, employees and agents arewarning letter, and at all times within the last three (3) years have been, in 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 applicable Healthcare LawsRegulatory Authorizations required to conduct its business as currently conducted, except where such non-compliance the failure to possess the same would not, individually or in the aggregate, reasonably be expected to be 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 to respect, of any term of any such Regulatory Authorizations, (d) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Parent, taken as a whole. In the past three (3) years, neither Parent nor any of its Subsidiaries has received any written notification, correspondence Applicable Regulatory Authorities or any other communication from third party alleging that any product of the FDA 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 Governmental Authority asserting non-compliance bythird party is considering any such claim, litigation, arbitration, action, suit, investigation or liability ofproceeding, Parent or (e) has not received written notice that any of its Subsidiaries under the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any applicable Healthcare Laws, except where such non-compliance would not, individually or in the aggregate, reasonably be expected to be material to Parent Regulatory Authorizations and its Subsidiaries, taken as a whole. Neither Parent nor has no knowledge that any of its Subsidiaries 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 nor has and does not have any ongoing reporting obligations pursuant to or under any Order by a Governmental Authority or corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority. Applicable Regulatory Authority and (bh) All clinical or preclinical studiesalong with its employees, tests or trials that have been or are being conducted by or on behalf of, or sponsored by, Parent officers and its Subsidiaries, or in which Parent’s or its Subsidiaries’ products or product candidates have participated, and which have been submitted to the FDA or other Governmental Authority in connection with applications for authorizations from any Governmental Authority, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application filed with or submitted to the FDA or comparable application submitted to any other Governmental Authority by or on behalf of Parent or any of its Subsidiaries has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority or institutional review board has commenced, or to the Knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Parent or any of its Subsidiaries. (c) To the Knowledge of Parent, neither Parent nor any of its Subsidiaries, nor, any director, officer, employee or agent of any of Parent or any of its Subsidiariesdirectors, has (i) made an untrue statement of a material fact not been excluded, suspended or a fraudulent statement to the FDA debarred from participation in any government health care program or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of 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 the FDA or any other Governmental Authority to invoke any similar policy. Neither Parent nor any of its Subsidiaries, norhuman clinical research and, to the Knowledge of ParentCompany’s Knowledge, any directoris not subject to a governmental inquiry, officerinvestigation, employee proceeding or agent of any of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any other similar applicable Law or authorized by 21 U.S.C. Section 335a(b) or any similar applicable Law. No legal proceeding action that would reasonably be expected to result in such a debarment is pending ordebarment, to the Knowledge of Parent, threatened against any of Parent suspension or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries. Neither Parent nor any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent of any of Parent or any of its Subsidiaries, has been debarred, suspended or excluded from participation in any federal health care program or convicted of any crime or, to the Knowledge of Parent, engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program, except as would not reasonably be expected to be material to Parent or any of its Subsidiaries, taken as a whole. No legal proceeding that would reasonably be expected to result in such an exclusion is pending or, to the Knowledge of Parent, threatened against any of Parent or any of its Subsidiaries or to the Knowledge of Parent, any director, officer, employee or agent of Parent or any of its Subsidiariesexclusion.